A Call Center During HAE Attacks (SOS HAE) (SOS AOH)

December 12, 2016 updated by: Assistance Publique - Hôpitaux de Paris

Hereditary Angioedema : Interest From the Use of a Call Center During the Attacks.

This clinical trial aims to compare morbidity and cost associated with acute attacks of hereditary angioedema in patients with an intervention based on a support after a phone call to the call center (SOS HAE) from a group of patients does not change their practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Investigators propose a study to determine whether a call center for an acute attack of HAE associated with intervention recommendations based on systematic early treatment (self-administration at home or by a caregiver) would reduce the morbidity and the socioeconomic impact.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

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

  • France
    • Ile de France
      • Bobigny, Ile de France, France, 93000
        • SAMU 93 - Hôpital Avicenne

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with an hereditary angioedema followed in a reference center for bradykinin angioedema (CRéAk)
  • Patient's age ≥ 18 years
  • Consent to the participation in the study
  • Affiliated to social security

Exclusion Criteria:

  • pregnant woman
  • recent history of myocardial infarction
  • recent history of stroke
  • allergy to icatibant or C1 inhibitor concentrate

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1: phone to call center
recommendations to phone to the call center for all the patients who have an acute attack
Other: phone to the call center
recommendations to phone to the call center for all the patients who have an acute attack
No Intervention: 2: usual strategy
usual strategy. No intervention (patients does not change their practice)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of hospital admissions for angioedema attack- no (%)
Time Frame: at 2 years
at 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of ICU admissions - no (%)
Time Frame: at 2 years
at 2 years
Number of ED admissions - no (%)
Time Frame: at 2 years
at 2 years
Number of hospital admissions for others causes - no (%)
Time Frame: at 2 years
at 2 years
Number of intubations - no (%)
Time Frame: at 2 years
at 2 years
Number of EMS interventions - no (%)
Time Frame: at 2 years
at 2 years
Number of working days lost
Time Frame: at 2 years
at 2 years
Mortality - no (%)
Time Frame: at 2 years
at 2 years
Mortality for angioedema attack- no (%)
Time Frame: at 2 years
at 2 years
Cost of angioedema attacks
Time Frame: at 2 years
at 2 years

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Frédéric ADNET, MD,PhD, Assistance Publique - Hopitaux de Paris

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

March 1, 2013

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

August 21, 2012

First Submitted That Met QC Criteria

September 3, 2012

First Posted (Estimate)

September 6, 2012

Study Record Updates

Last Update Posted (Estimate)

December 13, 2016

Last Update Submitted That Met QC Criteria

December 12, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P110109
  • 2012-A00044-39 (Other Identifier: IDRCB)

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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