Congenital Heart DiseaseNCT03255850
The Impact of Congenital Heart Disease on the Psychological Well Being and Quality of Life in the Hong Kong Chinese Adolescents
An observational study of Congenital Heart Disease, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 96 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Aug 2017to 31 Aug 2018
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
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 .
Who may be able to join
- pediatric patients with congenital heart disease
- aged at 12-17 years old
- fluent in Cantonese and able to read Chinese
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Congenital Heart Disease
- Keywords
- adolescents, quality of life, psychological well-being
- Medical subject headings
- Heart Defects, Congenital, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (2)
Self-esteem
Self-esteem level is measured by the Rosenberg Self-Esteem Scale (RSES). It consists of
Measured: 1-day
Depressive symptoms
Depressive symptoms is measured by The Center for Epidemiologic Studies Depression Scale
Measured: 1-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start15 Aug 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho Cheung William Li, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255850
- Sponsor's protocol ID
- MPhil_2
- Status last verified
- Sep 2018
- First submitted
- 17 Aug 2017
- Last updated
- 21 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Congenital Heart Disease on the Psychological Well Being and Quality of Life in the Hong Kong Chinese Adolescents
- ClinicalTrials.gov ID
- NCT03255850
- Acronym / sponsor ID
- MPhil_2
- Conditions
- Congenital Heart Disease
- Keywords
- adolescents, quality of life, psychological well-being
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 21 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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 .
Key inclusion criteria (3 listed)
- pediatric patients with congenital heart disease
- aged at 12-17 years old
- fluent in Cantonese and able to read Chinese
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Self-esteem
Time frame: 1-day
Depressive symptoms
Time frame: 1-day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Derived from this study: PubMed 30938874So 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.
- Individual participant dataSharing planned: No
Related trials for Congenital Heart Disease
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho Cheung William Li principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by The University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 3 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 21 Sep 2018. 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 Hong Kong. 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: 1 day). 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 NCT03255850, which also lists 1 linked publication.
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 21 Sep 2018.