RCT of Sensor-controlled Digital Game for Hypertension Self-care in a Native American Community

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2023
Cardiovascular disease is the leading cause of death among Native Americans (NAs).Hypertension (HTN) strongly elevates the morbidity and mortality risks related tocardiovascular disease. Lifestyle modifications promoted by U.S. HTN guidelines includesmodifiable self‐care behaviors such as regular physical activity which is associated withlower blood pressure, reduced cardiovascular risk, and beneficial cardiac structuralremodeling. Therefore, motivating physical activity behaviors would be key tocardiovascular health promotion efforts among a Native American community.One promising approach is the use of sensor‐controlled digital games (SCDGs), which offeraffordable, portable, and scalable tools to facilitate engagement in HTN self‐carebehaviors while being enjoyable and easy to use. The SCDG intervention integrates HTNparticipants' behavioral data from an activity tracker sensor to activate game progress,rewards, and feedback. The primary goal of this study is to test a culturally adaptedSCDG intervention (N‐SCDG) for improving daily physical activity self‐care behaviorsamong Lumbee tribal adults with HTN and examine approaches for sustaining the impact ofthe N‐SCDG at the community level.The investigators will compare the N‐SCDG intervention versus a sensor‐only control forthe primary outcome of engagement in the HTN selfcare behavior of physical activity andthe secondary outcomes of HTN self‐care knowledge, self‐care behaviors, self‐efficacy,systolic and diastolic blood pressure, cardiac hospitalization, and quality of life atbaseline, 3 months, and 6 months. The investigators will randomize 220 participants toeither the N‐SCDG intervention group, in which participants will receive sensors thattrack physical activity and will play the N‐SCDG on a mobile smart phone, or a controlgroup that will receive sensors, an app that tracks physical activity, and standardizedwritten HTN educational materials.
Epistemonikos ID: 3dbad3ad97ae3c465bad016c139c698d5eb5eaed
First added on: Feb 19, 2024