OA CARE Intervention for Osteoarthritis, Knee

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UNC Thurston Arthritis Research Center, Chapel Hill, NC
Osteoarthritis, Knee+6 More
OA CARE Intervention - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether the OA Clinic-Community CARE Model is an effective way to address all recommended components of knee/hip (osteoarthritis) care, including interventions for both patients and primary care providers (PCPs). OA CARE Intervention is used to treat Osteoarthritis, Knee and has previously been approved by the FDA for a different condition.

Eligible Conditions

  • Osteoarthritis, Knee
  • Weight Loss
  • Obesity
  • Overweight
  • Physical Inactivity
  • Osteoarthritis, Hip

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Osteoarthritis, Knee

Study Objectives

2 Primary · 18 Secondary · Reporting Duration: Baseline, Month 12 (Follow-up)

Baseline, Month 12 (Follow-up)
Change From Baseline to Month 12 in 2-minute march test
Change From Baseline to Month 12 in 30-second chair stand test
Change From Baseline to Month 12 in Body Weight
Change From Baseline to Month 12 in Objectively Assessed Physical Activity (accelerometer)
Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale
Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale
Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score
Change From Baseline to Month 12 in minutes of any physical activity (PA)
Change From Baseline to Month 12 in steps per day
Change From Baseline to Month 12 in timed up-and-go (TUG) test
Change from Baseline to Month 12 in Self-Reported Physical Activity
Change from Baseline to Month 12 in sedentary minutes
Baseline, Month 6 (Follow-up)
Change From Baseline to Month 6 in Objectively Assessed Physical Activity (accelerometer)
Change From Baseline to Month 6 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
Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score
Change From Baseline to Month 6 in minutes of any physical activity (PA)
Change From Baseline to Month 6 in steps per day
Change from Baseline to Month 6 in Self-Reported Physical Activity
Change from Baseline to Month 6 in sedentary minutes

Trial Safety

Safety Progress

1 of 3

Other trials for Osteoarthritis, Knee

Trial Design

2 Treatment Groups

OA CARE
1 of 2
Usual Care
1 of 2
Experimental Treatment
Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: OA CARE Intervention · Has Placebo Group · N/A

OA CARE
Behavioral
Experimental Group · 1 Intervention: OA CARE Intervention · Intervention Types: Behavioral
Usual Care
Behavioral
PlaceboComparator Group · 1 Intervention: Usual Care control group · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, month 12 (follow-up)
Closest Location: UNC Thurston Arthritis Research Center · Chapel Hill, NC
2013First Recorded Clinical Trial
2 TrialsResearching Osteoarthritis, Knee
4 CompletedClinical Trials

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
443 Previous Clinical Trials
1,069,471 Total Patients Enrolled
20 Trials studying Osteoarthritis, Knee
11,462 Patients Enrolled for Osteoarthritis, Knee
National Institutes of Health (NIH)NIH
2,393 Previous Clinical Trials
24,523,910 Total Patients Enrolled
10 Trials studying Osteoarthritis, Knee
2,384 Patients Enrolled for Osteoarthritis, Knee
University of North Carolina, Chapel HillLead Sponsor
1,348 Previous Clinical Trials
3,908,546 Total Patients Enrolled
17 Trials studying Osteoarthritis, Knee
1,073 Patients Enrolled for Osteoarthritis, Knee
Kelli D Allen, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
8 Previous Clinical Trials
1,773 Total Patients Enrolled
2 Trials studying Osteoarthritis, Knee
505 Patients Enrolled for Osteoarthritis, Knee

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a body mass index (BMI) of 27 or more.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.