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

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. Until recently, more than 50% of these patients were lost to follow up because of the lack of spe...

Full description

Saved in:

Bibliographic Details
Published in:	Health and quality of life outcomes Vol. 19; no. 1; p. 23
Main Authors:	Werner, Oscar, Bredy, Charlene, Lavastre, Kathleen, Guillaumont, Sophie, De La Villeon, Gregoire, Vincenti, Marie, Gerl, Cristelle, Dulac, Yves, Souletie, Nathalie, Acar, Philippe, Pages, Laurence, Picot, Marie-Christine, Bourrel, Gerard, Oude Engberink, Agnes, Million, Elodie, Abassi, Hamouda, Amedro, Pascal
Format:	Journal Article
Language:	English
Published:	England BioMed Central 19-01-2021 BMC
Subjects:	Adolescent Adolescents Adult Anaerobic threshold Cardiology Cardiology and cardiovascular system Cardiovascular diseases Congenital diseases Congenital heart disease Coronary artery disease Disease Education Exercise Health care Heart Heart Defects, Congenital - psychology Heart diseases Hospitals Human health and pathology Humans Knowledge Life Sciences Patient Education as Topic Patients Pediatrics Physical fitness Quality of Life Quantitative psychology Questionnaires Randomized Controlled Trials as Topic Research Design Study Protocol Teenagers Therapeutic education Transition Transition to Adult Care Young Adult Young adults Transition Congenital heart disease Adolescent Therapeutic education Quality of life
Online Access:	Get full text
Tags:	Add Tag No Tags, Be the first to tag this record!

Description
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. 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. Multicentre, 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. As 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. This study was approved by the National Ethics Committee (South-Mediterranean IV 2016-A01681-50) and was registered on Clinicaltrials.gov (NCT03005626).
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23 PMCID: PMC7814637
ISSN:	1477-7525 1477-7525
DOI:	10.1186/s12955-021-01668-1