Heart Failure Clinical Trial

Sensor-controlled Digital Game for Heart Failure Self-management

Summary

This study evaluates a sensor-controlled digital game (SCDG) to motivate self-management behaviors of weight monitoring and physical activity in older 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.

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Full Description

The primary goal of this study is to obtain initial efficacy data and undertake a comprehensive feasibility assessment of a SCDG intervention that synchronizes with a Bluetooth-enabled weight scale and activity tracker to activate game rewards and feedback based on older adult heart failure (HF) participants' real-time weight monitoring and exercise behaviors.

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. The goal of this proposal is to demonstrate the feasibility of the SCDG concept with an optimal number of sensors in a small study so as to lay a foundation for scaling this concept to include more relevant sensors in longer, larger studies.

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, 44 older adults diagnosed with the New York Heart Association's HF classification I to III from out-patient HF settings in central Texas will be recruited, and 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 12 weeks or a control group that will receive sensors and an app tracking activity and weight monitoring, and standardized written HF educational modules.

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Eligibility Criteria

Inclusion Criteria:

Age 55 years or older
New York Heart Association (NYHA) heart failure classification of I to III that permits minimal physical activity without discomfort
Understand 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
Ownership of a smartphone or digital tablet

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
History of renal failure which adversely affects heart failure prognosis
Diagnosis of an end stage or terminal illness (e.g., cancer).

Study is for people with:

Heart Failure

Estimated Enrollment:

38

Study ID:

NCT03947983

Recruitment Status:

Completed

Sponsor:

University of Texas at Austin

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There is 1 Location for this study

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Cardiac Floor, Seton Medical Center Austin
Austin Texas, 78705, United States
Cardiac Rehabilitation Center, Seton Medical Center Austin
Austin Texas, 78705, United States

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Study is for people with:

Heart Failure

Estimated Enrollment:

38

Study ID:

NCT03947983

Recruitment Status:

Completed

Sponsor:


University of Texas at Austin

How clear is this clinincal trial information?

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