South East Wales Trials Unit, Department of Primary Care & Public Health, School of Medicine, Cardiff University, 7th floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.
BMC Health Serv Res. 2010 Feb 9;10:36. doi: 10.1186/1472-6963-10-36.
Diabetes is the third most common chronic condition in childhood and poor glycaemic control leads to serious short-term and life-limiting long-term complications. In addition to optimal medical management, it is widely recognised that psychosocial and educational factors play a key role in improving outcomes for young people with diabetes. Recent systematic reviews of psycho-educational interventions recognise the need for new methods to be developed in consultation with key stakeholders including patients, their families and the multidisciplinary diabetes healthcare team.
METHODS/DESIGN: Following a development phase involving key stakeholders, a psychosocial intervention for use by paediatric diabetes staff and not requiring input from trained psychologists has been developed, incorporating a communication skills training programme for health professionals and a shared agenda-setting tool. The effectiveness of the intervention will be evaluated in a cluster-randomised controlled trial (RCT). The primary outcome, to be measured in children aged 4-15 years diagnosed with type 1 diabetes for at least one year, is the effect on glycaemic control (HbA1c) during the year after training of the healthcare team is completed. Secondary outcomes include quality of life for patients and carers and cost-effectiveness. Patient and carer preferences for service delivery will also be assessed. Twenty-six paediatric diabetes teams are participating in the trial, recruiting a total of 700 patients for evaluation of outcome measures. Half the participating teams will be randomised to receive the intervention at the beginning of the trial and remaining centres offered the training package at the end of the one year trial period.
The primary aim of the trial is to determine whether a communication skills training intervention for specialist paediatric diabetes teams will improve clinical and psychological outcomes for young people with type 1 diabetes. Previous research indicates the effectiveness of specialist psychological interventions in achieving sustained improvements in glycaemic control. This trial will evaluate an intervention which does not require the involvement of trained psychologists, maximising the potential feasibility of delivery in a wider NHS context.
Current Controlled Trials ISRCTN61568050.
糖尿病是儿童期第三大常见慢性疾病，血糖控制不佳会导致严重的短期和危及生命的长期并发症。除了最佳的医疗管理外，广泛认为心理社会和教育因素在改善糖尿病青少年的治疗效果方面发挥着关键作用。最近对心理教育干预措施的系统评价认识到需要与包括患者、他们的家人和多学科糖尿病医疗团队在内的主要利益相关者协商制定新方法。
方法/设计：在涉及主要利益相关者的发展阶段之后，开发了一种用于儿科糖尿病工作人员的心理社会干预措施，该措施不需要经过培训的心理学家的投入，包括针对卫生专业人员的沟通技巧培训计划和共享的议程设置工具。该干预措施的有效性将在一项群组随机对照试验 (RCT) 中进行评估。主要结局指标为经过培训的医疗团队完成后的一年内，评估至少患有 1 年 1 型糖尿病的 4-15 岁儿童的血糖控制（HbA1c）的影响。次要结局指标包括患者和照顾者的生活质量和成本效益。还将评估患者和照顾者对服务交付的偏好。26 个儿科糖尿病团队参与了该试验，共招募了 700 名患者评估结局指标。参与试验的一半团队将在试验开始时随机接受干预，其余中心在为期一年的试验结束时提供培训包。
试验的主要目的是确定针对专科儿科糖尿病团队的沟通技巧培训干预措施是否会改善 1 型糖尿病青少年的临床和心理结局。以前的研究表明，专门的心理干预措施在实现血糖控制的持续改善方面是有效的。本试验将评估一种不需要训练有素的心理学家参与的干预措施，最大限度地提高在更广泛的英国国家医疗服务体系背景下实施的可行性。
当前对照试验 ISRCTN61568050。
