Clinical Trial: A Call Center During HAE Attacks (SOS HAE)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Number of hospital admissions for angioedema attack- no (%) [ Time Frame: at 2 years ]

Original Primary Outcome: 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]


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • 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


Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: August 21, 2012
Date Started: March 2013
Date Completion:
Last Updated: December 12, 2016
Last Verified: December 2016