<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/NCT01720121</url>
  </required_header>
  <id_info>
    <org_study_id>UP 4250.08</org_study_id>
    <nct_id>NCT01720121</nct_id>
  </id_info>
  <brief_title>Digital Videos Disc and Printed Guidelines and Improve the Knowledge of Patients Undergoing Cardiac Catheterization</brief_title>
  <official_title>Digital Videos Disc and Printed Guidelines and Improve the Knowledge of Patients Undergoing Cardiac Catheterization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto de Cardiologia do Rio Grande do Sul</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto de Cardiologia do Rio Grande do Sul</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is randomized clinical trial to verify the effect of nursing guidelines for&#xD;
      patients undergoing left cardiac catheterization on an outpatient basis. Comparing three&#xD;
      approaches to direct guidelines about the procedure:&#xD;
&#xD;
        -  printed,&#xD;
&#xD;
        -  digital video disc (DVD)&#xD;
&#xD;
        -  conventional guidelines provide by nursing team&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is randomized clinical trial to verify the effect of nursing guidelines for&#xD;
      patients undergoing left cardiac catheterization on an outpatient basis. Comparing three&#xD;
      approaches to direct guidelines about the procedure:&#xD;
&#xD;
        -  guidelines printed, (GOI) with informative material&#xD;
&#xD;
        -  guidelines through a digital video disc (GDVD) six minutes&#xD;
&#xD;
        -  conventional guidelines provide by nursing team&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2009</start_date>
  <completion_date type="Actual">October 2009</completion_date>
  <primary_completion_date type="Actual">July 2009</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>Factorial Assignment</intervention_model>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>improvement of knowledge about the procedure after orientation</measure>
    <time_frame>four months</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Health Behavior</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group received the guidelines orientation provide by nursing team</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Guidelines printed group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patient received the informative material in details about the cardiac catheterization provide by the researchers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Guidelines digital video disc group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Guidelines digital video disc group: The patient received the informative provide by digital video disc in details about the cardiac catheterization</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Printed, digital video disc</intervention_name>
    <description>The three groups of patient received: 1)informative material in details about the cardiac catheterization provide by the researchers; 2)informative provide by a digital video disc; 3)the control group received the conventional informative provide by the nursing team.</description>
    <arm_group_label>Guidelines digital video disc group</arm_group_label>
    <arm_group_label>Guidelines printed group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing the procedure were included, with age equal or superior to 18&#xD;
             years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who had already undergone previous procedures similar severe comorbidities,&#xD;
             illiterate and who came to the facility to urgently&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eneida R Rabelo da Silva, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Rio Grande do Sul</affiliation>
  </overall_official>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>October 31, 2012</last_update_submitted>
  <last_update_submitted_qc>October 31, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01720121
org study id: UP 4250.08
nct id: NCT01720121
lead sponsor: 
has dmc: No
This study is randomized clinical trial to verify the effect of nursing guidelines for
      patients undergoing left cardiac catheterization on an outpatient basis. Comparing three
      approaches to direct guidelines about the procedure:

        -  printed,

        -  digital video disc (DVD)

        -  conventional guidelines provide by nursing team
This study is randomized clinical trial to verify the effect of nursing guidelines for
      patients undergoing left cardiac catheterization on an outpatient basis. Comparing three
      approaches to direct guidelines about the procedure:

        -  guidelines printed, (GOI) with informative material

        -  guidelines through a digital video disc (GDVD) six minutes

        -  conventional guidelines provide by nursing team
allocation: Randomized
intervention model: Factorial Assignment
masking: Single (Outcomes Assessor)
measure: improvement of knowledge about the procedure after orientation
time frame: four months
arm group label: Control group
arm group type: No Intervention
description: The control group received the guidelines orientation provide by nursing team
arm group label: Guidelines printed group
arm group type: Experimental
description: The patient received the informative material in details about the cardiac catheterization provide by the researchers
arm group label: Guidelines digital video disc group
arm group type: Experimental
description: Guidelines digital video disc group: The patient received the informative provide by digital video disc in details about the cardiac catheterization
intervention type: Other
intervention name: Printed, digital video disc
description: The three groups of patient received: 1)informative material in details about the cardiac catheterization provide by the researchers; 2)informative provide by a digital video disc; 3)the control group received the conventional informative provide by the nursing team.
arm group label: Guidelines digital video disc group
arm group label: Guidelines printed group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eneida R Rabelo da Silva, Professor
role: Principal Investigator
affiliation: Federal University of Rio Grande do Sul
responsible party type: Sponsor