Improving Self-management of Type 2 Diabetes in Latinx Patients: Protocol for a Sequential Multiple Assignment Randomized Trial Involving Community Health Workers, Registered Nurses, and Family Members.
Improving Self-management of Type 2 Diabetes in Latinx Patients: Protocol for a Sequential Multiple Assignment Randomized Trial Involving Community Health Workers, Registered Nurses, and Family Members.
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改善拉丁裔患者 2 型糖尿病的自我管理：涉及社区卫生工作者、注册护士和家庭成员的序贯多重分配随机试验方案。
DOI：
10.2196/44793
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发表时间：
2023-01-16
影响因子：
1.7
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中科院分区：
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墨西哥裔美国人的2型糖尿病（T2 DM）发病率为16.3%，约为非西班牙裔白色人的两倍。虽然已经开发了许多教育方法，并显示出改善糖尿病自我管理行为和血糖控制的西班牙语拉丁裔T2 DM患者，有很少的研究，以指导卫生从业人员关于哪些干预措施，以及何时，使资源得到有效利用，治疗效果最大化。本研究旨在描述一种适应性干预，将社区精神卫生工作者、糖尿病护士教育者、家庭成员和患者作为护理伙伴，同时促进墨西哥裔美国T2 DM患者的糖尿病自我管理。该项目结合了四种基于证据的、文化上量身定制的治疗方法，以确定哪种干预策略的顺序最有效，对谁最有效。鉴于T2 DM的患病率不断增加，更好地控制糖尿病并降低墨西哥裔美国人的相关医疗并发症是公共卫生的优先事项。该项目由美国国立护理研究所（美国国立卫生研究院拨款R 01 NR 015809）资助，采用序贯多分配随机试验，纳入330例西班牙语Latinx T2 DM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的循证糖尿病自我管理教育计划中，该计划以小组形式提供，由社区卫生工作者或糖尿病护士教育者领导，每两周进行一次1.5小时的会议。在研究的第二阶段，那些没有改善糖尿病自我管理行为的受试者被重新随机分配接受增强版的Tomando Control或专注于解决问题的多家庭小组治疗。主要结果测量是“糖尿病自我护理活动总结”。在基线和3、6和12个月时进行评价。该研究于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。于2017年3月至2020年9月期间，从Olive View-UCLA Medical Center的门诊初级保健诊所招募了合共330名患者，由于COVID-19的限制，于2020年5月至2020年7月期间短暂中断。研究干预措施已于二零二零年十二月完成。数据收集于二零一七年三月开始，并于二零二一年十二月完成。数据分析预计将于2023年春季完成，结果将于2023年秋季公布。这项试验的结果应该有助于医生选择最佳的方法来改善西班牙语，拉丁裔T2 DM患者的糖尿病自我管理。ClinicalTrials.gov NCT 03092063; https://clinicaltrials.gov/ct2/show/NCT03092063 DERR 1 -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 DERR1-10.2196/44793