Physical Activity Pathway for Patients With Osteoarthritis in Primary Care (OA-PCP) (R33)

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

Osteoarthritis

Treatments

Behavioral: Attention Control
Behavioral: OA-PCP Intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04533711
20-2134
4R33AG056568-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

291 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

291 participants in 2 patient groups, including a placebo group

OA-PCP
Experimental group
Description:
Participants assigned to the OA-PCP intervention will receive an initial physical activity (PA) coaching call then, 5 more calls over the course of 12 months. Participants, if they agree, will also receive monthly check-in emails between phone calls.
Treatment:
Behavioral: OA-PCP Intervention
Attention Control
Placebo Comparator group
Description:
Participants assigned to the Attention Control group will receive the same number of phone calls over the course of 12 months, focused on understanding osteoarthritis (OA) and current information on treatment options. Participants, if they agree, will also receive monthly check-in emails between phone calls.
Treatment:
Behavioral: Attention Control

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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