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Evaluation of Video-assisted Instructions of Nasal Self-packing in Patients With HHT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03841422
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
Freya Droege, University Hospital, Essen

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Hereditary Haemorrhagic Telangiectasia Procedure: video-assisted nasal self-packing

Detailed Description:
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.
Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Video-assisted Instructions of Nasal Self-packing in Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Procedure: video-assisted nasal self-packing
    video-assisted nasal self-packing

Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of video-assisted teaching [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Analyzing duration of consultation [ Time Frame: 1 year ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hereditary hemorrhagic telangiectasia who often suffer from recurrent nosebleeds
Criteria

Inclusion Criteria:

  • age above 17 years old

Exclusion Criteria:

  • patients younger than 18 years old
  • unable to provide informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841422


Contacts
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Contact: Freya Droege, Dr. med. +49201723 ext 2971 freya.droege@uk-essen.de
Contact: Jan Bosch, Dr. med. +49201723 ext 2971 jan.bosch@uk-essen.de

Locations
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Germany
University Hospital Essen Recruiting
Essen, Nordrhein Westphalen, Germany, 45122
Contact: Freya Droege, Dr. med.    +49201723 ext 2971    freya.droege@uk-essen.de   
Sponsors and Collaborators
University Hospital, Essen
Investigators
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Principal Investigator: Freya Droege, Dr. med. University Hospital, Essen
Study Chair: Freya Droege, Dr. med. University Hospital, Essen
More Information
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Additional Information:

Publications:

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Responsible Party: Freya Droege, Principle Investigator, University Hospital, Essen
ClinicalTrials.gov Identifier: NCT03841422    
Other Study ID Numbers: Nasal self-packing in HHT
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Freya Droege, University Hospital, Essen:
hereditary hemorrhagic telangiectasia
video-assisted teaching
nasal self-packing
Additional relevant MeSH terms:
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Telangiectasis
Telangiectasia, Hereditary Hemorrhagic
Vascular Diseases
Cardiovascular Diseases
Hemostatic Disorders
 Hemorrhagic Disorders
Hematologic Diseases
Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities