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
  Purpose

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.


Condition Intervention Phase
Hereditary Angioedema
Other: phone to the call center
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hereditary Angioedema : Interest From the Use of a Call Center During the Attacks.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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]


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 200
Study Start Date: March 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679912

Contacts
Contact: Frédéric ADNET, MD,PhD 33 (0)1 48 96 44 08 frederic.adnet@avc.aphp.fr

Locations
France
SAMU 93 - Hôpital Avicenne Recruiting
Bobigny, Ile de France, France, 93000
Principal Investigator: Frédéric ADNET, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Frédéric ADNET, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01679912     History of Changes
Other Study ID Numbers: P110109, 2012-A00044-39
Study First Received: August 21, 2012
Last Updated: April 30, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Hereditary angioedema
Emergency Medical Service
Health care coast
Telephone

Additional relevant MeSH terms:
Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on April 17, 2014