Pearl A. McElfish , Sheldon Riklon , Jennifer A. Andersen , James P. Selig , Jonell Hudson , Williamina Ioanna Bing , Francyne Wase-Jacklick , Jack Niedenthal , Kyle Lemari , Henry Otuafi , Philmar Mendoza-Kabua , Joseph A. Henske , Dinesh Edem , Brett Rowland , Janine Boyers Schuh , Gail O'Connor , Mohammed Ason , Andy Bauleni , Britni L. Ayers
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引用次数: 0
Abstract
Introduction
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.
Methods
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.
Summary
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.
期刊介绍:
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.