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

The University of Texas System (UT)

Status: Enrolling

Conditions: Heart Failure

Treatments: Behavioral: Sensor Only; Behavioral: Sensor-controlled digital game (SCDG)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05056129

STUDY00001438

R01HL160692 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Sensor-controlled digital game (SCDG)

Experimental group

Description:

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

Treatment:

Behavioral: Sensor-controlled digital game (SCDG)

Sensors-only

Active Comparator group

Description:

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

Treatment:

Behavioral: Sensor Only