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Recruiting
NCT05713591
Transition Care Model for Adolescents With Congenital Heart Disease
Conditions: Congenital Heart Disease
Sex: All
Ages: 12 Years – 18 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 964
Sponsor: IRCCS Policlinico S. Donato
Location: Italy
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.
Eligibility Criteria
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 DiseaseAll 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' parentsModerate and Complex CHD, according to the classification described by WarnesExclusion Criteria:Chromosomal abnormalities such as Down's syndrome and Marfan's syndromePatients with cognitive impairment (assessed using Six Item Screener, SIS): if SIS ≤4Not understanding the Italian languagePatients in pregnancySimple CHD, according to Warnes (2001) (25).
Source: ClinicalTrials.gov (NCT05713591). StuddyBuddy aggregates publicly available trial information.