Sitaram Bhartia Institute of Science and Research, B-16 Qutab Institutional Area, New Delhi, 110016, India.
Trials. 2023 Oct 17;24(1):673. doi: 10.1186/s13063-023-07712-3.
Diabetes self-management education (DSME) helps patients self-manage their condition and improve outcomes/quality of life. However, access to DSME is limited, particularly in low-income areas. This study aims to develop a DSME training kit (EK-DIN), understand barriers to implementation, and evaluate the effectiveness and sustainability of community leader (CL)-based rollout using a stepped wedge cluster randomized trial format.
The mixed methods study will begin with a qualitative study to evaluate the facilitators and barriers towards CL-based DSME. The in-depth interview notes will be transcribed for thematic analysis. These results will be utilized for a stakeholder's workshop to develop the EK-DIN kit, a patient-interfacing app, and an implementation plan. Rollout will be conducted in 30 clusters in Delhi, preselected by the DEDICOM-II survey in 5 steps (6 clusters every 3 months: 2 each from each socio-economic category; randomly selected per sequence). A CL from each cluster will be trained in using the EK-DIN kit/app over 1 month. The trained CL will conduct DSME sessions among the cluster residents using the EK-DIN kits provided fortnightly for 3 months. Compliance and blood parameters data will be collected at baseline, 3 months after the intervention, and every quarter thereafter till completion. Change in HbA1c before and after the intervention will be evaluated as the primary outcome using the swCRTdesign package for R version 4.0.2 and the swSummary function. The sustainability of the effects will be evaluated using the change in quarterly parameters after intervention completion.
A positive result will set the template for a generalizable public health intervention with proven community effectiveness, sustainability, cost-effectiveness, and positive quality-of-life impact. While a negative result will require the testing of alternative approaches, it would still add substantially to existing knowledge on the subject. Given the diverse socio-cultural setting in which the trial is being proposed and the high power of the study, the results (positive or negative) should be widely applicable and have policy implications.
CTRI/2023/07/054963. Date of Registration: 7th July 2023.
糖尿病自我管理教育（DSME）有助于患者自我管理病情并改善预后/生活质量。然而，DSME 的获取受到限制，特别是在低收入地区。本研究旨在开发一种 DSME 培训包（EK-DIN），了解实施的障碍，并使用阶梯式楔形集群随机试验设计评估基于社区领导者（CL）的推出的效果和可持续性。
这项混合方法研究将首先进行定性研究，以评估基于 CL 的 DSME 的促进因素和障碍。深入访谈的笔记将被转录进行主题分析。这些结果将用于利益相关者研讨会，以开发 EK-DIN 工具包、患者界面应用程序和实施计划。在德里的 30 个集群中进行推出，这些集群是通过 DEDICOM-II 调查分 5 个步骤预先选择的（每 3 个月 6 个集群：每个社会经济类别各 2 个；按顺序随机选择）。每个集群的一名 CL 将在 1 个月内接受使用 EK-DIN 工具包/应用程序的培训。经过培训的 CL 将使用提供的 EK-DIN 工具包每两周在集群居民中进行一次 DSME 课程，持续 3 个月。在基线、干预后 3 个月和此后每季度收集依从性和血液参数数据，直至完成。使用 R 版本 4.0.2 的 swCRTdesign 包和 swSummary 函数评估干预前后 HbA1c 的变化作为主要结果。使用干预完成后每季度参数的变化评估效果的可持续性。
积极的结果将为具有经过验证的社区有效性、可持续性、成本效益和积极的生活质量影响的可推广公共卫生干预措施设定模板。而负面结果将需要测试替代方法，但仍将大大增加关于该主题的现有知识。鉴于试验提出的多样化社会文化背景和研究的高功效，结果（积极或消极）应该具有广泛的适用性并具有政策意义。
CTRI/2023/07/054963。注册日期：2023 年 7 月 7 日。
