Congenital Heart DiseaseNCT03677232
The Living Experience of Hong Kong Chinese Adolescents With CHD.
An observational study of Congenital Heart Disease and Psychological Well-being, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study aims to explore the impacts of CHD and its limitations on adolescents and the living experience of adolescents living with CHD. Hong Kong Chinese adolescents with CHD are having reduced psychological well-being and quality of life than their healthy counterparts. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Congenital Heart Disease, Psychological Well-being, Quality of Life
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Aug 2017to 31 Aug 2018
- How long will I take part?
- 1 Day
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Hong Kong Chinese adolescents with CHD, aged 12 to 18, who are able to read and write Chinese, and are attending the outpatient clinic of Department of Pediatric Cardiology.
Who may be able to join
- Hong Kong Chinese adolescents
- aged 12 to 18
- able to read and write Chinese
- attending outpatient clinic of Department of Pediatric Cardiology
Who cannot join
- adolescents with non-structural heart disease
- with developmental delay or comorbid medical conditions
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to explore the impacts of CHD and its limitations on adolescents and the living experience of adolescents living with CHD.
Hong Kong Chinese adolescents with CHD are having reduced psychological well-being and quality of life than their healthy counterparts. Qualitative study is therefore needed to explore how CHD may impact on the adolescents' psychological well-being and quality of life.
Read the detailed description
A qualitative study was adopted. Purposive sampling of 30 adolescents with CHD were done. Thematic analysis was used for data analysis. The participants unfold negative impacts of CHD and its treatments, and the challenges they were facing with their relationship with others.
- Keywords
- Congenital Heart Disease, Hong Kong, Adolescent
- 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 |
|---|---|---|
| Hong Kong Chinese adolescents with CHD | Hong Kong Chinese adolescents with CHD aged 12-18 who are able to read and write chinese |
What is being measured
The primary outcome is the main question the study is designed to answer.
living experience of adolescents with CHD
Participants were asked to describe their living experiences with CHD and how has CHD affected their quality of life and psychological well-being during the semi-structure interview.
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 posted19 Sep 2018
- Study start11 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.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. LI William Ho Cheung, The University of Hong Kong
- Investigators
- William Li, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677232
- Sponsor's protocol ID
- UW 17-290
- Status last verified
- Sep 2018
- First submitted
- 5 Sep 2018
- Last updated
- 19 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Living Experience of Hong Kong Chinese Adolescents With CHD.
- ClinicalTrials.gov ID
- NCT03677232
- Acronym / sponsor ID
- UW 17-290
- Keywords
- Congenital Heart Disease, Hong Kong, Adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 11 Aug 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 19 Sep 2018 (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 explore the impacts of CHD and its limitations on adolescents and the living experience of adolescents living with CHD.
Hong Kong Chinese adolescents with CHD are having reduced psychological well-being and quality of life than their healthy counterparts. Qualitative study is therefore needed to explore how CHD may impact on the adolescents' psychological well-being and quality of life.
Detailed description
A qualitative study was adopted. Purposive sampling of 30 adolescents with CHD were done. Thematic analysis was used for data analysis. The participants unfold negative impacts of CHD and its treatments, and the challenges they were facing with their relationship with others.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hong Kong Chinese adolescents with CHD | – | –Hong Kong Chinese adolescents with CHD aged 12-18 who are able to read and write chinese |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Hong Kong Chinese adolescents with CHD, aged 12 to 18, who are able to read and write Chinese, and are attending the outpatient clinic of Department of Pediatric Cardiology.
Key inclusion criteria (4 listed)
- Hong Kong Chinese adolescents
- aged 12 to 18
- able to read and write Chinese
- attending outpatient clinic of Department of Pediatric Cardiology
Key exclusion criteria (2 listed)
- adolescents with non-structural heart disease
- with developmental delay or comorbid medical conditions
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
living experience of adolescents with CHD
Time frame: 1 day
Participants were asked to describe their living experiences with CHD and how has CHD affected their quality of life and psychological well-being during the semi-structure interview.
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 19 Sep 2018.
- Individual participant dataSharing planned: No
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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.
William Li, PhD 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 and Psychological Well-being, 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 4 inclusion and 2 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 19 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?
living experience of adolescents with CHD (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2018.