Transition Care Model for Adolescents With Congenital Heart Disease
- Conditions
- Congenital Heart Disease
- Interventions
- Behavioral: Transition care model
- Registration Number
- NCT05713591
- Lead Sponsor
- IRCCS Policlinico S. Donato
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 964
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Transition care model 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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').
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.
Trial Locations
- Locations (1)
IRCCS Policlinico San Donato
🇮🇹San Donato Milanese, MI, Italy