Osteoarthritis Clinical Trials

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A Remotely - Applied Behaviorally- Designed Intervention Incorporating Gamification, Social Incentives, and Health Coaching to Improve Durability of Physical Therapy for Knee Osteoarthritis (ReAKTIV)

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Birmingham VA Medical Center, Birmingham, AL
NOT_YET_RECRUITING
Birmingham
Nebraska
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
NOT_YET_RECRUITING
Omaha
Oregon
VA Portland Health Care System, Portland, OR
NOT_YET_RECRUITING
Portland
Pennsylvania
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
RECRUITING
Philadelphia
Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
NOT_YET_RECRUITING
Seattle
Contact Information
Primary
Joshua F Baker, MD MSCE
Joshua.Baker@va.gov
(215) 823-5800
Time Frame
Start Date: 2025-12-10
Estimated Completion Date: 2030-01-01
Participants
Target number of participants: 254
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov