search
Back to results

OA Clinic-Community CARE Model (OA CARE)

Primary Purpose

Osteoarthritis, Knee, Osteoarthritis, Hip, Overweight

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OA CARE Intervention
Usual Care control group
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinician diagnosis of knee or hip OA
  • Self-reported knee or hip pain of ≥3 (scale of 0-10) on most days of the week
  • Current Weekly Physical Activity <150 minutes per week
  • Body mass index (BMI) ≥27 kg/m^2

Exclusion Criteria:

  • No internet access and a device (computer, tablet, smartphone) to access the virtual weight loss intervention
  • Pain in chest when performing physical activity
  • Pain in chest when not performing physical activity
  • No documented diagnosis of knee or hip OA
  • Total knee or hip replacement surgery, meniscus tear, ligament tear, or other significant lower extremity injury or surgery in the last 6 months
  • Dementia or other memory loss condition
  • Active diagnosis of psychosis
  • Active Substance abuse disorder
  • Severe hearing or visual impairment
  • Serious/terminal illness as indicated by referral to hospice or palliative care
  • 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
  • Planning total joint replacement in next 6 months
  • Any other health conditions determined by the study team to be contraindications to a home exercise program or weight loss
  • Current participation in other study related to knee or hip osteoarthritis or physical activity
  • Unable to speak English

Sites / Locations

  • UNC Thurston Arthritis Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

OA CARE

Usual Care

Arm Description

Participants assigned to the OA CARE intervention will receive a 12-month Medical Membership to a local YMCA and participate in a 12-week weight loss program. Participants will also work with an OA CARE Navigator, who, in partnership with their primary care provider (PCP), will identify any additional programs or resources that may help them manage their osteoarthritis (OA) symptoms.

Participants assigned to this group will receive no additional treatment from the study for about 12 months.

Outcomes

Primary Outcome Measures

Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score
For the WOMAC total score, the test questions are scored on a scale of 0-4. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The overall WOMAC score is determined by summing the scores for all three subscales and the score ranges include 0-96 (derived from a 0-4 Likert scale), with higher scores indicating worse pain, stiffness, and functional limitations.
Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score
For the WOMAC total score, the test questions are scored on a scale of 0-4. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The overall WOMAC score is determined by summing the scores for all three subscales and the score ranges include 0-96 (derived from a 0-4 Likert scale), with higher scores indicating worse pain, stiffness, and functional limitations.

Secondary Outcome Measures

Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale
The 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
The 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 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale
The 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
The 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 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 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 6 in steps per day
Step counts measured via accelerometer
Change From Baseline to Month 12 in steps per day
Step counts measured via accelerometer
Change From Baseline to Month 6 in minutes of any physical activity (PA)
Minutes of any PA measured via accelerometer
Change From Baseline to Month 12 in minutes of any physical activity (PA)
Minutes of any PA measured via accelerometer
Change from Baseline to Month 6 in Self-Reported Physical Activity
Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. Separate scores are derived for physical activities of moderate or greater intensity (metabolic equivalents MET ≥ 3.0) and for all activities listed (light, moderate, and vigorous). Estimates of frequency (days per week) range from 0 to 7 days per week. Estimates of Variety (# different activities), while open, generally ranges from 0 to 5, values above 5 are checked. Estimates of minutes, generally range from 0 to 180 per day. Individuals reporting more than 180 minutes per day are checked. For all physical activity outcomes higher values equal a greater amount of activity.
Change from Baseline to Month 12 in Self-Reported Physical Activity
Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. Separate scores are derived for physical activities of moderate or greater intensity (metabolic equivalents (MET) ≥ 3.0) and for all activities listed (light, moderate, and vigorous). Estimates of frequency (days per week) range from 0 to 7 days per week. Estimates of Variety (# different activities), while open, generally ranges from 0 to 5, values above 5 are checked. Estimates of minutes, generally range from 0 to 180 per day. Individuals reporting more than 180 minutes per day are checked. For all physical activity outcomes higher values equal a greater amount of activity.
Change from Baseline to Month 6 in sedentary minutes
Sedentary minutes measured via accelerometer
Change from Baseline to Month 12 in sedentary minutes
Sedentary minutes measured via accelerometer
Change From Baseline to Month 12 in Body Weight
Body weight assessed using a research / clinical grade scale (e.g., Tanita) that will be calibrated regularly.
Change From Baseline to Month 12 in 30-second chair stand test
Assessed to test participant leg strength and endurance. Measured by total number of chair stands (up and down equals one stand) completed in 30 seconds.
Change From Baseline to Month 12 in timed up-and-go (TUG) test
Assessed to measure participant functional mobility. Measured by how many seconds it takes for participant to stand up, walk to the mark, turn around, return & sit back into a chair with their back resting on the back of the chair.
Change From Baseline to Month 12 in 2-minute march test
Assessed to evaluate participant functional aerobic endurance. Measured by number of steps completed in 2 minutes.

Full Information

First Posted
April 21, 2022
Last Updated
January 3, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
search

1. Study Identification

Unique Protocol Identification Number
NCT05349500
Brief Title
OA Clinic-Community CARE Model
Acronym
OA CARE
Official Title
Optimizing Osteoarthritis Care Through Clinical and Community Partnership
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 7, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 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 of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to test the OA Clinic-Community CARE Model (OA CARE) which will address all recommended components of knee/hip (osteoarthritis) OA care, include interventions for both patients and primary care providers (PCPs), and utilize a tailored approach that efficiently matches treatments with patients' needs. The patient component of OA CARE will include evidence-based weight management and exercise programs for all participants (delivered through the YMCA), as well as tailored referrals to physical therapy, additional weight management or nutrition services, sleep-related services and psychological services. The PCP component of OA CARE will include a video-based summary of current OA treatment guidelines (with emphasis on practical application), collaboration on patients' referrals to specific services described above, and progress reports on enrolled patients.
Detailed Description
This study will be a randomized pilot trial of OA CARE among n=60 patients with knee and/or hip osteoarthritis (OA) and overweight/obesity who are not currently meeting physical activity recommendations. Participants will be randomly assigned to OA CARE or a usual care (UC) group. Assessments will be conducted at baseline, 6 months and 12 months. Primary endpoint of the trial will be self-reported pain and function and secondary endpoint will be objectively assessed physical activity (PA), measured via accelerometer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Osteoarthritis, Hip, Overweight, Obesity, Physical Inactivity, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OA CARE
Arm Type
Experimental
Arm Description
Participants assigned to the OA CARE intervention will receive a 12-month Medical Membership to a local YMCA and participate in a 12-week weight loss program. Participants will also work with an OA CARE Navigator, who, in partnership with their primary care provider (PCP), will identify any additional programs or resources that may help them manage their osteoarthritis (OA) symptoms.
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
Participants assigned to this group will receive no additional treatment from the study for about 12 months.
Intervention Type
Behavioral
Intervention Name(s)
OA CARE Intervention
Intervention Description
Once assigned, participants will be contacted by the OA CARE Navigator to coordinate initiating a YMCA Medical Membership. Then, YMCA personnel will contact the participant to schedule the first Weight Loss Program (Program) group session. The Program will be delivered in groups with other OA CARE participants. Participants will also have access to all exercise facilities and programs at the YMCA during the study, and will be assigned a YMCA health coach. After initiation of the YMCA Medical Membership, the OA CARE Navigator will discuss participant's interests in referrals to other services related to osteoarthritis (OA) management. The Navigator will provide the participant's primary care provider (PCP) with a summary of this discussion and help the participant connect to any programs or resources that do not require provider referrals.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care control group
Intervention Description
Participants assigned to the usual care group will receive no additional treatment from the study for about 12 months. However, this group will be offered a 12-month Medical Membership to a local YMCA after completing the final assessment.
Primary Outcome Measure Information:
Title
Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score
Description
For the WOMAC total score, the test questions are scored on a scale of 0-4. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The overall WOMAC score is determined by summing the scores for all three subscales and the score ranges include 0-96 (derived from a 0-4 Likert scale), with higher scores indicating worse pain, stiffness, and functional limitations.
Time Frame
Baseline, Month 6 (Follow-up)
Title
Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score
Description
For the WOMAC total score, the test questions are scored on a scale of 0-4. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The overall WOMAC score is determined by summing the scores for all three subscales and the score ranges include 0-96 (derived from a 0-4 Likert scale), with higher scores indicating worse pain, stiffness, and functional limitations.
Time Frame
Baseline, Month 12 (Follow-up)
Secondary Outcome Measure Information:
Title
Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale
Description
The 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.
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
The 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.
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
The 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.
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
The 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.
Time Frame
Baseline, Month 12 (Follow-up)
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 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)
Title
Change From Baseline to Month 6 in steps per day
Description
Step counts measured via accelerometer
Time Frame
Baseline, Month 6 (Follow-up)
Title
Change From Baseline to Month 12 in steps per day
Description
Step counts measured via accelerometer
Time Frame
Baseline, Month 12 (Follow-up)
Title
Change From Baseline to Month 6 in minutes of any physical activity (PA)
Description
Minutes of any PA measured via accelerometer
Time Frame
Baseline, Month 6 (Follow-up)
Title
Change From Baseline to Month 12 in minutes of any physical activity (PA)
Description
Minutes of any PA measured via accelerometer
Time Frame
Baseline, Month 12 (Follow-up)
Title
Change from Baseline to Month 6 in Self-Reported Physical Activity
Description
Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. Separate scores are derived for physical activities of moderate or greater intensity (metabolic equivalents MET ≥ 3.0) and for all activities listed (light, moderate, and vigorous). Estimates of frequency (days per week) range from 0 to 7 days per week. Estimates of Variety (# different activities), while open, generally ranges from 0 to 5, values above 5 are checked. Estimates of minutes, generally range from 0 to 180 per day. Individuals reporting more than 180 minutes per day are checked. For all physical activity outcomes higher values equal a greater amount of activity.
Time Frame
Baseline, Month 6 (Follow-up)
Title
Change from Baseline to Month 12 in Self-Reported Physical Activity
Description
Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. Separate scores are derived for physical activities of moderate or greater intensity (metabolic equivalents (MET) ≥ 3.0) and for all activities listed (light, moderate, and vigorous). Estimates of frequency (days per week) range from 0 to 7 days per week. Estimates of Variety (# different activities), while open, generally ranges from 0 to 5, values above 5 are checked. Estimates of minutes, generally range from 0 to 180 per day. Individuals reporting more than 180 minutes per day are checked. For all physical activity outcomes higher values equal a greater amount of activity.
Time Frame
Baseline, Month 12 (Follow-up)
Title
Change from Baseline to Month 6 in sedentary minutes
Description
Sedentary minutes measured via accelerometer
Time Frame
Baseline, Month 6 (Follow-up)
Title
Change from Baseline to Month 12 in sedentary minutes
Description
Sedentary minutes measured via accelerometer
Time Frame
Baseline, Month 12 (Follow-up)
Title
Change From Baseline to Month 12 in Body Weight
Description
Body weight assessed using a research / clinical grade scale (e.g., Tanita) that will be calibrated regularly.
Time Frame
Baseline, Month 12 (Follow-up)
Title
Change From Baseline to Month 12 in 30-second chair stand test
Description
Assessed to test participant leg strength and endurance. Measured by total number of chair stands (up and down equals one stand) completed in 30 seconds.
Time Frame
Baseline, Month 12 (Follow-up)
Title
Change From Baseline to Month 12 in timed up-and-go (TUG) test
Description
Assessed to measure participant functional mobility. Measured by how many seconds it takes for participant to stand up, walk to the mark, turn around, return & sit back into a chair with their back resting on the back of the chair.
Time Frame
Baseline, Month 12 (Follow-up)
Title
Change From Baseline to Month 12 in 2-minute march test
Description
Assessed to evaluate participant functional aerobic endurance. Measured by number of steps completed in 2 minutes.
Time Frame
Baseline, Month 12 (Follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinician diagnosis of knee or hip OA Self-reported knee or hip pain of ≥3 (scale of 0-10) on most days of the week Current Weekly Physical Activity <150 minutes per week Body mass index (BMI) ≥27 kg/m^2 Exclusion Criteria: No internet access and a device (computer, tablet, smartphone) to access the virtual weight loss intervention Pain in chest when performing physical activity Pain in chest when not performing physical activity No documented diagnosis of knee or hip OA Total knee or hip replacement surgery, meniscus tear, ligament tear, or other significant lower extremity injury or surgery in the last 6 months Dementia or other memory loss condition Active diagnosis of psychosis Active Substance abuse disorder Severe hearing or visual impairment Serious/terminal illness as indicated by referral to hospice or palliative care 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 Planning total joint replacement in next 6 months Any other health conditions determined by the study team to be contraindications to a home exercise program or weight loss Current participation in other study related to knee or hip osteoarthritis or physical activity Unable to speak English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelli D Allen, PhD
Organizational Affiliation
University of North Carolina, 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

OA Clinic-Community CARE Model

We'll reach out to this number within 24 hrs