An Efficacy Trial of Community Health Worker-Delivered Chronic Pain Self-Management Support for Vulnerable Older Adults
Phase: NA
Conditions: Chronic Pain
Sponsor: University of Michigan

 
 
 
Cover Page for ClinicalTrials.gov 
 
 
Document: Study Protocol 
 
 
Study Title: An Efficacy Trial of Community Health 
Worker-Delivered Chronic Pain Self-Management 
Support for Vulnerable Older Adults 
 
 
Document Date: 8/30/2024 
 
 
NCT Number: NCT05278234 
 
 
 

An Efficacy Trial of Community Health Worker-Delivered Chronic Pain Self-
Management Support for Vulnerable Older Adults 
 
STEPS RCT 
National Clinical Trial Number (clinicaltrials.gov): NCT05278234 
Principal Investigator: 
Mary R. Janevic 
Associate Research Scientist 
School of Public Health 
Department of Health Behavior and Health Education 
University of Michigan 
 
Supported by: 
National Institute on Aging 
R01 AG071511-01 
Version Number 7 
Date: August 30, 2024 
 
 
 
 
 
 
Summary of Changes from Previous Version: 
Revision 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
2 
1.4 
Added breach of confidentiality to risks 
Per IRB pre-review request 
2.1 
9 
Clarified which PEERRS training 
Per IRB pre-review request 
2.1 
4.4 
Added description of how verbal consent is 
documented 
Per IRB pre-review request 
2.2 
1.4.1, 4.4 
Will send Detroit Resource List to all 
participants along with copy of consent form. 
IRB post-review request 

3 
2.1, 4, 4.3, 
5.2, 5.2.2, 6.1, 
9 
Added language about possible discomfort due 
to activity tracker (2.1), Added language 
describing additional resources to address 
participant barriers to study participation (4); 
updated informed consent options (4.4); activity 
tracker changed to Wyze Watch (5.2); added 
detail to describe intervention completion 
(5.2.2), Study Activity table updated to reflect 
changes in study measures and baseline 
assessment procedures for delayed participation 
in the intervention (6.1) Updated references for 
measures; updated internet platforms/electronic 
security (9)  fixed section numbers to match with 
table (Sections 7 – 14) 
These changes will improve the study design, 
including the recruitment strategies. Details 
were also added to clarify study activities and 
procedures.  
4 
5.2 
Updated study orientation length (5.2) 
Participants typically spend more time with 
CHWs during the orientation because they’re 
spending more time connecting and sharing 
about themselves and/or needing a bit more 
support with the website and activity tracker. 
We updated this in the protocol to be more 
accurate.  
5 
1.4.1. 
Following an AE (Adv00050649) in which a 
participant reported a muscle pull from 
exceeding her walking goal, we are adding 
muscle strain as a risk to study documents 
including consent forms. 
Per IRB request 
6 
10.2.2 
Added language to allow 2-month surveys to be 
completed prior to last intervention session, if 
needed.  
Some participants may need additional 
flexibility for scheduling the 2-month survey 
to ensure it is within the assessment windows.  
7 
4.6, 6.2 
Added checks as the default incentive options. 
Gift cards will remain as an alternative for 
participants who are not able to use checks. 
Participants have had issues with the HSIP 
gift cards that result in difficulty using the gift 
cards.  

 
 
Page 
Protocol summaryct.gov .................................................................................................................. 4 
1 
Rationale & Background ...................................................................................................... 5 
1.1 
Study Rationale 
5 
1.2 
Background 
5 
1.3 
Specific Aims 
6 
1.4 
Risk/Benefit Assessment 
6 
1.4.1 Known Potential Risks 
6 
1.4.2 Known Potential Benefits 
7 
1.4.3 Assessment of Potential Risks and Benefits 
7 
2 
OBJECTIVES & ENDPOINTS........................................................................................... 8 
3 
STUDY DESIGN ................................................................................................................... 9 
3.1 
Study Design 
9 
3.2 
Study flow 
9 
4 
Selection and enrollment of participants .......................................................................... 10 
4.1 
Inclusion Criteria 
10 
4.2 
Exclusion Criteria 
10 
4.3 
Recruitment 
10 
4.4 
Informed Consent & Enrollment 
11 
4.5 
Screen Failures 
12 
4.6 
Strategies for Recruitment and Retention 
12 
5 
STUDY INTERVENTIONS .............................................................................................. 13 
5.1 
STEPS Intervention Overview 
13 
5.2 
STEPS Intervention Process 
14 
5.3 
Control Study Arm 
16 
5.4 
Measures to Minimize Bias: Randomization and Blinding 
16 
5.5 
Study Intervention Adherence 
17 
5.6 
Concomitant Treatment 
17 
5.7 
Lifestyle Considerations 
17 
5.8 
Intervention Discontinuation 
17 

STEPS Protocol, v7 
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5.9 
Treatment Fidelity 
17 
5.9.1 Overall compliance 
17 
5.9.2 Community Health Worker Training and Tracking 
17 
5.10 
Withdrawal from the Study 
18 
5.11 
Lost to Follow-up 
18 
6 
STUDY PROCEDURES .................................................................................................... 19 
6.1 
Schedule of Activities 
19 
6.2 
Description of Activities 
20 
7 
safeTy ................................................................................................................................... 20 
7.1 
Potential Risks & Benefits 
20 
7.2 
Event Reporting Schedule 
21 
7.3 
Definitions for Events 
21 
7.4 
Classification of Adverse Events 
22 
7.4.1 Severity of Event 
22 
7.4.2 Relationship to Participation 
22 
7.4.3 Expectedness 
22 
8 
Quality Control and Data monitoring procedures .......................................................... 24 
9 
Confidentiality and privacy ............................................................................................... 25 
10 STATISTICAL CONSIDERATIONS .............................................................................. 28 
10.1 
Sample Size 
28 
10.2 
Data Analyses 
28 
10.2.1 
General Approach 
28 
10.2.2 
Primary & Secondary Endpoints 
28 
10.2.3 
Other Pre-specified Analyses 
29 
10.2.4 
Qualitative Data Analyses 
29 
11 Interim Analysis .................................................................................................................. 29 
12 Publications ......................................................................................................................... 29 
13 protocol amendment history .............................................................................................. 29 
14 REFERENCES .................................................................................................................... 29 
 
 

STEPS Protocol, v7 
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STATEMENT OF COMPLIANCE 
The trial will be carried out in accordance with International Conference on Harmonisation Good 
Clinical Practice (ICH GCP) and the following:  
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies 
(45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR 
Part 812)  
 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of NIH-funded clinical trials have 
completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the Institutional Review Board (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 to the study.  In addition, all changes to the consent form will be IRB-approved; a 
determination will be made regarding whether a new consent needs to be obtained from 
participants who provided consent, using a previously approved consent form. 
 
 

STEPS Protocol, v7 
4 
 
PROTOCOL SUMMARYCT.GOV 
Title: 
 
An Efficacy Trial of Community Health Worker-Delivered Chronic Pain Self-
Management Support for Vulnerable Older Adults 
Study Description: 
The purpose of this study is to test the efficacy of the STEPS (Seniors using 
Technology to Engage in Pain Self-management) intervention. We 
hypothesize that participants in the STEPS intervention, compared to a 
randomized control group, will have greater improvements in pain 
interference and pain intensity, and a more positive Global Impression of 
Change immediately following the intervention and at 12 months from 
baseline.  
Objectives*: 
 
Primary Objective: To test the efficacy of the STEPS intervention compared 
to a waitlist control condition. 
Secondary Objective: To examine the mechanisms of action of the STEPS 
intervention and to identify factors affecting engagement and program 
implementation. 
 
Endpoints*: 
Primary Endpoint: Improvement in pain interference at Months 2 (post-
program) and 12  
Secondary Endpoints: pain intensity, Global Impression of Change at Months 
2 and 12 
Study Population: 
We will recruit 414 adults from the Detroit community, age 50+ years who 
report chronic musculoskeletal pain of at least 3 months’ duration. 
 
 
Phase* or Stage: 
NIH Behavioral Intervention Stage III 
Description of Sites/Facilities 
Enrolling Participants: 
Participants (N = 414) will be primarily recruited through the Henry Ford 
Health System and community locations in Detroit.  
 
Description of Study 
Intervention/Experimental 
Manipulation: 
STEPS is a community health worker (CHW)-led chronic pain self-
management program designed for older adults living in underserved 
communities. It is a 7-week intervention that includes three primary 
components: a website that includes brief instructional videos for 6 weekly 
modules; weekly telephone calls with a CHW to support application of the 
content in a given module by reinforce key points, help participants practice 
new skills, discuss adaptations needed for a participant’s situation, and set a 
related goal. CHWs will also screen for social needs that could be addressed 
with appropriate community referrals; e.g. utility or insurance issues. 
Participants will set goals each week related to walking (step counts), using 
step-count data from the physical activity. Participants will also be given a 
wearable physical activity tracker at the orientation session to use throughout 
the course of the program track daily step counts by replying to an automated 
text each evening. 
Study Duration*: 
5 years 
 
Participant Duration: 
One year 

STEPS Protocol, v7 
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1 
RATIONALE & BACKGROUND 
1.1 
Study Rationale 
Our overall objective in this efficacy trial is to determine if an intervention developed and pilot-
tested by our team (STEPS, or Seniors using Technology to Engage in Pain Self-management),1 
which is delivered by CHWs with support from mobile health tools, can improve outcomes 
among older adults with musculoskeletal pain. Older adults in disadvantaged urban communities 
such as Detroit, Michigan, the study’s setting, face a barrage of psychosocial and environmental 
stressors that contribute to high levels of chronic pain-related disability. Older adults of color are 
especially at risk due to the health-damaging effects of structural racism, and many vulnerable 
older adults lack opportunities to learn cognitive-behavioral skills that can improve pain and 
functioning, and that – unlike medications – are virtually risk-free. Most CPSM interventions are 
group-based and face-to-face, making them hard to access for older adults with transportation or 
mobility challenges. Moreover, existing interventions do not address the social determinants of 
health (SDOH; e.g., housing issues) stemming from structural inequities, which strongly affect 
pain and its management. Thus, current CPSM programs fail to meet the needs of precisely those 
older adults who could most benefit from them. One novel way to bridge this gap is to enlist 
community health workers (CHWs) – frontline, lay public health workers with close ties to the 
communities they serve – to deliver telephone-based CPSM support that also addresses SDOH. 
1.2 
Background 
Chronic pain is a significant, modifiable factor affecting older adults’ ability to remain 
independent in their daily lives. Evidence-based cognitive and behavioral self-management 
strategies can help patients with chronic pain improve daily functioning and quality of life, while 
avoiding risks associated with opioids and other pharmacological treatments. Unfortunately, few 
chronic pain patients are offered structured opportunities to learn and practice self-management 
skills. The 2016 National Pain Strategy2 calls for expanding access to chronic pain self-
management (CPSM) support, and the Federal Pain Research Strategy designates research on 
sustainable CPSM delivery models as a “Top Priority”3). These federal documents shaping 
current directions in pain research also highlight the need to address population disparities in 
pain and pain treatment. Such disparities are amply documented in the literature. For example, 
African American adults and people of low socioeconomic status (SES) regardless of race have 
greater chronic pain severity and pain-related disability compared to their White and higher-SES 
counterparts, while having inferior access to high-quality pain treatment.4-6 7,8  
 
One untested but promising approach to providing CPSM support to underserved populations is 
through community health workers (CHWs). CHWs are non-professionals who have formal but 
limited training for specific health care-related tasks.9 10 Typically, CHWs are members of the 
communities they serve. They therefore enjoy a high level of client trust and deliver culturally 
appropriate, patient-centered services, such as supporting health behavior change, addressing 
social determinants of health, and providing linkages to formal health care services. This study 
will assess the efficacy of engaging CHWs to deliver chronic pain self-management support to 
underserved older adults.  
 

STEPS Protocol, v7 
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1.3 
Specific Aims 
Aim 1: Conduct a randomized controlled trial to assess the effects of a CHW-led chronic 
pain self-management intervention among 414 primarily African American older adults. 
We will enroll adults aged >50 years, given accelerated aging in African American adults due to 
the health effects of structural racism. 
H1: Intervention participants will have lower Pain Interference (primary outcome) compared 
to a usual-care control group at Months 2 (immediately post-program) and 12. H2: Compared 
to controls, the intervention group will have lower pain intensity and more positive Global 
Impression of Change (secondary outcomes). 
Aim 2: Assess potential mediators and moderators of intervention effects.  
H3: Intervention effects will be mediated by psychological changes (e.g., increased self-
efficacy for managing pain) and behaviors (e.g., increased physical activity, addressing 
SDOH). H4: Intervention effects will be moderated by age, sex, baseline pain interference, 
and therapeutic alliance with the CHW.  
Aim 3: Collect qualitative data from participants, CHWs, and other stakeholders to 
uncover subjective mechanisms of action, and factors affecting engagement and program 
implementation. This will provide context for quantitative findings and inform a toolkit for 
dissemination, if STEPS is successful. Otherwise, findings will inform a modified approach to 
providing CPSM support to this population for further testing. 
 
1.4 
Risk/Benefit Assessment 
1.4.1 Known Potential Risks 
A plausible but unlikely risk to participants is psychological distress during the course of 
telephone data collection (or telephone intervention sessions, for Intervention arm participants). 
If that occurs, study staff or community health workers will terminate the interaction (if deemed 
necessary) and/or offer psychological resources to the participant(s). We have an updated list of 
Detroit-area resources for psychological support, which will be provided to all participants 
(mailed or emailed along with a copy of their consent form). Participants will be informed as part 
of their informed consent process and immediately prior to each telephone interview that they 
can drop out of the study at any time and that they can refuse to answer any of the questions. In 
the event of participants reporting serious depressive symptoms or suicidal ideation, the staff 
member or CHW communicating with the participant will follow an established protocol, used in 
our other studies, which will include notifying the PI, providing a suicide hotline number, and 
calling 911 if needed. 
 
Another plausible but unlikely risk is a breach of confidentiality. Rigorous data security 
measures will be put in place to minimize the risk of breach of confidentiality. As part of their 
consent process, participants will be informed about the small risk of a breach of confidentiality.  
Email messages will only be used to reply to or contact participants if they choose this mode. A 
secure UM email (Google) account will be created for the study and will be monitored by study 
staff. 

STEPS Protocol, v7 
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A final risk is discomfort or skin irritation from the activity tracker wristbands. If this is reported 
by a participant, study staff will work with that participant to find a more comfortable option for 
wearing the tracker.  
 
Throughout the study, IRB guidelines will be followed to ensure the privacy and integrity of the 
information we collect. Any breach of confidentiality will be immediately reported to the PI and 
to the University of Michigan Health Sciences and Behavioral Sciences IRB. In addition, any 
complaints or concerns expressed to the study staff by participant participants, providers, or 
anyone else affected by this study will be immediately reported to the PI, and as appropriate, to 
the IRB.  All research data presented in reports, presentations, or manuscripts will use aggregate 
statistics only. 
 
Training of staff will include information about the importance of privacy and confidentiality 
and specific techniques to maintain confidentiality of all information in the context of this 
study.  Regular study team meetings will help ensure that all data quality and IRB policies and 
procedures are being followed. 
 
1.4.2 Known Potential Benefits 
The intervention being tested may benefit physical and/or mental health and functioning, as it 
incorporates evidence-based psychological principles to support self-management of chronic 
pain. The waitlist control group design, in which control group members will have the option of 
participating in a version of the intervention following the final data collection point and will 
receive all intervention materials, means that all participants will have access to key elements of 
intervention content.  
.  
1.4.3 Assessment of Potential Risks and Benefits 
This study is considered low risk to participants. It is non-invasive and offers a variety of 
resources for chronic pain management that are not commonly part of standard pain care. The 
intervention has been pilot-tested for feasibility and potential efficacy, and incorporates 
evidence-based strategies that may improve health and functioning. Burdens typical to research 
studies, such as frequent travel to a study site, have been eliminated and participants have the 
benefit of access to an intervention they can largely or entirely participate in from their homes. If 
the program is effective, it has the potential to be an adjunct to clinical care. Overall, given that 
the potential risks of participation are minimal, the potential benefits outweigh the potential 
risks. 
 
 
 
 
 
 

STEPS Protocol, v7 
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2 
OBJECTIVES & ENDPOINTS 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR ENDPOINTS 
Primary 
 
 
To determine if 
participating in the STEPS 
intervention leads to 
decreased pain interference 
with daily functioning. 
 
 
PROMIS Pain 
Interference 6a scale is 
the primary endpoint 
(pain interference is 
assessed at baseline, 2 
months (post-program) 
and 12 months. A 2.5 
point difference in T-
score is considered 
clinically significant. 
Pain interference is a patient-centered 
outcome that indicates pain’s impact on 
valued and necessary activities. This 
intervention teaches skills to gradually 
increase engagement in daily activities 
such as goal setting. It targets 
psychological mediators such as self-
efficacy and fear of movement and 
behavioral mediators such as physical 
activity. 
Secondary 
 
 
To determine if pain 
intensity and perceived 
change in pain and 
functioning show greater 
improvement in 
intervention vs. control 
group. 
The Pain Numerical 
Rating Scale (0 to 10) 
will be given at baseline, 
2, and 12 months.  
Patient Global 
Perception of Change 
since baseline will be 
assessed at 2 and 12 
months. Participants will 
be asked about pain and 
functioning in separate 
items. 
Although the intervention focuses on 
enhancing functioning rather than 
reducing pain per se, pain intensity may 
decrease as well, as seen in our pilot work. 
“Global impression of change” variables 
capture participants’ subjective 
perceptions of intervention benefit. 
Tertiary/Exploratory  
 
 
To examine whether the 
intervention is associated 
with reduced opioid and 
non-opioid pain 
medication use.  
The Quantitative 
Analgesic Questionnaire 
(QAQ) quantifies the 
pain medication regimen 
for both prescription and 
OTC medications, 
yielding an opioid score, 
non-opioid score, and 
total QAQ score.11       
 
The STEPS intervention has the potential 
to decrease reliance on pain medications, 
if participants are able to derive benefit 
from non-pharmacological self-
management strategies. In pilot work, a 
substantial number of STEPS participants 
reported taking less pain medication 
following the intervention. 
 
 

STEPS Protocol, v7 
9 
 
 
3 
STUDY DESIGN 
3.1 
Study Design 
● NIH Behavioral Intervention Stage 3 randomized controlled trial to examine the efficacy 
of the STEPS program in decreasing pain interference among older adults with chronic 
pain, compared to a waitlist control group.   
● Participants will be allocated into the two study arms in a 1:1 ratio by block 
randomization with mixed block sizes 
3.2 
Study flow 
 

STEPS Protocol, v7 
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4 
SELECTION AND ENROLLMENT OF PARTICIPANTS 
Eligibility criteria are broad with few exclusions and no upper age limit, in response to recent 
calls for heterogeneity in clinical trials with older adults and to maximize the relevance of this 
study to practice. Recruitment yield will be assessed and reasons for refusal will be tracked. 
Nearly all potential participants in our pilot studies had some form of internet access, but we will 
not make this a requirement. For the expected small number of participants without access, we 
will lend them inexpensive tablets pre-loaded with STEPS website content. If telephone minutes 
are a barrier for some eligible participants, we will provide additional support on an individual 
basis, such as a prepaid phone or additional telephone minutes. We will also support participants 
in getting a government issued telephone (such as an Obama Phone) if they are eligible. 
4.1 Inclusion Criteria  
Participants will be eligible if they:  
● Are 50+ years of age 
● Community-living  
● Have self-reported pain in muscles or joints for >3 months, 
● Report >4 (0-10 scale) mean pain intensity over last week, >1 day in past month when 
pain made it difficult to do usual activities,  
● Have a cell or landline phone. 
● Able to converse comfortably in English. 
4.2 Exclusion Criteria 
● Serious acute illness or hospitalization in last month; planned major surgery in next three 
months that would interfere with program participation (e.g., knee replacement) 
● Other issues that preclude meaningful participation in study procedures (e.g. severe 
physical, cognitive, or psychiatric disorder).   
4.3 
Recruitment 
Clinic-based recruitment: In Henry Ford Health System’s five Detroit-based Medical Centers, we 
will recruit via CHW tabling in waiting rooms. The study will also be featured in the CHW Hub 
quarterly newsletter distributed to HFHS departments and community partners. We will also 
discuss the study through other departmental meetings such as the monthly CHW Hub meeting, 
which will allow CHWs from across the system to gain knowledge of the program and refer 
patients who may be interested.  
 
 
Community-based recruitment: Flyers will be displayed at community locations in Detroit 
serving older adults, with or without an accompanying information session by study staff and/or 
CHWs. Interested participants will be screened on-site or can later call the study hotline.  
 
Healthier Black Elders Center Participant Resource Pool: Individuals meeting broad study 
criteria (age, diagnosis of musculoskeletal pain condition) will be initially contacted by mail and 

STEPS Protocol, v7 
11 
 
given the opportunity to opt out of further contact via the study hotline. Those not opting out will 
receive a call from study staff. 
4.4 
Informed Consent & Enrollment 
During recruitment contacts, whether they take place in person or via telephone, each patient will 
hear a brief description of the study before being asked if they wish to be screened for eligibility. 
Interested individuals will be screened by study staff on site or by telephone to further assess 
eligibility and invite to participate, if appropriate.  
Participants who are eligible will be offered more details about the study. They will be told that 
those agreeing to participate in the research will be randomly assigned to one of two groups 
(with an equal chance of being in either), after completing informed consent and a baseline 
telephone survey.   
The intervention and control conditions will be described as follows. Individuals in the 
intervention group will meet with a community health worker at an in-person study orientation 
session at the participant’s home, a HFHS site, or another mutually agreed-on location (or 
remotely if it is needed due to social distancing). At this session, they will be introduced to the 
program, learn how to use the online modules and choose a day and time for future weekly 
telephone sessions. The program will be delivered over 7 weeks. They will be told that they will 
be given a wearable physical activity tracker at the orientation session to use throughout the 
course of the program and keep after the study ends.  
After completing the one-year telephone survey, individuals in the control group will be given 
access to the online program, a wearable physical activity tracker to keep, and will be invited to a 
one-time in-person (or remote) workshop that includes key intervention content and personalized 
goal-setting support, and that will be led jointly by study staff and a community health worker. 
Participants in both groups will be asked to complete three data collection telephone interviews 
(at baseline, two months from baseline, and one year from baseline), each of approximately 45 
minutes in length. Participants in both groups will also receive a “Welcome to STEPS” kit that 
includes inexpensive study-themed items to enhance a feeling of belonging to the study. 
Informed consent procedures: If the individual expresses interest in participating after hearing 
the above description, they will be asked to verbally consent over the phone. Participants will 
have the option to have a copy of the consent document mailed or emailed to them to review 
beforehand, or they can choose to complete the verbal consent first and have a copy of the 
consent document mailed to them afterward. Consent documents that are mailed or emailed to 
participants will also include a community/psychological resource list. During the verbal consent 
process, the interviewer will read the informed consent document aloud, stopping to ask 
questions after each section. The verbal consent is documented in three ways. 1) With the 
participant’s permission, we will audiorecord the verbal consent interaction and securely store 
the audiofiles. 2) We write their full name, the date, and the interviewer's initials to document 
that verbal consent was attained and securely store these documents. 3) We will also indicate in 
REDCap that verbal consent was provided and document the date. 

STEPS Protocol, v7 
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Research staff will call potential participants approximately one week after mailing the consent 
document to go through the verbal consent process over the phone and answer any questions. For 
those potential participants who cannot be reached via phone or who say that they did not receive 
the consent form, a duplicate consent form and reminder letter will be sent. 
In some cases, study staff may go through the consent process with a prospective participant in-
person (e.g., at an information session). In these cases, they will go through the consent form in 
detail with the participant and written informed consent will be obtained, and the participant will 
be given a copy of the consent form for their records.  
Upon completing verbal consent or a signed written consent form, the participants will be 
enrolled in the study and will be scheduled for a baseline interview.  
Once patients have completed the baseline interview, and scheduled for their 8-week follow-up 
interview, randomization will occur to intervention or control groups per a computer-generated 
block randomization scheme. People who have been randomized to the intervention group will 
be scheduled into a study orientation session (in person or remote). 
Throughout recruitment calls, each patient will be encouraged to ask questions and reminded that 
even if they consent to be in the study, they are free to withdraw from it at any time, for any 
reason. 
4.5 
Screen Failures 
Individuals who sign the consent document and who subsequently are deemed ineligible or 
inappropriate for participation (e.g. unable to participate meaningfully in study activities, 
discovery that diagnoses are not consistent with study criteria, etc.) will not be enrolled, but 
instead classified as “screen failures.” 
4.6 
Strategies for Recruitment and Retention 
Recruitment: If we are not meeting recruitment goals via the three strategies listed in section 4.3, 
we will widen community outreach, increase presence in clinics at Henry Ford Health System 
and consider additional strategies such as social media.  
Retention: We will followed detailed protocols that we have successfully used in past studies 
with older adults from vulnerable populations to try to retain participants once enrolled, 
including making a specific number of contact attempts at different times, with the goal of 
maximizing retention without being bothersome to participants or coercive. Specifically, these 
are the guidelines we will follow: 
● We will call each participant 10 times without answer or response before marking them as 
Lost to Follow-up (Unable to Contact). 
● If we call someone and the number is disconnected, we will arrange for a call-back one week 
later. If we call then and it is still disconnected we will arrange for a call-back two weeks 
later, and, if we have their address, mail them an “Unable to Contact” letter. If we call then 
and it is still disconnected, we will arrange for a call-back one month later.  If it still 

STEPS Protocol, v7 
13 
 
disconnected at that point, we will mark the participant as Lost to Follow-up (Unable to 
Contact). 
● We will reschedule a participant's baseline survey 5 times. We will reschedule the follow-up 
as many times as it takes to get the participant to complete it, until a two-month window from 
originally scheduled date has passed. 
● We will reschedule attendance at the orientation session (intervention participants only) a 
maximum of 4 times. 
● All contact attempts will be documented in REDCap.  
We will offer incentives for each data collection point. All incentives are provided in the form of 
gift cards from the Human Subjects Incentive Program at the University of Michigan. 
In the STEPS intervention group, we will track session adherence. CHWs will be provided with 
guidelines for contact frequency. If participants do not respond back to CHWs, the study team 
will reach out to see if there are any issues that can be solved to increase engagement. Although 
not anticipated, if the CHW and participant are not a good match, we will assign a different 
CHW. 
In the control group throughout the one-year period, and in the intervention group following the 
conclusion of the STEPS intervention, we will encourage retention with such strategies as 
sending newsletters with study trinkets included (e.g., water bottles), providing incentives for 
telephone interview completion, and reminding control participants that they will receive a 
version of the intervention and an activity tracker after the final data collection point. 
 
5 
STUDY INTERVENTIONS 
Participants will be randomized to one of two study arms in a 1:1 ratio: Arm 1 will receive the 
STEPS intervention and Arm 2 will be in the control group and will be waitlisted to receive a 
one-time STEPS workshop and all intervention materials.  
5.1 
STEPS Intervention Overview 
This study’s overall premise is that community health workers (CHWs) – frontline public health 
workers with close ties to the communities they serve – can effectively teach cognitive and 
behavioral pain-management strategies to older adults in a disadvantaged urban setting, with 
support from mobile health tools. According to the biopsychosocial model of chronic pain, a 
complex interplay of biological, psychological, and social factors shape the pain experience, 
including pain-related disability and distress. Chronic pain self-management (CPSM) programs 
such as STEPS are grounded in this model, and have the overarching goal of reducing pain’s 
interference with daily functioning. Used alone or as an adjunct to medication as part of a 
multimodal treatment plan, these programs teach cognitive strategies (e.g., distraction) and 

STEPS Protocol, v7 
14 
 
behavioral strategies (e.g., relaxation, behavioral activation) derived from cognitive behavioral 
therapy (CBT) for pain. They also teach progressive physical activity and goal-setting.  
STEPS participants will learn evidence-based cognitive-behavioral strategies from short web-
based videos featuring University of Michigan experts. Videos can be easily accessed on a 
mobile device. A literacy-adapted participant workbook will reinforce video content and provide 
worksheets. Participants will be given an electronic activity tracker to facilitate gradual increase 
of physical activity. In weekly telephone calls, CHWs will motivate participants and guide them 
in applying new skills through structured discussions and goal setting. CHWs will draw on their 
deep knowledge of the Detroit community to connect participants with resources needed to 
address SDOH and other barriers to pain management (e.g., finding safe places to walk). We will 
measure pain-related outcomes and hypothesized mediators via self-report assessments at 
baseline, two months (post-program) and one year from baseline.  
 
 
5.2 
STEPS Intervention Process 
Orientation session: Intervention participants will meet with a CHW for a study orientation. The 
study orientation will be about 1.5 hours for most participants to complete. Depending on 
participant needs and social distancing guidelines, this can take place at the participant’s home, 
an HFHS site, another community location, or virtually. This orientation session will be 
scheduled after the participant completes the baseline survey and is randomized into the 
intervention group. A CHW or research assistant will contact the participant to schedule the 
orientation session, based on their availability. If the participant chooses to do the orientation 
session over the telephone or virtually (via videoconference), program materials will be mailed 
or delivered prior to the scheduled orientation. Dialpad or UM Zoom/UM Zoom Phone will be 
used for individual orientation sessions delivered via telephone or videoconference (see page 26 
for more details about Dialpad). 
At this initial session, participants will learn how to use the online modules, will choose a time 
for weekly telephone sessions with the CHW, and will be given a wearable activity tracker, also 
suitable for wheelchair users. Participants can log daily steps by replying to a text each evening 
or (in the few cases where this will not be feasible) on a worksheet. If the participant must use a 
worksheet, a CHW or study staff will check in with the participant individually each week, via 
telephone, to record the daily step counts for that week. They will use the activity tracker 
throughout the course of the program and keep after the study ends. Via videos and discussion 
with the CHW, they will receive basic pain psychoeducation; e.g., how symptoms interfere with 
function, and how feelings and behaviors affect pain. They will be introduced to SMART goal-
setting. The HFHS social needs assessment tool will be administered. 
Subsequent sessions: Weekly half-hour telephone sessions will be conducted by CHWs. Between 
sessions, participants will watch brief videos housed on the website, which incorporate familiar 
and cultural references and feature experts who are diverse in terms of race/ethnicity. (See Table 
below for details about each session.) 
CHW role: CHWs will reinforce important points of that week’s topic, help participants practice 
new skills, discuss adaptations needed for a participant’s situation, and set a related goal. 

STEPS Protocol, v7 
15 
 
Participants will set incremental (e.g., 10% more than a typical day) step-count goals each week. 
CHWs will provide basic technical support to participants for problems that arise with the 
STEPS website or activity trackers; anything they can’t resolve will be referred to research staff.   
STEPS Intervention Content by Week  
CHW role: All sessions will hav the same structure: 1) Recap key video points; 2) Structured discussion about 
video topic; 3) Try It Out activity for that week’s skill; 4) Goal setting and progress; 5) Review step count goal; 
6) Closing and reminders 
Week 1 (Orientation): Understanding Chronic Pain 
• 
How body and brain process pain signals 
• 
Holistic approach to managing pain signals 
and maintain quality of life 
• 
Ensure participants have access to videos, 
activity trackers, program materials 
• 
Administer SDOH screener and provide 
resources 
• 
Introduce goal setting and active goals 
Week 2: Staying Active 
• 
How physical activity helps manage pain and 
fatigue 
• 
Strategies for incorporating physical activity 
into daily routine 
• 
Using step counts to maintain/increase 
physical activity 
• 
Explore opportunities for physical activity and 
resources 
• 
Problem solve barriers and challenges 
Week 3: Relaxing and Reducing Stress 
• 
Explore how stress and pain are linked 
• 
Learn about the relaxation response and how 
relaxation help symptoms 
• 
Introduce relaxation techniques (such as deep 
breathing) 
• 
Identify major stressors and review problem-
solving steps (if needed) 
Week 4: Getting a Good Night’s Sleep 
• 
How pain impact sleep and vice versa 
• 
Learn strategies to get more restful sleep 
• 
Identify any barriers to restful sleep and 
problem solve 
• 
Explore better sleep strategies to try out  
Week 5: Partnering with Your Provider 
• 
How to get the most out of healthcare visits 
and planning for visits 
• 
Explore barriers and challenges to getting 
healthcare and provide resources/referrals 
• 
Introduce the appointment preparation 
worksheet 
Week 6: Doing What You Love 
• 
Exploring the importance of making time for 
wellbeing and self-growth 
• 
Identify ways to incorporate pleasant activities 
into daily life  
• 
Explore opportunities available in the Detroit 
community 
Week 7: Moving Forward 
• 
Review of sessions and strategies presented 
• 
Planning for long term goals 
• 
Celebrate successes and progress 
• 
Identify helpful resources moving forward 
 
Cognitive-behavioral content: Core topics are goal-setting, progressive exercise, communication 
with health care providers, sleep hygiene, pleasant activity scheduling, relaxation, problem 
solving, and a wrap-up session that focuses on skills maintenance.  
 
Addressing social determinants of health (SDOH): CHWs will assess needs around SDOH via an 
approved HFHS screening tool. This tool covers domains such as housing, insurance, utilities, 
food and transportation. In conjunction with HFH, we have developed a list of resources to 
address the problems elicited by the tool. Additionally, to address other challenges as they come 
up during sessions, CHWs are trained in an easy-to-use problem-solving process adapted from a 

STEPS Protocol, v7 
16 
 
lay-led mental health intervention for low- and middle-income countries.12 Serving as a “bridge” 
between communities and formal services is a core CHW competency.13  
Activity tracker component: The commercially-available Wyze Watch tracker (or near 
equivalent) activity tracker, can be worn on the wrist. While the device has the capability of 
being linked to an app compatible with most smartphones, we will not be using this app as part 
of the intervention.  Instead, participants will use the device more like a standard pedometer for 
the purposes of the intervention, though they are free to use other features including the app, on 
their own. 
Participants will be instructed to wear their tracker during waking hours, except showering, 
bathing, or swimming, every day throughout the intervention period. At any time if the 
participant has questions regarding the use of the tracker, a study staff member can be contacted 
by phone to assist. Participants will track their step counts in one of two ways, depending on 
preference: 
Report by text: Participants will be asked to use the display on their tracker to view and then 
manually input daily step counts via daily SMS messages they will receive at evening times 
convenient to them. A second text will be sent one hour later if there is no response to the first.  
Record on paper:  Alternatively, participants who do not wish to send a text will simply receive a 
text reminder each evening and will record that day’s step count on a form provided to them in 
the Participant Workbook. 
We will have a limited number of trackers to replace those that are lost or damaged. If those 
replacement trackers run out, participants who lose or damage their device will not be able to get 
a new one. No participant will receive more than one replacement tracker. All of this will be 
explained in the consent form. 
 
5.3 Control Study Arm 
Participants assigned to the control condition will be administered the baseline, post-program (2 
months), and one-year follow-up surveys. After that, they will be given full access to the online 
program, a wearable physical activity tracker to use and keep, and will be invited to attend a 
half-day small-group workshop that covers key intervention content and provides individual 
goal-setting guidance. The session will be led by study staff and a community health worker. In-
home or telephone-based sessions will be offered if social distancing is required or there are 
other significant barriers to in-person attendance. 
5.4 
Measures to Minimize Bias: Randomization and Blinding 
Participants will be randomized to intervention or control groups using a block randomization 
scheme with randomly selected block sizes. The study team member who randomizes 
participants will be blinded to participant responses on the baseline assessment and will only be 
informed if the assessments were completed. Participants will be informed by the study team of 
their study arm assignment and will be informed of next steps for their study arm. 

STEPS Protocol, v7 
17 
 
5.5 
Study Intervention Adherence 
Attendance of community health worker sessions will be the main mechanism of tracking 
adherence. Community health workers will also log information from participant reports about 
working towards their goals during their calls. Adherence to step-count reporting will also be 
tracked. 
5.6 Concomitant Treatment 
This study will not restrict participation in other types of treatments. However, participants in the 
STEPS study will not be able to participate in our other R01 study, Re-Engaging in Self-Care 
and Enjoying Today (RESET), and vice versa. These two studies are recruiting from the same 
population and have some overlapping intervention components. We will make this clear in the 
recruitment process.  
5.7 
Lifestyle Considerations 
This study does not have any restrictions regarding lifestyle and/or diet. 
5.8 
Intervention Discontinuation 
A participant may be temporarily suspended from the study if they are too acutely ill to 
participate or have a drastic change in disease severity in which the physician on the study team 
(Dr. Wisdom) feels that they should not take part in the intervention. These instances will be 
recorded as protocol deviations and all participants will be contacted to determine if they can 
complete outcome assessments if possible.  
5.9 Treatment Fidelity 
5.9.1 Overall compliance 
Compliance will be recorded as the number of telephone sessions completed by the participants 
in the STEPS program. The duration of calls will also be recorded.  
5.9.2 Community Health Worker Training and Tracking 
All CHWs who have not done so already will complete the MiCHWA CHW Certification 
Training Program, a 126-hour course covering topics such as: communication skills and 
motivational interviewing, documentation and reporting, navigating community resources, and 
healthy lifestyles.  STEPS-specific training will take place over eight training sessions 
(approximately four-hours each) with additional training as needed. Training content was 
developed and refined in the pilot, and uses an active learning approach, with an emphasis on 
role play and practice sessions with feedback. We focus on older adults’ needs, including 
multimorbidity and cognitive issues, as well as record-keeping, teaching goal-setting; managing 
common issues such as temporary increases in pain after activity, and knowing when to consult 
with a supervisor and the study team. A portion of the training will be devoted to assessing 
SDOH in this context and a review of relevant resources in the Detroit community and at HFHS.   

STEPS Protocol, v7 
18 
 
All intervention sessions will be audio recorded, with participants’ permission, and fidelity to the 
CHW manual will be checked via a checklist that was used in the pilot study to determine 
fidelity to the session protocol in the community health worker STEPS manual.  We will test for 
CHW “drift” from the protocol by listening to a random 10% of recorded calls each quarter of 
the enrollment and offer refresher training sessions as needed. Each CHW will meet regularly 
(weekly, biweekly, or monthly) with the supervisor and a research staff member for coaching 
and feedback. 
5.10 Withdrawal from the Study  
If participants withdraw or decline to finish the intervention, every effort should be made to 
gather primary outcome data (pain interference) as well as a query about adverse events.   
● The goal is to collect the information as close to a designated follow-up assessment as 
possible (2 or 12 months). Participants need to complete the assessment within one month 
of the first follow-up date and within two months of the second follow-up date in order to 
be counted as non-missing. 
● For intervention group participants wishing to discontinue participation in the 
intervention, the study team member will ask to call them during the next (or both, 
depending on the point in the study) scheduled assessment window(s). 
● Participants who state that they wish to withdraw completely from the study will not be 
contacted further. 
 
The reason for participant discontinuation or withdrawal from the study will be recorded in 
REDCap. Participants who sign the informed consent form and are randomized to the intervention 
but do not begin it may be replaced. Participants who sign the informed consent form, and are 
randomized and receive the study intervention, and subsequently withdraw, or are discontinued 
from the study, will not be replaced. 
5.11 Lost to Follow-up 
A participant will be considered lost to follow-up per the protocol presented in 4.6. 

STEPS Protocol, v7 
19 
 
6 
STUDY PROCEDURES  
6.1 
Schedule of Activities 
 
Activity 
Months 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
Eligibility Screening 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Consent Process 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Chronic conditions and overall health 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Pain Interference (PROMIS-43 6-item scale)14 
X 
 
X 
 
 
 
 
 
 
 
 
 
X 
PROMIS-29 +214,15 (except Pain Interference subscale) 
X 
 
X 
 
 
 
 
 
 
 
 
 
X 
Pain Intensity (Numerical Rating Scale)16 
X 
 
X 
 
 
 
 
 
 
 
 
 
X 
UCLA Loneliness 3-item and additional items17,18 
X 
 
X 
 
 
 
 
 
 
 
 
 
X 
Fear of Movement 19  
X 
 
X 
 
 
 
 
 
 
 
 
 
X 
Coping and Adaptation Processing Scale 20 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
Religious Coping (RCOPE) Scale 21 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Pain Self-Efficacy Questionnaire22 
X 
 
X 
 
 
 
 
 
 
 
 
 
X 
Pain Medication Use (QAQ)11 
X 
 
X 
 
 
 
 
 
 
 
 
 
X 
Primary Care Access23 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
Communication with Provider24,25 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
Pain Catastrophizing Scale 26,27 
X 
 
X 
 
 
 
 
 
 
 
 
 
X 
Physical Activity24 
X 
 
X 
 
 
 
 
 
 
 
 
 
X 
Health Literacy28 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Life Space Mobility 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Technology Use 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Pain Management Strategies29 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
Falls 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
COVID-19 infection and treatment items 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
Global impression of change in pain, functioning, 
quality of life, and use of pain medication30 
 
 
X 
 
 
 
 
 
 
 
 
 
X 
STEPS Evaluation Questions  (intervention group only) 
 
 
X 
 
 
 
 
 
 
 
 
 
 
Therapeutic Alliance scale31 (intervention group only) 
 
 
X 
 
 
 
 
 
 
 
 
 
 
STEPS: CHW sessions (intervention group only) 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
Step count tracking (intervention group only) 
 
X 
X 
 
 
 
 
 
 
 
 
 
X 
Qualitative interviews (subsample of intervention group) 
 
 
 
X 
X 
 
 
 
 
 
 
 
 
 
Notes: 
*Shaded rows represent measures on the telephone data collection surveys (at baseline, 2 and 12 
months). 
**Primary and secondary outcomes are bolded. 

STEPS Protocol, v7 
20 
 
***Allowable assessment windows: Participants need to complete the assessment within one 
month of the first follow-up date and within two months of the second follow-up date in 
order to be counted as non-missing. 
****If participant does not start intervention within one month of baseline assessment, then we 
will re-baseline them, for primary and secondary outcomes only, before starting the 
intervention and base follow up windows on the second baseline assessment. We will stagger 
enrollment to allow participants to start the intervention within one month. Delays in starting 
the intervention may be due to family situations, illnesses, difficult to reach participants, 
work obligations, etc. 
 
6.2 
Description of Activities 
● Telephone data collection surveys – participants will complete the validated measures tested 
as outcomes or mediators listed above as well as other measures to help characterize health 
and functional status, quality of life, and satisfaction with the intervention.    
● Randomization – will occur only after all baseline outcome assessments are completed. Once 
complete, a randomized study schedule with mixed blocks will be used to determine group 
assignment.  
● STEPS Program (Intervention) – participants will access the study website, learn how to use 
their tracker, and prepare for first call with their designated CHW.  
● Qualitative interviews - A subset of participants in the STEPS intervention study arm will be 
asked to participate in an approximately 30-minute interview about their experiences with the 
intervention (n = 30). This will be done to help understand facilitators and barriers to 
engagement in the program. Participants who are interviewed will be offered an additional 
$25 incentive (gift card) for their time. We will conduct telephone qualitative interviews with 
subsamples selected for maximum variation: participants with and without significant 
improvement, those who were very satisfied, and less satisfied, and those who dropped out 
(n=5 per subgroup or until data saturation; i.e. no new information emerging). Participant-
identified mechanisms of effect will be elicited with questions such as: What do you think 
helped you the most? Why do you think your pain (and/or function) did (or did not) improve? 
We will probe the mediating role of addressing SDOH by asking about the experience of 
getting referrals, whether participants followed up with these or not, and, if they did, what 
resulted, including impact on ability to manage pain. Other questions will address the 
relationship with the CHW, use of the online modules, experience with the activity tracker, 
and what participants liked most/least and why. Additional in-depth interviews will be 
conducted with CHWs and other stakeholders including representatives of health and social 
service agencies in Detroit, and HFHS clinical providers. We will pose open-ended questions 
about challenges, facilitators, and satisfaction with various aspects of STEPS and its 
implementation.  
7 
SAFETY 
7.1 
Potential Risks & Benefits 
Potential Risks: The risks of participation are minimal, as we are testing an adaptation of a 
cognitive-behavioral intervention for chronic pain self-management, which does not involve 

STEPS Protocol, v7 
21 
 
additional drugs or devices (with the exception of a commercially-available wearable activity 
tracker) and is non-invasive.   
 
Below we list the potential risks: 
 
1. Psychological distress (FREQUENCY: Infrequent. SERIOUSNESS: Mild).  A plausible 
but unlikely risk to participants is psychological distress during the course of the baseline 
or follow-up surveys or telephone sessions.  
2. Breach of confidentiality during study activities (FREQUENCY: rare, SERIOUSNESS: 
Mild). 
3. Risk of forced disclosure by entities outside of the research team (FREQUENCY: Rare, 
SERIOUSNESS: Mild). The study has a Certificate of Confidentiality (CoC), formal 
confidentiality protection, authorized by the Public Health Service Act (PHSA) section 
301(d) (42 U.S.C § 241(d)) to protect the privacy of human research participants enrolled 
in the study by withholding identifying characteristics from those not connected to the 
research. As a result, the study team may not be compelled in any Federal, State, or local 
civil, criminal, administrative, legislative, or other proceedings to identify participants. 
4.  There is an unlikely possibility of potential discomfort with wearing activity tracker due 
to wrist band. Participants are not required to wear the activity tracker while sleeping and 
the study team will provide an alternative band, if needed (FREQUENCY: infrequent, 
SERIOUSNESS: Mild).  
 
Potential Benefits: The intervention for chronic pain self-management will incorporate 
evidence-supported strategies to promote effective self-management of chronic pain as well as 
encourage gradual increases in moderate physical activity, and therefore has the potential for 
beneficial physical and/or psychological effects. 
7.2 Event Reporting Schedule 
This study will use a study-specific reporting schedule for adverse events, protocol deviations, 
ORIOs and unanticipated problems. The reporting schedule can be found in eResearch, Section 
32. 
7.3 Definitions for Events  
This study will use standard definitions of AEs/SAEs/ORIOs as follows: 
● Adverse Event (AE): Any untoward or unfavorable medical occurrence in a human 
study participant, including any abnormal sign (e.g. abnormal physical exam or 
laboratory finding), symptom, or disease, temporally associated with the participants’ 
involvement in the research, whether or not considered related to participation in the 
research.  The most likely example for the present study is elevated psychological 
distress. 
● Serious Adverse Event (SAE): Any adverse event that: results in death, is life 
threatening, or places the participant at immediate risk of death from the event as it 

STEPS Protocol, v7 
22 
 
occurred; Requires or prolongs hospitalization, causes persistent or significant 
disability or incapacity, results in congenital anomalies or birth defects, is another 
condition which investigators judge to represent significant hazards.  An example in 
the present study is a hospitalization. 
● ORIO – Other reportable incidents or occurrences describe a myriad of events that 
can have a direct effect on a participant safety and/or data integrity. Typical ORIOs 
include protocol deviations (see more information in 8.4), participant complaints, and 
incidents involving participants, their data or research facilities (e.g. breach of 
confidentiality, administering an incorrect version of a survey or consent, etc.) 
7.4 
Classification of Adverse Events 
7.4.1 Severity of Event 
We will use the standard grading scale in use by the University of Michigan Institutional 
Review Board - Health Sciences and Behavioral Sciences (UM IRB-HSBS) as follows: 
 
Grading scale: 
 
1. No adverse event 
2. Mild AE – No treatment needed 
3. Moderate AE – Resolved with treatment 
4. Severe AE – Inability to carry on normal activities, required professional medical 
attention 
5. Life-threatening or disabling AE 
6. Fatal AE 
7.4.2 Relationship to Participation 
We will use the standard relatedness scale in use by the University of Michigan Institutional 
Review Board - Health Sciences and Behavioral Sciences (UM IRB-HSBS) as follows: 
 
Relatedness scale: 
 
● Definitely related 
● Probably related 
● Possibly related 
● Unlikely to be related 
● Definitely not related 
7.4.3 Expectedness 
For an event to be classified as “expected” it should have been addressed in at least one of the 
following sources: this document, the research application, literature, proposal document, 
informed consent, or associated with the characteristics of the study population. 
7.4.4. Process for identifying AEs and SAEs 

STEPS Protocol, v7 
23 
 
 
Given the low likelihood of adverse events in this behavioral intervention study, passive 
monitoring for adverse events will be done by the PI, other research staff, and community 
health workers on an ongoing basis and will be reported to the IRB and other entities as 
described in the “AE/SAE Reporting” section below. 
 
It is possible that we will learn of adverse health-related events when conducting follow-up 
interviews at 2 and 12 months from baseline; community health workers may also learn of such 
events when speaking with participants or attempting to make contact. It is also possible that 
the study coordinator/research assistants providing technical or other support to participants 
will learn of such events.  
7.4.5. Process for reporting AEs and SAEs 
 
All AEs and SAEs will be collected on an Adverse Event form in the study’s REDCap 
database and will be reported immediately to the PI by the person learning of the event 
(generally, study staff or community health workers).  
 
The PI or designated staff member will complete the UM IRB-HSBS Adverse Event Reporting 
form. After reporting to the UM IRB-HSBS, the PI in conjunction with other investigative 
team members will determine necessity for further reporting and next steps, which will include 
the following: 
 
● No further reporting of a “definitely not related” AE (but not SAE) will occur.  
● All deaths will be reported to the UM IRB-HSBS within 24 hours of learning about this 
event.  
● All adverse events that are both serious (SAE) and unexpected (i.e., have not been 
previously reported for the study's intervention) will be reported to the UM IRB-HSBS 
within 48 hours of the study’s knowledge of the SAE. (All deaths within 24 hours, as 
per above.) 
● The summary of all SAEs will be reported to NIH Program Officer quarterly. 
No AEs or SAEs are expected for this minimal-risk study of a behavioral intervention 
(i.e., events known to be associated with the intervention or condition under study, which is 
chronic musculoskeletal pain). At the same time, it is certainly possible, based on the high 
morbidity and multimorbidity of this population (i.e., adults in Detroit who are 50+ years of 
age, predominantly African American, with chronic pain), that there will be one or more 
hospitalizations and/or other moderate to severe illness-related events during the study period 
that are unrelated to study participation. Nonetheless, if these occur, they will be reported as 
AEs or SAEs and the appropriate steps as outlined above will be taken. 
 
Below are the specific events that will trigger reporting to the parties described above: 
 
Acute Alerts/Serious Adverse Events 
● Hospitalization of Study Participant 
● Institutionalization of Participant 
● Emergency Room Visit of Participant 
● Death of Participant 

STEPS Protocol, v7 
24 
 
Safety Alerts/Adverse Events 
● Severe Medical Problem of Participant 
● Participant threatens to harm him or herself or others 
8 
QUALITY CONTROL AND DATA MONITORING PROCEDURES 
We will review study progress, and data and safety issues on a regular basis in the following 
ways: 
 
8.1. Training 
 
All study staff will complete PEERRS Human Subjects Research Protection course and Good 
Clinical Practice for Social and Behavioral Research training. They will also be trained on the 
project protocol, project data collection systems and other study-related topics by the Principal 
Investigator, Recruitment and Data Collection Coordinator, and Project Manager prior to 
beginning data collection. Additionally, the Project Manager, in cooperation with the PI and the 
Recruitment and Data Collection Coordinator, will develop a detailed manual of procedures, case 
report forms and other related study materials. The manual of procedures will provide step-by-
step instructions on the conduct of the trial. The manual of procedures and other study 
documents will be reviewed in detail with the staff and student research assistants involved in 
data collection. Additionally, any staff who join the team after the project starts will be required 
to complete the standardized training prior to enrolling participants. Training will be documented 
in an electronic regulatory binder. 
  
8.2. Meetings 
● Weekly or biweekly team meetings with all core study staff present, at which we will review 
enrollment and retention, participant safety, protocol adherence, completeness and 
integrity of data collection, and any problems encountered.  
● The investigative team will meet on a regular basis and the PI and Project Manager will 
provide study updates including data and safety issues listed above. 
  
8.3. Auditing 
 
● Auditing Selected Cases for Compliance with IRB Requirements. These annual audits 
will include a random review of 20% of the cases that have been collected since the 
previous review. 
● Conformance with Informed Consent Requirements. As part of these annual assessments, 
the project manager and PI will also review all consent forms for participants that have 
been seen since the previous review. 
● Quality Control for Telephone Interviews: We will check a random 10% of all data from 
telephone interviews input into REDCap by listening to audiorecordings of the interviews 
and verifying that data was input correctly. Any deviations will be discussed at regular 
study staff meetings.   

STEPS Protocol, v7 
25 
 
To document adherence to this plan we will maintain a monitoring log and create accompanying 
monitoring reports for each review. The monitoring log will be kept in the electronic regulatory 
binder. 
 
8.4 Protocol Deviations 
 
This protocol uses the University of Michigan definition of a protocol deviation 
(https://az.research.umich.edu/medschool/glossary/deviation) which defines a protocol deviation 
as “an incident involving non-compliance with the protocol, but one that does not have a 
significant effect on the subject’s rights, safety or welfare, and/or on the integrity of the data. 
Deviations may result from the action of the participant, researcher or staff.” 
  
Reportable protocol deviations will be reported and tracked in the REDCap database and will be 
discussed at investigator and project staff meetings. 
  
The following events will not be reported as protocol deviations: 
 
● A protocol deviation will not be reported for participants who skip/do not complete 
telephone interview items or entire interviews. Participants can decline to answer any 
survey question for any reason. We expect in an intensive, long duration protocol like this 
that participants may miss some assessments. 
● A protocol deviation will not be reported for out-of-window assessments. Use of this data 
will be assessed by the study investigators for each study analysis; some analyses may 
need tighter compliance to the assessment window while others will not. 
● A protocol deviation will not be reported for participants who do not report step count 
data for any reason, or for lost devices. 
Reportable protocol deviations will be reviewed at the project staff and investigator meetings, 
and summarized in the DSMB or ISM report that will be submitted to the U-M IRB--HSBS and 
NIH at annual review (coinciding with the scheduled continuing review) and in other DSMB or 
ISM reports (if applicable). 
 
 
9 
CONFIDENTIALITY AND PRIVACY 
Overview 
A number of steps will be taken to ensure participant confidentiality and to protect against the 
potential risks related to stress from loss of confidentiality, or potential coercion. Participants 
will be encouraged to ask questions throughout recruitment/screening calls and informed that 
their participation is voluntary and that they can refuse to participate at any time without penalty. 
Participants also will be reminded that they can skip questions in surveys that they may not wish 
to answer. As part of their consent process, participants will be informed about the small risk of a 
breach of confidentiality.  All data collection will take place over the telephone, such that 
participants can choose a location with the level of privacy they desire. There will be a line in 
both the recruitment/screening script and the telephone survey script, “Are you in a comfortable 
place that has the privacy that you desire?” If the answer is no, we can reschedule the interview.  

STEPS Protocol, v7 
26 
 
Email messages will only be used to reply to or contact participants if they choose this mode. A 
secure UM email (Google) account will be used for the study and will be monitored by study 
staff. Throughout the study, IRB guidelines will be followed to ensure the privacy and integrity 
of the information we collect. Any breach of confidentiality will be immediately reported to the 
PI and to the University of Michigan Health Sciences and Behavioral Sciences IRB, as an ORIO. 
In addition, any complaints or concerns expressed to the study staff by participant participants, 
providers, or anyone else affected by this study will be immediately reported to the PI, and to the 
IRB as an ORIO.  All research data will be presented in reports, presentations, or manuscripts in 
aggregate statistics only. 
 
Training and Monitoring 
As noted above, all study staff, including community health workers, and research assistants will 
complete the web-based University of Michigan's PEERRS (Program for Education and 
Evaluation in Responsible Research and Scholarship) course in Human Subjects Research 
Protection and NIH-approved Good Clinical Practice Training (NCATS Social and Behavioral 
Best Practices). Proof of their certification and completion of the training programs will be kept 
on file. Staff will have signed a pledge of confidentiality, and we will ensure that all staff 
understand that a breach of confidentiality is grounds for dismissal. Training of staff will include 
information about the importance of privacy and confidentiality and specific techniques to 
maintain confidentiality of all information in the context of this study. Regular study team 
meetings will be used to ensure that all data quality protocols and IRB policies and procedures 
are being followed.  
 
Managing and Protecting Data  
All study participant information will be collected, stored and managed by trained study staff and 
research assistants in REDCap. REDCap is a secure, web-based application designed to support 
data capture for research studies, providing 1) an intuitive interface for validated data entry; 2) 
audit trails for tracking data manipulation and export procedures; 3) automated export procedures 
for seamless data downloads to common statistical packages; and 4) procedures for importing 
data from external sources. It is HIPAA compliant and supported by the University of Michigan. 
This secure web application promotes high quality data collection; forced responses ensure that 
interviewers are not able to proceed with the survey if required data are missing; and each survey 
is designed so that only valid responses are entered.   
Electronic data security: We will use a commercial platform such as Mosio to send out SMS 
messages to participants, who choose this option for reporting daily step counts during the 
intervention period. Information stored about the participants includes first and last name, a 
telephone number, and a study ID. We understand that SMS is inherently unsecure; to mitigate 
this, we will only collect step counts, where participants choose to report via SMS instead of 
syncing with an app, and we will not use identifying language in the SMS questions asking for 
step count reports. 
For the electronic activity trackers, we will not be collecting or storing synced data; rather, 
participants will manually read their daily step counts and report by SMS or record on paper. 

STEPS Protocol, v7 
27 
 
For telephone calls and telephone-based group sessions, we will use DialPad or Zoom Phone to 
audio record calls and group sessions for quality assurance. Audio recordings will be stored in 
the secure University of Michigan School of Public Health server or a HIPAA-compliant file 
storage system (like Dropbox at U-M). Dialpad has strong security measures that take a 
comprehensive, multi-layered approach, including data encryption and access controls. Zoom 
and Zoom Phone are HIPAA-compliant and supported by the University of Michigan. 
On-site Access and Control: Users are instructed to lock their workstation and to never leave it 
unattended with an active desktop. This enables access control by allowing only the credentials 
of the validated user to unlock the workstation. This is especially true when a user is accessing 
study data. 
Remote Access: All connections from remote locations must use the University-configured 
Cisco VPN client, which encrypts all traffic to and from the servers. 
All databases will be maintained in access-restricted files throughout the study. Study personnel 
who leave the research team will have their access to study files revoked.  
The only paper records with identifiers will be the informed consent documents, and these will 
be kept in a locked office, in locked file cabinets in the University of Michigan School of Public 
Health. Access to the file cabinets will be restricted. 
We will report AEs/SAEs to the IRB, DSMB or ISM, and/or other parties in a blinded manner, 
using only the unique subject identifier to protect the participant’s identity. 
 
Qualitative interview data 
All audiofiles and transcripts associated with in-depth participant interviews will be stored on a 
secure University of Michigan School of Public Health server or a HIPAA compliant could file 
storage system (like Dropbox at U-M). No names or other identifying information will be 
included in transcripts, and thus no information will be included in any published or unpublished 
reports using interview data that could be used to identify any participant.  
 
 
Certificate of Confidentiality  
 
To further protect the privacy of study participants, a Certificate of Confidentiality will be issued 
by the National Institutes of Health (NIH).  This certificate protects identifiable research 
information from forced disclosure. It allows the investigator and others who have access to 
research records to refuse to disclose identifying information on research participation in any 
civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or 
local level. By protecting researchers and institutions from being compelled to disclose 
information that would identify research participants, Certificates of Confidentiality help achieve 
the research objectives and promote participation in studies by helping assure confidentiality and 
privacy to participants. 
 

STEPS Protocol, v7 
28 
 
10 
STATISTICAL CONSIDERATIONS 
10.1 Sample Size 
Sample size for the trial is based on our primary outcome of the PROMIS Pain Interference 6-
item subscale. Using the power curves provided by Cella et al. (2019) for this measure15, which 
are based on an independent-samples t-test with a 1% two-sided significance test and 80% 
power, a sample size of 165 in each group will be sufficient to detect a 2.5-point difference in T-
score, which is also the minimal clinically important difference for this scale.32This amount 
corresponds to a small effect size, aligning with what is generally observed for pain-related 
functional outcomes from similar interventions. Assuming a maximum attrition rate of 25% over 
one year, we will enroll up to 207 patients per arm (total n=414). This sample size will also allow 
sufficient power for planned moderation and mediation analyses. 
 
10.2 Data Analyses 
10.2.1 General Approach 
Descriptive statistics will be used to summarize background variables for the overall sample and 
by treatment group. Prior to conducting primary analyses, descriptive analyses will be conducted 
to examine data distribution, outliers and potentially important covariates for inclusion in 
multivariate model diagnostics. We will evaluate normality using normal quantile plots and 
standard tests of normality incorporated in basic statistical packages, including SPSS and SAS.  
10.2.2 Primary & Secondary Endpoints 
We will collect outcome data at three time points: baseline; 2 months from baseline (immediately 
post-program, for those in the intervention group); and 12 months from baseline. All quantitative 
process and outcome data will be collected in REDCap. For the primary and secondary 
endpoints, we will conduct analyses on change in outcomes over the three time points first for 
completers using one-way analyses of variance and then (to achieve robust findings) in an intent-
to-treat model in which linear mixed models will be used to examine all available data. 
Sensitivity analyses will assess whether different assumptions about missingness and dropouts 
impact results. We will consider an intervention “completer” to be someone who completed at 
least 4 telephone sessions (not including orientation) with the CHW. 
 
We will develop a two-level linear mixed-effects model that uses pain interference follow-up 
scores at 2 and 12 months as the dependent variables; treatment group, time and the treatment-
by-time interaction as categorical explanatory variables; and baseline pain interference score as a 
continuous covariate. If this model shows no significant time-by-group effect, we will drop the 
interaction term and test for the time-averaged effect of the intervention compared to usual care 
between 2 and 12 months. An unstructured variance-covariance matrix will be used to model the 
error variance. Secondary outcomes including pain intensity will be analyzed in a similar 
manner. We will also conduct a responder analysis by examining the cumulative distribution 
function of responders (i.e., a continuous plot of the proportion of patients at each scale score by 
arm who experience change at that level or better), and test whether this proportion differs 
between treatment groups. We will calculate effect sizes (Cohen’s d) for outcomes.  
 

STEPS Protocol, v7 
29 
 
10.2.3 Other Pre-specified Analyses 
We will use linear mixed models to examine mediators and moderators with respect to the 
primary and secondary outcomes. We will conduct descriptive analyses to explore feasibility and 
satisfaction. We will track and report on intervention process variables, including but not limited 
to: the frequency and duration of CHW sessions, CHW time spent per participant, participant 
goals set and level of achievement, and daily step counts. 
 
10.2.4 Qualitative Data Analyses 
Qualitative responses captured during interviews will be transcribed from audio recording and 
thematic codes will be created and verified through rater pairs.  Our codebook will include 
definitions, criteria, and examples. Initial codes will be based on interview questions, then 
modified as needed to fit the data. We will test the coding scheme on 2-4 transcripts in an 
iterative process until reaching consensus. The final coding scheme will be applied to enrich our 
understanding of statistical findings.  
 
11 
INTERIM ANALYSIS 
Interim analyses will be conducted by the Investigative Team when 50% and 75% of the sample 
has been accrued. Analyses will examine AEs and SAEs by arm, as well as any eligibility 
violations. Drop-out by arm and reasons for drop-out will also be assessed. Interim analyses will 
also include data on recruitment, baseline characteristics by arm, intervention engagement (e.g., 
sessions completed) for intervention arm, and amount of follow-up data collected. 
 
12 
PUBLICATIONS 
This study will be conducted in accordance with the National Institutes of Health (NIH) Public 
Access Policy, which ensures that the public has access to the published results of NIH funded 
research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from 
NIH funds to the digital archive PubMed Central upon acceptance for publication. 
 
13 
PROTOCOL AMENDMENT HISTORY 
See cover page. 
 
14 
REFERENCES 
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Janevic M, Robinson-Lane SG, Murphy SL, Courser R, Piette JD. A Pilot Study of a 
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Interagency Pain Research Coordinating Committee. National Pain Strategy,. US 
Department of Health and Human Services;2016. 
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Interagency Pain Research Coordinating Committee. Federal Pain Research Strategy. 
2017. 

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4. 
Grol-Prokopczyk H. Sociodemographic disparities in chronic pain, based on 12-year 
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Vaughn IA, Terry EL, Bartley EJ, Schaefer N, Fillingim RB. Racial-ethnic differences in 
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Janevic MR, McLaughlin SJ, Heapy AA, Thacker C, Piette JD. Racial and 
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Murtaugh CM, Beissner KL, Barrón Y, et al. Pain and function in home care: a need for 
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Barnett ML, Gonzalez A, Miranda J, Chavira DA, Lau AS. Mobilizing community health 
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Perry HB, Zulliger R, Rogers MM. Community health workers in low-, middle-, and 
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The Community Health Worker Core Consensus Project. C3 Project Findings: Roles & 
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Hanmer J, Cella D, Feeny D, et al. Selection of key health domains from PROMIS® for a 
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Cella D, Choi SW, Condon DM, et al. PROMIS® adult health profiles: efficient 
 
short-form measures of seven health domains. Value in Health. 2019;22(5):537-
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Goldsmith ES, Taylor BC, Greer N, et al. Focused evidence review: psychometric 
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2018;159(4):775-782 
 
 
Ame00123028 
 
In Section 4, for the expected small number of participants without access, we will lend them 
inexpensive tablets pre-loaded with STEPS website content. If telephone minutes are a barrier 
for some eligible participants, we will provide additional support for this as well, on an 
individual basis, such as a prepaid phone or additional telephone minutes. We will also support 
participants in getting a government issued telephone (such as an Obama Phone) if they are 
eligible. 
 
We will not be using electronic medical records as a recruitment strategy (not approved by 

STEPS Protocol, v7 
32 
 
Henry Ford Health; Section 4.1).  
 
In Section 4.4, we removed the option of having participants mail back a signed version of the 
consent form. To ensure that all participants go through the verbal consent process over the 
telephone with trained research staff, we will instead ask the participants if they prefer to receive 
a copy of the consent to review on their own before consenting, then we will schedule a follow 
up to go through the consent details over the telephone after they’ve had a chance to receive and 
review the consent document (1-2 weeks after the consent is mailed or emailed, based on the 
participant’s preferences). If participants are ok with verbally consenting right away or before 
having a copy of the consent sent to them, trained staff will review the consent details over the 
phone, obtain verbal consent if the participant is interested in participating, and send the consent 
document to the participant accordingly (along with a community resource list).  
 
In Section 5.2, we added an orientation session to the intervention and outlined the process for 
scheduling the intervention session post-baseline survey with the participant. We also included 
alternative options for participants to send in step counts using a paper step count log if they are 
unable to text step counts to the team.  
 
The STEPS Intervention Content Table was updated in this section to reflect changes to the 
sequence of sessions based on feedback from our CHWs and community partners. Information 
about the Wyze Watch activity tracker was added to this section as well as updated information 
about the STEPS social determinants of health screener.  
 
In Section 5.6, we outline that participants in the STEPS study will not be able to participate in 
our other R01 study, Re-Engaging in Self-Care and Enjoying Today (RESET), and vice versa. 
These two studies are recruiting from the same population and have some overlapping 
intervention components. We will make this clear in the recruitment process and added a 
screener question accordingly.  
 
In Section 6, the survey measures and schedule of activities was updated to reflect the updated 
survey instruments used at baseline, 2-months, and 12-months. We also outline procedures for 
delays between baseline assessments and intervention start dates. Details related to the 
qualitative interviews were added to Section 6. 
 
In Section 7.1 (Potential Risks and Benefits), language about the Certificate of Confidentiality 
was added as well as potential discomforts due to the Wyze Watch.  
 
In Section 9 (Confidentiality and Privacy), information was added about the technology 
platforms we intend to use for the study, including DialPad and Zoom Phone for weekly 
sessions. We also included information about UM Dropbox where we will store data securely.  
 
Since survey measures were updated, references were also updated to reflect these changes.  
 
 
 
 

STEPS Protocol, v7 
33 
 
Ame00137679 – 7/7/2023 
 
In Sections 1.4.1 (Known Potential Risks) and 7.1 (Potential Risks and Benefits) we will 
add the following text: Another possible risk is minor muscle injury, such as muscle 
strain, from doing physical activity that is encouraged by the STEPS program. 
Participants are encouraged to engage in physical activity of their choice, at a level that is 
comfortable for them. As with any physical activity, it is possible that participants could 
experience a muscle injury while doing physical activity as part of the STEPS program. 
To minimize this risk, the STEPS Community Health Worker will guide participants in 
increasing activity levels slowly and will encourage them to check with their doctor if 
they do not know whether or not a specific activity is appropriate. (FREQUENCY: 
infrequent, SERIOUSNESS: Mild). 
 
Ame00143442 – 12/13/2023 
 
For participants in the intervention group, we will allow participants to complete the 2-
month follow up survey prior to the last intervention session (session 7) if they need 
additional flexibility based on their schedule and/or if the last intervention session is 
delayed or missed. The last intervention session is a review and wrap-up session so there 
will not be new information presented during the session that would impact study 
outcomes. However, for most intervention participants, research staff will still attempt to 
conduct the 2-month follow up survey after the last intervention session is completed. 
 
Ame00152596 – 8/30/2024 
 
Instead of offering gift card incentives for telephone survey assessments and qualitative 
interviews, we will default to using checks instead. Gift cards may still be used if a study 
participant is not able to cash a check at the bank or has other barriers where a gift card 
would be preferred. All incentives are provided in the form of checks (or gift cards as a 
backup option) from the Human Subjects Incentive Program at the University of 
Michigan. Participants will receive $20 for the baseline assessment, $20 for the 2-month 
follow up assessment, and $25 for the 12-month follow-up assessment. Participants who 
complete a qualitative interview will be offered an incentive (a $25 check or gift card) for 
their time.