Completed

NCT Number: NCT03780400

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

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.

Completed

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis, Hip Osteoarthritis, Knee Rheumatic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Thurston Arthritis Research Center

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Osteoarthritis Physical Activity Care Pathway

Behavioral

The intervention includes brief physical activity (PA) counseling delivered via phone by a PA Counselor trained in relevant aspects of PA and motivational interviewing. During the initial call, the PA counselor will assess readiness for change in PA and will utilize appropriate PA counseling components to assess participant's PA preferences/needs, as well as referral to PA resources and goal setting. Approximately two weeks after the initial call, the PA counselor will contact participants to check in on whether they have successfully connected with PA programs or resources discussed, review progress toward PA goals and set new goals. Participants will be provided with linkage to PA programs and resources to include: self-directed, group classes/community, physical therapy and other clinical/supervised programs. Three months after the initial call, the PA counselor will call participants to assess PA and stage of change using appropriate PA counseling components and goal setting.

Primary outcomes

Change From Baseline to Month 4 for Minutes of Moderate to Vigorous Intensity PA Per Week

Time frame: Baseline, Month 4 (Follow-up)

Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer

Secondary outcomes

Change From Baseline to Month 4 for Steps Per Day

Time frame: Baseline, Month 4 (Follow-up)

Step counts were measured via an accelerometer device.
Change From Baseline to Month 4 for Minutes of Sedentary Activity

Time frame: Baseline, Month 4 (Follow-up)

Minutes of sedentary activity were measured via an accelerometer device.
Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale

Time frame: 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 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

National Institute on Aging (NIA)
National Institutes of Health (NIH)

Registry information

Official study title

Physical Activity Pathway for Patients With Osteoarthritis in Primary Care

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Dec 19, 2018
Registry last updated: Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed