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Rehabilitation for Arthritis of The Knee: mainTaining Improvement for Veterans

NCT06488144 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2026-01-08

No results posted yet for this 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.

Conditions

  • Osteoarthritis, Knee

Interventions

BEHAVIORAL

Health coach

Health Coaching

BEHAVIORAL

Remote Incentive Program

Behavioral incentive program including gamification, social incentivization, and monitoring.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Joshua F. Baker, MD MSCE · Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-10
Primary Completion
2029-05-31
Completion
2030-01-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06488144 on ClinicalTrials.gov