Digital game to help manage heart failure
Sensor-controlled Digital Game for Heart Failure Selfmanagement Behavior Adherence: A Randomized Controlled Trial
This study is testing a fun digital game to see if it can help adults with heart failure manage their health better by encouraging them to monitor their weight and stay active.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | University of Texas at Austin Academic / other |
| Locations | 1 site (Austin, Texas) |
| Trial ID | NCT05056129 on ClinicalTrials.gov |
What this trial studies
This study evaluates a sensor-controlled digital game designed to motivate self-management behaviors in adults with heart failure. Participants will be randomly assigned to either receive the digital game app along with weight monitoring and physical activity sensors or just the sensors alone. The game provides real-time feedback and rewards based on participants' weight and activity levels, aiming to encourage healthier behaviors. The primary goal is to assess the effectiveness of this intervention in improving self-management practices among heart failure patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 45 and older with a New York Heart Association classification of I to III who have experienced heart failure hospitalization in the past year.
Not a fit: Patients with severe visual or tactile impairments, end-stage illnesses, or those who have undergone heart transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance self-management and improve health outcomes for patients with heart failure.
How similar studies have performed: While the use of digital games for health management is a growing field, this specific approach using a sensor-controlled game for heart failure self-management is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Austin, Texas
- The University of Texas Austin — Austin, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Kavita Radhakrishnan, PhD — The University of Texas Austin
- Study coordinator: Angelica Rangel, MS
- Email: arangel@nursing.utexas.edu
- Phone: 512-956-8714
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.