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

NCT04533711 | Completed Results DMC

• 2 other identifiers: 20-21344R33AG056568-03
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Osteoarthritis; Knee Osteoarthritis; Hip Osteoarthritis

Outcome Measures

Primary Outcomes (2)

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

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

  Baseline, Month 6 (Follow-up)

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

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

  Baseline, Month 12 (Follow-up)

Secondary Outcomes (8)

• Change From Baseline to Month 6 for Steps Per Day

  Baseline, Month 6 (Follow-up)

• Change From Baseline to Month 12 for Steps Per Day

  Baseline, Month 12 (Follow-up)

• Change From Baseline to Month 6 for Minutes of Sedentary Activity

  Baseline, Month 6 (Follow-up)

• Change From Baseline to Month 12 for Minutes of Sedentary Activity

  Baseline, Month 12 (Follow-up)

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

  Baseline, Month 6 (Follow-up)

Study Arms (2)

OA-PCP

EXPERIMENTAL

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.

Behavioral: OA-PCP Intervention

Attention Control

PLACEBO COMPARATOR

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.

Behavioral: Attention Control

Interventions

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.

OA-PCP

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.

Attention Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UNC Thurston Arthritis Research Center

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Kelli Allen, PhD
• Organization: University of North Carolina at Chapel Hill

kdallen@email.unc.edu

919-966-0558

Study Officials

• Kelli D Allen, PhD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 31, 2020
• Study Start: November 30, 2020
• Primary Completion: December 4, 2023
• Study Completion: December 4, 2023
• Last Updated: October 24, 2024
• Results First Posted: October 24, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data will become available following publication of primary and secondary outcomes. Research study records will be maintained for no less than 6 years following the completion of the study.
• Access Criteria: Data will be accessible following publication of study results and will be available for no less than 6 years following the completion of the study.

Locations

US (1)