Ignite Creation Date:
2024-07-17 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488144
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-28
Brief Title:
Rehabilitation for Arthritis of The Knee mainTaining Improvement for Veterans
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ReAKTIV
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 participants 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
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 participants 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
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 eg strengthening peri-articular tissues and mobility training eg 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RX004770 | OTHER_GRANT | None | None |