Clinical trial NCT03780400: Physical Activity Pathway for Patients With Osteoarthritis in Primary Care (OA-PCP)
Official title: Physical Activity Pathway for Patients With Osteoarthritis in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Knee Osteoarthritis
Hip Osteoarthritis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2018-12-19
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline to Month 4 for Minutes of Moderate to Vigorous Intensity PA Per Week
timeFrame: Baseline, Month 4 (Follow-up)
Secondary outcomes:
measure: Change From Baseline to Month 4 for Steps Per Day
timeFrame: Baseline, Month 4 (Follow-up)
measure: Change From Baseline to Month 4 for Minutes of Sedentary Activity
timeFrame: Baseline, Month 4 (Follow-up)
measure: Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale
timeFrame: Baseline, Month 4 (Follow-up)
measure: Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale
timeFrame: Baseline, Month 4 (Follow-up)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Thurston Arthritis Research Center
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill
name: Kelli D Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beauchamp T, Arbeeva L, Cleveland RJ, Golightly YM, Hales DP, Hu DG, Allen KD. Accelerometer-Based Physical Activity Patterns and Associations With Outcomes Among Individuals With Osteoarthritis. J Clin Rheumatol. 2022 Mar 1;28(2):e415-e421. doi: 10.1097/RHU.0000000000001750.
citation: Allen K, Vu MB, Callahan LF, Cleveland RJ, Gilbert AL, Golightly YM, Griesemer I, Grimm K, Hales DP, Hu DG, Huffman K, Nelson AE, Pathak A, Rees J, Rethorn ZD, Wandishin AE. Osteoarthritis physical activity care pathway (OA-PCP): results of a feasibility trial. BMC Musculoskelet Disord. 2020 May 16;21(1):308. doi: 10.1186/s12891-020-03339-6.