Status:
UNKNOWN
Clinical and Medico-economic Validation of the HEPHAI Solution.
Lead Sponsor:
Hephai
Conditions:
Asthma COPD
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In a context where the use of inhalation devices for respiratory medications is associated with a high frequency of critical errors, our primary hypothesis is that the use of the HEPHAÏ solution reduc...
Detailed Description
The proper use of inhalation devices is crucial to relieving asthma and COPD symptoms and preventing exacerbations of these diseases. The improper use of these devices is currently considered a major ...
Eligibility Criteria
Inclusion
- Patient at least 18 years of age
- Patient followed in pulmonology for Asthma and/or COPD with implementation and/or follow-up of treatment with Innovair® or Trimbow®,
- Patient affiliated to a Social Security scheme,
- Patient with a hardware support allowing the operation of HEPHAÏ: smartphone, tablet, desktop or laptop computer with graphical interface, video, sound and a high-speed connection at the place of use.
Exclusion
- Patient previously enrolled in another interventional clinical study,
- Adult patients who are subject to a legal protection measure (guardianship, judicial safeguard, psychiatric care or deprived of liberty by judicial or administrative decision),
- Patient with at least one sensory, visual or tactile impairment, preventing the correct use of a smartphone, tablet and/or computer or preventing the correct performance of the exercise safely,
- Patient with a cognitive impairment, severely limiting their ability to concentrate and thus preventing the correct use of a smartphone, tablet and/or computer,
- Patient cared for by a specialized team of education, therapeutic for his asthma or COPD follow-up (e.g. asthma school, asthma referent IDE),
- Patient who does not understand French,
- Patient with an inhalation chamber prescription associated with their inhalation device prescription.
Key Trial Info
Start Date :
September 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT06099145
Start Date
September 19 2023
End Date
September 30 2024
Last Update
October 25 2023
Active Locations (5)
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1
CHU de Dijon
Dijon, France, 21079
2
Hôpital Arnaud de Villeneuve
Montpellier, France, 34090
3
Pitié-Salpêtrière Hospital
Paris, France, 75011
4
Hôpital COCHIN
Paris, France, 75014