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

• ClinicalTrials.gov Identifier: NCT04533711
• Recruitment Status: Recruiting
• First Posted: August 31, 2020
• Last Update Posted: January 14, 2022
• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institutes of Health (NIH); National Institute on Aging (NIA)
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis	Behavioral: OA-PCP Intervention; Behavioral: Attention Control	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Physical Activity Pathway for Patients With Osteoarthritis in Primary Care
• Actual Study Start Date: November 30, 2020
• Estimated Primary Completion Date: May 30, 2022
• Estimated Study Completion Date: May 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: OA-PCP; 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; 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.
Placebo Comparator: Attention Control; 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; 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Kelli D Allen, PhD; 919-966-0558; kdallen@email.unc.edu

Contact: Kimberlea F Grimm, MHS; 919-843-9256; kimberlea_grimm@med.unc.edu

Locations

United States, North Carolina

UNC Thurston Arthritis Research Center; Recruiting

Chapel Hill, North Carolina, United States, 27599

Contact: Kelli D Allen, PhD 919-966-0558 kdallen@email.unc.edu

Contact: Kimberlea F Grimm, MHS 919-843-9256 kimberlea_grimm@med.unc.edu

Sponsors and Collaborators

University of North Carolina, Chapel Hill

National Institutes of Health (NIH)

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Kelli D Allen, PhD; UNC Chapel Hill

More Information

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT04533711
• Other Study ID Numbers: 20-2134; 4R33AG056568-03 ( U.S. NIH Grant/Contract )
• First Posted: August 31, 2020
• Last Update Posted: January 14, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Deidentified individual data that supports the results will be shared following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/ sharing agreement with University of North Carolina at Chapel Hill (UNC).
• Supporting Materials: Statistical Analysis Plan (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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of North Carolina, Chapel Hill:

Osteoarthritis; Knee Osteoarthritis; Hip Osteoarthritis

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases