<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03255850</url>
  </required_header>
  <id_info>
    <org_study_id>MPhil_2</org_study_id>
    <nct_id>NCT03255850</nct_id>
  </id_info>
  <brief_title>The Impact of Congenital Heart Disease on the Psychological Well Being and Quality of Life in the Hong Kong Chinese Adolescents</brief_title>
  <official_title>The Impact of Congenital Heart Disease on the Psychological Well Being and Quality of Life in the Hong Kong Chinese Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to examine the psychological well-being and QoL of Hong Kong Chinese&#xD;
      adolescents with CHD by&#xD;
&#xD;
        -  comparing the self-esteem level, depressive symptoms, and quality of life of adolescents&#xD;
           suffering from CHD with healthy norms and cancer survivors.&#xD;
&#xD;
        -  identifying possible factors affecting the quality of life of adolescents suffering from&#xD;
           CHD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Congenital heart disease (CHD) is the most common type of congenital malformation in the&#xD;
      world with birth prevalence as 8 per 1000 live births. Survival rate has been drastically&#xD;
      improved as a result of improvement in surgical treatments and intensive care but adolescents&#xD;
      with CHD still suffer from limitations on their psychological functioning and restrained&#xD;
      quality of life. Number of evidences have indicated that adolescents with CHD experience more&#xD;
      depressive symptoms and lower self-esteem level than their healthy counterparts. In addition,&#xD;
      adolescents with CHD are more prone to develop emotional and behavioral problems than their&#xD;
      healthy norms. Given the above issues, It is imperative for nurses to develop psychological&#xD;
      interventions to promote psychological well-being among adolescents with CHD, with the goal&#xD;
      of improving their quality of life. There have been increasing concerns worldwide on the&#xD;
      quality of life of such population especially on how does the disease pose threats on their&#xD;
      daily living. However, at present, there is no study examining how does CHD affect the&#xD;
      psychological well-being and quality of life in Hong Kong Chinese adolescents. It is explicit&#xD;
      that Hong Kong has a distinctively different cultural context from that of the West. Hence,&#xD;
      the effects of CHD and its treatments are likely to differ markedly in the two regions .To&#xD;
      conclude, results of previous studies from the West may not fit into Hong Kong Chinese&#xD;
      cultural context.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>1 day</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-esteem</measure>
    <time_frame>1-day</time_frame>
    <description>Self-esteem level is measured by the Rosenberg Self-Esteem Scale (RSES). It consists of</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>1-day</time_frame>
    <description>Depressive symptoms is measured by The Center for Epidemiologic Studies Depression Scale</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">96</enrollment>
  <condition>Congenital Heart Disease</condition>
  <arm_group>
    <arm_group_label>Adolescents with CHD</arm_group_label>
    <description>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)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Childhood cancer survivors</arm_group_label>
    <description>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.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric with congenital heart disease, aged at 12-17 years old, fluent in Cantonese and&#xD;
        are attending the day centre and specialized outpatient sector of Department of Pediatric&#xD;
        Cardiology in Queen Mary Hospital .&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pediatric patients with congenital heart disease&#xD;
&#xD;
          -  aged at 12-17 years old&#xD;
&#xD;
          -  fluent in Cantonese and able to read Chinese&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pediatrics with major developmental delay or having significant co-morbid medical&#xD;
             condition&#xD;
&#xD;
          -  visiting because of altering in clinical condition&#xD;
&#xD;
          -  having acquired heart disease or non-structural heart disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ho Cheung William Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>September 19, 2018</last_update_submitted>
  <last_update_submitted_qc>September 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adolescents</keyword>
  <keyword>quality of life</keyword>
  <keyword>psychological well-being</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03255850
org study id: MPhil_2
nct id: NCT03255850
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Cross-Sectional
measure: Health related quality of life
time frame: 1 day
description: 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.
measure: Self-esteem
time frame: 1-day
description: Self-esteem level is measured by the Rosenberg Self-Esteem Scale (RSES). It consists of
measure: Depressive symptoms
time frame: 1-day
description: Depressive symptoms is measured by The Center for Epidemiologic Studies Depression Scale
arm group label: Adolescents with CHD
description: 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)
arm group label: Healthy control
description: 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.
arm group label: Childhood cancer survivors
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
last name: Ho Cheung William Li
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital
sharing ipd: No