Sensor-controlled Digital Game for Heart Failure Self-management

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Sensor-controlled Digital Gaming Intervention With Real-time Behavior Tracking to Motivate Self-management Behaviors in Older Adults With Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Sensor-controlled digital game (SCDG)
* Behavioral: Sensor Only


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors | Behavioral: Sensor-controlled digital game (SCDG)<br>* 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.<br>|
| Active Comparator: Control group<br>The control group will receive only the weight monitoring and physical activity sensors | Behavioral: Sensor Only<br>* Real-time behaviors of weight-monitoring and physical activity will be tracked by an off-the-shelf sensors and app (Withings). This group will also be provided with standardized evidence-based HF educational material.However, the data from the Withings sensors will not be routed to the SCDG.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Days With Weight-monitoring on Sensor Logs at 6 Weeks | This outcome will be measured by collecting number of days with weight-monitoring data. This measure will be collected from sensor logs within the apps for both intervention group (IG) and control group (CG). | 6 weeks | 
| Number of Days With Weight-monitoring on Sensor Logs at 12 Weeks | This outcome will be measured by collecting number of days with weight-monitoring data. This measure will be collected from sensor logs within the apps for both intervention group (IG) and control group (CG). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Days With Physical Activity on Sensor Logs at 6 Weeks | This outcome measure will be measured by collecting number of days with physical activity data. These measures will be collected from sensor logs within the apps for both IG and CG. | 6 weeks | 
| Number of Days With Physical Activity on Sensor Logs at 12 Weeks | This outcome measure will be measured by collecting number of days with physical activity data. These measures will be collected from sensor logs within the apps for both IG and CG. | 12 weeks | 
| Mean of Daily Steps on Physical Activity Sensor Logs at 6 Weeks | This outcome measure will be measured by calculating the average daily steps at end of 6 weeks. These measures will be collected from sensor logs within the apps for both IG and CG. | 6 weeks | 
| Mean of Daily Steps on Physical Activity Sensor Logs at 12 Weeks | This outcome measure will be measured by calculating the average daily steps at end of 12 weeks. These measures will be collected from sensor logs within the apps for both IG and CG. | 12 weeks | 
| Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 6 Weeks | The instrument used will be 9-item European Heart Failure Self-care Behavior Scale (HSBS; standardized score from 0 to 100 (every item is given an equal weight) with a higher score meaning better self-care). Items are on a Likert scale of 1 - 5. For calculating the standardized score, each item is reverse coded and then computed using the formula: (Sum of all ever-coded items - 9)*2.7777 | Baseline, 6 weeks | 
| Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 12 Weeks | The instrument used will be 9-item European Heart Failure Self-care Behavior Scale (HSBS; standardized score from 0 to 100 (every item is given an equal weight) with a higher score meaning better self-care. Items are on a Likert scale of 1 - 5. For calculating the standardized score, each item is reverse coded and then computed using the formula: (Sum of all ever-coded items - 9)*2.7777 | Baseline, 12 weeks | 
| Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 24 Weeks | The instrument used will be 9-item European Heart Failure Self-care Behavior Scale (HSBS; standardized score from 0 to 100 (every item is given an equal weight) with a higher score meaning better self-care). Items are on a Likert scale of 1 - 5. For calculating the standardized score, each item is reverse coded and then computed using the formula: (Sum of all ever-coded items - 9)*2.7777 | Baseline, 24 weeks | 
| Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6 Weeks | The instrument used will be items 13 - 15 on the KCCQ. Values for the QoL domain range from 0 to 100 with higher scores indicating better quality of life. Domain score will be transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. | Baseline, 6 weeks | 
| Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 Weeks | The instrument used will be items 13 - 15 on the KCCQ. Values for the QoL domain range from 0 to 100 with higher scores indicating better quality of life. Domain score will be transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. | Baseline, 12 weeks | 
| Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 24 Weeks | The instrument used will be items 13 - 15 on the KCCQ. Values for the QoL domain range from 0 to 100 with higher scores indicating better quality of life. Domain score will be transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. | Baseline, 24 weeks | 
| Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6 Weeks | The instrument used will be items 1-12 on the KCCQ. Values for the functional status summary score from 0 to 100 with higher scores indicating better quality of life. Summary score will be transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. | Baseline, 6 weeks | 
| Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 Weeks | The instrument used will be items 1-12 on the KCCQ. Values for the functional status summary score from 0 to 100 with higher scores indicating better quality of life. Summary score will be transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. | Baseline, 12 weeks | 
| Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 24 Weeks | The instrument used will be items 1-12 on the KCCQ. Values for the functional status summary score from 0 to 100 with higher scores indicating better quality of life. Summary score will be transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. | Baseline, 24 weeks | 
| Number of Heart Failure Hospitalizations in the Past 6 Months at End of 24 Weeks as Assessed by Self-report | This measure of number of cardiac hospitalizations in the past 6 months was obtained through participant self-report | Baseline, 24 weeks | 
| Number of Heart Failure Hospitalizations in the Past Month at End of 12 Weeks as Assessed by Self-report | This measure will be obtained through participant self-report | Baseline, 12 weeks | 
| Number of Heart Failure Hospitalizations in the Past Month at End of 6 Weeks as Assessed by Self-report | This measure will be obtained through participant self-report | Baseline, 6 weeks | 
| Number of Heart Failure Hospitalizations in the Past Month at End of 24 Weeks as Assessed by Self-report | This measure will be obtained through participant self-report | Baseline, 24 weeks | 
| Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 6 Weeks | The instrument used will be 30-item Atlanta Heart Failure Knowledge Test (AHFKT). Each correct answer is scored as 1 point, with no additional weighting of items; correct responses are then summed. Incorrect or skipped questions are awarded 0 points. Total scores range from 0 to 30. Higher scores indicate better HF knowledge | Baseline, 6 weeks | 
| Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 12 Weeks | The instrument used will be 30-item Atlanta Heart Failure Knowledge Test (AHFKT). Each correct answer is scored as 1 point, with no additional weighting of items; correct responses are then summed. Incorrect or skipped questions are awarded 0 points. Total scores range from 0 to 30. Higher scores indicate better HF knowledge | Baseline, 12 weeks | 
| Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 24 Weeks | The instrument used will be 30-item Atlanta Heart Failure Knowledge Test (AHFKT). Each correct answer is scored as 1 point, with no additional weighting of items; correct responses are then summed. Incorrect or skipped questions are awarded 0 points. Total scores range from 0 to 30. Higher scores indicate better HF knowledge | Baseline,24 weeks | 
| Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 24 Weeks | The instrument used will be 6-item Section C Self-efficacy section of Self-care of heart failure Index (SCHFI). Scores on the self-efficacy scale will range from 0 to 100, with higher scores reflecting better self-efficacy. To standardize scores the formula: (sum of Section C items - 6) * 5.56 will be used. | Baseline, 24 weeks | 
| Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 12 Weeks | The instrument used will be 6-item Section C Self-efficacy section of Self-care of heart failure Index (SCHFI). Scores on the self-efficacy scale will range from 0 to 100, with higher scores reflecting better self-efficacy. To standardize scores the formula: (sum of Section C items - 6) * 5.56 will be used. | Baseline, 12 weeks | 
| Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 6 Weeks | The instrument used will be 6-item Section C Self-efficacy section of Self-care of heart failure Index (SCHFI). Scores on the self-efficacy scale will range from 0 to 100, with higher scores reflecting better self-efficacy. To standardize scores the formula: (sum of Section C items - 6) * 5.56 will be used. | Baseline, 6 weeks | 
| Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 6 Weeks | In the 19-item Treatment Self-Regulation Questionnaire (TSRQ) adapted for heart failure, each item can receive a value ranging from 1 - 7, as selected by the participant. The scale has 2 sub-scales: autonomous and controlled motivation. Calculating the scores for the sub-scales will consist of averaging the items on that subscale. They are: Autonomous Regulation: 2, 3, 7, 10, 13, 16, 18, 19. Scores for Autonomous Regulation can range from 8 to 56. High scores indicate high autonomous motivation or intrinsic motivation for behavior engagement. Controlled Regulation: 1, 4, 5, 6, 8, 9, 11, 12, 14, 15, 17. Scores for Controlled Regulation can range from 8 to 56. High scores indicate high controlled motivation or extrinsic motivation for behavior engagement. Scoring for RAI will consist of subtracting the average for Controlled Regulation from the average for Autonomous Regulation. Higher RAI scores indicate higher autonomous or intrinsic motivation for behavior engagement. | Baseline, 6 weeks | 
| Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 12 Weeks | In the 19-item Treatment Self-Regulation Questionnaire (TSRQ) adapted for heart failure, each item can receive a value ranging from 1 - 7, as selected by the participant. The scale has 2 sub-scales: autonomous and controlled motivation. Calculating the scores for the sub-scales will consist of averaging the items on that subscale. They are: Autonomous Regulation: 2, 3, 7, 10, 13, 16, 18, 19. Scores for Autonomous Regulation can range from 8 to 56. High scores indicate high autonomous motivation or intrinsic motivation for behavior engagement. Controlled Regulation: 1, 4, 5, 6, 8, 9, 11, 12, 14, 15, 17. Scores for Controlled Regulation can range from 8 to 56. High scores indicate high controlled motivation or extrinsic motivation for behavior engagement. Scoring for RAI will consist of subtracting the average for Controlled Regulation from the average for Autonomous Regulation. Higher RAI scores indicate higher autonomous or intrinsic motivation for behavior engagement. | Baseline, 12 weeks | 
| Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 24 Weeks | In the 19-item Treatment Self-Regulation Questionnaire (TSRQ) adapted for heart failure, each item can receive a value ranging from 1 - 7, as selected by the participant. The scale has 2 sub-scales: autonomous and controlled motivation. Calculating the scores for the sub-scales will consist of averaging the items on that subscale. They are: Autonomous Regulation: 2, 3, 7, 10, 13, 16, 18, 19. Scores for Autonomous Regulation can range from 8 to 56. High scores indicate high autonomous motivation or intrinsic motivation for behavior engagement. Controlled Regulation: 1, 4, 5, 6, 8, 9, 11, 12, 14, 15, 17. Scores for Controlled Regulation can range from 8 to 56. High scores indicate high controlled motivation or extrinsic motivation for behavior engagement. Scoring for RAI will consist of subtracting the average for Controlled Regulation from the average for Autonomous Regulation. Higher RAI scores indicate higher autonomous or intrinsic motivation for behavior engagement. | Baseline, 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-management, digital game, sensor