NCT03704545
Completed
Not Applicable
Clinical Impact of Pharmaceutical Consultations in Patients Treated for Chronic Obstructive Pulmonary Disease at Home
Centre Hospitalier Universitaire de Nīmes1 site in 1 country174 target enrollmentJanuary 18, 2019
ConditionsChronic Obstructive Pulmonary Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Enrollment
- 174
- Locations
- 1
- Primary Endpoint
- Number of exacerbation events
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
The implementation of pharmaceutical consultations in the city or at the hospital could modify the occurrence of exacerbations related to chronic obstructive pulmonary disease after return of the patient to his home.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient has signed the consent form.
- •The patient is affiliated to a health insurance programme
- •The patient is at least 18 years old (≥).
- •The patient is admitted to complete hospitalization (for patients in the "Hospital and Control" groups).
- •The patient is diagnosed with stage 2 to 4 Chronic Obstructive Pulmonary Disease. The diagnosis as well as the stage of the disease are validated by a pulmonologist at the facility.
- •The patient has one or more inhaler devices to treat Chronic Obstructive Pulmonary Disease.
- •The patient returns to his / her home when discharged from hospital (for patients in the "Hospital and Control" groups).
- •The patient is available for a follow-up of 12 months.
Exclusion Criteria
- •The subject participates in another interventional study.
- •The subject is in an exclusion period determined by a previous study.
- •The patient is under safeguard of justice.
- •The subject refuses to sign the consent.
- •It is not possible to give the patient (or his/her trusted-person) informed information.
Outcomes
Primary Outcomes
Number of exacerbation events
Time Frame: Month 12
Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence.
Secondary Outcomes
- Medication Possession Ratio(12 months)
- Number of visits to the attending physician(Month 12)
- device usage learning curve(12 months)
- Number of hospitalisation events(Month 12)
- Usability score of devices(Month 12)
- satisfaction questionnaire(Month 12)
- Number of visits to the pulmonologist(Month 12)
- Number of visits to the hospital emergency service(Month 12)
- Quality of life questionnaire(Month 12)
Study Sites (1)
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