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 — BEHAVIORAL
    Health Coaching
  • Remote Incentive Program — BEHAVIORAL
    Behavioral 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 Intervention
    Neither Intervention
  • Experimental: Health Coaching, No Incentives
    Receives a Health Coach but no Incentive Program
  • Experimental: No Health Coach, Receives Incentives
    Does not receive a health coach but does receive the incentive program.
  • Experimental: Health Coaching, Receives Incentives
    Receives 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

Locations (5)

FacilityCityStateZIPSite coordinators
Birmingham VA Medical Center, Birmingham, ALBirminghamAlabama35233-1927
Maria Danila, MD
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NEOmahaNebraska68105-1850
Bryant England, MD
VA Portland Health Care System, Portland, ORPortlandOregon97207-2964
Jennifer Barton
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PAPhiladelphiaPennsylvania19104-4551
Joshua F Baker, MD MSCE
(215) 823-5800
Joshua F. Baker, MD MSCE (PRINCIPAL_INVESTIGATOR)
VA Puget Sound Health Care System Seattle Division, Seattle, WASeattleWashington98108-1532
Katherine Wysham, MD

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