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/NCT05980364</url>
    </required_header>
    <id_info>
      <org_study_id>02/60</org_study_id>
      <nct_id>NCT05980364</nct_id>
    </id_info>
    <brief_title>Cardiac Rehabilitation in Coronary Artery Diseases</brief_title>
    <official_title>In Cardiac Rehabilitation The Effect of Technology-Based Education Structured According to the Health Promotion Model on Healthy Lifestyle Behaviors, Health Fatalism and Risk Knowledge Level: A Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hatice Karabulak</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ataturk University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Ataturk University</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>
        Cardiac rehabilitation is approaches that focus on accelerating the recovery process of&#xD;
        patients after a cardiac event, improving their physical, psychological and social&#xD;
        conditions, and controlling risk factors. Cardiac rehabilitation is known to be an effective&#xD;
        and cost-effective approach in the secondary prevention of cardiovascular diseases, most of&#xD;
        which are caused by preventable risks. Ischemic heart diseases, one of the cardiovascular&#xD;
        diseases, are responsible for 16% of total deaths in the world and have increased&#xD;
        significantly since 2000, causing 8.9 million deaths in 2019.&#xD;
  &#xD;
        When coronary artery diseases cannot be prevented, the basic approach should be to ensure the&#xD;
        individual's compliance with treatment and healthy lifestyle behaviors, and to increase the&#xD;
        quality of life and life span.&#xD;
  &#xD;
        For this reason, the aim of the study is to examine the effects of technology-based education&#xD;
        structured according to the health promotion model in cardiac rehabilitation on healthy&#xD;
        lifestyle behaviors, health fatalism and risk knowledge level.&#xD;
  &#xD;
        Question 1. Does technology-based education structured according to the health promotion&#xD;
        model affect the healthy lifestyle behaviors score? Question 2. Does technology-based&#xD;
        education structured according to the health promotion model affect the health fatalism&#xD;
        score? Question 3. Does technology-based education structured according to the health&#xD;
        promotion model affect the cardiovascular disease risk factors knowledge level score?&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 15, 2022</start_date>
    <completion_date type="Actual">September 15, 2022</completion_date>
    <primary_completion_date type="Actual">June 15, 2022</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in healthy lifestyle behaviors score</measure>
      <time_frame>12 weeks</time_frame>
      <description>Increase in healthy lifestyle behaviors score</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in health fatalism score</measure>
      <time_frame>12 weeks</time_frame>
      <description>Decrease in health fatalism score</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in cardiovascular disease risk knowledge level score</measure>
      <time_frame>12 weeks</time_frame>
      <description>Increase in cardiovascular disease risk knowledge level score</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">62</enrollment>
    <condition>Have a Diagnosis of Coronary Artery Disease</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Technology-based training structured according to the Health Promotion Model</intervention_name>
      <description>Experimental group: A video recording was created with a total of 6 zoom applications to be shared with the patients. The content of the video recordings consists of a presentation accompanied by a slide show with open-ended questions prepared by considering the basic concepts of the trainings and the Health Promotion Model. Video recordings, each of which lasted approximately 15-25 minutes, were shared with patients once a week for a total of 6 weeks via WhatsApp. After each video, patients were given three days to watch the video recordings and create their own responses. After this three-day period, the researcher called the patients with whom he shared the content and gave counseling for 10-15 minutes and received feedback. Follow-up was done in the second 6-week period. During the monitoring process, two reminder interviews were made over the phone, with an interval of 2 weeks, for reminder and counseling, and the post-test data were collected at the end of the monitoring period.</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having a diagnosis of coronary artery disease (acute coronary syndrome, coronary&#xD;
               revascularization, atherosclerotic heart disease, etc.),&#xD;
  &#xD;
            -  Being stable in health (the patient's health status does not change suddenly and is&#xD;
               under control),&#xD;
  &#xD;
            -  If an interventional procedure has been performed, at least three months have passed&#xD;
               after discharge,&#xD;
  &#xD;
            -  Being between the ages of 18-65,&#xD;
  &#xD;
            -  Being literate,&#xD;
  &#xD;
            -  Using smart phone and internet,&#xD;
  &#xD;
            -  Living in the city center&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having a disability (vision, hearing, neurological, cognitive, etc.) that may&#xD;
               interfere with education,&#xD;
  &#xD;
            -  Cardiac rehabilitation is contraindicated&#xD;
  &#xD;
            -  To have participated in a cardiac rehabilitation program given by another institution&#xD;
               before or during the study,&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Prof.Dr.Canturk Capik</last_name>
      <role>Study Director</role>
      <affiliation>Ataturk University, Department of Public Health Nursing</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Kars Harakani State Hospital</name>
        <address>
          <city>Kars</city>
          <state>Merkez</state>
          <zip>36100</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 29, 2023</last_update_submitted>
    <last_update_submitted_qc>July 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Ataturk University</investigator_affiliation>
      <investigator_full_name>Hatice Karabulak</investigator_full_name>
      <investigator_title>PhD student</investigator_title>
    </responsible_party>
    <keyword>Nursing</keyword>
    <keyword>cardiac rehabilitation</keyword>
    <keyword>health promotion model</keyword>
    <keyword>healthy lifestyle behaviors</keyword>
    <keyword>health fatalism</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Coronary Artery Disease</mesh_term>
      <mesh_term>Myocardial Ischemia</mesh_term>
      <mesh_term>Coronary Disease</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/NCT05980364
  org study id: 02/60
  nct id: NCT05980364
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Cardiac rehabilitation is approaches that focus on accelerating the recovery process of
        patients after a cardiac event, improving their physical, psychological and social
        conditions, and controlling risk factors. Cardiac rehabilitation is known to be an effective
        and cost-effective approach in the secondary prevention of cardiovascular diseases, most of
        which are caused by preventable risks. Ischemic heart diseases, one of the cardiovascular
        diseases, are responsible for 16% of total deaths in the world and have increased
        significantly since 2000, causing 8.9 million deaths in 2019.
  
        When coronary artery diseases cannot be prevented, the basic approach should be to ensure the
        individual's compliance with treatment and healthy lifestyle behaviors, and to increase the
        quality of life and life span.
  
        For this reason, the aim of the study is to examine the effects of technology-based education
        structured according to the health promotion model in cardiac rehabilitation on healthy
        lifestyle behaviors, health fatalism and risk knowledge level.
  
        Question 1. Does technology-based education structured according to the health promotion
        model affect the healthy lifestyle behaviors score? Question 2. Does technology-based
        education structured according to the health promotion model affect the health fatalism
        score? Question 3. Does technology-based education structured according to the health
        promotion model affect the cardiovascular disease risk factors knowledge level score?
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Change in healthy lifestyle behaviors score
  time frame: 12 weeks
  description: Increase in healthy lifestyle behaviors score
  measure: Change in health fatalism score
  time frame: 12 weeks
  description: Decrease in health fatalism score
  measure: Change in cardiovascular disease risk knowledge level score
  time frame: 12 weeks
  description: Increase in cardiovascular disease risk knowledge level score
  arm group label: Experimental group
  arm group type: Experimental
  arm group label: Control group
  arm group type: No Intervention
  intervention type: Other
  intervention name: Technology-based training structured according to the Health Promotion Model
  description: Experimental group: A video recording was created with a total of 6 zoom applications to be shared with the patients. The content of the video recordings consists of a presentation accompanied by a slide show with open-ended questions prepared by considering the basic concepts of the trainings and the Health Promotion Model. Video recordings, each of which lasted approximately 15-25 minutes, were shared with patients once a week for a total of 6 weeks via WhatsApp. After each video, patients were given three days to watch the video recordings and create their own responses. After this three-day period, the researcher called the patients with whom he shared the content and gave counseling for 10-15 minutes and received feedback. Follow-up was done in the second 6-week period. During the monitoring process, two reminder interviews were made over the phone, with an interval of 2 weeks, for reminder and counseling, and the post-test data were collected at the end of the monitoring period.
  arm group label: Experimental group
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Prof.Dr.Canturk Capik
  role: Study Director
  affiliation: Ataturk University, Department of Public Health Nursing
  facility: 
  country: Turkey
  responsible party type: Sponsor-Investigator
  investigator affiliation: Ataturk University
  investigator full name: Hatice Karabulak
  investigator title: PhD student
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Ischemia
  mesh term: Coronary Disease
  sharing ipd: No