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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04301245
• Other study ID #: RETRO-ETP
• Status: Completed
• Start date: February 28, 2020
• Est. completion date: April 10, 2020

Study information

• Verified date: May 2020
• Source: ADIR Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: April 10, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Educational program
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.

Locations

Country	Name	City	State
France	ADIR Association	Bois-Guillaume

Sponsors (1)

Lead Sponsor	Collaborator
ADIR Association

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multiple logistic regression between the variables defined and the refusal of educational program	The variables are described below in primary outcomes	Baseline
Primary	Gender	Gender will be analysed in logistic regression.	Baseline
Primary	Age	Age will be analysed in logistic regression.	Baseline
Primary	Height	Height will be analysed in logistic regression.	Baseline
Primary	Weight	Weight will be analysed in logistic regression.	Baseline
Primary	Body mass index	Body mass index will be analysed in logistic regression.	Baseline
Primary	COPD stages	COPD stages will be analysed in logistic regression.	Baseline
Primary	Forced Expiratory Volume in one second	Forced Expiratory Volume in one second will be analysed in logistic regression.	Baseline
Primary	Forced Vital Capacity	Forced Vital Capacity will be analysed in logistic regression.	Baseline
Primary	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
Primary	Total Lung Capacity	Total Lung Capacity will be analysed in logistic regression.	Baseline
Primary	Residual Volume	Residual Volume will be analysed in logistic regression.	Baseline
Primary	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
Primary	Comorbidities	Comorbidities will be analysed in logistic regression.	Baseline
Primary	Tabacco status	Tabacco status will be analysed in logistic regression.	Baseline
Primary	Tabacco consumption	Tabacco consumption will be analysed in logistic regression.	Baseline
Primary	Prescription of oxygen	Prescription of oxygen will be analysed in logistic regression.	Baseline
Primary	Prescription of non invasive ventilation	Prescription of non invasive ventilation will be analysed in logistic regression.	Baseline
Primary	Arterial oxygen partial pressure	Arterial oxygen partial pressure will be analysed in logistic regression.	Baseline
Primary	Arterial carbon dioxide partial pressure	Arterial carbone dioxide partial pressure will be analysed in logistic regression.	Baseline
Primary	Location of the training sessions	Location of the training sessions will be analysed in logistic regression.	Baseline
Primary	Ambulance transport	Number of patients with an ambulance transport will be analysed in logistic regression.	Baseline
Primary	Distance between patient's home and center	Distance between patient's home and center will be analysed in logistic regression.	Baseline
Primary	Dyspnea	Dyspnea assessed by the modified Medical Research Council scale will be analysed in logistic regression.	Baseline
Primary	6-Minute Stepper Test	Number of steps during the 6-Minute Stepper Test will be analysed in logistic regression.	Baseline
Primary	6-Minute Walk Test	Distance during the 6-Minute Walk Test will be analysed in logistic regression.	Baseline
Primary	Maximal oxygen consumption	Maximal oxygen consumption during cardiopulmonary exercise testing will be analysed in logistic regression.	Baseline
Primary	Maximal workload	Maximal workload achieved during cardiopulmonary exercise testing will be analysed in logistic regression.	Baseline
Primary	Saint George's Respiratory Questionnaire	Quality of life assessed by Saint George's Respiratory Questionnaire will be analysed in logistic regression.	Baseline
Primary	Employment	Employment will be analysed in logistic regression.	Baseline
Primary	Educational level	Educational level assessed by the international classification "Classification Internationale Type de l'Education" will be analysed in logistic regression.	Baseline
Primary	Cognitive impairment	Cognitive impairment assessed by the Montreal Cognitive Assessment will be analysed in logistic regression.	Baseline
Primary	Anxiety and depression level	Anxiety and depression level assessed by the Hospital Anxiety and Depression scale will be analysed in logistic regression.	Baseline
Secondary	6-Minute Stepper Test	Change in number of steps during the 6-Minute Stepper Test will be compared between groups.	2 months
Secondary	6-Minute Walk Test	Change in distance during the 6-Minute Walk Test will be compared between groups.	2 months
Secondary	Saint George's Respiratory Questionnaire	Change in Saint George's Respiratory Questionnaire will be compared between groups.	2 months
Secondary	Anxiety and depression level	Anxiety and depression level assessed by the Hospital Anxiety and Depression scale will be analysed in logistic regression.	2 months
Secondary	Cognitive impairment	Change in cognitive impairment assessed by the Montreal Cognitive Assessment will be compared between groups.	2 months
Secondary	Number of hospitalizations	Number of hospitalizations will be compared between groups.	6 months
Secondary	Number of hospitalized patients	Number of hospitalized patients will be compared between groups.	6 months
Secondary	Number of days of hospitalization	Number of days of hospitalization will be compared between groups.	6 months
Secondary	Attendance rate at educational sessions	Attendance rate at education sessions will be analysed	2 months