Clinical trial NCT05349500: OA Clinic-Community CARE Model
Official title: Optimizing Osteoarthritis Care Through Clinical and Community Partnership
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Overweight
Obesity
Physical Inactivity
Weight Loss
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2022-04-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score
timeFrame: Baseline, Month 6 (Follow-up)
measure: Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score
timeFrame: Baseline, Month 12 (Follow-up)
Secondary outcomes:
measure: Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale
timeFrame: Baseline, Month 6 (Follow-up)
measure: Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale
timeFrame: Baseline, Month 12 (Follow-up)
measure: Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale
timeFrame: Baseline, Month 6 (Follow-up)
measure: Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale
timeFrame: Baseline, Month 12 (Follow-up)
measure: Change From Baseline to Month 6 in Objectively Assessed Physical Activity Per Week (Accelerometer), Log Transformed.
timeFrame: Baseline, Month 6 (Follow-up)
measure: Change From Baseline to Month 12 in Objectively Assessed Physical Activity Per Week (Accelerometer), Log Transformed
timeFrame: Baseline, Month 12 (Follow-up)
measure: Change From Baseline to Month 6 in Steps Per Day, Log Transformed
timeFrame: Baseline, Month 6 (Follow-up)
measure: Change From Baseline to Month 12 in Steps Per Day, Log Transformed
timeFrame: Baseline, Month 12 (Follow-up)
measure: Change From Baseline to Month 6 in Minutes of Any Physical Activity (PA) Per Day, Standardized to a 16 Hour Day
timeFrame: Baseline, Month 6 (Follow-up)
measure: Change From Baseline to Month 12 in Minutes of Any Physical Activity (PA) Per Day, Standardized to 16 Hour Day
timeFrame: Baseline, Month 12 (Follow-up)
measure: Change From Baseline to Month 6 in Self-Reported Minutes of Moderate to Vigorous Physical Activity Per Week, Square Root Transformed
timeFrame: Baseline, Month 6 (Follow-up)
measure: Change From Baseline to Month 12 in Self-Reported Minutes of Moderate to Vigorous Physical Activity Per Week, Square Root Transformed
timeFrame: Baseline, Month 12 (Follow-up)
measure: Change From Baseline to Month 6 in Sedentary Minutes Per Day, Standardized to a 16 Hour Day
timeFrame: Baseline, Month 6 (Follow-up)
measure: Change From Baseline to Month 12 in Sedentary Minutes Per Day, Standardized to a 16 Hour Day
timeFrame: Baseline, Month 12 (Follow-up)
measure: Change From Baseline to Month 12 in Body Weight
timeFrame: Baseline, Month 12 (Follow-up)
measure: Change From Baseline to Month 12 in 30-second Chair Stand Test
timeFrame: Baseline, Month 12 (Follow-up)
measure: Change From Baseline to Month 12 in Timed Up-and-go (TUG) Test
timeFrame: Baseline, Month 12 (Follow-up)
measure: Change From Baseline to Month 12 in 2-minute March Test
timeFrame: Baseline, Month 12 (Follow-up)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Thurston Arthritis Research Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Kelli D Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References: