Asthma Attack in the Emergency Department : Reasons Of This Attendance

NCT ID: NCT03099915

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 182 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-17
• Study Completion Date: 2019-12-31

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.

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.

Conditions

Asthma Attack; Emergency Medicine

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EA 7334, Patient-Centered Outcomes Research

UNKNOWN

Sponsor Role: collaborator

Bichat Hospital

OTHER

Sponsor Role: collaborator

Beaujon Hospital

OTHER

Sponsor Role: collaborator

Olivier CHASSANY

OTHER

Sponsor Role: lead

Responsible Party

Olivier CHASSANY

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Olivier CHASSANY, MD, PhD

Role: STUDY_DIRECTOR

EA 7334, University Paris-Diderot, Paris

Prabakar VAITTINADA AYAR, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Bichat-Claude Bernard

Enrique CASALINO, MD

Role: STUDY_CHAIR

Hôpital Bichat-Claude Bernard

Locations

Service d'accueil des urgences Hôpital Beaujon

Clichy, , France

Service d'acceuil des urgences hôpital Bichat- Claude Bernard

Paris, , France

Countries

France

Other Identifiers

AERO

Identifier Type: -

Identifier Source: org_study_id