Optimizing Osteoarthritis Care Through Clinical and Community Partnership
Phase: NA
Conditions: Osteoarthritis, Knee, Osteoarthritis, Hip, Overweight, Obesity, Physical Inactivity, Weight Loss
Sponsor: University of North Carolina, Chapel Hill

 
 
 
 
OA Clinic-Community CARE Model (OA CARE) 
 
 
NCT Number: NCT05349500 
 
Document Date: 3/4/2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

OA Clinic-Community CARE Model (OA CARE) 
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OA Clinic-Community CARE Model (OA CARE) 
 
Protocol Number: 22-0865 
 
NCT Number: NCT05349500 
 
Principal Investigator: Kelli D. Allen, PhD 
 
Sponsor: University of North Carolina at Chapel Hill 
 
Grant Title: Optimizing Osteoarthritis Care through Clinical and Community Partnership 
 
Grant Number: 1 R21 AR080309-01  
 
Funded by: 
 
National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of 
Health 
 
Version Number: 4.0 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Summary of Changes from Previous Version: 
 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
8.1 
Added language that the 
questionnaires at the 12-month follow-
up visit may be done over the phone 
instead of in-person 
Change made to reduce in-person 
visit time and participant burden 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
 
 
STATEMENT OF COMPLIANCE.………………………………………………………..………….....1 
INVESTIGATOR’S SIGNATURE…………………………………………………………………..……2 
1  
PROTOCOL SUMMARY…………………………………………………………………………... 3 
1.1 
Synopsis………………………………………………………………………………………3 
1.2 
Schema………………………………………………………………………………………. 5 
1.3 
Schedule of Activities………………………………………………………………………..6 
2 
 INTRODUCTION… ............................................................................................................ 7 
 2.1 
Study Rationale and Background…………………………………………………………. 7 
  2.1.1  Clinical Signficance ................................................................................................... 7 
  2.1.2  Scientific Rationale…………………………………………………………………………. 7 
  2.1.3  Prior Studies and Rationale for Development…………………………………………….8 
 2.2 
Risk/Benefit Assessment…………………………………………………………………. .. 8 
  2.2.1  Known Potential Risks…………………………………………………………………… ... 8 
  2.2.2 Known Potential Benefits…………………………………………………………………. . 9 
  2.2.3 Assessment of Potential Risks and Benefits………………………………………… ….9 
3 
STUDY OBJECTIVES AND ENDPOINTS ........................................................................... 9 
4 
STUDY DESIGN………………………………………………………………………………… .. 11 
 4.1  
Overall Design………………………………………………………………………………11 
 4.2  
Scientific Rationale for Study Design ....................................................................... 11 
 4.3   
Justification for Intervention ..................................................................................... 12 
 4.4  
End-of-Study Definition ........................................................................................... 12 
5 
STUDY POPULATION…………………………………………………………………………….12 
 5.1  
Inclusion Criteria ..................................................................................................... 12 
 5.2  
Exclusion Criteria .................................................................................................... 13 
 5.3  
Lifestyle Considerations .......................................................................................... 13 
 5.4  
Screen Failures……………………………………………………………………………..13 
 5.5  
Strategies for Recruitment and Retention………………………………………………. 13 
6 
STUDY INTERVENTIONS 
 6.1  
Study Intervention Administration ............................................................................ 14 
 6.2  
Fidelity..................................................................................................................... 16 
6.3  
Measures to Minimize Bias: Randomizaiton and Blinding……………………………..17 
6.4  
Study Intervention Adherence……………………………………………………………. 17 
6.5  
Concomitant Therapy………………………………………………………………………17 
7 
STUDY INTERVENTION DISCONTINUATION AND  
 
PARTICIPANT DISCONTINUATION/WITHDRAWAL……………………………………… ... 17 
 7.1   
Discontinuation of Study Intervention…………………………………………………… 17 
 7.2   
Participant Discontinuation/Withdrawal from the Study……………………………… . 17 
 7.3   
Lost to Follow-up………………………………………………………………………… .. 18 
8 
STUDY ASSESSMENTS AND PROCEDURES……………………………………………… . 18 
 8.1  
Endpoint and Other Non-Safety Assessments………………………………………… 18 
 8.2  
Safety Assessments……………………………………………………………………… . 19 
 8.3  
Adverse Events and Serious Adverse Events………………………………………… . 19 

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8.3.1  Definition of Adverse Events……………………………………………………………. .19 
8.3.2  Definition of Serious Adverse Events………………………………………………….... 19 
8.3.3  Classification of an Adverse Event……………………………………………………. ... 19 
8.3.4  Time Period and Frequence for Event Assessment and Follow-up…………………..20 
8.3.5  Adverse Event Reporting………………………………………………………………. ... 21 
8.3.6  Serious Adverse Event Reporting……………………………………………………… . 21 
8.3.7  Reporting Events to Participants……………………………………………………….. . 21 
8.3.8  Events of Special Interest……………………………………………………………….. . 21 
8.3.9  Reporting of Pregnancy………………………………………………………………….. . 21 
 8.4  
 Unanticipated Problems………………………………………………………………… ..21 
8.4.1  Definition of Unanticipated Problems…………………………………………………….21 
8.4.2  Unanticipated Problems Reporting……………………………………………………… 22 
8.4.3  Reporting Unanticipated Problems to Participants……………………………………. 22 
9 
STATISTICAL CONSIDERATIONS ...……………………………………………………….. .. .22 
9.1   
Statistical Hypotheses…………………………………………………………………… . 22 
9.2   
Sample Size Determination……………………………………………………………… 22 
9.3  
Populations for Analyses…………………………………………………………………. 23 
9.4  
Statistical Analyses……………………………………………………………………… .. 23 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ............... 23 
 10.1 Regulatory, Ethical, and Study Oversight Considerations…………………………………. 23 
10.1.1  Informed Consent Process……………………………………………………………….. 24 
10.1.2  Study Discontinuation and Closure……………………………………………………… 24 
10.1.3  Confidentiality and Privacy………………………………………………………………. . 25 
10.1.4  Future Use of Stored Specimens and Data……………………………………………. 26 
10.1.5  Key Roles and Study Governance………………………………………………………. 26 
10.1.6  Safety Oversight…………………………………………………………………………… 27 
10.1.7  Clinical Monitoring………………………………………………………………………… 27 
10.1.8  Quality Assurance and Quality Control…………………………………………………..27 
10.1.9  Data Handling and Record Keeping…………………………………………………….. 28 
10.1.10 Protocol Deviations………………………………………………………………………. 28 
10.1.11 Publication and Data Sharing Policy…………………………………………………… 28 
10.1.12 Conflict of Interest Policy………………………………………………………………… 29 
 10.2 
Additional Considerations………………………………………………………………… 29 
 10.3 
Abbreviations and Special Terms……………………………………………………… .. 29 
 10.4 
Protocol Amendment History……………………………………………………………. . 30 
11  
References………………………………………………………………………………………31 
 
 
 
 
 
 
 
 
 
 

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STATEMENT OF COMPLIANCE 
 
 
The trial will be carried out in accordance with International Council 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(s) must be obtained before any participant is consented. Any amendment to the 
protocol will require review and approval by the IRB before the changes are implemented to the study. 
All changes to the consent form(s) 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. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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INVESTIGATOR’S SIGNATURE 
 
The signature below constitutes the approval of this protocol and provides the necessary assurances that this 
study 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: 
 
 
Name:  
 
Title: 
 
 
 
 
Investigator Contact Information 
Affiliation: University of North Carolina at Chapel Hill 
Address: 3300 Thurston Bldg., CB #7280, Chapel Hill, NC  27599-7280 
Telephone:919-966-0558 
Email: kdallen@med.unc.edu 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1 
PROTOCOL SUMMARY 
 
 
1.1 
SYNOPSIS 
 
 
Title: 
OA Clinic-Community CARE Model (OA CARE) 
Grant Number: 
1 R21 AR080309-01  
Study Description: 
The overall objective of this study is to conduct a randomized pilot 
trial of OA CARE among n=60 patients with knee and/or hip 
osteoarthritis (OA) and overweight / obesity who are not currently 
meeting physical activity recommendations. Participants will be 
randomly assigned to OA CARE or a usual care (UC) group. 
Assessments will be conducted at baseline, 6 months and 12 
months.     
 
Objectives*: 
 
Specific Aim 1:  Assess the feasibility and acceptability of OA 
CARE.  Feasibility metrics will include recruitment rate, completion 
rates for weight loss and exercise program visits, referrals to and 
utilization of services noted above and proportion of participants 
completing follow-up assessments. Acceptability of OA CARE will 
be evaluated from both patient and Primary Care Provider (PCP) 
perspectives.    
Specific Aim 2: Obtain preliminary data on the efficacy of OA 
CARE with respect to the primary outcome of change in total 
Western Ontario and McMaster Universities Osteoarthritis 
Index (WOMAC) score.  The WOMAC will be administered at 
baseline, 6-months and 12-months, along with secondary outcomes 
including body weight, physical activity, physical function, sleep 
measures and psychological measures. We will also collect 
preliminary data on costs of OA CARE. 
 
Endpoints*: 
Primary Endpoint: 
WOMAC Total Score. This will be assessed at baseline and 6-
month and 12-month follow-up time points.   
 
Secondary Endpoints:  Objectively assessed physical activity (PA), 
measured via accelerometer, body weight, and objective 
assessments of physical function; WOMAC self-reported pain and 
function. These will be assessed at baseline and 6-month and 12-
month follow-up time points.   
 
Exploratory Endpoints:  self-reported sleep and psychological 
measures, balance, and preliminary data on costs of OA CARE 
 
Feasibility and acceptability metrics include recruitment, retention, 
intervention delivery, and outcome assessment. Perceptions of 
acceptability will be obtained from patients and providers using 
open-ended questions. 
 

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Study Population: 
N = 60 participants with knee and/or hip osteoarthritis (OA) and 
overweight / obesity who are not currently meeting physical activity 
recommendations. We will enroll both males and females from all 
racial and ethnic backgrounds.   
 
Phase* or Stage: 
Exploratory pilot trial  
 
Description of 
Sites/Facilities Enrolling 
Participants: 
 
We will recruit patients from UNC Health. In particular, we will 
partner with the UNC Internal Medicine Clinic and UNC Family 
Medicine.  
 
Description of Study 
Intervention/Experimental 
Manipulation: 
OA CARE includes evidence-based behavioral weight management 
and exercise interventions, as well as tailored referrals to physical 
therapy, psychological interventions, additional weight / nutrition-
related services and sleep-related services based on patient-
specific needs and in coordination with the PCP. 
 
Study Duration*: 
2 years 
 
Participant Duration: 
12 months 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.2 
SCHEMA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.3 
SCHEDULE OF ACTIVITIES 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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2 
INTRODUCTION 
 
2.1 
STUDY RATIONALE AND BACKGROUND 
 
 
2.1.1. CLINICAL SIGNIFICANCE  
Osteoarthritis (OA) is a Significant Burden for Individuals and Health Care Systems.  OA affects over 32 
million U.S. adults (1 in 7) and is a leading cause of pain and disability 1. OA also has substantial impacts on 
work participation, mental health, sleep, development of other chronic conditions and even mortality 2. Already 
associated with significant health care utilization and costs, the prevalence of OA is expected to rise 
substantially in coming decades 1. This will place increasing demands on health care systems, highlighting the 
importance of developing and implementing efficient models that ensure a high quality of care for patients.     
There are Persistent Deficiencies in Quality of Care for OA. Multiple studies have highlighted discordance 
between guideline-based OA care and actual clinical practice 3-7. Despite agreement across OA treatment 
guidelines regarding the effectiveness and centrality of lifestyle (e.g., weight management, physical activity) 
and rehabilitation therapies 8, pass rates for quality indicators related to these therapies are only about 40% 4. 
Data from primary care visits involving treatment for OA in the U.S. show that <50 out of 1000 addressed 
physical therapy as a potential treatment, and only about 250 out of 1000 addressed core lifestyle components 
9. Other studies have also documented low use of and recommendations for behavioral and rehabilitative 
therapies 3,5-7.  For example, in analyses of patients with knee OA across 3 different U.S. health systems, only 
40-50% of patients had ever received physical therapy for this condition 5. These gaps in care are highly 
problematic, as they fail to engage patients with evidence-based treatments that are known to improve key 
outcomes including pain, disability, mental health and even disease progression 10-13.    
Evidence-Based Care Models are Needed to Improve OA Care Quality in the US.  In response to the well-
established deficiencies in care quality for knee and hip OA, there has been increasing interest in the 
development of systematic OA care models internationally14-17. Care models are defined as organized, planned 
approaches to improving health, focusing on particular patient populations (e.g., individuals with OA) to ensure 
that every patient receives optimal medical care 18.  Although there have been several randomized controlled 
trials (RCTs) of OA care models 14,15,19, there are three major limitations with respect to how this research can 
inform care for OA in the U.S.  First, there have been no RCTs of OA care models in the U.S., and models 
developed in other countries are not designed to fit the organizational structures or payment models of U.S. 
healthcare systems. Second, the effectiveness of previously studied OA care models has been limited; we 
believe a key weakness has been the lack of robust incorporation of lifestyle components, particularly weight 
loss 15,19. Third, prior models have been limited in terms of reach and sustainability because of significant 
requirements for busy health care providers 14,15,17,19.  OA CARE will address each of these challenges, 
building an efficient, scalable model that is designed for sustainability and adequately addresses all 
components of guideline-concordant care. This exploratory trial will accomplish key steps toward the first RCT 
of an OA care model in the U.S.      
 
 
 
2.1.2. SCIENTIFIC RATIONALE 
 
 
The OA CARE model incorporates the following 4 key principles and evidence from the scientific literature: 
1) In alignment with OA treatment guidelines,8,10,20 OA CARE takes a multifactorial approach that includes both 
pharmacological and non-pharmacological components.  2) OA CARE emphasizes delivery of lifestyle 
interventions, which are considered first-line treatments, appropriate for all patients with hip and knee OA 8,10,20.  
3) OA CARE involves a stepped care approach, in which patients begin with first-line interventions (weight 
management and physical activity) and then advance to additional therapies as needed.21 A stepped care 
approach is efficient, patient-centered and supported by multiple studies, including our recent trial of a 
STepped Exercise Program for Knee Osteoarthritis (STEP-KOA).21,22 4) OA CARE will involve an innovative 
partnership with the YMCA to deliver weight management and exercise programs.  The Centers for Disease 
Control and Prevention, Institute of Medicine and other organizations have recommended and prioritized clinic-
community partnerships based on evidence for effectiveness 23. These partnerships address the problems of 
limited time in clinical visits and the large number of patients who need these types of services.  

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2.1.3. PRIOR STUDIES AND RATIONALE FOR DEVELOPMENT 
This study builds on our team’s successful trials, programs and collaborations, including the following:  
• 
We have collectively conducted over a dozen trials of behavioral interventions that support the 
evidence base for weight management, exercise, physical therapy, psychological and multi-component 
interventions as effective treatments for knee and hip OA 22,24-37.  These trials have given our team 
ample experience in patient recruitment, behavioral intervention delivery and fidelity monitoring, 
outcome assessment, and robust statistical analyses. We also have experience in delivering 
interventions involving PCPs and the use of algorithms to guide patient referrals to specific OA 
treatments 29,30.  
• 
The Osteoarthritis Action Alliance (OAAA), a key partner (Dr. Callahan, Director), is a national coalition 
of over 130 organizations with a mission of reducing the public health burden of OA.  The OAAA has 
experience in working with the YMCA (one of their member organizations) and other community 
organizations to deliver evidence-based lifestyle interventions, has developed stakeholder-informed 
patient and provider OA educational tools, and is engaged with vast network of partner organizations 
that will be instrumental in future implementation of OA CARE.   
• 
OA CARE has been developed in partnership with key stakeholders. At the outset of developing this 
care model, we convened a group of clinicians and clinic administrators representing Internal Medicine, 
Family Medicine, Orthopedics, Physical Therapy and Rheumatology. OA CARE is based on this 
group’s input regarding current gaps in care and processes that would be feasible and sustainable for 
clinics and providers.  We also received input from on the project from our Thurston Arthritis Research 
Center Patient Stakeholder Advisory Board; they emphasized the importance of including rural patients 
and suggested that for patients who receive physical therapy during the study, we aim to integrate this 
with exercise opportunities at the YMCA, since this could enhance the benefits of physical therapy visits 
and augment integration of OA CARE components.  We will engage with these stakeholder groups 
throughout all phases of this research program.  
• 
The YMCA is currently engaged in clinic-community partnership efforts of direct relevance to this study. 
In particular, our local partners at the Triangle YMCA are currently funded by Blue Cross Blue Shield to 
conduct a 5-year project focused on referrals of patients from health systems to YMCA Medical 
Memberships, which include access to a variety of group programs plus health coaching. Their project 
aims to evaluate YMCA Medical Memberships as a population health approach and potential coverage 
as a health benefit; these goals are directly aligned with our plans for implementing and evaluating OA 
CARE. In addition, the Triangle YMCA has set up processes for sharing patients’ outcome data with 
their PCPs through the electronic health record (EHR). The Triangle YMCA has been very successful 
during their first year of this project, enrolling >700 patients from 7 major health systems including 
University of North Carolina (UNC) Health.  
 
2.2 
RISK/BENEFIT ASSESSMENT 
 
2.2.1  KNOWN POTENTIAL RISKS 
 
Emotional distress: it is unlikely that the types of questions participants will be asked in this study will result 
in emotional distress, but we understand that participants may be uncomfortable with answering questions 
about some aspect of their health or other things about them. To minimize this risk, we will let participants 

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know they may choose not to answer any study questions and can still be involved in the study. Additionally, 
participants in the OA CARE intervention will have contact information for the study team (e.g. OA CARE 
Navigator) and a YMCA health coach to discuss any concerns. 
 
Breach of confidentiality: we will be collecting some elements of personal health information necessary for 
the study. To minimize breaches of confidentiality, all data will be stored on a secure UNC server or a UNC 
IRB approved platform for sharing PHI (with YMCA) and paper information will be stored in locked filing 
cabinets in the office of a study team member, and only approved study personnel will have access to those 
data. 
 
Personal health information (e.g. patient name and contact information only) will be shared with YMCA health 
coaches and personnel conducting the YMCA weight loss and exercise programs.  Any information shared 
between approved UNC study team members and YMCA personnel will be done verbally by phone, by 
encrypted email or a UNC IRB approved platform for sharing PHI. 
 
For participants in the OA CARE intervention, personal health information (e.g. patient name and DOB or 
MRN) will be shared with the participant’s PCP, as part of the brief progress reports sent by the OA CARE 
Navigator . Any information shared between approved UNC study team members (e.g. OA CARE Navigator) 
and the participant’s PCP will be done by encrypted email or UNC IRB approved platform for sharing PHI. 
 
Risks of Exercise:  Participants in the OA CARE intervention will be involved in physical activity programming 
at the YMCA. This will be tailored to individuals with knee OA.  However, exercise programs may be 
associated with risk of injury, muscle soreness, and joint pain. The risk of sudden death during physical activity 
is about 1 death per 656,000 hours of physical activity. In general, the risk of these events with moderate 
physical activity is very low. 
 
Risks of weight loss interventions: Participants in the OA CARE intervention will be involved in a weight 
management program at the YMCA. Side effects associated with weight loss in general may be hair loss, 
fatigue, weakness, gall bladder disease, and electrolyte abnormalities. Also, low blood sugar or low blood 
pressure (lightheaded or fainting) may occur during weight loss if a participant is taking medications for 
diabetes or high blood pressure. These risks are not specific to this research but also apply to usual care. 
2.2.2 KNOWN POTENTIAL BENEFITS 
 
Participants may experience improvements in pain, physical function or other symptoms related to OA, from 
participating in the OA Care program. It is possible that this study may not benefit participants directly, but 
participation in this study may lead to information that can benefit other patients with knee and/or hip OA, as 
well as their health care providers. 
 
 
2.2.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS 
This is a minimal risk study with physical risks that are comparable to those that would be encountered with 
exercise programs in clinical or community settings.  Furthermore, we do not anticipate any significant 
psychological, social, financial, or legal risks to be associated with participation in this study.  Given the high 
and increasing rate of OA, the persistent deficits of physical inactivity, and the lack of a standard, evidence-
based approach to address these deficits in primary care settings, we believe the value of the information to be 
gained outweighs the risks of participation in the study. 
 
3  
STUDY OBJECTIVES AND ENDPOINTS 
 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR ENDPOINTS 
Primary 
Assess the feasibility 
and acceptability of 
OA CARE 
Feasibility metrics will 
include recruitment rate, 
completion rates for 
weight loss and exercise 
program visits, referrals to 
and utilization of services 
noted above and 
proportion of participants 
completing follow-up 
assessments. 
Acceptability of OA CARE 
will be evaluated from 
both patient and PCP 
perspectives. PCP 
perspectives and 
recommendations will be 
conducted as a 
stakeholder engagement 
activity; PCPs will not be 
considered research 
participants.   
These metrics are essential for assessing the 
feasibility of conducting a larger scale trial of 
OA CARE.  
Obtain preliminary data 
on the efficacy of OA 
CARE with respect to the 
primary outcome of 
change in total Western 
Ontario and McMaster 
Universities 
Osteoarthritis Index 
(WOMAC) score.    
 
Western Ontario and 
McMaster Universities 
Osteoarthritis Index 
(WOMAC) pain, stiffness, 
and function subscales, 
assessed at baseline, 6 
months and 12 months. We 
will separately examine 
WOMAC pain and function 
subscales as secondary 
outcomes. 
This primary metric will be assessed because 
it is a key outcome in OA and can be 
improved with regular PA. The 12-month time 
point corresponds to the end of the OA CARE 
intervention, and the 6-month time point will 
allow assessment of the time course of 
changes in outcomes.  
 
Secondary 
Obtain data on the 
efficacy of the OA CARE 
program with respect to 
improvement in body 
weight, physical activity 
and physical function.   
 
Physical activity will be 
accessed via accelerometer.  
Moderate to vigorous 
physical activity (MVPA; 
primary metric), light 
intensity activity, sedentary 
minutes, step counts and 
other PA metrics, assessed 
at baseline, 6 months and 12 
months.   
 
Physical Function tests: 30-
second chair stand test,  
timed up-and-go test, 2-
minute march test and single 
These secondary metrics will be assessed 
because they are also key outcomes in OA, 
and they map onto the different components 
of the OA CARE intervention. The 12-month 
time point corresponds to the end of the OA-
CARE intervention, and the 6-month time 
point will allow assessment of the time 
courses of changes in outcomes.  
 
 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR ENDPOINTS 
leg stance assessed at 
baseline and 12 months.   
 
Body Weight will be 
assessed using a research / 
clinical grade scale. 
Participants’ height will also 
be measured to calculate 
body mass index (BMI).  
 
Tertiary / Exploratory  
Obtain data on the 
efficacy of the OA CARE 
program with respect to 
the change in 
exploratory outcomes. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exploratory outcomes 
include psychological 
measures (Patient Health 
Questionnaire-8, Pain 
Catastrophizing Scale and 
Arthritis Self-Efficacy Scale) 
assessed at baseline, 6 
months and 12 months. We 
will collect self-reported 
sleep measures (STOP 
Questionnaire and Insomnia 
Severity Index ) for the OA 
CARE intervention. We will 
also collect preliminary data 
on costs of OA CARE.  
 
 
 
 
These outcomes are also important for 
patients with knee OA and map onto OA 
CARE intervention components. The 12-
month time point corresponds to the end of 
the OA-CARE intervention, and the 6-month 
time point will allow assessment of the time 
courses of changes in outcomes.    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4  
STUDY DESIGN 
 
4.1  
OVERALL DESIGN   
The aim of this study is to conduct an exploratory randomized controlled trial with 60 patients with 
knee and / or hip OA equally randomized to OA CARE or a usual care (UC) control group (Figure 1) . 
Sub-aims are as follows:  

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Aim 1.  Assess the feasibility and acceptability of OA CARE.  Feasibility metrics will include recruitment 
rate, completion rates for weight loss and exercise program visits, referrals to and utilization of services noted 
above and proportion of participants completing follow-up assessments. Acceptability of OA CARE will be 
evaluated from both patient and PCP perspectives.    
Aim 2.  Obtain preliminary data on the efficacy of OA CARE with 
respect to the primary outcome of change in total Western Ontario 
and McMaster Universities Osteoarthritis Index (WOMAC) score.  The 
WOMAC will be administered at baseline, 6-months and 12-months, along 
with secondary outcomes including body weight, physical activity, physical 
function (baseline and 12 months only), sleep measures and psychological 
measures. We will also collect preliminary data on costs of OA CARE.  
 
This will be an exploratory RCT with 60 patients equally randomized to OA 
CARE or a usual care (UC) control group (Figure 1); randomization will be 
in block sizes of 20. Assessments will occur at baseline, 6-month follow-up 
and 12-month follow-up.  The UC group will be offered a 12-month YMCA 
Medical Membership (described below) once they have completed follow-
up assessments.  
 
4.2   
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
Although this exploratory trial is not designed with statistical power to test the efficacy of OA CARE, we have 
included a UC group (rather than conducting a single-group study) for several reasons. First, this provides an 
opportunity to assess acceptability of randomization to a UC group, from the patient perspective.  Second, we 
will be able to evaluate follow-up rates for both groups, which will inform potential adaptations and sample size 
estimation for a larger trial. Third, this will provide a better preliminary assessment of the efficacy of OA CARE 
(Aim 2) than a single group pre-post trial, since improvement is consistently observed in control groups within 
OA trials 22,29,31,38.  We have specifically selected a UC control group (versus an attention control condition) 
because our ultimate goal is to test how well OA CARE performs relative to the typical care patients receive for 
OA. Assessments for this trial will be conducted at baseline, 6-months (corresponding to the beginning of the 
second phase of OA CARE), and 12-months (intervention completion).  
 
4.3  
JUSTIFICATION FOR INTERVENTION 
 
This research addresses a clear need to improve care for patients with OA through an evidence-based, 
comprehensive and sustainable care model. This project lays the groundwork for an implementation-focused 
RCT that will collect rigorous cost data to inform payment models. Involvement of key stakeholders, as well as 
integration with national organizations including the YMCA and OAAA, will lead to a generalizable approach 
and strategies for widespread implementation in U.S. healthcare systems.       
  
4.4  
END-OF-STUDY DEFINITION 
 
A participant is considered to have completed the study if he or she has completed 12-month follow-up 
assessment.  
 
5 
  
STUDY POPULATION  
 
5.1  
INCLUSION CRITERIA 
 
Participants for this trial will be patients with a clinician diagnosis of knee or hip OA, self-reported knee or hip 
pain of ≥3 (scale of 0-10) on most days of the week, body mass index (BMI) ≥27 kgm2,, and not currently 
meeting physical activity recommendations 39. We will base study inclusion on a clinician diagnosis of hip or 

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knee OA, rather than obtaining new radiographs, because OA CARE is designed for providers to initiate at any 
point in the course of care (not necessarily directly following a diagnosis or new imaging). The rationale for BMI 
and physical activity criteria is that patients with higher BMI and who are inactive are at greater risk for OA 
progression and worse outcomes, and weight management and exercise are key components of OA CARE 
42,43.  We chose a minimum BMI of 27 kgm2 because of the association with earlier mortality and the 
precedence of this threshold in other OA trials 11,32,44.   
 
5.2  
EXCLUSION CRITERIA 
 
Exclusion Criteria and Sources of Information  
Criterion  
EMR 
Phone Screening  
No internet access and a device 
(computer, tablet, smartphone) to 
access the virtual weight loss 
intervention 
 
X 
Pain in chest when performing 
physical activity 
 
X 
Pain in chest when not performing 
physical activity 
 
X 
No documented diagnosis of knee or 
hip OA 
X 
X 
No lower extremity surgery in the past 
6 months 
X 
X 
Significant cognitive impairment 
X 
X 
Psychosis 
X 
 
X 
Uncontrolled Substance abuse 
disorder 
X 
X 
Severe hearing or visual impairment 
X 
X 
Serious/terminal illness as indicated 
by referral to hospice or palliative care 
X 
X 
Hospitalization for cardiovascular 
event in last 6 months 
X 
X 
History of ventricular tachycardia 
X 
X 
Unstable chronic obstructive 
pulmonary disease (2 hospitalizations 
within the previous 6 months and/or 
on oxygen) 
X 
X 
Stroke with moderate to severe 
aphasia 
X 
X 
Recent history (last 6 months) of 
three or more falls 
 
X 
Planning total joint replacement in 
next 6 months 
 
X 
Any other health conditions 
determined by the study team to be 
contraindications to a home exercise 
program or weight loss. 
X 
X 
Current participation in other study 
related to knee or hip osteoarthritis, 
weight loss or physical activity 
 
X 
Unable to speak English 
X 
X 
Pregnant or planning to become 
pregnant 
X 
X 
 
 

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5.3  
LIFESTYLE CONSIDERATIONS 
N/A 
 
5.4  
SCREEN FAILURES 
 
Screen failures are defined as participants who consent to participate in this study but are not subsequently 
assigned to the study intervention or entered in the study. Individuals who do not meet the criteria for 
participation in this trial (screen failure) because of meeting one or more exclusion criteria (e.g., development 
of an exclusionary health condition) will not be rescreened.   
 
5.5.  
STRATEGIES FOR RECRUITMENT AND RETENTION  
We will recruit patients from UNC Health. In particular, we will partner with the UNC Internal Medicine Clinic 
and UNC Family Medicine, which serves high proportions of patients who are African American and non-white 
Hispanic, as well as uninsured patients. This is important because of disparities in OA among these 
demographic groups45, and our aim for OA CARE to particularly reach the most vulnerable patients. Our team 
has a strong track record of recruiting African American and non-White Hispanic patients 28,31,46.  Our main 
recruitment method will mirror the process by which we envision OA CARE will ultimately function in clinical 
settings.  Specifically, PCPs will be asked to refer patients to OA CARE. This may occur via the EHR or 
another UNC approved method of transferring PHI.  A study team member will then screen the EHR for 
potential exclusion criteria and contact the patient to assess interest and administer a brief screening 
questionnaire.  If needed, we will also identify potential participants via an EHR data pull, then send 
introductory letters and follow up with a screening phone call.  However, a key goal for this exploratory study is 
to develop procedures to maximize provider referrals, as this will be critical for downstream implementation.  
All eligible patients will be asked to attend a baseline visit that will involve completion of consent, baseline 
assessments and receipt of an accelerometer.  Following return of the accelerometer, participants will be 
informed of their randomization assignment via telephone. A participant will be considered enrolled once they 
have consented and been randomized.   
 
To facilitate completion of recruitment calls, as well as baseline and follow-up assessment calls, we will call 
participants on different times of day and different days, across multiple weeks.  We have used this strategy 
successfully in prior studies to reach participants at times convenient to them.  
  
6.0  
STUDY INTERVENTIONS  
6.1  
STUDY INTERVENTION ADMINISTRATION 
 
OA CARE Intervention   

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Overview.  For patients, OA CARE includes 
evidence-based behavioral weight management and 
exercise interventions, as well as tailored referrals to 
physical therapy, psychological interventions, 
additional weight / nutrition-related services and 
sleep-related services based on patient-specific 
needs and in coordination with the PCP (Figure 2).  
These referrals will be based on screening 
questions administered six months after initiating 
weight management and exercise interventions; the 
rationale for this timing is that it allows us to 
evaluate which additional services patients may 
need after engaging in “first line” therapies for a 
meaningful period of time 4,8,10. PCPs of patients 
enrolled in OA CARE will be given a video-based 
summary of ACR treatment guidelines 10, 
collaborate on patient referrals, and receive brief 
progress reports on their enrolled patients.  An OA 
CARE Navigator will facilitate all activities within the 
care pathway, including scheduling patients for 
weight management and exercise classes (in 
collaboration with the YMCA), conducting 6-month 
screening questions, coordinating referrals with 
PCPs, preparing patient progress reports for PCPs, and serving as a point person for both patient and PCPs. 
Importantly for implementation, the OA CARE Navigator role does not require clinical or other specialized 
expertise, so in clinical settings this role could be performed by a variety of personnel (e.g., chronic care 
managers, nurses, schedulers).   
Weight Loss & Exercise Interventions. Evidence-based weight loss and exercise programs will be delivered by 
the Triangle YMCA, within the structure of the Medical Membership.  (All services provided to study 
participants by the YMCA will be their standard programming; they will note be delivering a study-specific 
intervention.) This membership provides access to multiple group exercise programs, exercise facilities, and a 
health coach who assists members with meeting health goals and selecting appropriate programs and classes. 
All patients in OA CARE will begin with participation in the YMCA’s Weight Loss Program (Program). This 
program involves 12 weekly sessions that include goal-setting, food and activity tracking, introduction to 
physical activity offerings, and weigh-ins. This Program is based on best practices from evidence-based 
behavioral weight loss programs.  Participants may repeat the program following the first 12-week session if 
they have not met weight loss goals and / or would like continued structure and support for these behavior 
changes.  The Triangle YMCA will deliver the Weight Loss Program to OA CARE members in groups of 
approximately 10; this will provide cohesion for OA CARE participants. In the beginning of the study, the 
Program will  be delivered virtually (e.g. video conferencing platform) for feasibility reasons (e.g., potential for 
study participants to reside in different geographic locations that would make travel to a central location 
challenging). However, the Program may be offered in-person in the future.  During the screening call, we will 
assess whether the patient has internet access and a device (computer, tablet, smartphone) on which they can 
access the Program. If the patient screens ineligible for this reason, we will ask the patient if they would like to 
be contacted, if the Program is offered in-person at a future date.  If we do offer the Program in person, this will 
no longer be considered an exclusion criterion. The YMCA offers many exercise programs and classes 
appropriate for individuals with OA. A YMCA health coach will assist participants with selecting an exercise 
program (including appropriateness based on their pain and functional limitations) and continuing to engage 
with exercise-based therapies throughout their 12-month involvement in OA CARE.  The UNC study team will 
also give participants instructions regarding how to access a free Walk With Ease workbook (through the 
OAAA’s online portal) and take advantage of other tools available through this program.   

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Additional Tailored Services. After 6-months, we will administer a series of questionnaires to assess patients’ 
needs for and interest in additional interventions included in OA treatment guidelines (Table 1) 10,20.  Our 
multidisciplinary study team, which includes individuals with deep expertise in OA treatment and guidelines, 
has developed algorithms to guide these referrals. Patients will be given information on the types of 
interventions shown in Table 1 (via mail or email), and the OA CARE Navigator will engage patients in a 
shared decision-making process (via phone) regarding additional referrals, with a focus on interventions for 
which they meet criteria shown in Table 1.  However, the OA CARE Navigator will facilitate referrals and 
recommendations for any services of interest to patients, regardless of criteria shown in the table. Any referrals 
for clinically-based services (e.g., physical therapy, sleep testing) will be coordinated with the PCP.  Table 1 
also shows examples of interventions and resources within each category, ranging from free, publicly available 
programs to individual clinical services; some services will be relevant regardless of geographic location and 
some will be customized based on local resources, as we have done previously 33. The OA CARE Navigator 
will also call participants about a month later to follow up on any questions they may have regarding resources 
or referrals.  The OA CARE Navigator may also conduct additional calls with a participant if needed to 
coordinate connection with resources or referrals.  
Table 1.  Criteria and Examples of Additional Tailored Services  
Type of Service 
Criteria  
Example Interventions & Resources 
Psychological 
Interventions 
Subgroups for Targeted Treatment (STarT 
Back) Tool 47-49: 4 or more psychosocial risk 
factors (pain bothersomeness, fear, worry, 
catastrophizing, depression) 50 
Free, evidence-based pain coping skills 
training programs (e.g. painTRAINER) and 
referral to local mental health providers who 
specialize in pain management 
Physical Therapy  
Persistent self-reported difficulty with 
walking or stair-climbing, balance 
difficulties, recent falls or pain as a limitation 
to engaging in regular exercise  
Referrals based on based on patients’ 
preferences for location, geography, and 
health insurance coverage  
Weight Management & 
Nutrition Services 
< 5% weight loss51   
Referrals to registered dieticians and other 
credentialled clinicians who specialize in 
weight loss support 
Sleep Services 
Sleep apnea: “high risk” based on the 
STOP questionnaire, score ≥ 2 52.  
Insomnia: score ≥11 on the Insomnia 
Severity Index 53.      
Referrals for sleep testing, recommendations 
for free, evidence-based cognitive behavioral 
therapy for insomnia programs (e.g., CBTI-
Coach app), and referrals to local providers or 
group programs focusing on sleep-related 
therapies.    
Provider Intervention.  As noted above, we have intentionally designed the PCP intervention to be brief, 
therefore maximizing feasibility and engagement.  There are three components to the PCP intervention.  The 
first is a set of brief videos summarizing current OA treatment guidelines, with a focus on practical application 
and the role of the PCP. Second, providers will receive progress reports for their enrolled patients through 
encrypted email or other UNC approved method of sharing PHI; this will include changes in symptoms and 
health behaviors from the study team at 6- and 12-months. Third, providers will be involved with referrals to 
additional clinical services, as described above.  The OA CARE Navigator will provide the PCP with 
information on patient requests for referrals, based on the 6-month assessment, and the referral process will 
follow the usual procedures within the primary care clinic.   
 
6.2  
FIDELITY  
 
Interventionist Training  
OA Care Navigator: The OA Care will be trained by the principal investigator prior to delivering the intervention. 
This training will include general instruction in intervention delivery steps, processes for communicating with 
YMCA personnel and PCPs vis email and the electronic health records, content for notes to PCPs, 
administration of 6-month screening questionnaires, and discussion of potential services and referrals during 
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include mock sessions with both experienced study team members and non-study member volunteers 
(observed by the principal investigator). The OA Care Navigator will also view the video created for PCPs, as 
well as other materials from the OAAA, to become highly familiar with OA symptoms and care.  
 
Fidelity Monitoring  
Monitoring of Intervention Contacts. Dr. Allen or another experienced study team member will monitor study 
intervention contacts and provide feedback to the interventionists, including the following:  
 
• OA CARE Navigator 6-month phone calls: The first 5 calls will be monitored with potential for additional 
calls if deemed appropriate by the principal investigator or other study team member. Monitoring will 
involve checks to ensure that all questions are asked per protocol, services and referrals are appropriately 
explained to patients, and the Navigator engages the patient in a meaningful discussion regarding their 
interest in services and referrals.  
 
 
6.3  
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING  
 
The randomization scheme will be generated by the study statistician and stored within the study database.  
The database will be configured so that blinded study personnel (e.g., those conducting follow-up 
assessments) will not have access to randomization information. The participants will not be notified of 
randomization assignment until all baseline assessments are complete.  In addition, an individual participant’s 
randomization assignment will not be known to any study personnel until baseline assessments are complete.  
 
6.4  
STUDY INTERVENTION ADHERENCE  
 
The study database will be used to track participants’ completion of all assessment visits, as well as all 
contacts with the OA CARE Navigator. The coordinator will also maintain close communication with the OA 
CARE Navigator regarding facilitation of all activities within the care pathway. The YMCA will provide 
documentation of patients’ participation in specific YMCA programs to the OA CARE Navigator; this 
information will also be summarized for PCPs. Also, for each patient, the OA CARE Navigator will maintain a 
checklist of intervention activities, target dates, dates of completion, and comments. 
 
6.5  
CONCOMITANT THERAPY 
  
Participants will be permitted to continue any other OA treatment during the course of the study.  
 
7  
STUDY INTERVENTION/ DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
7.1  
DISCONTINUATION OF STUDY INTERVENTION 
 
When a participant discontinues the OA CARE intervention, they will be asked if they are willing to continue 
with other remaining activities (e.g., follow-up assessments) based on the study protocol.  If a clinically 
significant finding is identified after enrollment (e.g. health-related changes that may change the safety level of 
participation), the investigator or qualified designee will determine if any change in participant management is 
needed. Any new clinically relevant finding will be reported as an adverse event (AE). The data to be collected 
at the time of study intervention discontinuation will include the reason(s) for discontinuing the participant from 
the intervention, and methods for determining the need to discontinue. 
 

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7.2  
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY  
 
Participants are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue a participant from the study for the following reasons: 
 
• 
Lost-to-follow up; unable to contact subject  
• 
Any event or medical condition or situation occurs such that continued collection of follow-up study data 
would not be in the best interest of the participant or might require an additional treatment that would 
confound the interpretation of the study 
• 
The participant meets an exclusion criterion (either newly developed or not previously recognized) that 
precludes further study participation 
The reason for participant discontinuation or withdrawal from the study will be recorded in the study database.   
Participants who discontinue or are withdrawn will be replaced up to the point of randomization assignment 
being given to the participant.  Once participants are given their randomization assignment, they will be 
counted toward the total study sample size and not replaced.  
 
7.3  
LOST TO FOLLOW-UP 
A participant will be considered lost to follow-up if he or she fails to return for the final, 12-month follow-up 
assessment.  If a participant misses intervention calls or follow-up assessments prior to the 12-month time 
point and cannot be contacted during the time frame, the study team will still attempt to contact the participant 
for remaining calls / assessments. The study team must attempt to contact a participant at least 3 times, on 
different days of the week, different times of day, and across at least 2 weeks, before they are considered to 
have missed a visit / assessment or be lost to follow-up.  These contact attempts will be documented in the 
study database.  
 
8   
STUDY ASSESSMENTS AND PROCEDURES 
 
8.1  
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
Measures will be collected at baseline, 6-months and 12-months by a trained study team member blinded to 
randomization assignment. Measures will be administered in-person at baseline and 12-months and at 6-
months via phone. We may schedule a time to call the participant before or after the in-person 12-month visit  
to complete the questionnaires over the phone. Participants will be paid $60 for baseline and 12-month 
assessments ($45 for in-person visits + $15 to wear and return the accelerometer) and $40 for 6-month 
assessments ($25 for phone-based assessments + $15 to wear and return the accelerometer).  
 
Feasibility Metrics. We will compute the proportion of patients who are eligible and who consent to participate 
in the study, mean number of intervention visits attended, and proportion of participants who complete follow-
up assessments. We will also determine the proportions of participants who meet criteria for and are interested 
in each type of additional intervention (at 6-month follow-up), and we will track participants’ use of these 
services during the study period.   
Acceptability of OA CARE. We will ask all participants in the OA CARE group to complete a series of 
satisfaction ratings and open-ended questions regarding different components of the intervention.  We will not 
collect formal measures from referring PCPs.  However, following the completion of the study, we will contact 
providers and ask for their suggestions on ways in which OA CARE could be improved. This will be 
approached as a stakeholder engagement type of activity, and PCPs will not be considered research 
participants for this purpose.  
Primary Patient Outcome:  Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).  The 
primary outcome for this study is the WOMAC, a measure of lower extremity pain (5 items), stiffness (2 items), 
and function (17 items).  All items are rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms). The 

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WOMAC has well established psychometric properties including reliability, construct validity and internal 
consistency 54.  The WOMAC has been widely used in trials of behavioral interventions for patients with lower 
extremity OA, confirming its sensitivity to change in this context. In addition to the total WOMAC score (primary 
outcome), we will separately examine WOMAC pain and function subscales. 
Secondary Patient Outcomes.  
Body Weight. We will assess body weight using a research / clinical grade scale (e.g., Tanita) that will be 
calibrated regularly.  We will also measure participants’ height in order to calculate body mass index.   
Physical Activity. All participants will be asked to wear an Actigraph GT3X+ (Pensacola, FL) 55at the hip during 
waking hours for 7 days. We will use data processing and logistical methods we have used successfully in 
prior work 33.  Physical activity metrics will include minutes of any intensity activity (primary), minutes of 
moderate to vigorous intensity physical activity, step counts and sedentary time.  We will also ask participants 
to complete a modified version of the Community Health Activities Model Program for Seniors Physical Activity 
Measure 56, which provides information on the types of activities in which participants are engaging.   
Physical Function.  We will administer tests recommended by the Osteoarthritis Research Society International 
for clinical trials of knee OA including a 30-second chair stand test and timed up-and-go test 57.  We will also 
include a 2-minute march test as an assessment of endurance 58 These tests will be conducted in accordance 
with established protocols 57,58.  
Exploratory Patient Outcomes.  
Sleep Measures. Sleep apnea symptoms will be assessed with the STOP Questionnaire 52, and insomnia 
symptoms will be assessed with the Insomnia Severity Index 53.  These measures were selected based on 
clinical practice guidelines 59.   
Psychological Measures.  We will assess depressive symptoms via the Patient Health Questionnaire-8 (8-item 
measure, higher  60, the Pain Catastrophizing Scale 61, and the Arthritis Self-Efficacy Scale 62,63.  These are all 
validated scales used widely in the context of OA trials.  
Balance. We will assess balance with a single leg stance test, using established protocols 58.  The maximum 
possible standing time will be 30 seconds, and we will also designate whether participants achieve a 
commonly utilized threshold of 10 seconds.    
Participant Characteristics. We will collect the following information to characterize the study sample: age, race 
/ ethnicity, sex, education level, work status, household income, health insurance status, marital status, 
comorbid illnesses 64, joints with arthritis symptoms, and duration of knee / hip OA symptoms. 
Costs. Although costs are not a primary focus of this exploratory trial, we will collect these data to refine 
processes for the larger trial. This will include costs of the YMCA Medical Membership, costs (to both the 
health system and patients) associated with additional clinical services that result from 6-month screening and 
referrals, and patients’ self-reported costs for engaging any additional community-based services or programs.   
 
8.2  
SAFETY ASSESSMENTS 
  If a study team member learns of any adverse events (AEs) that occur in the course of participants’ home 
exercise, this will be documented on the Adverse Events form, as described below.  
 
8.3  
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS  
 
8.3.1 DEFINITION OF ADVERSE EVENTS 
This protocol uses the definition of adverse event from DHHS Office for Human Research Protections (OHRP): 
Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for 
example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the 
subject’s participation in the research, whether or not considered related to the subject’s participation in the 

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research (modified from the definition of adverse events in the 1996 International Conference on 
Harmonization E-6 Guidelines for Good Clinical Practice). 
 
 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
This protocol uses the definition of serious adverse event from DHHS OHRP: any adverse event that results in 
death; is life-threatening (places the subject at immediate risk of death from the event as it occurred); results in 
inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant 
disability/incapacity; results in a congenital anomaly/birth defect; or based upon appropriate medical judgment, 
may jeopardize the subject’s health and may require medical or surgical intervention to prevent one of the 
other outcomes listed in this definition (examples of such events include allergic bronchospasm requiring 
intensive treatment in the emergency room or at home, blood dyscrasias or convulsions that do not result in 
inpatient hospitalization, or the development of drug dependency or drug abuse). 
 
 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
 
 
 
8.3.3.1 SEVERITY OF EVENT 
All AEs will be assessed by the PI or co-investigators, if the PI is not available.  The following guidelines will be 
used to describe severity:  
 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic measures. 
Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug therapy or 
other treatment. Severe events are usually potentially life-threatening or incapacitating.  Of note, the 
term “severe” does not necessarily equate to “serious”.] 
 
 
 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
All AEs will have their relationship to study procedures, including the intervention, assessed by the PI or co-
investigators based on temporal relationship and his/her clinical judgment. The degree of certainty about 
causality will be graded using the categories below.  
• 
Definitely Related – There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. The clinical event, including an abnormal laboratory test result, 
occurs in a plausible time relationship to study intervention administration and cannot be explained by 
concurrent disease or other drugs or chemicals. The response to withdrawal of the study intervention 
(dechallenge) should be clinically plausible. The event must be pharmacologically or 
phenomenologically definitive, with use of a satisfactory rechallenge procedure if necessary. 
• 
Probably Related – There is evidence to suggest a causal relationship, and the influence of other 
factors is unlikely. The clinical event, including an abnormal laboratory test result, occurs within a 
reasonable time after administration of the study intervention, is unlikely to be attributed to concurrent 
disease or other drugs or chemicals, and follows a clinically reasonable response on withdrawal 
(dechallenge). Rechallenge information is not required to fulfill this definition. 
• 
Not Related – The AE is completely independent of study intervention administration, and/or evidence 
exists that the event is definitely related to another etiology. There must be an alternative, definitive 
etiology documented by the clinician. 
 
 
8.3.3.3 EXPECTEDNESS 

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The PI or Dr. Saint-Surin (co-investigator on the study) will be responsible for determining whether an AE is 
expected or unexpected. An AE will be considered unexpected if the nature, severity, or frequency of the event 
is not consistent with the risk information previously described for the study procedures. 
 
 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
The occurrence of an AE or serious adverse event (SAE) may come to the attention of study team members 
during study visits.  All AEs, not otherwise precluded per the protocol, will be captured on the Adverse Event 
Form.  Information to be collected includes event description, time of onset, PI or co-investigator’s assessment 
of severity, relationship to study procedures (assessed only by those with the training and authority to make a 
diagnosis), and time of resolution/stabilization of the event. All AEs occurring while on study will be 
documented appropriately regardless of relationship. All AEs will be followed to adequate resolution. 
Any medical or psychiatric condition that is present at the time that the participant is screened will be 
considered as baseline and not reported as an AE. However, if the study participant’s condition deteriorates at 
any time during the study, it will be recorded as an AE.  
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event at 
each level of severity to be performed. Documentation of onset and duration of each episode will be 
maintained for AEs characterized as intermittent. 
The Project Coordinator will record events 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.  
Participants are identified in the EMR as a study participant and for each AE/SAE occurrence, research team 
members will receive an alert through EMR. AEs or SAEs may also be reported to study physical therapist 
during the course of intervention visits.  Events will be followed for outcome information until resolution or 
stabilization. 
 
 
8.3.5  ADVERSE EVENT REPORTING 
Once Dr. Allen (or a co-investigator) is contacted about the adverse event, she / he will make a determination 
about the reporting requirements in accordance with UNC IRB guidelines.   
The PI or a co-investigator will report any AEs to the UNC IRB that suggest new or increased risk to 
participants or others within 7 calendar days of when the PI became aware of the information. New or 
increased risk is defined as any incident, experience, outcome, or new information that are (1)unexpected, (2) 
related or at least possible related to participation in the research, and (3) indicates that subjects or others are 
at a greater risk of harm (including physical, psychological, economic, legal, or social harm) 
 For AEs that are not related to participation in the research and do not suggest new or increased risks to the 
participant, these will be reported to NIAMS on the bi-annual safety report submitted to the SO    
 
 
8.3.6 SERIOUS ADVERSE EVENT REPORTING 
Once Dr. Allen (or a co-investigator) is contacted about a serious adverse event, she / he will make a 
determination about the reporting requirements in accordance with UNC IRB guidelines.  This will include 
notification of the UNC IRB within 24-hours if a study-related death and within 48 hours if another SAE.  
All SAEs will be reported to the NIAMS (through the NIAMS Executive Secretary) within 48 hours of the 
investigator becoming aware of the event. The SAE Report Form will be completed and the SO’s review of the 
SAE report will be shared with the NIAMS once received. 
 
 
8.3.7 REPORTING EVENTS TO PARTICIPANTS 
N/A 

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8.3.8  EVENTS OF SPECIAL INTEREST 
N/A 
 
 
8.3.9 REPORTING OF PREGNANCY   
N/A 
 
8.4. 
UNANTICIPATED PROBLEMS 
 
 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
 
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human Research 
Protections (OHRP). 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: 
 
(1) Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are 
described in the IRB-approved research protocol and informed consent document; and (b) the 
characteristics of the participant population being studied; 
 
(2) 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 
 
(3) Suggests that 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. 
 
OHRP recognizes that it may be difficult to determine whether a particular incident, experience, or outcome is 
unexpected and whether it is related or possibly related to participation in the research.  OHRP notes that an 
incident, experience, or outcome that meets the three criteria above generally will warrant consideration of 
substantive changes in the research protocol or informed consent process/document or other corrective 
actions in order to protect the safety, welfare, or rights of participants or others.   
The following corrective actions or substantive changes that could be considered in response to an 
unanticipated problem include:  
 
o 
Changes to the research protocol initiated by the investigator prior to obtaining IRB approval to 
eliminate apparent immediate hazards to subjects;  
o 
modification of inclusion or exclusion criteria to mitigate the newly identified risks; 
o 
implementation of additional procedures for monitoring subjects; suspension of enrollment of new 
subjects;  
o 
suspension of research procedures in currently enrolled subjects;  

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o 
modification of informed consent documents to include a description of newly recognized risks;  
o 
provision of additional information about newly recognized risks to previously enrolled subjects. 
 
Only a small subset of adverse events occurring in human subjects participating in research will meet these 
three criteria for an unanticipated problem. Furthermore, there are other types of incidents, experiences, and 
outcomes that occur during the conduct of human subjects research that represent unanticipated problems but 
are not considered adverse events.  For example, some unanticipated problems involve social or economic 
harm instead of the physical or psychological harm associated with adverse events.  In other cases, 
unanticipated problems place subjects or others at increased risk of harm, but no harm occurs.   
 
 
8.4.2 UNANTICIPATED PROBLEMS REPORTING 
All UPs will be reported to UNC IRB within 48 hours of the PI becoming aware of the event.  All UPs will be 
reported to the NIAMS and the SO (through the NIAMS Executive Secretary) within 48 hours of the PI 
becoming aware of the event. 
 
 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS 
Participants will be given any new information gained during the course of the study that might affect their 
willingness to continue participation in the study.  
 
9  
STATISTICAL CONSIDERATIONS 
 
9.1  
STATISTICAL HYPOTHESES 
The aim of this study is to conduct an exploratory randomized controlled trial with 60 patients with 
knee and / or hip OA equally randomized to OA CARE or a usual care (UC) control group.  Sub-aims and 
associated hypotheses are:  
Aim 1.  Assess the feasibility and acceptability of OA CARE.  There are no specific hypotheses associated 
with this aim.  Analyses will be descriptive in nature.      
Aim 2.  Obtain preliminary data on the efficacy of OA CARE with respect to the primary outcome of 
change in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.  We 
hypothesize that participants in OA CARE will have clinically meaningful improvements in WOMAC scores at 
6- and 12-month follow-up relative to a UC control group.  Similarly, we hypothesize that participants in OA 
CARE will have greater improvements in secondary and exploratory outcomes compared with the control 
group.    
 
9.2  
SAMPLE SIZE DETERMINATION 
 
Due to the exploratory nature of this trial, the objective is to inform estimates for a larger RCT. Accordingly, we 
do not necessarily expect this trial to be highly powered. However, we do note that for the projected total of 
n=60 enrolled participants, equally allocated between the two arms of the trial at the two-sided 0.05 
significance level, and accounting for a conservative effect of clustering within the OA CARE arm, we would 
exceed 80% power to detect an effect size of at least 1.7 SD. This choice of sample size is deemed to be 
feasible for completion within the time frame of this exploratory trial and will allow sufficient experience with 
intervention delivery to inform the larger trial. We expect some drop-out and loss-to-follow-up among 
participants, and this exploratory trial will contribute to our sample size estimation for the larger RCT in this 
regard. However, based on rates of drop-out in prior trials 28,29,31, our target sample size of 60 participants will 
allow ample experience with study procedures. Our analytic strategy (described below) will also accommodate 
missing data due to dropout, missed visits, and loss-to-follow-up.   
 
9.3  
POPULATIONS FOR ANALYSES 

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The primary analyses will be conducted using an intent-to-treat approach.  Supportive exploratory analyses 
may be conducted to consider samples with greater completion of study intervention visits.  Since this is an 
exploratory trial, the nature of these supportive analyses will be based on observed patterns of intervention 
contacts.  
 
9.4  
STATISTICAL ANALYSES PLAN  
 
The primary patient outcome of the total WOMAC score will be statistically analyzed between experimental 
groups across the follow-up time points through a general linear mixed model (GLMM).  Fixed effects will 
include indicators for the OA CARE group, the 12-month follow-up time point, and their interaction (group by 
time).  Additional fixed effects will be baseline total WOMAC score and possibly any covariates exhibiting 
random imbalance between groups.  Random effects will be included for patients (to account for their repeated 
measures) and for grouping within the OA CARE arm (e.g. 10-participant Weight Management Program 
groups) to account for clustering. Customized statistical linear contrasts will be constructed to estimate the 
effect size via the difference in means for OA CARE versus usual care, along with the corresponding 95% 
confidence limits, separately at 6- and 12- months, to provide useful estimates that will inform the sample size 
estimation for the subsequent trial.  Estimated correlations among the follow-up time points, as well as 
estimated within-cluster intraclass correlation for the OA CARE arm, will also be useful in this regard. 
Exploratory testing of efficacy will also be conducted using these statistical contrasts. The approach outlined 
above will be repeated separately for the WOMAC pain and function subscale scores, as well as for the 
secondary outcomes identified above. If any of these outcomes exhibit distributions that deviate markedly from 
normality, alternatives will include transformations to normalize the distribution and variable categorization with 
appropriate data analysis (e.g., mixed-effects logistic models or logistic models utilizing generalized estimating 
equations to accommodate correlated observations). An intent-to-treat approach will be followed in these 
analyses to provide a conservative approach. A two-sided 0.05 significance level will be applied to each 
outcome with no adjustment for multiple comparison in keeping with the exploratory nature of the trial. The 
GLMM approach utilizes all available follow-up data and accommodates missing data under a missing at 
random (MAR) paradigm. If missing data are extensive and deemed not to be MAR, analyses will be 
conducted using multiple imputation, yielding complete data for all participants. The feasibility and acceptability 
metrics will be summarized through descriptive statistics, along with corresponding 95% confidence intervals, 
separately by experimental arm when appropriate. This includes frequencies and proportions of patients who 
are eligible, who consent to participate in the study, who complete follow-up assessments, who meet criteria 
for and are interested in each type of additional intervention (at 6-month follow-up), and who use of these 
services during the study period.  Means and standard deviations will be computed for the number of 
intervention visits attended by participants.  
 
10  
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
10.1 
REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
10.1.1 INFORMED CONSENT PROCESS 
 
10.1.1.1 CONSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
Consent forms describing in detail the study intervention, study procedures, and risks will be given to the 
participant and written documentation of informed consent will be completed prior to starting the study 
intervention.  The following consent materials are submitted with this protocol: Adult Consent Form.  
 

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10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
Once a potential participant meets the medical record and telephone screening criteria for eligibility, and is 
interested in participating, they will be asked to attend a baseline visit that will involve completion of consent, 
baseline assessments and receipt of an accelerometer. No other study activities will occur until this process is 
completed.   
 
We will use a UNC IRB approved consent form / script with included language that satisfies the HIPAA 
requirements and outlines the protection of health information utilized in the study.   
 
Written informed consent will be obtained by a trained study team member.  The study team member will read 
the IRB approved consent form to the potential participant and provide an opportunity for him/her to ask any 
questions that they may have about the research study.  We anticipate this process to take approximately 20 
minutes, but this time will not be limited should a participant have additional questions or concerns regarding 
the study.  During this phase of the consent process, it will be stressed that the participant is not obligated to 
participate in the study, that participation is completely voluntary, and that he/she may withdrawal from the 
study at any time without penalty.  Also, potential risks from participating in the study will be outlined in the 
consent form, as are the measures taken to protect against study specific risks.  Once the information in the 
consent form is fully reviewed and understood by the individual, he/she will be asked to decide at that time if 
they would like to voluntarily participate in the research study.  If the individual does choose to participate in the 
study, both the study team member and the participant will sign two copies of the informed consent form.  The 
participant will receive one copy for their records and the other copy will be stored in a locked file cabinet of a 
study team member.     
 
If after review of the consent form, the potential participant is not sure they would like to participate in the study 
at this time, they may choose to consider the study further, and then contact the study team if they decide later 
that they would like to participate.  
 
Once informed consent has been collected, the study team member will collect written HIPAA authorization, 
and no activities will commence until this is received by the study team. 
 
Participants will only be included if they have capacity to give legally effective consent. Additionally, this study 
will only recruit participants whom are English speakers.   
 
 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
This study may be temporarily 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 study participants, investigator, funding agency, and regulatory authorities. 
If the study is prematurely terminated or suspended, the PI will promptly inform study participants, the IRB, and 
sponsor/funding agency and will provide the reason(s) for the termination or suspension. Study participants will 
be contacted, as applicable, and be informed of changes to study visit schedule. 
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Demonstration of efficacy that would warrant stopping    
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 

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• 
Determination of futility 
 
The study may resume once concerns about safety, protocol compliance, and data quality are addressed, and 
satisfy the funding agency, sponsor, IRB or other relevant regulatory or oversight bodies (OHRP, SO). 
 
10.1.3 CONFIDENTIALITY AND PRIVACY 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, the 
safety and oversight monitor(s), and the sponsor(s) and funding agency. This confidentiality is extended to the 
data being collected as part of this study. Data that could be used to identify a specific study participant will be 
held in strict confidence within the research team. No personally-identifiable information from the study will be 
released to any unauthorized third party without prior written approval of the sponsor/funding agency.  
 
Personal health information (e.g. patient name and contact information) will be shared with YMCA so they may 
contact participants to enroll in the medical membership and participate in programs.  Any information shared 
between approved UNC study team members and YMCA personnel will be done verbally by phone, by 
encrypted email or a UNC IRB approved platform for sharing PHI.  
 
All research activities will be conducted in as private a setting as possible. 
The study monitor, other authorized representatives of the sponsor or funding agency, representatives of the 
IRB, regulatory agencies or representatives from companies or organizations supplying the product, may 
inspect all documents and records required to be maintained by the investigator, including but not limited to, 
medical records (office, clinic, or hospital) and pharmacy records for the participants in this study.  
 
The study participant’s contact information will be securely stored on a secure study database for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as long a 
period as dictated by the reviewing IRB, Institutional policies, or sponsor/funding agency requirements. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will be 
stored on a secure UNC server. The study data entry and study management systems used by research staff 
will be secured and password protected. At the end of the study, all study databases will be de-identified and 
archived on a secure UNC server. 
 
Measures Taken to Ensure Confidentiality of Data Shared per the NIH Data Sharing Policies  
It is NIH policy that the results and accomplishments of the activities that it funds should be made available to 
the public (see https://grants.nih.gov/policy/sharing.htm). The PI will ensure all mechanisms used to share data 
will include proper plans and safeguards for the protection of privacy, confidentiality, and security for data 
dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be traceable to a specific 
study participant). Plans for archiving and long-term preservation of the data will be implemented, as 
appropriate.  
 
Certificate of Confidentiality  
To further protect the privacy of study participants, the Secretary, Health and Human Services (HHS), has 
issued a Certificate of Confidentiality (CoC) to all researchers engaged in biomedical, behavioral, clinical or 
other human subjects research funded wholly or in part by the federal government.  Recipients of NIH funding 
for human subjects research are required to protect identifiable research information from forced disclosure per 
the terms of the NIH Policy (see https://humansubjects.nih.gov/coc/index). As set forth in 45 CFR Part 
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required to establish and maintain effective internal controls (e.g., policies and procedures) that provide 
reasonable assurance that the award is managed in compliance with Federal statutes, regulations, and the 
terms and conditions of award. It is the NIH policy that investigators and others who have access to research 
records will not disclose identifying information except when the participant consents or in certain instances 
when federal, state, or local law or regulation requires disclosure. NIH expects investigators to inform research 
participants of the protections and the limits to protections provided by a Certificate issued by this Policy. 
 
10.1.4 FUTURE USE OF STORED DATA 
 
Data collected for this study will be analyzed and stored on a secure UNC server. After the study is completed, 
the de-identified data will be made available to other researchers, available by request to the PI. Investigators 
requesting study data must adhere to regulatory requirements for data use (e.g., IRB approvals, data use 
agreements). No biological samples are collected for this study. 
 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
 
Principal Investigator 
Independent Safety Monitor 
Kelli D. Allen, PhD 
Michael K. Seifert, MD 
Assistant Professor of Orthopaedics, 
Primary Care and Interventional 
Sports Medicine 
University of North Carolina at 
Chapel Hill  
University of North Carolina at 
Chapel Hill 
3300 Thurston Bldg., CB #7280 
Chapel Hill, NC  27599-7280 
102 Mason Farm Road 
2nd Floor 
Chapel Hill, NC  27514 
919-966-0558 
919-966-6441 
kdallen@med.unc.edu 
michael_seifert@med.unc.edu 
 
 
10.1.6 SAFETY OVERSIGHT 
Because this study involves only survey-based assessments and digital recordings and participation in mild / 
moderate physical activity programs, this is a minimal risk study we do not believe it requires a data safety 
monitoring board.   
Safety oversight will be under the direction of the Safety Officer (SO). The SO will be independent from the 
study conduct and free of conflict of interest. The SO’s role is to advise the PI (and not the NIAMS) regarding 
participant safety, scientific integrity and ethical conduct of the study. On a biannual basis or as requested, the 
PI will provide to the SO a study summary, a report of all AEs, and any problems or issues that have been 
identified.   
 
10.1.7 CLINICAL MONITORING 
 
Since this is a single site study there will not be site visits conducted by the PI or co-investigators.  However, 
we will monitor the fidelity of intervention delivery as described above.  Navitas may conduct a site visit on 
behalf of the NIAMS, however, Navitas will not have the responsibility of the overall clinical monitoring for this 
study. 
 

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10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
 
Quality control (QC) procedures will be implemented as follows: 
 
Informed consent --- During the consenting process, the study team member will review the completed consent 
document to ensure the participant has signed and dated the consent form accurately prior to completing any 
other study activities.   
 
Source documents and the electronic data --- Data from the physical function and balance will be initially 
captured on source documents and will ultimately be entered into the study database; all other data from study 
measures will be entered directly into the study database.  To ensure accuracy site staff will compare a 
representative sample of source data against the database. 
 
Protocol Deviations – The study team will review protocol deviations on an ongoing basis and will implement 
corrective actions when the quantity or nature of deviations are deemed to be at a level of concern. 
 
Should independent monitoring become necessary, the PI will provide direct access to all trial related sites, 
source data/documents, and reports for the purpose of monitoring and auditing by the sponsor/funding agency, 
and inspection by local and regulatory authorities. 
 
 
10.1.9 DATA HANDLING AND RECORD KEEPING 
 
 
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES 
Study data will be stored on a secure UNC server in a folder accessible only to IRB-approved study team 
members. We will use REDCap to store all patient information and dispositions, responses to screening and 
outcome assessments. REDCap is a secure web application supported at UNC that can be used to build and 
manage case report forms, surveys, and other data capture mechanisms.  Additionally, for the OA CARE 
intervention, the participant’s name and contact information will be shared with the YMCA verbally by phone, 
by encrypted email or a UNC IRB approved platform for sharing PHI. Paper copies will be rare and if 
necessary will be kept to a minimum and if shared will be done via a UNC IRB approved platform for sharing 
PHI.  Any paper copies will be stored in the participant’s individual study folder, which will be kept in a locked 
file cabinet of a study team member. 
 
10.1.9.2 STUDY RECORDS RETENTION 
 
Research study records will be maintained for no less than 6 years following the completion of the study, after 
which time personal identifying information will be removed.  Research information in a subject’s medical 
record will be kept indefinitely. No records will be destroyed without the written consent of the sponsor/funding 
agency, if applicable. It is the responsibility of the sponsor/funding agency to inform the investigator when 
these documents no longer need to be retained. 
 
 
10.1.10 PROTOCOL DEVIATIONS 
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol,  
ICH GCP, or Manual of Procedures (MOP) requirements. The noncompliance may be either on the part of the 
participant, the investigator, or the study site staff. As a result of deviations, corrective actions will be 
developed by the site and implemented promptly.  
 
These practices are consistent with ICH GCP:  
• 
Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3  

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• 
Section 5.1 Quality Assurance and Quality Control, subsection 5.1.1  
• 
Section 5.20 Noncompliance, subsections 5.20.1, and 5.20.2.  
 
It will be the responsibility of the site investigator to use continuous vigilance to identify and report deviations 
that impact participant safety to the UNC IRB within 7 business days of the time the PI becomes aware to the 
event, if the protocol deviation harmed participant(s) or others or placed participant(s) or others at increased 
risk of harm. Otherwise, protocol deviations/violations that occur but do not affect participant safety will be 
submitted with the routine safety reports as noted. Protocol deviations will be sent to the reviewing IRB per 
their policies. The site investigator will be responsible for knowing and adhering to the reviewing IRB 
requirements. Further details about the handling of protocol deviations will be included in the MOP. 
Additionally, protocol deviations impacting participant safety will be sent to the NIAMS (through the NIAMS 
Executive Secretary) and the SO within 48 hours of the investigator becoming aware of the event, and that the 
SO’s feedback will be shared with the NIAMS once received. 
 
 
10.1.11 PUBLICATION AND DATA SHARING POLICY 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
- 
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. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, 
this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to 
ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals.  Data 
from this study may be requested from other researchers after the completion of the primary endpoint by 
contacting the study PI.  Considerations for ensuring confidentiality of these shared data are described in 
Section 10.1.3 
 
 
10.1.12 CONFLICT OF INTEREST POLICY 
 
The independence of this study from any actual or perceived influence is critical. Therefore, any actual conflict 
of interest of persons who have a role in the design, conduct, analysis, publication, or any aspect of this trial 
will be disclosed and managed. Furthermore, persons who have a perceived conflict of interest will be required 
to have such conflicts managed in a way that is appropriate to their participation in the design and conduct of 
this trial. The study leadership in conjunction with the National Institute on Aging has established policies and 
procedures for all study group members to disclose all conflicts of interest and will establish a mechanism for 
the management of all reported dualities of interest. 
 
10.2 
ADDITIONAL CONSIDERATIONS 
N/A 
 
10.3  ABBREVIATIONS 
 
ACR 
American College of Rheumatology 
AE 
Adverse Event 

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BMI 
Body Mass Index 
DHHS 
Department of Health and Human 
Services 
CoC 
Certificate of Confidentiality 
CFR 
Code of Federal Regulations 
EHR 
Electronic Health Record 
EMR 
Electronic Medical Record 
GCP 
Good Clinical Practice 
GLMM 
General Linear Mixed Model 
HHS 
Health and Human Services  
HIPAA 
Health Insurance Portability and 
Accountability Act of 1996 
ICH 
International Council on Harmonisation  
IRB 
Institutional Review Board 
MOP 
Manual of Procedures 
MVPA 
Moderate to Vigorous Intensity Physical 
Activity 
NIAMS 
National Institute of Arthritis and 
Musculoskeletal and Skin Diseases 
NIH  
National Institutes of Health 
OA 
Osteoarthritis 
OAAA 
Osteoarthritis Action Alliance  
OARSI 
Osteoarthritis Research Society 
International  
OA CARE 
OA Clinic-Community CARE Model 
OHRP 
Office for Human Research Protections 
PA 
Physical Activity 
PCP 
Primary Care Provider 
PI 
Principal Investigator 
QC 
Quality Control 
RCT 
Randomize Control Trial 
SAE 
Serious Adverse Event 
UC 
Usual Care 
UNC 
University of North Carolina 
WOMAC 
Western Ontario and McMaster 
Universities Osteoarthritis Index 
 
 
10.4 
PROTOCOL AMENDMENT HISTORY 
 
Version 
Date 
Description of Change  
Brief Rationale 
2.0 
7.26.22 
Revised column headers on 
Schedule of Activities 
Revised to correspond with 
visits described on the 
Schema 

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3.0 
09.06.22 
Updated Synopsis and Strategies 
for Recruitment and Retention 
 
Revised because we will also 
be recruiting patients from 
UNC Family Medicine 
 
 
 
 
 
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Osteoarthritis Research Society International. Osteoarthritis: a Serious Disease, Submitted to the U.S. 
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Dhawan A, Mather RC, 3rd, Karas V, et al. An epidemiologic analysis of clinical practice guidelines for 
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Kolasinski SL, Neogi T, Hochberg MC, et al. 2019 American College of Rheumatology/Arthritis 
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Messier SP, Mihalko SL, Legault C, et al. Effects of intensive diet and exercise on knee joint loads, 
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Kelley GA, Kelley KS, Hootman JM. Effects of exercise on depression in adults with arthritis: a 
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Gersing AS, Schwaiger BJ, Nevitt MC, et al. Weight loss regimen in obese and overweight individuals 
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Allen KD, Choong PF, Davis AM, et al. Osteoarthritis: Models for appropriate care across the disease 
continuum. Best practice & research Clinical rheumatology. 2016;30(3):503-535. 
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Jordan KP, Edwards JJ, Porcheret M, et al. Effect of a model consultation informed by guidelines on 
recorded quality of care of osteoarthritis (MOSAICS): a cluster randomised controlled trial in primary 
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Tan BY, Pereira MJ, Yang SY, et al. Collaborative model of care between Orthopaedics and allied 
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Egerton T, Hinman RS, Hunter DJ, et al. PARTNER: a service delivery model to implement optimal 

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