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CompletedNCT03255850Updated Sep 21, 2018

The Impact of Congenital Heart Disease on the Psychological Well Being and Quality of Life in the Hong Kong Chinese Adolescents

An observational study in Congenital Heart Disease, sponsored by The University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-09-21.

Sponsored by The University of Hong Kong · Observational

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Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
96
Ages
12 Years to 17 Years
Sex
All
01

Study summary

This study aims to examine the psychological well-being and QoL of Hong Kong Chinese adolescents with CHD by

  • comparing the self-esteem level, depressive symptoms, and quality of life of adolescents suffering from CHD with healthy norms and cancer survivors.
  • identifying possible factors affecting the quality of life of adolescents suffering from CHD.
Read the detailed description

Congenital heart disease (CHD) is the most common type of congenital malformation in the world with birth prevalence as 8 per 1000 live births. Survival rate has been drastically improved as a result of improvement in surgical treatments and intensive care but adolescents with CHD still suffer from limitations on their psychological functioning and restrained quality of life. Number of evidences have indicated that adolescents with CHD experience more depressive symptoms and lower self-esteem level than their healthy counterparts. In addition, adolescents with CHD are more prone to develop emotional and behavioral problems than their healthy norms. Given the above issues, It is imperative for nurses to develop psychological interventions to promote psychological well-being among adolescents with CHD, with the goal of improving their quality of life. There have been increasing concerns worldwide on the quality of life of such population especially on how does the disease pose threats on their daily living. However, at present, there is no study examining how does CHD affect the psychological well-being and quality of life in Hong Kong Chinese adolescents. It is explicit that Hong Kong has a distinctively different cultural context from that of the West. Hence, the effects of CHD and its treatments are likely to differ markedly in the two regions .To conclude, results of previous studies from the West may not fit into Hong Kong Chinese cultural context.

02

Conditions studied

  • Congenital Heart Disease

Keywords

  • adolescents
  • quality of life
  • psychological well-being
03

In context

Heart Defects, Congenital

991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.

This study's enrollment of 96 is below the median of 119 across 440 observational studies indexed under Heart Defects, Congenital.

Browse Heart Defects, Congenital studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pediatric with congenital heart disease, aged at 12-17 years old, fluent in Cantonese and are attending the day centre and specialized outpatient sector of Department of Pediatric Cardiology in Queen Mary Hospital .

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • pediatric patients with congenital heart disease
  • aged at 12-17 years old
  • fluent in Cantonese and able to read Chinese

Exclusion criteria

Exclusion Criteria:

  • pediatrics with major developmental delay or having significant co-morbid medical condition
  • visiting because of altering in clinical condition
  • having acquired heart disease or non-structural heart disease
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
96 participants (actual)
Patient registry
No

Groups and cohorts

  • Adolescents with CHD

    Adolescents with CHD are required to complete the Chinese version of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), Center for Epidemiological Studies -Depression Scale (CES-DC) and Rosenberg Self-Esteem Scale (RSES)

  • Healthy control

    Data of healthy control who completed the Chinese version of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), Center for Epidemiological Studies -Depression Scale (CES-DC) and Rosenberg Self-Esteem Scale (RSES) are retrieved from previous studies.

  • Childhood cancer survivors

    Data of childhood cancer survivors who completed the Chinese version of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), Center for Epidemiological Studies -Depression Scale (CES-DC) and Rosenberg Self-Esteem Scale (RSES) are retrieved from previous studies.

06

What researchers measure

Primary outcomes

  1. Health related quality of life

    Quality of life is measured by Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL) which aims at measuring patient's perceptions of the patient's HRQOL in various aspects namely the impact of disease and treatment on an individual's physical functioning(8 items ), emotional functioning(5 items), social functioning(5 items), and school functioning(5 items). The 5-point Likert scale is used for indicating the frequency of a problem has been during the past one month ,0=never a problem, 1=almost never a problem, 2=sometimes a problem, 3=often a problem and 4=almost always a problem. The PedsQL core scales can be completed within 10-15 minutes. Reversed scoring will be used to evaluate the items and linear transformed into 0-100 scale, thus higher PedsQL scores represents greater HRQOL.

    Time frame: 1 day

Secondary outcomes

  1. Self-esteem

    Self-esteem level is measured by the Rosenberg Self-Esteem Scale (RSES). It consists of

    Time frame: 1-day

  2. Depressive symptoms

    Depressive symptoms is measured by The Center for Epidemiologic Studies Depression Scale

    Time frame: 1-day

07

Study locations

1 site
  • The University of Hong Kong
    Hong Kong, Hong Kong
08

References and documents

Publications

  • So SCY, Li WHC, Ho KY. The impact of congenital heart disease on the psychological well-being and quality of life of Hong Kong Chinese adolescents: A cross-sectional study. J Clin Nurs. 2019 Sep;28(17-18):3158-3167. doi: 10.1111/jocn.14864. Epub 2019 Apr 21. PubMed 30938874 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2017 to primary completion in Aug 2018, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2017
First posted
Aug 21, 2017
StartActual
Aug 15, 2017
Primary completionActual
Aug 31, 2018
CompletionActual
Aug 31, 2018
Last update
Sep 21, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03255850
Responsible party
Sponsor
First posted
Aug 21, 2017
Start date
Aug 15, 2017
Primary completion
Aug 31, 2018
Completion
Aug 31, 2018
Last update
Sep 21, 2018

Study contacts

Ho Cheung William Li
principal investigator · The University of Hong Kong

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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