Sensor-controlled Digital Game for Heart Failure Self-management: A Clinical Trial
Recruiting · NCT05056129 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Texas at Austin
View the official record on ClinicalTrials.gov →Interventions studied
Sensor OnlySensor-controlled digital game (SCDG)
What this trial 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.
Who can take part
Age range
45 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- The University of Texas Austin - Austin, Texas, United States