<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/NCT03841422</url>
  </required_header>
  <id_info>
    <org_study_id>Nasal self-packing in HHT</org_study_id>
    <nct_id>NCT03841422</nct_id>
  </id_info>
  <brief_title>Evaluation of Video-assisted Instructions of Nasal Self-packing in Patients With HHT</brief_title>
  <official_title>Evaluation of Video-assisted Instructions of Nasal Self-packing in Patients With Hereditary Hemorrhagic Telangiectasia (HHT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Essen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Essen</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>
      Inserting nasal self-packings is a secure method leaving patients more self-confident. We&#xD;
      provide a video on https://www.youtube.com/watch?v=LaioLYfSJ-E demonstrating how to use nasal&#xD;
      self-packings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inserting nasal self-packings is a secure method leaving patients more self-confident. In HHT&#xD;
      centers, patients often learn how to use them, but these centers are rare. Providing a video&#xD;
      on https://www.youtube.com/watch?v=LaioLYfSJ-E demonstrating how to use nasal self-packings&#xD;
      may also help patients without access to HHT centers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2024</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of video-assisted teaching</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluation of video-assisted teaching using a questionnaire. Data about using new media (Do you use a smartphone/ tablet (yes/no)? Do you use the internet (e.g. youtube, facebook, instagram...)?) Moreover, patients feeling loosing control (before and after using pneumatic nasal self-packing: how often do have the feeling of losing control (scale form 1 to 5, 1 = very often, 5 = never) and safety (after learning the nasal self-packing with pneumatic tamponades do you feel safe? (scale 1 to 5, 1 = not very safe, 5 = safe) is analyzed. Additional data about number of blood transfusions, hospitalty and doctoral consulation rates (regarding recurrent nosebleeds in the last 12 months: How many bloodtranfusions did you get (because of nosebleeds/ gastrointestinal bleedings/ both)? How often did you see a doctor or needed to be treated in hospital?) is documented.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analyzing duration of consultation</measure>
    <time_frame>1 year</time_frame>
    <description>the duration of the consultation and seeing the video is documented and compared to the Duration of consultations in patients with HHT before having uploaded the video</description>
  </secondary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Hereditary Haemorrhagic Telangiectasia</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>video-assisted nasal self-packing</intervention_name>
    <description>video-assisted nasal self-packing</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with hereditary hemorrhagic telangiectasia who often suffer from recurrent&#xD;
        nosebleeds&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age above 17 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients younger than 18 years old&#xD;
&#xD;
          -  unable to provide informed consent&#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>Freya Droege, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Essen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Freya Droege, Dr. med.</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital, Essen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Freya Droege, Dr. med.</last_name>
    <phone>+49201723</phone>
    <phone_ext>2971</phone_ext>
    <email>freya.droege@uk-essen.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jan Bosch, Dr. med.</last_name>
    <phone>+49201723</phone>
    <phone_ext>2971</phone_ext>
    <email>jan.bosch@uk-essen.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital Essen</name>
      <address>
        <city>Essen</city>
        <state>Nordrhein Westphalen</state>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Freya Droege, Dr. med.</last_name>
      <phone>+49201723</phone>
      <phone_ext>2971</phone_ext>
      <email>freya.droege@uk-essen.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>https://www.youtube.com/watch?v=LaioLYfSJ-E</url>
    <description>video about using nasal self-packings</description>
  </link>
  <reference>
    <citation>Shovlin CL, Guttmacher AE, Buscarini E, Faughnan ME, Hyland RH, Westermann CJ, Kjeldsen AD, Plauchu H. Diagnostic criteria for hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber syndrome). Am J Med Genet. 2000 Mar 6;91(1):66-7. doi: 10.1002/(sici)1096-8628(20000306)91:13.0.co;2-p.</citation>
    <PMID>10751092</PMID>
  </reference>
  <reference>
    <citation>Droege F, Lueb C, Thangavelu K, Stuck BA, Lang S, Geisthoff U. Nasal self-packing for epistaxis in Hereditary Hemorrhagic Telangiectasia increases quality of life. Rhinology. 2019 Jun 1;57(3):231-239. doi: 10.4193/Rhin18.141.</citation>
    <PMID>30739126</PMID>
  </reference>
  <reference>
    <citation>Faughnan ME, Palda VA, Garcia-Tsao G, Geisthoff UW, McDonald J, Proctor DD, Spears J, Brown DH, Buscarini E, Chesnutt MS, Cottin V, Ganguly A, Gossage JR, Guttmacher AE, Hyland RH, Kennedy SJ, Korzenik J, Mager JJ, Ozanne AP, Piccirillo JF, Picus D, Plauchu H, Porteous ME, Pyeritz RE, Ross DA, Sabba C, Swanson K, Terry P, Wallace MC, Westermann CJ, White RI, Young LH, Zarrabeitia R; HHT Foundation International - Guidelines Working Group. International guidelines for the diagnosis and management of hereditary haemorrhagic telangiectasia. J Med Genet. 2011 Feb;48(2):73-87. doi: 10.1136/jmg.2009.069013. Epub 2009 Jun 23.</citation>
    <PMID>19553198</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>February 12, 2019</study_first_submitted>
  <study_first_submitted_qc>February 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>July 14, 2023</last_update_submitted>
  <last_update_submitted_qc>July 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Essen</investigator_affiliation>
    <investigator_full_name>Freya Droege</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>hereditary hemorrhagic telangiectasia</keyword>
  <keyword>video-assisted teaching</keyword>
  <keyword>nasal self-packing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Telangiectasis</mesh_term>
    <mesh_term>Telangiectasia, Hereditary Hemorrhagic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03841422
org study id: Nasal self-packing in HHT
nct id: NCT03841422
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Inserting nasal self-packings is a secure method leaving patients more self-confident. We
      provide a video on https://www.youtube.com/watch?v=LaioLYfSJ-E demonstrating how to use nasal
      self-packings.
Inserting nasal self-packings is a secure method leaving patients more self-confident. In HHT
      centers, patients often learn how to use them, but these centers are rare. Providing a video
      on https://www.youtube.com/watch?v=LaioLYfSJ-E demonstrating how to use nasal self-packings
      may also help patients without access to HHT centers.
observational model: Cohort
time perspective: Prospective
measure: Evaluation of video-assisted teaching
time frame: 1 year
description: Evaluation of video-assisted teaching using a questionnaire. Data about using new media (Do you use a smartphone/ tablet (yes/no)? Do you use the internet (e.g. youtube, facebook, instagram...)?) Moreover, patients feeling loosing control (before and after using pneumatic nasal self-packing: how often do have the feeling of losing control (scale form 1 to 5, 1 = very often, 5 = never) and safety (after learning the nasal self-packing with pneumatic tamponades do you feel safe? (scale 1 to 5, 1 = not very safe, 5 = safe) is analyzed. Additional data about number of blood transfusions, hospitalty and doctoral consulation rates (regarding recurrent nosebleeds in the last 12 months: How many bloodtranfusions did you get (because of nosebleeds/ gastrointestinal bleedings/ both)? How often did you see a doctor or needed to be treated in hospital?) is documented.
measure: Analyzing duration of consultation
time frame: 1 year
description: the duration of the consultation and seeing the video is documented and compared to the Duration of consultations in patients with HHT before having uploaded the video
intervention type: Procedure
intervention name: video-assisted nasal self-packing
description: video-assisted nasal self-packing
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Freya Droege, Dr. med.
role: Principal Investigator
affiliation: University Hospital, Essen
last name: Freya Droege, Dr. med.
role: Study Chair
affiliation: University Hospital, Essen
last name: Freya Droege, Dr. med.
phone: +49201723
phone ext: 2971
email: freya.droege@uk-essen.de
last name: Jan Bosch, Dr. med.
phone: +49201723
phone ext: 2971
email: jan.bosch@uk-essen.de
facility: 
status: Recruiting
contact: 
country: Germany
url: https://www.youtube.com/watch?v=LaioLYfSJ-E
description: video about using nasal self-packings
citation: Shovlin CL, Guttmacher AE, Buscarini E, Faughnan ME, Hyland RH, Westermann CJ, Kjeldsen AD, Plauchu H. Diagnostic criteria for hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber syndrome). Am J Med Genet. 2000 Mar 6;91(1):66-7. doi: 10.1002/(sici)1096-8628(20000306)91:13.0.co;2-p.
PMID: 10751092
citation: Droege F, Lueb C, Thangavelu K, Stuck BA, Lang S, Geisthoff U. Nasal self-packing for epistaxis in Hereditary Hemorrhagic Telangiectasia increases quality of life. Rhinology. 2019 Jun 1;57(3):231-239. doi: 10.4193/Rhin18.141.
PMID: 30739126
citation: Faughnan ME, Palda VA, Garcia-Tsao G, Geisthoff UW, McDonald J, Proctor DD, Spears J, Brown DH, Buscarini E, Chesnutt MS, Cottin V, Ganguly A, Gossage JR, Guttmacher AE, Hyland RH, Kennedy SJ, Korzenik J, Mager JJ, Ozanne AP, Piccirillo JF, Picus D, Plauchu H, Porteous ME, Pyeritz RE, Ross DA, Sabba C, Swanson K, Terry P, Wallace MC, Westermann CJ, White RI, Young LH, Zarrabeitia R; HHT Foundation International - Guidelines Working Group. International guidelines for the diagnosis and management of hereditary haemorrhagic telangiectasia. J Med Genet. 2011 Feb;48(2):73-87. doi: 10.1136/jmg.2009.069013. Epub 2009 Jun 23.
PMID: 19553198
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Essen
investigator full name: Freya Droege
investigator title: Principle Investigator
mesh term: Telangiectasis
mesh term: Telangiectasia, Hereditary Hemorrhagic
sharing ipd: Undecided