OA Clinic-Community CARE Model

NCT ID: NCT05349500

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-07
• Study Completion Date: 2024-02-08

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

OA CARE

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.

Group Type: EXPERIMENTAL

OA CARE Intervention

Intervention Type: BEHAVIORAL

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

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

Group Type: PLACEBO_COMPARATOR

Usual Care control group

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelli D Allen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

UNC Thurston Arthritis Research Center

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R21AR080309-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-0865

Identifier Type: -

Identifier Source: org_study_id