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NCT Number: NCT02463292

Quality of Life in Young Adults With Congenital Heart Disease

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UniversityHospital Zurich

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. Health related Quality of life

    Time frame: up to 12 months

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

Secondary outcomes

  1. Psychological adjustment

    Time frame: up to 12 months

    Psychological adjustment will be assessed by the symptom checklist-27 (SCL-27).

  2. Academic achievement / employment situation

    Time frame: up to 12 months

    Academic achievement / employment situation will be assessed by means of a self-developed questionnaire: Participants will be asked to give information on their own education by means of number of school years, number of school year repetitions, type of schooling, need for special schooling or tutoring, age at graduation from school, completed apprenticeship and current employment status.

  3. Medical data

    Time frame: up to 12 months

    Medical data will be collected only for the patients from their medical records: Exact cardiac diagnosis, number of surgeries on cardio-pulmonary bypass, number of interventional procedures, current functional class (according to the New Your Heart Association functional class), biometric characteristics (body weight, height, body mass index), current clinical findings (oxygen saturation, respiratory rate, heart rate, blood pressure), current medication, previous cardiovascular complications (arrhythmias, heart failure, endocarditis, stroke), current echocardiographic findings (ventricular function, residual valve regurgitation or stenosis, residual shunts), data from exercise testing (maximal exercise capacity, maximal oxygen uptake, heart rate reserve), findings from cardiac catheterization and cardiac MRI or CT, if available.

  4. Executive functions

    Time frame: up to 12 months

    Executive functions will be measured with the dysexecutive questionnaire (DEX) (Wilson, Alderman, Burgess, Emslie, & Evans, 1996).

  5. Major life events

    Time frame: up to 12 months

    Major life events will be assessed for the previous 12 months by a 12-item scale regarding for example unemployment, change of domicile, death of family members or friends (Landolt & Vollrath, 1998).

  6. Social support

    Time frame: up to 12 months

    Social support will be assessed by means of the the F-SozU, a 14-item short form questionnaire assessing subjectively perceived emotional and instrumental support as well as social integration (Fydrich, Sommer & Brähler, 2002).

  7. Emotional regulation

    Time frame: up to 12 months

    Emotional regulation is measured with the FEEL-E, an inventory that assesses 12 strategies (6 adaptive, 6 maladaptive) for regulation of temper, fear and grief (Grob & Horowitz, 2014).

  8. Socioeconomic status

    Time frame: up to 12 months

    Socioeconomic status will be calculated by means of a 6-point scale scoring for paternal occupation and maternal education.

  9. Biographical information

    Time frame: up to 12 months

    Participants will be asked to give information on their family status, own children, citizenship, mother tongue and parents'mother tongue on the same questionnaire they fill out information about education and academic career.

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Official study title

Quality of Life, Psychological Adjustment and Academic Achievement in Young Adults With Congenital Heart Disease

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 4, 2015
Registry last updated
Jun 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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