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Completed

NCT Number: NCT04533711

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis, Hip Osteoarthritis, Knee Rheumatic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Thurston Arthritis Research Center

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OA-PCP Intervention

Behavioral

The OA-PCP intervention includes brief physical activity (PA) counseling delivered via phone by a PA Coach trained in relevant aspects of PA and motivational interviewing. During the initial call, the PA Coach will ask participants about their current physical activity level and work with them to set physical activity goals. Then, after the first call, participants in this group will receive a call about two weeks later, then at about 3 months, 6 months, 9 months and 12 months later. During these calls, the PA coach will ask participants' about their progress toward PA goals and work with them to address any barriers or challenges. The coach will also help participants to identify any programs or resources that may help them to achieve their PA goals. Participants in this group will be asked to wear a wrist-worn monitor to help them track their PA during the intervention period. Also, if participants approve, the coach will use an online program to view their PA data.

Attention Control

Behavioral

This group will receive an intervention in the same "dose" (e.g., number and duration of phone calls and emails) as the OA-PCP group, but the content will not be PA-specific. During the first call, the Coach will discuss 2 topics, for which the amount of content parallels call #1 for the OA-PCP: What is OA? OA Diagnosis and OA Risk Factors. During the second call, the Coach will discuss the topic of Health Care Providers and Overview of OA Treatment Guidelines. Call topics for 3, 6, 9 and 12- month follow-up calls will be: Pain Medications, Mechanical Treatments (e.g., knee braces, footwear, joint protection), Complimentary and Alternative Therapies and discussion of OA and Mental Health, Sleep and Fatigue.

Primary outcomes

  1. Change From Baseline to Month 6 in Objectively Assessed Physical Activity (Accelerometer)

    Time frame: Baseline, Month 6 (Follow-up)

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

  2. Change From Baseline to Month 12 for Minutes in Objectively Assessed Physical Activity (Accelerometer)

    Time frame: Baseline, Month 12 (Follow-up)

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

Secondary outcomes

  1. Change From Baseline to Month 6 for Steps Per Day

    Time frame: Baseline, Month 6 (Follow-up)

    Step counts measured via an accelerometer device.

  2. Change From Baseline to Month 12 for Steps Per Day

    Time frame: Baseline, Month 12 (Follow-up)

    Step counts measured via an accelerometer device.

  3. Change From Baseline to Month 6 for Minutes of Sedentary Activity

    Time frame: Baseline, Month 6 (Follow-up)

    Minutes of sedentary activity measured via an accelerometer device.

  4. Change From Baseline to Month 12 for Minutes of Sedentary Activity

    Time frame: Baseline, Month 12 (Follow-up)

    Minutes of sedentary activity measured via an accelerometer device.

  5. Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale

    Time frame: Baseline, Month 6 (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.

  6. Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale

    Time frame: Baseline, Month 12 (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.

  7. Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale

    Time frame: Baseline, Month 6 (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.

  8. Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale

    Time frame: Baseline, Month 12 (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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute on Aging (NIA)
  • National Institutes of Health (NIH)

Registry information

Official study title

Physical Activity Pathway for Patients With Osteoarthritis in Primary Care

Acronym: OA-PCP

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2020
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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