Bridge: an International Longitudinal Study of Healthcare Transition of Adolescents With Severe Chronic Health Conditions
试验速览
- 阶段
- 不适用
- 入组人数
- 503
- 试验地点
- 2
- 主要终点
- Emergency admissions
研究概览
简要总结
At least 12% of children have a chronic disease that requires regular medical follow-up after patients reach legal maturity. This international study aims to provide prospective evidence for improving health and wellbeing outcomes in this population.
The primary hypothesis is that transition readiness will be more strongly associated with adherence to follow-up, fewer emergency visits and continued education than disease severity or chronological age.
The secondary hypothesis is that positive experiences of care will be associated with lower levels of anxiety. Positive care experiences and low anxiety will predict better health-related quality of life during the transition period.
A cohort of 504 young patients will be followed for three years. Patients have been recruited from pediatric hospitals 0-12 months prior to the transfer of care and follow-up will be completed after the patients have been followed for two years in adult healthcare.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents with a chronic medical condition (duration at least 6 months prior to recruitment)
- •Attend care and/or follow-up at either the New Children's Hospital in Helsinki, Finland or the Royal Children's Hospital in Melbourne, Australia in one or more of the following disciplines: endocrinology, gastroenterology, cardiology, rheumatology, neurology, pediatric surgery, nephrology and solid organ transplantation.
- •Care to be transferred to adult services within 0-12 months following recruitment
排除标准
- •Lack of fluency in study languages (Finnish, Swedish and English)
- •Cognitive limitations that inhibit responding to questionnaires
结局指标
主要结局
Emergency admissions
时间窗: Two years post-transfer
Data linkage will be used to gather information on emergency admissions after the transfer of care. Admissions related to the respective chronic health conditions will serve as one indicator of treatment adherence.
Change in 16D health-related quality of life
时间窗: Baseline to two years post-transfer
16D is a generic, validated self-report of health related quality of life (HRQoL). It has 16 dimensions, all rated on a 5-point Likert scale. The total 16D score varies from 0 to 1, with 1 being the best imaginable state of HRQoL and with a minimum important change of 0.015.
Change in PedsQL health-related quality of life
时间窗: Baseline to two years post-transfer
The Pediatric Quality of Life Inventory (PedsQL) is another validated generic tool to measure HRQoL. It includes 25 questions divided into 4 categories (physical, emotional, social and school). Scores range from 0 to 100, with 100 the best imaginable HRQoL.
Change in anxiety related to transition of care
时间窗: Baseline to two years post-transfer
The State-Trait Anxiety Inventory (STAI) is a validated, 6-item self-report tool to measure anxiety. Items are rated on a 4-point Likert scale. Possible scores range between 20-80, with higher scores indicating higher anxiety.
Missed appointments
时间窗: Two years post-transfer
Data linkage will be used to gather the number of missed appointments (uncancelled, not rescheduled) in adult health care. These will serve as one indicator of treatment adherence.
Change in health status
时间窗: Baseline to two years post-transfer
Patients will report on their symptom severity during the past week using the Visual Analog Scale (VAS). The VAS is a line, 10cm long, with worst imaginable health at one end, and best imaginable health at the other end. Patients make a mark indicating their health between these.
次要结局
- Change in employment status(Baseline to two years post-transfer)
- Change in educational status(Baseline to two years post-transfer)
研究者
Silja Kosola, MD PhD
Adjunct professor in Adolescent Medicine
University of Helsinki