NCT03780400

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

Completed NA Results posted Last updated 25 August 2020

What this trial tests

NA trial testing Osteoarthritis Physical Activity Care Pathway in Osteoarthritis in 60 participants. Completed in 31 December 2019.

Timeline

21 March 2019

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	21 March 2019
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	1 location across United States

Drugs / interventions tested

• Osteoarthritis Physical Activity Care Pathway

Conditions studied

• Osteoarthritis — all drugs for Osteoarthritis →

Sponsor

University of North Carolina, Chapel Hill

Who can join

65 and older, any sex, with Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline to Month 4 for Minutes of Moderate to Vigorous Intensity PA Per Week Primary · Baseline, Month 4 (Follow-up)

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

Group	Value	95% CI
OA-PCP	0.78	-1.6 – 3.2

Change From Baseline to Month 4 for Steps Per Day Secondary · Baseline, Month 4 (Follow-up)

Step counts were measured via an accelerometer device.

Group	Value	95% CI
OA-PCP	143.7	-174.9 – 462.2

Change From Baseline to Month 4 for Minutes of Sedentary Activity Secondary · Baseline, Month 4 (Follow-up)

Minutes of sedentary activity were measured via an accelerometer device.

Group	Value	95% CI
OA-PCP	-0.15	-17.0 – 16.7

Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale Secondary · 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.

Group	Value	95% CI
OA-PCP	-6.1	-8.7 – -3.4

Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale Secondary · 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.

Group	Value	95% CI
OA-PCP	-1.9	-2.7 – -1.0

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Osteoarthritis physical activity care pathway (OA-PCP): results of a feasibility trial.
   Allen K, Vu MB, Callahan LF, Cleveland RJ, et al · · 2020 · cited 9× · PMID 32416715 · DOI 10.1186/s12891-020-03339-6
2. Accelerometer-Based Physical Activity Patterns and Associations With Outcomes Among Individuals With Osteoarthritis.
   Beauchamp T, Arbeeva L, Cleveland RJ, Golightly YM, et al · · 2022 · cited 6× · PMID 33902099 · DOI 10.1097/rhu.0000000000001750