Asthma Attack in the Emergency Department : Reasons Of This Attendance

Emergency Medicine Clinical Trial

— AERO  

Official title:

Asthma Attack in the Emergency Department : Reasons Of This Attendance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03099915
• Other study ID #: AERO
• Status: Completed
• Start date: March 17, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2021
• Source: University Paris 7 - Denis Diderot
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: December 31, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma Attack
• Emergencies
• Emergency Medicine

Intervention

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

Locations

Country	Name	City	State
France	Service d'accueil des urgences Hôpital Beaujon	Clichy
France	Service d'acceuil des urgences hôpital Bichat- Claude Bernard	Paris

Sponsors (4)

Lead Sponsor	Collaborator
Olivier CHASSANY	Beaujon Hospital, Bichat Hospital, EA 7334, Patient-Centered Outcomes Research

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Poor observance of GINA criteria	Explanation of Asthma imbalance by poor observance and knowledge of GINA global strategy for asthma management and prevention criteria.	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
Secondary	GHQ-12 Psychometric tool	Psychological distress caused by asthma will be measured by general health questionnaire	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