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Completed

NCT Number: NCT04301245

Profile of COPD Patients Refusing Educational Program in Pulmonary Rehabilitation and Impact on the Benefits

Pulmonary rehabilitation (PR) has proven its efficacy to improve dyspnea, health status, exercise tolerance and quality of life for patients with stable Chronic Obstructive Pulmonary Disease (COPD). Exercise training has previously been thoroughly studied but education has been less studied in PR. Furthermore, only few studies have investigated the added value of an educational program (EP) to exercise training on clinical and physical factors. Characterizing those patients who refuse EP is therefore a first step to better target them and potentially improve their adherence and outcome following PR.

The aim of this study was to determine the characteristics of the COPD patients referred to PR who refused EP compare to those who accepted and to identify the independent predictive factors of refusal. The investigators also sought to compare the change in clinical outcomes and number and length of hospitalization at six months following PR among those patients who accepted or not to participate in EP.

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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 Pulmonary Rehabilitation Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ADIR Association

Bois-Guillaume, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of COPD,
  • >18 years old,
  • Stable state of COPD.

Exclusion criteria

  • Patients who have not been offered an educational program
  • Patients who have already been offered an educational program during a pulmonary rehabilitation in the same center.

Treatment and study plan

Educational program

Other

The educational program (EP) was offered during the initial session of the pulmonary rehabilitation. According to the french law, patients were free to participate or not.

The EP consisted of an educational diagnosis, educational workshops and an individual final assessment.

Primary outcomes

  1. Multiple logistic regression between the variables defined and the refusal of educational program

    Time frame: Baseline

    The variables are described below in primary outcomes

  2. Gender

    Time frame: Baseline

    Gender will be analysed in logistic regression.

  3. Age

    Time frame: Baseline

    Age will be analysed in logistic regression.

  4. Height

    Time frame: Baseline

    Height will be analysed in logistic regression.

  5. Weight

    Time frame: Baseline

    Weight will be analysed in logistic regression.

  6. Body mass index

    Time frame: Baseline

    Body mass index will be analysed in logistic regression.

  7. COPD stages

    Time frame: Baseline

    COPD stages will be analysed in logistic regression.

  8. Forced Expiratory Volume in one second

    Time frame: Baseline

    Forced Expiratory Volume in one second will be analysed in logistic regression.

  9. Forced Vital Capacity

    Time frame: Baseline

    Forced Vital Capacity will be analysed in logistic regression.

  10. Ratio between Forced Expiratory Volume in one second and Forced Vital Capacity

    Time frame: Baseline

    Ratio between Forced Expiratory Volume in one second and Forced Vital Capacity will be analysed in logistic regression.

  11. Total Lung Capacity

    Time frame: Baseline

    Total Lung Capacity will be analysed in logistic regression.

  12. Residual Volume

    Time frame: Baseline

    Residual Volume will be analysed in logistic regression.

  13. Diffusing capacity of the lungs for carbon monoxide divided by alveolar volume

    Time frame: Baseline

    Diffusing capacity of the lungs for carbon monoxide divided by alveolar volume will be analysed in logistic regression.

  14. Comorbidities

    Time frame: Baseline

    Comorbidities will be analysed in logistic regression.

  15. Tabacco status

    Time frame: Baseline

    Tabacco status will be analysed in logistic regression.

  16. Tabacco consumption

    Time frame: Baseline

    Tabacco consumption will be analysed in logistic regression.

  17. Prescription of oxygen

    Time frame: Baseline

    Prescription of oxygen will be analysed in logistic regression.

  18. Prescription of non invasive ventilation

    Time frame: Baseline

    Prescription of non invasive ventilation will be analysed in logistic regression.

  19. Arterial oxygen partial pressure

    Time frame: Baseline

    Arterial oxygen partial pressure will be analysed in logistic regression.

  20. Arterial carbon dioxide partial pressure

    Time frame: Baseline

    Arterial carbone dioxide partial pressure will be analysed in logistic regression.

  21. Location of the training sessions

    Time frame: Baseline

    Location of the training sessions will be analysed in logistic regression.

  22. Ambulance transport

    Time frame: Baseline

    Number of patients with an ambulance transport will be analysed in logistic regression.

  23. Distance between patient's home and center

    Time frame: Baseline

    Distance between patient's home and center will be analysed in logistic regression.

  24. Dyspnea

    Time frame: Baseline

    Dyspnea assessed by the modified Medical Research Council scale will be analysed in logistic regression.

  25. 6-Minute Stepper Test

    Time frame: Baseline

    Number of steps during the 6-Minute Stepper Test will be analysed in logistic regression.

  26. 6-Minute Walk Test

    Time frame: Baseline

    Distance during the 6-Minute Walk Test will be analysed in logistic regression.

  27. Maximal oxygen consumption

    Time frame: Baseline

    Maximal oxygen consumption during cardiopulmonary exercise testing will be analysed in logistic regression.

  28. Maximal workload

    Time frame: Baseline

    Maximal workload achieved during cardiopulmonary exercise testing will be analysed in logistic regression.

  29. Saint George's Respiratory Questionnaire

    Time frame: Baseline

    Quality of life assessed by Saint George's Respiratory Questionnaire will be analysed in logistic regression.

  30. Employment

    Time frame: Baseline

    Employment will be analysed in logistic regression.

  31. Educational level

    Time frame: Baseline

    Educational level assessed by the international classification "Classification Internationale Type de l'Education" will be analysed in logistic regression.

  32. Cognitive impairment

    Time frame: Baseline

    Cognitive impairment assessed by the Montreal Cognitive Assessment will be analysed in logistic regression.

  33. Anxiety and depression level

    Time frame: Baseline

    Anxiety and depression level assessed by the Hospital Anxiety and Depression scale will be analysed in logistic regression.

Secondary outcomes

  1. 6-Minute Stepper Test

    Time frame: 2 months

    Change in number of steps during the 6-Minute Stepper Test will be compared between groups.

  2. 6-Minute Walk Test

    Time frame: 2 months

    Change in distance during the 6-Minute Walk Test will be compared between groups.

  3. Saint George's Respiratory Questionnaire

    Time frame: 2 months

    Change in Saint George's Respiratory Questionnaire will be compared between groups.

  4. Anxiety and depression level

    Time frame: 2 months

    Anxiety and depression level assessed by the Hospital Anxiety and Depression scale will be analysed in logistic regression.

  5. Cognitive impairment

    Time frame: 2 months

    Change in cognitive impairment assessed by the Montreal Cognitive Assessment will be compared between groups.

  6. Number of hospitalizations

    Time frame: 6 months

    Number of hospitalizations will be compared between groups.

  7. Number of hospitalized patients

    Time frame: 6 months

    Number of hospitalized patients will be compared between groups.

  8. Number of days of hospitalization

    Time frame: 6 months

    Number of days of hospitalization will be compared between groups.

  9. Attendance rate at educational sessions

    Time frame: 2 months

    Attendance rate at education sessions will be analysed

Sponsors and collaborators

Lead sponsor

ADIR Association

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 10, 2020
Registry last updated
Jun 1, 2020

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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