<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/NCT04437563</url>
  </required_header>
  <id_info>
    <org_study_id>R210-A12901</org_study_id>
    <nct_id>NCT04437563</nct_id>
  </id_info>
  <brief_title>Improving Information to Caregivers Via Adaptation and Implementation of the HERMES Intervention</brief_title>
  <acronym>HERMESII</acronym>
  <official_title>Improving Information to Caregivers Via Adaptation and Implementation of the HERMES Intervention the Danish Health Care System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bispebjerg Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Herlev Gentofte University Hospital, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rigshospitalet, University of Copenhagen, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>South Jutland Hospital, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bispebjerg 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>
      The HERMES intervention was developed in a Danish setting after a comprehensive investigation&#xD;
      on caregivers' needs. The intervention consists of: 1) a systematic identification of the&#xD;
      caregiver's unmet information needs and 2) a subsequent consultation with a nurse providing&#xD;
      the lacking information. The evaluation carried out in a randomized trial at Herlev Hospital&#xD;
      showed positive results. It reduced the unmet information needs and improved the caregivers'&#xD;
      evaluation of the information from and communication with the health care professionals and&#xD;
      the perception of being seen and acknowledged as a caregiver. However, although research&#xD;
      projects may show a positive effect, this does not mean that the intervention will be easily&#xD;
      implemented in the health care system. Nor does it guarantee that the intervention will show&#xD;
      the expected results once implemented in a busy clinical routine.&#xD;
&#xD;
      Therefore, the present project will adapt the HERMES intervention to be implemented in Danish&#xD;
      departments of oncology and haematology by (in the first part of the project):&#xD;
&#xD;
        1. Elucidating how the HERMES intervention is best implemented in the clinical setting&#xD;
           according to the clinical staff.&#xD;
&#xD;
        2. Elucidating how the HERMES intervention is best implemented in the treatment and&#xD;
           follow-up period according to the patients and their caregivers.&#xD;
&#xD;
        3. Developing a technological solution (an app) for the HERMES intervention in which the&#xD;
           responses given by the caregivers will form the basis for a subsequent consultation with&#xD;
           the health care staff.&#xD;
&#xD;
        4. Revising the HERMES intervention based on the outcomes of a-c.&#xD;
&#xD;
        5. Testing the revised HERMES intervention in a pilot study.&#xD;
&#xD;
      In the second part of the project, the revised HERMES intervention will be tested in a large&#xD;
      scale trial with the purpose to:&#xD;
&#xD;
        1. Implement the revised HERMES intervention in the departments of oncology/haematology.&#xD;
&#xD;
        2. Test the effect of the revised HERMES intervention.&#xD;
&#xD;
        3. Evaluate the feasibility of the revised HERMES intervention in a large scale.&#xD;
&#xD;
        4. Elucidate the effectiveness and the feasibility of the intervention and assess&#xD;
           possibilities and potential needs for further adaptation in order to secure the future&#xD;
           applicability in the Danish Health Care System.&#xD;
&#xD;
      Thus, the overall aim is that by the end of the study, an evidence based and practical&#xD;
      implementable method to (continous) use of the HERMES intervention in the Danish health care&#xD;
      system is available.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2021</start_date>
  <completion_date type="Anticipated">July 15, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 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>
    <intervention_model_description>A stepped wedge cluster randomized controlled trial. All clusters (i.e., participating oncological departments) will start as controls and will change to intervention at various times determined by randomization. In this way, all departments will contribute to control and intervention groups, thus accounting for variation between departments.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of information from and communication with health care professionals</measure>
    <time_frame>Change from baseline (enrollment) to 3 months follow-up</time_frame>
    <description>Measured by the subscale 'Problems with the quality of information from and communication with health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more problems with the quality of information from and communication with health care professionals.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of information from and communication with health care professionals</measure>
    <time_frame>Change from baseline (enrollment) to 6 months follow-up</time_frame>
    <description>Measured by the subscale 'Problems with the quality of information from and communication with health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more problems with the quality of information from and communication with health care professionals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of information from health care professionals</measure>
    <time_frame>Change from baseline (enrollment) to 3 months follow-up</time_frame>
    <description>Measured by (a revised version of) the subscale 'Lack of information from health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of information from health care professionals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of information from health care professionals</measure>
    <time_frame>Change from baseline (enrollment) to 6 months follow-up</time_frame>
    <description>Measured by (a revised version of) the subscale 'Lack of information from health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of information from health care professionals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attention from health care professionals</measure>
    <time_frame>Change from baseline (enrollment) to 3 months follow-up</time_frame>
    <description>Measured by the subscale 'Lack of attention from health care professionals on the caregivers' wellbeing' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of attention from health care professionals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attention from health care professionals</measure>
    <time_frame>Change from baseline (enrollment) to 6 months follow-up</time_frame>
    <description>Measured by the subscale 'Lack of attention from health care professionals on the caregivers' wellbeing' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of attention from health care professionals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver involvement</measure>
    <time_frame>Change from baseline (enrollment) to 3 months follow-up</time_frame>
    <description>Measured by item 12 in the Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Item score range: 0-100. A higher score represents a worse outcome, i.e. more caregiver dissatisfaction with involvement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver involvement</measure>
    <time_frame>Change from baseline (enrollment) to 6 months follow-up</time_frame>
    <description>Measured by item 12 in the Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Item score range: 0-100. A higher score represents a worse outcome, i.e. more caregiver dissatisfaction with involvement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional functioning</measure>
    <time_frame>Change from baseline (enrollment) to 3 months follow-up</time_frame>
    <description>Measured by the European Organisation for Research and Treatment of Cancer (EORTC) Emotional Functioning 10 scale (EORTC EF10). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. worse emotional functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional functioning</measure>
    <time_frame>Change from baseline (enrollment) to 6 months follow-up</time_frame>
    <description>Measured by the EORTC Emotional Functioning 10 scale (EORTC EF10). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. worse emotional functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive emotional functioning</measure>
    <time_frame>Change from baseline (enrollment) to 3 months follow-up</time_frame>
    <description>Measured by a scale of five positively formulated items concerning emotional functioning which were excluded from the EORTC Computerized Adaptive Test (CAT) emotional functioning bank during the development of the item bank. Subscale score range: 0-100. A higher score represents a better outcome, i.e. more positive emotional functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive emotional functioning</measure>
    <time_frame>Change from baseline (enrollment) to 6 months follow-up</time_frame>
    <description>Measured by a scale of five positively formulated items concerning emotional functioning which were excluded from the EORTC Computerized Adaptive Test (CAT) emotional functioning bank during the development of the item bank. Subscale score range: 0-100. A higher score represents a better outcome, i.e. more positive emotional functioning</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>('Standard' care). No intervention offered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>('Standard' care +) The 'Herlev Hospital Empowerment of Relatives through More and Earlier information Supply' (HERMES) intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HERMES</intervention_name>
    <description>Via an app, the caregiver answers 14 questions about his/her need for (more) information. The caregiver presents his/her answers (i.e., need for information) to the health care professionals (HCPs), and the HCPs provide the caregiver with the lacking information.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (18+ years)&#xD;
&#xD;
          -  Primary caregiver (defined as the lay person (partner, family member, friend, etc)&#xD;
             most involved in the patient's disease course. The primary caregiver is appointed by&#xD;
             the patient)&#xD;
&#xD;
          -  Caregiver of an adult cancer patient starting up a treatment course in an oncological&#xD;
             department&#xD;
&#xD;
          -  Written informed consent to participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Caregivers not able to read and understand Danish&#xD;
&#xD;
          -  Caregivers with no or minimal contact to the oncological department&#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>Mogens Groenvold, PhD DMSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bispebjerg and Frederiksberg Hospital, University of Copenhagen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mathilde Adsersen, PhD</last_name>
    <phone>004538635131</phone>
    <email>mathilde.adsersen@regionh.dk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Aalborg Universitetshospital</name>
      <address>
        <city>Aalborg</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Charlotte B Rotboel, MD</last_name>
      <email>c.rotboel@rn.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ulla B Tange, MD</last_name>
      <email>ulla.brix.tange@regionh.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Herlev Hospital</name>
      <address>
        <city>Herlev</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katrine R Jervad, Nurse</last_name>
      <email>katrine.roshani.jervad@regionh.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospitalsenheden Vest</name>
      <address>
        <city>Herning</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hanne Linnet, MD</last_name>
      <email>hannsind@rm.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Naestved Sygehus</name>
      <address>
        <city>Naestved</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Rosted, PhD, Nurse</last_name>
      <email>eros@regionsjaelland.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Roskilde Universitetshospital</name>
      <address>
        <city>Roskilde</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Rosted, PhD, Nurse</last_name>
      <email>eros@regionsjaelland.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sygehus Soenderjylland</name>
      <address>
        <city>Soenderborg</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joan Lassen, Nurse</last_name>
      <email>joan.lassen@rsyd.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vejle Sygehus</name>
      <address>
        <city>Vejle</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hroenn Thorn, Nurse</last_name>
      <email>hronn.thorn@rsyd.dk</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>March 1, 2022</last_update_submitted>
  <last_update_submitted_qc>March 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bispebjerg Hospital</investigator_affiliation>
    <investigator_full_name>Mogens Groenvold</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>Informal caregivers</keyword>
  <keyword>Information</keyword>
  <keyword>Intervention</keyword>
  <keyword>Stepped wedge cluster randomized controlled trial</keyword>
  <!-- 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/NCT04437563
org study id: R210-A12901
nct id: NCT04437563
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The HERMES intervention was developed in a Danish setting after a comprehensive investigation
      on caregivers' needs. The intervention consists of: 1) a systematic identification of the
      caregiver's unmet information needs and 2) a subsequent consultation with a nurse providing
      the lacking information. The evaluation carried out in a randomized trial at Herlev Hospital
      showed positive results. It reduced the unmet information needs and improved the caregivers'
      evaluation of the information from and communication with the health care professionals and
      the perception of being seen and acknowledged as a caregiver. However, although research
      projects may show a positive effect, this does not mean that the intervention will be easily
      implemented in the health care system. Nor does it guarantee that the intervention will show
      the expected results once implemented in a busy clinical routine.

      Therefore, the present project will adapt the HERMES intervention to be implemented in Danish
      departments of oncology and haematology by (in the first part of the project):

        1. Elucidating how the HERMES intervention is best implemented in the clinical setting
           according to the clinical staff.

        2. Elucidating how the HERMES intervention is best implemented in the treatment and
           follow-up period according to the patients and their caregivers.

        3. Developing a technological solution (an app) for the HERMES intervention in which the
           responses given by the caregivers will form the basis for a subsequent consultation with
           the health care staff.

        4. Revising the HERMES intervention based on the outcomes of a-c.

        5. Testing the revised HERMES intervention in a pilot study.

      In the second part of the project, the revised HERMES intervention will be tested in a large
      scale trial with the purpose to:

        1. Implement the revised HERMES intervention in the departments of oncology/haematology.

        2. Test the effect of the revised HERMES intervention.

        3. Evaluate the feasibility of the revised HERMES intervention in a large scale.

        4. Elucidate the effectiveness and the feasibility of the intervention and assess
           possibilities and potential needs for further adaptation in order to secure the future
           applicability in the Danish Health Care System.

      Thus, the overall aim is that by the end of the study, an evidence based and practical
      implementable method to (continous) use of the HERMES intervention in the Danish health care
      system is available.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A stepped wedge cluster randomized controlled trial. All clusters (i.e., participating oncological departments) will start as controls and will change to intervention at various times determined by randomization. In this way, all departments will contribute to control and intervention groups, thus accounting for variation between departments.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Quality of information from and communication with health care professionals
time frame: Change from baseline (enrollment) to 3 months follow-up
description: Measured by the subscale 'Problems with the quality of information from and communication with health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more problems with the quality of information from and communication with health care professionals.
measure: Quality of information from and communication with health care professionals
time frame: Change from baseline (enrollment) to 6 months follow-up
description: Measured by the subscale 'Problems with the quality of information from and communication with health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more problems with the quality of information from and communication with health care professionals.
measure: Amount of information from health care professionals
time frame: Change from baseline (enrollment) to 3 months follow-up
description: Measured by (a revised version of) the subscale 'Lack of information from health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of information from health care professionals
measure: Amount of information from health care professionals
time frame: Change from baseline (enrollment) to 6 months follow-up
description: Measured by (a revised version of) the subscale 'Lack of information from health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of information from health care professionals
measure: Attention from health care professionals
time frame: Change from baseline (enrollment) to 3 months follow-up
description: Measured by the subscale 'Lack of attention from health care professionals on the caregivers' wellbeing' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of attention from health care professionals
measure: Attention from health care professionals
time frame: Change from baseline (enrollment) to 6 months follow-up
description: Measured by the subscale 'Lack of attention from health care professionals on the caregivers' wellbeing' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of attention from health care professionals
measure: Caregiver involvement
time frame: Change from baseline (enrollment) to 3 months follow-up
description: Measured by item 12 in the Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Item score range: 0-100. A higher score represents a worse outcome, i.e. more caregiver dissatisfaction with involvement
measure: Caregiver involvement
time frame: Change from baseline (enrollment) to 6 months follow-up
description: Measured by item 12 in the Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Item score range: 0-100. A higher score represents a worse outcome, i.e. more caregiver dissatisfaction with involvement
measure: Emotional functioning
time frame: Change from baseline (enrollment) to 3 months follow-up
description: Measured by the European Organisation for Research and Treatment of Cancer (EORTC) Emotional Functioning 10 scale (EORTC EF10). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. worse emotional functioning
measure: Emotional functioning
time frame: Change from baseline (enrollment) to 6 months follow-up
description: Measured by the EORTC Emotional Functioning 10 scale (EORTC EF10). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. worse emotional functioning
measure: Positive emotional functioning
time frame: Change from baseline (enrollment) to 3 months follow-up
description: Measured by a scale of five positively formulated items concerning emotional functioning which were excluded from the EORTC Computerized Adaptive Test (CAT) emotional functioning bank during the development of the item bank. Subscale score range: 0-100. A higher score represents a better outcome, i.e. more positive emotional functioning
measure: Positive emotional functioning
time frame: Change from baseline (enrollment) to 6 months follow-up
description: Measured by a scale of five positively formulated items concerning emotional functioning which were excluded from the EORTC Computerized Adaptive Test (CAT) emotional functioning bank during the development of the item bank. Subscale score range: 0-100. A higher score represents a better outcome, i.e. more positive emotional functioning
arm group label: Control
arm group type: No Intervention
description: ('Standard' care). No intervention offered.
arm group label: Intervention
arm group type: Experimental
description: ('Standard' care +) The 'Herlev Hospital Empowerment of Relatives through More and Earlier information Supply' (HERMES) intervention.
intervention type: Behavioral
intervention name: HERMES
description: Via an app, the caregiver answers 14 questions about his/her need for (more) information. The caregiver presents his/her answers (i.e., need for information) to the health care professionals (HCPs), and the HCPs provide the caregiver with the lacking information.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mogens Groenvold, PhD DMSc
role: Principal Investigator
affiliation: Bispebjerg and Frederiksberg Hospital, University of Copenhagen
last name: Mathilde Adsersen, PhD
phone: 004538635131
email: mathilde.adsersen@regionh.dk
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Bispebjerg Hospital
investigator full name: Mogens Groenvold
investigator title: Professor