Trial Outcomes & Findings for Physical Activity Pathway for Patients With Osteoarthritis in Primary Care (OA-PCP) (NCT NCT03780400)

NCT ID: NCT03780400

Last Updated: 2020-08-25

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: Baseline, Month 4 (Follow-up)
• Results posted on: 2020-08-25

Participant Flow

Participants with symptomatic, physician diagnosed knee or hip osteoarthritis (OA) were recruited from participating primary care providers in 3 University of North Carolina clinics between March 2019 and July 2019. The first participant was enrolled on March 21, 2019 and the last participant was enrolled on July 3, 2019.

Participant milestones

Measure	OA-PCP Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention.
Overall Study STARTED	60
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	OA-PCP Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention.
Overall Study Lost to Follow-up	5
Overall Study Withdrawal by Subject	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	OA-PCP n=60 Participants Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention.
Age, Continuous	72.4 years STANDARD_DEVIATION 5.6 • n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Education	48 Participants n=5 Participants
Marital Status	38 Participants n=5 Participants
Work Status	17 Participants n=5 Participants
Body Mass Index (BMI)	33.4 kg/m^2 STANDARD_DEVIATION 7.3 • n=5 Participants
Number of Comorbid Illnesses	4.3 illnesses STANDARD_DEVIATION 1.7 • n=5 Participants
Years with Arthritis Symptoms	11.1 years STANDARD_DEVIATION 9.5 • n=5 Participants
Number of Joints with Arthritis Symptoms	7.7 joints STANDARD_DEVIATION 2.9 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 4 (Follow-up)

Population: 7 participants did not complete month 4 follow-up assessment and 11 participants had inadequate physical activity data

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

Outcome measures

Measure	OA-PCP n=42 Participants Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention.
Change From Baseline to Month 4 for Minutes of Moderate to Vigorous Intensity PA Per Week	0.78 minutes Interval -1.6 to 3.2

SECONDARY outcome

Timeframe: Baseline, Month 4 (Follow-up)

Population: 7 participants did not complete month 4 follow-up assessment and 11 participants had inadequate physical activity data

Step counts were measured via an accelerometer device.

Outcome measures

Measure	OA-PCP n=42 Participants Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention.
Change From Baseline to Month 4 for Steps Per Day	143.7 steps Interval -174.9 to 462.2

SECONDARY outcome

Timeframe: Baseline, Month 4 (Follow-up)

Population: 7 participants did not complete month 4 follow-up assessment and 11 participants had inadequate physical activity data

Minutes of sedentary activity were measured via an accelerometer device.

Outcome measures

Measure	OA-PCP n=42 Participants Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention.
Change From Baseline to Month 4 for Minutes of Sedentary Activity	-0.15 minutes Interval -17.0 to 16.7

SECONDARY outcome

Timeframe: Baseline, Month 4 (Follow-up)

Population: 7 participants did not complete month 4 follow-up assessment

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.

Outcome measures

Measure	OA-PCP n=53 Participants Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention.
Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale	-6.1 units on a scale Interval -8.7 to -3.4

SECONDARY outcome

Timeframe: Baseline, Month 4 (Follow-up)

Population: 7 participants did not complete month 4 follow-up assessment

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.

Outcome measures

Measure	OA-PCP n=53 Participants Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention.
Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale	-1.9 units on a scale Interval -2.7 to -1.0

Adverse Events

OA-PCP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kelli D. Allen, PhD

University of North Carolina at Chapel Hill

Phone: 919-966-0558

Email: kdallen@email.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place