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

NCT ID: NCT04533711

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2023-12-04

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.

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

OA-PCP Intervention

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

Attention Control

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelli D Allen, PhD

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Locations

UNC Thurston Arthritis Research Center

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

4R33AG056568-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-2134

Identifier Type: -

Identifier Source: org_study_id