<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/NCT03810599</url>
  </required_header>
  <id_info>
    <org_study_id>2014/333</org_study_id>
    <nct_id>NCT03810599</nct_id>
  </id_info>
  <brief_title>Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study</brief_title>
  <acronym>BECARES</acronym>
  <official_title>Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study</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>
      An intervention study with longitudinal follow-up of patients with coronary artery disease&#xD;
      undergoing early cardiac rehabilitation is designed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective of the study is to investigate patient-reported outcomes, their relation&#xD;
      to clinical characteristics of the patients and the potential to predict health outcomes and&#xD;
      adverse events in coronary artery disease patients participating in an early cardiac&#xD;
      rehabilitation programme.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 9, 2013</start_date>
  <completion_date type="Anticipated">February 2029</completion_date>
  <primary_completion_date type="Anticipated">February 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Pre-post comparison.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to composite of total mortality, and hospitalization for heart failure and atherothrombotic disease (including non-fatal MI, unstable angina and stroke).</measure>
    <time_frame>Up to 10 years</time_frame>
    <description>Time to combined endpoint from inclusion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Self-reported health</measure>
    <time_frame>Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks</time_frame>
    <description>The EuroQol 5-dimensions-5 level questionnaire (EQ-5D-5L) is an 5 item self-report-questionnaire assessing self-reported health. The respondent rates each item on a 5-point scale ranging from 1(indicating no problem) to 5 (indicating extreme problems). This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-reported global health</measure>
    <time_frame>Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks</time_frame>
    <description>The VAS scale from the EQ-5D-5L assess global health. The scale goes from 0 to 100 were lower score indicates worse health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in post traumatic growth</measure>
    <time_frame>Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks</time_frame>
    <description>The Posttraumatic Growth Inventory-Short Form (PTGI-SF) is a 10 item scale measuring post traumatic growth. The respondent rates each item on a 6-point scale ranging from 0 (I did not experience this change as a result of my crisis) to 5 (I experienced this change to a very great degree as a result of my crisis). The scale is scored by adding all the responses.Individual factors are scored by adding responses to items on each factor. Factors are indicated by the Roman numerals after each item.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nicotine dependence</measure>
    <time_frame>Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks</time_frame>
    <description>The Fagerström test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anxiety and depression</measure>
    <time_frame>Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks</time_frame>
    <description>The Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale where seven of the items relate to anxiety and seven relate to depression. The respondent rates each item on a 4-point scale ranging from 0 (absence) to 3 (extreme presence). The total score is 42 (21 per subscale).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical and mental dimensions of health</measure>
    <time_frame>Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks</time_frame>
    <description>The Short Form Health Survey (SF-12) include 12 items with 3 to 5 response levels. It generates two health indices: mental health and physical health. The score range between 0 and 100, with 100 representing the highest level of health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in health status following myocardial infarction</measure>
    <time_frame>Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks</time_frame>
    <description>The Myocardial Infarction Dimensional Assessment Scale (MIDAS) is a PRO measure developed and validated to specifically measure the health status of individuals who have suffered a myocardial infarction. It consist of 7 domains, and is a 35 item scale where respondents rate each item on a 5-point scale ranging from 1 (never) to 5 (always). The function of the MIDAS is to indicate the extent of ill health in each of the seven domains assessed, therefore each dimension is scored separately using a simple scoring methodology.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">870</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Early cardiac rehabilitation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single Group: 5 week cardiac rehabilitation programme. Pre-post comparison.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early cardiac rehabilitation</intervention_name>
    <description>This is an early cardiac rehabilitation programme starting 1-2 weeks after hospital discharge (Phase 2A rehabilitation). The programme provided by a multidisciplinary team includes individual counseling, educational sessions and discussion in groups, and exercise training sessions three days a week for five weeks.&#xD;
For additional analysis there will be a comparison group that did not receive the intervention for practical reasons.</description>
    <arm_group_label>Early cardiac rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of coronary artery disease&#xD;
&#xD;
          -  &gt;=18 years of age&#xD;
&#xD;
          -  Has performed a negative exercise test (bike or treadmill) and thereby able to&#xD;
             participate in exercise training.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Unstable angina pectoris&#xD;
&#xD;
          -  Aortic stenosis&#xD;
&#xD;
          -  Left ventricular ejection fraction &lt;30%&#xD;
&#xD;
          -  Heart failure NYHA class III-IV&#xD;
&#xD;
          -  Serious arrhythmia in need of treatment&#xD;
&#xD;
          -  Being on the waiting list for percutaneous coronary intervention or coronary artery&#xD;
             bypass grafting.&#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>Tone M Norekvål, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Haukeland University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tone M Norekvål, PhD</last_name>
    <phone>+4799044635</phone>
    <email>tone.merete.norekval@helse-bergen.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nina B Fålun, MSc</last_name>
    <phone>+4790858527</phone>
    <email>nina.falun@helse-bergen.no</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <zip>5021</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tone M Norekvål, PhD</last_name>
      <phone>+4799044635</phone>
      <email>tone.merete.norekval@helse-bergen.no</email>
    </contact>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <link>
    <url>https://helse-bergen.no/en/procard/projects-in-procard/patient-reported-outcomes-in-the-bergen-early-cardiac-rehabilitation-study-becarespro</url>
    <description>Study website</description>
  </link>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>January 17, 2019</last_update_submitted>
  <last_update_submitted_qc>January 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiac rehabilitation adherence</keyword>
  <keyword>Patient-reported outcomes</keyword>
  <keyword>Post-traumatic growth</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Depression</keyword>
  <keyword>Adherence</keyword>
  <keyword>Lifestyle</keyword>
  <keyword>Self-reported health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery 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>


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/NCT03810599
org study id: 2014/333
nct id: NCT03810599
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An intervention study with longitudinal follow-up of patients with coronary artery disease
      undergoing early cardiac rehabilitation is designed.
The main objective of the study is to investigate patient-reported outcomes, their relation
      to clinical characteristics of the patients and the potential to predict health outcomes and
      adverse events in coronary artery disease patients participating in an early cardiac
      rehabilitation programme.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Pre-post comparison.
primary purpose: Prevention
masking: None (Open Label)
measure: Time to composite of total mortality, and hospitalization for heart failure and atherothrombotic disease (including non-fatal MI, unstable angina and stroke).
time frame: Up to 10 years
description: Time to combined endpoint from inclusion.
measure: Change in Self-reported health
time frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
description: The EuroQol 5-dimensions-5 level questionnaire (EQ-5D-5L) is an 5 item self-report-questionnaire assessing self-reported health. The respondent rates each item on a 5-point scale ranging from 1(indicating no problem) to 5 (indicating extreme problems). This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
measure: Change in self-reported global health
time frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
description: The VAS scale from the EQ-5D-5L assess global health. The scale goes from 0 to 100 were lower score indicates worse health.
measure: Change in post traumatic growth
time frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
description: The Posttraumatic Growth Inventory-Short Form (PTGI-SF) is a 10 item scale measuring post traumatic growth. The respondent rates each item on a 6-point scale ranging from 0 (I did not experience this change as a result of my crisis) to 5 (I experienced this change to a very great degree as a result of my crisis). The scale is scored by adding all the responses.Individual factors are scored by adding responses to items on each factor. Factors are indicated by the Roman numerals after each item.
measure: Nicotine dependence
time frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
description: The Fagerström test
measure: Change in anxiety and depression
time frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
description: The Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale where seven of the items relate to anxiety and seven relate to depression. The respondent rates each item on a 4-point scale ranging from 0 (absence) to 3 (extreme presence). The total score is 42 (21 per subscale).
measure: Change in physical and mental dimensions of health
time frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
description: The Short Form Health Survey (SF-12) include 12 items with 3 to 5 response levels. It generates two health indices: mental health and physical health. The score range between 0 and 100, with 100 representing the highest level of health
measure: Change in health status following myocardial infarction
time frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
description: The Myocardial Infarction Dimensional Assessment Scale (MIDAS) is a PRO measure developed and validated to specifically measure the health status of individuals who have suffered a myocardial infarction. It consist of 7 domains, and is a 35 item scale where respondents rate each item on a 5-point scale ranging from 1 (never) to 5 (always). The function of the MIDAS is to indicate the extent of ill health in each of the seven domains assessed, therefore each dimension is scored separately using a simple scoring methodology.
arm group label: Early cardiac rehabilitation
arm group type: Other
description: Single Group: 5 week cardiac rehabilitation programme. Pre-post comparison.
intervention type: Other
intervention name: Early cardiac rehabilitation
description: This is an early cardiac rehabilitation programme starting 1-2 weeks after hospital discharge (Phase 2A rehabilitation). The programme provided by a multidisciplinary team includes individual counseling, educational sessions and discussion in groups, and exercise training sessions three days a week for five weeks.
For additional analysis there will be a comparison group that did not receive the intervention for practical reasons.
arm group label: Early cardiac rehabilitation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tone M Norekvål, PhD
role: Principal Investigator
affiliation: Haukeland University Hospital
last name: Tone M Norekvål, PhD
phone: +4799044635
email: tone.merete.norekval@helse-bergen.no
last name: Nina B Fålun, MSc
phone: +4790858527
email: nina.falun@helse-bergen.no
facility: 
status: Recruiting
contact: 
country: Norway
url: https://helse-bergen.no/en/procard/projects-in-procard/patient-reported-outcomes-in-the-bergen-early-cardiac-rehabilitation-study-becarespro
description: Study website
responsible party type: Sponsor
mesh term: Coronary Artery Disease
sharing ipd: No