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/NCT05999695</url>
    </required_header>
    <id_info>
      <org_study_id>2022-08-003C</org_study_id>
      <nct_id>NCT05999695</nct_id>
    </id_info>
    <brief_title>Self-management of Patients With Acute Coronary Syndromes</brief_title>
    <official_title>Effects of the Self-management on Anxiety, Depression, Quality of Life and Self-management of Patients With Acute Coronary Syndromes: a Randomized Controlled Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Taipei Veterans General Hospital, Taiwan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Taipei Veterans General Hospital, Taiwan</source>
    <oversight_info>
      <has_dmc>No</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>
        Purpose :&#xD;
  &#xD;
        The purpose of this study is to investigate the tracking effect of selfmanagement programs on&#xD;
        anxiety, depression, and quality of life in patients with Acute Coronary Syndromes (ACS).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Research Design :&#xD;
  &#xD;
        This study the first phase is to construct and develop interventional measures for&#xD;
        self-management of patients with ACS. According to the associated factors of study, the&#xD;
        intervention measures are designed based on self-management. A pilot study will be conducted&#xD;
        to improve research and to develop better selfmanagement interventions in the future. At the&#xD;
        secondary stage: a randomized controlled trial with a random sampling design is used to&#xD;
        investigate the effects of self-management programs on anxiety, depression, and quality of&#xD;
        life in patients with ACS. The study will conduct in a cardiac medicine ward or coronary&#xD;
        intensive care center of a north medical center. Patients with ACS,who met the conditions and&#xD;
        agreed to join the study will be recruited. Then,the informed consent will be obtained. At&#xD;
        the first stage, 10subjects will be collect. At the secondary stage, a total of 104 subjects&#xD;
        will be enrolled, 52 in the experimental group will receive the self-management program, and&#xD;
        52 in the control group will receive a routine hospital care.&#xD;
  &#xD;
        Method &amp; Results:&#xD;
  &#xD;
        The data of demographic and disease characteristics, clinical indicators,depression, anxiety,&#xD;
        self-management, and quality of life will be collected.The Hospital Anxiety and Depression&#xD;
        Scale, the SF-36 Taiwan version of the Quality-of-Life Questionnaire and the Self-Management&#xD;
        Scale will used as tools to collect data. The efficacy of the intervention will be collected&#xD;
        1 month and 3 months after the intervention. Data will be statistically analyzed by GEE.&#xD;
  &#xD;
        Hypothesis :&#xD;
  &#xD;
        It is expected that the self-management program applied to patients with ACS can reduce&#xD;
        depression and anxiety, thereby improving the quality of life.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">December 11, 2022</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Hospital Anxiety and Depression Scale, HADS</measure>
      <time_frame>First time(baseline) is in the first day in the ward.The second time is one month after discharge.The third time is three months after discharge.</time_frame>
      <description>The Likert four-point scale (0-3 points) was used, and the two items were scored separately, and the total score was between 0-21 points. The higher the score, the higher the degree of anxiety or depression. A score below 7 means no anxiety or depression, a score between 8 and 10 means the patient is suspected of anxiety or depression, and a score greater than or equal to 11 means that the patient has anxiety or depression.&#xD;
  It is a measure to assess change at three-time points. change from Baseline Anxiety and Depression at 1 and 3 months.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The MOS 36-Item Short-Form Health Survey,SF36</measure>
      <time_frame>First time(baseline) is in the first day in the ward.The second time is one month after discharge.The third time is three months after discharge</time_frame>
      <description>Scores range from 0 to 100, with higher scores indicating better self-assessed health. Each item of the questionnaire is calculated separately according to the designed initial scores. Then the scores of the items related to each scale are added up and then subtracted from each scale to obtain the lowest score. Divide by the distance between the possible scores of each scale, and multiply by 100 to get the score.&#xD;
  It is a measure to assess change at three-time points. change from Baseline quality of life at 1 and 3 months.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Partner In Health scale, PIH</measure>
      <time_frame>First time(baseline) is in the first day in the ward.The second time is one month after discharge.The third time is three months after discharge</time_frame>
      <description>Items in the scale are graded on a nine-point scale, with 0 representing the worst and 8 representing the best. This is a closed and continuous variable. The scale scores range from 0 to 96, with higher scores indicating better selfmanagement.&#xD;
  It is a measure to assess change at three-time points. Change from self-management Baseline at 1 and 3 months.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">104</enrollment>
    <condition>Acute Coronary Syndromes</condition>
    <arm_group>
      <arm_group_label>self-management interventions</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>self-management interventions: According to the results of literature search and based on the theory of self-efficacy, the intervention measures of the self-management program were designed.&#xD;
  regular care:regular care</description>
    </arm_group>
    <arm_group>
      <arm_group_label>regular care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>regular care</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>self-management</intervention_name>
      <description>The experimental group received the &quot;SelfManagement Program for Acute Coronary Syndrome&quot;:&#xD;
  the research subjects completed the first data collection within one week of hospitalization. Guide the research subjects to browse this manual and watch the &quot;Acute Coronary Self-Care Video&quot;, and explain what they do not understand, hoping to stimulate the research subjects to discuss nursing issues, and jointly formulate self-management goals, and This handbook was given to study subjects to take home. Telephone interviews every 2 weeks in the first month after discharge, and then again after two and three months after discharge. Each call is about 10 minutes to track the completion of goals and self-management,including usual medication, regular exercise, balance Food and spiritual support and encouragement, etc.,and clarify any doubts.</description>
      <arm_group_label>self-management interventions</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>regular care</intervention_name>
      <description>gular care regular care The nurse implements routine nursing instructions, including disease and treatment profiles,symptom management, and outpatient follow-up. Scan the QRC with your mobile phone or provide the &quot;Care Guidance Leaflet for Coronary Artery Disease&quot; and &quot;Caring for Myocardial Infarction Patients&quot; which are all written in text.</description>
      <arm_group_label>regular care</arm_group_label>
      <arm_group_label>self-management interventions</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Over 20 years old&#xD;
  &#xD;
            -  The first diagnosis of acute coronary syndrome by a clinician,&#xD;
  &#xD;
            -  Clear consciousness, able to converse in Chinese and Taiwanese languages.&#xD;
  &#xD;
            -  Willingness to participate in this research&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those who are unable to take care of themselves&#xD;
  &#xD;
            -  Poor vision and inability to read&#xD;
  &#xD;
            -  Hard of hearing and deafness&#xD;
  &#xD;
            -  Inability to communicate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hui-Chuan Cheng</last_name>
      <role>Principal Investigator</role>
      <affiliation>Taipei Veterans General Hospital, Taiwan</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Taipei Veterans General Hospital</name>
        <address>
          <city>Taipei county,</city>
          <zip>112</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <results_reference>
      <citation>Bandura, A. (1977). Self-efficacy: toward a unifying theory of behavioral change. Psychological Review, 84(2), 191-215. https:// doi.org/10.1037//0033-295x.84.2.191 Gach, O., El, H. Z., &amp; Lancellotti, P.(2018). [Acute coronary syndrome]. Revue Médicale de Liège, 73(5-6),243-250. (Syndrome coronarien aigu.) Guo, P., &amp; Harris, R. (2016). The effectiveness and experience of self-management following acute coronary syndrome: A review of the literature. International Journal of Nursing Studies,61, 29-51. https://doi.org/10.1016/j.ijnurstu.2016.05.008 Hong, P. C., Chen,K. J., Chang, Y. C., Cheng, S. M., &amp; Chiang, H. H. (2021). Effectiveness of Theory-Based Health Information Technology Interventions on Coronary Artery Disease Self-Management Behavior: A Clinical Randomized Waitlist-Controlled Trial. Journal of Nursing Scholarship, 53(4), 418-427. https://doi.org/10.1111/ jnu.12661</citation>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Taipei Veterans General Hospital, Taiwan</investigator_affiliation>
      <investigator_full_name>Cheng, Hui- Chuan</investigator_full_name>
      <investigator_title>Nursing Supervisor</investigator_title>
    </responsible_party>
    <keyword>self-management</keyword>
    <keyword>acute coronary syndrome</keyword>
    <keyword>anxiety</keyword>
    <keyword>depression</keyword>
    <keyword>quality of life</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acute Coronary Syndrome</mesh_term>
      <mesh_term>Syndrome</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/NCT05999695
  org study id: 2022-08-003C
  nct id: NCT05999695
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Purpose :
  
        The purpose of this study is to investigate the tracking effect of selfmanagement programs on
        anxiety, depression, and quality of life in patients with Acute Coronary Syndromes (ACS).
  Research Design :
  
        This study the first phase is to construct and develop interventional measures for
        self-management of patients with ACS. According to the associated factors of study, the
        intervention measures are designed based on self-management. A pilot study will be conducted
        to improve research and to develop better selfmanagement interventions in the future. At the
        secondary stage: a randomized controlled trial with a random sampling design is used to
        investigate the effects of self-management programs on anxiety, depression, and quality of
        life in patients with ACS. The study will conduct in a cardiac medicine ward or coronary
        intensive care center of a north medical center. Patients with ACS,who met the conditions and
        agreed to join the study will be recruited. Then,the informed consent will be obtained. At
        the first stage, 10subjects will be collect. At the secondary stage, a total of 104 subjects
        will be enrolled, 52 in the experimental group will receive the self-management program, and
        52 in the control group will receive a routine hospital care.
  
        Method & Results:
  
        The data of demographic and disease characteristics, clinical indicators,depression, anxiety,
        self-management, and quality of life will be collected.The Hospital Anxiety and Depression
        Scale, the SF-36 Taiwan version of the Quality-of-Life Questionnaire and the Self-Management
        Scale will used as tools to collect data. The efficacy of the intervention will be collected
        1 month and 3 months after the intervention. Data will be statistically analyzed by GEE.
  
        Hypothesis :
  
        It is expected that the self-management program applied to patients with ACS can reduce
        depression and anxiety, thereby improving the quality of life.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Double (Participant, Outcomes Assessor)
  measure: Hospital Anxiety and Depression Scale, HADS
  time frame: First time(baseline) is in the first day in the ward.The second time is one month after discharge.The third time is three months after discharge.
  description: The Likert four-point scale (0-3 points) was used, and the two items were scored separately, and the total score was between 0-21 points. The higher the score, the higher the degree of anxiety or depression. A score below 7 means no anxiety or depression, a score between 8 and 10 means the patient is suspected of anxiety or depression, and a score greater than or equal to 11 means that the patient has anxiety or depression.
  It is a measure to assess change at three-time points. change from Baseline Anxiety and Depression at 1 and 3 months.
  measure: The MOS 36-Item Short-Form Health Survey,SF36
  time frame: First time(baseline) is in the first day in the ward.The second time is one month after discharge.The third time is three months after discharge
  description: Scores range from 0 to 100, with higher scores indicating better self-assessed health. Each item of the questionnaire is calculated separately according to the designed initial scores. Then the scores of the items related to each scale are added up and then subtracted from each scale to obtain the lowest score. Divide by the distance between the possible scores of each scale, and multiply by 100 to get the score.
  It is a measure to assess change at three-time points. change from Baseline quality of life at 1 and 3 months.
  measure: The Partner In Health scale, PIH
  time frame: First time(baseline) is in the first day in the ward.The second time is one month after discharge.The third time is three months after discharge
  description: Items in the scale are graded on a nine-point scale, with 0 representing the worst and 8 representing the best. This is a closed and continuous variable. The scale scores range from 0 to 96, with higher scores indicating better selfmanagement.
  It is a measure to assess change at three-time points. Change from self-management Baseline at 1 and 3 months.
  arm group label: self-management interventions
  arm group type: Experimental
  description: self-management interventions: According to the results of literature search and based on the theory of self-efficacy, the intervention measures of the self-management program were designed.
  regular care:regular care
  arm group label: regular care
  arm group type: Active Comparator
  description: regular care
  intervention type: Other
  intervention name: self-management
  description: The experimental group received the "SelfManagement Program for Acute Coronary Syndrome":
  the research subjects completed the first data collection within one week of hospitalization. Guide the research subjects to browse this manual and watch the "Acute Coronary Self-Care Video", and explain what they do not understand, hoping to stimulate the research subjects to discuss nursing issues, and jointly formulate self-management goals, and This handbook was given to study subjects to take home. Telephone interviews every 2 weeks in the first month after discharge, and then again after two and three months after discharge. Each call is about 10 minutes to track the completion of goals and self-management,including usual medication, regular exercise, balance Food and spiritual support and encouragement, etc.,and clarify any doubts.
  arm group label: self-management interventions
  intervention type: Other
  intervention name: regular care
  description: gular care regular care The nurse implements routine nursing instructions, including disease and treatment profiles,symptom management, and outpatient follow-up. Scan the QRC with your mobile phone or provide the "Care Guidance Leaflet for Coronary Artery Disease" and "Caring for Myocardial Infarction Patients" which are all written in text.
  arm group label: regular care
  arm group label: self-management interventions
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Hui-Chuan Cheng
  role: Principal Investigator
  affiliation: Taipei Veterans General Hospital, Taiwan
  facility: 
  country: Taiwan
  citation: Bandura, A. (1977). Self-efficacy: toward a unifying theory of behavioral change. Psychological Review, 84(2), 191-215. https:// doi.org/10.1037//0033-295x.84.2.191 Gach, O., El, H. Z., & Lancellotti, P.(2018). [Acute coronary syndrome]. Revue Médicale de Liège, 73(5-6),243-250. (Syndrome coronarien aigu.) Guo, P., & Harris, R. (2016). The effectiveness and experience of self-management following acute coronary syndrome: A review of the literature. International Journal of Nursing Studies,61, 29-51. https://doi.org/10.1016/j.ijnurstu.2016.05.008 Hong, P. C., Chen,K. J., Chang, Y. C., Cheng, S. M., & Chiang, H. H. (2021). Effectiveness of Theory-Based Health Information Technology Interventions on Coronary Artery Disease Self-Management Behavior: A Clinical Randomized Waitlist-Controlled Trial. Journal of Nursing Scholarship, 53(4), 418-427. https://doi.org/10.1111/ jnu.12661
  responsible party type: Principal Investigator
  investigator affiliation: Taipei Veterans General Hospital, Taiwan
  investigator full name: Cheng, Hui- Chuan
  investigator title: Nursing Supervisor
  mesh term: Acute Coronary Syndrome
  mesh term: Syndrome
  sharing ipd: No