Hereditary Haemorrhagic TelangiectasiaNCT03841422
Evaluation of Video-assisted Instructions of Nasal Self-packing in Patients with HHT
An observational study of Hereditary Haemorrhagic Telangiectasia, run by University Hospital, Essen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hereditary Haemorrhagic Telangiectasia
- What is being tested?
- video-assisted nasal self-packing
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 30 Jan 2019to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hereditary hemorrhagic telangiectasia who often suffer from recurrent nosebleeds
Who may be able to join
- age above 17 years old
Who cannot join
- patients younger than 18 years old
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hereditary Haemorrhagic Telangiectasia
- Being tested
- video-assisted nasal self-packing
- Keywords
- hereditary hemorrhagic telangiectasia, video-assisted teaching, nasal self-packing
- Medical subject headings
- Telangiectasia, Hereditary Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video-assisted nasal self-packingProcedure or surgery
video-assisted nasal self-packing
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start30 Jan 2019
- Primary completion1 Jul 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hereditary Haemorrhagic TelangiectasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Freya Droege, University Hospital, Essen
- Investigators
- Freya Droege, Dr. med., Principal investigator, University Hospital, EssenFreya Droege, Dr. med., Study chair, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841422
- Sponsor's protocol ID
- Nasal self-packing in HHT
- Status last verified
- Dec 2024
- First submitted
- 12 Feb 2019
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 10751092Droege 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.
PubMed 30739126Faughnan 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.
PubMed 19553198
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Video-assisted Instructions of Nasal Self-packing in Patients with Hereditary Hemorrhagic Telangiectasia (HHT)
- ClinicalTrials.gov ID
- NCT03841422
- Acronym / sponsor ID
- Nasal self-packing in HHT
- Conditions
- Hereditary Haemorrhagic Telangiectasia
- Keywords
- hereditary hemorrhagic telangiectasia, video-assisted teaching, nasal self-packing
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hereditary hemorrhagic telangiectasia who often suffer from recurrent nosebleeds
Key inclusion criteria (1 listed)
- age above 17 years old
Key exclusion criteria (2 listed)
- patients younger than 18 years old
- unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| video-assisted nasal self-packingvideo-assisted nasal self-packing | Procedure or surgery | – |
Primary outcome
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.
1 secondary outcome
Analyzing duration of consultation
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Background: PubMed 10751092Shovlin 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.
- Background: PubMed 30739126Droege 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.
- Background: PubMed 19553198Faughnan 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.
- video about using nasal self-packingsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Freya Droege, Dr. med. principal investigator
University Hospital, Essen
Freya Droege, Dr. med. study chair
University Hospital, Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hereditary Haemorrhagic Telangiectasia, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of video-assisted teaching (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03841422, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.