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

NCT ID: NCT05056129

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2026-01-31

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.

Detailed Description

The primary goal of this study is to obtain efficacy data through a randomized controlled trial of a SCDG intervention that synchronizes with a Bluetooth-enabled weight scale and activity tracker to activate game rewards and feedback based on real-time weight monitoring and exercise behaviors of adult heart failure (HF) participants who are older than 45 years.

The SCDG involves a narrative, the goal of which is to help the avatar maintain good health and quality of life 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. The goal of this proposal is to determine efficacy of the SCDG concept for heart failure self-management in a real-world setting.

In this study, the initial efficacy of the SCDG intervention for primary outcome of rate of engagement in HF self-management behavior of weight-monitoring and secondary outcomes of physical activity engagement, HF self-management-knowledge, and self-efficacy, HF-functional status, hospitalization, cognitive ability, depression and quality of life will be evaluated. For this study, 200 adults who are 45 years or older and who experienced HF hospitalization in the past 12 months will be recruited through online recruiting methods from 7 southern U.S states of Alabama, Arkansas, Georgia, Louisiana, Mississippi, Oklahoma, Texas. 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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Sensor-controlled digital game (SCDG)

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

Group Type: EXPERIMENTAL

Sensor-controlled digital game (SCDG)

Intervention Type: 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.

Sensors-only

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

Group Type: ACTIVE_COMPARATOR

Sensor Only

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kavita Radhakrishnan, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Austin

Locations

The University of Texas Austin

Austin, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Angelica Rangel, MS

Role: CONTACT

arangel@nursing.utexas.edu

512-956-8714

Facility Contacts

Kavita Radhakrishnan, PhD

Role: primary

kradhakrishnan@mail.nur.utexas.edu

512-471-7937

References

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.

Reference Type: DERIVED

PMID: 37163342 (View on PubMed)

Other Identifiers

R01HL160692

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00001438

Identifier Type: -

Identifier Source: org_study_id