NCT04048746

Brief Summary

Asthma is a common pathology (prevalence 6.4% in 2018, in France), currently managed by the general practitioner in general practice. It is a chronic disease at risk of exacerbation, which can lead to the use of care. The treatment of asthma is based on a basic treatment, to be taken every day, the purpose of which is to avoid acute exacerbations and lead a normal life. There is also an emergency treatment, to be taken in case of sudden worsening of the respiratory state. The asthmatic patient is the first actor in his care. He must be able to react in case of emergency. A good knowledge of the disease and its treatment as well as training in self-management of crises are thus fundamental and must be part of its medical care. The existence of an exacerbation represents a criterion of non-control of the disease, thus a failure of the long-term care of the patient. The optimization of this care includes individual issues aimed at improving the quality of life and collective by reducing the avoidable use of care and thus the expenses related to this disease. It relies on therapeutic education sessions as well as the provision of written information, clear and detailed by the doctor. This information consists of the writing of a detailed medication prescription as well as the dispensing of a written action plan. The action plan must describe the actions to be taken by the patient in case of exacerbation of his asthma, to regain control. Regarding the format, it can be coupled to the prescription drug (action plan and prescription on the same prescription) or distinct from the prescription drug (a prescription for drugs and a prescription for the action plan). In some countries, "ready-to-use" action plans have been validated by learned societies, which is not the case today in France. In Canada, a study demonstrated in 2006 that 46% of asthmatic patients followed in hospital had an action plan, while the national average was estimated at about 10% in 2010. There is little data in France on the proportion of patients with asthma action plans. Unlike the action plan, which is little distributed to the patient, the prescription drug for asthma is always given to the patient at the end of the consultation and specifies the procedures for taking treatments. As part of this work, the investigators are interested in evaluating the written information given to the adult asthmatic patient by their general practitioner: the action plan but also the prescription medication.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 24, 2019

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

1.2 years

First QC Date

August 6, 2019

Last Update Submit

September 30, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Written action plan

    This oucome measure the percentage of included patients who have received a written action plan from their general practitioner who follows them for their asthma regardless of the format (separate or part of the same prescription as the prescription drug).

    Day 1

Study Arms (1)

ASTHMA

The patient presents to the emergency department for an aggravation of his asthma. The patient later sees an emergency investigator for medical care for his aggravation of asthma. When the patient's condition is stabilized, the investigator checks his eligibility for study and offers to participate. If the patient agrees, the investigator gives him the questionnaire and possibly helps to fill it out. When the investigator returns to see the patient for a reassessment of his condition, he retrieves the completed questionnaire. He verifies that the patient has completed the questionnaire. Prescriptions and action plans are retrieved by the principal investigator either in digitized format from the patient's computerized medical record or in paper format. Each medication prescription and each action plan are read by the principal investigator and evaluated according to the grids.

Eligibility Criteria

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

Asthma patient consulting the Emergencies of the GHPSJ for the management of a worsening of his asthma

You may qualify if:

  • Patient whose age is ≥ 18 years
  • Asthma patient
  • Emergency Patient Counselor for GHPSJ for management of worsening asthma
  • Patient followed for his asthma in town by a general practitioner
  • Francophone patient

You may not qualify if:

  • Patient opposing his participation in the study
  • Patient under tutorship or curatorship
  • Patient deprived of liberty
  • Patient under safeguard of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Sergio Salmeron, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2019

First Posted

August 7, 2019

Study Start

July 24, 2019

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

October 5, 2020

Record last verified: 2020-09

Locations