Abstract
BackgroundRecent advances in the field of congenital heart disease (CHD) led to an improved prognosis of the patients and in consequence the growth of a new population: the grown up with congenital heart disease. Until recently, more than 50% of these patients were lost to follow up because of the lack of specialized structures. The critical moment is the transition between paediatric and adult unit. Therapeutic education is crucial to solve this issue by helping patients to become independent and responsible. The TRANSITION-CHD randomized trial aims to assess the impact of a transition education program on health-related quality of life (HRQoL) of adolescents and young adults with CHD.MethodsMulticentre, randomised, controlled, parallel arm study in CHD patients aged from 13 to 25 years old. Patients will be randomised into 2 groups (education program vs. no intervention). The primary outcome is the change in self-reported HRQoL between baseline and 12-month follow-up. A total of 100 patients in each group is required to observe a significant increase of the overall HRQoL score of 7 ± 13.5 points (on 100) with a power of 80% and an alpha risk of 5%. The secondary outcomes are: clinical outcomes, cardiopulmonary exercise test parameters (peak VO2, VAT, VE/VCO2 slope), level of knowledge of the disease using the Leuven knowledge questionnaire for CHD, physical and psychological status.DiscussionAs the current research is opening on patient related outcomes, and as the level of proof in therapeutic education is still low, we sought to assess the efficacy of a therapeutic education program on HRQoL of CHD patients with a randomized trial.Trial registrationThis study was approved by the National Ethics Committee (South-Mediterranean IV 2016-A01681-50) and was registered on Clinicaltrials.gov (NCT03005626).
Highlights
Recent advances in the field of congenital heart disease (CHD) led to an improved prognosis of the patients and in consequence the growth of a new population: the grown up with congenital heart disease
In the continuity of our clinical research program on health-related quality of life (HRQoL) in patients with CHD [6, 14, 30,31,32, 34], we expect to observe an improvement of HRQoL in patients undergoing the transition education program
Patient-reported outcomes (PRO) have been increasingly used in clinical research [35], using HRQoL as a primary outcome in the TRANSITIONCHD trial seems adapted to such a therapeutic education program
Summary
Recent advances in the field of congenital heart disease (CHD) led to an improved prognosis of the patients and in consequence the growth of a new population: the grown up with congenital heart disease. Young patients with a CHD are prone to interrupt their follow-up soon after transfer from paediatric to adult cardiology and are at risk to reintegrate the healthcare system when facing a complication [5, 6]. More than 30% of adults with a CHD are lost to follow-up despite a significant risk of arrhythmia, heart failure, pulmonary hypertension and acquired cardiovascular diseases [7, 8]. Some lost to followup adult patients with a CHD reintegrate the healthcare system for administrative issues: they may be referred to an expert CHD centre by an occupational medicine physician, or when taking out a bank loan by an insurance service. Lost to follow-up female CHD patients are frequently referred by obstetricians in early pregnancy
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