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Osteoarthritis, KneePhase 3ReAKTIVNCT06488144

Rehabilitation for Arthritis of The Knee: mainTaining Improvement for Veterans

A Phase 3 study testing Health coach and Remote Incentive Program in people with Osteoarthritis, Knee, run by VA Office of Research and Development at 5 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 40 to 90 years
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Health coach and Remote Incentive Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
254 participants
Where
5 sitesUnited States
Study dates
10 Dec 2025to 1 Jan 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • Non-English speakers or poor reading ability limiting ability to interact with text messages.
  • Pregnancy
  • Receiving physical therapy outside of the VA.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Joshua F Baker, MD MSCE contact

(215) 823-5800

Joshua.Baker@va.gov

5 sites in 1 country

United States5 sites, 5 recruiting
  • Birmingham VA Medical Center, Birmingham, AL

    Birmingham, Alabama, 35233-1927

    Maria Danila, MD, Maria.Danila@va.gov

    Not yet recruiting
  • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

    Omaha, Nebraska, 68105-1850

    Bryant England, MD, bryant.england@unmc.edu

    Not yet recruiting
  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

    Philadelphia, Pennsylvania, 19104-4551

    Joshua F Baker, MD MSCE, (215) 823-5800, Joshua.Baker@va.gov

    Joshua F. Baker, MD MSCE

    Recruiting
  • VA Portland Health Care System, Portland, OR

    Portland, Oregon, 97207-2964

    Jennifer Barton, Jennifer.Barton1@va.gov

    Not yet recruiting
  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

    Seattle, Washington, 98108-1532

    Katherine Wysham, MD, kwysham@uw.edu

    Not yet recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Health coach, Remote Incentive Program
Keywords
physical therapy, health coach, behavioral intervention
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health coachBehavioural

    Health Coaching

  • Remote Incentive ProgramBehavioural

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

Study groups in NCT06488144
Study groupRoleWhat they receive
No InterventionNo interventionNeither Intervention
Health Coaching, No IncentivesExperimentalReceives a Health Coach but no Incentive Program
Receives: Behavioral: Health coach
No Health Coach, Receives IncentivesExperimentalDoes not receive a health coach but does receive the incentive program.
Receives: Behavioral: Remote Incentive Program
Health Coaching, Receives IncentivesExperimentalReceives both a health coach and the incentive program
Receives: Behavioral: Health coach; Behavioral: Remote Incentive Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: all available measures between 6-18 months (time-averaged effect)

Secondary outcomes (5)
  1. Average Daily Step Counts

    Change in average daily step counts (averaged over the prior month) throughout follow-up (time-averaged effect).

    Measured: 0-18 Months

  2. 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.

    Measured: 6-18 months

  3. Change in gait speed

    Change in walking speed over a 4 meter testing zone (time-averaged effect)

    Measured: 6-18 months

  4. 30 second sit-to-stand

    Number of times a person can stand and sit within 30 seconds (time-averaged effect)

    Measured: 6-18 months

  5. 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).

    Measured: 6-18 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2024
  2. Study start10 Dec 2025
  3. Primary completion31 May 2029 (estimated)
  4. Study completion1 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
254 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06488144
Sponsor's protocol ID
F4770-R
Other IDs
RX004770
Acronym
ReAKTIV
Status last verified
Jan 2026
First submitted
28 Jun 2024
Last updated
8 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Health coach and Remote Incentive Program in people with Osteoarthritis, Knee, run by VA Office of Research and Development at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Joshua F Baker, MD MSCE ((215) 823-5800, Joshua.Baker@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

KOOS (Knee Osteoarthritis Outcome Score) (time frame: all available measures between 6-18 months (time-averaged effect)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.

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