<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/NCT02241694</url>
  </required_header>
  <id_info>
    <org_study_id>F7HAEM-4146</org_study_id>
    <secondary_id>U1111-1147-4202</secondary_id>
    <nct_id>NCT02241694</nct_id>
  </id_info>
  <brief_title>To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives</brief_title>
  <acronym>HERO</acronym>
  <official_title>Haemophilia, Experiences, Results and Opportunities (HERO) in Brazil: Assessment of Psychological Effects of Haemophilia on Patients and Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novo Nordisk A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This survey is conducted in South America. The purpose is to identify the key psychosocial&#xD;
      issues affecting patients with haemophilia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Qualitative assessments of perceived impact on daily life</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perceived disease control</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carrier status and reactions to haemophilia diagnosis</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genetic counselling and testing</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of haemophilia in siblings</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with support from partners, family, friends, others</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual intimacy with partners in long-term relationships</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment method, compliance and location</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified WHO-5 (World Health Organization-Five Well Being Index)</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge and information about haemophilia</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvements in haemophilia care</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Congenital Bleeding Disorder</condition>
  <condition>Haemophilia A</condition>
  <condition>Haemophilia B</condition>
  <condition>Haemophilia A With Inhibitors</condition>
  <condition>Haemophilia B With Inhibitors</condition>
  <condition>Relatives to/Carers of Patients</condition>
  <arm_group>
    <arm_group_label>survey</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No treatment given</intervention_name>
    <description>No treatment given. Participants are to complete a questionnaire in the study.</description>
    <arm_group_label>survey</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult males with haemophilia and parents/carers of children with haemophilia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men aged 18 years or above with haemophilia A or B (with or without inhibitors) OR&#xD;
             Parents/caregivers of children/adolescents younger than 18 years with haemophilia A or&#xD;
             B (with or without inhibitors); only one subject per household will be able to&#xD;
             participate&#xD;
&#xD;
          -  Patients currently receiving one of the following treatments: a. replacement factor&#xD;
             VIII therapy, b. replacement factor IX therapy, c. bypassing agents (recombinant&#xD;
             factor VIIa or APCC) OR Patients with haemophilia, not receiving any kind of treatment&#xD;
             with replacement factor VIII or IX or a bypassing agent (as appropriate), but who have&#xD;
             had at least one spontaneous haemorrhage into one or more joints within the last 12&#xD;
             months&#xD;
&#xD;
          -  The participants (patients with haemophilia and parents/caregivers for patients under&#xD;
             18 years old) must be able to complete a paper questionnaire in order to participate&#xD;
             in the study&#xD;
&#xD;
          -  Providing informed consent before the start of any study-related activities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability for the patients or parents/caregivers to understand and comply with verbal&#xD;
             instructions, unless assisted by a member of the HTC (Haemophilia Treatment Center) or&#xD;
             by a relative. (No other conditions were established for patients who cannot read or&#xD;
             write to be able to participate in this study in addition to the need of help from a&#xD;
             member of HTC or by a relative.)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Global Clinical Registry (GCR, 1452), GZZF</last_name>
    <role>Study Director</role>
    <affiliation>Novo Nordisk A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Säo Paulo</city>
        <zip>05001-400</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>July 9, 2015</last_update_submitted>
  <last_update_submitted_qc>July 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemostatic Disorders</mesh_term>
    <mesh_term>Hemophilia A</mesh_term>
    <mesh_term>Hemophilia B</mesh_term>
    <mesh_term>Blood Coagulation Disorders</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/NCT02241694
org study id: F7HAEM-4146
secondary id: U1111-1147-4202
nct id: NCT02241694
lead sponsor: 
has dmc: No
This survey is conducted in South America. The purpose is to identify the key psychosocial
      issues affecting patients with haemophilia.
observational model: Cohort
time perspective: Cross-Sectional
measure: Qualitative assessments of perceived impact on daily life
time frame: Day 1
measure: Perceived disease control
time frame: Day 1
measure: Carrier status and reactions to haemophilia diagnosis
time frame: Day 1
measure: Genetic counselling and testing
time frame: Day 1
measure: Impact of haemophilia in siblings
time frame: Day 1
measure: Satisfaction with support from partners, family, friends, others
time frame: Day 1
measure: Sexual intimacy with partners in long-term relationships
time frame: Day 1
measure: Treatment method, compliance and location
time frame: Day 1
measure: Modified WHO-5 (World Health Organization-Five Well Being Index)
time frame: Day 1
measure: Knowledge and information about haemophilia
time frame: Day 1
measure: Improvements in haemophilia care
time frame: Day 1
arm group label: survey
intervention type: Other
intervention name: No treatment given
description: No treatment given. Participants are to complete a questionnaire in the study.
arm group label: survey
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Global Clinical Registry (GCR, 1452), GZZF
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
country: Brazil
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
responsible party type: Sponsor
mesh term: Hemostatic Disorders
mesh term: Hemophilia A
mesh term: Hemophilia B
mesh term: Blood Coagulation Disorders