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Asthma Attack in the Emergency Department : Reasons Of This Attendance (AERO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099915
Recruitment Status : Unknown
Verified May 2018 by Olivier CHASSANY, University Paris 7 - Denis Diderot.
Recruitment status was:  Recruiting
First Posted : April 4, 2017
Last Update Posted : May 3, 2018
Sponsor:
Collaborators:
EA 7334, Patient-Centered Outcomes Research
Bichat Hospital
Beaujon Hospital
Information provided by (Responsible Party):
Olivier CHASSANY, University Paris 7 - Denis Diderot

Brief Summary:

Objective: Identify modifiable factors that may affect asthma control and the use of emergency room to define customized interventions for the management of asthma prior to emergency room.

Emergency department attendance is always a sign of poor balance or control of asthma. In spite of a decrease in the number of deaths that has been halved in 20 years and hospitalization due to asthmatic disease, the use of emergency center for this disease has not decreased. We now know that the passage through emergencies and hospitalization for aggravation of asthma is in itself a factor of mortality. Acting on the determinants of poor balance or control of asthma is essential to further reduce the mortality and morbidity of asthma.


Condition or disease Intervention/treatment
Asthma Attack Emergency Medicine Other: completion of self-reported questionnaires

Detailed Description:

There is two parts in this study:

Part 1 - Qualitative study by individual interviews until data saturation (although about ten patients should be enough to capture the concepts of interest) on the factors that induce an imbalance of asthma (based on the GINA (Global Initiative for Asthma) report whose criteria are validated).

An interview guide will be written to systematically address all aspects related to asthma control.

In agreement with the patient the interview will be recorded, and the verbatim will be transcribed and coded using a software (Nvivo version 10).

Preparation of a questionnaire

A questionnaire will be developed from:

  • analysis of patient verbatim
  • other data: GINA criteria, psychological criteria (psychological distress is assessed by the 12-item general health questionnaire (GHQ-12) which is valid psychometric tools in French) and social criteria.

Part 2-Observational cohort qualitative study. The questionnaire thus prepared will be placed in the patient file upon admission. As soon as possible it will be filled by the patient after improvement of his condition and collected by the doctor or nurse who took care of the patient.

To obtain sufficient power to demonstrate significant associations, and assuming that 15 variables are taken into account in a multivariate model and based on the recommendations of 10 subjects per variable, 150 patients are required.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Asthma Attack in the Emergency Department : Reasons Of This Attendance
Actual Study Start Date : March 17, 2017
Estimated Primary Completion Date : October 17, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma


Intervention Details:
  • Other: completion of self-reported questionnaires
    Single completion: Participants will have to complete self-reported questionnaires based on gina criteria and 12-item general health questionnaire


Primary Outcome Measures :
  1. Poor observance of GINA criteria [ Time Frame: Less than 24 hours: the outcome measure will be assessed the visiting day at emergency room, when the asthma attack will be solved, before discharge from hospital ]
    Explanation of Asthma imbalance by poor observance and knowledge of GINA global strategy for asthma management and prevention criteria.


Secondary Outcome Measures :
  1. GHQ-12 Psychometric tool [ Time Frame: Less than 24 hours: the outcome measure will be assessed the visiting day at emergency room, when the asthma attack will be solved, before discharge from hospital ]
    Psychological distress caused by asthma will be measured by general health questionnaire



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults visiting emergency department for asthma attack
Criteria

Inclusion Criteria:

  • Age> 18 years
  • Ambulatory patient, visiting one of these centers
  • Diagnosis of asthma already evolving for more than 6 months
  • Prescription of treatment for more than 3 months
  • Patient who can read and write French
  • Agreement for an individual interview (Part 1) or fill up a self-questionnaire (Part 2)
  • Health insurance coverage

Exclusion Criteria:

  • Patients with other etiology that may explain their dyspnea: heart failure, chronic obstructive pulmonary disease , pneumopathy
  • Patients with a social background that is not compatible with the study: a patient who does not speak French, is homeless or does not have a telephone number
  • Inpatients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099915


Contacts
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Contact: Prabakar VAITTINADA AYAR, MD 685923498 ext +33(0) pvaittinada@gmail.com

Locations
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France
Service d'accueil des urgences Hôpital Beaujon Recruiting
Clichy, France, 92110
Contact: Prabakar VAITTINADA AYAR, MD    685923498 ext +33(0)    pvaittinada@gmail.com   
Principal Investigator: Prabakar VAITTINADA AYAR, MD         
Service d'acceuil des urgences hôpital Bichat- Claude Bernard Recruiting
Paris, France, 75018
Contact: Prabakar VAITTINADA AYAR, MD    685923498 ext +33(0)    pvaittinada@gmail.com   
Principal Investigator: Prabakar VAITTINADA AYAR, MD         
Sponsors and Collaborators
Olivier CHASSANY
EA 7334, Patient-Centered Outcomes Research
Bichat Hospital
Beaujon Hospital
Investigators
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Study Director: Olivier CHASSANY, MD, PhD EA 7334, University Paris-Diderot, Paris
Principal Investigator: Prabakar VAITTINADA AYAR, MD Hôpital Bichat-Claude Bernard
Study Chair: Enrique CASALINO, MD Hôpital Bichat-Claude Bernard
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Responsible Party: Olivier CHASSANY, Director, University Paris 7 - Denis Diderot
ClinicalTrials.gov Identifier: NCT03099915    
Other Study ID Numbers: AERO
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Emergencies
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes