Rehabilitation for Arthritis of The Knee: mainTaining Improvement for Veterans

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years - 90 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06488144
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

VA Office of Research and Development
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Joshua F. Baker, MD MSCE
Principal Investigator Affiliation Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

U.S. Fed
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Knee
Additional Details

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.

Arms & Interventions

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

Interventions

Behavioral: - Health coach

Health Coaching

Behavioral: - Remote Incentive Program

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

Status

Address

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, 35233-1927

Site Contact

Maria Danila, MD

[email protected]

(215) 823-5800

Omaha, Nebraska

Status

Address

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Omaha, Nebraska, 68105-1850

Site Contact

Bryant England, MD

[email protected]

(215) 823-5800

Portland, Oregon

Status

Address

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964

Site Contact

Jennifer Barton

[email protected]

(215) 823-5800

Philadelphia, Pennsylvania

Status

Address

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104-4551

Site Contact

Joshua F Baker, MD MSCE

[email protected]

215-823-5800

Seattle, Washington

Status

Address

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532

Site Contact

Katherine Wysham, MD

[email protected]

(215) 823-5800