Rehabilitation for Arthritis of The Knee: mainTaining Improvement for Veterans
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT06488144
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Osteoarthritis, Knee
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - 90 Years
- Healthy Volunteers
- Not accepted
Interventions
- Health coach — BEHAVIORALHealth Coaching
- Remote Incentive Program — BEHAVIORALBehavioral incentive program including gamification, social incentivization, and monitoring.
Study Details
The aims are to determine whether 1) an incentive based on behaviorally-enhanced gamification and social incentives and 2) health coaching can promote adherence to exercise and physical activity after physical therapy for osteoarthritis of the knee (KOA). The research design is a randomized clinical trial with factorial design This randomized clinical trial of 254 patients using a factorial design will leverage a clinical trial platform developed through the University of Pennsylvania that allows for the remotely capture important patient-reported outcomes and other interaction through a participant's smart phone. The investigators will randomize participants to receive social incentives with gamification to promote adherence to prescribed exercises as well as maintenance of greater levels of physical activity and compare to controls that receive a Fitbit but no additional incentive. Participants may also be randomized to receive a health coach. The investigators will utilize mobile applications for smart phones and wearable activity trackers through the Way-to-Health platform and assess, in real time, the impact of the interventions on patient-reported function and pain (as measured by the Knee Osteoarthritis Outcome Score) as well as physical activity. Participants will be followed for 2 years, with a total of 5 in-person visits. Knee osteoarthritis (KOA) is one of the most prevalent and disabling conditions among Veterans and accounts for high morbidity and high costs for the VA. Importantly, while physical therapy is valuable for patients with KOA, lack of adherence to home exercises and low overall physical activity limit the durability of response. The current proposal aims to address two important knowledge gaps in the management of KOA in order to improve pain and function.
Key Dates
- Start date
- Dec 10, 2025
- Status verified
- Jan 2026
- Primary completion
- May 31, 2029
- Completion
- Jan 1, 2030
Study Design
- Enrollment
- 254 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- FACTORIAL
- Primary purpose
- TREATMENT
Arms
- No Intervention: No InterventionNeither Intervention
- Experimental: Health Coaching, No IncentivesReceives a Health Coach but no Incentive Program
- Experimental: No Health Coach, Receives IncentivesDoes not receive a health coach but does receive the incentive program.
- Experimental: Health Coaching, Receives IncentivesReceives both a health coach and the incentive program
Primary Outcome Measure
KOOS (Knee Osteoarthritis Outcome Score) [ Time Frame: all available measures between 6-18 months (time-averaged effect) ]
Central Contacts
- Joshua F Baker, MD MSCE(215) 823-5800
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Birmingham VA Medical Center, Birmingham, AL | Birmingham | Alabama | 35233-1927 | Maria Danila, MD |
| Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE | Omaha | Nebraska | 68105-1850 | Bryant England, MD |
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97207-2964 | Jennifer Barton |
| Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania | 19104-4551 | Joshua F. Baker, MD MSCE (PRINCIPAL_INVESTIGATOR) |
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | 98108-1532 | Katherine Wysham, MD |
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