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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation

Intervention / Treatment
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* Other: Educational program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ETEP group<br>Exercise Training and Educational Program (ETEP) group. Patients who accepted the educational program in addition to the exercise training. | Other: Educational program<br>* 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.<br>|
| ET group<br>Exercise Training (ET) group. Patients who refused the educational program and did only the exercise training. | Other: Educational program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple logistic regression between the variables defined and the refusal of educational program | The variables are described below in primary outcomes | Baseline | 
| Gender | Gender will be analysed in logistic regression. | Baseline | 
| Age | Age will be analysed in logistic regression. | Baseline | 
| Height | Height will be analysed in logistic regression. | Baseline | 
| Weight | Weight will be analysed in logistic regression. | Baseline | 
| Body mass index | Body mass index will be analysed in logistic regression. | Baseline | 
| COPD stages | COPD stages will be analysed in logistic regression. | Baseline | 
| Forced Expiratory Volume in one second | Forced Expiratory Volume in one second will be analysed in logistic regression. | Baseline | 
| Forced Vital Capacity | Forced Vital Capacity will be analysed in logistic regression. | Baseline | 
| Ratio between Forced Expiratory Volume in one second and Forced Vital Capacity | Ratio between Forced Expiratory Volume in one second and Forced Vital Capacity will be analysed in logistic regression. | Baseline | 
| Total Lung Capacity | Total Lung Capacity will be analysed in logistic regression. | Baseline | 
| Residual Volume | Residual Volume will be analysed in logistic regression. | Baseline | 
| Diffusing capacity of the lungs for carbon monoxide divided by alveolar volume | Diffusing capacity of the lungs for carbon monoxide divided by alveolar volume will be analysed in logistic regression. | Baseline | 
| Comorbidities | Comorbidities will be analysed in logistic regression. | Baseline | 
| Tabacco status | Tabacco status will be analysed in logistic regression. | Baseline | 
| Tabacco consumption | Tabacco consumption will be analysed in logistic regression. | Baseline | 
| Prescription of oxygen | Prescription of oxygen will be analysed in logistic regression. | Baseline | 
| Prescription of non invasive ventilation | Prescription of non invasive ventilation will be analysed in logistic regression. | Baseline | 
| Arterial oxygen partial pressure | Arterial oxygen partial pressure will be analysed in logistic regression. | Baseline | 
| Arterial carbon dioxide partial pressure | Arterial carbone dioxide partial pressure will be analysed in logistic regression. | Baseline | 
| Location of the training sessions | Location of the training sessions will be analysed in logistic regression. | Baseline | 
| Ambulance transport | Number of patients with an ambulance transport will be analysed in logistic regression. | Baseline | 
| Distance between patient's home and center | Distance between patient's home and center will be analysed in logistic regression. | Baseline | 
| Dyspnea | Dyspnea assessed by the modified Medical Research Council scale will be analysed in logistic regression. | Baseline | 
| 6-Minute Stepper Test | Number of steps during the 6-Minute Stepper Test will be analysed in logistic regression. | Baseline | 
| 6-Minute Walk Test | Distance during the 6-Minute Walk Test will be analysed in logistic regression. | Baseline | 
| Maximal oxygen consumption | Maximal oxygen consumption during cardiopulmonary exercise testing will be analysed in logistic regression. | Baseline | 
| Maximal workload | Maximal workload achieved during cardiopulmonary exercise testing will be analysed in logistic regression. | Baseline | 
| Saint George's Respiratory Questionnaire | Quality of life assessed by Saint George's Respiratory Questionnaire will be analysed in logistic regression. | Baseline | 
| Employment | Employment will be analysed in logistic regression. | Baseline | 
| Educational level | Educational level assessed by the international classification Classification Internationale Type de l'Education will be analysed in logistic regression. | Baseline | 
| Cognitive impairment | Cognitive impairment assessed by the Montreal Cognitive Assessment will be analysed in logistic regression. | Baseline | 
| Anxiety and depression level | Anxiety and depression level assessed by the Hospital Anxiety and Depression scale will be analysed in logistic regression. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-Minute Stepper Test | Change in number of steps during the 6-Minute Stepper Test will be compared between groups. | 2 months | 
| 6-Minute Walk Test | Change in distance during the 6-Minute Walk Test will be compared between groups. | 2 months | 
| Saint George's Respiratory Questionnaire | Change in Saint George's Respiratory Questionnaire will be compared between groups. | 2 months | 
| Anxiety and depression level | Anxiety and depression level assessed by the Hospital Anxiety and Depression scale will be analysed in logistic regression. | 2 months | 
| Cognitive impairment | Change in cognitive impairment assessed by the Montreal Cognitive Assessment will be compared between groups. | 2 months | 
| Number of hospitalizations | Number of hospitalizations will be compared between groups. | 6 months | 
| Number of hospitalized patients | Number of hospitalized patients will be compared between groups. | 6 months | 
| Number of days of hospitalization | Number of days of hospitalization will be compared between groups. | 6 months | 
| Attendance rate at educational sessions | Attendance rate at education sessions will be analysed | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation, Education