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:
Assistance Publique - Hôpitaux de Paris
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
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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 May 19, 2013