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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01679912
First received: August 21, 2012
Last updated: December 12, 2016
Last verified: December 2016

August 21, 2012
December 12, 2016
March 2013
September 2016   (Final data collection date for primary outcome measure)
Number of hospital admissions for angioedema attack- no (%) [ Time Frame: at 2 years ]
Percentage of patients hospitalized per year for an observation period of two years at 2 years [ Time Frame: at 2 years ]
Number of patients hospitalized per year for an observation period of two years [Time Frame : 2 years]
Complete list of historical versions of study NCT01679912 on ClinicalTrials.gov Archive Site
  • Number of ICU admissions - no (%) [ Time Frame: at 2 years ]
  • Number of ED admissions - no (%) [ Time Frame: at 2 years ]
  • Number of hospital admissions for others causes - no (%) [ Time Frame: at 2 years ]
  • Number of intubations - no (%) [ Time Frame: at 2 years ]
  • Number of EMS interventions - no (%) [ Time Frame: at 2 years ]
  • Number of working days lost [ Time Frame: at 2 years ]
  • Mortality - no (%) [ Time Frame: at 2 years ]
  • Mortality for angioedema attack- no (%) [ Time Frame: at 2 years ]
  • Cost of angioedema attacks [ Time Frame: at 2 years ]
  • Number of hospitalizations per year in intensive care unit [Time Frame : 2 years] [ Time Frame: at 2 years ]
    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 ]
  • Number of hospitalizations [Time Frame : 2 years] [ Time Frame: at 2 years ]
  • Number of intubations per year [Time Frame : 2 years] [ Time Frame: at 2 years ]
  • Number of interventions of Emergency Medical System [Time Frame : 2 years] [ Time Frame: at 2 years ]
  • Number of stop disease and duration [Time Frame : 2 years] [ Time Frame: at 2 years ]
  • Mortality [Time Frame : 2 years] [ Time Frame: at 2 years ]
  • Cost of the hospitalization [ Time Frame: at 2 years ]
    total cost : cost of one hospitalization x number of hospitalization
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
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)
Javaud N, Fain O, Durand-Zaleski I, Launay D, Bouillet L, Gompel A, Sobel A, Woimant M, Rabetrano H, Petrovic T, Lapostolle F, Boccon-Gibod I, Reuter PG, Bertrand P, Coppere B, Floccard B, Kanny G, Martin L, Vicaut E, Adnet F. Dedicated call center (SOS-HAE) for hereditary angioedema attacks: study protocol for a randomised controlled trial. Trials. 2016 Apr 30;17(1):225. doi: 10.1186/s13063-016-1350-0.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
September 2016
September 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01679912
P110109
2012-A00044-39 ( Other Identifier: IDRCB )
Yes
Not Provided
Not Provided
Not Provided
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
December 2016

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