Skip to main content

Table 1 Trial entry

From: Impact of a transition education program on health-related quality of life in pediatric patients with congenital heart disease: study design for a randomised controlled trial

Inclusion criteria
Male or female aged 13–25 years old
Patients with a congenital heart disease (CHD), as defined by the international ACC-CHD classification
Written informed consent for adult patients, or legal guardians and children’s assent for minors
Exclusion criteria
Patients who are unable to understand the study information or unable to complete study procedures
Patients with a severe intellectual disability that does not allow the completion of the quality of life questionnaire
Patient who intends to move to another region with a follow-up in another institution during the 12 month study period
Patients participating in concurrent interventional research which may overburden the patient or confound data collection