Transition Care Model for Adolescents With Congenital Heart Disease (TELEMACO)

San Donato Group (GSD)

Status: Enrolling

Conditions: Congenital Heart Disease

Treatments: Behavioral: Transition care model

Study type: Interventional

Funder types: Other

Identifiers

NCT05713591

127/int/2019

Details and patient eligibility

About

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.

Full 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).

Enrollment: 964 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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964 participants in 2 patient groups

Transition care model

Experimental group

Description:

Patients in the experimental arm will receive the TC intervention which encompasses three main pillars that guided a standardized and structured clinical pathway to ensure an optimal transition from childhood care to adult care. Briefly, the first pillar was designed to improve the understanding of the clinical condition through tailored education. Healthcare providers delivered specific information and education strategies. The second pillar aimed to support the development of functional coping strategies by discussing with a counselor and/or a psychologist. The TC encompassed for this pillar both structured face-to-face discussions and counseling moments. The third pillar hoped to improve the engagement of CHD adolescents and their families.

Treatment:

Behavioral: Transition care model

Usual care

No Intervention group

Description:

Patients in the control arm will receive a usual care approach without the high focus on standardization given by the experimental arm (e.g. without flyers and booklets or standardized moments of face-to-face counseling). Data collection will be performed using a consistent approach with the one described in the experimental arm: every three months in a year (T0, T1, T2, T3, and T4).