Quality of Life Among Children With Congenital Heart Disease

Completed

• Conditions: Congenital Heart Disease

• Registration Number: NCT01202916
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Congenital heart diseases (CHD) are the first cause of congenital malformations with an incidence of 8 for 1000 births. Within the two past decades prenatal diagnosis has had a great impact on CHD prevalence. France was the first country to show the impact of prenatal diagnosis on the lowering prevalence of the most severe CHD, the hypoplastic left heart syndrome. Since the 90's, great advances in pediatric cardiac surgery, intensive care and cardiac catheterization have led to lower mortality and morbidity in this population. Prevalence of " GUCH ", grown-ups with congenital heart disease has thus been significantly increasing. For all these reasons and as the investigators can also see in other many chronic diseases, new questions about the quality of life of these patients arise among patients, parents/future parents, doctors, patients associations, and public health organizations. In 2007 French government promoted a national public health plan for "improvement of the quality of life among patients suffering from chronic illnesses". First step of such a program is to correctly evaluate this quality of life. Indeed the concept of "quality of life" (QoL) remains subjective and difficult to appreciate and measure. Its analysis requires the use of validated questionnaires. Few questionnaires are available in Europe, especially in pediatrics. Few studies in this population have been led and no comparative study to a control randomized group has been published. The investigators study aims to analyze in the investigators tertiary care center in pediatric cardiology the QoL among 8 to 18 year old French patients with CHD using a validated questionnaire (Kidscreen™) and to compare it to same aged healthy children. The investigators secondarily intend to :- validate the French version of one reference pediatric QoL questionnaire used in most publications in the USA (PedsQL™). - compare the QoL to the severity of the CHD using a published semi-quantitative score.- compare the QoL to the severity of the CHD using the results of routine exercise tests (VO2 max) performed routinely in the investigators center. The investigators hypothesis are that :- Quality of life of most common and not severe CHD is close to that of healthy children. - QoL of severe CHD is not so well correlated to severity of CHD.- PedsQL™ is a simple questionnaire which can be used in France in routine follow-up of children with CHD.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-09-14
• Study First Submitted QC: 2010-09-15
• Study First Posted: 2010-09-16
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-05
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 316

Inclusion Criteria

• patients with congenital heart disease (defined by Chapter Q of the ICD-10)
• Patient participation in the study noted in the medical record.

Exclusion Criteria

• Age greater than or equal to 8 years and less than 18 years
• Whose parents signed written consent
• Obligation of membership or beneficiary of a French social security

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of Life questionnaire	one day

Trial Locations

Locations (1)

Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital; 🇫🇷 Montpellier, France