Centre for Health-Related Research, Bangor University, Bangor, UK.
BMC Pediatr. 2010 Sep 27;10:70. doi: 10.1186/1471-2431-10-70.
There is a lack of high quality, child-centred and effective health information to support development of self-care practices and expertise in children with acute and long-term conditions. In type 1 diabetes, clinical guidelines indicate that high-quality, child-centred information underpins achievement of optimal glycaemic control with the aim of minimising acute readmissions and reducing the risk of complications in later life. This paper describes the development of a range of child-centred diabetes information resources and outlines the study design and protocol for a randomized controlled trial to evaluate the information resources in routine practice. The aim of the diabetes information intervention is to improve children and young people's quality of life by increasing self-efficacy in managing their type 1 diabetes.
METHODS/DESIGN: We used published evidence, undertook qualitative research and consulted with children, young people and key stakeholders to design and produce a range of child-centred, age-appropriate children's diabetes diaries, carbohydrate recording sheets, and assembled child-centred, age-appropriate diabetes information packs containing published information in a folder that can be personalized by children and young people with pens and stickers. Resources have been designed for children/young people 6-10; 11-15; and 16-18 years.To evaluate the information resources, we designed a pragmatic randomized controlled trial to assess the effectiveness, cost effectiveness, and implementation in routine practice of individually tailored, age-appropriate diabetes diaries and information packs for children and young people age 6-18 years, compared with currently available standard practice.Children and young people will be stratified by gender, length of time since diagnosis (< 2 years and > 2 years) and age (6-10; 11-15; and 16-18 years). The following data will be collected at baseline, 3 and 6 months: PedsQL (generic, diabetes and parent versions), and EQ-5 D (parent and child); NHS resource use and process data (questionnaire and interview). Baseline and subsequent HbA1c measurements, blood glucose meter use, readings and insulin dose will be taken from routine test results and hand-held records when attending routine 3-4 monthly clinic visits.The primary outcome measure is diabetes self-efficacy and quality-of-life (Diabetes PedsQL). Secondary outcomes include: HbA1c, generic quality of life, routinely collected NHS/child-held data, costs, service use, acceptability and utility.
ISRCTN17551624.
目前缺乏高质量、以儿童为中心且有效的健康信息，无法为儿童的自我护理实践和专业技能发展提供支持。在 1 型糖尿病中，临床指南表明，高质量、以儿童为中心的信息是实现最佳血糖控制的基础，其目的是最大限度地减少急性再入院，并降低儿童后期并发症的风险。本文描述了一系列以儿童为中心的糖尿病信息资源的开发，并概述了一项随机对照试验的研究设计和方案，以评估常规实践中的信息资源。该糖尿病信息干预的目的是通过提高儿童和青少年管理 1 型糖尿病的自我效能感来提高他们的生活质量。
方法/设计：我们使用已发表的证据，进行定性研究，并咨询儿童、青少年和主要利益相关者，设计和制作了一系列以儿童为中心、适合年龄的儿童糖尿病日记、碳水化合物记录单，并组装了以儿童为中心、适合年龄的糖尿病信息包，其中包含文件夹中的已发表信息，该文件夹可以由儿童和青少年用钢笔和贴纸个性化。资源为 6-10 岁、11-15 岁和 16-18 岁的儿童/青少年设计。为了评估信息资源，我们设计了一项实用的随机对照试验，以评估针对 6-18 岁儿童和青少年的个性化、适合年龄的糖尿病日记和信息包的有效性、成本效益以及在常规实践中的实施情况，与当前可用的标准实践进行比较。儿童和青少年将根据性别、诊断后时间（<2 年和>2 年）和年龄（6-10 岁、11-15 岁和 16-18 岁）进行分层。将在基线、3 个月和 6 个月时收集以下数据：PedsQL（通用、糖尿病和父母版本）和 EQ-5D（父母和儿童）；NHS 资源使用和流程数据（问卷和访谈）。基线和随后的 HbA1c 测量、血糖仪使用、读数和胰岛素剂量将从常规测试结果和在常规 3-4 个月的诊所就诊时使用的手持记录中获取。主要结局测量指标是糖尿病自我效能和生活质量（糖尿病 PedsQL）。次要结局包括：HbA1c、通用生活质量、常规收集的 NHS/儿童持有数据、成本、服务使用、可接受性和实用性。
ISRCTN81351334。
