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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