All India Institute of Medical Sciences, Department of Endocrinology and Metabolism, New Delhi, India.
University of North Carolina at Chapel Hill, Department of Nutrition, Chapel Hill, USA.
Contemp Clin Trials. 2022 Aug;119:106830. doi: 10.1016/j.cct.2022.106830. Epub 2022 Jun 18.
This multi-center randomized controlled trial aims to evaluate the effectiveness of a context-specific transition intervention program to improve clinic visit adherence and clinical outcomes among emerging adults with type 1 diabetes mellitus (T1DM) in Delhi, India.
We will recruit patients with T1DM of duration ≥1 year and age 15-19.5 years from the participating pediatric sites. After a baseline assessment and a "basic introductory session", which apprises participants about the concept of transition, study participants (proposed sample size =156) will be randomly allocated into an intervention and control arm. Participants in the intervention arm will receive a structured transition program delivered over 15 months. On the other hand, control arm participants will continue to receive usual care from the pediatric site till the time of transfer to the adult site. The study assessments will be done at baseline, at the time of transfer, and at 1 and 2 years following the transfer. The primary outcome is the difference in clinic attendance rate between intervention and control arms at the end of 1 year post-transfer. The secondary outcomes include the difference in clinic attendance rate at the end of 2 years, the difference in proportion of participants with a minimum of 4 visits in the first follow-up year, and process indicators such as diabetes knowledge and self-management skills, diabetes treatment satisfaction, overall quality of life, diabetes-related distress, hospitalization for acute complications and screening for chronic diabetes complications, and HbA1c.
This study will provide important new evidence about a potential strategy to improve clinical care among adolescents and emerging adults with T1DM in lower resource contexts during the vulnerable phase of transition from pediatric to adult healthcare. The trial is registered on the Clinical Trials Registry of India (http://ctri.nic.in) under the CTRI registration number CTRI/2020/10/028379.
本多中心随机对照试验旨在评估一种特定于情境的过渡干预方案对改善印度德里新诊断为 1 型糖尿病（T1DM）的青少年患者的就诊依从性和临床结局的有效性。
我们将招募在参与儿科机构就诊时间≥1 年且年龄在 15-19.5 岁的 T1DM 患者。在基线评估和“基础介绍课程”后（让参与者了解过渡的概念），研究参与者（拟样本量=156）将被随机分配到干预组和对照组。干预组参与者将接受为期 15 个月的结构化过渡计划。另一方面，对照组参与者将继续接受儿科机构的常规护理，直至转移到成人机构。研究评估将在基线、转移时以及转移后 1 年和 2 年进行。主要结局是转移后 1 年时干预组和对照组之间的就诊率差异。次要结局包括转移后 2 年时就诊率差异、第 1 随访年内至少就诊 4 次的参与者比例差异、以及糖尿病知识和自我管理技能、糖尿病治疗满意度、总体生活质量、糖尿病相关困扰、急性并发症住院和慢性糖尿病并发症筛查等过程指标和糖化血红蛋白。
本研究将为在资源较少的环境中，为青少年和新诊断为 T1DM 的成年患者提供潜在的过渡策略，以改善其临床护理提供重要的新证据。该试验已在印度临床试验注册处（http://ctri.nic.in）注册，注册号为 CTRI/2020/10/028379。
