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Transition Care Model for Adolescents With Congenital Heart Disease — TELEMACO  

Congenital Heart Disease Clinical Trial

Official title:
Transition Care Model for Adolescents With Congenital Heart Disease (CHD): a Multicenter Study to Assess Its Effectiveness on Patient-reported Outcomes (TELEMACO Study)

Clinical Trial 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.

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05713591
Study type Interventional
Source IRCCS Policlinico S. Donato
Contact Serena Flocco
Phone +39 0252774940
Email serena.flocco@grupposandonato.it
Status Recruiting
Phase N/A
Start date May 3, 2021
Completion date December 31, 2024
View Details
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