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

NCT ID: NCT03917706

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 118 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2019-07-15

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.

Conditions

Congenital Heart Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Congenital Heart Disease

Adults suffering from congenital heart disease, followed within the CHU Brugmann hospital, operated during childhood.

Questionnaire

Intervention Type: OTHER

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

Interventions

Questionnaire

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pierre Wauthy

OTHER

Sponsor Role: lead

Responsible Party

Pierre Wauthy

Medical Director of the CHU Brugmann Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marine DENEUBOURG, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Brugmann

Locations

CHU Brugmann

Brussels, , Belgium

Countries

Belgium

Other Identifiers

CHUB-congenital cardiopathy

Identifier Type: -

Identifier Source: org_study_id