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

Primary Purpose

Osteoarthritis

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

OA-PCP Intervention

Attention Control

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Knee Osteoarthritis, Hip Osteoarthritis

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UNC Thurston Arthritis Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

OA-PCP

Attention Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Change From Baseline to Month 6 for Steps Per Day

Step counts measured via an accelerometer device.

Change From Baseline to Month 12 for Steps Per Day

Step counts measured via an accelerometer device.

Change From Baseline to Month 6 for Minutes of Sedentary Activity

Minutes of sedentary activity measured via an accelerometer device.

Change From Baseline to Month 12 for Minutes of Sedentary Activity

Minutes of sedentary activity measured via an accelerometer device.

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

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.

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

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

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.

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

Full Information

NCT ID

NCT04533711

First Posted

August 26, 2020

Last Updated

October 3, 2023

Sponsor

University of North Carolina, Chapel Hill

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04533711

Brief Title

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

Acronym

OA-PCP

Official Title

Physical Activity Pathway for Patients With Osteoarthritis in Primary Care

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 30, 2020 (Actual)

Primary Completion Date

November 30, 2023 (Anticipated)

Study Completion Date

November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

Keywords

Osteoarthritis, Knee Osteoarthritis, Hip Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

291 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OA-PCP

Arm Type

Experimental

Arm Description

Arm Title

Attention Control

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

OA-PCP Intervention

Intervention Description

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

Intervention Name(s)

Attention Control

Intervention Description

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 Outcome Measure Information:

Title

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

Description

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

Time Frame

Baseline, Month 6 (Follow-up)

Title

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

Description

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

Time Frame

Baseline, Month 12 (Follow-up)

Secondary Outcome Measure Information:

Title

Change From Baseline to Month 6 for Steps Per Day

Description

Step counts measured via an accelerometer device.

Time Frame

Baseline, Month 6 (Follow-up)

Title

Change From Baseline to Month 12 for Steps Per Day

Description

Step counts measured via an accelerometer device.

Time Frame

Baseline, Month 12 (Follow-up)

Title

Change From Baseline to Month 6 for Minutes of Sedentary Activity

Description

Minutes of sedentary activity measured via an accelerometer device.

Time Frame

Baseline, Month 6 (Follow-up)

Title

Change From Baseline to Month 12 for Minutes of Sedentary Activity

Description

Minutes of sedentary activity measured via an accelerometer device.

Time Frame

Baseline, Month 12 (Follow-up)

Title

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

Description

Time Frame

Baseline, Month 6 (Follow-up)

Title

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

Description

Time Frame

Baseline, Month 12 (Follow-up)

Title

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

Description

Time Frame

Baseline, Month 6 (Follow-up)

Title

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

Description

Time Frame

Baseline, Month 12 (Follow-up)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kelli D Allen, PhD

Organizational Affiliation

UNC Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

UNC Thurston Arthritis Research Center

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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).

IPD Sharing 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.

IPD Sharing 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.

Learn more about this trial

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

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