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Sensor-controlled Digital Game for Heart Failure Self-management

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Heart Failure

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03947983
201800216-001
R21NR018229 (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 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.

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.

Enrollment

38 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

38 participants in 2 patient groups

Intervention Group
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)
Control group
Active Comparator group
Description:
The control group will receive only the weight monitoring and physical activity sensors
Treatment:
Behavioral: Sensor Only

Trial documents
2

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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