Sensor-controlled digital game for Native American adults in the Lumbee Tribe with hypertension self-management: study protocol for a randomized controlled trial.

Background: Hypertension is a major risk factor for cardiovascular (CV) health in Native Americans (NAs), contributing to disparities in mortality, hospitalizations, and complications that include stroke and kidney diseases. However, despite the benefits of lifestyle modifications for CV health, systemic and cultural barriers hinder their adoption. To promote self-care behaviors, interventions must be culturally tailored and sustainable. Digital games (DGs) offer a promising, community-based approach to enhance self-care for hypertension (HTN) in NAs, aligning with traditional NA practices in which games foster skill-building and engagement. This study focuses on the Lumbee NA community, which faces significant HTN-related disparities. Using community-based participatory research, we are developing a culturally tailored, native-sensor-controlled digital game (N-SCDG) to support HTN self-care behaviors.

Methods: This is a prospective, randomized (1:1) controlled clinical trial with two groups, to evaluate the impact of a culturally tailored N-SCDG on engagement in HTN self-care behaviors and related health outcomes among Lumbee adults at 3 and 6 months. Adults aged ≥ 18 years from the Lumbee tribal community in Robeson County and diagnosed with HTN will be randomized into an N-SCDG intervention group or a sensor-only control group. Both groups will receive a Fitbit activity tracker to monitor physical activity (PA). The N-SCDG group will engage in the game, which incorporates evidence-based HTN education, while the control group will receive the same HTN education in written format. The primary outcome is the mean daily step count, recorded by the activity tracker at 3 and 6 months. Secondary outcomes include systolic blood pressure (SBP), diastolic blood pressure (DBP), BP control, HTN knowledge, self-efficacy, motivation for self-care, quality of life (QoL), and cardiac hospitalization rates.

Discussion: This evaluation of an N-SCDG to enhance HTN self-care in Lumbee adults will integrate culturally relevant design with evidence-based education and thus address a gap in use of digital health tools for NAs. The findings will provide vital data on the impact of digital health interventions to improve HTN outcomes and advance health equity in underserved NA communities.

Trial Registration: ClinicalTrials.gov NCT05671406. Registered on January 9, 2024.