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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03255850
Other study ID # MPhil_2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 15, 2017
Est. completion date August 31, 2018

Study information

Verified date September 2018
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date August 31, 2018
Est. primary completion date August 31, 2018
Accepts healthy volunteers No
Gender All
Age group 12 Years to 17 Years
Eligibility Inclusion Criteria:

- pediatric patients with congenital heart disease

- aged at 12-17 years old

- fluent in Cantonese and able to read Chinese

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

Study Design


Locations

Country Name City State
Hong Kong The University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 day
Secondary Self-esteem Self-esteem level is measured by the Rosenberg Self-Esteem Scale (RSES). It consists of 1-day
Secondary Depressive symptoms Depressive symptoms is measured by The Center for Epidemiologic Studies Depression Scale 1-day
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