Tailored Self-Management of TMD Pain Using Health Information Technology
Phase: NA
Conditions: Temporomandibular Joint Dysfunction Syndrome
Sponsor: HealthPartners Institute

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
Tailored Self-Management of TMD Pain using 
Health Information Technology 
 
NIDCR Protocol Number: 16-054-E  
NIDCR Grant Number:  U01 DE025609 
Principal Investigator:  James Fricton, DDS, MS 
NIDCR Program Official:  David Clark, DrPH 
NIDCR Medical Monitor: Kevin McBryde, MD 
Draft or Version Number:  0.71 
March 20, 2017 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
i 
 
 
STATEMENT OF COMPLIANCE 
The study will be conducted in accordance with the International Conference on Harmonisation 
guidelines for Good Clinical Practice (ICH E6), the Code of Federal Regulations on the 
Protection of Human Subjects (45 CFR Part 46), and the NIDCR Clinical Terms of Award. All 
personnel involved in the conduct of this study have completed human subjects’ protection 
training. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
ii 
 
SIGNATURE PAGE  
The signature below constitutes the approval of this protocol and the attachments, and provides 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable US federal regulations and ICH guidelines. 
Principal Investigator or Clinical Site Investigator: 
 
 
Signed: 
 
Date: 
1/30/2015 
 
Name: James R. Fricton 
 
Title: 
Senior Investigator, Health Partners Institute (HPI) 
 
 
 
 
 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
iii 
 
TABLE OF CONTENTS 
PAGE 
STATEMENT OF COMPLIANCE ........................................................................................ I 
SIGNATURE PAGE ........................................................................................................... II 
TABLE OF CONTENTS .................................................................................................... III 
PROTOCOL SUMMARY .................................................................................................. VI 
1 
KEY ROLES AND CONTACT INFORMATION ......................................................... 1 
2 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC 
RATIONALE ............................................................................................................. 3 
2.1 
Background Information ........................................................................... 3 
2.2 
Rationale .................................................................................................. 4 
2.3 
Potential Risks and Benefits ..................................................................... 5 
2.3.1 
Potential Risks ............................................................................................ 5 
2.3.2 
Potential Benefits ........................................................................................ 5 
3 
OBJECTIVES AND OUTCOME MEASURES........................................................... 6 
3.1 
Study Objectives ...................................................................................... 6 
3.1.1 
Objective 1 .................................................................................................. 6 
3.1.2 
Objective 2 .................................................................................................. 6 
3.1.3 
Objective 3 .................................................................................................. 6 
3.2 
Study Outcome Measures ........................................................................ 7 
3.2.1 
Objective 1 Outcome Measures .................................................................. 7 
3.2.2 
Objective 2 Outcome Measures ................................................................ 11 
3.2.3 
Objective 3 Outcome Measures ................................................................ 11 
4 
STUDY DESIGN .................................................................................................... 14 
5 
STUDY ENROLLMENT AND WITHDRAWAL ........................................................ 15 
5.1 
Subject Inclusion Criteria ........................................................................ 15 
5.2 
Subject Exclusion Criteria ....................................................................... 15 
5.3 
Strategies for Recruitment and Retention ............................................... 16 
5.4 
Treatment Assignment Procedures ........................................................ 17 
5.4.1 
Randomization Procedures ....................................................................... 17 
5.4.2 
Masking Procedures .................................................................................. 17 
5.5 
Subject Withdrawal ................................................................................. 18 
5.5.1 
Reasons for Withdrawal ............................................................................ 18 
5.5.2 
Handling of Subject Withdrawals or Subject Discontinuation of Study 
Intervention ............................................................................................... 18 
5.6 
Premature Termination or Suspension of Study ........................................ 18 
5.7       Study Behavioral or Social Intervention(s) Description  
5.7.1    PACT Program 
5.7.2    Control Group  
5.8       Administration of Intervention  
5.9      Procedures for Training Interventionists and Monitoring Intervention Fidelity  
5.10    Assessment of Subject Compliance with Study Intervention  

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
iv 
 
5.11  Concomitant Medications/Treatments  
6 
STUDY SCHEDULE ............................................................................................... 22 
6.1 
Screening (Week -1 Pre-Intervention) .................................................... 22 
6.2 
Enrollment/Baseline Visit (Website Visit 1, Week 0) ............................... 22 
6.3 
Intermediate Visits (8 weekly website visits during weeks 1 to 8) ........... 22 
6.4 
Final Study Visits (Final Visits, Weeks 8 and 16) .................................... 23 
6.5 
Withdrawal Visit ...................................................................................... 24 
6.6 
Unscheduled Visit ................................................................................... 24 
7 
STUDY PROCEDURES/EVALUATIONS ............................................................... 25 
7.1 
Outcome Measure Questionnaires ............................................................ 25 
7.2 
Hypothesis Mediators ................................................................................ 26 
7.3 Evaluation and Qualitative Interview………………………………………………26 
8 
ASSESSMENT OF SAFETY .................................................................................. 27 
8.1 
Specification of Safety Parameters ......................................................... 27 
8.1.1 
Unanticipated Problems ............................................................................ 27 
8.1.2 
Adverse Events ......................................................................................... 27 
8.1.3 
Serious Adverse Events ............................................................................ 27 
8.2 
Events Qualifying as an Adverse Event or Serious Adverse Event for 
the Purpose of this Protocol.................................................................... 28 
8.3 
Characteristics of an Adverse Event ....................................................... 28 
8.3.1 
Relationship to Study Intervention ............................................................. 28 
8.3.2 
Expectedness of SAEs ............................. Error! Bookmark not defined.29 
8.3.3 
Severity of Event ...................................... Error! Bookmark not defined.29 
8.4 
Time Period and Frequency for Event Assessment and Follow-Up ........ 29 
8.5 
Reporting Procedures............................................................................. 29 
8.5.1 
Adverse Events ......................................................................................... 29 
8.5.2 
Unanticipated Problem Reporting to IRB and NIDCR ................................ 29 
8.5.3 
Serious Adverse Event Reporting to NIDCR.............................................. 30 
8.5.4 
Reporting of SAEs and AEs to FDA .......................................................... 31 
8.5.5 
Reporting of Pregnancy ............................................................................. 31 
8.6 
Halting Rules .......................................................................................... 31 
9.       STUDY OVERSIGHT ............................................................................................. 33 
10. 
CLINICAL SITE MONITORING .............................................................................. 34 
11. 
STATISTICAL CONSIDERATIONS ........................................................................ 35 
12.1     Study Hypotheses ..................................................................................... 35 
12.2 
Sample Size Considerations................................................................... 35 
12.3 
Interim Safety Review............................................................................. 35 
12.4 
Final Analysis Plan ................................................................................. 35 
12. 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ........ 37 
13.  
QUALITY CONTROL AND QUALITY ASSURANCE .............................................. 38 
14. 
ETHICS/PROTECTION OF HUMAN SUBJECTS .................................................. 39 
15.1 
Ethical Standard ..................................................................................... 39 
15.2 
Institutional Review Board ...................................................................... 39 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
v 
 
15.3 
Informed Consent Process ..................................................................... 39 
15.4 
Exclusion of Women, Minorities, and Children (Special Populations) ..... 39 
15.5 
Subject Confidentiality ............................................................................ 39 
15.6 
Future Use of Stored Specimens and Other Identifiable Data................. 40 
15 
DATA HANDLING AND RECORD KEEPING ......................................................... 41 
16.1 
Data Management Responsibilities ........................................................ 41 
16.2 
Data Capture Methods ........................................................................... 41 
16.3 
Types of Data ......................................................................................... 41 
16.4 
Schedule and Content of Reports ........................................................... 41 
16.5 
Study Records Retention ........................................................................ 41 
16.6 
Protocol Deviations ................................................................................ 41 
16 
PUBLICATION/DATA SHARING POLICY .............................................................. 43 
17 
REFERENCES……………………………………………………………………...........44 
APPENDICES ........................................................................................................... 50-128 
APPENDIX A – J  ..................................................................................................... 
 
A: Scheule of Events 
 
 
B: PACT Content and Text for Introductory Video 
 
 
C: Traditional Self-Care Protocol 
 
 
D: Health Coach Phone Protocol for PACT Arm 
 
 
E: Telephone Screen 
 
 
F: Sample Consent Form 
 
 
G: Data Collection Forms at Baseline and Follow up 
 
 
H: Qualitative Interview 
 
 
I: Barriers to use of Consumer Health Information Technology (CHIT) 
 
 
J: Data Management and Safety Plan 
 
 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
vi 
 
PROTOCOL SUMMARY 
Title: 
 
Short Title 
Tailored Self-Management of TMD Pain using Health 
Information Technology 
TMD Self-Care Study 
Précis: 
This protocol describes activities to determine the feasibility 
and acceptability of proposed methods for a subsequent 
clinical trial of a tailored self-management program (PACT) 
designed to decrease pain in participants with 
temporomandibular disorders (TMD). The PACT program is a 
personalized program of exercise and behavioral changes 
implemented through a web-based program supported by a 
health coach. For this feasibility and acceptability study, 80 
adults with TMD pain will be randomized either to the PACT 
program or to traditional self-care.  This sample size was 
determined as the number needed to evaluate feasibility and 
acceptability of the primary intervention and determine the 
utility of the outcomes measures that will be collected at 
baseline, 8-week and 16-week follow-ups. 
Objectives: 
 
Objective 1: To evaluate the feasibility and acceptability of 
methods to conduct a full-scale multi-site randomized clinical 
trial comparing PACT self-management with traditional self-
care for TMD. Methods to be tested are: 
a. Participant recruitment, consent, enrollment, and 
retention; 
b. Participant adherence to the study; 
c. Completion of study questionnaires at 8-week and 16-
week follow-up; 
d. Participant perceptions of the online website 
functionality and acceptability; 
e. Participant perception of health coaches in the PACT 
program. 
 
Objective 2: To demonstrate ability to accurately capture 
outcome measures to be used in the multi-site study. 
 
Objective 3: To demonstrate ability to accurately capture 
potential mediators/moderators of specific behavioral and 
psychosocial factors on the PACT program’s observed effects 
on pain and functioning outcomes through self-report. 
Hypothesized mediators are self-efficacy, participant activation 
exercise frequency and sleep quality. Hypothesized 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
vii 
 
moderators are disability status, catastrophizing, depression, 
repetitive strain from oral habits, perceived stress, and social 
support. 
Population: 
The study will recruit 80 adults with TMD pain more than once 
a week from the HealthPartners Dental Group and selected 
dental clinics within the HealthPartners research network will 
be randomized. Ten participants will provide feedback on the 
online program during the development phase. 
Phase: 
Pilot 
Number of Sites: 
1 – HealthPartners Institute (HPI) 
Description of  
Intervention: 
Personalized Activated Care and Training (PACT) is a 
personalized 8-week progressive program with a health coach 
to enhance understanding, compliance, and success in self-
management of TMD pain. 
Study Duration: 
12-18 months 
Subject 
Participation 
Duration: 
4 months 
Estimated Time to 
Complete 
Enrollment: 
8 months 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
viii 
 
SCHEMATIC OF STUDY DESIGN: 
 
 
Fig. 1. Study design for pilot study 
Recruitment (n=80) 
Identification through EHR data or 
self-referral through clinic information 
Follow-up surveys 
at 2 & 4 months 
PACT Group (n=40)            (on-
line training with coach) 
Usual Self-Care Group (n=40) 
(e.g. rest, heat/cold, analgesics) 
Follow-up surveys 
at 2 & 4 months 
8 weeks of PACT self-
management on website 
8 weeks of usual self-care 
program on website  
Randomization 
Phase 1: 
Development  
0-6 months 
 
Phase 2a: 
Recruitment 
6-12 months 
Phase 2b: 
Intervention 6-
12 months 
Phase 3: 
Follow-up    8-
18 months 
Phase 4: 
Analysis      
18-24 months 
 
Qualitative data collection: Program evaluation 
and structured interviews 
Development 
Development of PACT intervention and 
test online program with 10 participants 
with TMD pain. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
1 
 
1 KEY ROLES AND CONTACT INFORMATION 
Principal Investigator:   
James Fricton, DDS, MS Sr. Research Investigator 
HealthPartners Institute  
8170 33rd Ave. S, MS 23301A Bloomington, MN 
55425 
952-967-5025 
952-967-5022 
Frict001@umn.edu 
James.R.Fricton@HealthPartners.com 
Medical Monitor: 
Kevin McBryde, MD 
Medical Officer 
Division of Extramural Research 
NIDCR/NIH 
6701 Democracy Blvd Rm.638 
Bethesda, MD 20892-4878 
Kevin.McBryde@nih.gov 
NIDCR Program Official:   
David Clark, DrPH 
Program Official 
NIDCR/NIH  
6701 Democracy Blvd Rm. 650 
Bethesda, MD 20892-878 
David.Clark2@nih.gov 
Clinical Site Investigators: 
Brad Rindal, DDS 
Associate Dental Director, Research 
HealthPartners Institute 
8170 33rd Ave. S, MS 23301A 
Bloomington, MN 55425 
952-967-5026 
Donald.B.Rindal@HealthPartners.com 
Institutions: 
HealthPartners Institute 
8170 33rd Ave. S, MS 23301A 
Bloomington, MN 55425 
Other Key Personnel: 
Co-Investigator: Robin R. Whitebird, PhD, MSW, LISW  
School of Social Work | University of St Thomas 
2115 Summit Ave | St. Paul, MN 55105  
Office: SCB #106 |Phone: 651-962-5867 
rrwhitebird@stthomas.edu 
 
Senior Statistician: Gabriela Vazquez-Benitez, PhD 
8170 33rd Ave. S, MS 23301A 
Bloomington, MN 55425 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
2 
 
952-967-6672 
Gabriela.X.VazquezBenitez@HealthPartners.com  

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
3 
 
2 INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE  
2.1 
Background Information 
Health problem. Temporomandibular disorders (TMD) are the second most common 
musculoskeletal pain condition, affecting about 10% of the general population.1,6-8 In 2011, 
the Institute of Medicine (IOM) made research on pain conditions such as 
temporomandibular disorders (TMD), among the highest priorities because of its high 
prevalence, functional limitations, missed work, opioid dependency, and high health care 
cost.1-12 More than 100 million U.S. adults are affected by chronic pain conditions, costing 
between $560 and $635 billion annually in medical care and lost productivity.1-6 TMDs are 
the second most common musculoskeletal pain condition, affecting about 10% of the 
general population.1,9-11 
 
Interventions. Self-management programs provide a convenient mechanism for health care 
professionals to improve the management of pain conditions at an earlier point in their 
development, when it is easier to prevent chronic pain. The study will employ a self-
management program, entitled Personalized Activated Care and Training (PACT) that is a 
tailored 8-week progressive web-based training program supported by a health coach to 
enhance understanding, compliance, and success in improving TMD pain. The program 
provides 8 weeks of structured didactic and experiential training on exercises and cognitive- 
behavioral training to reduce risk factors that contribute to delayed recovery and enhance 
protective factors that have evidence of improving TMD pain. 
 
Relevant research and scientific justification. Chronic pain in the jaw, head, and face are 
caused by conditions such as joint disk disorders, myofascial pain, and osteoarthritis. These 
conditions may begin with an injury or strain, but often persist due to the presence of risk 
factors such as repetitive strain, depression, poor sleep, stress, maladaptive postures, 
depression, catastrophizing, and others factors that can delay recovery, increase peripheral 
and central sensitization, and, ultimately cause the persistence of chronic pain.5-11 When an 
acute TMD pain becomes chronic it often results in severe jaw pain, headaches, missed work, 
disability, opioid dependency and higher cost of care.9-15 Half of the persons seeking care for 
TMD still have pain 5 years later, and 15% to 20% of them have long-term disability.15-19 The 
care for these patients often escalates to high-cost and higher- risk passive interventions such 
as opioid analgesics, polypharmacy, high-tech imaging, and surgery.8-12 Yet, clinical trials and 
systematic reviews have not found the outcomes of passive therapies to be any better than 
self-management strategies that activate the patient through exercise and cognitive and 
behavioral changes.32-43  The Institute of Medicine states the clinicians’ primary role in caring 
for chronic pain requires guiding, coaching, and assisting patients with day-to-day self-
management in addition to evidence-based medical treatments.1 However, most health 
professionals lack the time and training to perform this role, and find little support and 
reimbursement for doing so. As the Institute of Medicine simply stated, we need a revolution in 
health care to replace our current passive model of doctor-centered care with patient-centered 
care that integrates robust self-management with evidence-based treatments.1 Clinical trials 
have found that patients who are engaged in self-management have significantly more 
successful outcomes than passive biomedical treatments alone.12-14 Thus, the use of on-line 
self-management programs provides a convenient and cost-effective mechanism for health 
professionals to improve the management of pain conditions at an earlier point in their 
development, when it is easier to prevent chronic pain. 20-31 While training patient in self-
management is a laudable goal, the implementation as part of routine care is a challenge that 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
4 
 
most health professionals do not embrace due to time and training, and reimbursement. The 
use of Consumer Health Information Technology (CHIT) to empower and engage consumers 
to better manage their health is becoming an acceptable alternative to in-person training 
session for self-management.63-66 The use of CHIT has distinct advantages of being flexible, 
personalized, scalable, clinically effective, and cost-effective, and can help transform the 
health care system by allow most health professional to use with patients. The Center for 
Information Technology Leadership (2008), a nonprofit research center, concluded that CHIT 
could save $19 billion annually by focusing on prevention, early intervention, self-
management, and evidence-based care using CHIT.21 Partner’s Center for Connected Health 
also concluded that health care will not be reformed without consumer engagement.22    
However, these goals will not become reality unless research such as this study demonstrates 
efficacy. This project uses CHIT to engage patients, enhance understanding, adherence, and 
document outcomes. 
2.2 
Rationale 
While several distinct pathophysiological mechanisms may occur in TMD pain conditions, it is 
important to understand and address the complex interaction of diverse factors that can 
initiate, perpetuate, delay recovery, or even protect patients from increasing severity of pain 
due to changes to peripheral and central sensitization.44-60 Maixner, et al (2011) have identified 
biopsychosocial and genetic risk factors that contribute to the onset and persistence of painful 
TMD in the OPPERA Study.46-47 Their conceptual model describes the changes that can occur 
in human biology, behaviors, and relationships when a person develops a chronic pain 
condition. This model suggests the need to address the “whole” patient by addressing multiple 
inter-related risk factors that play a role in the progression of the pain and can be influenced to 
prevent progression.48-49 Addressing these factors can lead to tailored treatment strategies 
with more predictable outcomes in reducing pain, peripheral, and central pain sensitization by 
influencing the underlying causes. Risk factors such as behavioral factors (e.g., repetitive 
strain, muscle tension, postural habits), emotional risk factors (e.g., anxiety, depression), 
comorbid conditions (e.g., fibromyalgia), and cognitive factors (e.g., poor understanding of 
etiology, unrealistic expectations, somatization, coping strategies, catastrophizing) have been 
found to be important in the progression to chronic persistent pain.50-60 For example, our 
studies found depression, somatization, fibromyalgia, and premorbid perceived stress to be 
significant risk factors that increase central sensitization and play a key role in predicting poor 
outcomes in TMD pain patients.58-60 By reducing these factors, they will encourage healing 
and lessen pain. On the other hand, protective factors can reduce delayed recovery and also 
improve normal healing, and prevent chronic pain. Factors such as level of coping, self-
efficacy, patient beliefs (e.g., perceived control over pain), and social support can lead to more 
positive outcomes.51-57 Each of these factors are integrated into the PACT program. 
 
The PACT program provides structured education, exercises, and cognitive-behavioral 
training that have evidence of improving TMD pain by changing these risk factors and 
enhancing protective factors.26-42 The program is based on clinical guidelines, clinical 
experience, clinical trial research, research on risk factors, protective factors, and systematic 
reviews of self-management efficacy of pain. The educational content is based on an existing 
on-line training course on preventing chronic pain and has been adapted for the PACT 
program.67  
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
5 
 
2.3 
Potential Risks and Benefits 
2.3.1 
Potential Risks 
 
Potential risks include: 
 
1) Although the program includes simple exercises and behavioral changes, 
participant conditions may not improve or may have their pain aggravated. 
This is minimized by providing personalized experiential instruction on the 
exercises and behavioral changes and cautioning participants to seek 
additional care if their condition does not improve or worsens. Participants will 
be screened by TMD diagnostic criteria to ensure their condition is appropriate 
for the study. 
 
2) There is some risk associated with the release of personal health information 
(PHI) from health records. The investigators will protect subjects’ records so their 
name, address, phone number, and clinical information is kept private and will 
not be released without participants’ specific written permission. All data will be 
stored in a de-identified format without reference to participant identity.  
2.3.2 
Potential Benefits 
 
Potential benefits include: 
 
1) While this study is not designed to test the efficacy of the PACT program, 
participants may derive benefit from participation in the study with a reduction of 
pain, improvement in daily activities, and engagement in self-management 
strategies. In addition, the improved knowledge from use of PACT will enhance 
the participants’ own understanding of their condition and how to self-manage it. 
The information and knowledge gained from the study may be valuable in 
improving care and management of TMD pain and implementation of evidence-
based care with providers. 
 
2) The importance of knowledge gained. This research may provide information for 
the development of new, more effective strategies to predict, prevent, and 
manage TMD pain in participants of all racial and ethnic groups, as well as 
improve understanding and development of efficacious, cost-effective treatments 
that contribute to better outcomes for participants. 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
6 
 
3 OBJECTIVES AND OUTCOME MEASURES 
3.1 
Study Objectives 
3.1.1 
Objective 1 
Objective 1 is to evaluate the feasibility and acceptability of methods to conduct a full-scale 
multi-site randomized clinical trial comparing PACT self-management with traditional self-care 
for TMD.  
 
Participants will find the PACT program acceptable as an intervention to help improve 
TMD pain and the study will successfully recruit participants to test the intervention. 
 
The study will  reach recruitment, randomization, and retention goals 
 
The study will satisfactory collect study data (screening, baseline, follow up, qualitative) 
for evaluation purposes 
Methods to be tested are: 
a. Participant recruitment, consent, enrollment, and retention; 
b. Participant adherence to the study; 
c. Completion of study questionnaires at 8-week and 16-week follow-up; 
d. Participant perceptions of the online website functionality and acceptability; 
e. Participant perception of health coaches in the PACT program. 
3.1.2 
Objective 2 
Objective 2 is to demonstrate ability to accurately capture outcome measures to be used in the 
multi-site study. 
 
The PACT study will accurately define and capture accurate primary and secondary 
outcomes measures (jaw functioning, pain severity and pain interference) to be used in a 
larger multisite study  
3.1.3 
Objective 3 
Objective 3 is to demonstrate ability to accurately capture potential mediators/moderators of 
specific behavioral and psychosocial factors on the PACT program’s observed effects on pain 
and functioning outcomes through self-report. Hypothesized mediators are self-efficacy, 
participant activation exercise frequency and sleep quality. Hypothesized moderators are 
disability status, catastrophizing, depression, repetitive strain from oral habits, perceived stress, 
and social support. 
 
The PACT study will accurately define and capture hypothesized mediators including 
self-efficacy, participant activation exercise frequency and sleep quality  
 
The PACT study will accurately define and capture hypothesized moderators including 
disability status, catastrophizing, depression, repetitive strain from oral habits, perceived 
stress, and social support.  
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
7 
 
3.2 
Study Outcome Measures 
3.2.1 
Objective 1 Outcome Measures 
Four study methods will be tested, each with specific measures to evaluate feasibility and 
acceptability. The methods to be tested and their associated measures are as follows: 
 
a. Participant recruitment, consent, enrollment, and retention: Feasibility of participant 
recruitment will be measured by demonstrating the ability to meet the enrollment target 
for the study (N=80). Milestones toward meeting target enrollment are: the ability to 
identify an adequate number of individuals that meet eligibility criteria, and number (%) 
of individuals consenting to participate compared with the total number contacted.   
 
Objective 
Constructs 
Target outcomes  
Recruitment 
(identify) 
1. Identification of TMD patients 
using HPDG electronic 
records (EHRs) 
2. Percentage of participants 
recruited by both electronic 
health records (EHR) and 
self-referral 
1. Generate a list of new TMD 
patients for possible 
enrollment in the study 
during the 6 months of 
recruitment 
2. Participants will be recruited 
from both the search of the 
EHR and self-referral using 
brochures in the clinics 
Recruitment 
(enroll and 
consent) 
1. Percentage of contacting 
participants who meet 
eligibility criteria 
2. Percentage of contacted 
participants who consent to 
enroll in study 
 
1. 80% of participants who talk 
with staff meet eligibility 
criteria for study  
2. 30% of eligible participants 
contacted enroll in the study  
Recruitment 
(retention) 
1. Percentage of participants 
who start program after 
randomization 
 
1. 95% participants recruited 
for each arm start program 
after randomization 
 
 
b. Participant adherence will be measured by accessing the website at each of the follow-
up periods. Participant adherence to the study will also be measured by number of 
participants completing all 8 on-line modules (with a goal of 80%).  
 
 
 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
8 
 
Objective 
Constructs 
Target outcomes  
Intervention 
(adherence/ 
compliance) 
1. Number of participants 
accessing all online lessons  
2. Use of health coaches (PACT 
arm) 
3. Pain and risk assessment 
instruments within the PACT 
program (PACT arm) 
4. Time spent in online 
program per week (PACT 
arm) 
 
 
1. 80% of enrolled 
participants access all 
lessons as measured by 
Web site hits  
2. 90% of participants in 
PACT have at least 3 
phone meetings with the 
health coach (PACT arm) 
3. Completion of all pain and 
risk assessment 
instruments within the 
PACT program (PACT arm 
4. Time spent in each 
module of online program 
per week (PACT arm) 
 
c. Completion of questionnaires at 8-week and 16-week follow-ups, and program 
evaluation. Completion of questionnaires will be measured by the percent of 
participants who complete the 8-week and 16-week follow-up questionnaires and, the 
program evaluation. We expect that at least 80% of participants will complete all 
questionnaires. 
 
Objective 
Constructs 
Target outcomes  
Evaluation 
(adherence/ 
compliance) 
1. Number of participants completing 8-
week and 16-week follow-up 
questionnaires
2. Number of participants completing the 
program evaluation survey questions 
(PACT arm) 
1. 80% complete both 8- and 
16-week follow-up 
questionnaires 
2. 80% of participants in 
PACT group complete the 
program evaluation form 
Evaluation 
(instrument 
performance) 
1. Responsiveness to constructs in 
subscales of the survey.  
2. Inter-correlations between scales  
3. Participant burden is measured by time 
to complete.  
1. Outcome variables 
show changes in the 
expected direction 
2. Outcome variables are 
associated with 
mediator/moderator 
factors in the expected 
direction 
3. 90% of participants 
complete all surveys in 
estimated time
 
d. Participant perceptions of the online website functionality and acceptability will be 
measured by participant reports of problems and ease of use reported at the program 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
9 
 
evaluation.  These reports will come from the number of phone calls/questions received 
about web-site issues, and from the qualitative interview.   
 
e. Participant perception of health coaches in the PACT program will be evaluated by 
qualitative interviews of both health coaches and participants 
Objective 
Constructs 
Target outcomes for both arms 
Web-Site 
functionality 
1. Heuristic evaluation of functionality of 
the Web-based platform 
2. Mode of administration acceptance 
1. Less than 10% of 
participants note problems 
with website via comments 
section in each module or 
during program evaluation 
2. 90% of participants rate 
web-site accessibility for 
learning the concepts as 
very good to excellent 
Intervention 
(acceptability) 
1. Identification of self-reported barriers 
for improvement 
2. Pace in which participants complete 
the program  
1. 80% of participants identify 
at least one self-report 
barrier for improvement 
2. 60% of participants follow 
the timeline on the Web site 
to complete in 8 weeks 
Participant 
perceptions of 
program 
1. Qualitative interviews of participants 
1. At least ten 
randomly selected 
participants will 
agree to be 
interviewed to 
provide their 
perceptions about 
the content of the 
program and at least 
90% report that it is 
acceptable. 
Objective 
Constructs 
Target outcomes for both arms 
Participant 
perceptions of 
health coach 
1. Qualitative interviews of participants 
about health coaches 
1. At least ten randomly 
selected participants will 
agree to be interviewed to 
provide their perceptions 
about the content of the 
program. Of at least 10 
participants interviewed, 
90% will report that they 
found the health coaches to 
be helpful. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
10 
 
 
 
 
Health coach 
perception of 
program 
1. Qualitative interviews of participants 
1. Health coaches will 
provide their perceptions 
on the program and 
areas for development 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
11 
 
3.2.2 
Objective 2 Outcome Measures 
Outcome measures to be used are listed in the table below. Of the 80 patients participating in 
the study, we believe that 90% will complete the outcome measures at baseline and all follow-
up periods and report the burden of completing these is acceptable.   
 
Outcome Domain 
 Measure 
Primary 
Pain severity 
Graded Chronic Pain Scale (GCPS) with mean intensity ratings for reported
current, worst, and average pain.68-69  
Jaw Functioning 
Jaw Functional Limitation Scale (JFLS-8) identifies daily activities interfered 
with by jaw pain.40  
Secondary 
Pain interference 
Graded Chronic Pain Scale 
Pain timing 
Symptom Severity Index 
 
3.2.3 
Objective 3 Outcome Measures 
3.2.3.1 
Hypothesized mediators 
Of the 80 patients participating in the study, we believe that 90% will complete the mediator 
questionnaire at baseline and all follow-up periods and report the burden of completing these 
is acceptable. Specific measures of self-efficacy, participant activation, exercise frequency, 
and sleep quality will be made by questionnaires, as described in section 8.1.1. 
3.2.3.2 
Hypothesized moderators 
Of the 80 patients participating in the study, we believe that 90% will complete the moderator 
measures at baseline and all follow-up periods and report the burden of completing these is 
acceptable. Specific measures of disability status, catastrophizing, depression, oral habits, 
perceived stress, and social support will be made by questionnaires, as described in section 
8.1.1. 
 
Outcome Measures including Data Constructs, Scales, Sources and intervals. 
 
Construct 
Scale/ Variable 
Data Source
Target 
Baseline 
Intervent
ion 
Weeks  
from 
baseline 
Weeks  
from 
baseline 
Timing 
(weeks) 
 
At 
Enrollment 0-8 wks. 
8 wks. 
16 wks. 
Screening 
Eligibility 
DC-TMD 
Pain 
Screener and 
self-report 
criteria 
Phone 
Screen 
Potential 
participants 
screened 
X 
 
 
 
Demo- 
graphics 
Age, marital 
status, 
education, 
employment, 
Phone 
screen 
Potential 
participants 
screened 
X 
 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
12 
 
Outcome Measures including Data Constructs, Scales, Sources and intervals. 
 
Construct 
Scale/ Variable 
Data Source
Target 
Baseline 
Intervent
ion 
Weeks  
from 
baseline 
Weeks  
from 
baseline 
Timing 
(weeks) 
 
At 
Enrollment 0-8 wks. 
8 wks. 
16 wks. 
Other  
Descriptive 
Information 
Prior 
Medical 
Conditions 
Prior Medical 
Conditions 
On-line 
survey 
Participants 
X 
 
 
 
Objective 1 
Process 
Evaluation  
Recruitment 
Contact/consent Survey 
Center 
logs 
Participants 
X 
 
 
 
Compliance/ 
adherence 
Self-report of 
intervention 
practice 
On-line 
Survey 
Participants 
 
X 
 
 
Compliance/ 
adherence 
Program 
evaluation form 
On-line 
survey 
Participants 
 
 
X 
 
Acceptability 
Heuristic 
evaluation of 
ease of use and 
functionality 
Web hits 
Survey 
Participants 
 
 
X 
 
Participant 
experience 
Barriers 
and 
facilitators 
to 
adherence 
Qualitative 
interview 
Participants 
 
X 
X 
X 
Objective 2 
Primary 
Outcomes 
Pain Severity 
Graded Chronic 
Pain Scale-
severity (7 items;
of 10) 
On-line 
survey 
Participants 
X 
X 
X 
X 
Jaw 
Function 
Jaw Functional 
Limitation 
Scale (JFLS-8; 
items; short version) 
On-line 
survey 
Participants 
X 
X 
X 
X 
Objective 2 
Secondary 
Pain 
Outcomes  
Pain 
interference 
Graded Chronic 
Pain Scale- 
intensity (3 items 
of 10) 
On-line 
survey 
Participants 
X 
X 
X 
X 
Objective 3 
Mediators 
 
 
 
 
 
Self-efficacy 
Chronic Pain 
Self-efficacy 
Questionnaire  
(5 item Self-
efficacy for Pain 
management 
(PSE) scale)  
On-line 
survey 
Participants 
X 
X 
X 
X 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
13 
 
Outcome Measures including Data Constructs, Scales, Sources and intervals. 
 
Construct 
Scale/ Variable 
Data Source
Target 
Baseline 
Intervent
ion 
Weeks  
from 
baseline 
Weeks  
from 
baseline 
Timing 
(weeks) 
 
At 
Enrollment 0-8 wks. 
8 wks. 
16 wks. 
 
 
 
 
 
 
 
 
Participant 
Activation 
Patient 
Activation 
Measure 
(PAM; 7-items) 
On-line 
survey 
Participants 
X 
X 
X 
X 
 Exercise 
Global Physical 
Activity 
Questionnaire (2 
questions) 
 
On-line 
survey 
Participants 
X 
X 
X 
X 
Sleep quality 
 WHO World 
Health Survey  
(4 questions) 
On-line 
survey 
Participants 
X 
X 
X 
X 
Objective 3: 
Moderators 
Catastrophizing Pain 
Catastrophizing 
Scale 
(PCS; 14 items) 
On-line 
survey 
Participants 
X 
 
 
 
Depression 
Patient Health  
Questionnaire 
(PHQ8; 8 items) 
On-line 
survey 
Participants 
X 
 
 
 
Oral habits 
DC/TMD Oral  
Behavioral 
Checklist (15 
items) 
On-line 
survey 
Participants 
X 
 
 
 
Stress 
Perceived Stress
Scale  
(PSS; 10 items) 
On-line 
survey 
Participants 
X 
 
 
 
Social 
Support 
Social Support 
Questionnaire 
(SSQ; 6 items) 
On-line 
survey 
Participants 
X 
 
 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
14 
 
4 STUDY DESIGN 
The pilot study design is a 2-arm randomized clinical trial to test the methods that will be used 
in a future proposal for a full-scale multi-site clinical trial. 
 
Eighty participants with TMD will be recruited through 2 recruitment protocols (1-Inbound 
recruitment or self-referral and 2-outbound recruitment or ICD-9/ICD-10 code identification) 
and randomized in a 1:1 ratio to the PACT program or Traditional self-care. Participants will be 
aged 18 or older because significant adjustments would need to be made to the program to 
take into consideration the differing cognitive status and developmental age, and limited to 
English-speakers because one of the primary outcome instruments is only validated in English. 
 
The study should be completed in 12-18 months, with enrollment occurring for 8 months. 
 
Participants will be evaluated for eligibility over the telephone following verbal consent for 
screening, and information including demographics and eligibility criteria. Eligible participants 
will be consented over the telephone and will sign the consent electronically. Following consent 
participants will complete the baseline questionnaire and be randomized to PACT 
(intervention) or self-care (control). Weeks 1-8 (intermediate visits) will consist of weekly 
website visits. Participants in the self-care arm will be provided with traditional self-care 
material. Participants in the PACT arm will complete initial assessments for weekly lessons, 
and based on the assessment will be provided personalized lessons. Participants in the PACT 
arm will also receive weekly coaching sessions by phone. All participants will participate in 
usual care from their dentist and will be asked to limit concomitant medications to NSAIDs. 
Participants in both arms will complete follow-up measures at 8 and 16 weeks post-
intervention. Following the 8-week follow-up participants will be asked to complete a program 
evaluation, and at least 10 randomly-selected subjects will complete a qualitative interview. 
 
Data analysis will evaluate feasibility and acceptability of the primary intervention and 
determine the utility of the outcomes measures that will be collected at baseline, 8-week and 
16-week follow-ups. 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
15 
 
5 STUDY ENROLLMENT AND WITHDRAWAL  
5.1 
Subject Inclusion Criteria 
In order to be eligible to participate in this study, an individual must meet all of the following 
criteria: 
 
Age 18 or older  
 
Able and willing to access the internet on a regular basis 
 
Able and willing to participate in weekly phone coaching calls 
 
Able to read and speak English** 
 
Willing and able to comply with all study procedures  and be available for the duration 
of the study: 
 
Has a diagnosis of TMD pain using a self-report screener, specifically:  
1. Reporting pain in the jaw or temple area (on either side) in the last 30 days.  
2. Reporting pain or stiffness in the jaw on awakening in the last 30 days. 
3. Reporting changes in pain (either better or worse) in the jaw or temple area (on 
either side) in the last 30 days, after the following activities: chewing hard or tough 
food, opening the mouth or moving the jaw forward or to the side, jaw habits such 
as holding teeth together, clenching/grinding, or chewing gum, or other jaw 
activities such as talking, kissing, or yawning 
 
Has a frequency of TMD pain more than once a week with pain in the past 6 months 
 
Provides an electronically signed and dated informed consent form. 
 
5.2 
Subject Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation in 
this study: 
  Currently participating in any other TMD/TMJ related studies 
  Has major disc disorder requiring opioids or is scheduled to have surgery for TMD 
pain 
  Has any serious medical condition that might interfere with or prohibit participation in 
an online program 
 
Is pregnant  
 
Has been treated for a mental health disorder or substance abuse in the past six 
months  
 
** Note: This project is limited to subjects with the ability to read and speak English since one of the primary 
outcome instruments (Jaw Functional Limitation Scale) is only validated in English. 
  

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
16 
 
5.3 
Strategies for Recruitment and Retention 
Participants will be recruited using two recruitment protocols, which may run in the same 
clinics:  
A. 
Recruitment Protocol 1 relies on the participant proactively calling the Survey 
Research Center (SRC) following receiving information about the study from their 
dental clinic;  
B. 
Protocol 2 relies on the SRC initiating contact by sending a letter and making 
subsequent outbound telephone calls.  
 
All recruitment materials will be submitted to the Institutional Review Boards (IRBs) for review 
and approval prior to their use. 
 
Recruitment Protocol 1: Inbound recruitment – Self referral through clinic information 
 
Pre-implementation: 
A. 
Clinics will be identified for initial participant recruitment. Clinical directors/ and or 
managers will be contacted for participation in the study and process of recruitment.  
B. 
Clinicians at sites will be informed about the study and asked to refer patients with 
diagnosed TMD to the study, or direct patients to clinic brochures. 
 
Implementation: 
A. Brochures will be placed in clinic waiting rooms or other places staff deemed 
appropriate 
B. Dentist or hygienist will discuss the study or encourage patients to review the study 
brochure. 
C. Potential study participant interested in the study will contact the SRC at HPI.  The 
SRC will describe the study and proceed to the phone screening. 
 
Recruitment Protocol 2: ICD-9/ICD-10 code identification 
 
Pre-implementation: 
 
A. Clinics will be identified for initial participant direct recruitment. Clinic medical 
directors/ and or managers will be contacted to discuss the study and recruitment. 
B. Dental providers will be asked to review recruitment letter that will be sent to their 
patients identified using ICD-9/ICD-10 codes as having TMD, and to provide approval 
of use of their signature on the letter. 
 
Implementation: 
 
A. The study programmer will use the ICD-9/ICD-10 codes for TMD diagnosis (within 
specified timeframe) to identify all patients in HPDG from [DATE] thru [DATE] 
eligible for study recruitment. ICD10 codes are M26.6x, G44.209 and M79.x. We will 
cross check these codes with ICD-9 codes from the past including 524.6x and 729.x 
B. Once a potential participant is identified using ICD-9 / ICD-10 codes for TMD their 
contact information will be accessed. A weekly list will be generated from a search 
of the HealthPartners claims data. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
17 
 
C. Name, address, and primary dental provider will be used to generate recruitment 
letter with primary dental provider signature. 
D. The potential participants would then be sent an introductory letter signed by the 
provider and study PI and study brochure inviting participation. The letter will also 
contain a telephone number to call to decline to participate in, or be contacted about 
the study. 
E. Participants not declining participation within 1 week of initial recruitment letter will 
be contacted by the SRC regarding participation in the study. 
F. If after hearing a brief description of the study the potential participant is interested; 
the SRC will proceed with the phone screen.  
 
Compensation: 
 
Participants will be compensated for their participation in the study in an amount stated 
in the informed consent. 
 
5.4 
Assignment Procedures 
5.4.1 
Randomization Procedures 
Participants will be assigned to a study arm through a computer-generated randomization 
procedure completed within the programming of the TMD Pain Study website. The ratio 
between intervention and control arms will be 1:1. Randomization scheme will be prepared by 
the statistician using a permuted block design.  The maintenance of trial randomization 
scheme will occur within the database of the TMD Pain Study website and reviewed 
periodically by study coordinator to ensure that concealment has been maintained.  
 
Randomization process will be prepared by the statistician, a member of the Research 
Methodology Group at Health Partners Institute.  The maintenance of trial randomization 
scheme will occur within the database of the TMD Pain Study website. To ensure that the 
allocation cannot be predicted by researchers, the algorithm will be based on permuted blocks 
design of 4 and 2 with a 1:1 allocation ratio. Assignment will be accessed directly through the 
on-line PACT portal after a participant has completed the consent and baseline survey. The 
use of the online portal will assure allocation concealment, immediate notification of the 
assignment to the participants, and access to the assigned program. 
5.4.2 
Masking Procedures 
Since the control and intervention arms of the study are significantly different due to the 
more extensive training and health coaching in the PACT program, it may be apparent to 
patients which group they are in. As a result, it is probable that neither the intervention group 
nor the control group will be completely masked to the group they are in. However, both 
groups will complete all outcome measures through the web-based system. 
 
The following procedures will be used for blinding and protection from bias. Baseline data are 
collected prior to randomization. Participants and researchers are not blinded to allocation 
because of the nature of the study. Participants may share this information with their dental 
care team. Baseline and follow up data are collected through the online program and 
transferred to a database format with group assignment indicated,. All reports reviewed by the 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
18 
 
PI.   
5.5 
Subject Withdrawal 
Participants may withdraw voluntarily from the study at any time or the investigator may 
terminate participation for any of the following reasons: 
 
 
Participant reports that the TMD self-care practices result in: 
o sustained increased pain, 
o the jaw locks,  
o or if the participant appears to display serious emotional difficulties, 
dissatisfaction or confusion with care during the lessons.  
 
Participant refuses to participate in any of the PACT program activities after enrollment. 
 
Continued participation deemed to be not in the participant’s best interest. 
 
Investigator discretion.  
Participants withdrawn after randomization will not be replaced.  
5.5.1 
Reasons for Withdrawal 
Study staff will record reasons for withdrawal or discontinuation when possible. If the 
participant withdraws consent, no further evaluations will be performed, and no attempts will 
be made to collect additional data. 
5.5.2 
Handling of Subject Withdrawals or Subject Discontinuation of Study 
Intervention 
Study staff will contact each participant who is withdrawing or discontinuation to discuss and 
document the reasons for withdrawal or discontinuation. All information will be documented 
in a log of participant completion of study activities. 
 
Any participant discontinued due to TMD self-care practices resulting in sustained increased 
pain, the jaw locking, or displaying serious emotional difficulties, dissatisfaction or confusion 
with care during the lessons will be referred to their HealthPartners Dental Provider for 
further evaluation and follow-up. 
5.6 
Premature Termination or Suspension of Study 
This study may be suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will 
be provided by the suspending or terminating party to the PI or NIDCR. If the study is 
prematurely terminated or suspended, the principal investigator will promptly inform the IRB 
and will provide the reason(s) for the termination or suspension. The study will also inform 
participating clinics. Since this is a self-management behavioral study with minimal risks, there 
are few possible reasons for termination or suspension of the study.  
  
This study will be stopped prior to its completion if:  
 
The intervention is associated with adverse effects that call into question the safety 
of the intervention;  
 
Difficulty in study recruitment or retention will significantly impact the ability to 
evaluate the study endpoints;  

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
19 
 
 
Any new information becomes available during the trial that necessitates stopping 
the trial; or  
 
Other situations occur that might warrant stopping the trial. 
5.7 
Study Behavioral or Social Intervention(s) Description 
5.7.1 
PACT Program 
The Personalized Activated Care and Training (PACT) program is a self-management program 
designed to help participants with TMD pain understand the “big picture” of their condition, how 
to reduce risk factors and enhance protective factors using a cognitive-behavioral training 
approach. Eight lessons are delivered over 8-weeks.  The program is designed to improve 
participant engagement, understanding, and compliance. Activities in each module will include 
improving understanding of TMD, its causes and the role of self-care in healing. Activities are 
designed to teach concepts on how to reduce risk factors, improve protective factors, 
encourage healing, restore range of motion, reduce pain, and improve the healthy use of the 
jaw in everyday life. Risk factors include: behavioral factors (e.g., repetitive strain, muscle 
tension, postural habits, chemical use, diet), emotional factors (e.g., anxiety, depression), 
cognitive factors (e.g., poor understanding, poor coping strategies, catastrophizing), social 
factors (e.g., stress, conflict, abuse), and environmental factors (e.g. environmental risk and 
injury) that can lead to delayed recovery. Protective factors include: exercise, relaxation, 
coping, self-efficacy, participant beliefs (e.g., perceived control over pain), and social support 
that can lead to more positive outcomes.58-61 APPENDIX B:  CONTENT AND TEXT FOR 
INTRODUCTORY VIDEO provides more detailed information about each lesson. 
Questionnaires to assess risk factors briefly in each realm for each patient in the PACT 
program will also be administered online. Training patients on risk and protective factors are 
integrated to provide more personalized self-management training plan for the participant and 
supported by the coach.   
 
The PACT program will be compared to a usual self-care focused on traditional strategies 
implemented with a written handout at the initial visit to encourage healing and recovery. This 
information will be used as the content for usual self-care in the study. The format of usual 
self-care materials will match the format of the PACT program. Both the PACT program and 
the written handout will available through the web-based platform to encourage participant 
retention and to track the access of usual self-care training materials.  
5.7.2 
Control Group 
The control group will be able to download usual self-care pdfs from the website. Usual self-
care strategy in pdf form will include rest, heat/ cold, soft diet, palatal tongue posture, reduce 
gum chewing, and avoid strain during opening the jaw. A summary of self-care materials for 
TMD that is used in the HPDG clinics is presented in APPENDIX C: TRADITIONAL SELF-
CARE PROTOCOL. 
5.8 
Administration of Intervention 
Course material will be administered through an on-line website program. The focus will be 
on both didactic knowledge and interactive content. The use of a health coach is also 
integrated into the online intervention and will be conducted through telephone calls with 
study participants on a regular basis determined by the coach and participant at the start of 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
20 
 
the intervention period (see Appendix D for Health Coach Phone Protocol). 
 
Health Coach. The self-management program will also be supported by 3 three health coaches 
who have specialized training in health coaching with additional training in TMD and chronic 
pain. Health coaches are already employed within HealthPartners to engage patients with 
several chronic illnesses. Three of these trained coaches will provide the coaching services for 
the study. An agreement or pact with the participant is implemented by the health coach to 
ensure understanding of self-management program and the importance of each step. An initial 
phone call is held with the participant to ensure that they understand the basics on the self-
management training program and how to use the information technology. Phone support is 
provided on a weekly basis to answer questions and encourage understanding and adherence 
to the self-management program. A minimum phone contact of 3 calls including the initial call, 
touch base call, and final call is required. If a participant is very engaged in the health coaching, 
a maximum phone contact will be two times per week for three months. The average length of 
calls is intended to be initial call of 30-60 min. as needed with follow-up calls of 30 min.   Audio 
recordings of the telehealth visits will not be completed since the analysis of the coaching 
model itself is not the focus of study outcomes and it may interfere with coaching. Fidelity of the 
health coaching component of the PACT program will be assessed by review of the coaching 
logs, including the number of contacts and adherence to the coaching model with discussion of 
goals, barriers, understanding, and motivation.   Discussions will be held with health coaches to 
assess their experience and how they perceive it contributes to the overall the PACT program.      
5.9 
Procedures for Training Interventionists and Monitoring Intervention 
Fidelity 
The study intervention is a self-administered online self-management program supported by a 
health coach, in this context the interventionists for the PACT program are health coaches. 
 
Training. The study coordinator and health coaches will receive training on the study protocol, 
PACT manual, and the care of temporomandibular disorders including self-management. This 
includes participating in IRB training, study protocol training, as well as an on-line MOOC 
course on preventing chronic pain (www.coursera.org/learn/chronic_pain). Study staff are 
required to pass examinations after completing this online course in order to serve as health 
coaches for this study. Study staff will also participate in the on-line PACT training program 
themselves as if they were participants. Then, 3 one hour or more discussion groups and 
training sessions with the health coaches will occur before, during and after the study. The 
health coaches will be supervised by the Principal Investigator, Dr. James Fricton, and Dr. Brad 
Rindal as well as our consultant Dr. Karen Lawson, Director of the Health Coaching training 
program at the University of Minnesota. These investigators will meet with health coaches each 
month to review their discussions with patients, their barriers, and implementation of the 
program. Their notes about the health coaching experiences will be discussed also.  
 
In this study, Health Coaching is considered a relationship-centered, client-driven process 
designed to facilitate and empower a client to achieve self-determined goals related to health 
and overall well-being.  While the participant’s primary goal in this study is to improve their 
TMD pain and function, the coaching model includes the selection of goals and exploration on 
how to achieve them based on the participants’ preferences. Individuals may be just beginning 
to consider life change, may be exploring aspects of preparing for a change, or may be ready 
to implement actual actions.  In a safe and consistent space, participants can explore their 
thoughts, emotions, and actions, in a way that allows them to recognize the power of their own 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
21 
 
choices to impact their pain and well-being. Health Coaching is a methodology that is different 
from but supported by the on-line health education in the PACT program and the counseling or 
therapy received by health professionals such as the dental provider and physical therapist.  It 
is designed to work well in combination with those care strategies. By applying clearly defined 
knowledge and skills, they support individuals or groups in mobilizing their internal strengths 
and external resources to achieve sustainable changes in beliefs or behaviors. Health 
Coaching has the potential to help individuals, families, and groups achieve improved health 
and wellbeing.   
 
Fidelity of Health Coaching.  Fidelity to the coaching model will be assessed by analysis of the 
interviews and review of the coaching documentation with a focus on: 1) development a 
positive supportive health coaching relationship, 2) clarification of goals, 3) identifying 
strengths/resources/barriers, 4) monitoring completion of weekly modules, 5) inquiring about 
usefulness of information.  
 
Monitoring Protocols and Interventions. Once the participant has enrolled in the TMD Pain 
Study and been randomized to the PACT program or the control arm, the study coordinator will 
monitor compliance and adherence to the study protocol. The study coordinator will do this by 
monitoring completion of the baseline and follow-up questionnaires answer questions and the 
SRC will send reminders to participants, as needed. Compliance and adherence will be 
assessed by the number of on-line sessions that the study participants in both arms participate, 
data that will be collected each week by monitoring on-line access and health coaching reports. 
5.10 
Assessment of Subject Compliance with Study Intervention 
The assessment of subject compliance with study intervention corresponds to one of our 
feasibility aims (see section 3.2.b) Compliance and adherence to the study intervention will be 
assessed by the number of on-line sessions (or self-care materials accessed online by control 
arm) that the study participants in both arms participate in and self-reported program activities 
(PACT arm only), Information about the on-line sessions will be collected each week by 
monitoring on-line access.  
5.11 
Concomitant Medications/Treatments 
The study will allow the concomitant use of other TMD treatments such as medication, splints, 
and physical therapy. The use of these treatments will be monitored during study 
implementation. This will allow us to determine the likely extent of concomitant use of 
medication, splints, and physical therapy during the PACT program and, in the larger study, 
account for their effects in final analyses.  
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
22 
 
6 STUDY SCHEDULE 
The Schedule of Events table, found in APPENDIX A, provides an overview of initial, 
intermediate, and final study visits (including all contacts with participants; e.g., telephone, 
website, screening, and other contacts) Two weeks is the acceptable time windows for each of 
the activities. If each phase is not completed within this 2 week window after consenting, the 
project manager will call the patient to remind them and determine if there are barriers to 
completion. 
6.1 
Screening (Week -1 Pre-Intervention) 
After obtaining verbal consent, the TMD screener form (APPENDIX E) will be administered 
specific points of medical history, eligibility criteria, and contact information will be recorded. 
Screening will occur by telephone and the contact will be documented on the screening form. 
Inclusion and exclusion criteria will be reviewed and documented including the TMD screener 
form and exclusions such as serious co-morbid conditions or medical history that contributing to 
pain or prevent participation e.g. pregnancy, psychiatric disorder, or systemic pain disorder. 
 
All potential participants will be given a verbal explanation of the study, and will be screened by 
phone to ensure eligibility. If they meet eligibility criteria, a packet of study materials (including an 
overview of the study, consent, and HIPAA privacy information) will be emailed to the potential 
participant, and their contact information will be added to the coordinator contact list.   
 
6.2 
Enrollment/Baseline Visit (Website Visit 1, Week 0) 
 
1. The SRC will contact the participant to review the consent form, HIPAA privacy 
information, study information, and the risk and benefits for participation including the 
cost and compensation and will confirm understanding of the study information. If 
subject remains interested, a username and password to log into the study website will 
be emailed and the subject will be asked to read and electronically sign the informed 
consent within 1 week of the phone contact. 
2. Following consent participants will be directed to complete the baseline questionnaire 
(APPENDIX G) electronically within 1 week of contact. This timeline is not required for 
study participation, if the subject completes the consent form and/or baseline 
questionnaires beyond the 1-week limit, they will still be enrolled in the study. 
o If the consent and baseline questionnaire are not completed within 1 week, 
SRC will call the participant to confirm their interest in enrolling and encourage 
participation.  
o Criteria in the baseline questionnaire must be negative prior to randomization.   
3. When the consent is electronically signed and baseline questionnaire is completed 
and randomization will occur electronically through the website. 
6.3 
Intermediate Visits (8 weekly website visits during weeks 1 to 8) 
Once enrolled in the study participants will be randomized to one of two arms. 
1. Traditional Self- Care: control arm 
2. PACT: Intervention arm 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
23 
 
 
A. Traditional Self-Care Control Arm 
 
1. Participants randomized to the Traditional Self-Care arm will be electronically directed 
to the traditional self-care website landing page. 
2. Traditional self-care material will be available for the participant to review via the 
website. This material is equivalent to what is typically given to patients in the dental 
clinic. Traditional self-care includes focusing on rest and healing through changes in 
chewing, diet, heat/cold, over the counter analgesics, and reducing strain from oral 
and sleeping habits. 
3. Participant will also continue participate in usual care from their dentist such as a splint 
or anti- inflammatory medications as needed.  Some patients may be under care of 
another healthcare provider, such as a physical therapist.  
4. Adverse events will be recorded through the website assessments. 
 
B. PACT Experimental Arm 
 
1. Participants randomized to the PACT care arm will be electronically directed to the 
PACT website landing page which explains each step of the process. Participants will 
complete the initial PACT assessment for each lesson. Based on the assessment, the 
PACT website will provide personalized training lessons for each participant. 
2. Participants will also participate in weekly phone coach sessions. 
3. Participants will complete each lesson on a weekly basis in order to focus on, 
understand, and implement the steps in each lesson.  New material will only be 
made available to participants every 7 days.   
a. If participants fail to complete a lesson, they will be prohibited from 
accessing all future materials until the missed lesson is completed, 
even if it takes more than one week.  
b. Participants who fail to complete each lesson within a month will be 
called by the study coordinator to identify if problem exists and may 
result in study withdrawal. 
4. Participant will also continue participate in usual care from their dentist such as a splint 
or anti- inflammatory medications as needed.  Some patients may be under care of 
another healthcare provider such as a physical therapist.  
5. Adverse events will be recorded through the website assessments.  
 
6.4 
Final Study Visits (Final Visits, Weeks 8 and 16) 
All participants will be asked to complete the final follow-up outcomes evaluation at 8 weeks 
from the beginning of the intervention and at 16-weeks (2 months after program end). This 
includes questions about any adverse events and outcomes as reported by the participants 
during or after the lessons. 
 
Participants will receive weekly email reminders from the web-system to complete the post-
intervention questionnaires. There is a 2-week window in the completion of questionnaires at 
the 8-week and 16-week post-intervention time periods. If the questionnaire has not been 
completed at the 2-week period, participants will receive up to 3 reminder calls from the study 
coordinator to identify the barrier to completing the questionnaires and facilitate its completion. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
24 
 
If after two more weeks of time have passed without completion, the questionnaire will be not 
evaluable, and therefore, considered missing data. 
 At the end of the 8 week outcome questionnaire, participants will complete several program 
evaluation questions. In addition, at least ten randomly-selected subjects will complete a semi-
structured qualitative interview about their experience in the program. 
6.5 
Withdrawal Visit 
If a participant is discontinued before study completion, prior to withdrawal of consent and with 
the participant’s permission, an Early Termination visit will occur. Each of the procedures 
described for the Final Study Visit will be performed at (specify timeframe). 
6.6 
Unscheduled Visit 
Study participants are encouraged to work with the health coach on a regular basis, and may 
contact the Study Coordinator (SC) during the study. All contacts with the SC will be 
documented in the study records. PACT subjects will be able to make unscheduled calls to the 
health coach to have questions answered; however, they will be scheduled for future telehealth 
visits. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
25 
 
7 STUDY PROCEDURES/EVALUATIONS 
7.1 
Study Procedures/Evaluations 
7.1.1 
Outcome Measure Questionnaires 
The questionnaires that will be utilized are briefly described below. Copies of the questionnaires 
are reproduced in the appendix. All of the questionnaires are self-administered except for the 
qualitative interview which is conducted via phone by the study coordinator. For outcome 
measure questionnaires, responses will be recorded electronically through the study website. 
 
Telephone Screen. This is a method used to screen for TMD pain. This questionnaire will be 
completed baseline and repeated at the final study visits. 
 
Pain severity and Pain Interference. The Graded Chronic Pain Scale (GCPS) assesses 2 
dimensions of pain: pain intensity and pain-related disability with mean intensity ratings for 
reported current, worst, and average pain.68-69  
 
Jaw Functioning. Jaw Functional Limitation Scale (JFLS-8) identifies daily activities interfered 
with by jaw pain.40  This 20-item instrument measures limitations across 3 domains: mastication 
(6 items), vertical jaw mobility (4 items), and verbal and emotional expression (8 items). Two 
items are not scored as part of these 3 subscales. A degree of limitation is rated on a 0-10 scale 
from 0 (“no limitation”) to 10 (“severe limitation”).  
 
Hypothesized mediators  
 
Self-efficacy. The Chronic Pain Self-efficacy Scale 70is a 22-item instrument that measures a 
person’s beliefs in their capabilities to produce a given outcome, particularly regarding 
compliance and adherence with self-care in reducing pain. For the pilot study, we will be using 
the 5-item Self-efficacy for Pain management (PSE) subscale of the Chronic Pain Self-efficacy 
Scale. 
  
Participant activation. The Patient Activation Measure (PAM) is a 7-item instrument that 
gauges the knowledge, skills, and confidence essential to managing one’s own health and 
health care.71PAM segments consumers into 1 of 4 progressively higher activation levels, 
including disengaged, becoming aware, taking action, and maintaining behaviors.  
 
Exercise frequency. Type and frequency of conditioning exercises are measured using two 
questions from the Global Physical Activity Questionnaire. The questions measure exercise 
habits. 78 
 
Sleep quality. Quality of sleep is measured using four questions from the World Health Survey 
(WHO). 77   
 
Catastrophizing. The Pain Catastrophizing Scale is a 14-item instrument that will be 
measured at baseline.73 Participants who cope poorly due to catastrophizing often have 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
26 
 
negative outcomes. 
 
Depression. The Patient Health Questionnaire (PHQ9) is a widely-used 9-item depression 
screen with questions covering the core DSM V screening criteria for diagnosing depression. 
74 
 
Oral habits. The DC/TMD Oral Parafunctional Habits Scale measures frequency and duration 
of oral parafunctional habits that place repetitive strain on the jaw. 40 
 
Perceived Stress Scale (PSS). This questionnaire assesses 10 sources of stress and 
produces an overall perceived stress rating and has been used to measure stress associated 
with chronic disease.75-76 
 
Social support. The Social Support Questionnaire (shortened version) is a 6-item 
questionnaire designed to measure perceptions of social support and satisfaction with that 
social support. 72 
 
7.1.2 
Program Evaluation and Qualitative Interview 
7.1.2.1 
Program Evaluation 
As part of the 8-week follow up survey, the program evaluation involves 7 close-ended 
questions to assess participant experience with the overall program and an additional 11 close 
ended questions for participants involved in the PACT program to assess satisfaction and 
perceptions of the program. 
7.1.2.2 
Qualitative Interview of Participants 
At least 10 randomly selected participants will be asked to complete the qualitative interview. 
The qualitative interview involves 9 open-ended questions to assess participants’ satisfaction 
and perceptions of the program. 
7.1.2.3 
Website issues 
Phone calls and questions received about web-site issues will be documented throughout the 
study to assess functionality of the website. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
27 
 
8 ASSESSMENT OF SAFETY 
We will implement a meaningful safety system for the study by considering the risks of the 
study intervention, study procedures as well as the characteristics of the study population 
(individuals with TMD pain). There are no risks to other individuals in the study such as health 
coaches.  
 
Specifications of Safety Parameters that will be recorded by the Study Coordinator for 
each participant in their research record include; 
 
 
The study coordinator will be in frequent contact with the health coaches to identify any 
potential participant concerns with study staff. 
 
The participants also have the phone number for the study coordinator to call if a concern 
related to the study program arises. 
8.1 
Specification of Safety Parameters 
8.1.1 
Unanticipated Problems 
It is believed that risks to participants in the present study are minimal. Both traditional and 
PACT self-care is currently used by many TMD clinicians in the U.S. and abroad. It has been 
used with a wide variety of people, including adults with TMD and has been used in previous 
research with no reported risks to the research participants. The Office for Human Research 
Protections (OHRP) considers unanticipated problems involving risks to participants or 
others to include, in general, any incident, experience, or outcome that meets all of the 
following criteria: 
 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures 
that are described in the protocol-related documents, such as the IRB-approved research 
protocol and informed consent document; and (b) the characteristics of the participant 
population being studied; 
 
Related or possibly related to participation in the research (“possibly related” means 
there is a reasonable possibility that the incident, experience, or outcome may have 
been caused by the procedures involved in the research); and 
 
The research places participants or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
8.1.2 
Adverse Events 
An adverse event (AE) is generally defined as any unfavorable and unintended diagnosis, 
symptom, sign (including an abnormal laboratory finding), syndrome or disease which either 
occurs during the study, having been absent at baseline, or if present at baseline, appears to 
worsen. Adverse events are to be recorded regardless of their relationship to the study 
intervention. 
 
8.1.3 
Serious Adverse Events 
A serious adverse event (SAE) is generally defined as any untoward medical occurrence that 
results in death, is life threatening, requires inpatient hospitalization or prolongation of existing 
hospitalization, results in persistent or significant disability/incapacity, or is a congenital 
anomaly. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
28 
 
The study intervention is a patient-centered self-management program for TMD pain.  Potential 
participants with serious medical or psychiatric conditions are excluded from the study at initial 
screening. If study participants develops an increase in pain or other health concerns during the 
course of the study whether or not related to the study intervention would be considered an 
adverse event. The PACT program is a web-based, tailored 8-week program supported by a 
health coach to help enhance understanding, compliance, and success in self-management for 
TMD pain. There are self-report assessments at the end of each week throughout the entire 
program to monitor progress, compliance, adverse events, risk factors, and protective factors.  If 
study subjects develop an aggravation of the pain or a new symptom that the subject attributes 
to the study intervention this would be considered an adverse event. This will be monitored by 
both self-report within the PACT program weekly assessments as well as by the dental 
professional who is caring for the patient. Adverse events will be reported to the Study 
Coordinator, the PI and the PO.   
If participants screen for depression, we will provide a list of mental health providers who they 
can consult with to ensure their safety. 
8.2 
Events Qualifying as an Adverse Event or Serious Adverse Event for the 
Purpose of this Protocol  
Only those events considered to be related to the study intervention will be reported. A clinically 
significant change from the baseline in a pre-existing condition documented as screening will be 
reported as an AE if the change is considered at least possibly related to study intervention. 
8.3 
Characteristics of an Adverse Event 
8.3.1 
Relationship to Study Intervention 
All adverse events will have their relationship to study intervention assessed and documented 
in the participant research record and will be included in summary reporting to the IRB and the 
PI. Evaluation of relatedness will consider etiologies such as natural history of the underlying 
disease, concurrent illness, concomitant therapy, study-related procedures, accidents, and 
other external factors. In a clinical trial, the study intervention must always be suspect. AEs will 
be categorized according to the likelihood that they are related to the study intervention. 
Specifically, they will be labeled for this study as:  
 
1.  (Definitely unrelated, definitely related, probably related or possibly related to the study 
intervention) 
a. The event is known to occur with the study intervention. 
b. There is a temporal relationship between the intervention and event onset.  
c. The event abates when the intervention is discontinued. 
d. The event reappears upon a re-challenge with the intervention. 
 
2. Not Related (Unlikely, Not Related) 
a. There is no temporal relationship between the intervention and event onset.  
b. An alternate etiology has been established. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
29 
 
8.3.2 
Expectedness of SAEs 
The risk information to assess expectedness will be obtained from preclinical studies, the 
investigator’s brochure, published medical literature, the protocol, or the informed consent 
document. If an SAE occurs, the Safety Monitor, the NIDCR Medical Monitor and the Study PI 
will be responsible for determining whether an SAE is expected or unexpected. An adverse 
event will be considered unexpected if the nature, severity, or frequency of the event is not 
consistent with the risk information previously described for the intervention. This will be 
recorded in the participant research record and in summary reports of the study. 
8.3.3 
Severity of Event 
 
AEs will be labeled according to severity, which is based on their impact on the patient. An AE 
will be termed “mild” if it does not have an impact on the patient, “moderate” if it causes the 
patient some minor impact and inconvenience and “severe” if it causes a substantial disruption 
to the patient’s well-being. 
This will be recorded in the participant research record and in summary reports of the study. 
8.4 Time Period and Frequency for Event Assessment and Follow-Up 
The investigator will report all study intervention-related SAEs and related unexpected AEs with 
start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 
30 days (for SAEs) after the last day of study participation.  At each study visit, the investigator 
will inquire about the occurrence of AE/SAEs since the last visit (or since the first procedure at 
the first active phase visit).  The investigator will also review all source documentation related to 
study procedures for evidence of related AEs.  Events will be followed for outcome information 
until they return to baseline or stabilize.  Study intervention-related AEs will be followed until 
resolution or stabilization of the AE, after which the subject will be referred to a qualified 
clinician(s) for care and follow-up. 
8.5 
Reporting Procedures 
8.5.1 
Adverse Events 
Study intervention-related AEs will be monitored throughout this study and recorded on a case 
report form at each visit.  These events will be reported and reviewed by the PI as they occur, 
and reported to the IRB. DSM forms will be completed on a quarterly time frame for reporting 
and include summary reports of adverse events and others relevant to summary data will be 
reported to the DSM. 
8.5.2 
Unanticipated Problem Reporting to IRB and NIDCR 
Incidents or events that meet the OHRP criteria for unanticipated problems require the 
creation and completion of an unanticipated problem report form. This will follow the OHRP 
recommendations to include the following information when reporting an adverse event, or any 
other incident, experience, or outcome as an unanticipated problem to the IRB: 
 
 
Appropriate identifying information for the research protocol, such as the title, 
investigator’s name, and the IRB project number; 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
30 
 
 
A detailed description of the adverse event, incident, experience, or outcome; 
 
An explanation of the basis for determining that the adverse event, incident, experience, 
or outcome represents an unanticipated problem; 
 
A description of any changes to the protocol or other corrective actions that have been 
taken or are proposed in response to the unanticipated problem. 
 
To satisfy the requirement for prompt reporting, unanticipated problems will also be 
reported using the following timeline: 
 
 
Unanticipated problems that are serious adverse events will be reported to the IRB and 
to NIDCR within 1 week of the investigator becoming aware of the event. 
 
Any other unanticipated problem will be reported to the IRB and to NIDCR within 2 
weeks of the investigator becoming aware of the problem. 
 
All unanticipated problems should be reported to appropriate institutional officials (as 
required by an institution’s written reporting procedures), the supporting agency head (or 
designee), and OHRP within one month of the IRB’s receipt of the report of the problem 
from the investigator. 
 
All unanticipated problems will be reported to NIDCR’s centralized reporting system via Rho 
Product Safety: 
 
 
Product Safety Fax Line (US): 1-888-746-3293 
 
Product Safety Fax Line (International): 919-287-3998 
 
Product Safety Email: rho_productsafety@rhoworld.com 
 
General questions about SAE reporting can be directed to the Rho Product Safety Help Line 
(available 8:00AM – 5:00PM Eastern Time): 
 
 
US: 1-888-746-7231 
 
International: 919-595-6486 
8.5.3 
Serious Adverse Event Reporting to NIDCR 
 
SAEs that are unanticipated, serious, and possibly related to the study intervention will be 
reported to the IRB, and NIDCR in accordance with requirements. Unexpected fatal or life-
threatening AEs related to the intervention will be reported to the NIDCR Program Officer within 
7 days. Other serious and unexpected AEs related to the intervention will be reported to the 
NIDCR Program Official within 15 days Anticipated or unrelated SAEs will be handled in a less urgent 
manner but will be reported to the IRB, and NIDCR in accordance with their requirements. In the annual 
AE summary, the PI will state that they have reviewed all AE reports. 
 
SAE Reporting Contact Information: 
 
 
Product Safety Fax Line (US): 1-888-746-3293 
 
Product Safety Fax Line (International): 919-287-3998 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
31 
 
 
Product Safety Email: rho_productsafety@rhoworld.com 
 
General questions about SAE reporting can be directed to the Rho Product Safety Help Line 
(available 8:00AM – 5:00PM Eastern Time): 
 
 
US: 1-888-746-7231 
 
International: 919-595-6486 
 
The study clinician will complete a Serious Adverse Event Form and submit via fax or 
email within the following timelines: 
 
 
All deaths and immediately life-threatening events, whether related or unrelated, will be 
recorded on the Serious Adverse Event Form and submitted to Product Safety within 24 
hours of site awareness. 
 
Serious adverse events other than death and immediately life-threatening events, 
regardless of relationship, will be reported by fax within 72 hours of site awareness. 
 
All SAEs will be followed until resolution or stabilization. 
The study coordinator will be responsible for compiling the data and producing the necessary 
reports, as well as assuring that all parties obtain copies of these reports. Adverse events will 
be reported and reviewed by Dr. Fricton as they occur and reported to the IRB. The number of 
days by which a serious adverse event or unanticipated problem would be reported is 2 days. 
Summary reports of adverse events and others relevant to summary data will be reported to 
the PO at NIDCR. Reports will include description of study progress, subject recruitment, 
subject demographic data, subject status, and inclusion/exclusion criteria. These reports will be 
reviewed by the Principal Investigator and study team prior to presenting to NIDCR. 
 
8.5.4 
Reporting of SAEs and AEs to FDA 
The study coordinator will be responsible for compiling the data and producing the necessary 
reports, as well as assuring that all parties obtain copies of these reports. Adverse events will be 
reported and reviewed by Dr. Fricton as they occur and reported to the IRB. A serious adverse 
event or unanticipated problem will be reported in 2 days. These reports will be reviewed by the 
Principal Investigator and study team. 
8.5.5 
Reporting of Pregnancy 
This study will exclude potential participants who are pregnant. If pregnancy occurs during the 
course of the study, we will follow the participant and make appropriate modifications to study 
procedures including discontinuation of self-care, if warranted by the treating dental provider or 
medical provider. We will also continuing to conduct safety follow-up, by requesting permission 
from any pregnant women to pregnancy outcome. 
8.6 
Halting Rules  
Any SAE related to study intervention that results from the self-care protocols will be evaluated 
by the SMB to determine its’ relationship to the protocols. If the safety finding is serious and 
directly related, this would prompt temporary suspension of enrollment and/or study 
interventions until a safety review is convened (either routine or ad hoc). The objective of the 
safety review is to decide whether the study (or intervention for an individual or study cohort) 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
32 
 
should continue per protocol, proceed with caution, be further investigated, be discontinued, or 
be modified and then proceed. Suspension of enrollment is a potential outcome of a safety 
review. 
Subsequent review of serious, unexpected, and related AEs by the Medical Monitor, IRB, the 
sponsor(s), or relevant local regulatory authorities may also result in suspension of further trial 
interventions/administration of study product at a site. The study sponsor(s) retain the authority 
to suspend additional enrollment and study interventions for the entire study, as applicable. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
33 
 
9 STUDY OVERSIGHT 
This study has been designated by the NIDCR as appropriate for standard oversight, which 
means that the Principal Investigators and the grantee institution take full responsibility for the 
conduct of the study, and will report progress annually during the grant period, using the usual 
format required for NIH progress reports.   
The investigator will be responsible for monitoring safety and ensuring that the study is 
conducted according to the protocol and ensuring data integrity.  The PI will review the data for 
safety concerns and data trends at regular intervals, and will promptly report to the IRB and 
NIDCR any Unanticipated Problem (UP), protocol deviation, or any other significant event that 
arises during the conduct of the study. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
34 
 
10 CLINICAL SITE MONITORING 
Independent clinical site monitoring is not planned for this study however; the NIDCR reserves 
the right to conduct independent audits or clinical monitoring as necessary.  
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
35 
 
11 STATISTICAL CONSIDERATIONS 
11.1 
Study Hypotheses 
The study hypotheses for this project are included as part of Objective 1, 2 and 3 in section 3 of 
the protocol. 
11.2 
Sample Size Considerations 
This is a pilot randomized clinical trial of the PACT program for TMD pain to determine feasibility 
and acceptability of methods and preliminary outcomes to power a multisite randomized clinical 
trial of its efficacy. The study is not powered to detect statistically significant intervention effects. 
For this study a sample size of 80 participants has been selected. This will provide an adequate 
sample for feasibility assessments and is in line with the constraints of available study resources 
and timing considerations related to the funding mechanism of the study. Comparisons done as 
part of the feasibility analyses of patient characteristics in each stage will serve as an alert to 
potential sources of bias in the study and will be used to inform refinement of the protocol for a 
larger study. Results from the pilot study, in conjunction with previous findings of behavioral 
interventions will be used to estimate the parameters needed for the study trial. 
Our final target sample size for the pilot study will be a total of 80 consenting participants, with 
40 in each arm. A 2014 query of patient populations from selected HPDG TMD providers using 
ICD codes (524.6x and 729.x) during a 6-month period identified 550 new patients with TMD 
pain who may qualify for participation. We anticipate that a minimum of 40% of participants will 
meet eligibility criteria for the TMD pain study and that a minimum of 40% of eligible participants 
who talk with recruitment staff will enroll and complete the entire study, leaving a total final 
sample size for the 2 arms of 110 to achieve the final sample size of 60 participants. 
11.3 
Interim Safety Review 
We do not expect any safety events because this is a minimal risk self-care intervention. 
However, the safety review plan will include quarterly reports of participant accrual, enrollment, 
adherences to the intervention and adverse events. 
 
Study progress and safety will be reviewed following each recruitment and intervention phase – 
every 6 months. Progress reports, including patient recruitment, retention/attrition, and AEs will 
be provided to the PI and PO following each of the reviews. An Annual Report will be compiled 
and will include a list and summary of AEs. In addition, the Annual Report will address (1) 
whether AE rates are consistent with pre-study assumptions; (2) reason for dropouts from the 
study; (3) whether all participants met entry criteria; (4) whether continuation of the study is 
justified on the basis that additional data are needed to accomplish the stated aims of the study; 
and (5) conditions whereby the study might be terminated prematurely. The Annual Report will 
be sent to the PO and will be forwarded to the IRB and NIDCR. The IRB will review progress of 
this study on an annual basis. 
11.4 
Final Analysis Plan 
We will perform the following analysis and present results in preparation of the full study. The 
Primary outcomes for this study are acceptability and feasibility of the methods. The study is not 
sufficiently powered to test for mean changes from baseline to follow-up. Thus, we will conduct 
the following descriptive analysis at noted in the outcome measures: 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
36 
 
 
 
Number of participants, baseline characteristics and outcomes at baseline will be 
summarized descriptively 
 
Summary measures will include mean values (standard deviation SD) for continuous 
variables and frequency distribution for categorical variables. 
 
Outcome measures will be analyzed for departure of normality, and standard 
transformations will be applied. 
 
Percent of participants completing the measures for outcomes, mediating and moderating 
factors at baseline and each follow-up periods 
The acceptability of the outcomes, mediating and moderating measures at baseline and follow-
up periods 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
37 
 
12 SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS 
There are five main data instruments:  
1. TMD phone Screening Form  
2. Baseline questionnaire  
3. 8-week Post-intervention questionnaire with program evaluation questions  
4. 16-week Post-intervention questionnaire) 
5. Semi-Structured Interview (subgroup) 
Data collection will occur at multiple points across the study period, including eligibility 
screening, the baseline questionnaire prior to the start of the intervention, 1st post-intervention 
questionnaire (week 8), and 2nd post-interventional questionnaire (week 16).Data will be 
collected electronically in both arms. 
 
Web-based activity will be tracked in several ways using hits on the web-site pages including: 
1. accessing each module within the web-site 
2. accessing each self-report risk assessments 
3. each weekly pain and function assessments 
4. accessing the interactive components of the website including benefit balloons and 
barrier bricks  
 
Audio-recorded, transcribed, and coded coaching sessions will be used to assess fidelity to 
the PACT intervention. 
 
Study staff will maintain appropriate medical and research records for this study, in 
compliance with ICH E6, Section 4.9 and regulatory and institutional requirements for the 
protection of confidentiality of participants. Study staff will permit authorized representatives of 
NIDCR and regulatory agencies to examine (and when required by applicable law, to copy) 
research records for the purposes of quality assurance reviews, audits, and evaluation of the 
study safety, progress and data validity. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
38 
 
13 QUALITY CONTROL AND QUALITY ASSURANCE 
Quality control is the ongoing, concurrent review of data collection forms for completion and 
logic. Quality assurance is a comprehensive, retrospective review of all components of 
research records to assess adherence to protocol, standard operation procedures, and 
regulations and to evaluate the accuracy of the records. Quality management is the process of 
assessing the quality of processes within a system and encompasses quality assurance and 
quality control. 
The quality management program will include, but will not be limited to, the following: 
 
 
Dr. Brad Rindal will closely evaluate study processes and documentation based on 
NIDCR standards and the International Conference on Harmonisation (ICH), E6: Good 
Clinical Practice guidelines (GCP). 
 
Training of staff on the protocol, study procedures, and use of the data collection forms 
and systems 
 
Documentation and tracking of training for each staff member 
 
A Quality Management Plan that details the responsibility, scope, and frequency of 
quality management activities, including QM tools to facilitate the quality review of data, 
study essential documents, and other study-wide documents 
 
Quality of data and data handling is described in section 16. 
 
 
Quality Assurance. Staff for this study has a long history of experience with similar or larger 
research studies at HPI. Both the study coordinator and the staff within the HPI SRC have 
excellent history of quality data collection and have worked with Dr. Fricton on other similar 
studies. 
 
Quality Control Committee. The SRC has a manual of protocols and procedures that 
assure quality control of data collected by the Center.    
 
Metrics. All data will be reviewed for completeness. Since assessment data is all entered 
electronically within the PACT website, accuracy and completeness of the data is 
maximize through alerts and pop-ups if the data is inconsistent or not entered. 
 
Protocol Deviations. All deviations from protocol will be captured, documented, reviewed 
and addressed on an ongoing basis to insure integrity of the data. 
 
Monitoring Quality Assurance. Dr. Fricton will meet weekly with study staff to discuss 
study progress and problem-solve. The purpose of these meetings is to focus on the day-to-
day operations of the project and to assure that all necessary tasks are completed in a timely 
fashion and strictly according to study protocol. Biweekly meetings will include all co- 
investigators and will address scientific issues, including refinement of conceptual models, 
strategies to streamline and deploy the interventions efficiently and effectively, and strategies 
to maximize both recruitment and retention of study participants, as well as methods to 
assure uniformity and fidelity to intervention protocols and data collection. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
39 
 
14 ETHICS/PROTECTION OF HUMAN SUBJECTS 
14.1 
Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with the principles 
set forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human 
Subjects of Research, as drafted by the US National Commission for the Protection of Human 
Subjects of Biomedical and Behavioral Research (April 18, 1979) and codified in 45 CFR Part 
46 and/or the ICH E6. 
14.2 
Institutional Review Board 
The protocol, informed consent form(s), recruitment materials, and all participant materials 
will be submitted to the IRB for review and approval. Approval of both the protocol and the 
consent form must be obtained before any participant is enrolled. Any amendment to the 
protocol will require review and approval by the IRB before the changes are implemented in 
the study. 
14.3 
Informed Consent Process 
Informed consent is a process that is initiated prior to the individual agreeing to participate in 
the study and continues throughout study participation. Extensive discussion of risks and 
possible benefits of study participation will be provided to potential participants. A consent form 
describing in detail the study procedures and risks will be provided via email to the potential 
participant. Consent forms will be IRB-approved, and the potential participant is required to 
read and review the document or have the document read to him or her. The investigator or 
designee will explain the research study to the potential participant and answer any questions 
that may arise.  
 
The potential participant will sign the informed consent document electronically prior to any 
study-related assessments or procedures. Potential participants will be given the opportunity to 
discuss the study with their surrogates or think about it prior to agreeing to participate. They 
may withdraw consent at any time throughout the course of the study. A copy of the signed 
informed consent document will be emailed to participants for their records. The rights and 
welfare of the participants will be protected by emphasizing to them that the quality of their 
clinical care will not be adversely affected if they decline to participate in this study.  The 
consent process will be documented in the research record. 
14.4 
Exclusion of Women, Minorities, and Children (Special Populations) 
Adult individuals of any gender or racial/ethnic group may participate if they meet the study 
inclusion and exclusion criteria. The study does not intend to enroll children, pregnant women, 
prisoners, or other vulnerable populations. Pregnancies may interfere with retention and study 
participation if the participant delivers during study participation and thus, pregnant women will 
be excluded. Teens (and children) are excluded due to the design of the PACT program. We 
will also conform to NIH policy on inclusion of women and minorities.  
14.5 
Subject Confidentiality 
Participant confidentiality is strictly held in trust by the investigators, study staff, and the 
sponsor(s) and their agents. This confidentiality is extended to cover any study information 
relating to participants. The study protocol, documentation, data, and all other information 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
40 
 
generated by the TMD Pain Study will be held in strict confidence. No information concerning 
the study or the data will be released to any unauthorized third party without prior written 
approval of the sponsor. 
 
If needed, study monitors and other authorized representatives of the sponsor may inspect all 
study documents and records required to be maintained by the investigator, including but not 
limited to, medical records (office, clinic, or hospital) for the study participants. The clinical 
study site will permit access to such records. 
 
Confidentiality of study data will be ensured by assigning an arbitrary and unique participant 
identification number to each participant. All data collected in the study will be identified by 
participant identification number only. These data will be entered by identification number into 
the HPI computer database to which only the researchers directly involved in the study will have 
access. No protected health information (PHI) data will be included in the analytical dataset. No 
participant data will be individually identified or released to anyone other than the study 
investigators without specific written permission from the study participant. 
 
Data will be stored within a secure folder on the research server with limited access to project 
team members. A file containing a link between the study ID and individually identifying 
information will be maintained at HPI by HPI members of the study team. All electronic study 
data will be maintained in a computerized database residing on a username and password 
protected file- server to which only the researchers involved in the study will have access. All 
study related paper documents containing individually identifiable information will be maintained 
in locked file cabinets within HPI 
 
14.6 
Future Use of Stored Specimens and Other Identifiable Data 
De-identified study ID and no protected health information (PHI) data will be included in the 
analytical dataset. Data will be stored within a secure folder on the research server with limited 
access to project team members for the required timeframe. This study does not involve 
genetic testing or collection of specimens. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
41 
 
15 DATA HANDLING AND RECORD KEEPING 
The investigators in the TMD Pain Study will be responsible for ensuring the accuracy, 
completeness, legibility, and timeliness of the data reported.  Since most of the data collected 
will be through the secure PACT website, accuracy and completeness of the data is 
maximize through alerts and pop-ups if the data is inconsistent or not entered. All source 
documents will be completed in a neat, legible manner to ensure accurate interpretation of 
data. We will also maintain adequate case histories of study participants, including accurate 
case report forms (CRFs), and source documentation. See a comprehensive Data 
Management Plan located in the Manual of Operations and a Data Management and Safety 
and Monitoring Plan in APPENDIX J below.   
15.1 
Data Management Responsibilities 
Data collection and accurate documentation will be the responsibility of all TMD Self-Care 
Study staff under the supervision of the PI. A programmer from HPI will develop our initial 
contact tracking database using REDCap (Electronic Data Capture) software to track all 
phone calls, contacts, and information for participants. All source documents and 
assessment reports will be reviewed by the study team and data entry staff, who will ensure 
that they are accurate and complete. Unanticipated problems and adverse events will be 
reviewed by the investigator or designee. 
15.2 
Data Capture Methods 
Since assessment data is all entered electronically within the TMD Pain Study website, 
accuracy and completeness of the data is maximize through alerts and pop-ups if the data is 
inconsistent, out of range, or not entered. The database is centrally located with ongoing 
processing. The data entry procedures include a secure intra-net log-in that is password 
protected and data entry will have data quality checks with the electronic data system. 
15.3 
Types of Data 
Self-report assessment and outcome measure data that involve questionnaire responses are 
collected in the secure TMD Pain Study Website. Safety data are collected in a separate 
database related to each participant. 
15.4 
Schedule and Content of Reports 
Reports to monitor enrollment rate, will be generated each week by the data from REDCap 
Software and the TMD Pain Study website. These reports will be discussed at the weekly 
investigator meeting.  
15.5 
Study Records Retention 
Study records will be maintained for at least three years from the date that the grant federal 
financial report (FFR) is submitted to the NIH. No records will be destroyed without the written 
consent of the sponsor, if applicable. It is the responsibility of the sponsor to inform the 
investigator when these documents no longer need to be retained. 
15.6 
Protocol Deviations 
A protocol deviation is any noncompliance with the clinical study protocol, Good Clinical 
Practice, or Manual of Procedures requirements. The noncompliance may be on the part of the 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
42 
 
participant, the investigator, or study staff. As a result of deviations, corrective actions that 
address the non-compliance issue have been developed by the study staff and will be 
implemented promptly. These practices are consistent with investigator and sponsor obligations 
in ICH E6: 
 
 
Compliance with Protocol, Sections 4.5.1, 4.5.2, 4.5.3, and 4.5.4. 
 
Quality Assurance and Quality Control, Section 5.1.1 
 
Noncompliance, Sections 5.20.1 and 5.20.2. 
All deviations from the protocol will addressed in study participant source documents and 
promptly reported to NIDCR and the local IRB, according to their requirements. 
 
 
 
 
 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
43 
 
16 PUBLICATION/DATA SHARING POLICY 
This study will comply with the NIH Public Access Policy, which ensures that the public has 
access to the published results of NIH funded research. We will submit all final peer-
reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central 
upon acceptance for publication. 
 
The International Committee of Medical Journal Editors (ICMJE) member journals have 
adopted a clinical trials registration policy as a condition for publication. The ICMJE defines a 
clinical trial as any research project that prospectively assigns human subjects to intervention 
or concurrent comparison or control groups to study the cause-and-effect relationship between 
a medical intervention and a health outcome. Medical interventions include drugs, surgical 
procedures, devices, behavioral treatments, process-of-care changes, and the like. Health 
outcomes include any biomedical or health-related measures obtained in patients or 
participants, including pharmacokinetic measures and adverse events. 
 
The ICMJE policy requires that all clinical trials be registered in a public trials registry such as 
ClinicalTrials.gov, which is sponsored by the National Library of Medicine. Other biomedical 
journals are considering adopting similar policies. For interventional clinical trials performed 
under NIDCR grants and cooperative agreements, it is the grantee’s responsibility to register 
the trial in an acceptable registry, so the research results may be considered for publication in 
ICMJE member journals. The ICMJE does not review specific studies to determine whether 
registration is necessary; instead, the committee recommends that researchers who have 
questions about the need to register err on the side of registration or consult the editorial 
office of the journal in which they wish to publish. U.S. Public Law 110-85 (Food and Drug 
Administration Amendments Act of 2007 or FDAAA), Title VIII, Section 801 mandates that a 
"responsible party" (i.e., the sponsor or designated principal investigator) register and report 
results of certain "applicable clinical trials:" NIH grantees must take specific steps to ensure 
compliance with NIH implementation of FDAAA. These steps include; 
 
1. Determine if the competing application or funded grant supports an applicable clinical 
trial that is required under FDAAA to be registered in ClinicalTrials.gov 
2. Include a certification of compliance in the competing grant application and progress 
report. 
3. If the grant supports an applicable clinical trial, then determine which entity or individual is 
the responsible party 
4. If the grantee is not the sponsor and therefore not the responsible party, contact the 
responsible party to ensure that the responsible party registers the trial and reports 
results as appropriate. 
5. If the grantee is not the sponsor and therefore not the responsible party, contact the 
responsible party to ensure that the responsible party registers the trial and reports 
results as appropriate 
6. The responsible party must regularly update information in the applicable clinical trial 
record. 
7. If required, the responsible party must report summary results (including adverse event 
information) not later than 1 year after the trial completion date 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
44 
 
17. References 
1. Institute of Medicine. Relieving Pain in America: A Blueprint for Transforming Prevention, 
Care, Education, and Research. National Academies Press, Washington, DC; June 29, 
2011. 
2. DHHS. National Institutes of Health PA-13-118. Available at 
http://grants.nih.gov/grants/guide/pa-files/PA-13-118.html 
3. The Pain Action Alliance to Implement a National Strategy (PAINS) at 
http://www.painsproject.org 
4. Center for Disease Control and Prevention (CDC), "Prescription Drug Overdose in the 
United States: Fact Sheet," 
http://www.cdc.gov/homeandrecreationalsafety/overdose/facts.html; C. M. Jones, K. A. 
Mack, and L. J. Paulozzi, "Pharmaceutical overdose deaths, United States, 2010," JAMA 
309, no. 7 (2013) 
5. Stewart WF, Ricci JA, Chee E, Morganstein D, Lipton R. Lost Productive Time and Cost 
Due to Common Pain Conditions in the US Workforce. JAMA. 2003;290:2443-2454. 
6. Kato K SP, Evengard B, Pedersen NL. Chronic widespread pain and its co-morbidities: a 
population-based study. Arch Intern Med. 2006;166(15):1649-54. 
7. National Center for Health Statistics. Health, United States, 2006, Special Feature on 
Pain With Chartbook on Trends in Americans. Hyattsville, MD. Available at 
http://www.cdc.gov/nchs/data/hus/hus06.pdf. 
8. Portenoy, R, Zeltzer. A Call to Revolutionize Chronic Pain Care in America: An 
Opportunity in Health Care Reform. MayDayFund, Nov. 4, 2009. 
9. Berland D, Rodgers P. Rational Use Of Opioids For Management Of Chronic Non- 
Terminal Pain. American Family Physician. August 1 2012 Vol. 86 No. 3 
10. CDC. Vital Signs: Overdoses Of Prescription Opioid Pain Relievers—United States, 
1999-2008. Mmwr 2011; 60: 1-6. 
11. Dunn Km, Saunders Kw, Rutter Cm, Banta-Green Cj, Merrill Jo, Sullivan Md, Et Al. 
Opioid Prescriptions For Chronic Pain And overdose: a cohort study. Ann Intern Med. 
2010;152(2):85-92. 
12. Bohnert AS, Valenstein M, Bair MJ, Ganoczy D, McCarthy JF, Ilgen MA, et al. 
Association between opioid prescribing patterns and opioid overdose-related deaths. 
JAMA 2011;305(13):1315-1321. 
13. National Institute of Dental and Craniofacial Research. Facial Pain. 2009 [cited; Available 
from: http://www.nidcr.nih.gov/DataStatistics/FindDataByTopic/FacialPain 
14. DeLeuuw, R (ed.) Orofacial Pain: Guidelines for Assessment, Diagnosis, and 
Management. American Academy of Orofacial Pain. Quintessence. 2013. 
15. Magnusson T, Egermark I, Carlsson GE. A longitudinal epidemiologic study of signs and 
symptoms of temporomandibular disorders from 15 to 35 years of age. Journal of 
Orofacial Pain. 2000, 14(4):310-319 
 
16. LeResche L, Mancl LA, Drangsholt MT, Huang G, Von Korff M. Predictors of onset of 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
45 
 
facial pain and temporomandibular disorders in early adolescence. Pain. 2007; 129(3): 
269-78. 
17. Von Korff M, Le Resche L, Dworkin SF. First onset of common pain symptoms: a 
prospective study of depression as a risk factor. Pain. 1993; 55(2): 251-8. 
18. Lim PF, Smith S, Bhalang K, Slade GD, Maixner W. Development of temporomandibular 
disorders is associated with greater bodily pain experience. Clin J Pain. 2010; 26(2): 116-
20. 
19. Aggarwal VR, Macfarlane GJ, Farragher TM, McBeth J. Risk factors for onset of chronic 
oro-facial pain- results of the North Cheshire oro-facial pain prospective population study. 
Pain. 2010; 149(2): 354-9. 
20. Wagner TH, Baker LC, Bundorf MK, Singer S. Use of the Internet for health information by 
the chronically ill. Prev Chronic Dis. Oct 2004;1(4):A13. 
21. Kaelber, DC, Shah, S, Vincent, A, Pan, E, Hook, J, Johnston, D, Bates, D, and 
Middleton, B, The Value of Personal Health Records. Center for Information 
Technology Leadership. Charleston, Mass. 2008. 
22. Kvedar, JC (ed) Partners Center for Connected Health: Community Healthcare Discussion 
Report www.connected-health.org. 
23. Winkelman W & Leonard K. Overcoming Structural Constraints to Patient Utilization of 
Electronic Medical Records: A Critical Review and Proposal for an Evaluation Framework. 
JAMIA. 2004 11:151-161. 
24. Eaton LH, Doorenbos AZ, Schmitz KL, Carpenter KM, McGregor BA. Establishing 
treatment fidelity in a web-based behavioral intervention study. Nurs Res. 2011 Nov- 
Dec;60(6):430-5 
25. Wantland DJ, Portillo CJ, Holzemer WL, Slaughter R, McGhee EM. The effectiveness of 
Web-based vs. non-Web-based interventions: a meta-analysis of behavioral change 
outcomes. J Med Internet Res. 2004 Nov 10;6(4):e40. 
26. Paul CL, Carey ML, Sanson-Fisher RW, Houlcroft LE, Turon HE. The impact of web- 
based approaches on psychosocial health in chronic physical and mental health 
conditions. Health Educ Res. 2013 Jun;28(3):450-71. 
27. Fricton JR, Nelson A, Monsein M. IMPATH: microcomputer assessment of behavioral 
and psychosocial factors in craniomandibular disorders. Cranio 1987;5(4):372-81. 
28. Paone, D, Konreddy, H, Fricton, J. Partners in Care Health Information Technology Tool 
to Facilitate Senior’s Health and Function. Konreddy M.S. Thesis, University of 
Minnesota, 2010. 
29. Fricton, J, Davies D. Personal Health Records to Improve Health Information Exchange 
and Patient Safety in Advances in Patient Safety: New Directions and Alternative 
Approaches (eds: Henriksen, K Battles, JB, Keyes, MA, Grady, ML, Grady, ML) AHRQ, 
2008. 
30. Jimison H, Gorman P, Woods S, Nygren P, Walker M, Norris S, Hersh W. Barriers and 
Drivers of Health Information Technology Use for the Elderly, Chronically Ill, and 
Underserved. Evidence Report/Technology Assessment No. 175 (Prepared by the Oregon 
Evidence-based Practice Center under Contract No. 290-02-0024). AHRQ Publication No. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
46 
 
09-E004. Rockville, MD: Agency for Healthcare Research and Quality. November 2008. 
31. Riddle M., Clark, D. Behavioral and social intervention research at the National Institute of 
Dental and Craniofacial Research (NIDCR) Journal of Public Health Dentistry. Special 
Issue: Behavioral and Social Intervention Research Essentials. Volume 71, Issue 
Supplement s1, pages S123–S129, Winter 2011 
32. Truelove, E, Huggins, K, Manel, L, Dworkin, S. JADA The efficacy of traditional, low- cost 
and nonsplint therapies for temporomandibular disorder: A randomized controlled trial. 
JADA August 2006 137(8): 1099-1107. 
33. Schiffman EL, Look JO, Hodges JS, Swift JQ, Decker KL, Hathaway KM, Templeton 
RB, Fricton JR. Randomized effectiveness study of four therapeutic strategies for TMJ 
closed lock. J Dent Res. 2007 Jan;86(1):58-63. 
34. Fricton, J, Velly, A. Ouyang W., Look, J. Does exercise therapy improve headache? A 
systematic review with meta-analysis. Current Pain & Headache Reports 13(6):413-419, 
2009. 
35. Fricton, J, Look, JO, Wright, E, Alencar, F, Chen, H, Lang, M, Ouyang, W, Velly, AM. 
Systematic Review  of   Intraoral  Orthopedic  Appliance  for   Temporomandibular 
Disorders: 51 RCTs Reviewed. J Orofacial Pain 24:237-54.2010. 
36. Komiyama O, Kawara M, Arai M, Asano T, Kobayashi K. Posture correction as part of 
behavioural therapy in treatment of myofascial pain with limited opening. Journal of Oral 
Rehabilitation. 1999;26(5):428-35. 
37. Turk DC, Rudy TE, Kubinski JA, Zaki HS, Greco CM. Dysfunctional patients with 
temporomandibular disorders: evaluating the efficacy of a tailored treatment protocol. J 
Consult Clin Psychol 1996;64(1):139-46. 
38. Dworkin SF, Sherman J, Mancl L, Ohrbach R, LeResche L, Truelove E. Reliability, 
validity, and clinical utility of the research diagnostic criteria for Temporomandibular 
Disorders Axis II Scales: depression, non-specific physical symptoms, and graded 
chronic pain. J Orofac Pain. 2002;16(3):207-20. 
39. Dworkin SF, Huggins KH, Wilson L, Mancl L, Turner J, Massoth D, et al. A randomized 
clinical trial using research diagnostic criteria for temporomandibular disorders-axis II to 
target clinic cases for a tailored self-care TMD treatment program. J Orofac Pain 
2002;16(6):48-63. 
40. Schiffman EL, Ohrbach R, Truelove EL, Tai F, Anderson GC, Pan W, Gonzalez YM, John 
MT, Sommers E, List T, Velly AM, Kang W, Look JO. The Research Diagnostic Criteria for 
Temporomandibular Disorders. V: methods used to establish and validate revised Axis I 
diagnostic algorithms. J Orofac Pain. 2010 Winter;24(1):63-78. 
41. Institute for Healthcare Improvement’s (IHI) Triple Aim found at 
http://www.ihi.org/offerings/Initiatives/TripleAim. 
42. Turner JA, Mancl L, Aaron LA. Brief cognitive-behavioral therapy for 
temporomandibular disorder pain: effects on daily electronic outcome and process 
measures. Pain 2005;117(3):377-87. 
43. Flor H1, Birbaumer N. Comparison of the efficacy of electromyographic biofeedback, 
cognitive-behavioral therapy, and conservative medical interventions in the treatment of 
chronic musculoskeletal pain. J Consult Clin Psychol 1993;61(4):653-8. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
47 
 
44. Turner JA, Holtzman S, Mancl L. Mediators, moderators, and predictors of therapeutic 
change in cognitive-behavioral therapy for chronic pain. Pain 2007;127(3):276-86 
45. LeResche L. Epidemiology of temporomandibular disorders: Implications for the 
investigation of etiologic factors. Crit Rev Oral Biol Med. 1997; 8: 291-305. 
46. Maixner W, Greenspan JD, Dubner R, Bair E, Mulkey F, Miller V, Knott C, Slade GD, 
Ohrbach R, Diatchenko L, et al. Potential autonomic risk factors for chronic TMD: 
descriptive data and empirically identified domains from the OPPERA case-control study. 
J Pain. 2011 Nov; 12(11 Suppl):T75-91. 
47. Ohrbach R, Fillingim RB, Mulkey F, Gonzalez Y, Gordon S, Gremillion H, Lim PF, Ribeiro-
Dasilva M, Greenspan JD, Knott C, , et al. Clinical findings and pain symptoms as potential 
risk factors for chronic TMD: descriptive data and empirically identified domains from the 
OPPERA case-control study. J Pain. 2011 Nov; 12(11 Suppl):T27-45. 
48. Mansour M. Systems theory and human science (2002) Annual Reviews in Control, 
(26)1:1-13 
49. Bailey K. (2006). Living systems theory and social entropy theory. Systems Research 
and Behavioral Science, 22, 291-300. 
50. Wylie KR, Jackson C, Crawford PM. Does psychological testing help to predict the 
response to acupuncture or massage/relaxation therapy in patients presenting to a 
general neurology clinic with headache? Journal of Traditional Chinese Medicine. 
1997;17(2):130-9. 
51. Elliot NG, Donna PF. Factors associated with successful outcome from behavioral 
therapy for chronic temporomandibular joint (TMJ) pain. Journal of Psychosomatic 
Research 1984;28(6):441-8. 
52. Turner JA, Holtzman S, Mancl L. Mediators, moderators, and predictors of therapeutic 
change in cognitive-behavioral therapy for chronic pain. Pain 2007;127(3):276-86. 
53. Little P, Roberts L, Blowers H, et al. Should we give detailed advice and information 
booklets to patients with back pain?: a randomized controlled factorial trial of a self- 
management booklet and doctor advice to take exercise for back pain. Spine 
2001;26:2065-72. 
54. Fricton, J., Nelson, A., Monsein, M.: IMPATH: Microcomputer assessment of 
behavioral and psychosocial factors in craniomandibular disorders. J of 
Craniomandibular Practice, 5(4):372-381, 1987. 
55. Fricton, J, Oleson, T. Predictors of outcome for treatment of temporomandibular 
disorders. J Orofacial Pain. 10(1) 1996, 54-66. 
56. Turk DC, Okifuji A. Psychological factors in chronic pain: evolution and revolution. J 
Consult Clin Psychol 2002;70(3):678-90. 
57. Turk DC, Rudy TE. Toward an empirically derived taxonomy of chronic pain patients: 
integration of psychological assessment data. J Consult Clin Psychol 1988;56(2):233-8. 
58. Velly AM, Look JO, Schiffman E, Lenton PA, Kang W, Messner RP, Holcroft CA, 
Fricton JR. The Effect of Fibromyalgia and Widespread Pain on the Clinically 
Significant Temporomandibular Muscle and Joint Pain Disorders-A Prospective 18- 
Month Cohort Study. J Pain. 2010 May 11. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
48 
 
59. Velly AM, Look JO, Carlson C, Lenton PA, Kang W, Holcroft CA, Fricton JR. The effect 
of catastrophizing and depression on chronic pain – a prospective cohort study of 
temporomandibular muscle and joint pain disorders. Pain 2011; 152(10):2377-83 
60. Velly AM, Fricton JR. The impact of comorbid conditions on treatment of 
temporomandibular disorders. J Am Dent Assoc. 2011 Feb;142(2):170-2. 
61. Foster G, Taylor SJC, Eldridge SE, Ramsay J, Griffiths CJ. Self-management 
education programmes by lay leaders for people with chronic conditions. Cochrane 
Database Syst Rev. 2007;17(4):CD005108. 
62. Gensichen J, von Korff M, Peitz M, et al. Case management for depression by health 
care assistants in small primary care practices. Ann Intern Med. 2009;151:369-378. 
63. Debora Duarte Macea, Krzysztof Gajos, Yasser Armynd Daglia Calil, Felipe Fregni. The 
Efficacy of Web-Based Cognitive Behavioral Interventions for Chronic Pain: A Systematic 
Review and Meta-Analysis. The Journal of Pain. 2010 11(10): 917-929. 
64. van den Berg MH, Schoones JW, Vliet Vlieland TP. Internet-based physical activity 
interventions: a systematic review of the literature. J Med Internet Res. 2007 Sep 
30;9(3):e26. 
65. Bartholomew, LK, Mullen, PD. Five roles for using theory and evidence in the design and 
testing of behavior change interventions. Journal of Public Health Dentistry. Special Issue: 
Behavioral and Social Intervention Research Essentials. Volume 71, Issue Supplement s1: 
1752-7325, 2011 
66. Fry JP, Neff RA. Periodic prompts and reminders in health promotion and health behavior 
interventions: systematic review. J Med Internet Res. 2009 May 14;11(2):e16. doi: 
10.2196/jmir.1138. 
67. Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, 
Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz 
S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, 
McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, 
Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, J; W. IMMPACT. Pain 2005;113:9-
19. 
68. Von Korff M, Ormel J, Keefe FJ, Dworkin SF. Grading the severity of chronic pain. Pain 
1992;50(2):133-49. 
69. Elliott AM, Smith BH, Smith WC, Chambers WA. Changes in chronic pain severity over 
time: the Chronic Pain Grade as a valid measure. Pain 2000;88:303–8 
70. Anderson KO, Dowds BN, Pelletz RE, Edwards WT, Peeters-Asdourian C. Development 
and initial validation of a scale to measure self-efficacy beliefs in patients with chronic 
pain. Pain 1995, (63) 1:77-83. 
71. Hibbard JH, Stockard J, Mahoney ER, and Tusler M. Development of the Patient 
Activation Measure (PAM): Conceptualizing and Measuring Activation in Patients and 
Consumers. Health Serv Res. 2004 Aug; 39(4 Pt 1): 1005–1026. at 
http://www.insigniahealth.com/solutions/patient-activation-measure. 
72. Sullivan M J L, Bishop S, Pivik J. The Pain Catastrophizing Scale:  Development and 
validation. Psychol Assess 1995, 7: 524-532 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
49 
 
73. Kroenke K, Spitzer RL, Williams JBW. The PHQ-9. Validity of a Brief Depression Severity 
Measure. J Gen Intern Med. Sep 2001; 16(9): 606–613. 
74. Cohen, S., Kamarck, T., and Mermelstein, R. (1983). A global measure of perceived 
stress. Journal of Health and Social Behavior, 24, 386-396. 
75. Cohen, S., & Janicki-Deverts, D. (2012). Who's stressed? Distributions of psychological 
stress in the United States in probability samples from 1983, 2006 and 2009. Journal of 
Applied Social Psychology, 42, 1320-1334. 
76. World Health Organization. WHO STEPS Surveillance Manual: The WHO STEPwise 
Approach to Chronic Disease Risk Factor Surveillance. Geneva, Switzerland: World 
Health Organization; 2005:7. 
77. Gomes JL, Kingma M, Kamper SJ, Maher CG, Ferreira PH, Marques AP, Ferreira ML. 
The association between symptom severity and physical activity participation in people 
seeking care for acute low back pain. Eur Spine J. 2015 Mar;24(3):452-7. PMID: 
25597041. 
 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
Based on NIDCR Clinical Trial (Interventional) Protocol Template v4.0 - 20140103 
50 
 
 
SUPPLEMENTAL MATERIALS AND APPENDICES 
 
Appendix A. 
Schedule of Events  
Appendix B. 
PACT Content and Text for Introductory Video 
Appendix C. 
Traditional Self-Care Protocol  
Appendix D. 
Health Coach Phone Protocol for PACT Arm  
Appendix E. 
Telephone screen  
Appendix F. 
Sample Consent Form  
Appendix G. 
Data Collection Surveys at Baseline, 8 and 16 Week Post 
 
Intervention 
Appendix H. 
Qualitative Interview  
Appendix I. 
Barriers to use of Consumer Health Information Technology (CHIT) 
Appendix J. 
Data Management and Safety Plan 
 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
51 
 
APPENDIX A: SCHEDULE OF EVENTS 
Below is a schedule of events that include initial, intermediate, and final study visits, and 
all contacts with participants, e.g., telephone, website, screening, and other contacts 
includes the permissible time windows for study visits, For each visit, the purpose and 
description of what will occur at the visit. 
 
Contacts with 
participant 
Identificatio
n 
Phase 
Telephone 
Screening 
Phase 
Consent 
Phase 
 
Intervention 
Phase 
1st Post- 
Interventio
n Phase 
           
2ndPost- 
intervention 
Phase 
 
Interview 
Phase 
Time Period (weeks) 
Week 1  
Pre- 
 
Week 0 
Pre- 
 
Week 0 
Pre- 
Week 1-8 
Intervention 
 
Week 8 
Post- 
 
Week 16 
Post- 
 
Week 16 
Post- 
EMR List of 
TMD patients 
 
X 
 
 
 
 
 
 
Demographics 
information 
 
X 
 
X 
 
 
 
 
 
Inclusion/ Exclusion 
Criteria 
 
 
X 
 
 
 
 
 
Recruitment 
 
 
 
X 
 
X 
 
 
 
Consent/ HIPPA 
Form 
 
 
 
X 
X 
 
 
 
Baseline 
Questionnaire 
 
 
 
X 
X 
 
 
 
 
Intervention 
Compliance/ 
adherence 
 
 
 
 
X 
 
 
 
Coach support 
 
 
 
X 
 
 
 
Outcomes 
Compliance/ 
adherence 
 
 
 
 
 
X 
 
X 
 
 8 week 
Questionnaire 
 
 
 
 
 
X 
 
 
16 week 
Questionnaire 
 
 
 
 
 
 
X 
 
Qualitative interviews 
 
 
 
 
 
 
X 
Adverse Event 
Reporting 
 
 
 
 
X 
 
X 
 
 
 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
52 
 
APPENDIX B: PACT CONTENT AND TEXT FOR INTRODUCTORY VIDEO 
 
Description. The PACT program is an innovative self-management training program of care 
that focuses on integrating robust self-management training with a health coach to engage, 
empower and educate participants to reduce risk factors and enhance protective factors for the 
condition. In 2011, the Institute of Medicine (IOM) stated that health professional’s primary role 
for chronic pain should be guiding, coaching, and assisting participants with day-to-day self-
management of chronic pain and established research involving self-management as one of 
the highest priority topics. 
 
To support self-management, the use of web-based on-line programs has been applied to train 
participants in self-management for many chronic conditions, but has not yet been applied to 
participants with pain conditions such as TMD. The use of on-line training with health coaches 
have distinct advantages that require minimal change in work-flow and time commitment of 
busy health professionals while making the innovative care model affordable, rapidly deployed, 
scalable, and transferable to other settings and conditions. 
 
A. Background to the PACT program. Humans are complex, multi-dimensional, and dynamic 
beings and live within an ever-changing physical and social environment that contributes to 
the balance between health and illness. Yet, our traditional biomedical model is based on a 
scientific paradigm that is uni-dimensional, reductionistic, and inflexible that is based 
primarily on understanding the underlying pathophysiology. Health care professionals tend 
to see what they treat and treat what they see. If they see only the pathophysiology, they do 
not recognize and understand the complex risk and protective factors that interact and play 
a powerful role in the onset, perpetuation, and progression of any illness. As a result, 
success of treatment is often compromised by limited approaches that only address part of 
the problem. When treatment approaches are limited, outcomes are limited. This explains 
why systematic reviews of efficacy of nearly every biomedical treatment for chronic illnesses 
have shown that even with the most efficacious treatments, they improve outcomes by only 
slightly above placebo. Patients have more influence over the outcomes of their illness than 
any treatment provided by clinicians. Thus, when evidence-based biomedical treatments are 
combined with robust self-management training, they have transformed the patient from one 
of illness to health and wellness– thus, the development of a transformative care model. The 
clinical paradigms associated with the PACT program are described in Table 1. This is the 
basis for the PACT program and its 8 lessons. 
 
Table 1. Clinical paradigms associated with the PACT program 
New paradigm 
Description and presenting concept 
Understand the whole 
patient 
We need to identify all diagnoses, risk factors, and protective 
factors in the 7 realms of life (body, mind, spirit, lifestyle, emotion, 
social, and physical environment) to shift the balance from illness to 
health. 
Each patient is 
complex 
There are usually multiple conditions and interrelated contributing 
factors may initiate, result from, increase risk, or decrease risk of 
illness. Each need to be addressed as part of comprehensive 
management strategy. 
Self-responsibility is 
You have more influence on the problem than any treatment 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
53 
 
key to recovery 
provided. Will you take ownership and control of the condition? 
Self-care 
You will need to make daily changes in order to improve your 
condition. Will you be willing to take the time to do this? 
Education and training 
We will teach you how to make these changes. 
Long-term change 
Change only occurs over time and it may take months for the 
changes to have a large impact on reducing pain and symptoms.  
Strong provider-patient 
partnerships 
We, as health professionals, will support you as you make the 
changes. We can be an agent to help you change. 
Personal motivation  
Will you be able to make the changes needed? 
Social support 
You may need help to make these changes. 
Change process 
Change will occur incrementally over time. 
Fluctuation of progress  Expect ups and downs during the recovery process. 
 
B. Components of the PACT program. The total commitment time by patient to participate in 
the PACT program is about 1 hour of on-line education per week and 1 hour of activity per 
day for healthy habits and calming practice. In addition, there are several PAUSES during 
the day to pay attention to what is happening without judging in each of the 7 realms: Body, 
Lifestyle, Mind, Emotion, Spirit, Social life, and Environment (Table 2). The program includes 
the following components; 
 
 PACT with the Patient. All patients make a commitment to the program by signing a PACT 
agreement with the health professional and the health coach. This highlights the patient’s 
responsibility in complying  with  the  self-management. 
 Personalized Risk and Protective Factor Assessment. A self-assessment of the condition 
and its contributing factors is administered online or on paper, at home or in the office. The 
results are reviewed by the HCC to provide a personalized action plan to engage the 
patient in self-management, lifestyle changes and shared decision-making. 
 PACT On-line training. Based on the assessment, experiential lessons are generated to 
recommend exercises and lifestyle changes to improve the condition, reduce risk factors 
for delayed recovery, and enhance protective factors that encourage healing. The PACT 
program for pain conditions consists for 8 Lessons designed for an 8-week program. Each 
lesson includes about 4 to 5 ten-minute video sessions for a total of about 50 minutes per 
week. They start with a brief self-assessment to personalize the recommendations 
followed with recommended video sessions based on the risk factors present and 
protective factors that are weak. The program includes both print handouts on the content 
and experiential daily changes that are recommended. A diary is provided to track daily 
practice and achievement in goals. The lessons are focused on understanding the big 
picture of their condition, how it can be improved by the balance between risk and 
protective factors in a person’s life. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
54 
 
 Animated Characters. On-line training programs need to be brief, to the point, and 
engaging to have participants maintain interest over the 8 weeks of the program. One of 
the important elements is the animated characters that present the content. In PACT, we 
have 4 diverse characters with distinct positive personalities that present the content. 
Professor James Payne is a distinguished professor, researcher, and pain specialist who 
presents the lessons but also tells stories of the many patients he has managed over the 
years. Action Annie is a perky plain-speaking trainer whose main job is to help the 
participant implement their action plan within their lifestyle. Calming Kate is an 
experienced health professional who teaches mindfulness-based stress reduction with a 
calm voice, enlightening dialogue, and guided imagery. Barrier Bob is a no-nonsense 
barrier buster who helps participants identify and change barriers that may be confronted 
on the way to changing a person’s health and life.     
 TeleHealth Coach (THC). THCs are well-trained and certified health professionals who 
review assessments and provide self-management training to patients to facilitate their 
knowledge and skills necessary for self- management of chronic conditions. The process 
incorporates the needs, goals and life experiences of the patients and is guided by 
evidence-based interventions for the target condition. 
 Reminders. Reminders can be sent through on-line platform on an opt-in basis for 
participants to schedule health coach visits, track progress, identify adverse events, or 
personalize self-management protocols. Participants have the choice of electronic options 
such as email, social media, and phone messaging. 
 Outcomes Dashboard. The PACT website will provide updates of participant’s progress and 
change in assessments as part of the PACT program. 
 Action Plan. The action plan that is generated for each patient includes 3 components: 
Healthy habits, daily PAUSEs, and calming practice. Health habits means taking 
dedicated time each day to work on enhancing protective factors in order to decrease risk 
factors. PAUSE now means taking a time-out pause to check-in on what you are doing 
right now in a non-judgmental way. This is essential to living a life that is in the present 
and mindful of each protective factor to enhance health and well-being. P-pause, A-
assess, U-understand, S-Start fresh, and E-energize with protective actions to achieve a 
long now. 
 Calming practice includes spending a few minutes each day doing a brief relaxation 
technique allows many benefits. These include meditation to calm the mind, relaxing the 
muscles and nerves, contemplation about your life, prayer to ask for help, and reflection 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
55 
 
on how you will move forward. 
 Support team. Having friend or family team member who can support you and encourage 
you along your journey will help you be successful. If you haven't already, you will get 
another chance to sign up a teammate before you start Lesson 2, or can add one at any 
time using the team of your dashboard.  
 
Table 2. Description of the 7 realms in human systems approach to preventing chronic pain 
Realm 
Description 
Protective Factors 
Risk Factors 
Body 
Physical and 
physiologic 
aspects of the 
body 
Balanced relaxed posture, 
stretching, strengthening, and 
conditioning exercise 
Genetic risk, comorbid 
conditions, poor posture, tight 
weak muscles, hypo- or 
hypermobile joints, poor 
conditioning, and injury 
Lifestyle 
Lifestyles and 
behaviors that 
we do regularly  
Protective diet, steady 
pacing, being active, regular 
sleep, low risk behaviors, 
high energy, and compliance 
with protective actions 
Poor diet, sedentary life, 
prolonged sitting, poor sleep, 
hurrying/rushed, repetitive 
strain, high risk behaviors, 
chemical use, low energy 
Emotions 
Positive and 
negative feelings 
we experience 
Sustained positive emotions, 
such as joy, excitement, 
confidence, optimism, 
happiness, and contentment 
Prolonged negative emotional 
experiences, anger, anxiety, 
sadness, fear, and depression 
Social Life 
Social 
relationships 
with the people 
around us  
Positive relationships, social 
support, helping others, 
reward for recovery, eg, 
family, friends, colleagues, 
community, society  
Poor relationships, conflict, 
abuse, posttraumatic stress, 
low social support, isolation, 
secondary and tertiary gain 
Spirit 
Higher beliefs 
and purposes 
that drive us 
Purpose, direction, beliefs, 
faith, hope, self-compassion, 
and self-esteem  
Stress, burnout, disbelief, 
cynicism, doubt, helpless, and 
hopelessness  
Mind 
Thoughts and 
attitudes 
Whole understanding, 
resilience, self-efficacy, self-
control, accepting 
responsibility, realistic 
expectations, and engaging 
in active coping 
Ignorance of problem, low 
resilience, low self-
efficacy/control, refuse 
responsibility, poor compliance, 
unrealistic expectations, and 
passive coping 
Environment 
Physical 
environment that 
surrounds us 
Clean, organized, safe 
environment, and an 
approach that is protective, 
cautious, and careful  
Living within an unclean, 
chaotic, and disorganized 
environment with activities that 
are negligent, dangerous, risky, 
and increase risk of injury, 
accident, and trauma 
 
C. Lesson Content 
Lesson 1. Understanding Pain: The balance between health and illness. 
“The good physician treats the disease; the great physician treats the patient who has the 
disease.”- Sir William Osler. This lesson helps patients understanding their big picture of their 
health and illness and how risk factor and protective factors in each realm of our life can play a 
role. Several concepts are explained in simple ways for patients to understand and are 
integrated into the PACT program and explained in this first lesson in a simple format.  

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
56 
 
 Human System’s Theory (HST) explains the importance of understanding the whole person 
who has chronic pain and all risk and protective factors that contribute to their health or 
illness and not simply the physical and pathophysiologic. The whole becomes greater than 
the sum of its parts. Seven realms of our lives include the mind, body, and spirit that interact 
with the social and physical environment through behavioral and emotional processes.  
 Cybernetics explains how specific factors can generate a change which leads to either 
positive or negative feedback to the whole system. Thus, each realm of our lives are 
connected to the others and influences whether we maintain health or develop an illness.  
 Chaos Theory explains how small differences in initial conditions of the dynamic human 
system will often yield widely diverging outcomes. This suggests that the“little things” we do 
every day of our lives matter significantly over time to determine if we maintain health or 
develop chronic pain or illness. When applied to of multiple risk and protective factors have a 
large chronic illness. However, when these factors are combined they will accelerate the 
condition dramatically. 
 Behavioral medicine theories suggests that many chronic diseases have a behavioral 
component and these illnesses can be significantly and directly modified by behavior to 
supplement pharmacological or surgical treatments.  
 Cognitive- behavioral therapy (CBT) has been shown to be very effective for changing 
lifestyle factors that lead to chronic pain. The principles of Positive Psychology are also 
presented in these lessons suggesting that it is as effective to enhance protective factors 
through cultivating positive behaviors and virtues as it is with weakness and vices. Therapy 
is directed at improving the positive aspects of lives of normal people such as happiness, 
health, and wellness as much as healing illness, pain, and dysfunction.  
The sessions include; 
1. Introduction: How the program works. Understanding chronic pain: why it is such a 
problem for people, and how to best manage it. Understanding your pain by taking the 
self-assessment  
2. Understanding ourselves: The big picture of health and illness and the pain cycles and 
balance that occur between risk factors and protective factors. How little changes can 
have a big impact. Assess your risk and protective factors and the goals of how we want 
to be. 
3. Conditions: a summary of musculoskeletal, neuropathic, and neurovascular pain 
disorders 
4. Treatments: A review of pain treatments including medications and opioids, how to use 
them, their relative efficacy from systematic reviews in a simple easy to understand 
format. Preventing medical and dental treatment risks and chronic pain 
5. Causes: Review of the most common onset and perpetuating factors for chronic pain 
conditions 
6. Self-management: Training on self-management to be integrated with treatments to 
ensure pain problems are optimally managed. Using trigger point massage. 
7. Self-care for pain conditions 
8. Action Annie: Taking action with healthy habits, daily pauses, and calming practice 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
57 
 
9. Barrier Bob: Identifying barriers with solutions to ensure long-term compliance 
10. Calming Kate: Reviewing the principles and strategies for calming practice to calm the 
brain, relax the body, and gain insight into their lives.  
Lesson 2 Body: Exercise, posture, and reducing strain. 
This lesson focuses on the physical and pathophysiologic aspects of the body. Protective factors 
include balanced posture, relaxation exercise, stretching exercise, strengthening exercise, 
conditioning exercise, and genetic factors. Risk factors include poor posture, tense tight 
muscles, hypo- or hyper-mobile joints, weak muscles, and poor conditioning.  
The sessions include; 
1. Introduction to Your Body 
2. Assessment of physical risk and protective factors 
3. Stretch and strengthen: Feeling good each day 
4. Reducing strain: Preventing Pain 
5. Posture and Relaxation 
6. Fitness for Relief 
7. Case illustration 
8. Action Annie: action plan for stretching, strengthening, and fitness.  Taking pauses to 
scan for posture and strain  
9. Barrier Bob to overcome barriers to exercise with specific solutions 
10. Calming Kate for relaxing the body 
 
Lesson 3 Lifestyle: Diet, sleep, and energy. 
This lesson focuses behaviors and actions that we do on a daily basis that play a role in 
chronic pain. Protective factors including diet, activity level, sleep, pacing, variation in 
lifestyle, low risk behaviors, and how dietary supplements can be used. Risk factors include 
poor diet, inactivity, prolonged sitting, poor sleep, hurrying/ rushed, repetitive strain, high-risk 
behaviors, and adverse events from chemical use. Sessions include 
1. Introduction to your lifestyle and lifestyle cycles 
2. Assessment of your lifestyle risk and protective factors 
3. Active Lifestyle: Maximizing the lifestyle treadmill 
4. Pain-free Diet: Diet, nutrition, weight, and eating disorders in chronic pain 
5. Restful Sleep to Prevent Chronic Pain 
6. Substance Use and Abuse: Preventive use of substances, smoking, and illicit drug 
use 
7. Case illustration 
8. Action Annie: action plan for diet and sleep. Taking pauses to check-in on substance use 
and pacing. 
9. Barrier Bob to overcome barriers to lifestyle problems with specific solutions 
10. Calming Kate for maximizing your lifestyle 
 
Lesson 4 Mind: Improve understanding, self-efficacy, and resilience 
This lesson focuses on the thoughts and attitudes that we experience and how they impact 
chronic pain, health, and well-being. Protective factors include understanding whole problem, 
resilience and ability to rebound, self-efficacy and self-control, accepting responsibility, 
compliance, realistic expectations, and active coping. Risk factors include ignorance of 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
58 
 
problem, low resilience, low self-efficacy/ control, denying responsibility, poor compliance, 
unrealistic expectations, and passive coping.  
Sessions include;  
1. Introduction to your Mind and your mind cycles 
2. Assessment of cognitive risk and protective factors 
3. Resilience & Coping: bouncing back from adversity 
4. Everyday Optimism: Change your mind: Change your pain 
5. Self-Efficacy: You can do it. 
6. Realistic Expectations: 
7. Case illustration 
8. Action Annie: Steps to boost understanding, self-efficacy, and resilience. Taking pauses 
to check-in on automatic thoughts, understanding, expectations 
9. Barrier Bob to overcome barriers to lifestyle problems with specific solutions 
10. Calming Kate for maximizing your lifestyle 
 
Lesson 5 Emotions: Managing emotional challenges and pain. 
This lesson focuses on the personal expressions of feelings that we experience and how they 
play a role in chronic pain. Protective factors include emotional experiences such as feeling joy, 
confidence, calm, happiness, contentment, and optimism. Risk factors include anger, anxiety, 
nervousness, sadness, and depression.  Emotions can fluctuate daily and even hourly 
depending on the situation. Like pain in different areas of the body, it is important to recognize 
and talk about emotions, both positive and negative, and the reasons we have them. When do 
we feel happiness, contentment, calmness, excitement, passion or other emotions? On the 
other hand, when do we feel sadness, anxiety, depression, anger, or fear? This module allows 
us to focus on the activities and relationships that bring more positive emotions, which reduces 
chronic pain, than negative emotions that increase pain. In addition, pay attention to and ask 
about emotions in other people. “How do you feel?” Sessions include;  
1. Introduction to your emotions: the volume control on chronic pain,  
2. Assessment of emotional risk and protective factors,  
3. Lifting Depression & Sadness,  
4. Calming Anxiety & Fear,  
5. Resolving Anger & Frustration 
6. Overcoming Guilt & Shame 
7. Case illustration 
8. Action Annie: Harnessing positive psychology, creativity, and emotions for healing. 
Taking pauses to check-in on emotions. 
9. Barrier Bob to overcome barriers to lifestyle problems with specific solutions 
10. Calming Kate for maximizing your lifestyle 
 
Lesson 6 Spirit: Purpose, passion, and pain 
This lesson focuses on how purpose, beliefs, and passions that drive our health and wellness 
and how this can either drive stress, burn-out, and chronic pain or protect us from it. Protective 
factors include self-compassion, self-esteem, purpose and direction in life, beliefs, faith, hope, 
and optimism about the future. Risk factors include stress and burnout, disbelief/ cynicism, 
doubt, hopelessness, pessimism, feeling lost, meaningless in life, hate, loathing, and low self-
esteem. Sessions include; 
1. Introduction to Your Spirit and Brain neuroplasticity 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
59 
 
2. Assessment of spirit risk and protective factors 
3. Healing Power of Purpose and Passion 
4. Self-Compassion: Coming back to yourself and the efficacy of self-compassion 
5. Finding Hope & Faith in recovery 
6. Grit & Determination 
7. Case illustration 
8. Action Annie: Harnessing positive psychology, creativity, and emotions for healing. 
Taking pauses to check-in on emotions. 
9. Barrier Bob to overcome barriers to lifestyle problems with specific solutions 
10. Calming Kate for maximizing your lifestyle 
 
Lesson 7 Social Life: Social support for recovery 
This lesson focuses on the people that surround us on a daily basis and how this social 
environment can impact chronic pain, health, and well-being. Protective factors include 
helping others, creating harmony and peace, social support and it’s characteristics such as 
being tolerant, flexible, and treated as a healthy and well person even when illness to avoid 
secondary gain. Risk factors include being self-centered, conflict, abuse, post-traumatic 
stress, lack of support, secondary and tertiary gain, being intolerant and demanding. Sessions 
include; 
1. Introduction to your Social life and impact of social relationships on the brain,  
2. Assessment of social risk and protective factors,  
3. Social Support and its healing potential 
4. Love & Belonging 
5. Work Well-being: Disability, secondary gain, and the socioeconomics of pain 
6. Releasing Social Stress: Abuse, conflict, Post-traumatic Stress as Pain Amplifiers 
7. Case illustration 
8. Action Annie: Getting and giving the social support we need. Taking pauses to check-in 
on relationships. 
9. Barrier Bob to overcome barriers to lifestyle problems with specific solutions 
10. Calming Kate for maximizing your lifestyle 
 
Lesson 8 Environment: Creating a safe and protective environment 
This lesson focuses on factors in the physical environment that surrounds us and interact with 
every day. It can be both natural and man-made and can have a large impact on chronic pain 
as well as our health and well- being. Protective factors include how to create a clean, 
organized, and safe surrounding that is protective and careful of our health and well-being and 
not lead to injury and pain. Risk factors include living within an infectious, unclean, negligent, 
and chaotic physical environment that can be dangerous, threatening, accident- and injury-
prone that may injure us and cause chronic pain to persist. 
Sessions include; 
1. Introduction to Your Environment 
2. Assessment of environmental risks and their impact on chronic pain 
3. Safe Living: Preventing accidents and chronic pain 
4. Decluttering Your Life 
5. Clean & Healthy: Preventing infection with cleanliness 
6. Living Pollution Free 
7. Case illustration 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
60 
 
8. Action Annie:  Protect yourself: conduct an environmental scan of risk factors. Taking 
pauses to check-in on your environment for safety 
9. Barrier Bob to overcome barriers to lifestyle problems with specific solutions 
10. Calming Kate for maximizing your lifestyle 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
61 
 
Protective and Risk Factors of the PACT Intervention 
 
 
The PACT program website 
The goal of the PACT TMD web application is to provide a smooth, easy to navigate and rich 
user interface to the participants enrolled in the TMD Pain Study and to the health coaches, 
study coordinators and investigator. 
 
System Architecture/Infrastructure: This application provides secure anywhere/anytime 
remote access to all stakeholders. It is compatible with portable devices such as tablets and 
smart phones. This application uses 3- tier architecture standards with browser based front 
end thin client, Apache Tomcat application server as middleware and Oracle relational 
database as the backend platforms. Java, J2EE constitutes application's knowledge base. 
Application utilizes the J2EE based MVC (Model View Control) architecture to handle the 
application request-response workflow and supports JSP. Application is compatible with OSGi 
based J2EE containers to ensure security, modularity and services. Application strongly 
adheres to the OO (Object Oriented) Design principles and uses J2EE design patterns. 
Application interfaces with REDCap system to pull the user information. Application uses 
Single Sign-on (SSO) capabilities for easy login using unique username and password. It 
uses Spring Security framework for User Management and Role based access. Application 
uses jQuery, Bootstrap framework, Ajax, JavaScript to create visually appealing GUI 
(Graphical User Interface). Application provides reports on user behavior and user progress 
on the study modules. Reports can be generated using standard reporting tools and analytics 
such as Oracle SQL/PL SQL and jFree chart for visual representation of reports. Application is 
scalable to accommodate additional utilization or load, users and additional local/remote sites. 
Application's majority tools and technologies are open source and it follows agile methodology 
for the development. Application implements Log4j framework to log critical application 
activities. Application uses JUnit framework for unit testing. Application evaluation is done 
using Functional, Usability, Interface, Compatibility, Performance and Security testing 
strategies. Before application goes live, it will go through UAT (User Acceptance Test) phase 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
62 
 
to address any issues. Application can be monitored via alerting and monitoring tools that 
send notification to the system administrator whenever the application becomes inaccessible. 
Application uses open source version control system like SVN for source code version 
maintenance. 
 
Application development uses the following tools/technologies/languages: Java, J2EE, JSP, 
Spring MVC Framework, Spring Security Framework,J2EE design patterns, jQuery, AJAX, 
Bootstrap framework, JavaScript, Oracle SQL/PLSQL, Log4j, jFree chart, JUnit, Apache 
Tomcat V7.0, Shell script, SVN, REDCap. 
 
Control Flow: User log-in to the system using their unique user-id and password. For study 
participants after login, system presents a brief intro of study along with consent form. User 
gives his/her consent which is stored in the system data base; system then navigates to initial 
baseline survey form. Upon successful completion of the survey the survey results are stored 
in the database and based on pre-identified criteria system randomly assigns user to Usual-
self-care arm or PACT arm; system takes user to their respective arm’s program page. In the 
program page user has the opportunity to learn through the study modules. Based on user 
arm type, study modules present self-management lessons in the form of videos or slides. 
Once user completes the modules, then system prompts user to complete periodic (2month, 
4month) surveys. The survey responses are stored in database and analyzed later to 
understand how the program has helped participants in improving TMD pain. Users of the 
application can use the contact information provided in the consent form to contact study 
coordinator in case of any navigation issues or application accessibility issues. Users can get 
new password/reset one using “forgot password” links. 
 
 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 _________________________________________________________________________________________________________  
 
63 
 
 
Screen shots of the PACT website 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 _________________________________________________________________________________________________________  
 
64 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 _________________________________________________________________________________________________________  
 
65 
 
 
Sample screen shots of the PACT Program Arm. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 _________________________________________________________________________________________________________  
 
66 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
67 
 
www.youtube.com/PACT introductory video 
Slide 
Text 
1. Intro 
Welcome to the PACT study and thank you for participating. Hi My name is James Fricton and I am the 
principal investigator and a pain specialist who cares for and about patients with pain conditions. 
2. PACT 
PACT stands for Personalized Activated Care and Training. This study is about determining the best 
ways to help people prevent chronic pain from temporomandibular disorders or TMD. 
3. face 
The study is funded by the national Institutes of Dental and Craniofacial Research of the National 
Institutes of Health 
4. Big 
Elephant 
Chronic pain is the big elephant in the room of health care. It is the #1 cost driver of health care 
costs…costing more the diabetes, cancer, and heart disease combined. 
5. #1 
And it impacts nearly every person’s life. It has become # 1 chronic condition, the #1 reason for going to 
the doctor, and the #1 cause of disability, work loss, addiction and overdosages. 
6. TMD pic 
TMD is one of the most complex pain disorders. The number of different symptoms are not surprising 
knowing that there are more nerves per area than any other area of the body. 
7. $ 
Billions of dollars are spent on chronic pain, but the majority of those with pain over 1 month, still have 
pain 5 years later, despite the most innovative, extensive and expensive treatments. 
8. 
What does the PACT study help improve this? 
9. Root 
Research has shown that success in treating chronic pain is most successful if we change the root cause 
of the problem. 
10. 
This means reducing the risk factors that cause chronic pain while also enhancing the protective factors 
that improve recovery from pain 
11. 
It’s about changing the little things in our lives that cause chronic pain such as habits, stress, and posture. 
12. 
Thus, we designed the PACT program to help people prevent chronic pain through self-management. 
This study is designed to evaluate how different versions of self- management work. 
13. 
How do we do this? Well, it starts with you. The person with pain. 
14. 
We do this with engaging each participant in self-care 
15. 
Educating to know what to do to relieve the pain 
16. 
Empowering the participant: They have more control than any passive treatment 
17. 
Reducing the strain 
18. 
Healing the tissues 
19. 
And relieving the pain 
20. 
Thank you for participating 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 _________________________________________________________________________________________________________  
 
68 
 
®
APPENDIX C: TRADITIONAL SELF-CARE PROTOCOL 
 
 
 
Self-care tips for helping temporomandibular disorders (TMD)  
 
Jaw pain and difficulty with jaw movement are common signs of problems with the temporomandibular 
joint (TMJ) or jaw muscles. These problems as a group are called temporomandibular disorders or 
TMD. You can often improve these problems with some basic home care. 
 
1. 
Try moist heat: Moist heat can be especially helpful for sore muscles. Apply heat to the 
painful area of the jaw for 15 to 20 minutes, three to four times a day. Try using a wet towel 
over a hot water bottle, a gel-type heat pack, or a wet washcloth heated in a microwave. Take 
care to avoid burning your skin. 
 
2. 
Try ice: Ice treatment is often helpful if you have a sore jaw joint. Place an ice cube directly 
over your jaw joint in front of your ear. Move the ice cube over the jaw joint for four to five 
minutes. Take care to avoid frosting your skin. 
 
3. 
Eat a soft diet: A simple rule of thumb is to avoid chewing foods that make the pain worse or 
cause your jaw to “click.” Cook foods to a soft consistency and cut into smaller bites. Try to 
avoid biting off pieces of food with your front teeth. Place smaller pieces of food directly in 
the back of your mouth and chew on both sides to avoid overloading one side. 
 
4. 
Avoid chewing gum: Do not chew gum. Chewing gum puts a lot of pressure on your jaw 
joints for long periods of time. 
 
5. 
Practice good jaw position: The normal resting position of your jaw is to have your teeth 
slightly separated, and the tip of your tongue in the roof of your mouth behind your front 
teeth. This is a relaxed position with no tense jaw muscles. Your teeth should only touch when 
you chew or swallow. Check your jaw position several times during the day to make sure you 
are not clenching your teeth. 
 
6. 
Practice good jaw habits: Do you have any habits that m ay make your jaw problem worse? 
Ask your family or friends to let you know if they see you doing any of the following: 
clenching or grinding your teeth, biting your lip or your cheek, biting your fingernails or a 
pen, or thrusting your jaw forward and bracing your jaw, even with your teeth apart. 
 
7. 
Talk to your dentist at appointments: Tell your dentist or hygienist if you have been having 
problems with your jaw. Avoid holding your mouth open for long periods during the exam. 
 
8. 
Avoid caffeine: Avoid drinking a lot of caffeinated beverages, such as coffee or colas. They can 
contribute to jaw muscle tension and pain. Aim for two or less caffeinated beverages a day. 
 
9. 
Try a new sleeping position: Try not to sleep on your stomach, as this can put pressure on your jaw. 
 
10.    Use medications as necessary: Over-the-counter medications such as ibuprofen, aspirin or 
Tylenol can be helpful in reducing your jaw pain. Take these medications as prescribed on the 
product instructions. 
 
 
© 2003-7 HealthPartners  
10-07/120133 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 _________________________________________________________________________________________________________  
 
69 
 
 
Soft diet for temporomandibular joint pain  
 
 
Good nutrition is very important for good health and well-being. If you are having jaw pain or 
difficulty chewing, you will need to modify the texture of your diet while maintaining an adequate 
nutrient (carbohydrate, protein, vitamins, minerals) and caloric intake. 
 
Daily minimum food group requirements for adults include: 
4 servings from the grains group 
4 servings from the vegetable and fruit group 
2 servings from the meat and protein group 
2 servings from the milk group (4 servings for teenagers and young adults) 
 
The following chart is designed to help you make healthy food choices.* 
 
Food Group 
Allowed 
Avoid 
Grains 
(at least 4 servings/day) 
Bread or rolls 
All plain, easy to chew. 
Bread or rolls made with hard 
crust, seeds or nuts. Bagels. 
Crackers 
All plain, easy to chew. 
Seeds or nuts. 
Cereals 
Cooked cereals: cream of 
wheat, cream of rice, 
Malt-O-Meal™, oatmeal. 
Dry cereals: corn, rice, 
Granola or cereals that are 
advertised as “high fiber.” 
Potatoes/Pasta/Rice 
Mashed, baked (without skin), 
and creamed potatoes. 
Macaroni, pasta, rice, hominy. 
Potato skins, wild rice, 
popcorn 
Vegetables 
(at least 2 servings/day) 
Cooked, tender vegetables; 
tomato and vegetable juice. 
Tender lettuce, tomatoes. 
Raw vegetables. 
Fruit 
(at least 2 servings/day) 
All fruit juices. Raw fruits: soft, 
peeled such as banana, orange, 
peach, apricot or nectarine. 
Canned or cooked fruits without 
tough skins or membranes. 
All other fresh fruit. Dried 
fruit. 
 
*This material has been adapted from the Twin City District Dietetic Association manual. 
 
Continued 
 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
70 
 
APPENDIX D: HEALTH COACH PHONE PROTOCOL FOR PACT ARM  
 
The Health Coach will assist patients who are participating in the PACT program by assessing, 
educating, and supporting patients in self-management to prevent chronic pain. The Coach will 
interact with patients through an on-line video conferencing, by phone, or through the 
Integrated Resource Information System (IRIS).  Patients will be trained in reducing risk factors 
and enhancing protective factors for their pain condition.  The Coach will be responsible for 
developing a health coaching relationship with them and assisting the patient through the 
process of care by actively working towards better health by providing support, 
encouragement, and education. 
Health Coaching is relationship-centered, client-driven process designed to facilitate and 
empower a client to achieve self-determined goals related to health and overall well-being.  
While these goals may be informed by or suggested by others, such as an individual’s 
physician or other health provider, the selection of the goal and exploration where one is 
relationship to the goal is up to the client.  Individuals may be just beginning to consider a 
change, may be exploring aspects of preparing for a change, or may be ready to implement 
actual actions.  In a safe and consistent space, clients can explore their thoughts, emotions, 
and actions, in a way that allows them to recognize the power of their own choices to impact 
their wellness.   
Health Coaching is a methodology that differs from health education or counseling or therapy, 
though it can work well in combination with those other practices.  Health Coaches assume that 
people have strong intrinsic resources and strengths, can access the self-motivation needed to 
function autonomously and competently, and are able to realize positive change within a safe 
and confidential alliance, where they are inspired, respected, and supported. By applying 
clearly defined knowledge and skills, they support individuals or groups in mobilizing their 
internal strengths and external resources to achieve sustainable changes in beliefs or 
behaviors. Health Coaching has the potential to help individuals, families, and groups achieve 
improved health and wellbeing.   
Important Components of Health Coaching include; 
Building a relationship. Health coaching is relationship-centered, client-driven process 
designed to facilitate and empower a client to make changes that will help them achieve self-
determined goals related to health and overall well-being.  Health Coaching is a methodology 
that differs from health education, counseling or therapy, though it can work well in combination 
with those other practices.  Health coaches facilitate the following; 
Setting goals. While a person’s goals may be informed by the condition, such as to reduce the 
pain, or suggested by others, such as a health professional or the on-line training such as to do 
exercise, the health coach will help with selection of the goal and exploration where one is 
relationship to the goal is up to the client.   
Facilitating Change. Individuals may be just beginning to consider a change, may be exploring 
aspects of preparing for a change, or may be ready to implement actual actions.  In a safe, 
consistent, non-judgemental, and supportive space, clients can explore their thoughts, 
emotions, and actions, in a way that allows them to recognize the power of their own choices to 
impact their wellness.   

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
71 
 
Empowering people. Health coaches assume that people have strong intrinsic resources and 
strengths and can access the self-motivation and energy needed to accomplish their goals.  
Engaging responsibly. Health coaches assume that people will function autonomously and 
competently, and are able to realize positive change within a safe and confidential alliance with 
the health coach. The coach relationship is one of inspiration, respect, and non-judegmental 
support.  
Achieving goals.  By applying clearly defined knowledge and skills, the health coach can 
support individuals or groups in mobilizing their internal strengths and external resources to 
achieve sustainable changes in thoughts, emotions, and behaviors. Health Coaching has the 
potential to help individuals, families, and groups achieve their goal of improved health and 
wellbeing.   
Coach Protocol. Once the participant has enrolled in the PACT Study and been randomized to 
the PACT program, the phone coach will contact participant by telephone at varying intervals 
(see table 1). The role of the coach is to help the participant clarify their goals and identify 
strengths, resources, and barriers related to behavioral changes using motivational 
interviewing techniques. Coaches may also encourage completion of weekly educational 
module content and to inquire about the usefulness of the information, but that is a secondary 
focus. 
 
RESPONSIBILITIES  
(include but are not limited to): The 4 basic responsibilities would be to 1) facilitate the patient’s 
process of tapering the opioid medications and use of alternative medical management, 2) 
enhance understanding and compliance in self-management training for their condition address 
risk factors, and strengthen protective factors, 3) ensure patient is following up with health care 
provider for medical management, and 4) improve follow-up, outcomes, and quality of care. 
Thus, a health coach would also be working directly with the patients to help with the following; 
1) Call the patient for an initial consult using video conferencing such as Skype, if available. 
An in-person meeting can be arranged also as needed   
2) Understand the process of tapering opioids and replacing with alternative medical 
management interventions.  
3) Understand addiction medicine and the patient-centered barriers and problems 
associated tapering from opioids and help address each one during the process.   
4) Explain how the PACT program works and how to complete each training module and 
assessment instrument. 
5) Answers questions that many patients still have about their problem and how it will be 
addressed with treatment plan.   
6) Complete the assessment of risk and protective factors through the PACT program 
7) Call the patient biweekly by video-conferencing to reinforce compliance and 
understanding and ensure follow-up with each team member.   
8) Facilitate review of on-line modules for self-management training to reinforce the 
doctor’s information. 
9) Explain health education materials to patient, when questions arise 
10) Provides the patient with a pain diary to document progress with changing pain, 
functional status, identify triggers, risk factors, protective factors and barriers to success. 
They will work with the team to improve outcomes. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
72 
 
 
KNOWLEDGE AND SKILL 
Bachelor's degree or higher in health promotion, health education, nursing, athletic training, 
nutrition, psychology, social work, or other health related field or counseling and training 
certificate in health coaching.  Knowledge of specific disease and lifestyle related topics such as 
pain management, smoking cessation, weight management, nutrition, pre-post natal care, 
stress reduction and chronic conditions and certification from an accredited professional health 
coach training program preferred.   
PROTOCOL: Once the participant has enrolled in the PACT Study and been randomized to the 
PACT program, the phone coach will contact participant by telephone at varying intervals (see 
table 1). The role of the coach is to help the participant clarify their goals and identify strengths, 
resources, and barriers related to behavioral changes using motivational interviewing 
techniques.  Coaches may also encourage completion of weekly educational module content 
and to inquire about the usefulness of the information, but that is a secondary focus. 
Contact, duration, and frequency 
 
Minimum phone contact: Initial call, touch base call, and final call 
 
Maximum phone contact: Two times per week for three months 
 
The intention is for an initial call of 30-60 min (as needed) followed by 30 minute follow-
ups 
 
Documentation will occur at all calls to collect time and focus of the session and self-
identified goals (yes?) 
 
During the initial phone call, the phone coach will be responsible for: 
1) Explanation of coaching – how it works, expectations 
2) Set ground rules and determine interaction frequency   
 
At minimum the participant needs to have an initial call, a touch base call, and a final 
call 
3) Determination of participant needs, goals, and barriers.  What do they want to work on? 
 
Example questions that may be asked: What is important?  What strengths have led 
to success?  Types of barriers to success?  What steps have you taken to achieve 
your goal?  Pattern of thoughts getting in your way? 
4) Foster motivation and help participant to prioritize and address goals and barriers, 
applying collaborative communication techniques supporting the client’s power to direct 
their own agenda 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
73 
 
During program calls, the phone coachs’ responsibility will be to: 
1) Touch base on where the participant is at with their goals 
2) Help participant clarify goals and identify and address resources and barriers 
3) Check-in about online training program progression and impact 
4) Base discussion on current happenings in participant’s life and client’s agenda in the 
moment 
During the final phone call, the phone coach will be responsible for: 
1) Final determination of where the participant is at in achieving or moving toward their 
goal(s) 
2) Mention that the participant may be eligible, based on their insurance coverage, to have 
access to coaching services.  If this is something of interest, direct them to member 
services at their health plan 
Table 1: Frequency of Phone Calls for Health Coaches 
Time Period 
Frequency of 
Contact  
Content 
Study Month 1 
At most 2 
times/week 
1) Touch base on where the participant is at with their 
goal(s) 
2) Help participant clarify goals and identify and address 
resources and barriers 
3) Check-in about online training program progression 
and impact 
4) Base discussion on current happenings in participant’s 
life and client’s agenda in the moment 
Study Month 2 
Same as 
above 
Same as the above 
Study Month 3  Last call 
1) Final determination of where the participant is at in 
achieving their goal(s) 
2) Mention that the participant may be eligible, based on 
their insurance coverage, to have access to coaching 
services.  If this is something of interest, direct them to 
member services at their health plan 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
74 
 
Forms and Supplies Needed 
  Participant’s home phone number and email address. 
  PACT program website access 
  Weekly Log 
 
Chart on Preventing Chronic Pain in the Seven Realms 
Triggers pain flares 
Risk Factors to avoid 
Protective actions to follow 
B 
Body 
Poor posture 
Tensing, strain to muscle 
Over-vigorous exercise, 
strenuous labor 
Acute injury 
Menstrual cycle, thyroid, 
hormonal changes 
Tense and poor postures 
Repetitive muscle strain 
Poor conditioning 
Weak muscles 
Illness, obesity, hypermobile 
joints 
Balanced relaxed posture during 
day 
Conditioning exercises 
Strengthening exercise 
Avoid physical risks to avoid 
injury 
L 
Lifestyle 
Diet triggers* (see below) 
Dehydration 
Poor sleep/ oversleeping 
Chemical, caffeine, tobacco 
products 
Stress-too busy, shift work 
hours 
Poor diet and sleep 
Inactivity/ prolonged sitting 
Hurrying, feeling rushed 
Extreme sports/activity 
Chemical and tobacco use 
Irregular lifestyle, shift work 
Healthy diet daily(see handout) 
Diet supplements 
Staying active all 
day Follow good 
sleep routine 
Pace through-out 
the day 
Take actions to be safe daily 
E 
Emotion 
Anxious/ crisis situation 
Prolonged depression or 
sadness 
Prolonged anger 
Anger 
Anxiety 
Nervousness 
Sadness 
Depression 
Be creative: cooking, art, music, 
writing 
Deep breathing exercise 
Practice relaxation to calm 
muscles, nerves 
Practice positive psychology: 
Identify blessings 
Identify, discover, 
express your emotions 
S 
Society 
Stress- family 
Stress- people at work 
Stress- new/changing job 
Stress- loss of job 
Stress- financial 
PTSD 
Self-centered and ego- 
centric 
Conflict and abuse Lack of 
social support Feeling 
lonely and isolated 
Secondary gain 
Intolerant/ Unforgiving 
Cultivate positive relationships 
Help others daily 
Be courteous and respectful 
Provide social support to those 
around you 
Create win-win in resolving 
conflicts 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
75 
 
S 
Spirit 
Feeling lost 
Burned-out 
Hate and dislikes in life 
Self-abuse 
Stress and burnout 
Hate and loathing 
Low self esteem 
Lost and meaningless life 
Disbelief/ cynicism/ doubt 
Hopelessness and 
pessimism 
Mindfulness meditation and 
prayer 
Find meaning in life 
Maintain love and passion in life 
Explore dreams, hopes, and 
aspirations 
M 
Mind 
Stress- confusion, being ill- 
prepared 
Stress- dishonest, cheating 
Stress- fail to meet 
expectations 
Stress- out of control 
situations 
Stress- poor resilience 
Ignorance of whole problem 
Low resilience and coping 
Low self-efficacy/ control 
Deny responsibility 
Poor compliance 
Unrealistic expectations 
Learn about condition/risk/ 
protective 
factors 
humor, balance, flexible, tough, 
centered 
Self-motivated, growth, 
responsible write positive 
affirmations 
Practice adapt to new situations 
Learn realistic outcomes 
E 
Environment 
Air pollution/ allergens 
Weather changes 
Noise 
Vibration 
High altitudes and 
environmental triggers 
Infection prone and unclean 
Chaotic environment 
Dangerous surroundings 
Accident prone 
Negligent 
Clean and organize the home 
Reduce air pollution, 
allergens, vibrations 
Follow food safety 
plan create safe 
home and work 
environment 
Reduce risks and drive 
defensively 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
76 
 
APPENDIX E: TELEPHONE SCREEN  
 
Initial Phone Contact 
Incoming call (Protocol 1 HP Member or Non-HP Member contacts SRC) 
 Thank you for calling the TMD Self-Care Study. Before I describe the study I would like to 
start by asking how you heard about the TMD Self-Care Study. 
 
1) How did you hear about the study?  (Do not read list– let the participant tell you, okay to check more than one 
if volunteered)  
a) Brochure 
 
describe what brochure, where from, etc.: ______________________________ 
b) Clinic 
 
describe which clinic, etc.: ______________________________ 
c) Health Professional describe who, where, etc.: ______________________________ 
d) Friend 
 
describe: ______________________________ 
e) Recruitment letter describe: ______________________________ 
f) Other 
 
describe: ______________________________ 
g) Do not remember 
 
Outgoing call (Protocol 2) 
 Hello.  May I please speak with [full name of potential participant]?  
If respondent is not available, schedule a call back and end call. 
If respondent is on the phone, continue.  
 This is [INSERT FIRST NAME] from the HealthPartners Institute.  I’m following up to a letter 
we recently sent you about a study that you may be able to participate in called the TMD 
Self-Care Study.  Is now a good time to tell you more about this study? 
 If no: When is a better time to reach you? (schedule a call back if possible, or thank them 
and end call) 
 If Yes: Great! I’ll need to ask you some question to determine your eligibility. But first, I 
would like to ask a few questions about you. This helps us understand who may or may not 
be interested in studies like the TMD Self-Care Study. We ask these questions of everyone 
before determining if they are eligible. These questions are not used to determine if you are 
eligible.  (Go to question 2) 
Messages 
 Initial message: (Protocol 2) 
Hello.  This message is for [full name of respondent].  This is [INSERT FIRST NAME] from the 
HealthPartners Institute.  I’m calling about a letter we recently sent about an exciting new 
research study.  Please call us at 952-967-5696 to learn more. If you reach our voicemail, 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
77 
 
please leave your full name, phone number and the best time to reach you.  If we don’t hear 
back, we’ll try you again later. Thank you! 
 Second (final) message: 
Hello.  This message is for [full name of respondent].  This is [INSERT FIRST NAME] from the 
HealthPartners Institute following up on a letter recently sent inviting you to participate in 
an exciting new research study.  Sorry we missed you again.  Please call us at 952-967-5696 
if you are interested. We will not call you again unless we hear from you.  Thank you! 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
78 
 
2) How do you describe yourself? (check one) 
a) Male 
b) Female 
c) Transgender 
d) Do not identify as female, male, or transgender 
3) What is your age?     ______   (if less than 18 years old; not eligible) 
4) Do you consider yourself to be Hispanic or Latino?  
a) No, not Hispanic/Latino 
b) Yes, Hispanic/Latino 
5) Which of the following do you consider yourself (mark all that apply)? 
a) White 
b) American Indian/Alaskan Native 
c) Asian 
d) Native Hawaiian or Pacific Islander 
e) Black or African American 
f) Other (describe):__________________________ 
g) Don’t know/refuse [do not read] 
 
Thank you for answering these questions. Now I’ll tell you more about the study. 
 
Study description: 
HealthPartners Institute is conducting a new study called TMD Self-Care Study that is funded by 
the National Institute of Health. The study is looking at a new way of helping people manage 
chronic pain from TMJ or temporomandibular muscle and joint pain, which is pain in the face 
and jaw.   
 
The study will be randomizing people into one of two self-management online programs, the 
Personalized Activated Care and Training (PACT) program or the traditional care program. In the 
PACT program people will move through an eight week online course that includes audio, video 
and written materials along with phone coaching. In the traditional care program people will 
receive information about self-care of TMJ using video and written materials. Both groups will 
be asked to complete three surveys and will receive up to $100 in Target gift cards for 
participation. This includes a $20 gift card for completion of the initial survey, $35 gift card for 
completing the survey at two months and $45 gift card for completing the survey at four 
months.   
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
79 
 
6) Are you interested in seeing if you are eligible for this study?  
a) No:  Thank and end call. 
b) Yes: continue 
Great, I’ll need to ask you some questions to determine your eligibility.  

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
80 
 
Phone Screen for Study Eligibility 
If at any time the caller does not meet eligibility criteria stop the screening, thank them for their 
interest, and refer to section “B” at the end of the screen.  Mark disposition as ineligible. 
 
7) Are you able and willing to access to the internet on a regular basis? 
a) NO 
If NO, go to section B 
b) YES  
If asked, program is mobile responsive and can be accessed using cell phone or tablet. 
8) Are you able to read and speak in English?   
a) NO 
If NO, go to section B 
b) YES  
9) Will you be reachable by phone and able to participate in phone coaching calls if you are assigned to the PACT 
program?  
 
a) NO 
If NO, go to section B 
b) YES  
 
These next questions are related to your TMD symptoms.  
10) Has a health professional ever told you that you have TMD/TMJ?   
a) NO  
If NO, go to section B 
b) YES  
11) In the last 30 days, which of the following best describes any pain in your jaw or temple area on either side? 
a) No pain (0 points) 
b) From very brief to more than once a week, but it does stop (1 point) 
c) Continuous (2 points) 
12) In the last 30 days, have you had pain or stiffness in your jaw on awakening? 
a) No (0 points) 
b) Yes (1 point) 
13) In the last 30 days, did the following activities change any pain (that is, make it better or make it worse) in 
your jaw or temple are on either side? 
a) Chewing hard or tough food 
1) No (0 points) 
2) Yes (1 point) 
b) Opening your mouth or moving your jaw forward or to the side 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
81 
 
1) No  
2) Yes  
c) Jaw habits such as holding teeth together, clenching/grinding, or chewing gum 
1) No  
2) Yes  
d) Other jaw activities such as talking, kissing, or yawning 
1) No  
 
 
 
2) Yes  
14) How long have you experienced jaw or temple pain? (Check one) 
 
Less than 1 month 
 
1 month or more but less than 3 months 
 
3 months or more but less than 6 months 
 
6 months or more but less than 1 year 
 
1 year or more but less than 3 years 
 
3 years or more 
 
 
15) In the last 30 days, where did you have any jaw or temple pain? (Check yes or no for each) 
 
Left jaw area  
 Yes 
 No  
 
Right jaw area  
 Yes 
 No  
Left temple 
area  
 Yes 
 No  
Right temple 
area  
 Yes 
 No  
 
[INSERT scoring information] 
16) Are you currently participating in any other TMD/TMJ related studies?   
e) No 
f) Yes 
If YES, go to section B. 
17) Are you scheduled to have surgery for your TMD/TMJ disorder? 
g) No 
h) Yes 
If YES, go to section B. 
Now I need to ask you a few additional medical questions. 
18) Do you have any serious medical conditions that might interfere with or prohibit you from participating in an 
online self-care program or currently pregnant? 
i) 
No 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
82 
 
j) 
Yes 
If YES, go to section B. 
19) Have you received treatment for a mental health disorder or substance abuse in the past six months? 
k) No 
l) 
Yes 
If YES, go to section B. 
20)  
End Phone Screen – determine eligibility 
 
If Questions 11, 12 and 13a = 2 or more then participant is eligible. 
If Questions 11, 12 and 13a = less than 2 then participant is NOT eligible.  
Yes/ No Eligible 
A. Eligible 
Based on your responses, you are eligible for study participation. The next step would be for 
me to send you information about the study by email, including a study brochure and 
consent form. I will also send you instructions including a link to the study website with log-
in information.  You will then be directed to the study website to complete the consent form 
to enroll you in the study.  
Would you like me to send study information to you so you can get started?  
 
Yes:   
Incoming calls: Great, I will need to collect your contact information so I can email you 
study materials.  If you have a few minutes, I would like to briefly review the study with 
you and answer any additional questions you may have while we are on the phone.  
Once you receive the email you can enter the website, review the consent form online, 
and get started.   
  
Outgoing calls: Great, I will need to confirm the contact information we have for you. I 
will briefly review the study with you now while we are on the phone and answer any 
additional questions that might come up.  In addition I will email you instructions for 
participation in the study including a study brochure, a link to the study website and 
your username/password to access the study website so you can complete the consent 
form to enroll into the study.  
 
No:   
I’m sorry to hear that.  Would you mind telling me why? ___________________ 
 
Thinking about it:  
Collect patient name only below to identify if they call back. 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
83 
 
Contact Information (auto-populated for outgoing calls) 
21) What is your full name? ____________________________________________________ 
22) What is your mailing address?  
Address     
 
 
 
 
 
 
 
 
 
 
City  
 
 
 
 
 
 
State 
 
 
Zip 
 
 
23) What is your preferred method of contact, phone or email?  If phone also obtain preferred 
time of day to contact: 
a) Home phone  
(        )   
 
 
 
 
_  
b) Work phone 
(        )   
 
____ 
 
 
_  
c) Cell phone  
(        )___________________________________   
d) Email address 
 ________________________________________ 
24) Can we leave message at: 
a) Home                 YES  NO  
b) Work 
 
YES  NO  
c) Cell  
 
YES  NO 
 
25) Are you able and willing to receive text messages? 
a) YES (standards rates would apply; just know you won’t be able to text us back) 
b) NO 
 
26) (If yes to any item in 25) May we call ourselves TMD Self-care Study when we call?  
a) YES   
b) NO   
If NO: OK, is there any other name you would like us to use? ______________________ 
 
B. Ineligible 
I’m sorry, but you are not eligible for this study.   
 
We thank you for your interest and your willingness to go through our phone screen. We appreciate 
your time and consideration.   
 
If the potential participant pushes for why this makes them not eligible: 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
84 
 
You know, I can’t speak specifically to why the study has chosen the eligibility criteria it did, that would 
be a question for the study coordinator, but I do know they have specific reasons for each criterion.  
Would you like to discuss further with the study coordinator, Liz Grossman at 952-XXX-XXXX?  
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
85 
 
APPENDIX F: SAMPLE CONSENT FORM  
You are invited to participate in a research study called TMD Self-Care using PACT - 
Personalized Activated Care and Training for the self-management for temporomandibular 
disorder (TMD) pain. This study is being conducted by Dr. James Fricton at HealthPartners 
Institute. It is funded by the National Institutes of Health, National Institute of Dental and 
Craniofacial Research. You were selected as a possible participant because you have TMD 
pain and are interested in self-management. We ask that you read this form and ask any 
questions you may have before agreeing to participate in the study. 
 
Purpose: 
The purpose of the study is to examine new ways to help people with the self-management of 
their TMD pain. We will be looking at a new online self-management program and comparing it 
with traditional self-management for TMD pain. We will be enrolling a total of 80 people.  
 
Procedures:   
If you are eligible to participate you will be randomized to one of two programs. Randomization 
is similar to the toss of a coin; you will have an equal chance of being in either program. 
Participants in both programs will continue with their usual care for TMD pain (such as splints or 
medications). The two programs are: 
 
The PACT Program which consists of an 8 week online educational program based on 
reducing lifestyle and other risk factors that lead to increased TMD pain, and enhancing 
protective factors that lead to decreased TMD pain. The program is completed at the 
participants own pace. Participants in the program complete brief weekly assessments, receive 
online materials in video, audio and written format, and receive weekly phone coaching.  
Participants will be linked to a phone coach that will help clarify goals and identify strengths, 
resources, and barriers related to behavioral changes.  Coaches may also encourage 
participants to review and complete weekly module content.  At minimum, this involves an initial 
call, a touch base call, and a final call near the end of the program with a limit of two calls per 
week during the course of the program. Access to the internet is required for this program. 
 
Traditional TMD Care which consists of self-care materials provided by dentists and oral pain 
specialists that focus on self-care education including diet, oral habits and use of heat to reduce 
pain. The materials will be provided in an online program using video and audio materials. 
Access to the internet is required for this program. 
 
Participants in both programs will also need to: 
 
Complete 3 surveys: before starting their program, at 2 months and at 4 months 
 
Complete a program evaluation and in some cases, structured interview 
 
Participate in and complete their self-care program materials 
 
Risk and Benefits of Being in the Study 
There are minimal psychological or physical risks from participating in this study. You may skip 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
86 
 
any survey questions you don’t want to answer. You may benefit from learning new strategies 
and techniques for managing your TMD pain through an online program that others have found 
interesting. 
 
Research Related Injury: If you think you have suffered any type of research-related injury, let 
the study Project Manager know as soon as possible.  Neither the study sponsor nor the 
HealthPartners Institute would be responsible for any payment. If you do begin to experience 
increased health concerns during the study the study team will refer you to your regular 
healthcare providers. 
 
Costs and Compensation: There are no costs to participating in the study; all materials are 
provided free of charge. Participants will also be paid up to $100.00 in Target gift cards for 
participation in the study. This includes a $20.00 gift card for completion of the initial survey, a 
$35.00 gift card for completing the survey at 2 months and $45.00 gift card for completing the 
survey at 4 months. You may be invited to participate in a qualitative phone interview about your 
experience in the study. Those participating in the interview will be offered a $25.00 Target gift 
card for their participation. 
 
Confidentiality 
Your records from the study will be kept private. Research records will be kept on secure 
password protected servers and only study team members will have access to the information. 
We will not include any information that will make it possible to identify individual subjects in any 
reports that we might publish.  
 
Voluntary Nature of the Study 
Participation in this study is voluntary. Your decision whether or not to participate in this study 
will not affect your current or future relations with HealthPartners or the HealthPartners Institute. 
You are free to withdraw from the study at any time. The investigators can also decide to end 
your participation in the study if you are not able to complete the tasks or no longer have 
internet access required by the study.   
 
Contacts and Questions 
You may ask any questions you have now; if you have questions later you can contact the study 
coordinator, at: 952 – XXX-XXXX. You may also contact the study investigator Jim Fricton at: 
952 – XXX-XXXX. If you have questions about your rights as a research subject, you may 
contact the HealthPartners Office of Research Subjects at (651) 254-4757 
 
Subject name:  
 
By checking the box below, I acknowledge that: 
 
I have read this form and the research study has been explained to me. 
 
I have been given the chance to ask questions, and my questions have been answered.  I 
have been told who to call if I have more questions. 
 
I agree to be in the research study described above. 
 
I will receive a copy of this consent form. A copy will be put in my study record. 
 
I am not giving up any of my legal rights by signing this form.  
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
87 
 
O Agreed 
Date: _____________________ 
APPENDIX G: DATA COLLECTION SURVEYS AT BASELINE, 8 WEEK and  
16 WEEK POST-INTERVENTION  
 
 
Baseline Survey 
 
Thank you for participating in the TMD Self-Care Study. The following 
questions are about your experiences with this study and should take 
about 5-10 minutes to answer. The first questions are about your jaw 
and temple pain. Please answer all the questions as best as you can. 
 
Graded Chronic Pain 
1. On how many days in the last 30 days have you had jaw or temple pain?  _____ Number 
of Days 
 
2. 
How would you rate your jaw or temple pain RIGHT NOW?  
No 
Pain 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Pain as 
bad as 
could be 
 
3. In the last 30 days, how would you rate your WORST jaw or temple pain?  
No 
Pain 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Pain as 
bad as 
could be 
 
4.  In the last 30 days, ON AVERAGE, how would you rate your jaw or temple pain? 
That is, your usual pain at times you were in pain. 
No 
Pain 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Pain as 
bad as 
could be 
 
5. In the last 30 days, how many days did your jaw or temple pain keep you from 
doing your USUAL ACTIVITIES like work, school, or housework?  
  _____ Number of Days 
 
 
 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
88 
 
6. In the last 30 days, how much has jaw and temple pain interfered with your DAILY 
ACTIVITIES, rated on a scale of 0-10, where 0 is “no interference” and 10 is “unable 
to carry on any activities”? 
No 
interference 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Unable to 
carry on any 
activities 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7. In the last 30 days, how much has jaw and temple pain interfered with your 
RECREATIONAL, SOCIAL AND FAMILY ACTIVITIES, rated on a scale of 0-10 
where 0 is “no interference” and 10 is “unable to carry on any activities”? 
  
No 
interference 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Unable to 
carry on any 
activities 
 
 
 
 
 
 
 
 
 
 
 
 
 
8. In the last 30 days, how much has jaw and temple pain interfered with your 
ABILITY TO WORK, INCLUDING HOUSEWORK, rated on a scale of 0-10, where 0 
is “no interference” and 10 is “unable to carry on any activities”?  
 
No 
interference 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Unable to 
carry on any 
activities 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Jaw Functioning 
9. For each of the items below, please indicate the level of limitation during the 
last 30 days. If the activity has been completely avoided because it is too 
difficult, then fill in “10”. If you avoid an activity for reasons other than pain 
or difficulty fill in the “not applicable” (N/A). 
 
No 
Limitation 
 
 
 
 
    Severe 
Limitation 
In the LAST 30 days: 
N/A 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
a. Chew tough food 
 
 
 
 
 
 
 
 
 
 
 
 
b. Chew chicken 
(e.g. prepared in oven) 
 
 
 
 
 
 
 
 
 
 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
89 
 
c. Eat soft food requiring 
no chewing (e.g., 
mashed potatoes, apple 
sauce, pudding, pureed 
food) 
 
 
 
 
 
 
 
 
 
 
 
 
d. Open wide enough to 
drink from cup 
 
 
 
 
 
 
 
 
 
 
 
 
e. Swallow 
 
 
 
 
 
 
 
 
 
 
 
 
f. 
Yawn 
 
 
 
 
 
 
 
 
 
 
 
 
g. Talk 
 
 
 
 
 
 
 
 
 
 
 
 
h. Smile 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Chronic Pain Self-Efficacy 
We would like to know about how you manage your pain. For each of the 
following questions, please choose the number that best indicates how certain or 
uncertain you are.  
 
 
Very 
Uncertain 
 
 
 
 
Very 
 Certain 
10. How certain are you that you 
can decrease your pain quite a 
bit? 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11. How certain are you that you 
can continue most of your daily 
activities? 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
12. How certain you that you 
can keep your pain from 
interfering with your sleep? 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
90 
 
13. How certain are you that you 
can make a small-to-moderate 
reduction in your pain by using 
methods other than taking extra 
medications? 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
14. How certain are you that you 
can make a large reduction in 
your pain by using methods 
other than taking extra 
medications? 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
The following questions are about how you manage your own health 
and healthcare.  
PAM 7 
15. How much do you agree or disagree with the following statements?  
 
Disagree 
Strongly 
Disagree 
Agree 
Agree  
Strongly 
a. Taking an active role in my own 
health care is the most important factor 
in determining my health and ability to 
function. 
 
 
 
 
b. I know the lifestyle changes like diet 
and exercise that are recommended for 
my health condition. 
 
 
 
 
c. I am confident that I can follow 
through on medical recommendations 
my health care provider makes such as 
changing my diet or doing regular 
exercise. 
 
 
 
 
d. I am confident that I can find 
trustworthy sources of information about 
my health condition and my health 
choices 
 
 
 
 
e. I know how to prevent further 
problems with my health condition 
 
 
 
 
f. I am able to handle symptoms of my 
health condition on my own at home 
 
 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
91 
 
g. I am confident that I can maintain 
lifestyle changes like diet and exercise 
even during times of stress 
 
 
 
 
 
 
 
The next questions are about your sleep and exercise habits. 
  
16. Overall in the last 30 days, how much of a problem did you have with 
sleeping, such as falling asleep, waking up frequently during the night or waking up 
too early in the morning? 
a. None 
b. Mild 
c. Moderate 
d. Severe 
e. Extreme 
  
17. In the last 30 days, how much of a problem did you have due to not feeling 
rested and refreshed during the day (e.g. feeling tired, not having energy)? 
a. None 
b. Mild 
c. Moderate 
d. Severe 
e. Extreme 
  
19. In a typical week, on how many days do you do vigorous-intensity sports, 
fitness or recreational (leisure) activities that cause large increases in breathing or 
heart rate (such as running, aerobics, soccer) for at least 10 minutes continuously? 
 
 
__ days 
  
20. On a typical day that you do vigorous-intensity sports, fitness or 
recreational activities, how much time do you spend doing them? 
 
 
__ minutes 
  
20. In a typical week, on how many days do you do moderate-intensity sports, 
fitness or recreational (leisure) activities that cause a small increase in breathing or 
heart rate (such as brisk walking, cycling, swimming, volleyball) for at least 10 
minutes continuously? 
___days 
  

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
92 
 
21. On a typical day that you do moderate-intensity sports, fitness or recreational 
(leisure) activities, how much time do you spend doing them? 
 
 
___minutes 
  
Overall Program Evaluation 
The following questions are about your experience with the TMD Self-
Care Programs. 
 
22. Please indicate how much you agree or disagree with the following 
statements about the TMD Self-Care program. 
 
 
Strongly 
Disagree 
Disagree 
Neither 
Agree 
nor 
Disagree 
Agree 
Strongly 
Agree  
a. I was satisfied with the information I 
received in the program 
 
 
 
 
 
b. I received the right amount of 
information 
 
 
 
 
 
c. The information was relevant and 
applicable to me 
 
 
 
 
 
d. I found the online learning information 
and materials to be clear and 
understandable 
 
 
 
 
 
e. I found the information presented 
valuable in managing my TMD pain 
 
 
 
 
 
f. I have a better understanding of how 
to manage my TMD pain as a result of 
participating in the program.  
 
 
 
 
 
g. I found the online program easy to 
access and navigate 
 
 
 
 
 
 
Thank you for participating in this study and completing this survey.  
We will be mailing you a $35 dollar Target gift card as a thank you for 
completing this survey.  
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
93 
 
TMD Self-Care Study Follow up Survey 
(8-week follow-up Survey including  
Program Evaluation Questions) 
 
Thank you for participating in the TMD Self-Care Study. The following 
questions are about your experiences with this study and should take 
about 5-10 minutes to answer. The first questions are about your jaw 
and temple pain. Please answer all the questions as best as you can. 
 
Graded Chronic Pain 
1. On how many days in the last 30 days have you had jaw or temple pain?  _____ Number 
of Days 
 
2. How would you rate your jaw or temple pain RIGHT NOW?  
No 
Pain 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Pain as 
bad as 
could be 
 
3. In the last 30 days, how would you rate your WORST jaw or temple pain?  
No 
Pain 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Pain as 
bad as 
could be 
 
4.  In the last 30 days, ON AVERAGE, how would you rate your jaw or temple pain? 
That is, your usual pain at times you were in pain. 
No 
Pain 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Pain as 
bad as 
could be 
 
5. In the last 30 days, how many days did your jaw or temple pain keep you from 
doing your USUAL ACTIVITIES like work, school, or housework?  
  _____ Number of Days 
 
 
6. In the last 30 days, how much has jaw and temple pain interfered with your DAILY 
ACTIVITIES, rated on a scale of 0-10, where 0 is “no interference” and 10 is “unable 
to carry on any activities”? 
No 
interference 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Unable to 
carry on any 
activities 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
94 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7. In the last 30 days, how much has jaw and temple pain interfered with your 
RECREATIONAL, SOCIAL AND FAMILY ACTIVITIES, rated on a scale of 0-10 
where 0 is “no interference” and 10 is “unable to carry on any activities”? 
  
No 
interference 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Unable to 
carry on any 
activities 
 
 
 
 
 
 
 
 
 
 
 
 
 
8. In the last 30 days, how much has jaw and temple pain interfered with your 
ABILITY TO WORK, INCLUDING HOUSEWORK, rated on a scale of 0-10, where 0 
is “no interference” and 10 is “unable to carry on any activities”?  
 
No 
interference 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Unable to 
carry on any 
activities 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Jaw Functioning 
9. For each of the items below, please indicate the level of limitation during the 
last 30 days. If the activity has been completely avoided because it is too 
difficult, then fill in “10”. If you avoid an activity for reasons other than pain 
or difficulty fill in the “not applicable” (N/A). 
 
No 
Limitation 
 
 
 
 
    Severe 
Limitation 
In the LAST 30 days: 
N/A 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
a. Chew tough food 
 
 
 
 
 
 
 
 
 
 
 
 
b.Chew chicken 
(e.g. prepared in oven) 
 
 
 
 
 
 
 
 
 
 
 
 
c. Eat soft food requiring 
no chewing (e.g., mashed 
potatoes, apple sauce, 
pudding, pureed food) 
 
 
 
 
 
 
 
 
 
 
 
 
d. Open wide enough to 
drink from cup 
 
 
 
 
 
 
 
 
 
 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
95 
 
e. Swallow 
 
 
 
 
 
 
 
 
 
 
 
 
f. Yawn 
 
 
 
 
 
 
 
 
 
 
 
 
g. Talk 
 
 
 
 
 
 
 
 
 
 
 
 
h. Smile 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Chronic Pain Self-Efficacy 
We would like to know about how you manage your pain. For each of the 
following questions, please choose the number that best indicates how certain or 
uncertain you are.  
 
 
Very 
Uncertain 
 
 
 
 
Very 
 Certain 
10. How certain are you that you 
can decrease your pain quite a 
bit? 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11. How certain are you that you 
can continue most of your daily 
activities? 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
12. How certain you that you 
can keep your pain from 
interfering with your sleep? 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
13. How certain are you that you 
can make a small-to-moderate 
reduction in your pain by using 
methods other than taking extra 
medications? 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
14. How certain are you that you 
can make a large reduction in 
your pain by using methods 
other than taking extra 
medications? 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
96 
 
 
 
The following questions are about how you manage your own health 
and healthcare.  
PAM 7 
15. How much do you agree or disagree with the following statements?  
 
Disagree 
Strongly 
Disagree 
Agree 
Agree  
Strongly 
a. Taking an active role in my own 
health care is the most important factor 
in determining my health and ability to 
function. 
 
 
 
 
b. I know the lifestyle changes like diet 
and exercise that are recommended for 
my health condition. 
 
 
 
 
c. I am confident that I can follow 
through on medical recommendations 
my health care provider makes such as 
changing my diet or doing regular 
exercise. 
 
 
 
 
d. I am confident that I can find 
trustworthy sources of information about 
my health condition and my health 
choices 
 
 
 
 
e. I know how to prevent further 
problems with my health condition 
 
 
 
 
f. I am able to handle symptoms of my 
health condition on my own at home 
 
 
 
 
g. I am confident that I can maintain 
lifestyle changes like diet and exercise 
even during times of stress 
 
 
 
 
 
 
 
The next questions are about your sleep and exercise habits. 
  
16. Overall in the last 30 days, how much of a problem did you have with 
sleeping, such as falling asleep, waking up frequently during the night or waking up 
too early in the morning? 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
97 
 
f. None 
g. Mild 
h. Moderate 
i. Severe 
j. Extreme 
  
17. In the last 30 days, how much of a problem did you have due to not feeling 
rested and refreshed during the day (e.g. feeling tired, not having energy)? 
f. None 
g. Mild 
h. Moderate 
i. Severe 
j. Extreme 
  
19. In a typical week, on how many days do you do vigorous-intensity sports, 
fitness or recreational (leisure) activities that cause large increases in breathing or 
heart rate (such as running, aerobics, soccer) for at least 10 minutes continuously? 
 
 
__ days 
  
 
20. On a typical day that you do vigorous-intensity sports, fitness or 
recreational activities, how much time do you spend doing them? 
 
 
__ minutes 
  
20. In a typical week, on how many days do you do moderate-intensity sports, 
fitness or recreational (leisure) activities that cause a small increase in 
breathing or heart rate (such as brisk walking, cycling, swimming, volleyball) 
for at least 10 minutes continuously? 
 
 
___days 
  
21. On a typical day that you do moderate-intensity sports, fitness or recreational 
(leisure) activities, how much time do you spend doing them? 
 
 
___minutes 
  
Overall Program Evaluation 
 
The following questions are about your experience with the TMD Self-
Care Programs. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
98 
 
 
22. Please indicate how much you agree or disagree with the following 
statements about the TMD Self-Care program. 
  
 
Strongly 
Disagree 
Disagree 
Neither 
Agree 
nor 
Disagree 
Agree 
Strongly 
Agree  
a. I was satisfied with the information I 
received in the program 
 
 
 
 
 
b. I received the right amount of 
information 
 
 
 
 
 
c. The information was relevant and 
applicable to me 
 
 
 
 
 
d. I found the online learning information 
and materials to be clear and 
understandable 
 
 
 
 
 
e. I found the information presented 
valuable in managing my TMD pain 
 
 
 
 
 
f. I have a better understanding of how 
to manage my TMD pain as a result of 
participating in the program.  
 
 
 
 
 
g. I found the online program easy to 
access and navigate 
 
 
 
 
 
 
 
 
Thank you for participating in this study and completing this survey.  
We will be mailing you a $35 dollar Target gift card as a thank you for 
completing this survey.  
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
99 
 
 
8-week follow-up Survey including Program Evaluation 
Questions (PACT ONLY) 
 
 
Thank you for participating in the TMD Self-Care Study. The following 
questions are about your experiences with this study and should take 
about 5-10 minutes to answer. The first questions are about your jaw 
and temple pain. Please answer all the questions as best as you can. 
 
Graded Chronic Pain 
1. On how many days in the last 30 days have you had jaw or temple pain?  _____ Number 
of Days 
 
2. How would you rate your jaw or temple pain RIGHT NOW?  
No 
Pain 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Pain as 
bad as 
could be 
 
3. In the last 30 days, how would you rate your WORST jaw or temple pain?  
No 
Pain 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Pain as 
bad as 
could be 
 
4.  In the last 30 days, ON AVERAGE, how would you rate your jaw or temple pain? 
That is, your usual pain at times you were in pain. 
No 
Pain 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Pain as 
bad as 
could be 
 
5. In the last 30 days, how many days did your jaw or temple pain keep you from 
doing your USUAL ACTIVITIES like work, school, or housework?  
  _____ Number of Days 
 
 
6. In the last 30 days, how much has jaw and temple pain interfered with your DAILY 
ACTIVITIES, rated on a scale of 0-10, where 0 is “no interference” and 10 is “unable 
to carry on any activities”? 
No 
interference 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Unable to 
carry on 
any 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
100 
 
activities 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7. In the last 30 days, how much has jaw and temple pain interfered with your 
RECREATIONAL, SOCIAL AND FAMILY ACTIVITIES, rated on a scale of 0-10 
where 0 is “no interference” and 10 is “unable to carry on any activities”? 
  
No 
interference 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Unable to 
carry on 
any 
activities 
 
 
 
 
 
 
 
 
 
 
 
 
 
8. In the last 30 days, how much has jaw and temple pain interfered with your 
ABILITY TO WORK, INCLUDING HOUSEWORK, rated on a scale of 0-10, where 0 
is “no interference” and 10 is “unable to carry on any activities”?  
 
No 
interference 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Unable to 
carry on any 
activities 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Jaw Functioning 
9. For each of the items below, please indicate the level of limitation during the 
last 30 days. If the activity has been completely avoided because it is too 
difficult, then fill in “10”. If you avoid an activity for reasons other than pain 
or difficulty fill in the “not applicable” (N/A). 
 
No 
Limitation 
 
 
 
 
    Severe 
Limitation 
In the LAST 30 days: 
N/A 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
a.  Chew tough food 
 
 
 
 
 
 
 
 
 
 
 
 
b. Chew chicken 
(e.g. prepared in oven) 
 
 
 
 
 
 
 
 
 
 
 
 
c. Eat soft food requiring no 
chewing (e.g., mashed 
potatoes, apple sauce, 
pudding, pureed food) 
 
 
 
 
 
 
 
 
 
 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
101 
 
d. Open wide enough to 
drink from cup 
 
 
 
 
 
 
 
 
 
 
 
 
e. Swallow 
 
 
 
 
 
 
 
 
 
 
 
 
f. Yawn 
 
 
 
 
 
 
 
 
 
 
 
 
g. Talk 
 
 
 
 
 
 
 
 
 
 
 
 
h. Smile 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Chronic Pain Self-Efficacy 
We would like to know about how you manage your pain. For each of the 
following questions, please choose the number that best indicates how certain or 
uncertain you are.  
 
 
Very 
Uncertain 
 
 
 
 
Very 
 Certain 
10. How certain are you that you 
can decrease your pain quite a 
bit? 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11. How certain are you that you 
can continue most of your daily 
activities? 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
12. How certain you that you 
can keep your pain from 
interfering with your sleep? 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
13. How certain are you that you 
can make a small-to-moderate 
reduction in your pain by using 
methods other than taking extra 
medications? 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
102 
 
14. How certain are you that you 
can make a large reduction in 
your pain by using methods 
other than taking extra 
medications? 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
The following questions are about how you manage your own health 
and healthcare.  
PAM 7 
15. How much do you agree or disagree with the following statements?  
 
Disagree 
Strongly 
Disagree 
Agree 
Agree  
Strongly 
a. Taking an active role in my own 
health care is the most important factor 
in determining my health and ability to 
function. 
 
 
 
 
b. I know the lifestyle changes like diet 
and exercise that are recommended for 
my health condition. 
 
 
 
 
c. I am confident that I can follow 
through on medical recommendations 
my health care provider makes such as 
changing my diet or doing regular 
exercise. 
 
 
 
 
d. I am confident that I can find 
trustworthy sources of information about 
my health condition and my health 
choices 
 
 
 
 
e. I know how to prevent further 
problems with my health condition 
 
 
 
 
f. I am able to handle symptoms of my 
health condition on my own at home 
 
 
 
 
g. I am confident that I can maintain 
lifestyle changes like diet and exercise 
even during times of stress 
 
 
 
 
 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
103 
 
The next questions are about your sleep and exercise habits. 
  
16. Overall in the last 30 days, how much of a problem did you have with 
sleeping, such as falling asleep, waking up frequently during the night or waking up 
too early in the morning? 
k. None 
a. Mild 
b. Moderate 
c. Severe 
d. Extreme 
  
17. In the last 30 days, how much of a problem did you have due to not feeling 
rested and refreshed during the day (e.g. feeling tired, not having energy)? 
a. None 
b. Mild 
c. Moderate 
d. Severe 
e. Extreme 
  
19. In a typical week, on how many days do you do vigorous-intensity sports, 
fitness or recreational (leisure) activities that cause large increases in breathing or 
heart rate (such as running, aerobics, soccer) for at least 10 minutes continuously? 
 
 
__ days 
  
 
20. On a typical day that you do vigorous-intensity sports, fitness or 
recreational activities, how much time do you spend doing them? 
 
 
__ minutes 
  
20. In a typical week, on how many days do you do moderate-intensity sports, 
fitness or recreational (leisure) activities that cause a small increase in 
breathing or heart rate (such as brisk walking, cycling, swimming, volleyball) 
for at least 10 minutes continuously? 
 
 
___days 
  
21. On a typical day that you do moderate-intensity sports, fitness or recreational 
(leisure) activities, how much time do you spend doing them? 
 
 
___minutes 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
104 
 
  
Overall Program Evaluation 
 
The following questions are about your experience with the TMD Self-
Care Programs. 
 
22. Please indicate how much you agree or disagree with the following 
statements about the TMD Self-Care program. 
  
 
Strongly 
Disagree 
Disagree 
Neither 
Agree 
nor 
Disagree 
Agree 
Strongly 
Agree  
a. I was satisfied with the information I 
received in the program 
 
 
 
 
 
b. I received the right amount of 
information 
 
 
 
 
 
c. The information was relevant and 
applicable to me 
 
 
 
 
 
d. I found the online learning information 
and materials to be clear and 
understandable 
 
 
 
 
 
e. I found the information presented 
valuable in managing my TMD pain 
 
 
 
 
 
f. I have a better understanding of how 
to manage my TMD pain as a result of 
participating in the program.  
 
 
 
 
 
g. I found the online program easy to 
access and navigate 
 
 
 
 
 
 
 
PACT Program Evaluation 
 
23. The next questions are about your participation in the PACT Self-Care program. 
To what extent do you agree or disagree with the following statements. 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
105 
 
 
Strongly 
Disagree 
Disagree 
Neither 
Agree 
nor 
Disagree 
Agree 
Strongly 
Agree  
a. I was interested and engaged by the 
PACT learning modules. 
 
 
 
 
 
b. I found the subject matter relevant 
and interesting. 
 
 
 
 
 
c. The amount of learning material 
presented in each module was about 
right.  
 
 
 
 
 
d. I have a better understanding of how 
to prevent and relieve pain as a result of 
the program. 
 
 
 
 
 
e. I have a better understanding of how 
to use different self-care strategies to 
manage my TMD pain. 
 
 
 
 
 
f. I found the recommended “action 
plan” activities from each learning 
module helpful. 
 
 
 
 
 
g. I found the individual self- 
assessments at within the program 
helpful in my learning. 
 
 
 
 
 
h. The time commitment for the program 
was about right. 
 
 
 
 
 
i. The program held my interest over the 
8 weeks. 
 
 
 
 
 
j. I found it easy to move through the 
online modules and lessons. 
 
 
 
 
 
k. I would recommend the PACT 
program to others who have TMD pain. 
 
 
 
 
 
 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
106 
 
24. To what degree did was each of the following features/components of the PACT 
Self-Care program helpful in contributing to your learning? 
 
 
Not at all 
Helpful  
Somewhat 
Helpful 
Helpful 
Very 
Helpful 
Extremely 
Helpful 
NA 
a. Video lessons 
 
 
 
 
 
 
b. Narrated PowerPoint 
presentations 
 
 
 
 
 
 
c. Graphic Illustrations 
 
 
 
 
 
 
d. Presentations by Professor 
James  
 
 
 
 
 
 
e. Self-assessments at the end 
of each module 
 
 
 
 
 
 
f. Online animated characters 
used to support learning  
 
 
 
 
 
 
g. Recommended exercises 
and activities in each module. 
 
 
 
 
 
 
 
25. To what degree did the follow three aspects of the PACT Self-Care program help 
you in your learning? 
 
 
Not at all 
Helpful  
Somewhat 
Helpful 
Helpful 
Very 
Helpful 
Extremely 
Helpful 
NA 
a. Daily pauses  
 
 
 
 
 
 
 
b. Calming activities  
 
 
 
 
 
 
 
c. Helpful habits 
 
 
 
 
 
 
 
26. What did you like most about the program? 
 
 
 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
107 
 
27. What suggestions do you have for improving the online PACT Self-Care 
program? 
 
 
 
28. In addition to the 8 week survey, some participants will be selected for a more 
in-depth interview about their experience in the TMD Self-Care Study.  The phone 
interview would take 20-30 minutes and would be scheduled at a time that was 
convenient for you. All feedback would be confidential and you would receive a $25 
Target gift card as a thank you for your time. If you are selected, would you be 
interested in participating in this conversation?  
 
Yes I would be interested.  
 
Preferred contact phone number____________________ 
 
 
 
 
Thank you for participating in this study and completing this survey.  
We will be mailing you a $35 dollar Target gift card as a thank you for 
completing this survey.  
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
108 
 
 
TMD Self-Care Study  
16 Week Follow up Survey  
 
Thank you for participating in the TMD Self-Care Study. The following 
questions are about your experiences with this study and should take 
about 5-10 minutes to answer. The first questions are about your jaw 
and temple pain. Please answer all the questions as best as you can. 
 
Graded Chronic Pain 
1. On how many days in the last 30 days have you had jaw or temple pain?  _____ Number 
of Days 
 
2. How would you rate your jaw or temple pain RIGHT NOW?  
No 
Pain 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Pain as 
bad as 
could be 
 
3. In the last 30 days, how would you rate your WORST jaw or temple pain?  
No 
Pain 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Pain as 
bad as 
could be 
 
4.  In the last 30 days, ON AVERAGE, how would you rate your jaw or temple pain? 
That is, your usual pain at times you were in pain. 
No 
Pain 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Pain as 
bad as 
could be 
 
5. In the last 30 days, how many days did your jaw or temple pain keep you from 
doing your USUAL ACTIVITIES like work, school, or housework?  
  _____ Number of Days 
 
 
6. In the last 30 days, how much has jaw and temple pain interfered with your DAILY 
ACTIVITIES, rated on a scale of 0-10, where 0 is “no interference” and 10 is “unable 
to carry on any activities”? 
No 
interference 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Unable to 
carry on any 
activities 
 
 
 
 
 
 
 
 
 
 
 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
109 
 
 
7. In the last 30 days, how much has jaw and temple pain interfered with your 
RECREATIONAL, SOCIAL AND FAMILY ACTIVITIES, rated on a scale of 0-10 
where 0 is “no interference” and 10 is “unable to carry on any activities”? 
  
No 
interference 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Unable to 
carry on 
any 
activities 
 
 
 
 
 
 
 
 
 
 
 
 
 
8. In the last 30 days, how much has jaw and temple pain interfered with your 
ABILITY TO WORK, INCLUDING HOUSEWORK, rated on a scale of 0-10, where 0 
is “no interference” and 10 is “unable to carry on any activities”?  
 
No 
interference 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Unable to 
carry on 
any 
activities 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Jaw Functioning 
9. For each of the items below, please indicate the level of limitation during the 
last 30 days. If the activity has been completely avoided because it is too 
difficult, then fill in “10”. If you avoid an activity for reasons other than pain 
or difficulty fill in the “not applicable” (N/A). 
 
No 
Limitation 
 
 
 
 
    Severe 
Limitation 
In the LAST 30 days: 
N/A 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
a. Chew tough food 
 
 
 
 
 
 
 
 
 
 
 
 
b. Chew chicken 
(e.g. prepared in oven) 
 
 
 
 
 
 
 
 
 
 
 
 
c. Eat soft food requiring 
no chewing (e.g., 
mashed potatoes, apple 
sauce, pudding, pureed 
food) 
 
 
 
 
 
 
 
 
 
 
 
 
d. Open wide enough to 
drink from cup 
 
 
 
 
 
 
 
 
 
 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
110 
 
e. Swallow 
 
 
 
 
 
 
 
 
 
 
 
 
f. 
Yawn 
 
 
 
 
 
 
 
 
 
 
 
 
g. Talk 
 
 
 
 
 
 
 
 
 
 
 
 
h. Smile 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Chronic Pain Self-Efficacy 
 
We would like to know about how you manage your pain. For each of the 
following questions, please choose the number that best indicates how certain or 
uncertain you are.  
 
 
Very 
Uncertain 
 
 
 
 
Very 
 Certain 
10. How certain are you that you 
can decrease your pain quite a 
bit? 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11. How certain are you that you 
can continue most of your daily 
activities? 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
12. How certain you that you 
can keep your pain from 
interfering with your sleep? 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
13. How certain are you that you 
can make a small-to-moderate 
reduction in your pain by using 
methods other than taking extra 
medications? 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
14. How certain are you that you 
can make a large reduction in 
your pain by using methods 
other than taking extra 
medications? 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
111 
 
 
 
The following questions are about how you manage your own health 
and healthcare.  
PAM 7 
15. How much do you agree or disagree with the following statements?  
 
Disagree 
Strongly 
Disagree 
Agree 
Agree  
Strongly 
a. Taking an active role in my own 
health care is the most important factor 
in determining my health and ability to 
function. 
 
 
 
 
b. I know the lifestyle changes like diet 
and exercise that are recommended for 
my health condition. 
 
 
 
 
c. I am confident that I can follow 
through on medical recommendations 
my health care provider makes such as 
changing my diet or doing regular 
exercise. 
 
 
 
 
d. I am confident that I can find 
trustworthy sources of information about 
my health condition and my health 
choices 
 
 
 
 
e. I know how to prevent further 
problems with my health condition 
 
 
 
 
f. I am able to handle symptoms of my 
health condition on my own at home 
 
 
 
 
g. I am confident that I can maintain 
lifestyle changes like diet and exercise 
even during times of stress 
 
 
 
 
 
 
The next questions are about your sleep and exercise habits. 
  
16. Overall in the last 30 days, how much of a problem did you have with 
sleeping, such as falling asleep, waking up frequently during the night or waking up 
too early in the morning? 
a. None 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
112 
 
b. Mild 
c. Moderate 
d. Severe 
e. Extreme 
  
17. In the last 30 days, how much of a problem did you have due to not feeling 
rested and refreshed during the day (e.g. feeling tired, not having energy)? 
a. None 
b. Mild 
c. Moderate 
d. Severe 
e. Extreme 
  
18. In a typical week, on how many days do you do vigorous-intensity sports, 
fitness or recreational (leisure) activities that cause large increases in breathing or 
heart rate (such as running, aerobics, soccer) for at least 10 minutes continuously? 
 
 
__ days 
  
 
29. On a typical day that you do vigorous-intensity sports, fitness or 
recreational activities, how much time do you spend doing them? 
 
 
__ minutes 
  
20. In a typical week, on how many days do you do moderate-intensity sports, 
fitness or recreational (leisure) activities that cause a small increase in 
breathing or heart rate (such as brisk walking, cycling, swimming, volleyball) 
for at least 10 minutes continuously? 
 
 
___days 
  
21. On a typical day that you do moderate-intensity sports, fitness or recreational 
(leisure) activities, how much time do you spend doing them? 
 
 
___minutes 
  
 
 
 
 
Thank you for participating in this study and completing this survey.  

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
113 
 
We will be mailing you a $45 dollar Target gift card as a thank you for 
completing this survey.  
 
 
APPENDIX H. QUALITATIVE INTERVIEW  
(FOR PACT STUDY INTERVENTION PARTICIPANTS) 
 
Thank you for agreeing to take the time to talk with me about your participation in the TMD Self-
Care Study. We are particularly interested in your perceptions about the PACT Program as we 
continue to work on developing and improving the program. This interview will take 
approximately 20-30 minutes.  All feedback you provide will be confidential and you will receive 
a $25 Target gift card as a thank you for your time.  
 
1. I would like to start by asking you to tell me about your overall thoughts about the PACT 
Program? What did you think about it? 
2. How has the PACT program affected the way you think about your TMD pain 
3. How has the PACT program affected how you manage your TMD pain? 
4. What did you learn from the PACT program that was new to you? 
5. Have you made any changes in your life as a result of your participation in the PACT 
program? If yes, please tell me about them.  
6. What did you learn in the PACT program that continues to be helpful to you in managing 
your TMD pain? 
PROBE: Are there specific ways you take care of yourself now based on what you 
learned from the PACT program?  
7. Considering your life in general, what do you think has changed for you as a result of 
your participation in the PACT program? 
8. Has your reaction to stressful situations changed as a result of participating in the PACT 
program? 
9. Please tell me about your experience with your health coach.  
PROBES: 
a. What was the most helpful part of having a phone coach? 
b. How frequently did you meet with the coach? 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
114 
 
c. What did you find difficult about working with the health coach? 
d. Do you think your opinion of the PACT program would change if the health 
coach was not a part of the program? 
10. Considering your participation in the PACT program what were the least helpful parts of 
the program? 
11. What parts of the program were the most helpful for you? 
12. If you could make a change to the PACT program what would it be? 
13. Of the seven main modules, which were the most effective for you?  
PROBES: to remind you the 7 modules are Body, Lifestyle, Mind, Emotions, Spirit, 
Social Life and Environment 
 
14. What parts of your Action Plan were most helpful? (Health habits, daily pauses, and 
calming practice were the 3 main components of the action plan). 
 
15. What did you think about the amount of information that was conveyed in each module? 
16. What did you think about the use of animation and graphics in the program? 
17. Did you find the assessments at the end of each module helpful? 
18. Is there anything else about your experience with PACT Program or the study you think it 
would be helpful for us to know?  
 
 
Thank you for your feedback.  
We will be mailing you a $25 dollar Target gift card as a thank you 
for completing this interview 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
115 
 
APPENDIX I: BARRIERS TO CONSUMER HEALTH INFORMATION TECHNOLOGY 
(CHIT) 
The use of consumer health information technology (CHIT) as part of health professional care, 
particularly, in small primary care practices, has the potential to transform their role from a 
passive recipient of care to taking an active role in improving their health.  CHIT is a secure set 
of online tools that provides e-tools to help them manage their health, health care, wellness, 
and their associated costs.1-3 CHIT are simple, inexpensive, and an easy-to-use method to 
facilitate patient engagement aspects in this study and can include many features such as 
calendar and alerts, health records, communication, health education, incentives, and cost 
management tools (Fig.2).The Center for Information Technology Leadership (CITL, 2008), a 
nonprofit research center, released findings on the value of personal health records (PHRs), 
concluding that CHIT could save $19 billion annually on a national level by focusing on 
prevention, early intervention, self-management, and evidence- based care.2 In January, the 
non-profit Partners Center for Connected Health released a report concluding that EMRs will 
not reform health care without consumer engagement, stating:  "True healthcare reform will 
require a  more patient-centered approach and a broader policy palette, including incentives for 
providers to adopt more population health management tools and for patients and consumers 
to take more ownership of their health." 34Furthermore, Institute for Medicine (2008) 35 also 
states that many of the goals suggested in using HIT to improve health care requires a 
consumer focus. 
 
However, many barriers exist in the use of CHIT, particularly with health disparity populations. 
Even when research results of health IT in an ambulatory setting are available, its scalability 
and generalizability to broader settings and with people of different cultures are often limited 
due to many issues including lack of awareness of  its  functionality,  insufficient  training  of  
users, inadequate  considerations  of  workflow  issues  such  as integration to existing workflow 
and coordination between settings or staff, concerns regarding security of the data in the 
system, cost considerations, and other challenges. Jimison et al (2008)19  conducted a review 
of barriers to the use of consumer HIT for the elderly, chronically ill, or underserved populations 
and found that the most common barriers were the lack of perceived benefit by consumers, its 
inconvenience of manual data entry, and lack of integration into the user's daily routine. 
However, they also found that several types of interactive consumer health IT were usable and 
effective in multiple settings in these populations. There was a more positive effect when the 
systems provided a complete feedback loop that included: (a) monitoring of current patient 
status, (b) interpretation of the data in comparison to individualized, treatment goals, (c) 
adjustment of the management plan as needed, (d) communication back to the patient with 
tailored recommendations or advice, and (e) repetition of this cycle at appropriate intervals. 
 
Despite the promise of CHIT, their implementation, adoption, and the meaningful use of them 
has been disappointing. We need more knowledge about what tools within the CHIT both 
engage patients to be more active in their health maintenance and health care and encourage 
health care providers to be more patient- centered in their care and employing evidence-based 
shared decision-making. Jimison et al (2008), CITL, and the IOM suggest features for CHIT in 
order to engage both patients and health care providers. These include: 
 
 
 
Access to integrated health information with health information exchange (HIE) to allow a 
person to transfer medical  records  into  one  location  to  improve  security  and  privacy  

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
116 
 
and  easier  direct  access  by  the consumer. 
 
Integration of non-biased evidence-based health information that can be integrated into 
a personalized “learning” health care system that analyzes ongoing patient experience as 
relevant to the care process. 
 
Empowerment of patients and their families in health care decisions and their 
implementation, timely and focused communication with professional health care 
providers, and care that is integrated into daily activities including calendar with 
reminders of health events. 
 
Tracking patient biometrics such as weight, body mass, exercise, blood pressure, blood 
sugar, and other biometrics at home with CHIT connected-devices. Participants can 
store data automatically with wireless connections, document recordings, and graph 
data over time and allow doctors to view progress. 
 
Privacy  and  security  standards  to  ensure  confidential  and  secure  health  
information  with  adequate authentication, encryption, and access controls. 
 
Shared vocabulary, data elements, data models, use of data standards for data 
exchange with EHRs. 
 
Universally accessible content that patients of diverse health literacy, skill levels, 
backgrounds, languages, and capabilities including intuitive interfaces to organize and 
present complex health information. 
 
Customizable to allow both simple and complex features to be included based on user 
preference with clear and easy training programs. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
117 
 
APPENDIX J: DATA MANAGEMENT AND SAFETY MONITORING PLAN 
 
 
 
Tailored Self-Management of TMD Pain using Health Information Technology 
1U01 DE025609-01 (PI: Fricton)  
The Data and Safety Monitoring Plan (DSMP) outlined below will adhere to the protocol 
approved by The HealthPartners Institutional Review Board and the recommendations of the 
National Institute for Dental and Craniofacial Research at 
http://www.nidcr.nih.gov/Research/ToolsforResearchers/Toolkit/DSMBGuidelines.htm.  
I. 
Confidentiality 
A. Protection of Subject Privacy 
During this study, limited medical information will be obtained including patient self-report 
data. All of the materials collected are for research purposes only, and data will be kept in 
strict confidence. No information will be given to anyone without permission from the subject. 
 
Confidentiality of study data will be ensured by assigning an arbitrary and unique subject 
identification number to each participant in the study. All data collected in the study will be 
identified by subject identification number only. These data will be entered by identification 
number into a computer database to which only the researchers directly involved in the 
study will have access. No participant data will be individually identified or released to 
anyone other than the study investigators without specific written permission from the study 
participant. 
 
B. Database Protection  
The database will be secured with password protection. A file containing a link between the 
study ID and individually identifying information will be maintained at HPRF by HPRF 
members of the study team. All electronic study data will be maintained in a computerized 
database residing on a username and password protected file-server to which only the 
researchers involved in the study will have access. All study related paper documents 
containing individually identifiable information will be maintained in locked file cabinets within 
HPRF.  
 
C. Confidentiality During Adverse Event (AE) Reporting  
AE reports and annual summaries will not include subject or group-identifiable material. 
Each report will only include the identification code. 
 
II. 
Adverse Event Information 
A. Definition  
An adverse event (AE) is generally defined as any unfavorable and unintended diagnosis, 
symptom, sign (including an abnormal laboratory finding), syndrome or disease which either 
occurs during the study, having been absent at baseline, or if present at baseline, appears to 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
118 
 
worsen. Adverse events are to be recorded regardless of their relationship to the study 
intervention.   
 
A serious adverse event (SAE) is generally defined as any untoward medical occurrence 
that results in death, is life threatening, requires inpatient hospitalization or prolongation of 
existing hospitalization, results in persistent or significant disability/incapacity, or is a 
congenital anomaly. 
 
If participants screen for depression and/or suicidal ideation, we will provide a list of mental 
health providers who they can consult with to ensure their safety. 
 
The study intervention is a patient-centered self-management program for TMD pain.  The 
PACT program is a web-based, tailored 8-week program supported by a health coach to help 
enhance understanding, compliance, and success in self-management for TMD pain. There 
are self-report assessments at the end of each week throughout the entire program to monitor 
progress, compliance, adverse events, risk factors, and protective factors.  If study subjects 
develop an aggravation of the pain or a new symptom that the subject attributes to the study 
intervention this would be considered an adverse event. This will be monitored by both self-
report within the PACT program weekly assessments as well as by the dental professional 
who is caring for the patient. In both cases, this will be reported to the PI and PO. 
 
B. Classification of AE Severity  
AEs will be labeled according to severity, which is based on their impact on the patient. An 
AE will be termed “mild” if it does not have an impact on the patient, “moderate” if it causes 
the patient some minor impact and inconvenience and “severe” if it causes a substantial 
disruption to the patient’s well-being. 
 
C. AE Attribution Scale  
AEs will be categorized according to the likelihood that they are related to the study 
intervention. Specifically, they will be labeled definitely unrelated, definitely related, probably 
related, or possibly related to the study intervention. 
 
D. Expected Risks 
It is believed that risks to subjects in the present study are minimal. The PACT program 
uses well-tested cognitive-behavioral strategies to help patients reduce lifestyle risk factors 
and enhance protective factors to prevent chronic pain.  Study risks are considered to be 
minimal and are addressed in the protocol and consent form. 
 
E. AE Reporting and Follow-Up 
The study coordinator will be responsible for compiling the data and producing the 
necessary reports, as well as assuring that all parties obtain copies of these reports. 
Adverse events will be reported and reviewed by Dr. Fricton as they occur and reported to 
the IRB. The number of days by which a serious adverse event or unanticipated problem 
would be reported is 2 days. Summary reports of adverse events and others relevant to 
summary data will be reported to the PI and the PO at NIDCR. Reports will include 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
119 
 
description of study progress, subject recruitment, subject demographic data, subject status, 
and inclusion/exclusion criteria. These reports will be reviewed by the Principal Investigator 
and study team prior to being presented to NIDCR. 
 
F. SAE Reporting 
SAEs that are unanticipated, serious, and possibly related to the study intervention will be 
reported to the IRB and NIDCR in accordance with requirements.   
 
 
Unexpected fatal or life-threatening AEs related to the intervention will be reported to the 
NIDCR Program Officer within 7 days. Other serious and unexpected AEs related to the 
intervention will be reported to the NIDCR Program Official within 15 days. 
 
Anticipated or unrelated SAEs will be handled in a less urgent manner but will be 
reported to the IRB and NIDCR in accordance with their requirements. In the annual AE 
summary, the PI will state that he has reviewed all AE reports.  
 
III. 
Data Quality and Safety Review Board and Monitoring 
 
The study coordinator will submit data to the PI and they will evaluate the timeliness, 
completeness, and accuracy of the data to ensure an adequate evaluation of the safety and 
welfare of study participants. This will include a review of:  
 
Data for evidence of study-related adverse events from the self-report and clinical data;  
 
Data for evidence of efficacy according to pre-established statistical guidelines; 
 
Data quality, completeness, and timeliness;  
 
Adequacy of compliance with goals for recruitment and retention, including those related to 
the participation of women and minorities; 
 
Adherence to the protocol;  
 
Factors that might affect the study outcome or compromise the confidentiality of the trial 
data (such as protocol violations, unmasking, etc.); and, 
 
Factors external to the study such as scientific or therapeutic developments that may impact 
participant safety or the ethics of the study. 
The PI will also provide recommendations to NIDCR as to whether the study should continue 
without change, be modified, or terminated. Recommendations regarding modification of the 
design and conduct of the study could include:  
 
 
Modifications of the study protocol based upon the review of the safety data;  
 
Suspension or early termination of the study or of one or more study arms because of 
serious concerns about subjects’ safety, inadequate performance or rate of enrollment;  
 
Suspension or early termination of the study or of one or more study arms because study 
objectives have been obtained according to pre-established statistical guidelines; 
 
Optional approaches for NIDCR and investigators to consider when the PI determines that 
the incidence of primary study outcomes is substantially less than expected such as 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
120 
 
recommendations to increase the number of trial centers or extend the recruitment period; 
and,  
 
Corrective actions regarding a study center whose performance appears unsatisfactory or 
suspicious. 
 
Confidentiality must always be maintained during all phases of Study Coordinator, PI review 
and deliberations. 
 
A. Data Quality and Management 
Description of Plan for Data Quality and Management―The study coordinator and study 
staff will review all data collection forms on an ongoing basis for data completeness and 
accuracy as well as protocol compliance.  
 
 
The study coordinator will review all surveys and the Activity logs submitted for 
completeness at the time of completion by the study participant. 
 
Semi-structured interview data will be reviewed by the study PI on an ongoing basis as 
interviews are completed. 
 
Weekly study participation will be reviewed by the study coordinator on an ongoing basis 
during the intervention. The study coordinator will also assure the program evaluation is 
completed. 
  
Frequency of Data Review for this Study― The frequency of data review for this study 
differs according to the type of data and is summarized as follow: 
 
Data type 
Frequency of 
review 
Reviewer 
Subject accrual (including compliance 
with protocol enrollment criteria) 
Quarterly 
 
Study Coordinator and PI 
Status of all enrolled subjects, as of 
date of reporting  
Quarterly 
 
Study Coordinator and PI  
Adherence data regarding study 
intervention 
Quarterly 
 
Study Coordinator and PI  
AEs and rates ) 
Quarterly 
 
Study Coordinator and PI 
SAEs 
Per occurrence 
Study Coordinator and PI and 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
121 
 
 
B. Subject Accrual and Compliance 
Measurement and Reporting of Subject Accrual, Compliance with Inclusion/Exclusion 
Criteria― Review of rate of subject accrual and compliance with inclusion exclusion criteria 
will occur during each recruitment phase to ensure that a sufficient number of participants 
are being enrolled and that they meet the study criteria; 
 
Measurement and Reporting of Participant Adherence to Treatment Protocol  
Adherence will be assessed by the number of participants, using health coach (PACT only), 
and number of online modules completed.   
 
C. Justification of Sample Size  
This is a pilot randomized clinical trial of the PACT program for TMD pain to determine 
feasibility and acceptability of methods and preliminary outcomes to power a multisite 
randomized clinical trial of its efficacy. The study is not powered to detect statistically 
significant intervention effects. For this study we have selected a sample size of 80 
participants. This will provide an adequate sample for feasibility assessments and is in line 
with the constraints of available study resources and timing considerations related to the 
funding mechanism of the study. Comparisons done as part of the feasibility analyses of 
patient characteristics in each stage will serve as an alert to potential sources of bias in the 
study and will be used to inform refinement of the protocol for a larger study. Results from 
the pilot study, in conjunction with previous findings of behavioral interventions will be used 
to estimate the parameters needed for the study trial.  
  
D. Stopping Rules  
This study will be stopped prior to its completion if: (1) the intervention is associated with 
adverse effects that call into question the safety of the intervention; (2) difficulty in study 
recruitment or retention will significantly impact the ability to evaluate the study endpoints; 
(3) any new information becomes available during the trial that necessitates stopping the 
trial; or (4) other situations occur that might warrant stopping the trial. 
 
E. Designation of PI/PO in the Role of Data Safety Monitor   
The PI, Dr. James Fricton will provide data safety monitoring oversight for the study.  
 
  
F. Safety Review Plan  
NIDCR  

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
122 
 
Study progress and safety will be reviewed following each recruitment and intervention 
phase – every 6 months by the Study Coordinator in collaboration with the PI. Progress 
reports, including patient recruitment, retention/attrition, and AEs will be provided to the PI 
following each of the reviews. An Annual Report will be compiled and will include a list and 
summary of AEs. In addition, the Annual Report will address (1) whether AE rates are 
consistent with pre-study assumptions; (2) reason for dropouts from the study; (3) whether 
all participants met entry criteria; (4) whether continuation of the study is justified on the 
basis that additional data are needed to accomplish the stated aims of the study; and (5) 
conditions whereby the study might be terminated prematurely. The Annual Report will be 
sent to the IRB and NIDCR. The IRB will review progress of this study on an annual basis. 
 
G. Study Report Outline for the Interim or Annual Reports  
The study coordinator and statistician will prepare a study safety report which begins with a 
brief introduction section describing the study status, issues, and procedures that produced 
the report (e.g., data obtained by specific date). A study description with a current timetable 
and study schedule will be included. Data are presented that describe the administrative 
status of the study, including recruitment and forms handling. The study data report will 
describe demographic, baseline characteristics, subject status, and safety assessment.  
 
Study Report Outline 
I. 
Table of Contents 
II. 
Introduction 
a. Summary of Study Status and Issues or Problems 
b. Report Preparation Procedures 
III. 
Study Description 
a. Project Organization Chart, Personnel 
b. Brief Statement of Purpose of Trial 
c. Projected Timetable and Schedule 
d. List of Any Resource Centers 
IV. 
Study Administration 
a. Recruitment Status 
i. 
Enrollment by Month for 6 months of enrollment 
ii. 
Comparison of Targeted to Actual Enrollment 
b. Retention Status 
i. 
Overall Subject Status 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
123 
 
ii. 
Individual Subject Status 
V. 
Study Data Reports/Tables or Figures 
a. General Information 
i. 
Enrollment (see Appendix A, Table 1) 
ii. 
Demographic/Baseline Data (see Appendix A, Table 2) 
iii. 
Subject Status (see Appendix A, Table 3) 
b. Safety Assessment 
i. 
Treatment Duration for All Subjects (see Appendix A, Table 3) 
ii. 
AE Data 
1. Overall Listing (see Appendix A, Table 4) 
2. Specific Symptom Listing (see Appendix A, Table 5) 
3. Out-of-Range Values (see Appendix A, Table 6) 
4. SAE Listing (see Appendix A, Table 7) 
5. Subject Deaths (see Appendix A, Table 8) 
 
IV. 
Informed Consent 
A structured enrollment screening process will be implemented to assure that all subjects obtain 
complete information about the study and appropriate questions are asked to insure their 
understanding about the project prior to and during the consent process.  
 
The SRC will contact all study participants completing the initial phone screen who are eligible 
and still express interest in the study. The SRC staff member will first provide a complete overview 
of the study and detail the requirements of study participation as specified in the consent form. 
The SRC will then ask whether the potential participant is still interested in study participation. If 
yes, they will describe the benefits and risks of study participation and discuss issues of 
confidentiality. Following this the SRC staff member will again ask about continued interest in the 
study and elicit questions from the potential participant. The participant will then be asked if they 
still wish to proceed. If the subject wishes to proceed, the SRC will then email the participant the 
study consent and HIPPA form along with a link to the website with log-in information (username 
and password).  Subjects will be asked to visit the study website and log-in to complete the 
consent form electronically before continuing on in the study. 
 
V. 
Reporting Changes in Study Status 
During the funding of this study, any action by an IRB or one of the study investigators that results 
in a temporary or permanent suspension of the study will be reported to the NIDCR Program 
Official within 1 business day of notification. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
124 
 
 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
125 
 
Data Safety and Monitoring Plan  
Appendix A 
Table 1. Enrollment by Month of Study 
 
Week 
# 
# 
Expected 
(400 ) 
# 
Screened 
# Enrolled  
# 
Withdrawn 
# Actual 
(#Enrolled - #Withdrawn) 
# Cumulative 
 
 
 
 
 
 
Table 2. Demographics 
Characteristics 
N 
N% 
Gender 
 
 
Female 
 
 
Male 
 
 
Ethnicity 
 
 
Hispanic or Latino 
 
 
Not Hispanic or Latino 
 
 
Unknown 
 
 
Age 
 
 
Mean (SE) 
 
 
Median (min, max) 
 
 
Race 
 
 
Asian 
 
 
Nat Hawaiian/Other Pac 
Islander 
 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
126 
 
Black or African American 
 
 
White 
 
 
Other 
 
 
More than one race 
 
 
Unknown 
 
 
 
Table 3. Subject Status 
Pt 
Identifier 
Date 
Enrolled 
Date 
Completed 
Study 
Study 
Status 
Reason for 
Withdrawal 
% Adherence 
to Intervention  
(# of Modules 
completed 
Intervention 
Duration 
(Weeks) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Status:  
 
 
% Adherence to Intervention: 
A = Active 
 
 
(# Modules completed/total #)*100 
C = Completed 
 
 
 
 
or 
W = Withdrew  
L = Lost to Follow Up 
 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
127 
 
Table 4. Adverse Events 
 
Pt 
Identifier 
AE 
Onse
t 
 
AE 
En
d 
AE 
Description 
 
Severity 
 
SAE? 
(Y/N) 
Relatedness 
Action 
Taken 
Outcome 
Comments 
 
 
 
 
 
 
 
 
 
 
 
 
Severity of AE: 
 
 
Relatedness to Intervention:  
1 = Mild 
 
 
 
1 = Definitely Unrelated  
2 = Moderate  
 
 
2 = Possibly Related 
3 = Severe 
 
 
 
3 = Probably Related 
 
 
 
 
 
4 = Definitely Related 
 
 
Action Taken:  
 
 
 
 
 
0 = None 
 
 
 
Outcome: 
1 = Dose modification  
 
1 = Resolved 
2 = Medical intervention  
 
2 = Recovered with minor sequelae 
- (specify in comments) 
 
3 = Recovered with major sequelae 
3 = Hospitalization 
 
 
4 = Continuing treatment 
4 = Intervention discontinued  
5 = Condition worsening 
5 = Other 
 
 
 
6 = Patient death** 
 
**Provide further details regarding all reported serious AEs and deaths in the SAE and Subject 
Deaths tables listed at the end of this section. 

Tailored Self-Management of TMD Pain using Health Information Technology 
Version 0.71 
Protocol 16-054-E 
20 March 2017 
 ________________________________________________________________________________________________________  
 
128 
 
Table 5. Frequency of Specific Symptoms 
Symptoms 
Description of AE  
 
N% 
Jaw Fatigue 
 
Jaw pain 
 
Jaw joint clicking 
 
Jaw joint locking 
 
Difficulty chewing 
 
 
Table 6. Serious Adverse Events 
 
 
Pt 
Identifier 
Age 
Treatment 
Date 
SAE 
SAE Date 
Related to 
Intervention 
Description of Actions and Outcomes 
(e.g., hospitalization, withdrawn from 
study) 
Subj001 
Subj002 
Subj003