Clinical trial NCT05713591: Transition Care Model for Adolescents With Congenital Heart Disease
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Heart Disease
Keywords: congenital heart disease
transition care
quality of life
engagement
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 964
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The model of Transition Care (TC) is a complex educational intervention that encompasses three main steps (first step: understanding of their clinical condition; second step: education and support; third step: involvement and collaboration). Each step was developed to include, simplify and standardize the implementation of targeted and personalized interventions.

After the eligibility criteria check, patients will be randomized in experimental or control arms. Patients in the experimental arm were involved in the model TC, while patients in the control group received the standard of care. Data collection for each group was performed at baseline and at three, six, nine, and twelve months.
Primary purpose: SUPPORTIVE_CARE

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).

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).

Primary outcomes:
measure: Physical and mental quality of life
timeFrame: up to 12 months
Secondary outcomes:
measure: Engagement
timeFrame: Every 3 months from baseline, up to 12 months
measure: Healthcare needs
timeFrame: Every 3 months from baseline, up to 12 months
measure: Satisfaction of patients
timeFrame: Every 3 months from baseline, up to 12 months
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: MI
Study officials:
References: