Taggart Laurence, Coates Vivien, Clarke Mike, Bunting Brendan, Davies Melanie, Carey Marian, Northway Ruth, Brown Michael, Truesdale-Kennedy Maria, Martin-Stacey Lorraine, Scott Gillian, Karatzias Thanos
Institute of Nursing and Health Research, Ulster University, Shore Road, Newtownabbey, Co Antrim BT37 0QB, Northern Ireland.
MRC Hub for Trials Methodology Research, Queen's University Belfast, Malone Road, Belfast, BT7 1NN, Northern Ireland.
Trials. 2015 Apr 10;16:148. doi: 10.1186/s13063-015-0644-y.
The need for structured education programmes for type 2 diabetes is a high priority for many governments around the world. One such national education programme in the United Kingdom is the DESMOND Programme, which has been shown to be robust and effective for patients in general. However, these programmes are not generally targeted to people with intellectual disabilities (ID), and robust evidence on their effects for this population is lacking. We have adapted the DESMOND Programme for people with ID and type 2 diabetes to produce an amended programme known as DESMOND-ID. This protocol is for a pilot trial to determine whether a large-scale randomised trial is feasible, to test if DESMOND-ID is more effective than usual care in adults with ID for self-management of their type 2 diabetes, in particular as a means to reduce glycated haemoglobin (Hb1Ac), improve psychological wellbeing and quality of life and promote a healthier lifestyle. This protocol describes the rationale, methods, proposed analysis plan and organisational and administrative details.
METHODS/DESIGN: This trial is a two arm, individually randomised, pilot trial for adults with ID and type 2 diabetes, and their family and/or paid carers. It compares the DESMOND-ID programme with usual care. Approximately 36 adults with mild to moderate ID will be recruited from three countries in the United Kingdom. Family and/or paid carers may also participate in the study. Participants will be randomly assigned to one of two conditions using a secure computerised system with robust allocation concealment. A range of data will be collected from the adults with ID (biomedical, psychosocial and self-management strategies) and from their carers. Focus groups with all the participants will assess the acceptability of the intervention and the trial.
The lack of appropriate structured education programmes and educational materials for this population leads to secondary health conditions and may lead to premature deaths. There are significant benefits to be gained globally, if structured education programmes are adapted and shown to be successful for people with ID and other cognitive impairments.
Registered with International Standard Randomised Controlled Trial (identifier: ISRCTN93185560 ) on 10 November 2014.
为2型糖尿病患者制定结构化教育项目是世界上许多国家政府的高度优先事项。英国的一个此类国家级教育项目是糖尿病自我管理教育与支持项目（DESMOND项目），该项目已被证明总体上对患者是有力且有效的。然而，这些项目一般并非针对智障人士，且缺乏关于其对该人群效果的有力证据。我们已针对智障合并2型糖尿病患者对DESMOND项目进行了调整，以产生一个修订后的项目，即糖尿病自我管理教育与支持智障人士项目（DESMOND-ID）。本方案是一项试点试验，以确定大规模随机试验是否可行，测试DESMOND-ID在智障成年患者自我管理2型糖尿病方面是否比常规护理更有效，特别是作为降低糖化血红蛋白（Hb1Ac）、改善心理健康和生活质量以及促进更健康生活方式的一种手段。本方案描述了基本原理、方法、拟议的分析计划以及组织和管理细节。
方法/设计：本试验是一项双臂、个体随机的试点试验，针对智障合并2型糖尿病的成年人及其家庭和/或付费护理人员。它将DESMOND-ID项目与常规护理进行比较。将从英国的三个国家招募约36名轻度至中度智障的成年人。家庭和/或付费护理人员也可参与研究。将使用具有强大分配隐藏功能的安全计算机系统将参与者随机分配到两种情况之一。将从智障成年人（生物医学、心理社会和自我管理策略）及其护理人员那里收集一系列数据。与所有参与者进行的焦点小组讨论将评估干预措施和试验的可接受性。
该人群缺乏适当的结构化教育项目和教育材料会导致继发性健康状况，并可能导致过早死亡。如果结构化教育项目经过调整并被证明对智障和其他认知障碍患者成功，那么全球将获得重大益处。
于2014年11月10日在国际标准随机对照试验注册库注册（标识符：ISRCTN93185560）。
