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

Primary Purpose

Congenital Heart Disease

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Transition care model
Sponsored by
IRCCS Policlinico S. Donato
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Congenital Heart Disease focused on measuring congenital heart disease, transition care, quality of life, engagement

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts 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).

Sites / Locations

  • IRCCS Policlinico San DonatoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Transition care model

Usual care

Arm 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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Engagement
Patient engagement will be measured through the Patient Health Engagement scale. The score will be computed based on four main constructs: blackout, arousal, adhesion, and eudaimonic project. The final score has been computed through the median of the values of each item, ranging from 1 to 7, and a higher score indicates a better perception of engagement.
Healthcare needs
Adolescent healthcare needs will be measured through the Healthcare Needs Scale for Youth with congenital heart disease during the transition to adulthood. The score will be computed based on four main constructs: healthcare education, clinical support, emotional support, and continuum of care. The final score ranged from 0 to 100 and higher scores indicate higher needs.
Satisfaction of patients
Adolescent satisfaction will be measured through the visual analog scale. The VAS consists of a 10 cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

Full Information

First Posted
January 25, 2023
Last Updated
February 3, 2023
Sponsor
IRCCS Policlinico S. Donato
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1. Study Identification

Unique Protocol Identification Number
NCT05713591
Brief Title
Transition Care Model for Adolescents With Congenital Heart Disease
Acronym
TELEMACO
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Donato

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
congenital heart disease, transition care, quality of life, engagement

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
964 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transition care model
Arm Type
Experimental
Arm 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.
Arm Title
Usual care
Arm Type
No Intervention
Arm 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).
Intervention Type
Behavioral
Intervention Name(s)
Transition care model
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical and mental quality of life
Description
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.
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Engagement
Description
Patient engagement will be measured through the Patient Health Engagement scale. The score will be computed based on four main constructs: blackout, arousal, adhesion, and eudaimonic project. The final score has been computed through the median of the values of each item, ranging from 1 to 7, and a higher score indicates a better perception of engagement.
Time Frame
Every 3 months from baseline, up to 12 months
Title
Healthcare needs
Description
Adolescent healthcare needs will be measured through the Healthcare Needs Scale for Youth with congenital heart disease during the transition to adulthood. The score will be computed based on four main constructs: healthcare education, clinical support, emotional support, and continuum of care. The final score ranged from 0 to 100 and higher scores indicate higher needs.
Time Frame
Every 3 months from baseline, up to 12 months
Title
Satisfaction of patients
Description
Adolescent satisfaction will be measured through the visual analog scale. The VAS consists of a 10 cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Time Frame
Every 3 months from baseline, up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serena Flocco
Phone
+39 0252774940
Email
serena.flocco@grupposandonato.it
First Name & Middle Initial & Last Name or Official Title & Degree
Rosario Caruso
Phone
+39 0252774940
Email
rosario.caruso@grupposandonato.it
Facility Information:
Facility Name
IRCCS Policlinico San Donato
City
San Donato Milanese
State/Province
MI
ZIP/Postal Code
20097
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serena Flocco
Phone
+39 0252774940
Email
serena.flocco@grupposandonato.it

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.

Learn more about this trial

Transition Care Model for Adolescents With Congenital Heart Disease

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