NCT03677232

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 11, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
Last Updated

September 19, 2018

Status Verified

September 1, 2018

Enrollment Period

1.1 years

First QC Date

September 5, 2018

Last Update Submit

September 17, 2018

Conditions

Keywords

Congenital Heart Disease, Hong Kong, Adolescent

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Hong Kong Chinese adolescents with CHD

Hong Kong Chinese adolescents with CHD aged 12-18 who are able to read and write chinese

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Heart Defects, CongenitalPsychological Well-Being

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPersonal SatisfactionBehavior

Study Officials

  • William Li, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 5, 2018

First Posted

September 19, 2018

Study Start

August 11, 2017

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

September 19, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations