NCT05713591

Transition Care Model for Adolescents With Congenital Heart Disease

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 964 (estimated)
• Sponsor: IRCCS Policlinico S. Donato · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Congenital Heart Disease

Interventions

Type	Name	Description
BEHAVIORAL	Transition care model	The transition care model (TC) consists in multidisciplinary standardized interventions to educate and support adolescents with congenital heart disease, representing a key element in the adequate delivery of care to these individuals during their transition from childhood to adulthood. This model encompasses three main pillars previously described.

Timeline

• Start date: 2021-05-03
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-02-06
• Last updated: 2023-02-06

Locations

1 site across 1 country: Italy