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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

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

Clinicaltrials.gov identifier NCT03931096

Recruitment Status Completed

First Posted April 30, 2019

Last update posted March 10, 2020

Study Description

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.

  • Condition or Disease:Congenital Heart Disease
  • Intervention/Treatment: Other: Quality of life questionnaire
  • Phase: N/A
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

Study Design
  • Study Type: Observational
  • Actual Enrollment: 248 participants
  • Observational Model: Case-Control
  • Time Perspective: Cross-Sectional
  • Official Title: Quality of Life Assessment of Children With Congenital Heart Disease Aged 5 to 7 Years : a Multicentre Controlled Cross-sectional Study
  • Actual Study Start Date: February 2019
  • Actual Primary Completion Date: December 2019
  • Actual Study Completion Date: December 2019
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: children with congenital heart disease
Groupe 1: case: children with congenital heart disease aged 5 to 7 years.
Other: Quality of life questionnaire
Self and proxy PedsQL 4.0 questionnaires.
: control children
Groupe 2: control children recruited in schools aged 5 to 7 years.
Other: Quality of life questionnaire
Self and proxy PedsQL 4.0 questionnaires.
Outcome Measures
  • Primary Outcome Measures: 1. score of the self QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) [ Time Frame: 1 day ]
    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.
  • Secondary Outcome Measures: 1. score of proxy QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) [ Time Frame: 1 day ]
    Comparison of the total score of proxy QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) between patients with CHD and schoolchildren aged 5 to 7 years. The proxy 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
  • 2. score by dimensions of self and proxy QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) [ Time Frame: 1 day ]
    Comparison of score by dimensions of self and proxy QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) between patients with CHD and schoolchildren aged 5 to 7 years.The proxy 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 o get score by dimensions of scale we must sum the items scores over the number of items answered. If more than 50% of the items in the scale are missing, the scale scores should not be computed.
  • 3. 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. [ Time Frame: 1 day ]
    Comparison of 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. The 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.
  • 4. 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. [ Time Frame: 1 day ]
    Comparison of 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. The 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
  • 5. 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. [ Time Frame: 1 day ]
    Comparison of 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. The 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
  • 6. score of QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) to the prognostic classification of the CHD using Davey B.T classification. [ Time Frame: 1 day ]
    Comparison of score of QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) to the prognostic classification of the CHD using Davey B.T. The 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
  • 7. impact of variables related to the patient and to the CHD on his quality of life with the scores of QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) [ Time Frame: 1 day ]
    Study of the association of the following variables related to the patient and to the CHD with the scores of QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) . Univariate end multivariate analysis will be performed. The variables are: sex of the patient, age at diagnosis of CHD (pre or post natal) number of cardiac surgeries type of cardiac surgery (thoracotomy or sternotomy) number of cardiac catheterizations type of medical treatment left ventricular ejection fraction (LVEF) the presence of pulmonary arterial hypertension the presence of a mechanical valve the presence of a pacemaker or defibrillator the presence of hypertension of the right ventricle.
  • 8. Psychometric properties of the QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) . [ Time Frame: 1 day ]
    Evaluation of the psychometric properties of the QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) .The Pediatric Quality of Life Inventory Version 4.0 (PedsQLTM 4.0) is a questionnaire widely used in pediatric clinical trials. This questionnaire was translated and linguistically validated in French, but no complete psychometric validation for French children has been performed yet. Reliability and validity are considered the main measurement properties of such instruments.
Eligibility Criteria
  • Ages Eligible for Study: 5 to 7 Years (Child)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • 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
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.

Contacts and Locations
Contacts
Locations

France
Uhmontpellier
Montpellier

Sponsors and Collaborators

University Hospital, Montpellier

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

Investigators

Principal Investigator: Pascal AMEDRO, MD, PhD University Hospital, Montpellier

More Information
  • Responsible Party: University Hospital, Montpellier
  • ClinicalTrials.gov Identifier: NCT03931096 History of Changes
  • Other Study ID Numbers: RECHMPL19_0061
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: March 10, 2020
  • Last Verified: March 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Plan Description: NC
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University Hospital, Montpellier: health related quality of life
    congenital heart disease
    PedsQL 4.0
    psychometric properties
    pediatrics
    cardiology
  • Additional relevant MeSH terms: Heart Diseases Heart Defects, Congenital