Quality of Life Among Children With Congenital Heart Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01202916
First received: September 14, 2010
Last updated: February 10, 2012
Last verified: February 2012
  Purpose

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.


Condition
Congenital Heart Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Quality of Life Among Children With Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Quality of Life questionnaire [ Time Frame: one day ] [ Designated as safety issue: No ]

Enrollment: 316
Study Start Date: September 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Congenital Heart Disease
Healthy children

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • children with congenital heart disease
  • healthy children
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202916

Locations
France
UH Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: AMEDRO Pascam, MD UH Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01202916     History of Changes
Other Study ID Numbers: UF8422
Study First Received: September 14, 2010
Last Updated: February 10, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Montpellier:
children with congenital heart disease

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 11, 2014