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AsthmaASTHMAVILLENCT04048746

Evaluation of the Written Information Delivered by the General Practitioner of the Patients Presenting to the Emergency Room for an Aggravation of Asthma

An observational study of Asthma, run by Fondation Hôpital Saint-Joseph at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
How many people
10 participants
Where
1 siteFrance
Study dates
24 Jul 2019to 30 Sep 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Groupe Hospitalier Paris Saint-Joseph

    Paris, 75014

Other trials in France

About this study

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.

Read more

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.

Conditions
Asthma
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04048746
Study groupRoleWhat they receive
ASTHMAThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2019
  2. Study start24 Jul 2019
  3. Primary completion30 Sep 2020
  4. Study completion30 Sep 2020

Why it stopped: The PI decided to stop.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04048746
Sponsor's protocol ID
ASTHMAVILLE
Acronym
ASTHMAVILLE
Status last verified
Sep 2020
First submitted
6 Aug 2019
Last updated
5 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by Fondation Hôpital Saint-Joseph at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The PI decided to stop.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Written action plan (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.

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