Sensor-controlled Digital Game for Heart Failure Self-management: A Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sensor-controlled digital game (SCDG), Sensor Only.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sensor-controlled Digital Game for Heart Failure Selfmanagement Behavior Adherence: A Randomized Controlled Trial
Overview
This study evaluates a sensor-controlled digital game (SCDG) to motivate self-management behaviors of weight monitoring and physical activity in adults with heart failure (HF). Half of the participants will receive the SCDG app and weight monitoring and physical activity sensors and the other half will receive only the weight monitoring and physical activity sensors.
Detailed description
The primary goal of this study is to obtain efficacy data through a randomized controlled trial of a SCDG intervention that synchronizes with a Bluetooth-enabled weight scale and activity tracker to activate game rewards and feedback based on real-time weight monitoring and exercise behaviors of adult heart failure (HF) participants who are older than 45 years.
The SCDG involves a narrative, the goal of which is to help the avatar maintain good health and quality of life by using game points, earned via the participant's real-time behaviors, in game tasks that help maintain the avatar's optimal HF health status. Real-time behaviors of weight-monitoring and physical activity will be tracked by an off-the-shelf sensors and app (Withings). The data from the Withings sensors will then be routed to our SCDG app. The digital game paired with sensors will enable objective tracking of real-time behaviors such as physical activity, and weight monitoring, and provide personalized, contextually relevant feedback (e.g., reduce fluid intake or call doctor for weight gain) to motivate engagement in and generate habit formation of heart failure related self-management behaviors. The goal of this proposal is to determine efficacy of the SCDG concept for heart failure self-management in a real-world setting.
In this study, the initial efficacy of the SCDG intervention for primary outcome of rate of engagement in HF self-management behavior of weight-monitoring and secondary outcomes of physical activity engagement, HF self-management-knowledge, and self-efficacy, HF-functional status, hospitalization, cognitive ability, depression and quality of life will be evaluated. For this study, 200 adults who are 45 years or older and who experienced HF hospitalization in the past 12 months will be recruited through online recruiting methods from 7 southern U.S states of Alabama, Arkansas, Georgia, Louisiana, Mississippi, Oklahoma, Texas. Recruited, participants will be randomized to either the SCDG intervention group that will receive sensors tracking weight monitoring and activity and play the SCDG on a mobile smartphone for 24 weeks or a control group that will receive sensors and an app tracking activity and weight monitoring, and standardized written HF educational modules.
Interventions
- Behavioral Sensor-controlled digital game (SCDG)
The SCDG will involve a narrative, the goal of which is to help an avatar in the game avoid rehospitalization by using game points, earned via the participant's real-time behaviors, in game tasks that help maintain the avatar's optimal HF health status. Real-time behaviors of weight-monitoring and physical activity will be tracked by an off-the-shelf sensors and app (Withings). The data from the Withings sensors will then be routed to our SCDG app. The digital game paired with sensors will enab - Behavioral Sensor Only
Real-time behaviors of weight-monitoring and physical activity will be tracked by an off-the-shelf sensors and app (Withings). This group will also be provided with standardized evidence-based HF educational material.However, the data from the Withings sensors will not be routed to the SCDG.
Primary outcome measures
- Number of Days With Weight-monitoring on Sensor Logs at 6 Weeks [Time frame: 6 weeks]
- Number of Days With Weight-monitoring on Sensor Logs at 12 Weeks [Time frame: 12 weeks]
- Number of Days With Weight-monitoring on Sensor Logs at 24 Weeks [Time frame: 24 weeks]
Secondary outcome measures (12)
- Mean of Daily Steps on Physical Activity Sensor Logs at 6 Weeks [Time frame: 6 weeks]
- Mean of Daily Steps on Physical Activity Sensor Logs at 12 Weeks [Time frame: 12 weeks]
- Mean of Daily Steps on Physical Activity Sensor Logs at 24 Weeks [Time frame: 24 weeks]
- Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 6 Weeks [Time frame: Baseline, 6 weeks]
- Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 12 Weeks [Time frame: Baseline, 12 weeks]
- Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 24 Weeks [Time frame: Baseline, 24 weeks]
- Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6 Weeks [Time frame: Baseline, 6 weeks]
- Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 Weeks [Time frame: Baseline, 12 weeks]
- Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 24 Weeks [Time frame: Baseline, 24 weeks]
- Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6 Weeks [Time frame: Baseline, 6 weeks]
- Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 Weeks [Time frame: Baseline, 12 weeks]
- Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 24 Weeks [Time frame: Baseline, 24 weeks]
Eligibility criteria
Inclusion criteria
- Age 45 years or older
- New York Heart Association (NYHA) heart failure classification of I to III that permits minimal physical activity without discomfort
- have experienced HF hospitalization in the past 12 months
- be fluent in English
- Pass a mini-cognitive screen
- Score of less than 2 (able to independently walk without using a cane or walker) on the Outcome and Assessment Information Set item for ambulation/locomotion
Exclusion criteria
- severe visual (e.g., legally blind) or tactile (e.g., severe arthritis) impairments that adversely prevent the use of a smartphone or sensor devices;
- a history of renal failure, which adversely affects HF prognosis
- a diagnosis of an end-stage or terminal illness (e.g., cancer)
- undergone heart transplantation, or implantation of a durable mechanical circulatory support device (e.g., left ventricular assist device) due to unique self-management needs.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Health services research
Study locations
United States · 1 center
- The University of Texas Austin — Austin
Publications
- Tunis R, Clifford N, West E, Heitkemper E, Burgermaster M, Radhakrishnan K. Developing psychosocial phenotypes to understand engagement with digital health technologies for heart failure. NPJ Digit Med. 2026 Apr 4;9(1):420. doi: 10.1038/s41746-026-02571-z. PMID 41935162
- Radhakrishnan K, Julien C, O'Hair M, Tunis R, Lee G, Rangel A, Custer J, Baranowski T, Rathouz PJ, Kim MT. Sensor-Controlled Digital Game for Heart Failure Self-management: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 May 10;12:e45801. doi: 10.2196/45801. PMID 37163342
Identifiers
NCT: NCT05056129 · STUDY00001438 · R01HL160692