Development of a Quality of Life Assessment Tool for Adult Patients With a Congenital Heart Disease, Having Had Surgery During Childhood
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|ClinicalTrials.gov Identifier: NCT03917706|
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
The mortality due to congenital heart diseases has decreased in recent decades, even for infants with the most complex lesions.Therapeutic advances have prolonged the lifespan of people with these diseases. However, there are specific social and psychological troubles that appear later in life and can compromise employability, insurability and social integration.
There are different types of congenital heart disease: those not operated in adulthood, and those operated for curative or palliative purposes. It is estimated that about 10 out of 1000 babies are born with a congenital cardiac malformation. One-third of these have a critical diagnosis requiring a surgical intervention.
Data from the literature show that there is an unusually high prevalence of psychosocial, neurological, developmental and psychiatric disabilities among survivors, as they enter formal education.There are many factors that influence developmental outcomes at school age. Early intervention is an essential element in controlling these comorbidities. The continuous monitoring of the development by a multidisciplinary team would make it possible to identify a developmental disorder as soon as it appears and respond to it as quickly as possible.For many children and their families, the burden of the developmental consequences is higher than the daily impact of the heart disease.
Most studies and measures of quality of life in congenital heart patients require methodological improvements.They contribute little to the scientific basis of the quality of life in these patients. Future quality of life studies must invest in rigorous conceptualization, adequate operational definition and a good measure of quality of life.
The investigators propose to develop a reproducible and reliable quality of life measurement tool, suitable for adult patients suffering from congenital heart disease and having had surgery during childhood.
|Condition or disease||Intervention/treatment|
|Congenital Heart Disease||Other: Questionnaire|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Development of a Quality of Life Assessment Tool for Adult Patients With a Congenital Heart Disease, Having Had Surgery During Childhood|
|Actual Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Congenital Heart Disease
Adults suffering from congenital heart disease, followed within the CHU Brugmann hospital, operated during childhood.
Patients will be contacted by phone in order to fill in a questionnaire regarding their quality of life.
- Quality of life assessment [ Time Frame: 30 minutes ]Quality of life will be assessed by means of a questionnaire adapted to adult patients suffering from congenital cardiopathy and having had surgery during childhood. There are 76 short closed questions, about 6 different domains (physical activity, social life, family life, professional life, scholarity, psychological comfort).
- Medical antecedents [ Time Frame: 30 minutes ]List of medical antecedents of the patient
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917706
|Contact: Marine DENEUBOURG, MDfirstname.lastname@example.org|
|Contact: Pierre Wauthy, MD||3224773995||Pierre.Wauthy@chu-brugmann.be|
|Brussels, Belgium, 1020|
|Contact: Pierre Wauthy, MD|
|Principal Investigator:||Marine DENEUBOURG, MD||CHU Brugmann|