Congenital Heart Disease
Conditions
Keywords
congenital heart disease, transition care, quality of life, engagement
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).
Interventions
BEHAVIORALTransition 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.
Sponsors
IRCCS Policlinico S. Donato
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes 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.
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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical and mental quality of life | up to 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Engagement | Every 3 months from baseline, up to 12 months | 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 | Every 3 months from baseline, up to 12 months | 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 | Every 3 months from baseline, up to 12 months | 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'). |
Countries
Italy
Contacts
Primary ContactSerena Flocco
Backup ContactRosario Caruso
Outcome results
None listed