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Completed

NCT Number: NCT03704545

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nimes University Hospital

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pharmaceutical consultation at the hospital

Other

During 20 minutes, the patient will be educated about chronic obstructive pulmonary disease treatments and their use.

Pharmaceutical consultation at the pharmacy

Other

During 20 minutes, the patient will be educated about chronic obstructive pulmonary disease treatments and their use.

Follow-up pharmaceutical consultation at the pharmacy

Other

During 10 minutes, the patient will get more information about his chronic obstructive pulmonary disease treatments and their use.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  1. Number of visits to the attending physician

    Time frame: Month 3

  2. Number of visits to the attending physician

    Time frame: Month 6

  3. Number of visits to the attending physician

    Time frame: Month 9

  4. Number of visits to the attending physician

    Time frame: Month 12

  5. Number of visits to the pulmonologist

    Time frame: Month 3

  6. Number of visits to the pulmonologist

    Time frame: Month 6

  7. Number of visits to the pulmonologist

    Time frame: Month 9

  8. Number of visits to the pulmonologist

    Time frame: Month 12

  9. Number of visits to the hospital emergency service

    Time frame: Month 3

  10. Number of visits to the hospital emergency service

    Time frame: Month 6

  11. Number of visits to the hospital emergency service

    Time frame: Month 9

  12. Number of visits to the hospital emergency service

    Time frame: Month 12

  13. Number of hospitalisation events

    Time frame: Month 3

  14. Number of hospitalisation events

    Time frame: Month 6

  15. Number of hospitalisation events

    Time frame: Month 9

  16. Number of hospitalisation events

    Time frame: Month 12

  17. Medication Possession Ratio

    Time frame: 12 months

    unit = percent

  18. Usability score of devices

    Time frame: Month 3

    Score between 0 and 3

  19. Usability score of devices

    Time frame: Month 6

    Score between 0 and 3

  20. Usability score of devices

    Time frame: Month 9

    Score between 0 and 3

  21. Usability score of devices

    Time frame: Month 12

    Score between 0 and 3

  22. 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.

  23. 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.

  24. 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.

  25. device usage learning curve

    Time frame: 12 months

  26. satisfaction questionnaire

    Time frame: Month 12

    This questionnaire is composed with 4 questions. Each item is scored in a 4 point scale.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: BPCObs

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 12, 2018
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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