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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pharmaceutical consultation at the hospital
Pharmaceutical consultation at the pharmacy
Follow-up pharmaceutical consultation at the pharmacy
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nimes University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control group

Experimental group from the hospital

Experimental group from the city

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
October 10, 2018
Last Updated
January 2, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT03704545
Brief Title
Clinical Impact of Pharmaceutical Consultations in Patients Treated for Chronic Obstructive Pulmonary Disease at Home
Acronym
BPCObs
Official Title
Clinical Impact of Pharmaceutical Consultations in Patients Treated for Chronic Obstructive Pulmonary Disease at Home
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 18, 2019 (Actual)
Primary Completion Date
October 21, 2021 (Actual)
Study Completion Date
October 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Title
Experimental group from the hospital
Arm Type
Experimental
Arm Title
Experimental group from the city
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Pharmaceutical consultation at the hospital
Intervention Description
During 20 minutes, the patient will be educated about chronic obstructive pulmonary disease treatments and their use.
Intervention Type
Other
Intervention Name(s)
Pharmaceutical consultation at the pharmacy
Intervention Description
During 20 minutes, the patient will be educated about chronic obstructive pulmonary disease treatments and their use.
Intervention Type
Other
Intervention Name(s)
Follow-up pharmaceutical consultation at the pharmacy
Intervention Description
During 10 minutes, the patient will get more information about his chronic obstructive pulmonary disease treatments and their use.
Primary Outcome Measure Information:
Title
Number of exacerbation events
Description
Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence.
Time Frame
Month 3
Title
Number of exacerbation events
Description
Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence.
Time Frame
Month 6
Title
Number of exacerbation events
Description
Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence.
Time Frame
Month 9
Title
Number of exacerbation events
Description
Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence.
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
Number of visits to the attending physician
Time Frame
Month 3
Title
Number of visits to the attending physician
Time Frame
Month 6
Title
Number of visits to the attending physician
Time Frame
Month 9
Title
Number of visits to the attending physician
Time Frame
Month 12
Title
Number of visits to the pulmonologist
Time Frame
Month 3
Title
Number of visits to the pulmonologist
Time Frame
Month 6
Title
Number of visits to the pulmonologist
Time Frame
Month 9
Title
Number of visits to the pulmonologist
Time Frame
Month 12
Title
Number of visits to the hospital emergency service
Time Frame
Month 3
Title
Number of visits to the hospital emergency service
Time Frame
Month 6
Title
Number of visits to the hospital emergency service
Time Frame
Month 9
Title
Number of visits to the hospital emergency service
Time Frame
Month 12
Title
Number of hospitalisation events
Time Frame
Month 3
Title
Number of hospitalisation events
Time Frame
Month 6
Title
Number of hospitalisation events
Time Frame
Month 9
Title
Number of hospitalisation events
Time Frame
Month 12
Title
Medication Possession Ratio
Description
unit = percent
Time Frame
12 months
Title
Usability score of devices
Description
Score between 0 and 3
Time Frame
Month 3
Title
Usability score of devices
Description
Score between 0 and 3
Time Frame
Month 6
Title
Usability score of devices
Description
Score between 0 and 3
Time Frame
Month 9
Title
Usability score of devices
Description
Score between 0 and 3
Time Frame
Month 12
Title
Quality of life questionnaire
Description
The quality of life questionnaire BPCO-VQ11 is composed of 11 items. Each item is scored in a 5 point scale.
Time Frame
Month 1
Title
Quality of life questionnaire
Description
The quality of life questionnaire BPCO-VQ11 is composed of 11 items. Each item is scored in a 5 point scale.
Time Frame
Month 6
Title
Quality of life questionnaire
Description
The quality of life questionnaire BPCO-VQ11 is composed with11 items. Each item is scored in a 5 point scale.
Time Frame
Month 12
Title
device usage learning curve
Time Frame
12 months
Title
satisfaction questionnaire
Description
This questionnaire is composed with 4 questions. Each item is scored in a 4 point scale.
Time Frame
Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Nimes University Hospital
City
Nîmes
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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