Transition Care Model for Adolescents With Congenital Heart Disease (NCT05713591) | Clinical Trial Compass
UnknownNot Applicable
Transition Care Model for Adolescents With Congenital Heart Disease
Italy964 participantsStarted 2021-05-03
Plain-language summary
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.
Who can participate
Age range12 Years – 18 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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).