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Sensor-controlled Digital Game for Heart Failure Self-management: A Clinical Trial

Sensor-controlled Digital Game for Heart Failure Selfmanagement Behavior Adherence: A Randomized Controlled Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 24 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a sensor-controlled digital game helps adults with heart failure check their weight and stay active. It is for adults age 45 or older who were hospitalized for heart failure in the past year. Half will get the game app and sensors that track weight and activity; the other half will get only the sensors.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 45 or older.
  • Have heart failure in classes I to III, meaning you can do at least light activity without discomfort.
  • Have been hospitalized for heart failure in the past 12 months.
  • Be fluent in English.
  • Pass a short test of memory and thinking.
  • Be able to walk on your own without a cane or walker.

Who can't join

  • Have severe problems with vision or touch, such as blindness or severe arthritis, that prevent you from using a smartphone or sensors.
  • Have a history of kidney failure.
  • Have an illness in its final stage or one expected to cause death, such as terminal cancer.
  • Have had a heart transplant or a long-term implanted device that helps your heart pump blood.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

TX