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首页> 外文期刊>BMC Pediatrics >Multicentre randomized controlled trial of structured transition on diabetes care management compared to standard diabetes care in adolescents and young adults with type 1 diabetes (Transition Trial)
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Multicentre randomized controlled trial of structured transition on diabetes care management compared to standard diabetes care in adolescents and young adults with type 1 diabetes (Transition Trial)

机译:与1型糖尿病的青少年和年轻人相比,与标准糖尿病治疗相比,糖尿病治疗管理进行结构化过渡的多中心随机对照试验(过渡试验)

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Background Transition from pediatric to adult diabetes care is a high risk period during which there is an increased rate of disengagement from care. Suboptimal transition has been associated with higher risks for acute and chronic diabetes-related complications. The period of emerging adulthood challenges current systems of healthcare delivery as many young adults with type 1 diabetes (T1D) default from diabetes care and are at risk for diabetes complications which are undetected and therefore untreated. Despite the importance of minimizing loss to follow-up there are no randomized control trials evaluating models of transition from pediatric to adult diabetes care. Methods/Design This is a multicentre randomized controlled trial. A minimum of 188 subjects with T1D aged between 17 and 20?years will be evaluated. Eligible subjects will be recruited from three pediatric care centres and randomly assigned in a 1:1 ratio to a structured transition program that will span 18?months or to receive standard diabetes care. The structured transition program is a multidisciplinary, complex intervention aiming to provide additional support in the transition period. A Transition Coordinator will provide transition support and will provide the link between pediatric and adult diabetes care. The Transition Coordinator is central to the intervention to facilitate ongoing contact with the medical system as well as education and clinical support where appropriate. Subjects will be seen in the pediatric care setting for 6?months and will then be transferred to the adult care setting where they will be seen for one year. There will then be a one-year follow-up period for outcome assessment. The primary outcome is the proportion of subjects who fail to attend at least one outpatient adult diabetes specialist visit during the second year after transition to adult diabetes care. Secondary outcome measures include A1C frequency measurement and levels, diabetes related emergency room visits and hospital admissions, frequency of complication screening, and subject perception and satisfaction with care. Discussion This trial will determine if the support of a Transition Coordinator improves health outcomes for this at-risk population of young adults. Trial registration Trial Registration Number: NCT01351857
机译:背景技术从儿科到成人糖尿病护理的过渡是高风险时期,在此期间,脱离护理的比率增加。次优过渡与急性和慢性糖尿病相关并发症的较高风险相关。成年期对当前的医疗服务体系构成了挑战,因为许多患有1型糖尿病(T1D)的年轻成年人无法接受糖尿病治疗,并且有发生糖尿病并发症的风险,这些并发症未被发现,因此未得到治疗。尽管最小化损失对随访的重要性,但尚无评估从儿科到成人糖尿病治疗过渡模型的随机对照试验。方法/设计这是一个多中心随机对照试验。至少要对188名T1D年龄在17至20岁之间的受试者进行评估。合格的受试者将从三个儿科护理中心招募,并以1:1的比例随机分配到结构化的过渡计划,该计划将持续18个月,或接受标准的糖尿病护理。结构化过渡计划是一项多学科,复杂的干预措施,旨在在过渡期间提供额外的支持。过渡协调员将提供过渡支持,并将提供儿科和成人糖尿病护理之间的联系。过渡协调员是干预的中心,以促进与医疗系统的持续联系以及适当的教育和临床支持。受试者将在儿科护理环境中被观察6个月,然后将被转移到成人护理环境中被观察一年。然后将有一个为期一年的随访结果评估。主要结局是在转换为成人糖尿病护理后的第二年内未参加至少一次门诊成人糖尿病专科医生就诊的受试者所占的比例。次要结果指标包括A1C频率测量和水平,与糖尿病相关的急诊室就诊和入院,并发症筛查的频率以及受试者的感知和对护理的满意度。讨论该试验将确定过渡协调员的支持是否可以改善这一处于危险中的年轻人口的健康状况。试用注册试用注册号:NCT01351857

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