Clinical trial NCT02463292: Quality of Life in Young Adults With Congenital Heart Disease
Official title: Quality of Life, Psychological Adjustment and Academic Achievement in Young Adults With Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Keywords: quality of life
young adults
congenital heart disease
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Yound adult patients with congenital heart disease

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.

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

Primary outcomes:
measure: Health related Quality of life
timeFrame: up to 12 months
Secondary outcomes:
measure: Psychological adjustment
timeFrame: up to 12 months
measure: Academic achievement / employment situation
timeFrame: up to 12 months
measure: Medical data
timeFrame: up to 12 months
measure: Executive functions
timeFrame: up to 12 months
measure: Major life events
timeFrame: up to 12 months
measure: Social support
timeFrame: up to 12 months
measure: Emotional regulation
timeFrame: up to 12 months
measure: Socioeconomic status
timeFrame: up to 12 months
measure: Biographical information
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: UniversityHospital Zurich
Study officials:
affiliation: University Children's Hospital, Zurich
name: Markus Landolt, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bullinger, M. & Kirchberger, I. (1998). SF-36 Fragebogen zum Gesundheitszustand. Göttingen: Hogrefe.
citation: 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.
citation: Landolt, M.A. & Vollrath, M.E. (1998). Life Event Scale. Zurich: University Children's Hospital.
citation: Fydrich, T., Sommer, G., & Brähler, E. (2007). Fragebogen zur sozialen Unterstützung (F-SozU). Göttingen: Hogrefe.
citation: Grob, A. & Horowitz, L.M., Fragebogen zur Erhebung der Emotionsregulation bei Erwachsenen (FEELE). (2010). Bern: Huber