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

This study is currently recruiting participants.

Verified March 2013 by Assistance Publique - Hôpitaux de Paris

Sponsor:

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT01679912

First received: August 21, 2012

Last updated: April 30, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 21, 2012

Last Updated Date

April 30, 2013

Start Date ^ICMJE

March 2013

Estimated Primary Completion Date

March 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percentage of patients hospitalized per year for an observation period of two years at 2 years [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]

Number of patients hospitalized per year for an observation period of two years [Time Frame : 2 years]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01679912 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of hospitalizations per year in intensive care unit [Time Frame : 2 years] [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
Number of hospitalizations per year in intensive care unit [Time Frame : 2 years]
Number of emergency departments visits per year [Time Frame : 2 years] [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
Number of hospitalizations [Time Frame : 2 years] [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
Number of intubations per year [Time Frame : 2 years] [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
Number of interventions of Emergency Medical System [Time Frame : 2 years] [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
Number of stop disease and duration [Time Frame : 2 years] [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
Mortality [Time Frame : 2 years] [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
Cost of the hospitalization [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
total cost : cost of one hospitalization x number of hospitalization

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Call Center During HAE Attacks (SOS HAE)

Official Title ^ICMJE

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

Brief Summary

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.

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 ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hereditary Angioedema

Intervention ^ICMJE

Other: phone to the call center

recommendations to phone to the call center for all the patients who have an acute attack

Study Arm (s)

Experimental: 1: phone to call center
recommendations to phone to the call center for all the patients who have an acute attack

Intervention: Other: phone to the call center
No Intervention: 2: usual strategy
usual strategy. No intervention (patients does not change their practice)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

September 2015

Estimated Primary Completion Date

March 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Frédéric ADNET, MD,PhD

33 (0)1 48 96 44 08

frederic.adnet@avc.aphp.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01679912

Other Study ID Numbers ^ICMJE

P110109, 2012-A00044-39

Has Data Monitoring Committee

Yes

Responsible Party

Assistance Publique - Hôpitaux de Paris

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Frédéric ADNET, MD,PhD

Assistance Publique - Hôpitaux de Paris

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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