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/NCT06020391</url>
    </required_header>
    <id_info>
      <org_study_id>2022066</org_study_id>
      <nct_id>NCT06020391</nct_id>
    </id_info>
    <brief_title>Cooperation for Better Treatment of Polypharmacy in the Community</brief_title>
    <official_title>The COOP II Study: Cooperation for Better Treatment of Polypharmacy in the Community. A Randomized, Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Oslo University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Oslo</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>South-Eastern Norway Regional Health Authority</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>City of Oslo</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Oslo 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>
        The elderly population today relies heavily on medication consumption. While there are cases&#xD;
        where using multiple medications is necessary and reasonable, it also increases the risk of&#xD;
        inappropriate treatment and adverse drug effects. This randomized, controlled trial aims to&#xD;
        examine the effectiveness of incorporating drug reviews as an integral part of clinical&#xD;
        practice for older patients admitted to a Municipal Acute Bed Unit in Oslo, Norway. In&#xD;
        Norwegian, such units are called &quot;Kommunale Akutte Døgnenheter&quot; (KAD). The intervention&#xD;
        involves a clinical drug review conducted by a KAD physician under the guidance of a&#xD;
        geriatrician, followed by a telephone consultation between the KAD physician and the&#xD;
        patient's family physician (FP). The primary outcome measure is health-related quality of&#xD;
        life, while secondary outcome measures include physical and cognitive function, dry mouth,&#xD;
        hospital admissions, and survival. The environmental impact of the study intervention will&#xD;
        also be assessed and compared to usual care.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of this study is to evaluate the effect of collaborative drug reviews by KAD&#xD;
        physicians, supervised by geriatricians, and FPs on clinically relevant outcome measures in&#xD;
        the KAD patient population aged 70+. The investigators will also assess the environmental&#xD;
        impact of the study intervention and compare it to usual care.&#xD;
  &#xD;
        The study is a randomized, single-blind, controlled trial with 16 weeks follow-up and&#xD;
        acquisition of registry data for one year.&#xD;
  &#xD;
        The investigators will recruit 1-4 KAD physicians to take part in the study. The project&#xD;
        physicians will be responsible for the patient's general medical treatment, but will also&#xD;
        perform a structured, clinical drug review that goes beyond what is considered usual care.&#xD;
        The project physicians will provide necessary information on the patient's medical history&#xD;
        and drug use from the medical records, carry out a medical history from the patient, and a&#xD;
        physical examination. Relevant blood analyses and other supplementary tests will be ordered&#xD;
        if not already available. The clinical drug review will be aimed at evaluating whether&#xD;
        current medications are indicated, whether the patient's medical conditions are&#xD;
        satisfactorily compensated, whether dosages are appropriate, whether the patient has adverse&#xD;
        drug effects, and whether drug-drug or drug-disease interactions are present or likely to&#xD;
        occur. The investigators will develop a structured framework for the drug reviews, and the&#xD;
        KAD physicians will receive clinical supervision from a consultant in geriatric medicine.&#xD;
  &#xD;
        After performing the clinical drug review, the KAD physician will offer the patient's FP a&#xD;
        telephone based or digital meeting with the purpose of combining the assessments of the KAD&#xD;
        physician and the competence of the FP in a common drug review. The two physicians will&#xD;
        review the patient's drug list systematically and discuss if any adjustments should be done,&#xD;
        as well as the patient's need for further follow-up.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 6, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</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>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Health-related quality of life (HRQoL)</measure>
      <time_frame>16 weeks</time_frame>
      <description>HRQoL assessed with the 15-dimensional instrument 15D. 15D is a generic, 15-dimensional instrument concerning different aspects of HRQoL. The dimensions are mobility, vision, hearing, breathing, sleeping, eating, speech, elimination, usual activities, mental function, discomfort and symptoms, depression, distress, vitality, and sexual activity. Each dimension is rated on an ordinal scale with five levels, and the respondent chooses the level best describing his/her present health status. Single index scores are calculated by population-based utility weights, and range from 0 to 1, with higher scores indicating better HRQoL.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of drugs in use</measure>
      <time_frame>16 weeks</time_frame>
      <description>The number of drugs in use at baseline and at week 16 will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of new drugs started</measure>
      <time_frame>16 weeks</time_frame>
      <description>The number of new drugs started in the period from baseline to week 16 will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of drug withdrawals</measure>
      <time_frame>16 weeks</time_frame>
      <description>The number of drug withdrawals in the period from baseline to week 16 will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of drugs with increased dosages</measure>
      <time_frame>16 weeks</time_frame>
      <description>The number of drugs with increased dosages when comparing baseline to week 16 will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of drugs with reduced dosages</measure>
      <time_frame>16 weeks</time_frame>
      <description>The number of drugs with reduced dosages when comparing baseline to week 16 will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Handgrip strength</measure>
      <time_frame>16 weeks</time_frame>
      <description>Handgrip strength measured with a standard dynamometer, with three attempts on each hand. The highest value of all six attempts will be reported, measured in kilograms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Digit span forward</measure>
      <time_frame>16 weeks</time_frame>
      <description>Results will be reported as the maximum digit span completed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Digit span backwards</measure>
      <time_frame>16 weeks</time_frame>
      <description>Results will be reported as the maximum digit span completed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Unstimulated whole saliva flow</measure>
      <time_frame>16 weeks</time_frame>
      <description>Unstimulated whole saliva flow will be measured by the spitting method by weighing plastic cups before and after a collection period of 3 minutes. Results will be reported as milliliters/minute.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Shortened Xerostomia Inventory (SXI)</measure>
      <time_frame>16 weeks</time_frame>
      <description>The Shortened Xerostomia Inventory (SXI) is a five-item summated rating scale which combines the responses to five individual items into a single sum score. The sum score can range from 5 to 15, with higher values representing more severe xerostomia.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The eight-item Visual Analog Scale xerostomia questionnaire</measure>
      <time_frame>16 weeks</time_frame>
      <description>This is a Visual Analog Scale with eight questions related to xerostomia where participants will be asked to mark their response to each item by placing a vertical line on the 100 millimeter horizontal scale. Results will be reported as millimeters.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Orthostatic blood pressure</measure>
      <time_frame>16 weeks</time_frame>
      <description>Supine blood pressure and pulse rate will be measured twice, after a minimum of five minutes of rest, and the mean value will be used for the analyses. The patient will then stand up, and measurements will be repeated after one and three minutes. Orthostatic hypotension will be defined as a fall in systolic blood pressure of at least 20 mmHg or a fall in diastolic blood pressure of at least 10 mmHg after one and/or three minutes in standing position.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Falls</measure>
      <time_frame>16 weeks</time_frame>
      <description>Number of falls.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Admissions to health institutions</measure>
      <time_frame>16 weeks and 1 year</time_frame>
      <description>The number of hospital admissions, nursing home admissions, and KAD readmissions in the period from baseline to week 16, as well as in the period from baseline to one year.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality</measure>
      <time_frame>16 weeks and 1 year</time_frame>
      <description>Mortality in the period from baseline to week 16, as in the period from baseline to one year.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Environmental impact measures</measure>
      <time_frame>16 weeks</time_frame>
      <description>Environmental impact analysis will follow life cycle assessment according to the International Organization for Standardization (14040) standards to quantify greenhouse gas emissions. We will include data such as types and quantities of medications administered, types and quantities of medical equipment used during the KAD stay, number and length of hospital admissions, nursing home admissions and KAD readmissions, and number of outpatient and FP consultations.&#xD;
  These data will be assessed and converted to carbon dioxide equivalents, and combined to report the environmental impact of the intervention expressed in carbon dioxide equivalents.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">350</enrollment>
    <condition>Drug Usage</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Collaborative drug review.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Usual care.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Collaborative drug review</intervention_name>
      <description>Structured, clinical drug review including medical history, physical examination, and supplementary tests. The work-up will be aimed at evaluating whether current medications are indicated, whether the patient's medical conditions are satisfactorily compensated, whether dosages are appropriate, whether the patient has adverse drug effects, and whether drug-drug or drug-disease interactions are present or likely to occur. The KAD physicians will receive clinical supervision from a consultant in geriatric medicine.&#xD;
  The KAD physician will offer the patient's FP a telephone meeting with the purpose of combining the assessments of the KAD physician and the competence of the FP in a common drug review. The two physicians will review the patient's drug list systematically and discuss if any adjustments should be done, as well as the patient's need for further follow-up.</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 70+&#xD;
  &#xD;
            -  Admitted to KAD&#xD;
  &#xD;
            -  Use of at least six different systemic medications taken regularly&#xD;
  &#xD;
            -  Informed consent by the patient&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previously included in the study&#xD;
  &#xD;
            -  Not speaking or understanding Norwegian&#xD;
  &#xD;
            -  Residing outside of the municipality of Oslo&#xD;
  &#xD;
            -  Planned discharge within 24 hours&#xD;
  &#xD;
            -  Isolated for infection control reasons&#xD;
  &#xD;
            -  Considered too ill to approach or life expectancy judged to be less than six months&#xD;
  &#xD;
            -  Personnel at KAD discourage participation (in case of important reasons not covered by&#xD;
               the other exclusion criteria)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>70 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rita Romskaug, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dept. of Geriatric Medicine, Oslo University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rita Romskaug, MD, PhD</last_name>
      <phone>98094324</phone>
      <phone_ext>+47</phone_ext>
      <email>ritulf@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Leonor R Santervas, MD</last_name>
      <phone>47152153</phone>
      <phone_ext>+47</phone_ext>
      <email>leonor.roa@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Oslo University Hospital</name>
        <address>
          <city>Oslo</city>
          <country>Norway</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rita Romskaug, MD, PhD</last_name>
        <phone>98094324</phone>
        <phone_ext>47</phone_ext>
        <email>ritulf@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Leonor R Santervas, MD</last_name>
        <phone>47152153</phone>
        <phone_ext>47</phone_ext>
        <email>leonor.roa@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Norway</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
      <investigator_full_name>Rita Romskaug</investigator_full_name>
      <investigator_title>MD, PhD</investigator_title>
    </responsible_party>
    <keyword>Polypharmacy</keyword>
    <keyword>Geriatrics</keyword>
    <keyword>Drug review</keyword>
    <keyword>Medication review</keyword>
    <keyword>Elderly</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>We plan to share all individual participant data collected during the trial, after deidentification.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Beginning 9 months and ending 3 years following publication of the main results of the study.</ipd_time_frame>
      <ipd_access_criteria>Data will be shared with researchers who provide a methodologically sound proposal. As for now, we plan to upload data to Sikt (www.sikt.no) or a similar service for depositing and sharing data.</ipd_access_criteria>
    </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/NCT06020391
  org study id: 2022066
  nct id: NCT06020391
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The elderly population today relies heavily on medication consumption. While there are cases
        where using multiple medications is necessary and reasonable, it also increases the risk of
        inappropriate treatment and adverse drug effects. This randomized, controlled trial aims to
        examine the effectiveness of incorporating drug reviews as an integral part of clinical
        practice for older patients admitted to a Municipal Acute Bed Unit in Oslo, Norway. In
        Norwegian, such units are called "Kommunale Akutte Døgnenheter" (KAD). The intervention
        involves a clinical drug review conducted by a KAD physician under the guidance of a
        geriatrician, followed by a telephone consultation between the KAD physician and the
        patient's family physician (FP). The primary outcome measure is health-related quality of
        life, while secondary outcome measures include physical and cognitive function, dry mouth,
        hospital admissions, and survival. The environmental impact of the study intervention will
        also be assessed and compared to usual care.
  The aim of this study is to evaluate the effect of collaborative drug reviews by KAD
        physicians, supervised by geriatricians, and FPs on clinically relevant outcome measures in
        the KAD patient population aged 70+. The investigators will also assess the environmental
        impact of the study intervention and compare it to usual care.
  
        The study is a randomized, single-blind, controlled trial with 16 weeks follow-up and
        acquisition of registry data for one year.
  
        The investigators will recruit 1-4 KAD physicians to take part in the study. The project
        physicians will be responsible for the patient's general medical treatment, but will also
        perform a structured, clinical drug review that goes beyond what is considered usual care.
        The project physicians will provide necessary information on the patient's medical history
        and drug use from the medical records, carry out a medical history from the patient, and a
        physical examination. Relevant blood analyses and other supplementary tests will be ordered
        if not already available. The clinical drug review will be aimed at evaluating whether
        current medications are indicated, whether the patient's medical conditions are
        satisfactorily compensated, whether dosages are appropriate, whether the patient has adverse
        drug effects, and whether drug-drug or drug-disease interactions are present or likely to
        occur. The investigators will develop a structured framework for the drug reviews, and the
        KAD physicians will receive clinical supervision from a consultant in geriatric medicine.
  
        After performing the clinical drug review, the KAD physician will offer the patient's FP a
        telephone based or digital meeting with the purpose of combining the assessments of the KAD
        physician and the competence of the FP in a common drug review. The two physicians will
        review the patient's drug list systematically and discuss if any adjustments should be done,
        as well as the patient's need for further follow-up.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: Single (Outcomes Assessor)
  measure: Health-related quality of life (HRQoL)
  time frame: 16 weeks
  description: HRQoL assessed with the 15-dimensional instrument 15D. 15D is a generic, 15-dimensional instrument concerning different aspects of HRQoL. The dimensions are mobility, vision, hearing, breathing, sleeping, eating, speech, elimination, usual activities, mental function, discomfort and symptoms, depression, distress, vitality, and sexual activity. Each dimension is rated on an ordinal scale with five levels, and the respondent chooses the level best describing his/her present health status. Single index scores are calculated by population-based utility weights, and range from 0 to 1, with higher scores indicating better HRQoL.
  measure: Number of drugs in use
  time frame: 16 weeks
  description: The number of drugs in use at baseline and at week 16 will be reported.
  measure: Number of new drugs started
  time frame: 16 weeks
  description: The number of new drugs started in the period from baseline to week 16 will be reported.
  measure: Number of drug withdrawals
  time frame: 16 weeks
  description: The number of drug withdrawals in the period from baseline to week 16 will be reported.
  measure: Number of drugs with increased dosages
  time frame: 16 weeks
  description: The number of drugs with increased dosages when comparing baseline to week 16 will be reported.
  measure: Number of drugs with reduced dosages
  time frame: 16 weeks
  description: The number of drugs with reduced dosages when comparing baseline to week 16 will be reported.
  measure: Handgrip strength
  time frame: 16 weeks
  description: Handgrip strength measured with a standard dynamometer, with three attempts on each hand. The highest value of all six attempts will be reported, measured in kilograms.
  measure: Digit span forward
  time frame: 16 weeks
  description: Results will be reported as the maximum digit span completed.
  measure: Digit span backwards
  time frame: 16 weeks
  description: Results will be reported as the maximum digit span completed.
  measure: Unstimulated whole saliva flow
  time frame: 16 weeks
  description: Unstimulated whole saliva flow will be measured by the spitting method by weighing plastic cups before and after a collection period of 3 minutes. Results will be reported as milliliters/minute.
  measure: The Shortened Xerostomia Inventory (SXI)
  time frame: 16 weeks
  description: The Shortened Xerostomia Inventory (SXI) is a five-item summated rating scale which combines the responses to five individual items into a single sum score. The sum score can range from 5 to 15, with higher values representing more severe xerostomia.
  measure: The eight-item Visual Analog Scale xerostomia questionnaire
  time frame: 16 weeks
  description: This is a Visual Analog Scale with eight questions related to xerostomia where participants will be asked to mark their response to each item by placing a vertical line on the 100 millimeter horizontal scale. Results will be reported as millimeters.
  measure: Orthostatic blood pressure
  time frame: 16 weeks
  description: Supine blood pressure and pulse rate will be measured twice, after a minimum of five minutes of rest, and the mean value will be used for the analyses. The patient will then stand up, and measurements will be repeated after one and three minutes. Orthostatic hypotension will be defined as a fall in systolic blood pressure of at least 20 mmHg or a fall in diastolic blood pressure of at least 10 mmHg after one and/or three minutes in standing position.
  measure: Falls
  time frame: 16 weeks
  description: Number of falls.
  measure: Admissions to health institutions
  time frame: 16 weeks and 1 year
  description: The number of hospital admissions, nursing home admissions, and KAD readmissions in the period from baseline to week 16, as well as in the period from baseline to one year.
  measure: Mortality
  time frame: 16 weeks and 1 year
  description: Mortality in the period from baseline to week 16, as in the period from baseline to one year.
  measure: Environmental impact measures
  time frame: 16 weeks
  description: Environmental impact analysis will follow life cycle assessment according to the International Organization for Standardization (14040) standards to quantify greenhouse gas emissions. We will include data such as types and quantities of medications administered, types and quantities of medical equipment used during the KAD stay, number and length of hospital admissions, nursing home admissions and KAD readmissions, and number of outpatient and FP consultations.
  These data will be assessed and converted to carbon dioxide equivalents, and combined to report the environmental impact of the intervention expressed in carbon dioxide equivalents.
  arm group label: Intervention group
  arm group type: Experimental
  description: Collaborative drug review.
  arm group label: Control group
  arm group type: No Intervention
  description: Usual care.
  intervention type: Other
  intervention name: Collaborative drug review
  description: Structured, clinical drug review including medical history, physical examination, and supplementary tests. The work-up will be aimed at evaluating whether current medications are indicated, whether the patient's medical conditions are satisfactorily compensated, whether dosages are appropriate, whether the patient has adverse drug effects, and whether drug-drug or drug-disease interactions are present or likely to occur. The KAD physicians will receive clinical supervision from a consultant in geriatric medicine.
  The KAD physician will offer the patient's FP a telephone meeting with the purpose of combining the assessments of the KAD physician and the competence of the FP in a common drug review. The two physicians will review the patient's drug list systematically and discuss if any adjustments should be done, as well as the patient's need for further follow-up.
  arm group label: Intervention group
  criteria: 
  gender: All
  minimum age: 70 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Rita Romskaug, MD, PhD
  role: Principal Investigator
  affiliation: Dept. of Geriatric Medicine, Oslo University Hospital
  last name: Rita Romskaug, MD, PhD
  phone: 98094324
  phone ext: +47
  email: ritulf@gmail.com
  last name: Leonor R Santervas, MD
  phone: 47152153
  phone ext: +47
  email: leonor.roa@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Norway
  responsible party type: Principal Investigator
  investigator affiliation: Oslo University Hospital
  investigator full name: Rita Romskaug
  investigator title: MD, PhD
  sharing ipd: Yes
  ipd description: We plan to share all individual participant data collected during the trial, after deidentification.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Analytic Code
  ipd time frame: Beginning 9 months and ending 3 years following publication of the main results of the study.
  ipd access criteria: Data will be shared with researchers who provide a methodologically sound proposal. As for now, we plan to upload data to Sikt (www.sikt.no) or a similar service for depositing and sharing data.