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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Rehabilitation
• Interventions: Other: Educational program

• Registration Number: NCT04301245
• Lead Sponsor: ADIR Association

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-28
• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-10
• Primary Completion: 2020-03-31
• Study Completion: 2020-04-10
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-29
• Last Update Posted: 2020-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ETEP group	Educational program	Exercise Training and Educational Program (ETEP) group. Patients who accepted the educational program in addition to the exercise training.
ET group	Educational program	Exercise Training (ET) group. Patients who refused the educational program and did only the exercise training.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ADIR Association; 🇫🇷 Bois-Guillaume, France