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

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ClinicalTrials.gov Identifier: NCT03255850
Recruitment Status : Completed
First Posted : August 21, 2017
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

Tracking Information
First Submitted Date August 17, 2017
First Posted Date August 21, 2017
Last Update Posted Date September 21, 2018
Actual Study Start Date August 15, 2017
Actual Primary Completion Date August 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 19, 2018)
Health related quality of life [ Time Frame: 1 day ]
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.
Original Primary Outcome Measures
 (submitted: August 17, 2017)
  • Quality of life [ Time Frame: baseline ]
    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.
  • Self-esteem [ Time Frame: baseline ]
    Self-esteem level is measured by the Rosenberg Self-Esteem Scale (RSES). It consists of 10 items using a 4-point Likert scale ranging from 1 to 4 (strongly disagree to strongly agree), producing an index of self-esteem scores ranging from 10 to 40. Higher scores indicate higher self-esteem level.
  • Depression level [ Time Frame: baseline ]
    Depression level is measured by The Center for Epidemiologic Studies Depression Scale for Children (CES-DC). It acts as a detection tool for depressive disorder,it consists of 20 standardized items concerning the emotional ,cognitive and behavioral-related components of depression and assesses in 4-point Likert Scale concerning on the incidence during last week scored from 0 to 3(0= "not at all," 1= "a little," 2= "sometimes," 3= "a lot"), the total score ranging from 0 to 60, higher score represents higher intensity of symptoms while a score at 16 or greater indicates a person suffers from some depressive symptoms.
Change History Complete list of historical versions of study NCT03255850 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 19, 2018)
  • Self-esteem [ Time Frame: 1-day ]
    Self-esteem level is measured by the Rosenberg Self-Esteem Scale (RSES). It consists of
  • Depressive symptoms [ Time Frame: 1-day ]
    Depressive symptoms is measured by The Center for Epidemiologic Studies Depression Scale
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Impact of Congenital Heart Disease on the Psychological Well Being and Quality of Life in the Hong Kong Chinese Adolescents
Official Title The Impact of Congenital Heart Disease on the Psychological Well Being and Quality of Life in the Hong Kong Chinese Adolescents
Brief 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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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 .
Condition Congenital Heart Disease
Intervention Not Provided
Study Groups/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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 19, 2018)
96
Original Estimated Enrollment
 (submitted: August 17, 2017)
300
Actual Study Completion Date August 31, 2018
Actual Primary Completion Date August 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number NCT03255850
Other Study ID Numbers MPhil_2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party The University of Hong Kong
Study Sponsor The University of Hong Kong
Collaborators Not Provided
Investigators
Principal Investigator: Ho Cheung William Li The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date September 2018