The CHAPTER III Study of Young Adolescents: Congenital Heart Adolescents Participating in Transition Evaluation Research
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- TRANSITION-Q Questionnaires
研究概览
简要总结
The CHAPTER III Study (Congenital Heart Adolescents Participating in Transition Evaluation Research) is a cluster randomized controlled trial evaluating the impact of a nurse-led transition intervention in combination with usual care, versus usual care alone, on preparing adolescents with congenital heart disease (CHD) to successfully transition from pediatric to adult cardiology care. The Canadian Pediatric Society and American Academy of Pediatrics have recommended that transition interventions begin in early adolescence. Therefore, the investigators propose to conduct a nurse-led intervention that addresses the educational needs of 13-14 year olds.
详细描述
BACKGROUND:
The numbers of youth and young adults with congenital heart disease (CHD) is rapidly increasing, yet youth, parents, and health care providers (HCPs) are unprepared to manage the health care transition from pediatric to adult cardiology care. Both youth and parents report significant anxiety regarding the transition process. When transition is not managed well, youth may not engage with adult HCPs,which may lead to late detection of new problems,excess morbidity, and diminished quality of life.This speaks to the urgency of addressing clinical and health services research gaps, which leave affected youth, families, HCPs, and policy makers with insufficient evidence for transition program delivery.
OBJECTIVE:
The primary aim is to determine the impact of a nurse-led transition intervention in combination with usual care, compared to usual care alone, on self-management and self-advocacy skills among 13-14 year olds with moderate or complex CHD using a validated instrument. [Hypothesis: the transition intervention will result in superior self-management and self-advocacy skills compared to usual care alone]. The secondary aim is to determine knowledge of their CHD lesion [Hypothesis: the transition intervention will result in superior knowledge of the CHD lesion compared to usual care alone].
METHODS:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 13 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(i) moderate or complex CHD (as defined by the 2001 Bethesda Guidelines) (ii) followed at the Stollery Children's Hospital
排除标准
- •(i) less than a Grade 6 level of reading and comprehension, based on parent report (ii) heart transplantation, as this results in distinct health challenges
研究组 & 干预措施
Intervention
Adolescents will attend a single one-on-one session with a nurse. Sessions will be youth-oriented, interactive, and engaging. They will make a health passport, go over their cardiac anatomy, watch videos among other things.
The adolescent will be given a study email address and encouraged to contact the nurse by email or text messaging with follow-up.
干预措施: CHAPTER III Study Intervention (Behavioral)
Usual Care
Youth seen in the Cardiology clinic see a nurse only to measure weight, height, and blood pressure. They rely on their cardiologist for information about their heart condition. The approach and amount of time taken by each cardiologist with a youth varies.
结局指标
主要结局
TRANSITION-Q Questionnaires
时间窗: 6 Months
Change in TRANSITION-Q Questionnaire score between baseline, 1 month, and 6-months post enrollment.
次要结局
- MyHeart Scale(6 Months)