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

Evaluation of Video-assisted Instructions of Nasal Self-packing in Patients With Hereditary Hemorrhagic Telangiectasia (HHT)

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.

Study Overview

• Status: Recruiting
• Conditions: Hereditary Haemorrhagic Telangiectasia
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Freya Droege, Dr. med.; Phone Number: 2971 +49201723; Email: freya.droege@uk-essen.de
• Study Contact Backup: Name: Jan Bosch, Dr. med.; Phone Number: 2971 +49201723; Email: jan.bosch@uk-essen.de

Study Locations

• Germany
  • Nordrhein Westphalen
    • Essen, Nordrhein Westphalen, Germany, 45122
      • Recruiting
      • University Hospital Essen
      • Contact: Freya Droege, Dr. med.; Phone Number: 2971 +49201723; Email: freya.droege@uk-essen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with hereditary hemorrhagic telangiectasia who often suffer from recurrent nosebleeds

Description

Inclusion Criteria:

• age above 17 years old

Exclusion Criteria:

• patients younger than 18 years old
• unable to provide informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of video-assisted teaching	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analyzing duration of consultation	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	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Essen
• Investigators: Principal Investigator: Freya Droege, Dr. med., University Hospital, Essen; Study Chair: Freya Droege, Dr. med., University Hospital, Essen

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• video about using nasal self-packings

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2019
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 12, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: hereditary hemorrhagic telangiectasia; video-assisted teaching; nasal self-packing
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Cardiovascular Abnormalities; Vascular Malformations; Telangiectasis; Telangiectasia, Hereditary Hemorrhagic
• Other Study ID Numbers: Nasal self-packing in HHT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No