Frequency of Common Medical Conditions in People With and Without HHT

NCT02464644 | Completed

• 1 other identifier: CLS/2012/2
• Study Type: interventional
• Target: 2,174
• Locations: 1 country
• Sites: 1

Brief Summary

Hereditary Hemorrhagic Telangiectasia (HHT) affects 1 in 5,000 people. The purpose of this study is to provide data regarding the frequency of common health conditions and the tolerability of therapies in HHT by using a questionnaire. This will be filled in by both people with HHT, and controls who will be members of the general population without HHT. The questionnaire has been designed primarily for web based entry, but can also be circulated in paper format on request

Conditions

Hereditary Hemorrhagic Telangiectasia (HHT)

Keywords

On-line Questionnaire; No travel; Health; Medicines; Drugs; Lifestyle; Family; Help for others; Rare condition; General population

Outcome Measures

Primary Outcomes (1)

• Prevalence of nosebleeds.

  The data outcome will be captured at the time of reporting by study participants, indicating the % of respondents affected by nosebleeds at that time. Subsequent calculations will standardise for age and other participant variables.

  Day 1

Secondary Outcomes (1)

• Efficacy of nosebleed treatments

  Day 1

Study Arms (2)

People with HHT

EXPERIMENTAL

People with HHT will identify themselves within the questionnaire, first by statement of what they think is their diagnosis, and second by provision of the HHT diagnostic criteria within specific questions. They will be directed to appropriate questions, according to answers to the previous questions.

Other: Questionnaire

Controls without HHT

OTHER

People without HHT will identify themselves within the questionnaire, first by statement of what they think is their diagnosis, and second by provision of the HHT diagnostic criteria within specific questions. They will be directed to appropriate questions, according to answers to the previous questions.

Other: Questionnaire

Interventions

Questionnaire OTHER

To capture large sufficiently large numbers of individuals for appropriate statistical power (see below), a web based questionnaire design was considered the most appropriate tool. SurveyMonkey was identified as the most suitable means to generate the questionnaire, facilitate confidential answers by the target populations, and for analysis of questionnaire data. The designed survey can also be presented in paper format, and used in our clinical service.

Also known as: Survey, Confidential, SurveyMonkey SSL encryption feature, Web-link collector does not collect IP addresses

Controls without HHT; People with HHT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or over.
• Capacity to fill in a questionnaire.

You may not qualify if:

• Age under 18
• Unable to fill in a questionnaire

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

NHLI Cardiovascular Sciences, Imperial College London

London, SL9 0QR, United Kingdom

Location

Related Publications (10)

• Silva BM, Hosman AE, Devlin HL, Shovlin CL. Lifestyle and dietary influences on nosebleed severity in hereditary hemorrhagic telangiectasia. Laryngoscope. 2013 May;123(5):1092-9. doi: 10.1002/lary.23893. Epub 2013 Feb 12.

  PMID: 23404156 RESULT

• Devlin HL, Hosman AE, Shovlin CL. Antiplatelet and anticoagulant agents in hereditary hemorrhagic telangiectasia. N Engl J Med. 2013 Feb 28;368(9):876-8. doi: 10.1056/NEJMc1213554. No abstract available.

  PMID: 23445111 RESULT

• Finnamore H, Le Couteur J, Hickson M, Busbridge M, Whelan K, Shovlin CL. Hemorrhage-adjusted iron requirements, hematinics and hepcidin define hereditary hemorrhagic telangiectasia as a model of hemorrhagic iron deficiency. PLoS One. 2013 Oct 16;8(10):e76516. doi: 10.1371/journal.pone.0076516. eCollection 2013.

  PMID: 24146883 RESULT

• Hosman AE, Devlin HL, Silva BM, Shovlin CL. Specific cancer rates may differ in patients with hereditary haemorrhagic telangiectasia compared to controls. Orphanet J Rare Dis. 2013 Dec 20;8:195. doi: 10.1186/1750-1172-8-195.

  PMID: 24354965 RESULT

• Elphick A, Shovlin CL. Relationships between epistaxis, migraines, and triggers in hereditary hemorrhagic telangiectasia. Laryngoscope. 2014 Jul;124(7):1521-8. doi: 10.1002/lary.24526. Epub 2014 Jan 23.

  PMID: 24458873 RESULT

• Shovlin CL, Awan I, Cahilog Z, Abdulla FN, Guttmacher AE. Reported cardiac phenotypes in hereditary hemorrhagic telangiectasia emphasize burdens from arrhythmias, anemia and its treatments, but suggest reduced rates of myocardial infarction. Int J Cardiol. 2016 Jul 15;215:179-85. doi: 10.1016/j.ijcard.2016.04.006. Epub 2016 Apr 7.

  PMID: 27116331 RESULT

• Patel T, Elphick A, Jackson JE, Shovlin CL. Injections of Intravenous Contrast for Computerized Tomography Scans Precipitate Migraines in Hereditary Hemorrhagic Telangiectasia Subjects at Risk of Paradoxical Emboli: Implications for Right-to-Left Shunt Risks. Headache. 2016 Nov;56(10):1659-1663. doi: 10.1111/head.12963. Epub 2016 Oct 11.

  PMID: 27727478 RESULT

• Shovlin CL, Patel T, Jackson JE. Embolisation of PAVMs reported to improve nosebleeds by a subgroup of patients with hereditary haemorrhagic telangiectasia. ERJ Open Res. 2016 Apr 29;2(2):00035-2016. doi: 10.1183/23120541.00035-2016. eCollection 2016 Apr.

  PMID: 27730189 RESULT

• Shovlin CL, Gilson C, Busbridge M, Patel D, Shi C, Dina R, Abdulla FN, Awan I. Can Iron Treatments Aggravate Epistaxis in Some Patients With Hereditary Hemorrhagic Telangiectasia? Laryngoscope. 2016 Nov;126(11):2468-2474. doi: 10.1002/lary.25959. Epub 2016 Apr 23.

  PMID: 27107394 RESULT

• Hosman AE, Shovlin CL. Cancer and hereditary haemorrhagic telangiectasia. J Cancer Res Clin Oncol. 2017 Feb;143(2):369-370. doi: 10.1007/s00432-016-2298-x. Epub 2016 Nov 11.

  PMID: 27837281 RESULT

MeSH Terms

Conditions

Telangiectasia, Hereditary Hemorrhagic

Interventions

Surveys and Questionnaires; Confidentiality

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Telangiectasis; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Forensic Psychiatry; Psychiatry; Behavioral Sciences; Behavioral Disciplines and Activities; Patient Rights; Human Rights; Social Control, Formal; Health Care Economics and Organizations; Jurisprudence

Study Officials

• Claire L Shovlin, PhD MB BChir FRCP

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: June 8, 2015
• Study Start: April 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)