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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Pharmaceutical consultation at the pharmacy; Other: Pharmaceutical consultation at the hospital; Other: Follow-up pharmaceutical consultation at the pharmacy

• Registration Number: NCT03704545
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-10
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-12
• Study Start: 2019-01-18
• Primary Completion: 2021-10-21
• Study Completion: 2022-10-21
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-02
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group from the city	Follow-up pharmaceutical consultation at the pharmacy	-
Experimental group from the city	Pharmaceutical consultation at the pharmacy	-
Experimental group from the hospital	Pharmaceutical consultation at the hospital	-

Primary Outcome Measures

Name	Time	Method
Number of exacerbation events	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 Outcome Measures

Name	Time	Method
Medication Possession Ratio	12 months	unit = percent
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	Score between 0 and 3
satisfaction questionnaire	Month 12	This questionnaire is composed with 4 questions. Each item is scored in a 4 point scale.
Number of visits to the pulmonologist	Month 12
Number of visits to the hospital emergency service	Month 12
Quality of life questionnaire	Month 12	The quality of life questionnaire BPCO-VQ11 is composed with11 items. Each item is scored in a 5 point scale.

Trial Locations

Locations (1)

Nimes University Hospital; 🇫🇷 Nîmes, France