OA Clinic-Community CARE Model (OA CARE)

University of North Carolina (UNC)

Status: Completed

Conditions: Weight Loss; Physical Inactivity; Overweight; Osteoarthritis, Hip; Obesity; Osteoarthritis, Knee

Treatments: Behavioral: OA CARE Intervention; Behavioral: Usual Care control group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05349500

22-0865

1R21AR080309-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

OA CARE

Experimental group

Description:

Participants assigned to the OA CARE intervention will receive a 12-month Medical Membership to a local YMCA and participate in a 12-week weight loss program. Participants will also work with an OA CARE Navigator, who, in partnership with their primary care provider (PCP), will identify any additional programs or resources that may help them manage their osteoarthritis (OA) symptoms.

Treatment:

Behavioral: OA CARE Intervention

Usual Care

Placebo Comparator group

Description:

Participants assigned to this group will receive no additional treatment from the study for about 12 months.

Treatment:

Behavioral: Usual Care control group