Chronic Obstructive Pulmonary DiseaseEDURESPINCT04473313
Educational Follow-up in COPD Patients After Pulmonary Rehabilitation.
An observational study of Chronic Obstructive Pulmonary Disease, run by University Hospital, Brest at 2 sites in France.
Trial summary
After pulmonary rehabilitation, the challenge is to maintain the benefits reached during the program and increase physical activity. As exercise training, education is the corner stone of pulmonary rehabilitation. Education allows to support behavioral changes in daily life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 220 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Jul 2020to 16 Aug 2023
- 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: COPD patients, all stages
Who may be able to join
- COPD patients COPD patients admitted for pulmonary rehabilitation program in pulmonary rehabilitation unit of CH des Pays de Morlaix or CHU Brest
Who cannot join
- inability to answer to the questionnaire
- refusal to participate.
- inability to perform the pulmonary rehabilitation program.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Educational Follow-up in COPD Patients After Pulmonary Rehabilitation: a Cohort Study
After pulmonary rehabilitation, the challenge is to maintain the benefits reached during the program and increase physical activity.
As exercise training, education is the corner stone of pulmonary rehabilitation. Education allows to support behavioral changes in daily life.
Read more
Recommendations about modalities for maintaining physical activity are still clear, however for educational follow up recommendations need to be clarified.
After a pulmonary rehabilitation program, there is no defined plan for educational follow up nor location to perform education session.
The aim of this study is to evaluate the proportion of patients who succeed to establish and maintain the objectives they defined during the pulmonary rehabilitation program, one year after this program.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Realization of the objective(s) defined by the patient during a common educational assessment (educational diagnosis) at the end end of the pulmonary rehabilitation program
Determination of the objective(s) defined by the patient during a common educational assessment (educational diagnosis) at the end of the pulmonary rehabilitation program and evaluation of the realization of this (these) objective(s) after one year (yes or no)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start16 Jul 2020
- Primary completion16 Aug 2023
- Study completion16 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Beaumont, PhD, Principal investigator, CH des pays de Morlaix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473313
- Sponsor's protocol ID
- 29BRC20.0212 - EDURESPI
- Acronym
- EDURESPI
- Status last verified
- Aug 2024
- First submitted
- 13 Jul 2020
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.
PubMed 24127811Peran L, Le Ber C, Pichon R, Cabillic M, Beaumont M. [Follow-up and evaluation of plans developed during pulmonary rehabilitation]. Rev Mal Respir. 2018 Nov;35(9):929-938. doi: 10.1016/j.rmr.2018.08.002. Epub 2018 Sep 7. French.
PubMed 30201399
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Follow-up in COPD Patients After Pulmonary Rehabilitation: a Cohort Study
- ClinicalTrials.gov ID
- NCT04473313
- Acronym / sponsor ID
- EDURESPI / 29BRC20.0212 - EDURESPI
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 16 Aug 2023 (actual)
- First posted
- 16 Jul 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.
After pulmonary rehabilitation, the challenge is to maintain the benefits reached during the program and increase physical activity.
As exercise training, education is the corner stone of pulmonary rehabilitation. Education allows to support behavioral changes in daily life.
Recommendations about modalities for maintaining physical activity are still clear, however for educational follow up recommendations need to be clarified.
After a pulmonary rehabilitation program, there is no defined plan for educational follow up nor location to perform education session.
The aim of this study is to evaluate the proportion of patients who succeed to establish and maintain the objectives they defined during the pulmonary rehabilitation program, one year after this program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients, all stages
Key inclusion criteria (1 listed)
- COPD patients COPD patients admitted for pulmonary rehabilitation program in pulmonary rehabilitation unit of CH des Pays de Morlaix or CHU Brest
Key exclusion criteria (3 listed)
- inability to answer to the questionnaire
- refusal to participate.
- inability to perform the pulmonary rehabilitation program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Realization of the objective(s) defined by the patient during a common educational assessment (educational diagnosis) at the end end of the pulmonary rehabilitation program
Time frame: one year
Determination of the objective(s) defined by the patient during a common educational assessment (educational diagnosis) at the end of the pulmonary rehabilitation program and evaluation of the realization of this (these) objective(s) after one year (yes or no)
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 12 Aug 2024.
- Background: PubMed 24127811Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.
- Background: PubMed 30201399Peran L, Le Ber C, Pichon R, Cabillic M, Beaumont M. [Follow-up and evaluation of plans developed during pulmonary rehabilitation]. Rev Mal Respir. 2018 Nov;35(9):929-938. doi: 10.1016/j.rmr.2018.08.002. Epub 2018 Sep 7. French.
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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.
Marc Beaumont, PhD principal investigator
CH des pays de Morlaix
2 sites 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, run by University Hospital, Brest at 2 sites 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 1 inclusion and 3 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 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Realization of the objective(s) defined by the patient during a common educational assessment (educational diagnosis) at the end end of the pulmonary rehabilitation program (time frame: one year). 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 NCT04473313, which also lists 2 linked publications.
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 12 Aug 2024.