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

Primary Purpose

Hereditary Angioedema

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
phone to the call center
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hereditary Angioedema focused on measuring Hereditary angioedema, Emergency Medical Service, Health care coast, Telephone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SAMU 93 - Hôpital Avicenne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1: phone to call center

2: usual strategy

Arm Description

recommendations to phone to the call center for all the patients who have an acute attack

usual strategy. No intervention (patients does not change their practice)

Outcomes

Primary Outcome Measures

Number of hospital admissions for angioedema attack- no (%)

Secondary Outcome Measures

Number of ICU admissions - no (%)
Number of ED admissions - no (%)
Number of hospital admissions for others causes - no (%)
Number of intubations - no (%)
Number of EMS interventions - no (%)
Number of working days lost
Mortality - no (%)
Mortality for angioedema attack- no (%)
Cost of angioedema attacks

Full Information

First Posted
August 21, 2012
Last Updated
December 12, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01679912
Brief Title
A Call Center During HAE Attacks (SOS HAE)
Acronym
SOS AOH
Official Title
Hereditary Angioedema : Interest From the Use of a Call Center During the Attacks.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Angioedema
Keywords
Hereditary angioedema, Emergency Medical Service, Health care coast, Telephone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: phone to call center
Arm Type
Experimental
Arm Description
recommendations to phone to the call center for all the patients who have an acute attack
Arm Title
2: usual strategy
Arm Type
No Intervention
Arm Description
usual strategy. No intervention (patients does not change their practice)
Intervention Type
Other
Intervention Name(s)
phone to the call center
Intervention Description
recommendations to phone to the call center for all the patients who have an acute attack
Primary Outcome Measure Information:
Title
Number of hospital admissions for angioedema attack- no (%)
Time Frame
at 2 years
Secondary Outcome Measure Information:
Title
Number of ICU admissions - no (%)
Time Frame
at 2 years
Title
Number of ED admissions - no (%)
Time Frame
at 2 years
Title
Number of hospital admissions for others causes - no (%)
Time Frame
at 2 years
Title
Number of intubations - no (%)
Time Frame
at 2 years
Title
Number of EMS interventions - no (%)
Time Frame
at 2 years
Title
Number of working days lost
Time Frame
at 2 years
Title
Mortality - no (%)
Time Frame
at 2 years
Title
Mortality for angioedema attack- no (%)
Time Frame
at 2 years
Title
Cost of angioedema attacks
Time Frame
at 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric ADNET, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
SAMU 93 - Hôpital Avicenne
City
Bobigny
State/Province
Ile de France
ZIP/Postal Code
93000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
31109849
Citation
Javaud N, Altar A, Fain O, Reuter PG, Desmaizieres M, Petrovic T, Ghazali A, Durand-Zaleski I, Bouillet L, Vicaut E, Launay D, Martin L, Floccard B, Gompel A, Sobel A, Boccon-Gibod I, Kanny G, Lapostolle F, Adnet F. Hereditary angioedema, emergency management of attacks by a call center. Eur J Intern Med. 2019 Sep;67:42-46. doi: 10.1016/j.ejim.2019.05.007. Epub 2019 May 18.
Results Reference
derived
PubMed Identifier
29503044
Citation
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, Mezaour M, Coppere B, Floccard B, Kanny G, Baker E, Martin L, Vicaut E, Adnet F. Specialist Advice Support for Management of Severe Hereditary Angioedema Attacks: A Multicenter Cluster-Randomized Controlled Trial. Ann Emerg Med. 2018 Aug;72(2):194-203.e1. doi: 10.1016/j.annemergmed.2018.01.053. Epub 2018 Mar 2.
Results Reference
derived
PubMed Identifier
27140403
Citation
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.
Results Reference
derived

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A Call Center During HAE Attacks (SOS HAE)

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