Clinical Impact of Pharmaceutical Consultations in Patients Treated for Chronic Obstructive Pulmonary Disease at Home

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2020

Interventions

  • Other: Pharmaceutical consultation at the hospital
    • During 20 minutes, the patient will be educated about chronic obstructive pulmonary disease treatments and their use.
  • Other: Pharmaceutical consultation at the pharmacy
    • During 20 minutes, the patient will be educated about chronic obstructive pulmonary disease treatments and their use.
  • Other: Follow-up pharmaceutical consultation at the pharmacy
    • During 10 minutes, the patient will get more information about his chronic obstructive pulmonary disease treatments and their use.

Arms, Groups and Cohorts

  • No Intervention: Control group
  • Experimental: Experimental group from the hospital
  • Experimental: Experimental group from the city

Clinical Trial Outcome Measures

Primary Measures

  • Number of exacerbation events
    • Time Frame: Month 3
    • Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence.
  • Number of exacerbation events
    • Time Frame: Month 6
    • Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence.
  • Number of exacerbation events
    • Time Frame: Month 9
    • Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence.
  • 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 Measures

  • Number of visits to the attending physician
    • Time Frame: Month 3
  • Number of visits to the attending physician
    • Time Frame: Month 6
  • Number of visits to the attending physician
    • Time Frame: Month 9
  • Number of visits to the attending physician
    • Time Frame: Month 12
  • Number of visits to the pulmonologist
    • Time Frame: Month 3
  • Number of visits to the pulmonologist
    • Time Frame: Month 6
  • Number of visits to the pulmonologist
    • Time Frame: Month 9
  • Number of visits to the pulmonologist
    • Time Frame: Month 12
  • Number of visits to the hospital emergency service
    • Time Frame: Month 3
  • Number of visits to the hospital emergency service
    • Time Frame: Month 6
  • Number of visits to the hospital emergency service
    • Time Frame: Month 9
  • Number of visits to the hospital emergency service
    • Time Frame: Month 12
  • Number of hospitalisation events
    • Time Frame: Month 3
  • Number of hospitalisation events
    • Time Frame: Month 6
  • Number of hospitalisation events
    • Time Frame: Month 9
  • Number of hospitalisation events
    • Time Frame: Month 12
  • Medication Possession Ratio
    • Time Frame: 12 months
    • unit = percent
  • Usability score of devices
    • Time Frame: Month 3
    • Score between 0 and 3
  • Usability score of devices
    • Time Frame: Month 6
    • Score between 0 and 3
  • Usability score of devices
    • Time Frame: Month 9
    • Score between 0 and 3
  • Usability score of devices
    • Time Frame: Month 12
    • Score between 0 and 3
  • Quality of life questionnaire
    • Time Frame: Month 1
    • The quality of life questionnaire BPCO-VQ11 is composed of 11 items. Each item is scored in a 5 point scale.
  • Quality of life questionnaire
    • Time Frame: Month 6
    • The quality of life questionnaire BPCO-VQ11 is composed of 11 items. Each item is scored in a 5 point scale.
  • Quality of life questionnaire
    • Time Frame: Month 12
    • The quality of life questionnaire BPCO-VQ11 is composed with11 items. Each item is scored in a 5 point scale.
  • device usage learning curve
    • Time Frame: 12 months
  • satisfaction questionnaire
    • Time Frame: Month 12
    • This questionnaire is composed with 4 questions. Each item is scored in a 4 point scale.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Nīmes
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Jean-Marie KINOWSKI, +33(0)4.66.68.31.04, jean.marie.kinowski@chu-nimes.fr

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