Kopelowicz Alex, Nandy Karabi, Ruiz Maria Elena, Polzin Rhonda, Kurator Kevin, Wali Soma
Department of Psychiatry & Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles, CA, United States.
Department of Population & Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX, United States.
JMIR Res Protoc. 2023 Jan 16;12:e44793. doi: 10.2196/44793.
The rate of Type 2 diabetes mellitus (T2DM) among Mexican American individuals is 16.3%, about twice that of non-Hispanic White individuals. While a number of education approaches have been developed and shown to improve diabetes self-management behaviors and glycemic control for Spanish-speaking Latinx patients with T2DM, there is little research to guide health practitioners regarding which interventions to apply and when so that resources are used efficiently, and treatment outcomes are maximized.
This study aimed to describe an adaptive intervention that integrates community mental health workers, diabetes nurse educators, family members, and patients as partners in care while promoting diabetes self-management for Mexican American individuals with T2DM. The project incorporates four evidence-based, culturally tailored treatments to determine what sequence of intervention strategies work most efficiently and for whom. Given the increasing prevalence of T2DM, achieving better control of diabetes and lowering the associated medical complications experienced disproportionally by Mexican American individuals is a public health priority.
Funded by the National Institute of Nursing Research (National Institutes of Health grant R01 NR015809), this project used a sequential multiple assignment randomized trial and included 330 Spanish-speaking Latinx patients with T2DM. In the first phase of the study, subjects were randomly assigned to an evidence-based diabetes self-management educational program called Tomando Control delivered in a group format for 6, biweekly 1.5-hour sessions, led either by a community health worker or a diabetes nurse educator. In the second phase of the study, those subjects who did not improve their diabetes self-management behaviors were rerandomized to receive either an augmented version of Tomando Control or a multifamily group treatment focused on problem-solving. The primary outcome measure was the "Summary of Diabetes Self-Care Activities." Evaluations were made at baseline and at 3, 6, and 12 months.
This study was funded in June 2016 for a period of 5 years. Institutional review board approval was obtained in November 2016. Between March 2017 and September 2020, a total of 330 patients were recruited from the outpatient primary care clinics of Olive View-UCLA Medical Center, with a brief hiatus between May 2020 and July 2020 due to COVID-19 restrictions. The study interventions were completed in December 2020. Data collection began in March 2017 and was completed in December 2021. Data analysis is expected to be completed in Spring 2023, and results will be published in Fall 2023.
The results of this trial should help practitioners in selecting the optimal approach for improving diabetes self-management in Spanish-speaking, Latinx patients with T2DM.
ClinicalTrials.gov NCT03092063; https://clinicaltrials.gov/ct2/show/NCT03092063.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44793.
墨西哥裔美国人中2型糖尿病（T2DM）的发病率为16.3%，约为非西班牙裔白人的两倍。虽然已经开发了多种教育方法，并证明这些方法可改善说西班牙语的拉丁裔T2DM患者的糖尿病自我管理行为和血糖控制，但几乎没有研究能指导医疗从业者应采用何种干预措施以及何时采用，以便有效利用资源并使治疗效果最大化。
本研究旨在描述一种适应性干预措施，该措施将社区心理健康工作者、糖尿病护士教育者、家庭成员和患者整合为护理伙伴，同时促进墨西哥裔美国T2DM患者的糖尿病自我管理。该项目纳入了四种基于证据且针对特定文化背景的治疗方法，以确定哪种干预策略序列对谁最有效且效率最高。鉴于T2DM的患病率不断上升，更好地控制糖尿病并降低墨西哥裔美国人不成比例地经历的相关医疗并发症是一项公共卫生优先事项。
该项目由美国国立护理研究机构（美国国立卫生研究院拨款R01 NR015809）资助，采用序贯多重分配随机试验，纳入了330名说西班牙语的拉丁裔T2DM患者。在研究的第一阶段，受试者被随机分配到一个名为“Tomando Control”的基于证据的糖尿病自我管理教育项目，该项目以小组形式进行，为期6周，每两周进行一次1.5小时的课程，由社区卫生工作者或糖尿病护士教育者授课。在研究的第二阶段，那些未改善糖尿病自我管理行为的受试者被重新随机分配，接受“Tomando Control”的强化版或专注于解决问题的多家庭小组治疗。主要结局指标是“糖尿病自我护理活动总结”。在基线以及3个月、6个月和12个月时进行评估。
本研究于2016年6月获得资助，为期5年。2016年11月获得机构审查委员会批准。在2017年3月至2020年9月期间，从奥利夫维尤 - 加州大学洛杉矶分校医学中心的门诊初级保健诊所共招募了330名患者，由于2020年5月至7月的新冠疫情限制，招募工作有短暂中断。研究干预措施于2020年12月完成。数据收集于2017年3月开始，2021年12月完成。数据分析预计于2023年春季完成，结果将于2023年秋季发表。
该试验结果应有助于从业者为说西班牙语的拉丁裔T2DM患者选择改善糖尿病自我管理的最佳方法。
ClinicalTrials.gov NCT03092063；https://clinicaltrials.gov/ct2/show/NCT03092063。
国际注册报告识别码（IRRID）：DERR1-10.2196/44793。
