Transition Care Model for Adolescents With Congenital Heart Disease

NCT ID: NCT05713591

Last Updated: 2023-02-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 964 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-03
• Study Completion Date: 2024-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Transition care model

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.

Group Type: EXPERIMENTAL

Transition care model

Intervention Type: BEHAVIORAL

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.

Usual care

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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 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).

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IRCCS Policlinico S. Donato

OTHER

Sponsor Role: lead

Responsible Party

Serena Francesca Flocco

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Policlinico San Donato

San Donato Milanese, MI, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Serena Flocco

Role: CONTACT

serena.flocco@grupposandonato.it

+39 0252774940

Rosario Caruso

Role: CONTACT

rosario.caruso@grupposandonato.it

+39 0252774940

Facility Contacts

Serena Flocco

Role: primary

serena.flocco@grupposandonato.it

+39 0252774940

Other Identifiers

127/int/2019

Identifier Type: -

Identifier Source: org_study_id