Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03099915
Other study ID # AERO
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04021771 - Trial of Simulation-based Mastery Learning to Communicate Diagnostic Uncertainty N/A
Not yet recruiting NCT06372379 - Development of a Multipurpose Dashboard to Monitor the Situation of Emergency Departments
Not yet recruiting NCT06354764 - Propensity to Hospitalize Patients From the ED in European Centers.
Completed NCT05870137 - Assessing Mixed Reality for Emergency Medical Care Delivery in a Simulated Environment N/A
Completed NCT05073406 - Cognition at Altitude in HEMS - Part II N/A
Completed NCT03457272 - Development and Evaluation of a Patient Safety Model N/A
Completed NCT04138446 - Effects of Acute Hypobaric Hypoxia Exposure on Neurocognitive Performance of Pre-hospital Emergency Service Providers N/A
Completed NCT02661607 - Point of Care Echocardiography Versus Chest Radiography for the Assessment of Central Venous Catheter Placement N/A
Recruiting NCT05937763 - ED Adaptive Staffing Study
Completed NCT03848559 - Airway Management With Simulated Microgravity Using a Submerged Model N/A
Completed NCT04328519 - The Charlson Comorbidity Index: Predicting Severity in Emergency Departments
Completed NCT03314480 - REDucing Unnecessary Computed Tomography Imaging for MaxillOfacial INjury
Enrolling by invitation NCT05809648 - A Study to Assess the Accuracy of Magnetocardiography (MCG) to Diagnose True Ischemia in Patients With Chest Pain in the ED
Completed NCT04206566 - Pre-hospital Advanced Airway Management Studying Expedited Routines
Completed NCT03733158 - Flexible Tip Bougie Catheter Intubation N/A
Completed NCT03420027 - Prehospital and Emergency Feasibility of MACOCHA Score Assessment to Predict Difficult Tracheal Intubation
Recruiting NCT03486171 - Tracheal Intubation and Prehospital Emergency Setting
Not yet recruiting NCT06240572 - Development of a Natural Language Processing Tool to Enable Clinical Research in Emergency Medicine
Completed NCT00448331 - Facilitated Referral for Children Screening Positive for Mental Illness Phase 0
Completed NCT04460196 - Healthcare Renunciation During the Confinement Period in Connection With the COVID-19 Epidemic in Adult Emergency Departments