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出境医 / 临床实验 / Quality of Life Assessment of Children With Congenital Heart Disease Aged 5 to 7 Years (QoL-CHD-5-7)
Quality of Life Assessment of Children With Congenital Heart Disease Aged 5 to 7 Years (QoL-CHD-5-7)
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 | Intervention/treatment |
|---|---|
| Congenital Heart Disease | Other: Quality of life questionnaire |
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 1, 2019 |
| Actual Primary Completion Date : | December 1, 2019 |
| Actual Study Completion Date : | December 31, 2019 |
Arms and Interventions
| Group/Cohort | 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.
Other Name: Quality of life questionnaire: Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0).
|
|
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.
Other Name: Quality of life questionnaire: Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0).
|
Outcome Measures
Primary Outcome Measures :
- 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 :
- 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
- 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.
- 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.
- 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
- 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
- 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
- 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.
- 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 Years 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
Locations
| France | |
| Uhmontpellier | |
| Montpellier, France, 34295 | |
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 |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 8, 2019 | ||||
| First Posted Date | April 30, 2019 | ||||
| Last Update Posted Date | March 10, 2020 | ||||
| Actual Study Start Date | February 1, 2019 | ||||
| Actual Primary Completion Date | December 1, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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.
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Quality of Life Assessment of Children With Congenital Heart Disease Aged 5 to 7 Years | ||||
| Official Title | Quality of Life Assessment of Children With Congenital Heart Disease Aged 5 to 7 Years : a Multicentre Controlled Cross-sectional Study | ||||
| 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 |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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 | ||||
| Condition | Congenital Heart Disease | ||||
| Intervention | Other: Quality of life questionnaire
Self and proxy PedsQL 4.0 questionnaires.
Other Name: Quality of life questionnaire: Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0).
|
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| Study Groups/Cohorts |
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| 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
248 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Actual Study Completion Date | December 31, 2019 | ||||
| Actual Primary Completion Date | December 1, 2019 (Final data collection date for primary outcome measure) | ||||
| 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:
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| Sex/Gender |
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| Ages | 5 Years to 7 Years (Child) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03931096 | ||||
| Other Study ID Numbers | RECHMPL19_0061 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | University Hospital, Montpellier | ||||
| Study Sponsor | University Hospital, Montpellier | ||||
| Collaborators | Pediatric and Congenital Cardiology Department of Necker-enfant malades University Hospital, Paris, France | ||||
| Investigators |
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| PRS Account | University Hospital, Montpellier | ||||
| Verification Date | March 2020 | ||||
