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

NCT05056129 | Recruiting DMC

• 2 other identifiers: STUDY00001438R01HL160692
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Number of Days With Weight-monitoring on Sensor Logs at 6 Weeks

  This outcome will be measured by collecting number of days with weight-monitoring data. This measure will be collected from sensor logs within the apps for both intervention group (IG) and control group (CG).

  6 weeks

• Number of Days With Weight-monitoring on Sensor Logs at 12 Weeks

  This outcome will be measured by collecting number of days with weight-monitoring data. This measure will be collected from sensor logs within the apps for both intervention group (IG) and control group (CG).

  12 weeks

• Number of Days With Weight-monitoring on Sensor Logs at 24 Weeks

  This outcome will be measured by collecting number of days with weight-monitoring data. This measure will be collected from sensor logs within the apps for both intervention group (IG) and control group (CG).

  24 weeks

Secondary Outcomes (21)

• Mean of Daily Steps on Physical Activity Sensor Logs at 6 Weeks

  6 weeks

• Mean of Daily Steps on Physical Activity Sensor Logs at 12 Weeks

  12 weeks

• Mean of Daily Steps on Physical Activity Sensor Logs at 24 Weeks

  24 weeks

• Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 6 Weeks

  Baseline, 6 weeks

• Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 12 Weeks

  Baseline, 12 weeks

Study Arms (2)

Sensor-controlled digital game (SCDG)

EXPERIMENTAL

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

Behavioral: Sensor-controlled digital game (SCDG)

Sensors-only

ACTIVE COMPARATOR

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

Behavioral: Sensor Only

Interventions

Sensor-controlled digital game (SCDG) BEHAVIORAL

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-controlled digital game (SCDG)

Sensor Only BEHAVIORAL

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.

Sensors-only

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas at Austin: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

The University of Texas Austin

Austin, Texas, 78701, United States

RECRUITING

Related Publications (1)

• Radhakrishnan K, Julien C, O'Hair M, Tunis R, Lee G, Rangel A, Custer J, Baranowski T, Rathouz PJ, Kim MT. Sensor-Controlled Digital Game for Heart Failure Self-management: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 May 10;12:e45801. doi: 10.2196/45801.

  PMID: 37163342 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Kavita Radhakrishnan, PhD

  The University of Texas Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angelica Rangel, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 24, 2021
• Study Start: November 1, 2022
• Primary Completion: December 30, 2025
• Study Completion: January 31, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

US (1)