~169 spots leftby Mar 2029

Health Coaching + Incentives for Knee Osteoarthritis

(ReAKTIV Trial)

Recruiting in Palo Alto (17 mi)
+4 other locations
Joshua F. Baker, MD, MSCE - Center for ...
Overseen byJoshua Baker, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: VA Office of Research and Development
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Joshua F. Baker, MD, MSCE - Center for ...

Joshua Baker, MD

Principal Investigator

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

Eligibility Criteria

This trial is for veterans with knee osteoarthritis who have completed physical therapy. It's designed to help them stick to their exercise routines and stay active. Participants need a smartphone to use the study apps and trackers, but can't join if they have conditions that interfere with following the program.

Inclusion Criteria

PT feels that they are able to safely and reliably participate in ongoing exercise
I have been diagnosed with chronic knee osteoarthritis.
I am starting physical therapy for knee arthritis soon or started within the last week.
See 3 more

Exclusion Criteria

Treating provider or LSI believes life-expectancy is less than 1 year
I do not have severe heart, kidney, lung diseases, or other chronic illnesses that limit my ability to exercise.
Pregnancy
See 6 more

Treatment Details

Interventions

  • Health coach (Behavioural Intervention)
  • Remote Incentive Program (Behavioural Intervention)
Trial OverviewThe study tests whether incentives like games and social rewards, along with health coaching, can keep patients on track with exercises after physical therapy. Using smart technology, it compares these methods against standard care over two years.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: No Health Coach, Receives IncentivesExperimental Treatment1 Intervention
Does not receive a health coach but does receive the incentive program.
Group II: Health Coaching, Receives IncentivesExperimental Treatment2 Interventions
Receives both a health coach and the incentive program
Group III: Health Coaching, No IncentivesExperimental Treatment1 Intervention
Receives a Health Coach but no Incentive Program
Group IV: No InterventionActive Control1 Intervention
Neither Intervention

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
VA Portland Health Care System, Portland, ORPortland, OR
Birmingham VA Medical Center, Birmingham, ALBirmingham, AL
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PAPhiladelphia, PA
VA Puget Sound Health Care System Seattle Division, Seattle, WASeattle, WA
More Trial Locations
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Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1691
Patients Recruited
3,759,000+