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

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Behavioral: Osteoarthritis Physical Activity Care Pathway

• Registration Number: NCT03780400
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

This is a multi-phase study that will develop and 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.

Detailed Description

This study will be a single group pilot trial of the OA-PCP. The feasibility and acceptability of the OA-PCP will be assessed among n=60 patients with hip and knee OA in two primary care clinics. All patients in the trial will participate in the OA-PCP and will complete assessments at baseline and 4-month follow-up. Feasibility metrics will include rates of recruitment, intervention engagement and retention; acceptability will be assessed from both patients and health care providers.

Study Timeline

• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Study Start: 2019-03-21
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-07
• Results First Submitted: 2020-08-10
• Results First Submitted QC: 2020-08-10
• Last Update Submitted: 2020-08-10
• Results First Posted: 2020-08-25
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Physician diagnosis of knee or hip OA
• Current Joint Symptoms
• Current Weekly Physical Activity <150 minutes per week.

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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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Osteoarthritis Physical Activity Care Pathway	Osteoarthritis Physical Activity Care Pathway	4 month physical activity (PA) counseling intervention

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Month 4 for Minutes of Moderate to Vigorous Intensity PA Per Week	Baseline, Month 4 (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 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale	Baseline, Month 4 (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 4 for Minutes of Sedentary Activity	Baseline, Month 4 (Follow-up)	Minutes of sedentary activity were measured via an accelerometer device.
Change From Baseline to Month 4 for Steps Per Day	Baseline, Month 4 (Follow-up)	Step counts were measured via an accelerometer device.
Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale	Baseline, Month 4 (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