<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/NCT03781661</url>
  </required_header>
  <id_info>
    <org_study_id>2016/1380</org_study_id>
    <nct_id>NCT03781661</nct_id>
  </id_info>
  <brief_title>Providing Patient Information and CT Examination Results</brief_title>
  <acronym>INFOCT</acronym>
  <official_title>Providing Patients With Extended Information and Examination Results Immediately After a Diagnostic CT of the Coronary Arteries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Haukeland University Hospital</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>
      Chest pain is a common cause of visits in the Emergency Room and General Practice, and is&#xD;
      most commonly connected as a symptom of coronary disease, as for instance angina pectoris and&#xD;
      acute myocardial infarct. Approximately 75-80% of these patients are not diagnosed with&#xD;
      coronary disease or other cardiac findings. However, many of these patients still report&#xD;
      chest pain and worries about cardiac disease.&#xD;
&#xD;
      This study is based on patients that are referred to a CT-examination of the coronary&#xD;
      arteries on the background of chest pain, where the CT-examination shows normal coronary&#xD;
      arteries.&#xD;
&#xD;
      The study aims to evaluate whether providing an intervention to this group of patients has an&#xD;
      effect on patient satisfaction, patient's worry of cardiac disease and incidence of chest&#xD;
      pain.&#xD;
&#xD;
      The intervention group will be compared with a similar group going through the same&#xD;
      CT-examination, but is receiving the examination result from their regular general&#xD;
      practitioner (RGP), which is considered standard care.&#xD;
&#xD;
      The hypothesis is that patients with chest pain with no coronary findings receiving extended&#xD;
      information before getting the normal examination results experience a better patient&#xD;
      satisfaction than those receiving the examination result from their RGP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized controlled study. Eligible patients going through a CT-examination&#xD;
      of the heart's coronary arteries, Coronary CT Angiogram (CCTA) will after an informed consent&#xD;
      be randomized into two groups, either the intervention group or standard care.&#xD;
&#xD;
      The intervention consists of extended information regarding the benefits of doing a CCTA,&#xD;
      thereby emphasising the specificity and accuracy of the CCTA's ability to exclude coronary&#xD;
      disease. After this, there will be given an opportunity of a visual go-through and&#xD;
      explanation of CT-images. Then they will be informed of the examination result that shows&#xD;
      normal coronary arteries.&#xD;
&#xD;
      Follow up is planned after one month, six months and twelve months, where the participants&#xD;
      receive the same questionnaire as at baseline to fill out and return. The questionnaire&#xD;
      consists of Seattle Angina Questionnaire and RAND-12, in addition to social demographic and&#xD;
      clinical data, such as sex, height, weight and current medication.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 11, 2018</start_date>
  <completion_date type="Actual">March 4, 2020</completion_date>
  <primary_completion_date type="Actual">March 4, 2019</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>
    <intervention_model_description>Experimental randomized controlled trial</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient satisfaction: Seattle Angina Questionnaire</measure>
    <time_frame>1 month</time_frame>
    <description>Our primary outcome is to examine whether patients with chest pain with normal coronary arteries experience greater satisfaction with their treatment if they receive extended information and the examination results immediately after the CT examination than those who receive the examination result from their RGP.&#xD;
This is measured with 2 single items in Seattle Angina Questionnaire regarding satisfaction with treatment. Values range from 1-5, 1 is the lowest level of satisfaction, and 5 is the highest level of satisfaction. Greater satisfaction with treatment will be defined by a higher score at follow-up after 1 month.&#xD;
In addition, there is a separate question of patients' trust in the CT examination measured with a VAS-scale , ranging from 1-10, 1 represents lowest possible degree of trust, and 10 represents highest possible degree of trust. Greater trust in the CT-examination is defined by higher scores at follow-up after 1 month.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Worry of having heart disease</measure>
    <time_frame>1 month, 6 months, 12 months</time_frame>
    <description>To examine if patients report less worry of having a heart attack or sudden death after having a CT examination of the heart's arteries, when receiving extended information and the normal examination result immediately after the CT examination.&#xD;
This is measured with a single item in Seattle Angina Questionnaire regarding worry of having heart attack or die suddenly. Values range from 1-5, 1 represents &quot;worry all the time&quot; and 5 represents &quot;never worry&quot;. Less worry of having a heart attack or die suddenly will be defined by higher scores at follow-up after 1, 6 and 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of chest pain</measure>
    <time_frame>1 month, 6 months, 12 months</time_frame>
    <description>To examine if patients with chest pain with normal coronary arteries report less chest pain and/or less use of health care services if they receive extended information and the examination results immediately after the CT examination compared to those who receive the examination result from their RGP.&#xD;
This is measured with 2 single items in Seattle Angina Questionnaire. One item regards limitations in everyday activities because of chest pain. Values range from 1-5, 1 represents lowest level, and 5 represents highest level of function. The second item is about incidence of chest pain the last week. Values range from 1-5, 1 represents high incidence of chest pain and 5 represents no chest pain. Less chest pain is associated with higher scores at all times of follow up, compared to baseline.&#xD;
In addition, clinical data regarding participants use of primary and secondary health care the last 4 weeks is collected at all times of follow-up and is compared to baseline data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction: Seattle Angina Questionnaire</measure>
    <time_frame>6 months, 12 months</time_frame>
    <description>To examine whether patients with chest pain with normal coronary arteries experience greater satisfaction with their treatment if they receive extended information and the examination results immediately after the CT examination than those who receive the examination result from their RGP.&#xD;
This is measured with 2 single items in Seattle Angina Questionnaire regarding satisfaction with treatment. Values range from 1-5, 1 is the lowest level of satisfaction, and 5 is the highest level of satisfaction. Greater satisfaction with treatment will be defined by a higher score at follow-up after 6 and 12 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Chest Pain</condition>
  <condition>Nonmalignant Condition</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants in the intervention group will be provided with extended information of the advantages of the CT examination of the heart's arteries. This will be given to the participants both orally and written in form of a leaflet. In addition will they be given the opportunity for a visual go-through of their own calcium score images. After this they will be informed of the normal examination result.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control Group receives standard care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Extended information</intervention_name>
    <description>The extended information consists out of an information leaflet and a visual go-through of the participants calcium score images. The patients are then given the normal examination result.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ability to speak and read Norwegian fluently&#xD;
&#xD;
          -  competent to give informed consent&#xD;
&#xD;
          -  referred from cardiologist&#xD;
&#xD;
          -  experienced chest pain&#xD;
&#xD;
          -  Calcium score = 0 and CCTA must show normal coronary arteries&#xD;
&#xD;
          -  received information letter on ongoing research in the Heart department of Haukeland&#xD;
             University Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  admitted patients&#xD;
&#xD;
          -  heart disease or coronary anomalies shown on the CCTA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tone M Norekvaal, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bergen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <zip>5021</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>October 13, 2020</last_update_submitted>
  <last_update_submitted_qc>October 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non coronary Chest Pain</keyword>
  <keyword>Extended Information</keyword>
  <keyword>Normal Examination Result</keyword>
  <keyword>Coronar Computed Tomography Angiography</keyword>
  <keyword>CCTA</keyword>
  <keyword>Calcium score</keyword>
  <keyword>Diagnostic Examination</keyword>
  <keyword>Patient Satisfaction</keyword>
  <keyword>Normal Coronary Arteries</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Precancerous Conditions</mesh_term>
    <mesh_term>Chest Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03781661
org study id: 2016/1380
nct id: NCT03781661
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chest pain is a common cause of visits in the Emergency Room and General Practice, and is
      most commonly connected as a symptom of coronary disease, as for instance angina pectoris and
      acute myocardial infarct. Approximately 75-80% of these patients are not diagnosed with
      coronary disease or other cardiac findings. However, many of these patients still report
      chest pain and worries about cardiac disease.

      This study is based on patients that are referred to a CT-examination of the coronary
      arteries on the background of chest pain, where the CT-examination shows normal coronary
      arteries.

      The study aims to evaluate whether providing an intervention to this group of patients has an
      effect on patient satisfaction, patient's worry of cardiac disease and incidence of chest
      pain.

      The intervention group will be compared with a similar group going through the same
      CT-examination, but is receiving the examination result from their regular general
      practitioner (RGP), which is considered standard care.

      The hypothesis is that patients with chest pain with no coronary findings receiving extended
      information before getting the normal examination results experience a better patient
      satisfaction than those receiving the examination result from their RGP.
This study is a randomized controlled study. Eligible patients going through a CT-examination
      of the heart's coronary arteries, Coronary CT Angiogram (CCTA) will after an informed consent
      be randomized into two groups, either the intervention group or standard care.

      The intervention consists of extended information regarding the benefits of doing a CCTA,
      thereby emphasising the specificity and accuracy of the CCTA's ability to exclude coronary
      disease. After this, there will be given an opportunity of a visual go-through and
      explanation of CT-images. Then they will be informed of the examination result that shows
      normal coronary arteries.

      Follow up is planned after one month, six months and twelve months, where the participants
      receive the same questionnaire as at baseline to fill out and return. The questionnaire
      consists of Seattle Angina Questionnaire and RAND-12, in addition to social demographic and
      clinical data, such as sex, height, weight and current medication.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Experimental randomized controlled trial
primary purpose: Supportive Care
masking: None (Open Label)
measure: Patient satisfaction: Seattle Angina Questionnaire
time frame: 1 month
description: Our primary outcome is to examine whether patients with chest pain with normal coronary arteries experience greater satisfaction with their treatment if they receive extended information and the examination results immediately after the CT examination than those who receive the examination result from their RGP.
This is measured with 2 single items in Seattle Angina Questionnaire regarding satisfaction with treatment. Values range from 1-5, 1 is the lowest level of satisfaction, and 5 is the highest level of satisfaction. Greater satisfaction with treatment will be defined by a higher score at follow-up after 1 month.
In addition, there is a separate question of patients' trust in the CT examination measured with a VAS-scale , ranging from 1-10, 1 represents lowest possible degree of trust, and 10 represents highest possible degree of trust. Greater trust in the CT-examination is defined by higher scores at follow-up after 1 month.
measure: Worry of having heart disease
time frame: 1 month, 6 months, 12 months
description: To examine if patients report less worry of having a heart attack or sudden death after having a CT examination of the heart's arteries, when receiving extended information and the normal examination result immediately after the CT examination.
This is measured with a single item in Seattle Angina Questionnaire regarding worry of having heart attack or die suddenly. Values range from 1-5, 1 represents "worry all the time" and 5 represents "never worry". Less worry of having a heart attack or die suddenly will be defined by higher scores at follow-up after 1, 6 and 12 months.
measure: Incidence of chest pain
time frame: 1 month, 6 months, 12 months
description: To examine if patients with chest pain with normal coronary arteries report less chest pain and/or less use of health care services if they receive extended information and the examination results immediately after the CT examination compared to those who receive the examination result from their RGP.
This is measured with 2 single items in Seattle Angina Questionnaire. One item regards limitations in everyday activities because of chest pain. Values range from 1-5, 1 represents lowest level, and 5 represents highest level of function. The second item is about incidence of chest pain the last week. Values range from 1-5, 1 represents high incidence of chest pain and 5 represents no chest pain. Less chest pain is associated with higher scores at all times of follow up, compared to baseline.
In addition, clinical data regarding participants use of primary and secondary health care the last 4 weeks is collected at all times of follow-up and is compared to baseline data.
measure: Patient satisfaction: Seattle Angina Questionnaire
time frame: 6 months, 12 months
description: To examine whether patients with chest pain with normal coronary arteries experience greater satisfaction with their treatment if they receive extended information and the examination results immediately after the CT examination than those who receive the examination result from their RGP.
This is measured with 2 single items in Seattle Angina Questionnaire regarding satisfaction with treatment. Values range from 1-5, 1 is the lowest level of satisfaction, and 5 is the highest level of satisfaction. Greater satisfaction with treatment will be defined by a higher score at follow-up after 6 and 12 months.
arm group label: Intervention Group
arm group type: Experimental
description: The participants in the intervention group will be provided with extended information of the advantages of the CT examination of the heart's arteries. This will be given to the participants both orally and written in form of a leaflet. In addition will they be given the opportunity for a visual go-through of their own calcium score images. After this they will be informed of the normal examination result.
arm group label: Control group
arm group type: No Intervention
description: Control Group receives standard care.
intervention type: Other
intervention name: Extended information
description: The extended information consists out of an information leaflet and a visual go-through of the participants calcium score images. The patients are then given the normal examination result.
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Tone M Norekvaal, Professor
role: Principal Investigator
affiliation: University of Bergen
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Precancerous Conditions
mesh term: Chest Pain
sharing ipd: No