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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 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: May 30, 2014
Last verified: April 2014

August 21, 2012
May 30, 2014
March 2013
March 2016   (final data collection date for primary outcome measure)
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]
Same as current
Complete list of historical versions of study NCT01679912 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Call Center During HAE Attacks (SOS HAE)
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hereditary Angioedema
Other: phone to the call center
recommendations to phone to the call center for all the patients who have an acute attack
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
September 2016
March 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Frédéric ADNET, MD,PhD 33 (0)1 48 96 44 08 frederic.adnet@avc.aphp.fr
France
 
NCT01679912
P110109, 2012-A00044-39
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Frédéric ADNET, MD,PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
April 2014

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