Clinical trial NCT04533711: Physical Activity Pathway for Patients With Osteoarthritis in Primary Care (OA-PCP) (R33)
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: 2020-08-31
Enrollment: 240
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

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 6 in Objectively Assessed Physical Activity (Accelerometer)
timeFrame: Baseline, Month 6 (Follow-up)
measure: Change From Baseline to Month 12 for Minutes in Objectively Assessed Physical Activity (Accelerometer)
timeFrame: Baseline, Month 12 (Follow-up)
Secondary outcomes:
measure: Change From Baseline to Month 6 for Steps Per Day
timeFrame: Baseline, Month 6 (Follow-up)
measure: Change From Baseline to Month 12 for Steps Per Day
timeFrame: Baseline, Month 12 (Follow-up)
measure: Change From Baseline to Month 6 for Minutes of Sedentary Activity
timeFrame: Baseline, Month 6 (Follow-up)
measure: Change From Baseline to Month 12 for Minutes of Sedentary Activity
timeFrame: Baseline, Month 12 (Follow-up)
measure: Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale
timeFrame: Baseline, Month 6 (Follow-up)
measure: Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale
timeFrame: Baseline, Month 12 (Follow-up)
measure: Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale
timeFrame: Baseline, Month 6 (Follow-up)
measure: Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale
timeFrame: Baseline, Month 12 (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: