Frequency of Common Medical Conditions in People With and Without HHT

September 25, 2023 updated by: Imperial College London

A Questionnaire Study on Hereditary Hemorrhagic Telangiectasia (HHT) and Other Medical Conditions, Compared to the General Population

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hereditary Hemorrhagic Telangiectasia (HHT) affects 1 in 5,000 people, usually causing nosebleeds, skin blood spots, and/or anemia as a result of bleeding from the nose or gut. The majority of people with HHT also have abnormal blood vessels (arteriovenous malformations) in internal organs such as the lungs, liver and brain. Management of this multisystem disorder is highly challenging.

The Lead Applicant has spent 20 years working on this rare disease, and identified multiple areas where more evidence is required to assist clinicians and patients with this lifelong condition. A particular issue is what happens when people with HHT have other common medical conditions such as asthma, cancer, diabetes, or heart disease. Do they have the same pattern of problems as the general population? Can they use the same drugs? Are further safeguards needed? For these important questions, current advice can only be based on theoretical considerations and anecdotal data.

The ultimate goal of this study is to use information derived from a questionnaire to provide evidence to assist clinicians treating people with HHT.

Data will be entered from April 2012. Data will be analysed on average 6-8 months after entry.

Study Type

Interventional

Enrollment (Actual)

2174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SL9 0QR
        • NHLI Cardiovascular Sciences, Imperial College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Age under 18
  • Unable to fill in a questionnaire

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: People with HHT

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
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.
Other Names:
  • Survey
  • Confidential
  • SurveyMonkey SSL encryption feature
  • Web-link collector does not collect IP addresses
Other: Controls without HHT

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
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.
Other Names:
  • Survey
  • Confidential
  • SurveyMonkey SSL encryption feature
  • Web-link collector does not collect IP addresses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of nosebleeds.
Time Frame: Day 1
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of nosebleed treatments
Time Frame: Day 1
The data outcome will be captured at the time of reporting by study participants, indicating the % of respondents reporting beneficial, null or detrimental effects from nosebleed treatments. Subsequent calculations will standardise for age and other participant variables.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Principal Investigator: Claire L Shovlin, PhD MB BChir FRCP, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

April 30, 2012

First Submitted That Met QC Criteria

June 3, 2015

First Posted (Estimated)

June 8, 2015

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLS/2012/2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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