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

NCT04301245 | Completed

• 1 other identifier: RETRO-ETP
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Pulmonary Rehabilitation

Keywords

Chronic Obstructive Pulmonary Disease; Pulmonary Rehabilitation; Education

Outcome Measures

Primary Outcomes (33)

• 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 Outcomes (9)

• 6-Minute Stepper Test

  2 months

• 6-Minute Walk Test

  2 months

• Saint George's Respiratory Questionnaire

  2 months

• Anxiety and depression level

  2 months

• Cognitive impairment

  2 months

Study Arms (2)

ETEP group

Exercise Training and Educational Program (ETEP) group. Patients who accepted the educational program in addition to the exercise training.

Other: Educational program

ET group

Exercise Training (ET) group. Patients who refused the educational program and did only the exercise training.

Other: Educational program

Interventions

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.

ET group; ETEP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred for pulmonary rehabilitation between July 2015 and July 2019 to ADIR Association, Rouen University Hospital, France

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ADIR Association: lead

Study Sites (1)

ADIR Association

Bois-Guillaume, France

Location

Related Publications (1)

• Smondack P, Gravier FE, Combret Y, Muir JF, Cuvelier A, Debeaumont D, Medrinal C, Prieur G, Bonnevie T. Factors influencing participation in educational workshops as part of a pulmonary rehabilitation program in patients with chronic obstructive pulmonary disease: a retrospective study. Expert Rev Respir Med. 2022 Mar;16(3):341-349. doi: 10.1080/17476348.2022.1991793. Epub 2021 Nov 2.

  PMID: 34623218 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Jean-François Muir, MD PhD

  ADIR Association, Rouen University Hospital, Rouen, France;Normandie University, UNIROUEN, UPRES EA 3830, Rouen University Hospital, Haute-Normandie Research and Biomedical Innovation, Rouen, France

  PRINCIPAL INVESTIGATOR

• Antoine Cuvelier, MD PhD

  Normandie University, Rouen University Hospital, Haute-Normandie Research and Biomedical Innovation, Rouen, France ; Pulmonary, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital, Rouen, France.

  STUDY CHAIR

• David Debeaumont, MD

  Department of Respiratory and Exercise Physiology and CICCRB 1404, Rouen University Hospital, Rouen France.

  STUDY CHAIR

• Tristan Bonnevie, PT MSc

  ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Rouen University Hospital, Haute- Normandie Research and Biomedical Innovation, Rouen, France.

  STUDY CHAIR

• Francis-Edouard Gravier, PT MSc

  ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Rouen University Hospital, Haute- Normandie Research and Biomedical Innovation, Rouen, France

  STUDY CHAIR

• Pauline Smondack, PT

  ADIR Association, Rouen University Hospital, Rouen, France.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 10, 2020
• Study Start: February 28, 2020
• Primary Completion: March 31, 2020
• Study Completion: April 10, 2020
• Last Updated: June 1, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)