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

Osteoarthritis Clinical Trial

Official title:

Physical Activity Pathway for Patients With Osteoarthritis in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03780400
• Other study ID #: 18-0877
• Secondary ID: 1R21AG056568
• Status: Completed
• Phase: N/A
• Start date: March 21, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2020
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Behavioral:
• Osteoarthritis Physical Activity Care Pathway
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.

Locations

Country	Name	City	State
United States	UNC Thurston Arthritis Research Center	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Month 4 for Minutes of Moderate to Vigorous Intensity PA Per Week	Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer	Baseline, Month 4 (Follow-up)
Secondary	Change From Baseline to Month 4 for Steps Per Day	Step counts were measured via an accelerometer device.	Baseline, Month 4 (Follow-up)
Secondary	Change From Baseline to Month 4 for Minutes of Sedentary Activity	Minutes of sedentary activity were measured via an accelerometer device.	Baseline, Month 4 (Follow-up)
Secondary	Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale	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.	Baseline, Month 4 (Follow-up)
Secondary	Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale	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.	Baseline, Month 4 (Follow-up)