Quality of Life in Young Adults With Congenital Heart Disease

NCT ID: NCT02463292

Last Updated: 2016-06-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 325 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-05-31

Brief Summary

This study aims to evaluate the psychosocial situation of adult congenital heart disease (CHD) patients in terms of health-related quality of life, mental health, academic achievement, and employment status. By assessing a wide variety of medical (e.g., disease severity) and psychosocial (e.g., life events, coping strategies, personality) risk factors it will be possible to better understand the variables that influence psychosocial outcome of young adults with congenital heart disease. This will further improve the understanding of the lifelong consequences of a congenital heart malformation. Factors that proof to be predictors of favorable outcome represent a resource of resilience and therefore should play an important role in the care of CHD patients. By implementing those results in patient care the investigators aim to achieve an improved psychosocial outcome among adult congenital heart disease (ACHD).

Hypothesis 1: It is expected that perceived health status, health-related quality of life and psychological adjustment will not differ between the patient and the control group. However, academic achievement and employment status are expected to be poorer in young adults with congenital heart disease compared to healthy controls.

Hypothesis 2: It is assumed that parental socioeconomic status, problems in emotional regulation and impaired social support will be related to a negative psychosocial outcome and health-related quality of life. Moreover, the investigators hypothesize that disease severity is associated with academic outcome and employment status.

Detailed Description

Background: With an incidence of 6 in 1000 live born children congenital heart disease is among the most common birth defects. Survival rates of children with CHD have significantly improved during the past decades due to better surgical and intensive care medicine. Nowadays, even children requiring open- heart surgery for CHD most frequently have a good cardiac outcome and survive into adulthood. Even those with the most complex forms of CHD have sufficient cardiac outcome. However, impaired quality of life, mental health and behavior problems, as well as neurocognitive and motor impairments have been described to occur more frequently in children with CHD compared to healthy children and may persist into adolescence.

Current findings on QoL, psychological adjustment, and academic achievements in young adults with CHD are currently quite inconsistent due to methodological reasons. Moreover, little is known on risk factors for a negative outcome. To date, mainly medical risk factors have been examined while psychosocial characteristics (e.g., socioeconomic status, parenting, family characteristics) have not been systematically studied. Importantly, little is known about academic achievements and employment situations of young adults with CHD.

Aims: In this study the investigators aim to evaluate the psychosocial situation of adult CHD patients in terms of health-related quality of life, mental health, academic achievement, and employment status.

Methods: The study is designed as a case-control study beeing a mono-center project. The patient group will consist of a maximum of 350 patients with congenital heart disease treated at the cardiologic department of the University Hospital Zurich and a control group consisting of the same amount of also up to 350 individuals beeing good friends of the patients with same gender and similar age.

Recruitment: Participants will be consecutively recruited from May 1st, 2015 to April 30th, 2016. Eligible patients will be contacted by the study nurse during the outpatient consultation at the university hospital. Patients will be informed about the study during their consultation by the study nurse as well as the doctor with whom they have their appointment.The control group will be recruited as good friends (same gender, approx. same age) of the patients.

Conditions

Congenital Heart Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

patient group

The patient group will consist of a maximum of 350 patients (male and female subjects,18 years to 30 years of age, in command of the German language)) with congenital heart disease (Tetralogy of Fallot, Transposition of the great arteries, univentricular heart disease, ventricular septal defect) treated at the cardiologic department of the University Hospital Zurich. Eligible patients will be contacted by the study nurse during the outpatient consultation at the university hospital. No intervention.

no intervention

Intervention Type: OTHER

no intervention

peer control group

The control group will be recruited as good friends (same gender, approx. same age of the patients, in command of the German language). The patients will be given a study information for controls to hand this to their good friend and ask the friend to contact the study nurse for participation in the study. No intervention.

no intervention

Intervention Type: OTHER

no intervention

Interventions

no intervention

no intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Congenital heart disease (Tetralogy of Fallot, Transposition of the great arteries, univentricular heart disease, ventricular septal defect) treated at the University hospital Zurich.
• Male and Female subjects 18 years to 30 years of age
• Written informed consent by the participant after information about the project
• In command of the German language

Exclusion Criteria

• Diagnosis of a chromosomal or genetic syndrome as well as other congenital or acquired neurological impairments leading to mental disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Children's Hospital, Zurich

OTHER

Sponsor Role: lead

Responsible Party

Markus A. Landolt

Prof. Markus Landolt, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Markus Landolt, PHD

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital, Zurich

Locations

UniversityHospital Zurich

Zurich, , Switzerland

Countries

Switzerland

References

Bullinger, M. & Kirchberger, I. (1998). SF-36 Fragebogen zum Gesundheitszustand. Göttingen: Hogrefe.

Reference Type: BACKGROUND

Burgess, P. W., Alderman, N., Wilson, B. A., Evans, J. J., & Emslie, H. (1996). The dysexecutive Questionnaire. In B. A. Wilson, N. Alderman, P. W. Burgess, H. Emslie, & J. J. Evans (Eds.), Behavioral assessment of the dysexecutive syndrome. Bury St. Edmunds, UK: Thames Valley Test Company.

Reference Type: BACKGROUND

Landolt, M.A. & Vollrath, M.E. (1998). Life Event Scale. Zurich: University Children's Hospital.

Reference Type: BACKGROUND

Fydrich, T., Sommer, G., & Brähler, E. (2007). Fragebogen zur sozialen Unterstützung (F-SozU). Göttingen: Hogrefe.

Reference Type: BACKGROUND

Grob, A. & Horowitz, L.M., Fragebogen zur Erhebung der Emotionsregulation bei Erwachsenen (FEELE). (2010). Bern: Huber

Reference Type: BACKGROUND

Other Identifiers

QLYACHD

Identifier Type: -

Identifier Source: org_study_id