NCT03099915

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

March 17, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

2 years

First QC Date

March 17, 2017

Last Update Submit

April 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • GHQ-12 Psychometric tool

    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

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults visiting emergency department for asthma attack

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service d'accueil des urgences Hôpital Beaujon

Clichy, 92110, France

Location

Service d'acceuil des urgences hôpital Bichat- Claude Bernard

Paris, 75018, France

Location

Study Officials

  • Olivier CHASSANY, MD, PhD

    EA 7334, University Paris-Diderot, Paris

    STUDY DIRECTOR
  • Prabakar VAITTINADA AYAR, MD

    Hôpital Bichat-Claude Bernard

    PRINCIPAL INVESTIGATOR
  • Enrique CASALINO, MD

    Hôpital Bichat-Claude Bernard

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

March 17, 2017

First Posted

April 4, 2017

Study Start

March 17, 2017

Primary Completion

March 30, 2019

Study Completion

December 31, 2019

Last Updated

April 27, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations