Department of Medicine, Clinical Science Institute, National University of Ireland, Galway, Ireland.
Trials. 2009 Sep 23;10:88. doi: 10.1186/1745-6215-10-88.
Structured education programmes for individuals with Type 1 diabetes have become a recognised means of delivering the knowledge and skills necessary for optimal self-management of the condition. The Dose Adjustment for Normal Eating (DAFNE) programme has been shown to improve biomedical (HbA(1c) and rates of severe hypoglycaemia) and psychosocial outcomes for up to 12 months following course delivery. The optimal way to support DAFNE graduates and maintain the benefits of the programme has not been established. We aimed to compare 2 different methods of follow-up of DAFNE graduates in a pragmatic clinical trial delivered in busy diabetes clinics on the island of Ireland.
Six participating centres were cluster randomised to deliver either group follow-up or a return to traditional one-to-one clinic visits. In the intervention arm group follow-up was delivered at 6 and 12 months post DAFNE training according to a curriculum developed for the study. In the control arm patients were seen individually in diabetes clinics as part of routine care. Study outcomes included HbA(1c) levels, self-reported rates of severe hypoglycaemia, body weight and measures of diabetes wellbeing and quality of life. These were measured at 6, 12 and 18 months after recruitment. Generalisability (external validity) was maximised by recruiting study participants from existing DAFNE waiting lists in each centre, by using broad inclusion criteria (including HbA(1c) values less than 13 percent with no lower limit) and by using existing clinic staff to deliver the training and follow-up. Internal validity and treatment fidelity were maximised by quality assuring the training of all DAFNE educators, by external peer review of the group follow-up sessions and by striving for full attendance at follow-up visits. Assays of HbA(1c) were undertaken in a central laboratory.
This pragmatic clinical trial evaluating group follow-up after a structured education programme has been designed to have broad generalisability. The results should inform how best to manage the well educated patient with Type 1 diabetes in the real world of clinical practice
Current Controlled Trials ISRCTN79759174.
针对 1 型糖尿病患者的结构化教育计划已成为提供最佳自我管理条件所需的知识和技能的公认手段。Dose Adjustment for Normal Eating（DAFNE）计划已被证明可以在课程交付后长达 12 个月内改善生物医学（HbA（1c）和严重低血糖发生率）和心理社会结果。尚未确定支持 DAFNE 毕业生并维持该计划效益的最佳方法。我们旨在比较在爱尔兰岛繁忙的糖尿病诊所进行的实用临床试验中两种不同的 DAFNE 毕业生随访方法。
六个参与中心被集群随机分配到提供小组随访或恢复传统一对一诊所就诊。在干预臂组随访是在 DAFNE 培训后 6 个月和 12 个月根据为研究制定的课程进行的。在对照组中，患者作为常规护理的一部分在糖尿病诊所接受个体就诊。研究结果包括 HbA（1c）水平、自我报告的严重低血糖发生率、体重以及糖尿病健康和生活质量的衡量标准。这些在招募后 6、12 和 18 个月进行测量。通过在每个中心从现有的 DAFNE 候补名单中招募研究参与者、使用广泛的纳入标准（包括 HbA（1c）值低于 13%且无下限）并使用现有的诊所工作人员提供培训和随访，最大限度地提高了普遍性（外部有效性）。通过确保所有 DAFNE 教育者的培训质量、对小组随访会议进行外部同行评审以及努力确保随访就诊的全部出席，最大限度地提高了内部有效性和治疗保真度。HbA（1c）的测定在中央实验室进行。
这项评估结构化教育计划后小组随访的实用临床试验旨在具有广泛的普遍性。结果应该为如何在临床实践的现实世界中最好地管理接受过良好教育的 1 型糖尿病患者提供信息。
当前对照试验 ISRCTN79759174。
