NCT06488144 Rehabilitation for Arthritis of The Knee: mainTaining Improvement for Veterans
| NCT ID | NCT06488144 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | VA Office of Research and Development |
| Condition | Osteoarthritis, Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 254 participants |
| Start Date | 2025-12-10 |
| Primary Completion | 2029-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 254 participants in total. It began in 2025-12-10 with a primary completion date of 2029-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Clinical diagnosis or chronic knee osteoarthritis. * Age between 40-90 years * Initiating physical therapy for KOA (has initial appointment within the next month or had first PT visit within the last 7 days) * To be randomized: PT feels that they are able to safely and reliably participate in ongoing exercise. * To be randomized: must have completed at least 4 virtual or in-person appointments with PT * To be randomized: must sync their Fitbit at least monthly. Exclusion Criteria: * Lack of a smart phone allowing interaction with the WTH platform * Inability to walk 2 blocks without assistance * Poorly controlled crystalline arthritis or other diagnosis of inflammatory arthritis. * Treating provider or LSI believes life-expectancy is \<1 year * Based on LSI or treating provider discretion: exclusions may occur for severe heart failure, unstable angina, end stage renal disease, severe chronic obstructive or other pulmonary disease, or other chronic illness felt to limit participants ability to participate in exercise or resulting in potential safety risk * Severe pain in a non-knee area limiting daily function * Non-English speakers or poor reading ability limiting ability to interact with text messages. * Pregnancy * Receiving physical therapy outside of the VA.
Contact & Investigator
Joshua F. Baker, MD MSCE
PRINCIPAL INVESTIGATOR
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Frequently Asked Questions
Who can join the NCT06488144 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 90 Years, studying Osteoarthritis, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06488144 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 254 participants.
Is NCT06488144 currently recruiting?
Yes, NCT06488144 is actively recruiting participants. Contact the research team at Joshua.Baker@va.gov for enrollment information.
Where is the NCT06488144 trial being conducted?
This trial is being conducted at Birmingham, United States, Omaha, United States, Portland, United States, Philadelphia, United States and 1 additional location.
Who is sponsoring the NCT06488144 clinical trial?
NCT06488144 is sponsored by VA Office of Research and Development. The principal investigator is Joshua F. Baker, MD MSCE at Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA. The trial plans to enroll 254 participants.