Congenital Heart DiseaseQoL-CHD-5-7NCT03931096
Quality of Life Assessment of Children With Congenital Heart Disease Aged 5 to 7 Years
An observational study of Congenital Heart Disease, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Quality of life questionnaire
- How many people
- 248 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Groups 1 : Children with congenital heart disease aged 5 to 7 years Groups 2 : Healthy children aged 5 to 7 years
Who may be able to join
- Children with CHD (as defined in the ACC-CHD classification) aged 5 to 7 years or same aged school children.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life Assessment of Children With Congenital Heart Disease Aged 5 to 7 Years : a Multicentre Controlled Cross-sectional Study
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.
Read the 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
- Being tested
- Quality of life questionnaire
- Keywords
- health related quality of life, congenital heart disease, pediatrics, cardiology, PedsQL 4.0, psychometric properties
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life questionnaireOther
Also called Quality of life questionnaire: Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0).
Self and proxy PedsQL 4.0 questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| children with congenital heart disease | Groupe 1: case: children with congenital heart disease aged 5 to 7 years. Receives: Other: Quality of life questionnaire | |
| control children | Groupe 2: control children recruited in schools aged 5 to 7 years. Receives: Other: Quality of life questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (8)
score of proxy QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales)
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
Measured: 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)
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.
Measured: 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.
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.
Measured: 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.
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
Measured: 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.
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
Measured: 1 day
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.
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
Measured: 1 day
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)
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.
Measured: 1 day
Psychometric properties of the QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) .
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start1 Feb 2019
- Primary completion1 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric and Congenital Cardiology Department of Necker-enfant malades University Hospital, Paris, France
- Responsible party
- Sponsor
- Investigators
- Pascal AMEDRO, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931096
- Sponsor's protocol ID
- RECHMPL19_0061
- Acronym
- QoL-CHD-5-7
- Status last verified
- Mar 2020
- First submitted
- 8 Apr 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
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.
PubMed 33183312
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Assessment of Children With Congenital Heart Disease Aged 5 to 7 Years : a Multicentre Controlled Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03931096
- Acronym / sponsor ID
- QoL-CHD-5-7 / RECHMPL19_0061
- Conditions
- Congenital Heart Disease
- Keywords
- health related quality of life, congenital heart disease, pediatrics, cardiology, PedsQL 4.0, psychometric properties
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Pediatric and Congenital Cardiology Department of Necker-enfant malades University Hospital, Paris, France
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children with congenital heart disease | – | Other: Quality of life questionnaireGroupe 1: case: children with congenital heart disease aged 5 to 7 years. |
| control children | – | Other: Quality of life questionnaireGroupe 2: control children recruited in schools aged 5 to 7 years. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Groups 1 : Children with congenital heart disease aged 5 to 7 years Groups 2 : Healthy children aged 5 to 7 years
Key inclusion criteria (1 listed)
- Children with CHD (as defined in the ACC-CHD classification) aged 5 to 7 years or same aged school children.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life questionnaireAlso: Quality of life questionnaire: Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0).Self and proxy PedsQL 4.0 questionnaires. | Other | children with congenital heart disease, control children |
Primary outcome
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.
8 secondary outcomes
score of proxy QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 day
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
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
Psychometric properties of the QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) .
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Derived from this study: PubMed 33183312Abassi 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.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal AMEDRO, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
score of the self QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03931096, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.