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NCT06488144 · ClinicalTrials.gov registry record · Phase 3
Rehabilitation for Arthritis of The Knee: mainTaining Improvement for Veterans
A Phase 3 study of Osteoarthritis, Knee, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 254
- Enrollment target
- 5
- Study locations
NCT06488144: Recruiting Phase 3 study of Osteoarthritis, Knee, sponsored by VA Office of Research and Development.
NCT06488144 is a Phase 3 study of Osteoarthritis, Knee that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 254 participants, below the 495-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (49% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06488144, a Phase 3 study of Osteoarthritis, Knee, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 254 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
The KOOS score is a validated and widely used measure of knee-related pain and physical functioning that has been validated in both knee injury and KOA populations. The KOOS measures symptoms and disability on five subscales: Pain, other Symptoms, Function in Activities of Daily Living, Function in Sports and Recreation, and Quality of Life (QOL). Range is from 0-100 for each subscale with lower scores suggesting worse patient experience.
Conditions Studied
Interventions
- BEHAVIORAL Health coach
- BEHAVIORAL Remote Incentive Program
Study Locations (5)
Alabama
- Birmingham VA Medical Center, Birmingham, AL - Birmingham
Nebraska
- Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE - Omaha
Oregon
- VA Portland Health Care System, Portland, OR - Portland
Pennsylvania
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA - Philadelphia
Washington
- VA Puget Sound Health Care System Seattle Division, Seattle, WA - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 254 participants |
| Start Date | 2025-12-10 |
| Est. Completion | 2030-01-01 |
| Phase | Phase 3 |
What NCT06488144 shows while recruiting
NCT06488144 is an interventional study that assigns participants to a tested intervention. The registered 254 participants enrollment target is mid-sized for trials with a published cap, below the 495-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (49% lower).
The record links to 1 condition, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 2 interventions - of which Health coach is the first listed.
NCT06488144 lists 5 locations in 5 states (Alabama, Nebraska, Oregon).
Frequently Asked Questions
What is clinical trial NCT06488144 about?
NCT06488144 is a clinical study titled "Rehabilitation for Arthritis of The Knee: mainTaining Improvement for Veterans". 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...
What is the current status of trial NCT06488144?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 254 participants. The study started on 2025-12-10. Estimated completion is 2030-01-01.
What conditions does trial NCT06488144 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee.
What interventions are being tested in trial NCT06488144?
The interventions under investigation include: Health coach (BEHAVIORAL), Remote Incentive Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT06488144?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06488144 being conducted?
This trial has 5 study locations across Alabama, Nebraska, Oregon, Pennsylvania, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteoarthritis, Knee
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06488144's enrollment target sits among peer trials
254 29th of 112 higher than 84 of 112 other Osteoarthritis, Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis, Knee trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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