This study evaluates a sensor-controlled digital game (SCDG) to motivate self-management behaviors of physical activity in Native American adults with hypertension (HTN). Half of the participants will receive the SCDG app and physical activity sensors and the other half will receive only the physical activity sensors.
Native American participants with hypertension (HTN) in the sensor controlled digital game intervention group will show increased PA behaviors; improved HTN knowledge, self-care behaviors, self-efficacy, motivation, and quality of life (QoL); and larger reduction in systolic and diastolic blood pressure and cardiac hospitalizations at baseline,3 months, and 6 months as compared to participants in the sensor-only control group.
Adults in a Native American tribal community in southeastern U.S.
Age 18 years or older
Systolic BP ≥140mm Hg and/or diastolic BP ≥90mm Hg on 2 separate measurements or who are on antihypertensive medication will be included.
Pass a mini-cognitive screen
Severe visual (e.g., legal blindness) or tactile (e.g., severe arthritis) impairments that adversely prevent use of a smart phone or sensor devices;
Chronic kidney disease stage 4-5,
Diagnosis of end stage or terminal illness (e.g., cancer or heart failure)
Prior heart transplantation or implantation of a durable mechanical circulatory support device (e.g., left ventricular assist devise) due to unique self-care needs.
Parallel
Sensor-controlled digital game
BehavioralThe SCDG will involve a narrative, the goal of which is to help an avatar in the game avoid hospitalization by using game points, earned via the participant's real-time behaviors, in game tasks that help maintain the avatar's optimal Hypertension 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 to motivate engagement in and generate habit formation of heart failure related self-management behaviors.
Sensor only
BehavioralReal-time behaviors of physical activity will be tracked by an off-the-shelf sensor and app (Withings). This group will also be provided with standardized evidence-based Hypertension educational material. However, the data from the Withings sensor will not be routed to the SCDG.
Mean of Daily Steps on Physical Activity Sensor Logs at 3 months
This outcome measure will be measured by calculating the average daily steps at end of 3 months. These measures will be collected from sensor logs within the apps for both IG and CG.
Mean of Daily Steps on Physical Activity Sensor Logs at 6 months
This outcome measure will be measured by calculating the average daily steps at end of 6 months. These measures will be collected from sensor logs within the apps for both IG and CG.
Change from baseline in Mean Systolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 3 months.
Systolic blood Pressure (SBP) of participants will be measured at baseline using a FDA approved digital sphygmomanometer (A\&D UA-767). The A\&D UA-767 is a fully automated device based on the oscillometric method and has been validated against a mercury sphygmomanometer. Participants will be instructed to refrain from using tobacco products, alcohol, or caffeine for 30 minutes before measurement. Participants will sit quietly, resting the left arm on a flat surface (at the heart's level) for at least 5 minutes before the first measurement. Three measurements will be taken at 1-minute intervals; the second and third readings recorded in mmHg will be averaged to obtain the mean SBP.
Change from baseline in Mean Systolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 6 months.
Systolic blood Pressure (SBP) of participants will be measured at baseline using a FDA approved digital sphygmomanometer (A\&D UA-767). The A\&D UA-767 is a fully automated device based on the oscillometric method and has been validated against a mercury sphygmomanometer. Participants will be instructed to refrain from using tobacco products, alcohol, or caffeine for 30 minutes before measurement. Participants will sit quietly, resting the left arm on a flat surface (at the heart's level) for at least 5 minutes before the first measurement. Three measurements will be taken at 1-minute intervals; the second and third readings recorded in mmHg will be averaged to obtain the mean SBP.
Change from baseline in Mean Diastolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 3 months.
Diastolic blood Pressure (DBP) of participants will be measured at baseline using a FDA approved digital sphygmomanometer (A\&D UA-767). The A\&D UA-767 is a fully automated device based on the oscillometric method and has been validated against a mercury sphygmomanometer. Participants will be instructed to refrain from using tobacco products, alcohol, or caffeine for 30 minutes before measurement. Participants will sit quietly, resting the left arm on a flat surface (at the heart's level) for at least 5 minutes before the first measurement. Three measurements will be taken at 1-minute intervals; the second and third readings recorded in mmHg will be averaged to obtain the mean DBP.
Change from baseline in Mean Diastolic Blood Pressure as measured by a FDA approved digital sphygmomanometer at 6 months.
Diastolic blood Pressure (DBP) of participants will be measured at baseline using a FDA approved digital sphygmomanometer (A\&D UA-767). The A\&D UA-767 is a fully automated device based on the oscillometric method and has been validated against a mercury sphygmomanometer. Participants will be instructed to refrain from using tobacco products, alcohol, or caffeine for 30 minutes before measurement. Participants will sit quietly, resting the left arm on a flat surface (at the heart's level) for at least 5 minutes before the first measurement. Three measurements will be taken at 1-minute intervals; the second and third readings recorded in mmHg will be averaged to obtain the mean DBP.
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University of Texas at Austin
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
