- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04533711
Physical Activity Pathway for Patients With Osteoarthritis in Primary Care (OA-PCP) (R33) (OA-PCP)
February 27, 2024 updated by: University of North Carolina, Chapel Hill
Physical Activity Pathway for Patients With Osteoarthritis in Primary Care
The purpose of this study is to test an osteoarthritis (OA) primary care Physical activity Care Pathway (OA-PCP), a scalable intervention that includes: 1) a practical process for physical inactivity screening in primary care, 2) a brief, tailored physical activity (PA) counseling intervention via telephone, 3) connection of patients with community programs and other resources to support PA, and 4) follow-up with patients to deliver additional appropriate counseling and referrals to PA resources.
This program will be compared to another program that provides education on a variety of topics important to understanding osteoarthritis (OA) and its care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will be a randomized pilot trial of the refined OA-PCP among n=240 patients age ≥65 with hip and/or knee OA recruited from primary care clinics.
Participants will be assigned equally to either the OA-PCP or an attention control group.
Participants will complete assessments at baseline, and 6-month and 12-month follow-up.
Primary endpoint of the trial will be objectively assessed PA, measured via accelerometer and secondary endpoint will be self-reported pain and function.
Study Type
Interventional
Enrollment (Actual)
291
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- UNC Thurston Arthritis Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 65 or older
- One other chronic health condition that qualified under Chronic Care Management (CCM) guidelines, including: diabetes, depression, hypertension, hyperlipidemia, heart failure, atrial fibrillation, ischemic heart disease, stroke/transient ischemic attack (TIA), peripheral vascular disease, Chronic obstructive pulmonary disease (COPD), bronchiectasis, asthma, rheumatoid arthritis, osteoarthritis, HIV/AIDS, chronic kidney disease, hepatitis (chronic & viral B & C) and osteoporosis
- Current Joint Symptoms
- Self-reported physical activity <150 minutes per week
- Willing to make a change in PA over the next 3 months
Exclusion Criteria:
- Pain in chest when performing physical activity
- Pain in chest when not performing physical activity
- Loss of balance because of dizziness or loss of consciousness
- Recommendation from doctor to only perform physical activity under medical supervision
- No documented diagnosis of knee or hip OA
- Dementia or other memory loss condition
- Active diagnosis of psychosis
- Active Substance abuse disorder
- Total knee or hip replacement surgery, meniscus tear, ligament tear, or other significant lower extremity injury or surgery in the last 6 months
- Severe hearing or visual impairment
- Serious/terminal illness as indicated by referral to hospice or palliative care
- Unstable angina
- Hospitalization for cardiovascular event in last 6 months
- History of ventricular tachycardia
- Unstable chronic obstructive pulmonary disease (2 hospitalizations within the previous 6 months and/or on oxygen)
- Stroke with moderate to severe aphasia
- Recent history (last 6 months) of three or more falls
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OA-PCP
Participants assigned to the OA-PCP intervention will receive an initial physical activity (PA) coaching call then, 5 more calls over the course of 12 months.
Participants, if they agree, will also receive monthly check-in emails between phone calls.
|
The OA-PCP intervention includes brief physical activity (PA) counseling delivered via phone by a PA Coach trained in relevant aspects of PA and motivational interviewing.
During the initial call, the PA Coach will ask participants about their current physical activity level and work with them to set physical activity goals.
Then, after the first call, participants in this group will receive a call about two weeks later, then at about 3 months, 6 months, 9 months and 12 months later.
During these calls, the PA coach will ask participants' about their progress toward PA goals and work with them to address any barriers or challenges.
The coach will also help participants to identify any programs or resources that may help them to achieve their PA goals.
Participants in this group will be asked to wear a wrist-worn monitor to help them track their PA during the intervention period.
Also, if participants approve, the coach will use an online program to view their PA data.
|
Placebo Comparator: Attention Control
Participants assigned to the Attention Control group will receive the same number of phone calls over the course of 12 months, focused on understanding osteoarthritis (OA) and current information on treatment options.
Participants, if they agree, will also receive monthly check-in emails between phone calls.
|
This group will receive an intervention in the same "dose" (e.g., number and duration of phone calls and emails) as the OA-PCP group, but the content will not be PA-specific.
During the first call, the Coach will discuss 2 topics, for which the amount of content parallels call #1 for the OA-PCP: What is OA? OA Diagnosis and OA Risk Factors.
During the second call, the Coach will discuss the topic of Health Care Providers and Overview of OA Treatment Guidelines.
Call topics for 3, 6, 9 and 12- month follow-up calls will be: Pain Medications, Mechanical Treatments (e.g., knee braces, footwear, joint protection), Complimentary and Alternative Therapies and discussion of OA and Mental Health, Sleep and Fatigue.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline to Month 6 in Objectively Assessed Physical Activity (accelerometer)
Time Frame: Baseline, Month 6 (Follow-up)
|
Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer
|
Baseline, Month 6 (Follow-up)
|
Change From Baseline to Month 12 for Minutes in Objectively Assessed Physical Activity (accelerometer)
Time Frame: Baseline, Month 12 (Follow-up)
|
Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer
|
Baseline, Month 12 (Follow-up)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline to Month 6 for Steps Per Day
Time Frame: Baseline, Month 6 (Follow-up)
|
Step counts measured via an accelerometer device.
|
Baseline, Month 6 (Follow-up)
|
Change From Baseline to Month 12 for Steps Per Day
Time Frame: Baseline, Month 12 (Follow-up)
|
Step counts measured via an accelerometer device.
|
Baseline, Month 12 (Follow-up)
|
Change From Baseline to Month 6 for Minutes of Sedentary Activity
Time Frame: Baseline, Month 6 (Follow-up)
|
Minutes of sedentary activity measured via an accelerometer device.
|
Baseline, Month 6 (Follow-up)
|
Change From Baseline to Month 12 for Minutes of Sedentary Activity
Time Frame: Baseline, Month 12 (Follow-up)
|
Minutes of sedentary activity measured via an accelerometer device.
|
Baseline, Month 12 (Follow-up)
|
Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale
Time Frame: Baseline, Month 6 (Follow-up)
|
The Western Ontario and McMasters Universities Osteoarthritis (WOMAC) function subscale includes 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty), with ranges of 0-68 for the function subscale with higher scores indicating worse symptoms and function.
|
Baseline, Month 6 (Follow-up)
|
Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale
Time Frame: Baseline, Month 12 (Follow-up)
|
The Western Ontario and McMasters Universities Osteoarthritis (WOMAC) function subscale includes 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty), with ranges of 0-68 for the function subscale with higher scores indicating worse symptoms and function.
|
Baseline, Month 12 (Follow-up)
|
Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale
Time Frame: Baseline, Month 6 (Follow-up)
|
The Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale is a measure of lower extremity pain.
It includes 5 items rated on a Likert scale of 0 (no pain) to 4 (extreme pain), with a total range of 0-20 with higher scores indicating worse symptoms and function.
|
Baseline, Month 6 (Follow-up)
|
Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale
Time Frame: Baseline, Month 12 (Follow-up)
|
The Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale is a measure of lower extremity pain.
It includes 5 items rated on a Likert scale of 0 (no pain) to 4 (extreme pain), with a total range of 0-20 with higher scores indicating worse symptoms and function.
|
Baseline, Month 12 (Follow-up)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kelli D Allen, PhD, UNC Chapel Hill
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 30, 2020
Primary Completion (Actual)
December 4, 2023
Study Completion (Actual)
December 4, 2023
Study Registration Dates
First Submitted
August 26, 2020
First Submitted That Met QC Criteria
August 26, 2020
First Posted (Actual)
August 31, 2020
Study Record Updates
Last Update Posted (Actual)
March 1, 2024
Last Update Submitted That Met QC Criteria
February 27, 2024
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-2134
- 4R33AG056568-03 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Deidentified individual data that supports the results will be shared following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/ sharing agreement with University of North Carolina at Chapel Hill (UNC).
IPD Sharing Time Frame
Data will become available following publication of primary and secondary outcomes.
Research study records will be maintained for no less than 6 years following the completion of the study.
IPD Sharing Access Criteria
Data will be accessible following publication of study results and will be available for no less than 6 years following the completion of the study.
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoarthritis
-
Sanford HealthActive, not recruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder Osteoarthritis | Ankle Osteoarthritis | Wrist OsteoarthritisUnited States
-
University of EdinburghHospital for Special Surgery, New YorkRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited Kingdom
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
University of California, San FranciscoStanford University; Robert Wood Johnson FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
University of VermontCompletedOsteoarthritis of Knee | Osteoarthritis Of HipUnited States
-
Hospital for Special Surgery, New YorkRoyal Infirmary of EdinburghRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited States, United Kingdom
-
Ottawa Hospital Research InstituteNot yet recruitingKnee Osteoarthritis | Hip Osteoarthritis
-
University Hospital, LilleCompleted
-
Massachusetts General HospitalNewton-Wellesley Hospital; The New England Baptist HospitalCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
Clinical Trials on OA-PCP Intervention
-
Duke UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other collaboratorsCompletedOsteoarthritisUnited States
-
University of North Carolina, Chapel HillNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other collaboratorsCompletedObesity | Overweight | Osteoarthritis, Knee | Weight Loss | Osteoarthritis, Hip | Physical InactivityUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Canadian Arthritis Network; Michael...Completed
-
Kaiser PermanenteCompleted
-
University of UtahStanford UniversityCompleted
-
The George Institute for Global Health, ChinaCompleted
-
Oasis Pharmaceuticals, LLCMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases...RecruitingNonalcoholic Steatohepatitis | Nonalcoholic Fatty LiverUnited States
-
Seno Medical Instruments Inc.Completed
-
Duke UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)Completed