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/NCT06034054</url>
    </required_header>
    <id_info>
      <org_study_id>DGulistan-01</org_study_id>
      <nct_id>NCT06034054</nct_id>
    </id_info>
    <brief_title>Acute Coronary Syndrome and Nurse Counselling</brief_title>
    <official_title>The Effect of Nurse Counselling on Quality of Life, Functional Capacity and Knowledge, Attitudes and Beliefs in Patients With Acute Coronary Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Iskenderun State Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Iskenderun State Hospital</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>
        The goal of this clinical trial is to examine in patients with acute coronary syndrome. The&#xD;
        main questions it aims to answer are:&#xD;
  &#xD;
          -  Does nurse counseling affect quality of life?&#xD;
  &#xD;
          -  Does nurse counseling affect functional capacity?&#xD;
  &#xD;
          -  Does nurse counseling affect knowledge, attitudes and beliefs about syndromes?&#xD;
  &#xD;
        Participants will be trained using the training booklet, and nursing counseling will then be&#xD;
        provided for six months.&#xD;
  &#xD;
        If there is a comparison group: Researchers will compare with the control group to see if the&#xD;
        nurse counseling has had an effect.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After obtaining verbal and written consent from the participants, they are required to answer&#xD;
        the questions on the Diagnosis Form, Acute Coronary Syndrome Response Index, and Multiple&#xD;
        Quality of Life Scale. Then, preliminary measurements will be made and a 6-minute corridor&#xD;
        walking test will be applied. While the control group will be followed up routinely, the&#xD;
        training booklet prepared for the intervention group will be explained orally. Participants&#xD;
        will then be informed that they will be called monthly. They will be told that they can reach&#xD;
        these monthly calls and consult the nurse when they need it. After this stage, interviews&#xD;
        with patients will begin. The standard way of communication with the participants by the&#xD;
        researchers is by telephone, and a total of 6 interviews will be provided, the first of which&#xD;
        is in the 1st month after the application of the tests. In each call, all the information in&#xD;
        the training booklet will be repeated, additional information will be given in line with the&#xD;
        needs and demands of the person, their questions will be answered and the interview will be&#xD;
        ended. Although it varies according to the individual interviewed, it is predicted that these&#xD;
        telephone interviews will last for 30 minutes on average. Apart from these standard calls,&#xD;
        individuals in need will be able to reach the researcher face-to-face during phone calls,&#xD;
        text messages, instant messaging methods or hospital visits, and in this way, the counseling&#xD;
        process will continue actively for 6 months. After six months, the final tests will be done.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 1, 2020</start_date>
    <completion_date type="Actual">July 1, 2021</completion_date>
    <primary_completion_date type="Actual">February 1, 2021</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>Health Services Research</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Life quality</measure>
      <time_frame>6 mounth</time_frame>
      <description>Multidimensional index of life quality will be applied(This scale is the &quot;multidimensional quality of life scale&quot;, the Turkish validity and reliability of which was established in 2012.)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional capacity</measure>
      <time_frame>6 mounth</time_frame>
      <description>Functional Capacity Evaluation Form will be applied.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Coronary Syndromes</measure>
      <time_frame>6 mount</time_frame>
      <description>Acute Coronary Syndrome Response Index will be applied.It was translated into Turkish and a reliability and validity study was conducted in 2016. A questionnaire consisting of 33 items was applied to evaluate the knowledge, attitudes and beliefs of individuals with acute coronary syndrome regarding the disease.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">66</enrollment>
    <condition>Acute Myocardial Infarction</condition>
    <condition>Coronary Artery Disease</condition>
    <arm_group>
      <arm_group_label>Nursing counseling</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The individuals included in nursing counseling group were given counseling by the research nurse for 6 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Individuals included in control group were followed up routinely in the outpatient clinic for 6 months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>nursing counceling</intervention_name>
      <description>Providing an educational booklet containing information about pastry, verbally explaining the content of the prepared educational booklet.&#xD;
  Answering the information and questions that the patient needs in addition, and receiving contact information in October.&#xD;
  Monthly calls will be made to patients 6. providing information that the same tests will be performed again per month, if necessary, this monthly call counseling by reaching out without waiting indicating what they can receive.</description>
      <arm_group_label>Nursing counseling</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years old, diagnosed with Acute Coronary Syndrome and treated with a stent,&#xD;
  &#xD;
            -  Treatment preventing communication is not a problem, literate,&#xD;
  &#xD;
            -  There is no obstacle to performing the 6-minute walk test.&#xD;
  &#xD;
            -  who did not accept to participate, were included in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  &lt;18 years of age,&#xD;
  &#xD;
            -  Mental or cognitive impairment,&#xD;
  &#xD;
            -  Diagnosed with SpO2 &lt;80,&#xD;
  &#xD;
            -  Peripheral arterial disease, lower extremity amputation, impaired tumor or open wound&#xD;
               of lower extremity, and deep vein thrombosis, 6 munites corridor Walk test Parts of&#xD;
               individuals who are contraindicated in making are not included.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>sevgin samancıoğlu bağlama, assoc.prof</last_name>
      <role>Study Director</role>
      <affiliation>Muğla Sıtkı Koçman University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>İskenderun State Hospital</name>
        <address>
          <city>Hatay</city>
          <zip>31200</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Iskenderun State Hospital</investigator_affiliation>
      <investigator_full_name>Deniz Gülistan ER</investigator_full_name>
      <investigator_title>Angiography nurse</investigator_title>
    </responsible_party>
    <keyword>Acute Coronary Syndrome</keyword>
    <keyword>Counseling</keyword>
    <keyword>Nursing</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Coronary Artery Disease</mesh_term>
      <mesh_term>Myocardial Infarction</mesh_term>
      <mesh_term>Acute Coronary Syndrome</mesh_term>
      <mesh_term>Infarction</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/NCT06034054
  org study id: DGulistan-01
  nct id: NCT06034054
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to examine in patients with acute coronary syndrome. The
        main questions it aims to answer are:
  
          -  Does nurse counseling affect quality of life?
  
          -  Does nurse counseling affect functional capacity?
  
          -  Does nurse counseling affect knowledge, attitudes and beliefs about syndromes?
  
        Participants will be trained using the training booklet, and nursing counseling will then be
        provided for six months.
  
        If there is a comparison group: Researchers will compare with the control group to see if the
        nurse counseling has had an effect.
  After obtaining verbal and written consent from the participants, they are required to answer
        the questions on the Diagnosis Form, Acute Coronary Syndrome Response Index, and Multiple
        Quality of Life Scale. Then, preliminary measurements will be made and a 6-minute corridor
        walking test will be applied. While the control group will be followed up routinely, the
        training booklet prepared for the intervention group will be explained orally. Participants
        will then be informed that they will be called monthly. They will be told that they can reach
        these monthly calls and consult the nurse when they need it. After this stage, interviews
        with patients will begin. The standard way of communication with the participants by the
        researchers is by telephone, and a total of 6 interviews will be provided, the first of which
        is in the 1st month after the application of the tests. In each call, all the information in
        the training booklet will be repeated, additional information will be given in line with the
        needs and demands of the person, their questions will be answered and the interview will be
        ended. Although it varies according to the individual interviewed, it is predicted that these
        telephone interviews will last for 30 minutes on average. Apart from these standard calls,
        individuals in need will be able to reach the researcher face-to-face during phone calls,
        text messages, instant messaging methods or hospital visits, and in this way, the counseling
        process will continue actively for 6 months. After six months, the final tests will be done.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: Double (Participant, Outcomes Assessor)
  measure: Life quality
  time frame: 6 mounth
  description: Multidimensional index of life quality will be applied(This scale is the "multidimensional quality of life scale", the Turkish validity and reliability of which was established in 2012.)
  measure: Functional capacity
  time frame: 6 mounth
  description: Functional Capacity Evaluation Form will be applied.
  measure: Acute Coronary Syndromes
  time frame: 6 mount
  description: Acute Coronary Syndrome Response Index will be applied.It was translated into Turkish and a reliability and validity study was conducted in 2016. A questionnaire consisting of 33 items was applied to evaluate the knowledge, attitudes and beliefs of individuals with acute coronary syndrome regarding the disease.
  arm group label: Nursing counseling
  arm group type: Experimental
  description: The individuals included in nursing counseling group were given counseling by the research nurse for 6 months.
  arm group label: Control
  arm group type: No Intervention
  description: Individuals included in control group were followed up routinely in the outpatient clinic for 6 months.
  intervention type: Other
  intervention name: nursing counceling
  description: Providing an educational booklet containing information about pastry, verbally explaining the content of the prepared educational booklet.
  Answering the information and questions that the patient needs in addition, and receiving contact information in October.
  Monthly calls will be made to patients 6. providing information that the same tests will be performed again per month, if necessary, this monthly call counseling by reaching out without waiting indicating what they can receive.
  arm group label: Nursing counseling
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: sevgin samancıoğlu bağlama, assoc.prof
  role: Study Director
  affiliation: Muğla Sıtkı Koçman University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Iskenderun State Hospital
  investigator full name: Deniz Gülistan ER
  investigator title: Angiography nurse
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Infarction
  mesh term: Acute Coronary Syndrome
  mesh term: Infarction
  sharing ipd: No