Development of a Quality of Life Assessment Tool for Adult Patients With a Congenital Heart Disease, Having Had Surgery During Childhood

Completed

• Conditions: Congenital Heart Disease
• Interventions: Other: Questionnaire

• Registration Number: NCT03917706
• Lead Sponsor: Pierre Wauthy

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-08
• Study Start: 2018-04-01
• Study First Submitted QC: 2019-04-16
• Study First Posted: 2019-04-17
• Status Verified: 2019-07
• Primary Completion: 2019-07-15
• Study Completion: 2019-07-15
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• congenital heart disease,
• patients having had surgery during childhood,
• patients followed within the CHU Brugmann Hospital.

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Congenital Heart Disease	Questionnaire	Adults suffering from congenital heart disease, followed within the CHU Brugmann hospital, operated during childhood.

Primary Outcome Measures

Name	Time	Method
Quality of life assessment	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).

Secondary Outcome Measures

Name	Time	Method
Medical antecedents	30 minutes	List of medical antecedents of the patient

Trial Locations

Locations (1)

CHU Brugmann; 🇧🇪 Brussels, Belgium