Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden
Gothenburg Centre for Person-Centred Care (GPCC), University of Gothenburg, Gothenburg, Sweden.
BMJ Open. 2020 Apr 14;10(4):e036496. doi: 10.1136/bmjopen-2019-036496.
Adolescence is a critical period for youths with chronic conditions, when they are supposed to take over the responsibility for their health. Type 1 diabetes (T1D) is one of the most common chronic conditions in childhood and inadequate self-management increases the risk of short-term and long-term complications. There is a lack of evidence regarding the effectiveness of transition programmes. As a part of the Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS research programme, the objective of this study is to evaluate the effectiveness and experiences of different transitional care models, including a person-centred transition programme aiming to empower adolescents with T1D to become active partners in their health and care.
In this randomised controlled trial, patients are recruited from two paediatric diabetes clinics at the age of 16 years. Patients are randomly assigned to either the intervention group (n=70) where they will receive usual care plus the structured transition programme, or to the control group (n=70) where they will only receive usual care. Data will be collected at 16, 17 and 18.5 years of age. In a later stage, the intervention group will be compared with adolescents in a dedicated youth clinic in a third setting. The primary outcome is patient empowerment. Secondary outcomes include generic, diabetes-specific and transfer-specific variables.
The study has been approved by the Ethical Review Board in Stockholm (Dnr 2018/1725-31). Findings will be reported following the Consolidated Standards of Reporting Trials statement and disseminated in peer-reviewed journals and at international conferences.
NCT03994536.
青春期是患有慢性疾病的年轻人的关键时期，他们应该开始承担自己的健康责任。1 型糖尿病（T1D）是儿童期最常见的慢性疾病之一，自我管理不足会增加短期和长期并发症的风险。关于过渡项目的有效性还缺乏证据。作为瑞典过渡效果项目的一部分，该项目支持青少年慢性医疗条件研究计划，本研究的目的是评估不同过渡护理模式的效果和经验，包括以患者为中心的过渡项目，旨在使患有 T1D 的青少年积极参与自己的健康和护理。
在这项随机对照试验中，患者在 16 岁时从两家儿科糖尿病诊所招募。患者被随机分配到干预组（n=70），他们将接受常规护理加结构化过渡方案，或对照组（n=70），他们将只接受常规护理。数据将在 16、17 和 18.5 岁时收集。在后期，干预组将与第三个环境中的专门青年诊所中的青少年进行比较。主要结果是患者授权。次要结果包括一般、糖尿病特定和转移特定变量。
该研究已获得斯德哥尔摩伦理审查委员会的批准（编号 2018/1725-31）。研究结果将按照临床试验报告标准进行报告，并在同行评议期刊和国际会议上发表。
NCT03994536。
