NCT06488144

Brief 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). 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P50-P75 for phase_3

Timeline
44mo left

Started Dec 2025

Typical duration for phase_3

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Dec 2025Jan 2030

First Submitted

Initial submission to the registry

June 28, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
1.4 years until next milestone

Study Start

First participant enrolled

December 10, 2025

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2029

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

3.5 years

First QC Date

June 28, 2024

Last Update Submit

January 6, 2026

Conditions

Keywords

physical therapyhealth coachbehavioral intervention

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

  • Average Daily Step Counts

    0-18 Months

  • Change in Self Efficacy for excercise

    6-18 months

  • Change in gait speed

    6-18 months

  • 30 second sit-to-stand

    6-18 months

  • Patient Reported Outcomes Measurement Information System Pain Intensity

    6-18 Months

Study Arms (4)

No Intervention

NO INTERVENTION

Neither Intervention

Health Coaching, No Incentives

EXPERIMENTAL

Receives a Health Coach but no Incentive Program

Behavioral: Health coach

No Health Coach, Receives Incentives

EXPERIMENTAL

Does not receive a health coach but does receive the incentive program.

Behavioral: Remote Incentive Program

Health Coaching, Receives Incentives

EXPERIMENTAL

Receives both a health coach and the incentive program

Behavioral: Health coachBehavioral: Remote Incentive Program

Interventions

Health coachBEHAVIORAL

Health Coaching

Health Coaching, No IncentivesHealth Coaching, Receives Incentives

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

Health Coaching, Receives IncentivesNo Health Coach, Receives Incentives

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, 35233-1927, United States

NOT YET RECRUITING

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

Omaha, Nebraska, 68105-1850, United States

NOT YET RECRUITING

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

NOT YET RECRUITING

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

Philadelphia, Pennsylvania, 19104-4551, United States

RECRUITING

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

Seattle, Washington, 98108-1532, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Joshua F. Baker, MD MSCE

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua F Baker, MD MSCE

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2024

First Posted

July 5, 2024

Study Start

December 10, 2025

Primary Completion (Estimated)

May 31, 2029

Study Completion (Estimated)

January 1, 2030

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations