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
  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 2016
Estimated Primary Completion Date: March 2016 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 30, 2014
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 August 28, 2014