Rehabilitation for Arthritis of The Knee: mainTaining Improvement for Veterans (ReAKTIV)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Behavioral: Health coach; Behavioral: Remote Incentive Program

Detailed Description

Knee osteoarthritis (KOA) is a high-priority problem among the aging population, and in particular, among Veterans. Few interventions have been shown effective in the long-term management of symptoms. Current guidelines for non-operative KOA management include strong recommendations for exercise delivered through standard physical therapy (PT) and the promotion of greater physical activity. Standard physical therapy (PT) interventions characterized by 6-8 week of supervised exercises (e.g., strengthening peri-articular tissues) and mobility training (e.g., improving biomechanics and movement patterns) are safe and effective at improving and facilitating mobility, activity participation, and overall quality of life. While PT is a recognized and necessary aspect of KOA care, its clinical benefits are often short-lived and begin to decline following PT due to poor long-term adherence - leading physicians to increasingly rely on the use of non-steroidal anti-inflammatories and opioids over time. The lack of effective strategies to sustain the clinical benefits achieved in PT for individuals with KOA remains a critical gap.

The investigators aim to study two interventions designed based on their ability to address 5 key theories for maintaining behaviors that are supported by the literature. Specifically, the proposed study will evaluate a remote and behaviorally-designed intervention in combination with health coaching to influence long-term behavioral change after standard-of-care PT. The behavioral intervention utilizes tools such as goal setting, gamification (the use of game design elements), loss aversion, monitoring, and social incentives, to 1) increase motivation, 2) improve self-monitoring and self-regulation, 3) provide psychological and physical resources, 4) influence the development of healthy long-term habits, and 5) a provide supportive environment with social support. The behavioral intervention will be studied combined with health coaching with a focus on the same goals but through motivational interviewing to address personal, environmental, and social barriers. The investigators aim to clearly quantify the value of each as well as their value when used in combination.

The investigators has already utilized concepts from behavioral economics (a scientific field aiming to understand how to motivate individuals) to develop remotely-applied interventions that incorporate the concepts of gamification, social incentives, and loss aversion to promote improvements in physical activity using an innovative web-based platform. The investigators SPiRE-funded pilot study "Marching On for Veterans with Osteoarthritis of the Knee" demonstrated excellent feasibility, rapid recruitment, improvements in reported symptoms, and high patient satisfaction. The multi-site study is actively enrolling Veterans and is ahead of schedule.

The investigators propose to fill important knowledge gaps in this area with a large, pragmatic clinical trial. In this study, the investigators will randomize in a factorial design to receive no intervention, the remote behavioral intervention, a remote health coach, or both, after being released from a standard PT intervention with proven efficacy in order to promote the maintenance of symptomatic gains observed during PT. To accomplish these aims, the investigators will utilize innovative mobile applications for smart phones through the Way-to-Health (WTH) platform and assess, in real time, the impact of the intervention on the primary outcome of patient-reported symptoms as measured by the Knee Osteoarthritis Outcome score. The investigators will also monitor adherence to specific knee-related exercises at home. Way to Health allows for the recording of outcomes in real time, as they occur, thereby avoiding information bias due to poor recall and participation bias. The investigative team includes investigators with experience conducting similar trials using this infrastructure as well as expertise in behavioral economics and motivational interviewing. The study also involves a centralized organizational structure in close collaboration with investigators across the country.

Aim 1: To determine if a personalized and remotely-applied behavioral intervention based on insights from behavioral economics can sustain the symptomatic gains following physical therapy for KOA. Hypothesis: A remotely-applied program will result in maintenance of higher KOOS scores after PT by promoting greater adherence, self-efficacy, habituation, and social support.

Aim 2: To determine if a remote health coach can sustain the symptomatic gains following physical therapy for KOA. Hypothesis: Those that are randomized to receive a health coach will maintain higher KOOS scores after PT.

Aim 3: To determine how the behavioral intervention and health coaching interventions interact with each other. Hypothesis: The effect of both interventions will be additive such that the greatest improvement in symptoms will occur among those that receive both interventions.

• Study Type: Interventional
• Enrollment (Estimated): 254
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Joshua F Baker, MD MSCE; Phone Number: (215) 823-5800; Email: Joshua.Baker@va.gov

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233-1927
      • Not yet recruiting
      • Birmingham VA Medical Center, Birmingham, AL
      • Contact: Maria Danila, MD; Email: Maria.Danila@va.gov
  • Nebraska
    • Omaha, Nebraska, United States, 68105-1850
      • Not yet recruiting
      • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
      • Contact: Bryant England, MD; Email: bryant.england@unmc.edu
  • Oregon
    • Portland, Oregon, United States, 97207-2964
      • Not yet recruiting
      • VA Portland Health Care System, Portland, OR
      • Contact: Jennifer Barton; Email: Jennifer.Barton1@va.gov
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-4551
      • Recruiting
      • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
      • Contact: Joshua F Baker, MD MSCE; Phone Number: (215) 823-5800; Email: Joshua.Baker@va.gov
      • Principal Investigator: Joshua F. Baker, MD MSCE
  • Washington
    • Seattle, Washington, United States, 98108-1532
      • Not yet recruiting
      • VA Puget Sound Health Care System Seattle Division, Seattle, WA
      • Contact: Katherine Wysham, MD; Email: kwysham@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Lack of a smart phone allowing interaction with the WTH platform
• Inability to walk 2 blocks without assistance
• Poorly controlled crystalline arthritis or other diagnosis of inflammatory arthritis.
• Treating provider or LSI believes life-expectancy is <1 year
• Based on LSI or treating provider discretion: exclusions may occur for severe heart failure, unstable angina, end stage renal disease, severe chronic obstructive or other pulmonary disease, or other chronic illness felt to limit participants ability to participate in exercise or resulting in potential safety risk
• Severe pain in a non-knee area limiting daily function
• Non-English speakers or poor reading ability limiting ability to interact with text messages.
• Pregnancy
• Receiving physical therapy outside of the VA.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Intervention; Neither Intervention
Experimental: Health Coaching, No Incentives; Receives a Health Coach but no Incentive Program	Behavioral: Health coach; Health Coaching
Experimental: No Health Coach, Receives Incentives; Does not receive a health coach but does receive the incentive program.	Behavioral: Remote Incentive Program; Behavioral incentive program including gamification, social incentivization, and monitoring.
Experimental: Health Coaching, Receives Incentives; Receives both a health coach and the incentive program	Behavioral: Health coach; Health Coaching; Behavioral: Remote Incentive Program; Behavioral incentive program including gamification, social incentivization, and monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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 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
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
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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Joshua F. Baker, MD MSCE, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: behavioral intervention; physical therapy; health coach
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: F4770-R; RX004770 (Other Grant/Funding Number: VA Rehabilitation Research & Development)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No