ClinicalTrials.gov
ClinicalTrials.gov Menu

Quality of Life Among Children With Congenital Heart Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01202916
Recruitment Status : Completed
First Posted : September 16, 2010
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Congenital Heart Disease

Study Type : Observational
Actual Enrollment : 316 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Quality of Life Among Children With Congenital Heart Disease
Study Start Date : September 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

Group/Cohort
Congenital Heart Disease
Healthy children



Primary Outcome Measures :
  1. Quality of Life questionnaire [ Time Frame: one day ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202916


Locations
France
Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: AMEDRO Pascal, MD, PhD UH Montpellier

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01202916     History of Changes
Other Study ID Numbers: 8422
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

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