NCT05056129 · University of Texas at Austin
Sensor-controlled Digital Game for Heart Failure Self-management: A Clinical Trial
(SCDG)
What this study is about
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.
View original scientific description
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.
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 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.
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
This outcome will be measured by collecting number of days with weight-monitoring data. This measure will be collected from sensor logs within the apps for both intervention group (IG) and control group (CG).
Number of Days With Weight-monitoring on Sensor Logs at 12 Weeks
Time frame: 12 weeks
This outcome will be measured by collecting number of days with weight-monitoring data. This measure will be collected from sensor logs within the apps for both intervention group (IG) and control group (CG).
Number of Days With Weight-monitoring on Sensor Logs at 24 Weeks
Time frame: 24 weeks
This outcome will be measured by collecting number of days with weight-monitoring data. This measure will be collected from sensor logs within the apps for both intervention group (IG) and control group (CG).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Austin, Texas
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 16, 2026 · Source of record for eligibility and locations