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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 4

Conditions: Hereditary Angioedema

Treatments: Other: phone to the call center

Study type: Interventional

Funder types: Other

Identifiers

NCT01679912

2012-A00044-39 (Other Identifier)

P110109

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

1: phone to call center

Experimental group

Description:

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

Treatment:

Other: phone to the call center

2: usual strategy

No Intervention group

Description:

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