A Telehealth Diabetes Intervention for Rural Populations: Protocol for a Randomized Controlled Trial.
A Telehealth Diabetes Intervention for Rural Populations: Protocol for a Randomized Controlled Trial.
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DOI：
10.2196/34255
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发表时间：
2022-06-14
影响因子：
1.7
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中科院分区：
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糖尿病自我管理教育和支持（DSMES）是糖尿病护理的重要组成部分，与改善临床，心理和行为结果相关。美国糖尿病护理和教育专家协会、美国糖尿病协会和美国家庭医生学会都推荐DSMES，但在农村地区，获得语言和文化上适当的DSMES是一项挑战。糖尿病一日（D1D）计划是一项既定的DSMES团体干预措施，尚未在农村社区进行调整或评估。本文的具体目的是：（1）调整现有的D1D计划，使其适用于农村社区，称为农村D1D（R-D1D）;（2）进行一项患者水平的随机对照试验，以检查R-D1D和标准患者教育的效果，以达到，有效性，采用，实施和维护框架为指导。这是一个协议的试点II型混合实施效果试验的文化适应虚拟DSMES计划，农村人口，R-D1D。我们将使用靴子营翻译，一个基于社区参与性研究原则的过程，以适应现有的DSMES计划的农村人口，在英语和西班牙语。2个农村初级保健诊所的受试者（4个队列，N = 16+护理伙伴，2个英语组和2个西班牙语组）将被随机分配至干预组或标准教育对照组。评估以范围、有效性、采用、实施和维护框架为指导。将使用患者报告的结局指标和家庭A1c检测试剂盒评估患者水平的有效性结局（血红蛋白A1c、糖尿病痛苦和糖尿病自我护理行为）。将使用调查和访谈评估实践水平和患者水平的可接受性和可行性。这项研究得到了国家护理研究所的支持。研究程序已获得批准，适应过程已完成。于二零二一年七月开始招募及入组。据我们所知，这将是第一项研究，以评估有效性和实施成果的虚拟交付DSMES，文化适应农村人口。这项研究对其他农村地区提供专业糖尿病护理有限的服务具有影响。ClinicalTrials.gov
Diabetes self-management education and support (DSMES) is a crucial component of diabetes care associated with improved clinical, psychosocial, and behavioral outcomes. The American Association of Diabetes Care and Education Specialists, the American Diabetes Association, and the American Academy of Family Physicians all recommend DSMES yet accessing linguistically and culturally appropriate DSMES is challenging in rural areas. The Diabetes One-Day (D1D) program is an established DSMES group intervention that has not been adapted or evaluated in rural communities. The specific aims of this paper are (1) to adapt the existing D1D program for use in rural communities, called rural D1D (R-D1D); and (2) to conduct a patient-level randomized controlled trial to examine the effects of R-D1D and standard patient education, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. This is a protocol for a pilot type II hybrid implementation-effectiveness trial of a culturally adapted virtual DSMES program for rural populations, R-D1D. We will use Boot Camp Translation, a process grounded in the principles of community-based participatory research, to adapt an existing DSMES program for rural populations, in both English and Spanish. Participants at 2 rural primary care clinics (4 cohorts of N=16 plus care partners, 2 in English and 2 in Spanish) will be randomized to the intervention or standard education control. The evaluation is guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Patient-level effectiveness outcomes (hemoglobin A1c, diabetes distress, and diabetes self-care behaviors) will be assessed using patient-reported outcomes measures and a home A1c test kit. Practice-level and patient-level acceptability and feasibility will be assessed using surveys and interviews. This study is supported by the National Institute of Nursing. The study procedures were approved, and the adaptation processes have been completed. Recruitment and enrollment started in July 2021. To our knowledge, this will be the first study to evaluate both effectiveness and implementation outcomes for virtually delivered DSMES, culturally adapted for rural populations. This research has implications for delivery to other rural locations where access to specialty diabetes care is limited. ClinicalTrials.gov NCT04600622; https://clinicaltrials.gov/ct2/show/NCT04600622 DERR1-10.2196/34255