Transition Care Model for Adolescents With Congenital Heart Disease

NCT05713591 | Unknown DMC

• 1 other identifier: 127/int/2019
• Study Type: interventional
• Target: 964
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

congenital heart disease; transition care; quality of life; engagement

Outcome Measures

Primary Outcomes (1)

• Physical and mental quality of life

  This outcome will be measured through a self-report tool such as a short-form survey. The short-form survey allows for assessing physical and mental health. The score will be computed for each domain and a higher score indicates a better perception of quality of life.

  up to 12 months

Secondary Outcomes (3)

• Engagement

  Every 3 months from baseline, up to 12 months

• Healthcare needs

  Every 3 months from baseline, up to 12 months

• Satisfaction of patients

  Every 3 months from baseline, up to 12 months

Study Arms (2)

Transition care model

EXPERIMENTAL

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.

Behavioral: Transition care model

Usual care

NO INTERVENTION

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).

Interventions

Transition care model 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.

Transition care model

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, MI, 20097, Italy

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Serena Flocco

CONTACT

+39 0252774940; serena.flocco@grupposandonato.it

Rosario Caruso

CONTACT

+39 0252774940; rosario.caruso@grupposandonato.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Eligible patients who signed the written informed consent will be blindly randomized (allocation 1:1) in each involved CHD center at the baseline phase. However, considering the type of interventions is not possible to guarantee the patients' blindness during the study, as well as for the care provider. The eligible patients will be randomized by using a pre-determined randomization sheet that considers patients' entry ID (the chronological number of enrollment) to perform randomization (each CHD center that participates in the research project will have a specific pre-determined randomization sheet). Patients will be randomized on a 1:1 basis to receive the TC model or usual care during the transition from childhood to adulthood. Only the outcome assessor and the principal investigator will be blind to the patient allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 6, 2023
• Study Start: May 3, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)