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Behavioural Intervention
Health Coaching + Incentives for Knee Osteoarthritis (ReAKTIV Trial)
Phase 3
Waitlist Available
Led By Joshua F. Baker, MD MSCE
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have completed at least 4 virtual or in-person appointments with PT
Age between 40-90 years
Must not have
Inability to walk 2 blocks without assistance
Poorly controlled crystalline arthritis or other diagnosis of inflammatory arthritis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-18 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
"This trial aims to see if using a combination of gamification, social incentives, and health coaching can help patients with knee osteoarthritis adhere to their exercise routines after physical therapy. The study will
Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Since this trial focuses on non-drug interventions like gamification and health coaching, traditional medication side effects are not a concern. However, participants may experience discomfort or injury from increased physical activity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had at least 4 sessions with a physical therapist.
Select...
I am between 40 and 90 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot walk 2 blocks without help.
Select...
I have uncontrolled arthritis or another type of inflammatory arthritis.
Select...
I have severe pain in a part of my body other than my knee that limits my daily activities.
Select...
I am getting physical therapy outside of the VA system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
KOOS (Knee Osteoarthritis Outcome Score)
Secondary study objectives
30 second sit-to-stand
Average Daily Step Counts
Change in Self Efficacy for excercise
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
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 Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,668 Previous Clinical Trials
3,765,612 Total Patients Enrolled
22 Trials studying Osteoarthritis
3,533 Patients Enrolled for Osteoarthritis
Joshua F. Baker, MD MSCEPrincipal InvestigatorCorporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
2 Previous Clinical Trials
255 Total Patients Enrolled
2 Trials studying Osteoarthritis
255 Patients Enrolled for Osteoarthritis