Clinical trial NCT03704545: Clinical Impact of Pharmaceutical Consultations in Patients Treated for Chronic Obstructive Pulmonary Disease at Home
Official title: Clinical Impact of Pharmaceutical Consultations in Patients Treated for Chronic Obstructive Pulmonary Disease at Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Number of exacerbation events
timeFrame: Month 3
measure: Number of exacerbation events
timeFrame: Month 6
measure: Number of exacerbation events
timeFrame: Month 9
measure: Number of exacerbation events
timeFrame: Month 12
Secondary outcomes:
measure: Number of visits to the attending physician
timeFrame: Month 3
measure: Number of visits to the attending physician
timeFrame: Month 6
measure: Number of visits to the attending physician
timeFrame: Month 9
measure: Number of visits to the attending physician
timeFrame: Month 12
measure: Number of visits to the pulmonologist
timeFrame: Month 3
measure: Number of visits to the pulmonologist
timeFrame: Month 6
measure: Number of visits to the pulmonologist
timeFrame: Month 9
measure: Number of visits to the pulmonologist
timeFrame: Month 12
measure: Number of visits to the hospital emergency service
timeFrame: Month 3
measure: Number of visits to the hospital emergency service
timeFrame: Month 6
measure: Number of visits to the hospital emergency service
timeFrame: Month 9
measure: Number of visits to the hospital emergency service
timeFrame: Month 12
measure: Number of hospitalisation events
timeFrame: Month 3
measure: Number of hospitalisation events
timeFrame: Month 6
measure: Number of hospitalisation events
timeFrame: Month 9
measure: Number of hospitalisation events
timeFrame: Month 12
measure: Medication Possession Ratio
timeFrame: 12 months
measure: Usability score of devices
timeFrame: Month 3
measure: Usability score of devices
timeFrame: Month 6
measure: Usability score of devices
timeFrame: Month 9
measure: Usability score of devices
timeFrame: Month 12
measure: Quality of life questionnaire
timeFrame: Month 1
measure: Quality of life questionnaire
timeFrame: Month 6
measure: Quality of life questionnaire
timeFrame: Month 12
measure: device usage learning curve
timeFrame: 12 months
measure: satisfaction questionnaire
timeFrame: Month 12
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Nimes University Hospital
Study officials:
References: