OA Clinic-Community CARE Model

NCT05349500 | Completed Results

• 2 other identifiers: 22-08651R21AR080309-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (18)

• Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale

  Baseline, Month 6 (Follow-up)

• Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale

  Baseline, Month 12 (Follow-up)

• Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale

  Baseline, Month 6 (Follow-up)

• Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale

  Baseline, Month 12 (Follow-up)

• Change From Baseline to Month 6 in Objectively Assessed Physical Activity Per Week (Accelerometer), Log Transformed.

  Baseline, Month 6 (Follow-up)

Study Arms (2)

OA CARE

EXPERIMENTAL

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.

Behavioral: OA CARE Intervention

Usual Care

PLACEBO COMPARATOR

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

Behavioral: Usual Care control group

Interventions

OA CARE Intervention 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.

OA CARE

Usual Care control group 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.

Usual Care

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

UNC Thurston Arthritis Research Center

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Overweight; Obesity; Sedentary Behavior; Weight Loss

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Body Weight Changes

Results Point of Contact

• Title: Kelli Allen, PhD
• Organization: University of North Carolina at Chapel Hill

kdallen@email.unc.edu

919-966-0558

Study Officials

• Kelli D Allen, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 27, 2022
• Study Start: June 7, 2022
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data will become available following publication of primary and secondary outcomes. Research study records will be maintained for no less than 6 years following the completion of the study.
• Access Criteria: Data will be accessible following publication of study results and will be available for no less than 6 years following the completion of the study.

Locations

US (1)