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

Health and Quality of Life Outcomes

Elodie Million¹  Agnes Oude Engberink¹  Gerard Bourrel¹  Laurence Pages²  Marie-Christine Picot²  Yves Dulac³  Philippe Acar³  Nathalie Souletie³  Kathleen Lavastre⁴  Hamouda Abassi⁴  Pascal Amedro⁴  Oscar Werner⁴  Gregoire De La Villeon⁴  Sophie Guillaumont⁴  Charlene Bredy⁴  Marie Vincenti⁴  Cristelle Gerl⁴ 

[1] Department of General Medicine, University of Montpellier;Epidemiology and Clinical Research Department, University Hospital;Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Toulouse University Hospital;Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital;

关键词: Transition;    Therapeutic education;    Congenital heart disease;    Quality of life;    Adolescent;   

DOI  :  10.1186/s12955-021-01668-1

来源: DOAJ

【 摘 要 】

Abstract Background 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. Methods 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. Discussion 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. Trial registration This study was approved by the National Ethics Committee (South-Mediterranean IV 2016-A01681-50) and was registered on Clinicaltrials.gov (NCT03005626).

【 授权许可】

Unknown