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Clinical Trials/NCT03704545
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

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.

Registry
clinicaltrials.gov
Start Date
January 18, 2019
End Date
October 21, 2021
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

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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