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

NCT03931096 | Completed

• 1 other identifier: RECHMPL19_0061
• Study Type: observational
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

health related quality of life; congenital heart disease; pediatrics; cardiology; PedsQL 4.0; psychometric properties

Outcome Measures

Primary Outcomes (1)

• score of the self QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales)

  Comparison of the total score of the self QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) between patients with CHD and control children recruited in schools, aged 5 to 7 years. The self QoL questionnaire PedsQL 4.0 is composed of 23 items comprising 4 dimensions. Items are reversed scored and linearly transformed to a 0-100 scale. In order to get a total score we must sum all the items scores over the number of items answered on all the Scales. If more than 50% of the items in the scale are missing, the scale scores should not be computed.

  1 day

Secondary Outcomes (8)

• score of proxy QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales)

  1 day

• score by dimensions of self and proxy QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales)

  1 day

• score of QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) to the type of the CHD using the ACC-CHD classification.

  1 day

• score of QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) to the severity of the CHD using the BETHESDA classification.

  1 day

• score of QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) to the patient functional status using the Ross classification.

  1 day

Study Arms (2)

children with congenital heart disease

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

Other: Quality of life questionnaire

control children

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

Other: Quality of life questionnaire

Interventions

Quality of life questionnaire OTHER

Self and proxy PedsQL 4.0 questionnaires.

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

children with congenital heart disease; control children

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Groups 1 : Children with congenital heart disease aged 5 to 7 years Groups 2 : Healthy children aged 5 to 7 years

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Pediatric and Congenital Cardiology Department of Necker-enfant malades University Hospital, Paris, France: collaborator

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Related Publications (1)

• 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.

  PMID: 33183312 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Pascal AMEDRO, MD, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 30, 2019
• Study Start: February 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 31, 2019
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

FR (1)