<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/NCT03276130</url>
  </required_header>
  <id_info>
    <org_study_id>Sobi.HAEM89-003</org_study_id>
    <nct_id>NCT03276130</nct_id>
  </id_info>
  <brief_title>Management of Health-Related QoL Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B</brief_title>
  <acronym>MIND</acronym>
  <official_title>Management of Health-Related Quality of LIfe Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swedish Orphan Biovitrum</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Swedish Orphan Biovitrum</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The puropse of this non-interventional register and survey study is to identify the patterns&#xD;
      of prescribed pain, anti-depressive and anti-anxiety medication and management of pain,&#xD;
      depression and anxiety for people with haemophilia. The study will be conducted in the Nordic&#xD;
      countries (Sweden, Norway, Denmark, Finland) and the aim is to cover the entire haemophilia&#xD;
      population in the register part of the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2018</start_date>
  <completion_date type="Actual">January 30, 2020</completion_date>
  <primary_completion_date type="Actual">January 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Use of medication for pain, depression and anxiety (yes/no?)</measure>
    <time_frame>Retrospectively 10 years</time_frame>
    <description>Based on Registry data</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Annualised consumption of pain medications as assessed by filled prescription</measure>
    <time_frame>Retrospectively 10 years</time_frame>
    <description>Based on Registry data</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Annualised consumption of anti-anxiety medications as assessed by filled prescription</measure>
    <time_frame>Retrospectively 10 years</time_frame>
    <description>Based on Registry data</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Annualised consumption of anti-depressive medications as assessed by filled prescription</measure>
    <time_frame>Retrospectively 10 years</time_frame>
    <description>Based on Registry data</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of pain medications as measured by expected doses of medicines.</measure>
    <time_frame>Retrospectively 10 years</time_frame>
    <description>Based on Registry data</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of anti-depressive medications as measured by expected doses of medicines.</measure>
    <time_frame>Retrospectively 10 years</time_frame>
    <description>Based on Registry data</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of anti-anxiety medications as measured by expected doses of medicines.</measure>
    <time_frame>Retrospectively 10 years</time_frame>
    <description>Based on Registry data</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacological and non-pharmacological treatments for management of Health-Related Quality of Life (HRQoL) impairment, including treatment of pain</measure>
    <time_frame>Inclusion in survey study</time_frame>
    <description>Assessed by Health Care Professional (HCP) survey in Part B1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacological and non-pharmacological treatments for management of HRQoL impairment, including treatment of anxiety</measure>
    <time_frame>Inclusion in survey study</time_frame>
    <description>Assessed by HCP survey in Part B1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacological and non-pharmacological treatments for management of HRQoL impairment, including treatment of depression</measure>
    <time_frame>Inclusion in survey study</time_frame>
    <description>Assessed by HCP survey in Part B1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The perspective and experience of HCPs with direct and frequent patient Contacts on the strategies for the management of HRQoL impairment, including treatment of pain at each Haemophlia Treatment Centre</measure>
    <time_frame>Inclusion in survey study</time_frame>
    <description>Assessed by HCP survey in Part B1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The perspective and experience of HCPs with direct and frequent patient Contacts on the strategies for the management of HRQoL impairment, including treatment of anxiety at each Haemophlia Treatment Centre</measure>
    <time_frame>Inclusion in survey study</time_frame>
    <description>Assessed by HCP survey in Part B1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The perspective and experience of HCPs with direct and frequent patient Contacts on the strategies for the management of HRQoL impairment, including treatment of depression at each Haemophlia Treatment Centre</measure>
    <time_frame>Inclusion in survey study</time_frame>
    <description>Assessed by HCP survey in Part B1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-reported current and previous use of medications for pain</measure>
    <time_frame>Inclusion in survey study</time_frame>
    <description>Assessed by patient survey in Part B2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-reported current and previous use of medications for anxiety</measure>
    <time_frame>Inclusion in survey study</time_frame>
    <description>Assessed by patient survey in Part B2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-reported current and previous use of medications for depression</measure>
    <time_frame>Inclusion in survey study</time_frame>
    <description>Assessed by patient survey in Part B2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social and physical activity level</measure>
    <time_frame>Inclusion in survey study</time_frame>
    <description>Assessed by patient survey in Part B2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Euro-QoL 5 Dimensions 5 Levels (EQ-5D-5L)</measure>
    <time_frame>Inclusion in survey study</time_frame>
    <description>Assessed by patient survey in Part B2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient satisfaction with current management of pain</measure>
    <time_frame>Inclusion in survey study</time_frame>
    <description>Assessed by patient survey in Part B2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient satisfaction with current management anxiety</measure>
    <time_frame>Inclusion in survey study</time_frame>
    <description>Assessed by patient survey in Part B2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient satisfaction with current management of depression</measure>
    <time_frame>Inclusion in survey study</time_frame>
    <description>Assessed by patient survey in Part B2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient satisfaction of received treatment for pain</measure>
    <time_frame>Inclusion in Survey study</time_frame>
    <description>Assessed by patient survey in Part B2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient satisfaction of received treatment for anxiety</measure>
    <time_frame>Inclusion in Survey study</time_frame>
    <description>Assessed by patient survey in Part B2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient satisfaction of received treatment for depression</measure>
    <time_frame>Inclusion in Survey study</time_frame>
    <description>Assessed by patient survey in Part B2</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">2300</enrollment>
  <condition>Haemophilia A</condition>
  <condition>Haemophilia B</condition>
  <arm_group>
    <arm_group_label>Part A: Retrospective register study</arm_group_label>
    <description>To describe the usage of prescribed pain, anti-depressive and anti-anxiety medication during a 10-year period based on retrospective data from patient and drug registries. Population: All People with Haemophilia A and B identified through national administrative register or from local register at each treatment centre. The People with Haemophilia group will be compared against an age and gender matched control group from the general population.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B1: Survey to HTC</arm_group_label>
    <description>The survey will be sent out to the relevant physician at each Haemophilia Treatment Centers (HTC) with direct and frequent patient contacts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B2: Survey to PwH</arm_group_label>
    <description>All People with Haemophilia (PwH) listed at HTCs will be invited to participate in the patient survey.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All PwH in Sweden, Norway, Denmark and Finland&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Part A population will be defined by having:&#xD;
&#xD;
          -  at least one health care contact with main diagnosis haemophilia A or haemophilia B,&#xD;
             and/or;&#xD;
&#xD;
          -  at least one prescription of factor VIII or factor IX concentrates, or;&#xD;
&#xD;
          -  bypassing agents used in the treatment of PwH during the inclusion period.&#xD;
&#xD;
          -  Part B1 population: Relevant physician at each HTC with direct and frequent patient&#xD;
             contact.&#xD;
&#xD;
          -  Part B2 population: PwH 5 years or older listed at participating HTCs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  NA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bent Winding</last_name>
    <role>Study Director</role>
    <affiliation>Swedish Orphan Biovitrum</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research Site</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research Site</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research Site</name>
      <address>
        <city>Göteborg</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research Site</name>
      <address>
        <city>Malmö</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research Site</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Finland</country>
    <country>Sweden</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Blood coagulation disorder</keyword>
  <keyword>Haematologic diseases</keyword>
  <keyword>Coagulation protein disorder</keyword>
  <keyword>Hemorrhagic disorder</keyword>
  <keyword>Genetic diseases, inborn</keyword>
  <keyword>Pain</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Pain medication</keyword>
  <keyword>Anxiety medication</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemophilia A</mesh_term>
    <mesh_term>Hemophilia B</mesh_term>
  </condition_browse>
  <!-- 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/NCT03276130
org study id: Sobi.HAEM89-003
nct id: NCT03276130
lead sponsor: 
has dmc: No
The puropse of this non-interventional register and survey study is to identify the patterns
      of prescribed pain, anti-depressive and anti-anxiety medication and management of pain,
      depression and anxiety for people with haemophilia. The study will be conducted in the Nordic
      countries (Sweden, Norway, Denmark, Finland) and the aim is to cover the entire haemophilia
      population in the register part of the study.
observational model: Cohort
time perspective: Retrospective
measure: Use of medication for pain, depression and anxiety (yes/no?)
time frame: Retrospectively 10 years
description: Based on Registry data
measure: Annualised consumption of pain medications as assessed by filled prescription
time frame: Retrospectively 10 years
description: Based on Registry data
measure: Annualised consumption of anti-anxiety medications as assessed by filled prescription
time frame: Retrospectively 10 years
description: Based on Registry data
measure: Annualised consumption of anti-depressive medications as assessed by filled prescription
time frame: Retrospectively 10 years
description: Based on Registry data
measure: Duration of pain medications as measured by expected doses of medicines.
time frame: Retrospectively 10 years
description: Based on Registry data
measure: Duration of anti-depressive medications as measured by expected doses of medicines.
time frame: Retrospectively 10 years
description: Based on Registry data
measure: Duration of anti-anxiety medications as measured by expected doses of medicines.
time frame: Retrospectively 10 years
description: Based on Registry data
measure: Pharmacological and non-pharmacological treatments for management of Health-Related Quality of Life (HRQoL) impairment, including treatment of pain
time frame: Inclusion in survey study
description: Assessed by Health Care Professional (HCP) survey in Part B1
measure: Pharmacological and non-pharmacological treatments for management of HRQoL impairment, including treatment of anxiety
time frame: Inclusion in survey study
description: Assessed by HCP survey in Part B1
measure: Pharmacological and non-pharmacological treatments for management of HRQoL impairment, including treatment of depression
time frame: Inclusion in survey study
description: Assessed by HCP survey in Part B1
measure: The perspective and experience of HCPs with direct and frequent patient Contacts on the strategies for the management of HRQoL impairment, including treatment of pain at each Haemophlia Treatment Centre
time frame: Inclusion in survey study
description: Assessed by HCP survey in Part B1
measure: The perspective and experience of HCPs with direct and frequent patient Contacts on the strategies for the management of HRQoL impairment, including treatment of anxiety at each Haemophlia Treatment Centre
time frame: Inclusion in survey study
description: Assessed by HCP survey in Part B1
measure: The perspective and experience of HCPs with direct and frequent patient Contacts on the strategies for the management of HRQoL impairment, including treatment of depression at each Haemophlia Treatment Centre
time frame: Inclusion in survey study
description: Assessed by HCP survey in Part B1
measure: Self-reported current and previous use of medications for pain
time frame: Inclusion in survey study
description: Assessed by patient survey in Part B2
measure: Self-reported current and previous use of medications for anxiety
time frame: Inclusion in survey study
description: Assessed by patient survey in Part B2
measure: Self-reported current and previous use of medications for depression
time frame: Inclusion in survey study
description: Assessed by patient survey in Part B2
measure: Social and physical activity level
time frame: Inclusion in survey study
description: Assessed by patient survey in Part B2
measure: Euro-QoL 5 Dimensions 5 Levels (EQ-5D-5L)
time frame: Inclusion in survey study
description: Assessed by patient survey in Part B2
measure: Patient satisfaction with current management of pain
time frame: Inclusion in survey study
description: Assessed by patient survey in Part B2
measure: Patient satisfaction with current management anxiety
time frame: Inclusion in survey study
description: Assessed by patient survey in Part B2
measure: Patient satisfaction with current management of depression
time frame: Inclusion in survey study
description: Assessed by patient survey in Part B2
measure: Patient satisfaction of received treatment for pain
time frame: Inclusion in Survey study
description: Assessed by patient survey in Part B2
measure: Patient satisfaction of received treatment for anxiety
time frame: Inclusion in Survey study
description: Assessed by patient survey in Part B2
measure: Patient satisfaction of received treatment for depression
time frame: Inclusion in Survey study
description: Assessed by patient survey in Part B2
arm group label: Part A: Retrospective register study
description: To describe the usage of prescribed pain, anti-depressive and anti-anxiety medication during a 10-year period based on retrospective data from patient and drug registries. Population: All People with Haemophilia A and B identified through national administrative register or from local register at each treatment centre. The People with Haemophilia group will be compared against an age and gender matched control group from the general population.
arm group label: Part B1: Survey to HTC
description: The survey will be sent out to the relevant physician at each Haemophilia Treatment Centers (HTC) with direct and frequent patient contacts.
arm group label: Part B2: Survey to PwH
description: All People with Haemophilia (PwH) listed at HTCs will be invited to participate in the patient survey.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: N/A
healthy volunteers: No
last name: Bent Winding
role: Study Director
affiliation: Swedish Orphan Biovitrum
facility: 
facility: 
facility: 
facility: 
facility: 
country: Denmark
country: Finland
country: Sweden
responsible party type: Sponsor
mesh term: Hemophilia A
mesh term: Hemophilia B