Chronic Obstructive Pulmonary DiseaseNCT04301245

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

An observational study of Chronic Obstructive Pulmonary Disease and Pulmonary Rehabilitation, run by ADIR Association at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation
What is being tested?: Educational program
How many people: 201 participants
Where: 1 siteFrance
Study dates: 28 Feb 2020to 10 Apr 2020
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

France1 site

ADIR Association
Bois-Guillaume

Other trials in France

About this study

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
Being tested: Educational program
Keywords: Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation, Education
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Educational programOther
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.

Study groups in NCT04301245
Study group	Role	What they receive
ETEP group		Exercise Training and Educational Program (ETEP) group. Patients who accepted the educational program in addition to the exercise training. Receives: Other: Educational program
ET group		Exercise Training (ET) group. Patients who refused the educational program and did only the exercise training. Receives: Other: Educational program

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (9)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Feb 202010 Apr 2020

First posted10 Mar 2020
Study start28 Feb 2020
Primary completion31 Mar 2020
Study completion10 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 201 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04301245
Sponsor's protocol ID: RETRO-ETP
Status last verified: May 2020
First submitted: 6 Mar 2020
Last updated: 1 Jun 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 34623218

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
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Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
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All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Profile of COPD Patients Refusing Educational Program in Pulmonary Rehabilitation and Impact on the Benefits
ClinicalTrials.gov ID: NCT04301245
Acronym / sponsor ID: RETRO-ETP
Conditions: Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation
Keywords: Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation, Education
Study type: Observational
Recruitment status: Completed
Enrolment: 201 participants (actual)
Lead sponsor: ADIR AssociationUniversity, hospital or other
Study start: 28 Feb 2020 (actual)
Primary completion: 31 Mar 2020 (actual)
Study completion: 10 Apr 2020 (actual)
First posted: 10 Mar 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
ETEP group	–	Other: Educational programExercise Training and Educational Program (ETEP) group. Patients who accepted the educational program in addition to the exercise training.
ET group	–	Other: Educational programExercise Training (ET) group. Patients who refused the educational program and did only the exercise training.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients referred for pulmonary rehabilitation between July 2015 and July 2019 to ADIR Association, Rouen University Hospital, France

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Educational programThe 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.	Other	ET group, ETEP group

Primary outcome

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

9 secondary outcomes

6-Minute Stepper Test
Time frame: 2 months
6-Minute Walk Test
Time frame: 2 months
Saint George's Respiratory Questionnaire
Time frame: 2 months
Anxiety and depression level
Time frame: 2 months
Cognitive impairment
Time frame: 2 months
Number of hospitalizations
Time frame: 6 months
Number of hospitalized patients
Time frame: 6 months
Number of days of hospitalization
Time frame: 6 months
Attendance rate at educational sessions
Time frame: 2 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
Derived from this study: PubMed 34623218Smondack 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.
Individual participant dataSharing planned: No

Related trials for Chronic Obstructive Pulmonary Disease

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jean-François Muir, MD PhD principal investigator

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

Antoine Cuvelier, MD PhD study chair

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.

David Debeaumont, MD study chair

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Obstructive Pulmonary Disease and Pulmonary Rehabilitation, run by ADIR Association at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Multiple logistic regression between the variables defined and the refusal of educational program (time frame: Baseline). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04301245, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.