Clinical trial NCT03947983: Sensor-controlled Digital Game for Heart Failure Self-management
Official title: A Pilot Sensor-controlled Digital Gaming Intervention With Real-time Behavior Tracking to Motivate Self-management Behaviors in Older Adults With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: self-management
digital game
sensor
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-05-13
Enrollment: 38
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into two arms of intervention group or control group. The control group will receive only the weight monitoring and physical activity sensors while the intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

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).

Primary outcomes:
measure: Number of Days With Weight-monitoring on Sensor Logs at 6 Weeks
timeFrame: 6 weeks
measure: Number of Days With Weight-monitoring on Sensor Logs at 12 Weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Days With Physical Activity on Sensor Logs at 6 Weeks
timeFrame: 6 weeks
measure: Number of Days With Physical Activity on Sensor Logs at 12 Weeks
timeFrame: 12 weeks
measure: Mean of Daily Steps on Physical Activity Sensor Logs at 6 Weeks
timeFrame: 6 weeks
measure: Mean of Daily Steps on Physical Activity Sensor Logs at 12 Weeks
timeFrame: 12 weeks
measure: Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 6 Weeks
timeFrame: Baseline, 6 weeks
measure: Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 12 Weeks
timeFrame: Baseline, 12 weeks
measure: Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 24 Weeks
timeFrame: Baseline, 24 weeks
measure: Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6 Weeks
timeFrame: Baseline, 6 weeks
measure: Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 Weeks
timeFrame: Baseline, 12 weeks
measure: Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 24 Weeks
timeFrame: Baseline, 24 weeks
measure: Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6 Weeks
timeFrame: Baseline, 6 weeks
measure: Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 Weeks
timeFrame: Baseline, 12 weeks
measure: Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 24 Weeks
timeFrame: Baseline, 24 weeks
measure: Number of Heart Failure Hospitalizations in the Past 6 Months at End of 24 Weeks as Assessed by Self-report
timeFrame: Baseline, 24 weeks
measure: Number of Heart Failure Hospitalizations in the Past Month at End of 12 Weeks as Assessed by Self-report
timeFrame: Baseline, 12 weeks
measure: Number of Heart Failure Hospitalizations in the Past Month at End of 6 Weeks as Assessed by Self-report
timeFrame: Baseline, 6 weeks
measure: Number of Heart Failure Hospitalizations in the Past Month at End of 24 Weeks as Assessed by Self-report
timeFrame: Baseline, 24 weeks
measure: Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 6 Weeks
timeFrame: Baseline, 6 weeks
measure: Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 12 Weeks
timeFrame: Baseline, 12 weeks
measure: Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 24 Weeks
timeFrame: Baseline,24 weeks
measure: Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 24 Weeks
timeFrame: Baseline, 24 weeks
measure: Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 12 Weeks
timeFrame: Baseline, 12 weeks
measure: Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 6 Weeks
timeFrame: Baseline, 6 weeks
measure: Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 6 Weeks
timeFrame: Baseline, 6 weeks
measure: Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 12 Weeks
timeFrame: Baseline, 12 weeks
measure: Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 24 Weeks
timeFrame: Baseline, 24 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: Cardiac Floor, Seton Medical Center Austin
state: Texas
city: Austin
country: United States
facility: Cardiac Rehabilitation Center, Seton Medical Center Austin
state: Texas
Study officials:
affiliation: The University of Texas Austin
name: Kavita Radhakrishnan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Radhakrishnan K, Julien C, Baranowski T, O'Hair M, Lee G, Sagna De Main A, Allen C, Viswanathan B, Thomaz E, Kim M. Feasibility of a Sensor-Controlled Digital Game for Heart Failure Self-management: Randomized Controlled Trial. JMIR Serious Games. 2021 Nov 8;9(4):e29044. doi: 10.2196/29044.