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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03917706
• Other study ID #: CHUB-congenital cardiopathy
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: July 15, 2019

Study information

• Verified date: July 2019
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: July 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• congenital heart disease,

• patients having had surgery during childhood,

• patients followed within the CHU Brugmann Hospital.

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Other:
• Questionnaire
Patients will be contacted by phone in order to fill in a questionnaire regarding their quality of life.

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Wauthy

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life assessment	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).	30 minutes
Secondary	Medical antecedents	List of medical antecedents of the patient	30 minutes