Harte Rory, Norton Lindsey, Whitehouse Christina, Lorincz Ilona, Jones Denerale, Gerald Norma, Estrada Irene, Sabini Carolyn, Mitra Nandita, Long Judith A, Cappella Joseph, Glanz Karen, Volpp Kevin G, Kangovi Shreya
Division of General Internal Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Penn Center for Community Health Workers, Penn Medicine, Philadelphia, PA, USA.
Contemp Clin Trials Commun. 2021 Dec 9;25:100878. doi: 10.1016/j.conctc.2021.100878. eCollection 2022 Feb.
Insulin-dependent diabetes is a challenging disease to manage and involves complex behaviors, such as self-monitoring of blood glucose. This can be especially challenging in the face of socioeconomic barriers and in the wake of the COVID-19 pandemic. Digital health self-monitoring interventions and community health worker support are promising and complementary best practices for improving diabetes-related health behaviors and outcomes. Yet, these strategies have not been tested in combination. This protocol paper describes the rationale and design of a trial that measures the combined effect of digital health and community health worker support on glucose self-monitoring and glycosylated hemoglobin.
The study population was uninsured or publicly insured; lived in high-poverty, urban neighborhoods; and had poorly controlled diabetes mellitus with insulin dependence. The study consisted of three arms: usual diabetes care; digital health self-monitoring; or combined digital health and community health worker support. The primary outcome was adherence to blood glucose self-monitoring. The exploratory outcome was change in glycosylated hemoglobin.
The design of this trial was grounded in social justice and community engagement. The study protocols were designed in collaboration with frontline community health workers, the study aim was explicit about furthering knowledge useful for advancing health equity, and the population was focused on low-income people. This trial will advance knowledge of whether combining digital health and community health worker interventions can improve glucose self-monitoring and diabetes-related outcomes in a high-risk population.
胰岛素依赖型糖尿病是一种管理起来颇具挑战性的疾病，涉及复杂行为，如血糖自我监测。面对社会经济障碍以及在新冠疫情之后，这可能尤其具有挑战性。数字健康自我监测干预措施和社区卫生工作者支持是改善糖尿病相关健康行为及结果的有前景且互补的最佳实践。然而，这些策略尚未进行联合测试。本方案文件描述了一项试验的基本原理和设计，该试验旨在衡量数字健康与社区卫生工作者支持相结合对血糖自我监测和糖化血红蛋白的综合影响。
研究人群为未参保或参加公共保险者；居住在高贫困率的城市社区；患有胰岛素依赖型糖尿病且控制不佳。该研究包括三个组：常规糖尿病护理；数字健康自我监测；或数字健康与社区卫生工作者支持相结合。主要结局是血糖自我监测的依从性。探索性结局是糖化血红蛋白的变化。
本试验的设计基于社会正义和社区参与。研究方案是与一线社区卫生工作者合作设计的，研究目的明确是为推进有助于促进健康公平的知识，且研究人群聚焦于低收入人群。该试验将推进关于数字健康与社区卫生工作者干预措施相结合是否能改善高危人群血糖自我监测及糖尿病相关结局的知识。
