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

NCT03917706 | Completed

• 1 other identifier: CHUB-congenital cardiopathy
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Medical antecedents

  30 minutes

Study Arms (1)

Congenital Heart Disease

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

Other: Questionnaire

Interventions

Questionnaire OTHER

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

Congenital Heart Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults suffering from congenital heart disease, having had surgery during childhood, followed within the CHU Brugmann Hospital.

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• Pierre Wauthy: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Marine DENEUBOURG, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director of the CHU Brugmann Hospital

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: April 17, 2019
• Study Start: April 1, 2018
• Primary Completion: July 15, 2019
• Study Completion: July 15, 2019
• Last Updated: July 16, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)