Trial Outcomes & Findings for Sensor-controlled Digital Game for Heart Failure Self-management (NCT NCT03947983)

NCT ID: NCT03947983

Last Updated: 2021-06-28

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 38 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2021-06-28

Participant Flow

Participant milestones

Measure	Intervention Group The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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 heart failure (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.	Control Group The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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 heart failure (HF) educational material.However, the data from the Withings sensors will not be routed to the SCDG.
Overall Study STARTED	19	19
Overall Study 12 Weeks	15	17
Overall Study COMPLETED	14	13
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sensor-controlled Digital Game for Heart Failure Self-management

Baseline characteristics by cohort

Measure	Intervention Group n=19 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=19 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.	Total n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=93 Participants	9 Participants n=4 Participants	20 Participants n=27 Participants
Age, Categorical >=65 years	8 Participants n=93 Participants	10 Participants n=4 Participants	18 Participants n=27 Participants
Sex: Female, Male Female	10 Participants n=93 Participants	10 Participants n=4 Participants	20 Participants n=27 Participants
Sex: Female, Male Male	9 Participants n=93 Participants	9 Participants n=4 Participants	18 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=93 Participants	19 Participants n=4 Participants	35 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) White	16 Participants n=93 Participants	13 Participants n=4 Participants	29 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	19 participants n=93 Participants	19 participants n=4 Participants	38 participants n=27 Participants
Last heart failure hospitalization < 6 months	6 Participants n=93 Participants	5 Participants n=4 Participants	11 Participants n=27 Participants
Last heart failure hospitalization 7 months to 1 year	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Last heart failure hospitalization > 1 year	11 Participants n=93 Participants	11 Participants n=4 Participants	22 Participants n=27 Participants
Duration with heart failure diagnosis < 30 days	5 Participants n=93 Participants	6 Participants n=4 Participants	11 Participants n=27 Participants
Duration with heart failure diagnosis 1 month to 1 year	8 Participants n=93 Participants	5 Participants n=4 Participants	13 Participants n=27 Participants
Duration with heart failure diagnosis > 1 year	6 Participants n=93 Participants	8 Participants n=4 Participants	14 Participants n=27 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Based on participants available for data collection 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).

Outcome measures

Measure	Intervention Group n=15 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=17 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Number of Days With Weight-monitoring on Sensor Logs at 6 Weeks	35.8 days Standard Deviation 6.0	32.9 days Standard Deviation 10.5

PRIMARY outcome

Timeframe: 12 weeks

Population: Based on participants available for data collection 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).

Outcome measures

Measure	Intervention Group n=15 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=17 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Number of Days With Weight-monitoring on Sensor Logs at 12 Weeks	69.7 days Standard Deviation 16.1	60.1 days Standard Deviation 18.7

SECONDARY outcome

Timeframe: 6 weeks

Population: Based on participants available for data collection 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.

Outcome measures

Measure	Intervention Group n=15 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=16 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Number of Days With Physical Activity on Sensor Logs at 6 Weeks	36.7 Days Standard Deviation 10.9	39.2 Days Standard Deviation 6.6

SECONDARY outcome

Timeframe: 12 weeks

Population: Based on participants available for data collection 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.

Outcome measures

Measure	Intervention Group n=15 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=16 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Number of Days With Physical Activity on Sensor Logs at 12 Weeks	76.6 days Standard Deviation 11.02	69.6 days Standard Deviation 17.3

SECONDARY outcome

Timeframe: 6 weeks

Population: Based on participants available for data collection 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.

Outcome measures

Measure	Intervention Group n=15 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=16 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Mean of Daily Steps on Physical Activity Sensor Logs at 6 Weeks	2742 steps Standard Deviation 2499	2638 steps Standard Deviation 1573

SECONDARY outcome

Timeframe: 12 weeks

Population: Based on participants available for data collection 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.

Outcome measures

Measure	Intervention Group n=15 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=16 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Mean of Daily Steps on Physical Activity Sensor Logs at 12 Weeks	2887 steps Standard Deviation 2821	2541 steps Standard Deviation 1604

SECONDARY outcome

Timeframe: Baseline, 6 weeks

Population: Based on participants available for data collection for this measure 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

Outcome measures

Measure	Intervention Group n=15 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=15 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 6 Weeks	4.9 score on a scale Standard Deviation 20.4	-2.7 score on a scale Standard Deviation 9.9

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: Based on participants available for data collection for this measure 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

Outcome measures

Measure	Intervention Group n=15 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=16 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 12 Weeks	9.3 score on a scale Standard Deviation 16.5	2.6 score on a scale Standard Deviation 12.4

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: Based on participants available for data collection for this measure 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

Outcome measures

Measure	Intervention Group n=12 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=13 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Change From Baseline in Heart Failure Self-management Behaviors as Measured by the European Heart Failure Self-care Behavior Scale at 24 Weeks	10.2 score on a scale Standard Deviation 13.4	0.5 score on a scale Standard Deviation 9.8

SECONDARY outcome

Timeframe: Baseline, 6 weeks

Population: Based on participants available for data collection for this measure 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.

Outcome measures

Measure	Intervention Group n=14 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=16 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6 Weeks	5.8 score on a scale Standard Deviation 13.1	8.7 score on a scale Standard Deviation 15.3

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: Based on participants available for data collection for this measure 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.

Outcome measures

Measure	Intervention Group n=14 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=16 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 Weeks	8.2 score on a scale Standard Deviation 13.5	13.0 score on a scale Standard Deviation 19.3

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: Based on participants available for data collection for this measure 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.

Outcome measures

Measure	Intervention Group n=13 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=13 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Change From Baseline in Heart Failure-related Quality of Life (QOL) on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 24 Weeks	10.8 score on a scale Standard Deviation 16.9	15.4 score on a scale Standard Deviation 19.6

SECONDARY outcome

Timeframe: Baseline, 6 weeks

Population: Based on participants available for data collection for this measure 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.

Outcome measures

Measure	Intervention Group n=14 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=16 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6 Weeks	6.9 score on a scale Standard Deviation 14.1	1.7 score on a scale Standard Deviation 11.8

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: Based on participants available for data collection for this measure 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.

Outcome measures

Measure	Intervention Group n=14 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=16 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 Weeks	3.7 score on a scale Standard Deviation 14.1	4.1 score on a scale Standard Deviation 12.6

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: Based on participants available for data collection for this measure 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.

Outcome measures

Measure	Intervention Group n=13 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=13 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Change From Baseline in Heart Failure-related Functional Status on Kansas City Cardiomyopathy Questionnaire (KCCQ) at 24 Weeks	7.4 score on a scale Standard Deviation 10.7	6.5 score on a scale Standard Deviation 11.7

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: Based on participants available for data collection for this measure at 24 weeks.

This measure of number of cardiac hospitalizations in the past 6 months was obtained through participant self-report

Outcome measures

Measure	Intervention Group n=13 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=13 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Number of Heart Failure Hospitalizations in the Past 6 Months at End of 24 Weeks as Assessed by Self-report	2 hospitalizations	2 hospitalizations

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: Based on participants available for data collection for this measure at 12 weeks.

This measure will be obtained through participant self-report

Outcome measures

Measure	Intervention Group n=15 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=16 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Number of Heart Failure Hospitalizations in the Past Month at End of 12 Weeks as Assessed by Self-report	0 hospitalizations	1 hospitalizations

SECONDARY outcome

Timeframe: Baseline, 6 weeks

Population: Based on participants available for data collection for this measure at 6 weeks.

This measure will be obtained through participant self-report

Outcome measures

Measure	Intervention Group n=15 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=16 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Number of Heart Failure Hospitalizations in the Past Month at End of 6 Weeks as Assessed by Self-report	1 hospitalizations	1 hospitalizations

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: Based on participants available for data collection for this measure at 24 weeks.

This measure will be obtained through participant self-report

Outcome measures

Measure	Intervention Group n=13 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=13 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Number of Heart Failure Hospitalizations in the Past Month at End of 24 Weeks as Assessed by Self-report	1 hospitalizations	0 hospitalizations

SECONDARY outcome

Timeframe: Baseline, 6 weeks

Population: Based on participants available for data collection for this measure 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

Outcome measures

Measure	Intervention Group n=14 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=16 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 6 Weeks	1.9 score on a scale Standard Deviation 2.5	2.1 score on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: Based on participants available for data collection for this measure 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

Outcome measures

Measure	Intervention Group n=14 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=16 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 12 Weeks	1.4 score on a scale Standard Deviation 1.7	1.1 score on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: Baseline,24 weeks

Population: Based on participants available for data collection for this measure 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

Outcome measures

Measure	Intervention Group n=12 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=13 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Change From Baseline in Heart Failure Self-management Knowledge on Atlanta Heart Failure Knowledge Test (AHKT) at 24 Weeks	1.1 score on a scale Standard Deviation 2.1	1.1 score on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: Baseline, 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.

Outcome measures

Measure	Intervention Group n=12 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=13 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 24 Weeks	3.0 score on a scale Standard Deviation 18.0	7.0 score on a scale Standard Deviation 16.5

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: Based on participants available for data collection for this measure 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.

Outcome measures

Measure	Intervention Group n=14 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=16 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 12 Weeks	1.0 score on a scale Standard Deviation 20.5	10.2 score on a scale Standard Deviation 12.3

SECONDARY outcome

Timeframe: Baseline, 6 weeks

Population: Based on participants available for data collection for this measure 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.

Outcome measures

Measure	Intervention Group n=14 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=16 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Change From Baseline in Heart Failure Self-efficacy on Self-efficacy Section of Self-care of Heart Failure Index at 6 Weeks	2.2 score on a scale Standard Deviation 25.7	6.9 score on a scale Standard Deviation 18.1

SECONDARY outcome

Timeframe: Baseline, 6 weeks

Population: Based on participants available for data collection for this measure 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.

Outcome measures

Measure	Intervention Group n=14 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=17 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 6 Weeks	-0.1 score on a scale Standard Deviation 1.2	-0.2 score on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: Based on participants available for data collection for this measure 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.

Outcome measures

Measure	Intervention Group n=14 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=17 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 12 Weeks	0.1 score on a scale Standard Deviation 2.6	-0.3 score on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: Based on participants available for data collection for this measure 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.

Outcome measures

Measure	Intervention Group n=13 Participants The intervention group will receive a sensor-controlled digital game (SCDG) app and weight monitoring and physical activity sensors Sensor-controlled digital game (SCDG): 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.	Control Group n=13 Participants The control group will receive only the weight monitoring and physical activity sensors Sensor Only: 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.
Change From Baseline in Relative Autonomy Index (RAI) as Measured on Treatment Self-Regulation Questionnaire (TSRQ) at 24 Weeks	-0.6 score on a scale Standard Deviation 2.5	-0.2 score on a scale Standard Deviation 2.7

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kavita Radhakrishnan

The University of Texas Austin

Phone: 5124717936

Email: kradhakrishnan@mail.nur.utexas.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place