A Call Center During HAE Attacks (SOS HAE)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hereditary Angioedema : Interest From the Use of a Call Center During the Attacks.

Conditions
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Hereditary Angioedema

Intervention / Treatment
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* Other: phone to the call center


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1: phone to call center<br>recommendations to phone to the call center for all the patients who have an acute attack | Other: phone to the call center<br>* recommendations to phone to the call center for all the patients who have an acute attack<br>|
| No Intervention: 2: usual strategy<br>usual strategy. No intervention (patients does not change their practice) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospital admissions for angioedema attack- no (%) |  | at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ICU admissions - no (%) |  | at 2 years | 
| Number of ED admissions - no (%) |  | at 2 years | 
| Number of hospital admissions for others causes - no (%) |  | at 2 years | 
| Number of intubations - no (%) |  | at 2 years | 
| Number of EMS interventions - no (%) |  | at 2 years | 
| Number of working days lost |  | at 2 years | 
| Mortality - no (%) |  | at 2 years | 
| Mortality for angioedema attack- no (%) |  | at 2 years | 
| Cost of angioedema attacks |  | at 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telephone, Hereditary angioedema, Emergency Medical Service, Health care coast