University of Arkansas for Medical Sciences Northwest, 2708 S. 48(th) St, Springdale, AR 72762, USA.
University of Arkansas for Medical Sciences Northwest, 2708 S. 48(th) St, Springdale, AR 72762, USA.
Contemp Clin Trials. 2024 Nov;146:107705. doi: 10.1016/j.cct.2024.107705. Epub 2024 Sep 30.
The Republic of the Marshall Islands (RMI) is an independent nation and a member of the United States (US) Affiliated Pacific Islands through a Compact of Free Association. Health disparities in the RMI are striking, with high rates of type 2 diabetes mellitus (T2DM). The International Diabetes Federation has documented age-adjusted prevalence of T2DM at 23.0 %, compared to the US (13.2 %) and globally (9.8 %). T2DM has a devastating impact on patients and their families.
The purpose of this article is to present the study protocol for the fully powered two-arm cluster randomized controlled trial using a wait-list control to evaluate the effectiveness of a Family Diabetes Self-Management Education and Support (Family DSMES) program when delivered in a group setting by community health workers (CHWs) in faith-based organizations (FBOs) in the RMI. The study used a community engaged approach, and the study protocol includes adaptations based on the results of our one-arm pilot study.
This study will provide new and innovative information on the effectiveness of Family DSMES delivered in a group setting by CHWs in FBOs in the RMI. The knowledge gained from this research will inform DSMES interventions conducted with Marshallese and other Pacific Islander communities, as well as DSMES interventions conducted in other low-resource countries.
马绍尔群岛共和国(RMI)是一个独立的国家,通过自由联合协定成为美国的联盟太平洋岛屿之一。RMI 的健康差异显著,2 型糖尿病(T2DM)发病率很高。国际糖尿病联合会记录的 RMI 的 T2DM 年龄调整患病率为 23.0%,而美国(13.2%)和全球(9.8%)的患病率为 9.8%。T2DM 对患者及其家庭造成了毁灭性的影响。
本文旨在介绍一项完全基于两臂集群随机对照试验的研究方案,采用等待名单对照来评估家庭糖尿病自我管理教育和支持(Family DSMES)计划在 RMI 中的信仰组织(FBO)中的社区卫生工作者(CHWs)以小组形式进行时的有效性。该研究采用了社区参与的方法,并根据我们的单臂试点研究结果对研究方案进行了调整。
本研究将提供有关 RMI 中 FBO 中的 CHWs 以小组形式提供家庭 DSMES 的有效性的新的和创新的信息。从这项研究中获得的知识将为与马绍尔群岛和其他太平洋岛民社区进行的 DSMES 干预以及在其他资源匮乏国家进行的 DSMES 干预提供信息。