Recruiting

Digital Game

Sponsor:

University of Texas at Austin

Code:

NCT05056129

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Sensor-controlled digital game (SCDG)

Sensor Only

Study Details

Brief 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.

Conditions

Heart Failure

Study ID

NCT05056129

Start date

Nov 1, 2022

Status verified date

Jan, 2026

Completion date

Jan 31, 2026

Anticipated

Primary completion date

Dec 30, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Sensor-controlled digital game (SCDG)

The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors

active comparator: Sensors-only

The control group will receive only the weight monitoring and physical activity sensors

Interventions

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.

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 measure

  • Number of Days With Weight-monitoring on Sensor Logs at 6 Weeks [ Time Frame: 6 weeks ]
  • Number of Days With Weight-monitoring on Sensor Logs at 12 Weeks [ Time Frame: 12 weeks ]
  • Number of Days With Weight-monitoring on Sensor Logs at 24 Weeks [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Angelica Rangel, MS

512-956-8714arangel@nursing.utexas.edu

Locations

The University of Texas Austin

Recruiting

Austin, Texas, United States, 78701

Contacts

Kavita Radhakrishnan, PhD

512-471-7937kradhakrishnan@mail.nur.utexas.edu

Principal Investigator:

Kavita Radhakrishnan, PhD

More Information

Sponsor

University of Texas at Austin

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2026-01-16.