Radhakrishnan Kavita, Im Cheongin Rachel, Brooks Jada L, Fallon Gail Currin, Rangel Angelica, Julien Christine, O'Hair Matthew, Liang Huigang, Lowe John
School of Nursing, The University of Texas at Austin, 1710 Red River St, Austin, TX, 78712, USA.
School of Nursing, The University of North Carolina at Chapel Hill, Carrington Hall, S Columbia St, Chapel Hill, NC27599, USA.
Trials. 2025 Sep 1;26(1):329. doi: 10.1186/s13063-025-09026-y.
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.
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.
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.
ClinicalTrials.gov NCT05671406. Registered on January 9, 2024.
高血压是美国原住民（NA）心血管（CV）健康的主要危险因素，导致了死亡率、住院率以及包括中风和肾脏疾病在内的并发症方面的差异。然而，尽管生活方式改变对心血管健康有益，但系统和文化障碍阻碍了这些改变的实施。为了促进自我护理行为，干预措施必须在文化上进行调整且具有可持续性。数字游戏（DG）提供了一种有前景的、基于社区的方法，以增强美国原住民对高血压（HTN）的自我护理，这与美国原住民的传统做法相一致，即游戏促进技能培养和参与度。本研究聚焦于面临显著高血压相关差异的伦贝族美国原住民社区。通过基于社区的参与性研究，我们正在开发一款经过文化调整的、由本地传感器控制的数字游戏（N-SCDG），以支持高血压自我护理行为。
这是一项前瞻性、随机（1:1）对照临床试验，分为两组，旨在评估经过文化调整的N-SCDG对伦贝族成年人在3个月和6个月时参与高血压自我护理行为及相关健康结果的影响。来自罗伯逊县伦贝族部落社区且年龄≥18岁并被诊断为高血压的成年人将被随机分为N-SCDG干预组或仅使用传感器的对照组。两组都将获得一个Fitbit活动追踪器以监测身体活动（PA）。N-SCDG组将参与该游戏，游戏融入了基于证据的高血压教育内容，而对照组将以书面形式接受相同的高血压教育。主要结局是活动追踪器在3个月和6个月时记录的平均每日步数。次要结局包括收缩压（SBP）、舒张压（DBP）、血压控制、高血压知识、自我效能感、自我护理动机、生活质量（QoL）以及心脏住院率。
这项对N-SCDG以增强伦贝族成年人高血压自我护理的评估将把与文化相关的设计与基于证据的教育相结合，从而填补美国原住民在使用数字健康工具方面的空白。研究结果将提供关于数字健康干预对改善高血压结局及促进服务不足的美国原住民社区健康公平性影响的重要数据。
ClinicalTrials.gov NCT05671406。于2024年1月9日注册。
