RecruitingNot ApplicableNCT05056129

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


Sponsor

University of Texas at Austin

Enrollment

200 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 45 Years

Inclusion Criteria6

  • 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 Criteria4

  • 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.

Interventions

BEHAVIORALSensor-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.

BEHAVIORALSensor 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.


Locations(1)

The University of Texas Austin

Austin, Texas, United States

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NCT05056129


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