xml: <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/NCT05974098</url>
    </required_header>
    <id_info>
      <org_study_id>atrial fibrillation2023</org_study_id>
      <nct_id>NCT05974098</nct_id>
    </id_info>
    <brief_title>Quality of Life Influencing Factors</brief_title>
    <official_title>Exploring the Impact of Illness Perceptions, Coping Strategies on Quality of Life in Paroxysmal Atrial Fibrillation Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University People's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking University People's Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Background: quality of life is impaired in patients with paroxysmal atrial fibrillation. The&#xD;
        purpose of this study is to explore the mediating effects of self-efficacy, coping,&#xD;
        depression, and anxiety on the quality of life of patients with paroxysmal atrial&#xD;
        fibrillation. Methods: It is a cross-sectional study trial. This study aims to enroll 100&#xD;
        patients with paroxysmal atrial fibrillation. Illness perceptions (Brief Illness Perceptions&#xD;
        Questionnaire; BIPQ), coping styles (Carver Brief-COPE scale; B-COPE), depression Patient&#xD;
        Health Questionnaire-9 ,PHQ-9),anxiety (The Generalized Anxiety Disorder Questionnaire, GAD&#xD;
        7) and quality of life (12-item Short Form Health Survey,SF12) will be analysed. This study&#xD;
        intends to use correlation analysis and mediation analyses to assess the mediating effects of&#xD;
        self-efficacy, coping, depression and anxiety on the quality of life of patients with&#xD;
        paroxysmal atrial fibrillation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Ecologic or Community</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The 12-item Short Form Health Survey (SF-12)</measure>
      <time_frame>Quality of life was measured at the start of the study，Up to 24 weeks</time_frame>
      <description>The 12-item Short Form Health Survey (SF-12) is a 12-item, multipurpose short-form survey that is used to measure generic HRQoL (derived from the SF-36). The findings are weighted and summed to produce clearly interpretable scales for a participant's physical and mental well-being26. SF-12 is divided into two domains: the physical component summary (PCS) and the mental component summary (MCS). Each domain scores from 0 to 100, with higher scores indicating a better health status. The SF-12's PCS and MCS scores are based on the norms of a broad population in the United States of America, with a mean of 50</description>
    </primary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Paroxysmal Atrial Fibrillation</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Observational study</intervention_name>
      <description>This study intends to use correlation analysis and mediation analyses to assess the mediating effects of self-efficacy, coping, depression and anxiety on the quality of life of patients with paroxysmal atrial fibrillation.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients are from the Department of Cardiology and Department of Psychiatry, a&#xD;
          comprehensive tertiary hospital in China. All patients who are interviewed provided written&#xD;
          informed consents.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. age 18-75 years;&#xD;
  &#xD;
            2. AF diagnosis, based on a 12-lead ECG and cardiologist-led examination following the&#xD;
               2016 ESC Guidelines for the Management of Atrial Fibrillation&#xD;
  &#xD;
            3. paroxysmal AF diagnosis given by a cardiologist according to the conversion back to&#xD;
               the normal sinus rhythm occurs spontaneously within a week&#xD;
  &#xD;
            4. ability to read and write in Chinese.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. severe complications such as unstable coronary artery disease, heart failure with&#xD;
               severe systolic dysfunction(ejection fraction≤35%)&#xD;
  &#xD;
            2. AF soon after thoracic surgery;&#xD;
  &#xD;
            3. malignant disease with a 1-year survival rate or a terminal illness diagnosis;&#xD;
  &#xD;
            4. a diagnosed psychiatric condition that interfered with participation (including severe&#xD;
               depression, bipolar disorder, psychotic illness of any type, dementia, acute&#xD;
               suicidality, severe personality disorder)&#xD;
  &#xD;
            5. participation in another study&#xD;
  &#xD;
            6. cognitive impairment interfering with their ability to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Peking University People's Hospital</investigator_affiliation>
      <investigator_full_name>Qu Shan</investigator_full_name>
      <investigator_title>Head of the Department of Medical Psychology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atrial Fibrillation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05974098
  org study id: atrial fibrillation2023
  nct id: NCT05974098
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Background: quality of life is impaired in patients with paroxysmal atrial fibrillation. The
        purpose of this study is to explore the mediating effects of self-efficacy, coping,
        depression, and anxiety on the quality of life of patients with paroxysmal atrial
        fibrillation. Methods: It is a cross-sectional study trial. This study aims to enroll 100
        patients with paroxysmal atrial fibrillation. Illness perceptions (Brief Illness Perceptions
        Questionnaire; BIPQ), coping styles (Carver Brief-COPE scale; B-COPE), depression Patient
        Health Questionnaire-9 ,PHQ-9),anxiety (The Generalized Anxiety Disorder Questionnaire, GAD
        7) and quality of life (12-item Short Form Health Survey,SF12) will be analysed. This study
        intends to use correlation analysis and mediation analyses to assess the mediating effects of
        self-efficacy, coping, depression and anxiety on the quality of life of patients with
        paroxysmal atrial fibrillation.
  observational model: Ecologic or Community
  time perspective: Cross-Sectional
  measure: The 12-item Short Form Health Survey (SF-12)
  time frame: Quality of life was measured at the start of the study，Up to 24 weeks
  description: The 12-item Short Form Health Survey (SF-12) is a 12-item, multipurpose short-form survey that is used to measure generic HRQoL (derived from the SF-36). The findings are weighted and summed to produce clearly interpretable scales for a participant's physical and mental well-being26. SF-12 is divided into two domains: the physical component summary (PCS) and the mental component summary (MCS). Each domain scores from 0 to 100, with higher scores indicating a better health status. The SF-12's PCS and MCS scores are based on the norms of a broad population in the United States of America, with a mean of 50
  intervention type: Other
  intervention name: Observational study
  description: This study intends to use correlation analysis and mediation analyses to assess the mediating effects of self-efficacy, coping, depression and anxiety on the quality of life of patients with paroxysmal atrial fibrillation.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  responsible party type: Principal Investigator
  investigator affiliation: Peking University People's Hospital
  investigator full name: Qu Shan
  investigator title: Head of the Department of Medical Psychology
  mesh term: Atrial Fibrillation
  sharing ipd: No