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

Chronic Obstructive Pulmonary Disease Clinical Trial

— BPCObs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03704545
• Other study ID #: NIMAO/2017-03/JMK-01
• Status: Completed
• Phase: N/A
• Start date: January 18, 2019
• Est. completion date: October 21, 2022

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: October 21, 2022
• Est. primary completion date: October 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Pharmaceutical consultation at the hospital
During 20 minutes, the patient will be educated about chronic obstructive pulmonary disease treatments and their use.
• Pharmaceutical consultation at the pharmacy
During 20 minutes, the patient will be educated about chronic obstructive pulmonary disease treatments and their use.
• 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.

Locations

Country	Name	City	State
France	Nimes University Hospital	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of exacerbation events	Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence.	Month 3
Primary	Number of exacerbation events	Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence.	Month 6
Primary	Number of exacerbation events	Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence.	Month 9
Primary	Number of exacerbation events	Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence.	Month 12
Secondary	Number of visits to the attending physician		Month 3
Secondary	Number of visits to the attending physician		Month 6
Secondary	Number of visits to the attending physician		Month 9
Secondary	Number of visits to the attending physician		Month 12
Secondary	Number of visits to the pulmonologist		Month 3
Secondary	Number of visits to the pulmonologist		Month 6
Secondary	Number of visits to the pulmonologist		Month 9
Secondary	Number of visits to the pulmonologist		Month 12
Secondary	Number of visits to the hospital emergency service		Month 3
Secondary	Number of visits to the hospital emergency service		Month 6
Secondary	Number of visits to the hospital emergency service		Month 9
Secondary	Number of visits to the hospital emergency service		Month 12
Secondary	Number of hospitalisation events		Month 3
Secondary	Number of hospitalisation events		Month 6
Secondary	Number of hospitalisation events		Month 9
Secondary	Number of hospitalisation events		Month 12
Secondary	Medication Possession Ratio	unit = percent	12 months
Secondary	Usability score of devices	Score between 0 and 3	Month 3
Secondary	Usability score of devices	Score between 0 and 3	Month 6
Secondary	Usability score of devices	Score between 0 and 3	Month 9
Secondary	Usability score of devices	Score between 0 and 3	Month 12
Secondary	Quality of life questionnaire	The quality of life questionnaire BPCO-VQ11 is composed of 11 items. Each item is scored in a 5 point scale.	Month 1
Secondary	Quality of life questionnaire	The quality of life questionnaire BPCO-VQ11 is composed of 11 items. Each item is scored in a 5 point scale.	Month 6
Secondary	Quality of life questionnaire	The quality of life questionnaire BPCO-VQ11 is composed with11 items. Each item is scored in a 5 point scale.	Month 12
Secondary	device usage learning curve		12 months
Secondary	satisfaction questionnaire	This questionnaire is composed with 4 questions. Each item is scored in a 4 point scale.	Month 12