Rehabilitation for Arthritis of The Knee: mainTaining Improvement for Veterans
NCT Number: NCT06488144
Acronym: ReAKTIV
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Osteoarthritis, Knee
Interventions: BEHAVIORAL: Health coach|BEHAVIORAL: Remote Incentive Program
Sponsor: VA Office of Research and Development
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 254
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-04-01
Completion Date: 2029-06-30
Locations: Birmingham VA Medical Center, Birmingham, AL, Birmingham, Alabama, 35233-1927, United States|Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE, Omaha, Nebraska, 68105-1850, United States|VA Portland Health Care System, Portland, OR, Portland, Oregon, 97207-2964, United States|Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, Philadelphia, Pennsylvania, 19104-4551, United States|VA Puget Sound Health Care System Seattle Division, Seattle, WA, Seattle, Washington, 98108-1532, United States

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 Measures: KOOS (Knee Osteoarthritis Outcome Score), 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., all available measures between 6-18 months (time-averaged effect)
Secondary Outcome Measures: Average Daily Step Counts, Change in average daily step counts (averaged over the prior month) throughout follow-up (time-averaged effect)., 0-18 Months|Change in Self Efficacy for excercise, Self-efficacy for exercise scale (change from baseline; time-averaged effect). Range 0-100 with higher scores representing more confidence in exercise., 6-18 months|Change in gait speed, Change in walking speed over a 4 meter testing zone (time-averaged effect), 6-18 months|30 second sit-to-stand, Number of times a person can stand and sit within 30 seconds (time-averaged effect), 6-18 months|Patient Reported Outcomes Measurement Information System Pain Intensity, Change from baseline in PROMIS Pain Intensity (time-averaged effect). Scale 0-100 (higher score indicates more pain)., 6-18 Months