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Congenital Heart DiseaseNCT02463292

Quality of Life in Young Adults With Congenital Heart Disease

An observational study of Congenital Heart Disease, run by University Children's Hospital, Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 years
Conditions the study is for
Congenital Heart Disease
How many people
325 participants
Where
1 siteSwitzerland
Study dates
May 2015to May 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Yound adult patients with congenital heart disease

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • UniversityHospital Zurich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: Quality of Life, Psychological Adjustment and Academic Achievement 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.

Read the 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.

Being tested
no intervention
Keywords
quality of life, young adults, congenital heart disease
Medical subject headings
Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • no interventionOther

    no intervention

Study groups in NCT02463292
Study groupRoleWhat they receive
patient groupThe 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.
Receives: Other: no intervention
peer control groupThe 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.
Receives: Other: no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health related Quality of life

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

    Measured: up to 12 months

Secondary outcomes (9)

  1. Psychological adjustment

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

    Measured: up to 12 months

  2. Academic achievement / employment situation

    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.

    Measured: up to 12 months

  3. Medical data

    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.

    Measured: up to 12 months

  4. Executive functions

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

    Measured: up to 12 months

  5. Major life events

    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).

    Measured: up to 12 months

  6. Social support

    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).

    Measured: up to 12 months

  7. Emotional regulation

    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).

    Measured: up to 12 months

  8. Socioeconomic status

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

    Measured: up to 12 months

  9. Biographical information

    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.

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionMay 2016
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
325 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02463292
Sponsor's protocol ID
QLYACHD
Status last verified
Jun 2016
First submitted
28 May 2015
Last updated
14 Jun 2016
Results posted
No
Data monitoring committee
No

Publications

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

  • 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.

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

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

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

Questions about this trial

What is this clinical trial studying?

An observational study of Congenital Heart Disease, run by University Children's Hospital, Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health related Quality of life (time frame: up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02463292, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2016.

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