N/A N=60 Randomized Single-blind Treatment

OA Clinic-Community CARE Model

Osteoarthritis, Knee · Osteoarthritis, Hip · Overweight · Obesity · Physical Inactivity

Bottom Line

View on ClinicalTrials.gov: NCT05349500 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score — -7.8; 3.2 units on a scale — p=0.019

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: OA CARE Intervention (Behavioral); Usual Care control group (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score	-7.8; 3.2	0.019 sig
PRIMARY Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score	-8.3; -3.3	0.286
SECONDARY Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale	-1.5; 0.5	0.046 sig
SECONDARY Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale	-2.1; -0.4	0.128
SECONDARY Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale	-4.9; 2.6	0.031 sig
SECONDARY Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale	-4.5; -2.6	0.564
SECONDARY Change From Baseline to Month 6 in Objectively Assessed Physical Activity Per Week (Accelerometer), Log Transformed.	0.2; -0.0	0.349
SECONDARY Change From Baseline to Month 12 in Objectively Assessed Physical Activity Per Week (Accelerometer), Log Transformed	-0.3; -0.1	0.303
SECONDARY Change From Baseline to Month 6 in Steps Per Day, Log Transformed	0.00; -0.0	0.507
SECONDARY Change From Baseline to Month 12 in Steps Per Day, Log Transformed	-0.1; -0.1	0.729
SECONDARY Change From Baseline to Month 6 in Minutes of Any Physical Activity (PA) Per Day, Standardized to a 16 Hour Day	-0.0; 0.0	0.421
SECONDARY Change From Baseline to Month 12 in Minutes of Any Physical Activity (PA) Per Day, Standardized to 16 Hour Day	-0.1; -0.1	0.648
SECONDARY Change From Baseline to Month 6 in Self-Reported Minutes of Moderate to Vigorous Physical Activity Per Week, Square Root Transformed	4.6; 1.2	0.034 sig
SECONDARY Change From Baseline to Month 12 in Self-Reported Minutes of Moderate to Vigorous Physical Activity Per Week, Square Root Transformed	4.3; 2.2	0.315
SECONDARY Change From Baseline to Month 6 in Sedentary Minutes Per Day, Standardized to a 16 Hour Day	10.5; -2.9	0.444
SECONDARY Change From Baseline to Month 12 in Sedentary Minutes Per Day, Standardized to a 16 Hour Day	18.6; 9.3	0.638
SECONDARY Change From Baseline to Month 12 in Body Weight	-7.6; -5.4	0.688
SECONDARY Change From Baseline to Month 12 in 30-second Chair Stand Test	-0.9; -0.6	0.709
SECONDARY Change From Baseline to Month 12 in Timed Up-and-go (TUG) Test	0.5; 2.0	0.089
SECONDARY Change From Baseline to Month 12 in 2-minute March Test	29.7; 14.8	0.066

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05349500). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.