OA Clinic-Community CARE Model

Obesity Clinical Trial

— OA CARE  

Official title:

Optimizing Osteoarthritis Care Through Clinical and Community Partnership

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05349500
• Other study ID #: 22-0865
• Secondary ID: 1R21AR080309-01
• Status: Completed
• Phase: N/A
• Start date: June 7, 2022
• Est. completion date: February 8, 2024

Study information

• Verified date: January 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the OA Clinic-Community CARE Model (OA CARE) which will address all recommended components of knee/hip (osteoarthritis) OA care, include interventions for both patients and primary care providers (PCPs), and utilize a tailored approach that efficiently matches treatments with patients' needs. The patient component of OA CARE will include evidence-based weight management and exercise programs for all participants (delivered through the YMCA), as well as tailored referrals to physical therapy, additional weight management or nutrition services, sleep-related services and psychological services. The PCP component of OA CARE will include a video-based summary of current OA treatment guidelines (with emphasis on practical application), collaboration on patients' referrals to specific services described above, and progress reports on enrolled patients.

Description:

This study will be 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. Primary endpoint of the trial will be self-reported pain and function and secondary endpoint will be objectively assessed physical activity (PA), measured via accelerometer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 8, 2024
• Est. primary completion date: February 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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
• Current Weekly Physical Activity <150 minutes per week
• Body mass index (BMI) =27 kg/m^2

Exclusion Criteria:

• No internet access and a device (computer, tablet, smartphone) to access the virtual weight loss intervention
• Pain in chest when performing physical activity
• Pain in chest when not performing physical activity
• No documented diagnosis of knee or hip OA
• Total knee or hip replacement surgery, meniscus tear, ligament tear, or other significant lower extremity injury or surgery in the last 6 months
• Dementia or other memory loss condition
• Active diagnosis of psychosis
• Active Substance abuse disorder
• Severe hearing or visual impairment
• Serious/terminal illness as indicated by referral to hospice or palliative care
• 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
• Planning total joint replacement in next 6 months
• Any other health conditions determined by the study team to be contraindications to a home exercise program or weight loss
• Current participation in other study related to knee or hip osteoarthritis or physical activity
• Unable to speak English

Related Conditions & MeSH terms

• Obesity
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee
• Overweight
• Physical Inactivity
• Weight Loss

Intervention

Behavioral:
• OA CARE Intervention
Once assigned, participants will be contacted by the OA CARE Navigator to coordinate initiating a YMCA Medical Membership. Then, YMCA personnel will contact the participant to schedule the first Weight Loss Program (Program) group session. The Program will be delivered in groups with other OA CARE participants. Participants will also have access to all exercise facilities and programs at the YMCA during the study, and will be assigned a YMCA health coach. After initiation of the YMCA Medical Membership, the OA CARE Navigator will discuss participant's interests in referrals to other services related to osteoarthritis (OA) management. The Navigator will provide the participant's primary care provider (PCP) with a summary of this discussion and help the participant connect to any programs or resources that do not require provider referrals.
• Usual Care control group
Participants assigned to the usual care group will receive no additional treatment from the study for about 12 months. However, this group will be offered a 12-month Medical Membership to a local YMCA after completing the final assessment.

Locations

Country	Name	City	State
United States	UNC Thurston Arthritis Research Center	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score	For the WOMAC total score, the test questions are scored on a scale of 0-4. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The overall WOMAC score is determined by summing the scores for all three subscales and the score ranges include 0-96 (derived from a 0-4 Likert scale), with higher scores indicating worse pain, stiffness, and functional limitations.	Baseline, Month 6 (Follow-up)
Primary	Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score	For the WOMAC total score, the test questions are scored on a scale of 0-4. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The overall WOMAC score is determined by summing the scores for all three subscales and the score ranges include 0-96 (derived from a 0-4 Likert scale), with higher scores indicating worse pain, stiffness, and functional limitations.	Baseline, Month 12 (Follow-up)
Secondary	Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale	The 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)
Secondary	Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale	The 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)
Secondary	Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale	The 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)
Secondary	Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale	The 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)
Secondary	Change From Baseline to Month 6 in Objectively Assessed Physical Activity (accelerometer)	Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer	Baseline, Month 6 (Follow-up)
Secondary	Change From Baseline to Month 12 in Objectively Assessed Physical Activity (accelerometer)	Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer	Baseline, Month 12 (Follow-up)
Secondary	Change From Baseline to Month 6 in steps per day	Step counts measured via accelerometer	Baseline, Month 6 (Follow-up)
Secondary	Change From Baseline to Month 12 in steps per day	Step counts measured via accelerometer	Baseline, Month 12 (Follow-up)
Secondary	Change From Baseline to Month 6 in minutes of any physical activity (PA)	Minutes of any PA measured via accelerometer	Baseline, Month 6 (Follow-up)
Secondary	Change From Baseline to Month 12 in minutes of any physical activity (PA)	Minutes of any PA measured via accelerometer	Baseline, Month 12 (Follow-up)
Secondary	Change from Baseline to Month 6 in Self-Reported Physical Activity	Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. Separate scores are derived for physical activities of moderate or greater intensity (metabolic equivalents MET = 3.0) and for all activities listed (light, moderate, and vigorous). Estimates of frequency (days per week) range from 0 to 7 days per week. Estimates of Variety (# different activities), while open, generally ranges from 0 to 5, values above 5 are checked. Estimates of minutes, generally range from 0 to 180 per day. Individuals reporting more than 180 minutes per day are checked. For all physical activity outcomes higher values equal a greater amount of activity.	Baseline, Month 6 (Follow-up)
Secondary	Change from Baseline to Month 12 in Self-Reported Physical Activity	Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. Separate scores are derived for physical activities of moderate or greater intensity (metabolic equivalents (MET) = 3.0) and for all activities listed (light, moderate, and vigorous). Estimates of frequency (days per week) range from 0 to 7 days per week. Estimates of Variety (# different activities), while open, generally ranges from 0 to 5, values above 5 are checked. Estimates of minutes, generally range from 0 to 180 per day. Individuals reporting more than 180 minutes per day are checked. For all physical activity outcomes higher values equal a greater amount of activity.	Baseline, Month 12 (Follow-up)
Secondary	Change from Baseline to Month 6 in sedentary minutes	Sedentary minutes measured via accelerometer	Baseline, Month 6 (Follow-up)
Secondary	Change from Baseline to Month 12 in sedentary minutes	Sedentary minutes measured via accelerometer	Baseline, Month 12 (Follow-up)
Secondary	Change From Baseline to Month 12 in Body Weight	Body weight assessed using a research / clinical grade scale (e.g., Tanita) that will be calibrated regularly.	Baseline, Month 12 (Follow-up)
Secondary	Change From Baseline to Month 12 in 30-second chair stand test	Assessed to test participant leg strength and endurance. Measured by total number of chair stands (up and down equals one stand) completed in 30 seconds.	Baseline, Month 12 (Follow-up)
Secondary	Change From Baseline to Month 12 in timed up-and-go (TUG) test	Assessed to measure participant functional mobility. Measured by how many seconds it takes for participant to stand up, walk to the mark, turn around, return & sit back into a chair with their back resting on the back of the chair.	Baseline, Month 12 (Follow-up)
Secondary	Change From Baseline to Month 12 in 2-minute march test	Assessed to evaluate participant functional aerobic endurance. Measured by number of steps completed in 2 minutes.	Baseline, Month 12 (Follow-up)