Transition Care Model for Adolescents With Congenital Heart Disease (CHD): a Multicenter Study to Assess Its Effectiveness on Patient-reported Outcomes (TELEMACO Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 964
- 试验地点
- 2
- 主要终点
- Physical and mental quality of life
研究概览
简要总结
The primary aim of this study is to assess the effectiveness of a standardized transition care model (TC) on the perceived mental and physical health of adolescents with congenital heart disease (CHD). Furthermore, the secondary aims of this research are focused on providing a description of the impact of a standardized TC on overall healthcare needs, satisfaction, and engagement.
Therefore, a prospective, randomized, controlled, single-blind, and multi-center study will be conducted.
详细描述
Congenital heart diseases (CHD) are some of the most prevalent and serious birth defects, representing a major global health problem. With a prevalence of 9.1 for 1000 live births, the CHD are the leading causes of birth defects associated with morbidity, mortality, and medical expenditures. Currently, 1.3 million children live with a CHD worldwide (3), and approximately 90% of them can survive into adulthood. In this scenario, the transition from childhood to adulthood is one of the most complex and delicate part of life for CHD patients. The multi-disciplinary standardized interventions to educate and support patients with CHD, described as "Transition Clinic" (TC), represent a key element in delivering care for patients during the transition from childhood to adulthood. However, most recent literature focuses on the CHD childhood clinical management or the CHD adulthood challenges (i.e., GUCH challenges). Thus, the attention to exploring the peculiarities of the transition period from childhood to adulthood in patients with CHD is underinvestigated by the lack of experimental studies [i.e. randomized controlled trial (RCT)] as the published evidence is related to the assessment of effects of the same model on outcomes without a control arm (pre-post test study design).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Eligible patients who signed the written informed consent will be blindly randomized (allocation 1:1) in each involved CHD center at the baseline phase. However, considering the type of interventions is not possible to guarantee the patients' blindness during the study, as well as for the care provider.
The eligible patients will be randomized by using a pre-determined randomization sheet that considers patients' entry ID (the chronological number of enrollment) to perform randomization (each CHD center that participates in the research project will have a specific pre-determined randomization sheet). Patients will be randomized on a 1:1 basis to receive the TC model or usual care during the transition from childhood to adulthood.
Only the outcome assessor and the principal investigator will be blind to the patient allocation.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescent patients (aged between 12 and 18 years)
- •Diagnosis of CHD, according to 2018 AHA/ACC Guideline for the Management of Adults With Congenital Heart Disease
- •All patients who express the willingness to participate in the study through the signing of the informed consent form and signature of informed consent by patients' parents
- •Moderate and Complex CHD, according to the classification described by Warnes
排除标准
- •Chromosomal abnormalities such as Down's syndrome and Marfan's syndrome
- •Patients with cognitive impairment (assessed using Six Item Screener, SIS): if SIS ≤4
- •Not understanding the Italian language
- •Patients in pregnancy
- •Simple CHD, according to Warnes (2001) (25).
结局指标
主要结局
Physical and mental quality of life
时间窗: up to 12 months
This outcome will be measured through a self-report tool such as a short-form survey. The short-form survey allows for assessing physical and mental health. The score will be computed for each domain and a higher score indicates a better perception of quality of life.
次要结局
- Engagement(Every 3 months from baseline, up to 12 months)
- Satisfaction of patients(Every 3 months from baseline, up to 12 months)
- Healthcare needs(Every 3 months from baseline, up to 12 months)
研究者
Serena Francesca Flocco
Principal Investigator
IRCCS Policlinico S. Donato