RegistRare: a Retro-prospective Registry of Rare Primary Headaches in Italian Tertiary Headache Centres (RegistRare)

January 23, 2018 updated by: Silvia Benemei

RegistRare: a Retro-prospective Registry of Rare Primary Headaches in Italian Tertiary

Retro-prospective survey on specific and overall prevalence and incidence of rare primary headaches (Part One, Chapter 3 and Chapter 4, ICHD-3 beta) in patients referred to Italian Tertiary Headache Centres in a 3-year (May 1, 2014-April 30, 2017 - retrospective data) and annually (from May 1, 2017 - prospective data).

Study Overview

Status

Recruiting

Conditions

Detailed Description

We planned to collect data from May 1, 2014 and afterwards, by means of both retrospective and prospective approaches.

All patients who have received or will receive a diagnosis of rare primary headache will be asked to participate and, to this aim, to give their informed consent. Each participating Centre should have received the approval of the competent Ethics Committee before commencing any study procedures.

The registry will contain anagraphic information and data about diagnosis, treatment, comorbidity, and clinical features of the headache. Patients' data will be coded through the Italian Health System unique identifier, in order to avoid duplications of patients referring to more than one Centre and also to monitor multiple referrals.

A web-based open source platform (SurveyMonkey.org) will be used to collect data.

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

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

Study Contact

Study Locations

  • Italy
      • Florence, Italy, 50139
        • Recruiting
        • Careggi University Hospital
        • Contact:
          • Silvia Benemei, MD
        • Sub-Investigator:
          • Chiara Lupi, MD

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Retrospective data collection:

Patients referred to Italian Tertiary Headache Centres in a 3-year (May 1, 2014 to April 30, 2017) period

Prospective data collection:

Patients referred to Italian Tertiary Headache Centres after April 30, 2017

Description

Inclusion Criteria:

  • diagnosis of rare primary headaches (Part One, Chapter 3 and Chapter 4, ICHD-3 beta)
  • signed informed consent

Exclusion Criteria:

  • none

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and prevalence in Tertiary headache Centres
Time Frame: 10 years
10 years

Collaborators and Investigators

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

Sponsor

Silvia Benemei

Collaborators

University of Roma La Sapienza
University of Trieste
University of L'Aquila
University of Naples
University of Modena and Reggio Emilia
Maggiore Bellaria Hospital, Bologna

Investigators

  • Study Chair: Silvia Benemei, MD, Careggi University Hospital

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)

September 1, 2017

Primary Completion (ANTICIPATED)

August 1, 2027

Study Completion (ANTICIPATED)

August 1, 2027

Study Registration Dates

First Submitted

January 23, 2018

First Submitted That Met QC Criteria

January 23, 2018

First Posted (ACTUAL)

January 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RegistRare

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

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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