The Living Experience of Hong Kong Chinese Adolescents Wi... | NCT03677232

Studies
The Living Experience of Hong Kong Chinese Adolescents With CHD.

NCT03677232

Sponsor

The University of Hong Kong

Status

Completed

Last Update Posted

Sep 19, 2018Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Congenital Heart Disease
Psychological Well-being
Quality of Life
Adolescent
Chinese

Interventions

Not provided

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 11, 2017Actual

Primary Completion Date

Aug 31, 2018Actual

Completion Date

Aug 31, 2018Actual

First Submitted Date

Sep 5, 2018

First Submission Date that Met QC Criteria

Sep 17, 2018

First Posted Date

Sep 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2018

Last Update Posted Date

Sep 19, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. LI William Ho Cheung, Associate Professor, The University of Hong KongPrincipal Investigator

Lead Sponsor

The University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hong Kong Chinese adolescents with CHD		Hong Kong Chinese adolescents with CHD aged 12-18 who are able to read and write chinese

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hong Kong Chinese adolescents
aged 12 to 18
able to read and write Chinese
attending outpatient clinic of Department of Pediatric Cardiology

Exclusion Criteria:

adolescents with non-structural heart disease
with developmental delay or comorbid medical conditions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William Li, PhD	The University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Hong Kong		Hong Kong			Hong Kong

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006330	Heart Defects, Congenital
D000092862	Psychological Well-Being

Ancestor Terms

ID	Term
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D000013	Congenital Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided