Quality of Life in Young Adults With Congenital Heart Disease

NCT02463292 | Completed

• 1 other identifier: QLYACHD
• Study Type: observational
• Target: 325
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

quality of life; young adults; congenital heart disease

Outcome Measures

Primary Outcomes (1)

• Health related Quality of life

  Health related Quality of life will be assessed by the SF-36 questionnaire (Bullinger \& Kirchberger, 1998).

  up to 12 months

Secondary Outcomes (9)

• Psychological adjustment

  up to 12 months

• Academic achievement / employment situation

  up to 12 months

• Medical data

  up to 12 months

• Executive functions

  up to 12 months

• Major life events

  up to 12 months

Study Arms (2)

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.

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.

Other: no intervention

Interventions

no intervention OTHER

no intervention

patient group; peer control group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Yound adult patients with congenital heart disease

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

UniversityHospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (5)

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

  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.

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

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

Study Officials

• Markus Landolt, PHD

  University Children's Hospital, Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Markus Landolt, PhD

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 4, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 14, 2016

Record last verified: 2016-06

Locations

CH (1)