Clinical trial NCT04301245: Profile of COPD Patients Refusing Educational Program in Pulmonary Rehabilitation and Impact on the Benefits
Official title: Profile of COPD Patients Refusing Educational Program in Pulmonary Rehabilitation and Impact on the Benefits
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Pulmonary Rehabilitation
Keywords: Chronic Obstructive Pulmonary Disease
Pulmonary Rehabilitation
Education
Lead sponsor: ADIR Association
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Multiple logistic regression between the variables defined and the refusal of educational program
timeFrame: Baseline
measure: Gender
timeFrame: Baseline
measure: Age
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Body mass index
timeFrame: Baseline
measure: COPD stages
timeFrame: Baseline
measure: Forced Expiratory Volume in one second
timeFrame: Baseline
measure: Forced Vital Capacity
timeFrame: Baseline
measure: Ratio between Forced Expiratory Volume in one second and Forced Vital Capacity
timeFrame: Baseline
measure: Total Lung Capacity
timeFrame: Baseline
measure: Residual Volume
timeFrame: Baseline
measure: Diffusing capacity of the lungs for carbon monoxide divided by alveolar volume
timeFrame: Baseline
measure: Comorbidities
timeFrame: Baseline
measure: Tabacco status
timeFrame: Baseline
measure: Tabacco consumption
timeFrame: Baseline
measure: Prescription of oxygen
timeFrame: Baseline
measure: Prescription of non invasive ventilation
timeFrame: Baseline
measure: Arterial oxygen partial pressure
timeFrame: Baseline
measure: Arterial carbon dioxide partial pressure
timeFrame: Baseline
measure: Location of the training sessions
timeFrame: Baseline
measure: Ambulance transport
timeFrame: Baseline
measure: Distance between patient's home and center
timeFrame: Baseline
measure: Dyspnea
timeFrame: Baseline
measure: 6-Minute Stepper Test
timeFrame: Baseline
measure: 6-Minute Walk Test
timeFrame: Baseline
measure: Maximal oxygen consumption
timeFrame: Baseline
measure: Maximal workload
timeFrame: Baseline
measure: Saint George's Respiratory Questionnaire
timeFrame: Baseline
measure: Employment
timeFrame: Baseline
measure: Educational level
timeFrame: Baseline
measure: Cognitive impairment
timeFrame: Baseline
measure: Anxiety and depression level
timeFrame: Baseline
Secondary outcomes:
measure: 6-Minute Stepper Test
timeFrame: 2 months
measure: 6-Minute Walk Test
timeFrame: 2 months
measure: Saint George's Respiratory Questionnaire
timeFrame: 2 months
measure: Anxiety and depression level
timeFrame: 2 months
measure: Cognitive impairment
timeFrame: 2 months
measure: Number of hospitalizations
timeFrame: 6 months
measure: Number of hospitalized patients
timeFrame: 6 months
measure: Number of days of hospitalization
timeFrame: 6 months
measure: Attendance rate at educational sessions
timeFrame: 2 months
Other outcomes:
Locations:
city: Bois-Guillaume
country: France
facility: ADIR Association
Study officials:
affiliation: ADIR Association, Rouen University Hospital, Rouen, France;Normandie University, UNIROUEN, UPRES EA 3830, Rouen University Hospital, Haute-Normandie Research and Biomedical Innovation, Rouen, France
name: Jean-François Muir, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: 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.
name: Antoine Cuvelier, MD PhD
role: STUDY_CHAIR
affiliation: Department of Respiratory and Exercise Physiology and CICCRB 1404, Rouen University Hospital, Rouen France.
name: David Debeaumont, MD
role: STUDY_CHAIR
affiliation: ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Rouen University Hospital, Haute- Normandie Research and Biomedical Innovation, Rouen, France.
name: Tristan Bonnevie, PT MSc
role: STUDY_CHAIR
affiliation: ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Rouen University Hospital, Haute- Normandie Research and Biomedical Innovation, Rouen, France
name: Francis-Edouard Gravier, PT MSc
role: STUDY_CHAIR
affiliation: ADIR Association, Rouen University Hospital, Rouen, France.
name: Pauline Smondack, PT
role: STUDY_CHAIR
References:
citation: 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.