Clinical trial NCT05056129: Sensor-controlled Digital Game for Heart Failure Self-management: A Clinical Trial
Official title: Sensor-controlled Digital Game for Heart Failure Selfmanagement Behavior Adherence: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-09-24
Enrollment: 200
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

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
measure: Number of Days With Weight-monitoring on Sensor Logs at 24 Weeks
timeFrame: 24 weeks
Secondary outcomes:
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: Mean of Daily Steps on Physical Activity Sensor Logs at 24 Weeks
timeFrame: 24 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 Month at End of 6 Weeks
timeFrame: Baseline, 6 weeks
measure: Number of Heart Failure Hospitalizations in the Past Month at End of 12 Weeks
timeFrame: Baseline, 12 weeks
measure: Number of Heart Failure Hospitalizations in the Past Month at End of 24 Weeks
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 6 Weeks
timeFrame: Baseline, 6 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 24 Weeks
timeFrame: Baseline, 24 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas Austin
state: Texas
Study officials:
affiliation: The University of Texas Austin
name: Kavita Radhakrishnan, PhD
role: PRINCIPAL_INVESTIGATOR
References: