Quality of Life Assessment of Children With Congenital Heart Disease Aged 5 to 7 Years

NCT ID: NCT03931096

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 248 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2019-12-31

Brief Summary

Congenital heart diseases (CHD) are the firt cause of congenital malformations (8 for 1000 births). Since the 90's, great advances in prenatal diagnosis, pediatric cardiac surgery, intensive care, and cardiac catheterization have reduced morbidity and early mortality in this population. Prevalence of " GUCH ", grown-ups with congenital heart disease has thus been significantly increasing. Nowadays, quality of life (QoL) assessment of this population is in the foreground. Our team is a reference center in the management of patient with CHD, from the fetal period to adulthood. The investigators have been conducting a clinical research program on health related QoL in pediatric and congenital heart disease. The investigators thus demonstrated the link between cardiopulmonary fitness and QoL in children with CHD aged 8 to 18 years, the correlation between functional class and QoL in adults with CHD, and the impact of therapeutic education on QoL in children under anticoagulants. Currently, no controlled cross-sectional quality of life study assessment has been leaded in the youngest children with CHD. This present study therefore extends our work in younger children aged 5 to 7 years.

Detailed Description

248 patients will be enrolled in this study.

Patient from groups 1 is included during his annual medical check-up. Quality of life questionnaire and other examinations are performed during this site visit. Its is a part of his usual care. No supplementary visit, directly related to the research, are necessary. 2 sites will participate to the enrollment, belonging to the French national network for complex congenital heart diseases (M3C) .

Participants (healthy children) from groups 2 are included from schools.The prior agreement of the Ministry of National Education was obtained before any procedure related to this study. 3 schools will participate to the enrolment

Conditions

Congenital Heart Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

children with congenital heart disease

Groupe 1: case: children with congenital heart disease aged 5 to 7 years.

Quality of life questionnaire

Intervention Type: OTHER

Self and proxy PedsQL 4.0 questionnaires.

control children

Groupe 2: control children recruited in schools aged 5 to 7 years.

Quality of life questionnaire

Intervention Type: OTHER

Self and proxy PedsQL 4.0 questionnaires.

Interventions

Quality of life questionnaire

Self and proxy PedsQL 4.0 questionnaires.

Intervention Type: OTHER

Other Intervention Names

Quality of life questionnaire: Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0).

Eligibility Criteria

Inclusion Criteria

• Children with CHD (as defined in the ACC-CHD classification) aged 5 to 7 years or same aged school children.

Exclusion Criteria

• Other comorbidity affecting quality of life (polymalformative syndrome, extracardiac organ failure, neurodegenerative disease, severe genetic disease, psychomotor retardation).
• Surgical procedure during the last 6 months.
• Inability to understand the QoL questionnaire (parents and / or child): non-french speaker, severe intellectual disability.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pediatric and Congenital Cardiology Department of Necker-enfant malades University Hospital, Paris, France

UNKNOWN

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascal AMEDRO, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Uhmontpellier

Montpellier, , France

Countries

France

References

Abassi H, Huguet H, Picot MC, Vincenti M, Guillaumont S, Auer A, Werner O, De La Villeon G, Lavastre K, Gavotto A, Auquier P, Amedro P. Health-related quality of life in children with congenital heart disease aged 5 to 7 years: a multicentre controlled cross-sectional study. Health Qual Life Outcomes. 2020 Nov 12;18(1):366. doi: 10.1186/s12955-020-01615-6.

Reference Type: DERIVED

PMID: 33183312 (View on PubMed)

Other Identifiers

RECHMPL19_0061

Identifier Type: -

Identifier Source: org_study_id