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

NCT03780400 | Completed Results

• 2 other identifiers: 18-08771R21AG056568
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis

Keywords

Osteoarthritis; Knee Osteoarthritis; Hip Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Month 4 for Minutes of Moderate to Vigorous Intensity PA Per Week

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

  Baseline, Month 4 (Follow-up)

Secondary Outcomes (4)

• Change From Baseline to Month 4 for Steps Per Day

  Baseline, Month 4 (Follow-up)

• Change From Baseline to Month 4 for Minutes of Sedentary Activity

  Baseline, Month 4 (Follow-up)

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

  Baseline, Month 4 (Follow-up)

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

  Baseline, Month 4 (Follow-up)

Study Arms (1)

Osteoarthritis Physical Activity Care Pathway

EXPERIMENTAL

4 month physical activity (PA) counseling intervention

Behavioral: Osteoarthritis Physical Activity Care Pathway

Interventions

Osteoarthritis Physical Activity Care Pathway BEHAVIORAL

The intervention includes brief physical activity (PA) counseling delivered via phone by a PA Counselor trained in relevant aspects of PA and motivational interviewing. During the initial call, the PA counselor will assess readiness for change in PA and will utilize appropriate PA counseling components to assess participant's PA preferences/needs, as well as referral to PA resources and goal setting. Approximately two weeks after the initial call, the PA counselor will contact participants to check in on whether they have successfully connected with PA programs or resources discussed, review progress toward PA goals and set new goals. Participants will be provided with linkage to PA programs and resources to include: self-directed, group classes/community, physical therapy and other clinical/supervised programs. Three months after the initial call, the PA counselor will call participants to assess PA and stage of change using appropriate PA counseling components and goal setting.

Osteoarthritis Physical Activity Care Pathway

Eligibility Criteria

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

You may qualify if:

• Physician diagnosis of knee or hip OA
• Current Joint Symptoms
• Current Weekly Physical Activity \<150 minutes per week.

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

Related Publications (2)

• Beauchamp T, Arbeeva L, Cleveland RJ, Golightly YM, Hales DP, Hu DG, Allen KD. Accelerometer-Based Physical Activity Patterns and Associations With Outcomes Among Individuals With Osteoarthritis. J Clin Rheumatol. 2022 Mar 1;28(2):e415-e421. doi: 10.1097/RHU.0000000000001750.

  PMID: 33902099 DERIVED

• Allen K, Vu MB, Callahan LF, Cleveland RJ, Gilbert AL, Golightly YM, Griesemer I, Grimm K, Hales DP, Hu DG, Huffman K, Nelson AE, Pathak A, Rees J, Rethorn ZD, Wandishin AE. Osteoarthritis physical activity care pathway (OA-PCP): results of a feasibility trial. BMC Musculoskelet Disord. 2020 May 16;21(1):308. doi: 10.1186/s12891-020-03339-6.

  PMID: 32416715 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Kelli D. 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
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: March 21, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 25, 2020
• Results First Posted: August 25, 2020

Record last verified: 2020-07

Locations

US (1)