Ignite Creation Date:
2024-05-06 @ 7:05 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02463292
Status:
COMPLETED
Last Update Posted:
2016-06-14
First Post:
2015-05-28
Brief Title:
Quality of Life in Young Adults With Congenital Heart Disease
Sponsor:
University Childrens Hospital Zurich
Organization:
University Childrens Hospital Zurich
Study Overview
Official Title:
Quality of Life Psychological Adjustment and Academic Achievement in Young Adults With Congenital Heart Disease
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg disease severity and psychosocial eg 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
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 eg 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 appointmentThe control group will be recruited as good friends same gender approx same age of the patients
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 eg 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 appointmentThe control group will be recruited as good friends same gender approx same age of the patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None