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Completed

NCT Number: NCT03099915

Asthma Attack in the Emergency Department : Reasons Of This Attendance

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'accueil des urgences Hôpital Beaujon, Clichy, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

completion of self-reported questionnaires

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Olivier CHASSANY

Other

Collaborators

  • Beaujon Hospital
  • Bichat Hospital
  • EA 7334, Patient-Centered Outcomes Research

Registry information

Acronym: AERO

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 4, 2017
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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