Physical Activity Pathway for Patients With Osteoarthritis in Primary Care (OA-PCP) (R33)

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Behavioral: OA-PCP Intervention; Behavioral: Attention Control

• Registration Number: NCT04533711
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

The purpose of this study is to test an osteoarthritis (OA) primary care Physical activity Care Pathway (OA-PCP), a scalable intervention that includes: 1) a practical process for physical inactivity screening in primary care, 2) a brief, tailored physical activity (PA) counseling intervention via telephone, 3) connection of patients with community programs and other resources to support PA, and 4) follow-up with patients to deliver additional appropriate counseling and referrals to PA resources. This program will be compared to another program that provides education on a variety of topics important to understanding osteoarthritis (OA) and its care.

Detailed Description

This study will be a randomized pilot trial of the refined OA-PCP among n=240 patients age ≥65 with hip and/or knee OA recruited from primary care clinics. Participants will be assigned equally to either the OA-PCP or an attention control group. Participants will complete assessments at baseline, and 6-month and 12-month follow-up. Primary endpoint of the trial will be objectively assessed PA, measured via accelerometer and secondary endpoint will be self-reported pain and function.

Study Timeline

• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-31
• Study Start: 2020-11-30
• Status Verified: 2023-10
• Primary Completion: 2023-12-04
• Study Completion: 2023-12-04
• Results First Submitted: 2024-09-19
• Results First Submitted QC: 2024-10-22
• Last Update Submitted: 2024-10-22
• Results First Posted: 2024-10-24
• Last Update Posted: 2024-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Age 65 or older
• One other chronic health condition that qualified under Chronic Care Management (CCM) guidelines, including: diabetes, depression, hypertension, hyperlipidemia, heart failure, atrial fibrillation, ischemic heart disease, stroke/transient ischemic attack (TIA), peripheral vascular disease, Chronic obstructive pulmonary disease (COPD), bronchiectasis, asthma, rheumatoid arthritis, osteoarthritis, HIV/AIDS, chronic kidney disease, hepatitis (chronic & viral B & C) and osteoporosis
• Current Joint Symptoms
• Self-reported physical activity <150 minutes per week
• Willing to make a change in PA over the next 3 months

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Exclusion Criteria

• Pain in chest when performing physical activity
• Pain in chest when not performing physical activity
• Loss of balance because of dizziness or loss of consciousness
• Recommendation from doctor to only perform physical activity under medical supervision
• No documented diagnosis of knee or hip OA
• Dementia or other memory loss condition
• Active diagnosis of psychosis
• Active Substance abuse disorder
• Total knee or hip replacement surgery, meniscus tear, ligament tear, or other significant lower extremity injury or surgery in the last 6 months
• Severe hearing or visual impairment
• Serious/terminal illness as indicated by referral to hospice or palliative care
• Unstable angina
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OA-PCP	OA-PCP Intervention	Participants assigned to the OA-PCP intervention will receive an initial physical activity (PA) coaching call then, 5 more calls over the course of 12 months. Participants, if they agree, will also receive monthly check-in emails between phone calls.
Attention Control	Attention Control	Participants assigned to the Attention Control group will receive the same number of phone calls over the course of 12 months, focused on understanding osteoarthritis (OA) and current information on treatment options. Participants, if they agree, will also receive monthly check-in emails between phone calls.

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Month 6 in Objectively Assessed Physical Activity (Accelerometer)	Baseline, Month 6 (Follow-up)	Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer
Change From Baseline to Month 12 for Minutes in Objectively Assessed Physical Activity (Accelerometer)	Baseline, Month 12 (Follow-up)	Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Month 6 for Steps Per Day	Baseline, Month 6 (Follow-up)	Step counts measured via an accelerometer device.
Change From Baseline to Month 6 for Minutes of Sedentary Activity	Baseline, Month 6 (Follow-up)	Minutes of sedentary activity measured via an accelerometer device.
Change From Baseline to Month 12 for Minutes of Sedentary Activity	Baseline, Month 12 (Follow-up)	Minutes of sedentary activity measured via an accelerometer device.
Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale	Baseline, Month 6 (Follow-up)	The Western Ontario and McMasters Universities Osteoarthritis (WOMAC) function subscale includes 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty), with ranges of 0-68 for the function subscale with higher scores indicating worse symptoms and function.
Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale	Baseline, Month 12 (Follow-up)	The Western Ontario and McMasters Universities Osteoarthritis (WOMAC) function subscale includes 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty), with ranges of 0-68 for the function subscale with higher scores indicating worse symptoms and function.
Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale	Baseline, Month 6 (Follow-up)	The Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale is a measure of lower extremity pain. It includes 5 items rated on a Likert scale of 0 (no pain) to 4 (extreme pain), with a total range of 0-20 with higher scores indicating worse symptoms and function.
Change From Baseline to Month 12 for Steps Per Day	Baseline, Month 12 (Follow-up)	Step counts measured via an accelerometer device.
Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale	Baseline, Month 12 (Follow-up)	The Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale is a measure of lower extremity pain. It includes 5 items rated on a Likert scale of 0 (no pain) to 4 (extreme pain), with a total range of 0-20 with higher scores indicating worse symptoms and function.

Trial Locations

Locations (1)

UNC Thurston Arthritis Research Center; 🇺🇸 Chapel Hill, North Carolina, United States