COPDMPSAT-ETPNCT06298487
Evaluation of the Impact of Therapeutic Education Workshops for COPD Patients in the North-West Val d'Oise Area
A study testing Patient questionnaires in people with COPD, run by Hôpital NOVO at 1 site in France.
Trial summary
The aim of this study is to assess the impact of the Patient Therapeutic Education (PTE) workshops offered by the Maison de Prévention de la Santé et d'Accompagnement Thérapeutique (MPSAT) on the follow-up and feelings of the COPD patients who take part. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Patient questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2024to 7 Feb 2025
- Phase
- Interventional
- 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
Who may be able to join
- Patient aged 18 or over
- Patient living in the NOVO hospital area and the border towns of Yvelines, Oise and Eure
- Patient with a diagnosis of COPD confirmed by EFR, whatever the stage
- For PTE group :
- Patient who has already attended at least 3 PTE workshops offered by MPSAT
- For Control group :
- Patient on waiting list for PTE workshops offered by MPSAT
Who cannot join
- Patient refusing to take part in study
- Patient under legal protection
- Patient with cognitive disorders, unstable clinical conditions, language barriers or other conditions that prevent them from understanding the study and answering the questionnaires
Trial locations and contacts
1 site in 1 country.
France1 site
Pneumology, respiratory rehabilitation and follow-up and rehabilitation care department - Hôpital NOVO
Pontoise, 95300
About this study
Official title: Evaluation of the Multidimensional Impact of Therapeutic Education Workshops for COPD Patients, Cared for by the Maison de Prévention de la Santé et d'Accompagnement Thérapeutique, in the North-West Val d'Oise Area
The aim of this study is to assess the impact of the Patient Therapeutic Education (PTE) workshops offered by the Maison de Prévention de la Santé et d'Accompagnement Thérapeutique (MPSAT) on the follow-up and feelings of the COPD patients who take part. These workshops are organised outside the hospital environment and supervised by hospital and town professionals in the NOVO zone.
Read the detailed description
In France, the ageing of the population (around 20% of the population is aged 65 or over), coupled with medical advances, lifestyle changes and environmental problems, is leading to an increase in chronic diseases, which are responsible for the majority of deaths.
Chronic obstructive pulmonary disease (COPD) is one of the most widespread chronic diseases in France. The departments most affected by COPD in terms of prevalence and (underestimated) mortality are the most vulnerable: Seine-et-Marne (77), Val-d'Oise (95) and Seine-Saint-Denis (93).
In the field of nursing, patient therapeutic education workshops (PTE) are an approach that aims to improve patients' health and well-being by actively involving them in managing their own health. The Maison de Prévention de la Santé et d'Accompagnement Thérapeutique (MPSAT), an innovative structure, seeks to promote this new approach by improving the management and care of COPD patients. In this context of changes in the management of the care pathway for chronic patients, one of the essential actions is therefore to actively involve the patient in the follow-up and to provide them with the means to understand their pathology: the main focus of this work will be on this crucial stage which is Patient Therapeutic Education (PTE). However, in 80% of cases, PTE programmes are developed almost exclusively in public hospitals. The PTE workshops run by the MPSAT, which take place outside the hospital, are fully justified here. The MPSAT, that will be at the heart of this research project, aims to promote this new approach by improving the management and care pathway for COPD patients.
The aim of this study is to answer the following question : in the context of developments in the management of patients suffering from chronic diseases in France, and in particular COPD, what is the impact of the MPSAT's therapeutic education workshops, organised outside the hospital environment and supervised by professionals from both the hospital and urban environments of the NOVO territory, on the COPD patients who take part in them?
- Conditions
- COPD
- Being tested
- Patient questionnaires
- Keywords
- COPD, Patient Therapeutic Education (PTE), House of Prevention-Health and Therapeutic Support (MPSAT), City-hospital
- 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.
Patient questionnairesOther
Patients questionnaires, on paper or online (Microsoft Form) and data collection on patients medical file
| Study group | Role | What they receive |
|---|---|---|
| PTE group | Other | Group composed of patients who have already taken part in at least 3 Patient Therapeutic Education (PTE) workshops at the Maison de Prévention de la Santé et d'Accompagnement Therapeutique (MPSAT) Receives: Other: Patient questionnaires |
| Control group | Other | Group made up of patients on the waiting list for Patient Therapeutic Education (PTE) workshops at the Maison de Prévention de la Santé et d'Accompagnement Thérapeutique (MPSAT) Receives: Other: Patient questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the overall impact of the PTE workshops offered by the MPSAT on patients' knowledge, skills, attitudes and behaviours with regard to COPD management and care
The overall impact of the PTE workshops will be assessed using the overall score of the HEIQ (Health Education Impact Questionnaire) validated in French It will be compared between patients in the PTE group (who attended at least 3 PTE workshops) and those in the control group (who did not attend any PTE workshops) For each item, the patient ticks the answer that best correspond to him or her : Strongly disagree, Disagree, Agree or Strongly agree
Measured: At the end of the study, an average of 6 month
Secondary outcomes (5)
Measure of the impact of PTE workshops on quality of life (comparison of PTE group versus Control group)
Patients' quality of life will be assessed using the validated short health-related quality of life questionnaire for routine practice in COPD patients (VQ11) and will be compared between both groups For each item, the patient ticks the answer that best correspond to him or her : Not at all, Somewhat, Moderately, Very much or Extremely
Measured: At the end of the study, an average of 6 month
Comparison of anxiety/depression levels in patients in the PTE group versus Control group
Patients' anxiety and depression levels will be assessed using the validated Hospital Anxiety and Depression (HAD) questionnaire and will be compared between both groups For each item, the patient ticks the answer that best correspond to him or her with score between 0 and 3 (0 is the worst score and 3 the best score)
Measured: At the end of the study, an average of 6 month
Comparison of levels of motivation towards physical activity during free time in the PTE group versus Control group
Motivation for physical activity during free time will be assessed using the short version of the questionnaire Behavioural Regulation in Exercise Questionnaire (BREQ-2) and will be compared between both groups the patient ticks the answer that best correspond to him or her :not at all true, moderately true or completely true
Measured: At the end of the study, an average of 6 month
Comparison of the number of hospital admissions for COPD exacerbations in patients in the PTE group versus Control group
The number of hospitalisations of patients of PTE and Control groups will be obtained by examining their medical records and using the questionnaire on patient characteristics, which will provide information on any hospitalisations outside the NOVO hospital One of the questions in the questionnaire on patient characteristics concerns the number of hospitalisations, the year, the duration in days and the place of hospitalisation. For each item, the patient the patient can reply in free text
Measured: At the end of the study, an average of 6 month
Comparison of the perception/feelings of patients in the PTE group versus Control group, concerning PTE workshops organised in a city/hospital setting
The workshops are offered close to home and run by two types of professional, one from the town and one from the hospital, with the possibility of integrating a new healthcare professional such as an advanced practice nurse The perception/feelings of patients in the PTE group versus Control group, regarding these workshops, will be evaluated using a questionnaire on patient follow-up and satisfaction For each question, the patient ticks the answer or answers that best correspond to him or her
Measured: At the end of the study, an average of 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start11 Mar 2024
- Primary completion7 Feb 2025
- Study completion7 Feb 2025
Why it stopped: There is no longer any point in continuing the research, as the objectives and evaluation criteria defined in the protocol are now being evaluated in everyday practice.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Bruno PHILIPPE, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298487
- Sponsor's protocol ID
- CHRD 1023
- Acronym
- MPSAT-ETP
- Status last verified
- Aug 2024
- First submitted
- 1 Mar 2024
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Adeloye D, Song P, Zhu Y, Campbell H, Sheikh A, Rudan I; NIHR RESPIRE Global Respiratory Health Unit. Global, regional, and national prevalence of, and risk factors for, chronic obstructive pulmonary disease (COPD) in 2019: a systematic review and modelling analysis. Lancet Respir Med. 2022 May;10(5):447-458. doi: 10.1016/S2213-2600(21)00511-7. Epub 2022 Mar 10.
PubMed 35279265Fuhrman C, Delmas MC; pour le groupe epidemiologie et recherche clinique de la SPLF. [Epidemiology of chronic obstructive pulmonary disease in France]. Rev Mal Respir. 2010 Feb;27(2):160-8. doi: 10.1016/j.rmr.2009.08.003. Epub 2010 Jan 19. French.
PubMed 20206064Brinchault G, Diot P, Dixmier A, Goupil F, Guillais P, Gut-Gobert C, Leroyer C, Marchand-Adam S, Meurice JC, Morel H, Person C, Cavailles A. [Comorbidities of COPD]. Rev Pneumol Clin. 2015 Dec;71(6):342-9. doi: 10.1016/j.pneumo.2015.09.009. Epub 2015 Nov 14. French.
PubMed 26585876Roche N, Zureik M, Soussan D, Neukirch F, Perrotin D; Urgence BPCO (COPD Emergency) Scientific Committee. Predictors of outcomes in COPD exacerbation cases presenting to the emergency department. Eur Respir J. 2008 Oct;32(4):953-61. doi: 10.1183/09031936.00129507. Epub 2008 May 28.
PubMed 18508819Bourbeau J, Julien M, Maltais F, Rouleau M, Beaupre A, Begin R, Renzi P, Nault D, Borycki E, Schwartzman K, Singh R, Collet JP; Chronic Obstructive Pulmonary Disease axis of the Respiratory Network Fonds de la Recherche en Sante du Quebec. Reduction of hospital utilization in patients with chronic obstructive pulmonary disease: a disease-specific self-management intervention. Arch Intern Med. 2003 Mar 10;163(5):585-91. doi: 10.1001/archinte.163.5.585.
PubMed 12622605Peytremann-Bridevaux I, Staeger P, Bridevaux PO, Ghali WA, Burnand B. Effectiveness of chronic obstructive pulmonary disease-management programs: systematic review and meta-analysis. Am J Med. 2008 May;121(5):433-443.e4. doi: 10.1016/j.amjmed.2008.02.009.
PubMed 18456040Bischoff EW, Hamd DH, Sedeno M, Benedetti A, Schermer TR, Bernard S, Maltais F, Bourbeau J. Effects of written action plan adherence on COPD exacerbation recovery. Thorax. 2011 Jan;66(1):26-31. doi: 10.1136/thx.2009.127621. Epub 2010 Oct 30.
PubMed 21037270Belanger A, Hudon C, Fortin M, Amirall J, Bouhali T, Chouinard MC. Validation of a French-language version of the health education impact Questionnaire (heiQ) among chronic disease patients seen in primary care: a cross-sectional study. Health Qual Life Outcomes. 2015 May 24;13:64. doi: 10.1186/s12955-015-0254-0.
PubMed 26306793
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Multidimensional Impact of Therapeutic Education Workshops for COPD Patients, Cared for by the Maison de Prévention de la Santé et d'Accompagnement Thérapeutique, in the North-West Val d'Oise Area
- ClinicalTrials.gov ID
- NCT06298487
- Acronym / sponsor ID
- MPSAT-ETP / CHRD 1023
- Conditions
- COPD
- Keywords
- COPD, Patient Therapeutic Education (PTE), House of Prevention-Health and Therapeutic Support (MPSAT), City-hospital
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There is no longer any point in continuing the research, as the objectives and evaluation criteria defined in the protocol are now being evaluated in everyday practice.
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 7 Mar 2024 (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.
The aim of this study is to assess the impact of the Patient Therapeutic Education (PTE) workshops offered by the Maison de Prévention de la Santé et d'Accompagnement Thérapeutique (MPSAT) on the follow-up and feelings of the COPD patients who take part. These workshops are organised outside the hospital environment and supervised by hospital and town professionals in the NOVO zone.
Detailed description
In France, the ageing of the population (around 20% of the population is aged 65 or over), coupled with medical advances, lifestyle changes and environmental problems, is leading to an increase in chronic diseases, which are responsible for the majority of deaths.
Chronic obstructive pulmonary disease (COPD) is one of the most widespread chronic diseases in France. The departments most affected by COPD in terms of prevalence and (underestimated) mortality are the most vulnerable: Seine-et-Marne (77), Val-d'Oise (95) and Seine-Saint-Denis (93).
In the field of nursing, patient therapeutic education workshops (PTE) are an approach that aims to improve patients' health and well-being by actively involving them in managing their own health. The Maison de Prévention de la Santé et d'Accompagnement Thérapeutique (MPSAT), an innovative structure, seeks to promote this new approach by improving the management and care of COPD patients. In this context of changes in the management of the care pathway for chronic patients, one of the essential actions is therefore to actively involve the patient in the follow-up and to provide them with the means to understand their pathology: the main focus of this work will be on this crucial stage which is Patient Therapeutic Education (PTE). However, in 80% of cases, PTE programmes are developed almost exclusively in public hospitals. The PTE workshops run by the MPSAT, which take place outside the hospital, are fully justified here. The MPSAT, that will be at the heart of this research project, aims to promote this new approach by improving the management and care pathway for COPD patients.
The aim of this study is to answer the following question : in the context of developments in the management of patients suffering from chronic diseases in France, and in particular COPD, what is the impact of the MPSAT's therapeutic education workshops, organised outside the hospital environment and supervised by professionals from both the hospital and urban environments of the NOVO territory, on the COPD patients who take part in them?
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTE group | Other | Other: Patient questionnairesGroup composed of patients who have already taken part in at least 3 Patient Therapeutic Education (PTE) workshops at the Maison de Prévention de la Santé et d'Accompagnement Therapeutique (MPSAT) |
| Control group | Other | Other: Patient questionnairesGroup made up of patients on the waiting list for Patient Therapeutic Education (PTE) workshops at the Maison de Prévention de la Santé et d'Accompagnement Thérapeutique (MPSAT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient aged 18 or over
- Patient living in the NOVO hospital area and the border towns of Yvelines, Oise and Eure
- Patient with a diagnosis of COPD confirmed by EFR, whatever the stage
- Patient who has already attended at least 3 PTE workshops offered by MPSAT
- Patient on waiting list for PTE workshops offered by MPSAT
Key exclusion criteria (3 listed)
- Patient refusing to take part in study
- Patient under legal protection
- Patient with cognitive disorders, unstable clinical conditions, language barriers or other conditions that prevent them from understanding the study and answering the questionnaires
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 |
|---|---|---|
| Patient questionnairesPatients questionnaires, on paper or online (Microsoft Form) and data collection on patients medical file | Other | Control group, PTE group |
Primary outcome
Evaluation of the overall impact of the PTE workshops offered by the MPSAT on patients' knowledge, skills, attitudes and behaviours with regard to COPD management and care
Time frame: At the end of the study, an average of 6 month
The overall impact of the PTE workshops will be assessed using the overall score of the HEIQ (Health Education Impact Questionnaire) validated in French It will be compared between patients in the PTE group (who attended at least 3 PTE workshops) and those in the control group (who did not attend any PTE workshops) For each item, the patient ticks the answer that best correspond to him or her : Strongly disagree, Disagree, Agree or Strongly agree
5 secondary outcomes
Measure of the impact of PTE workshops on quality of life (comparison of PTE group versus Control group)
Time frame: At the end of the study, an average of 6 month
Comparison of anxiety/depression levels in patients in the PTE group versus Control group
Time frame: At the end of the study, an average of 6 month
Comparison of levels of motivation towards physical activity during free time in the PTE group versus Control group
Time frame: At the end of the study, an average of 6 month
Comparison of the number of hospital admissions for COPD exacerbations in patients in the PTE group versus Control group
Time frame: At the end of the study, an average of 6 month
Comparison of the perception/feelings of patients in the PTE group versus Control group, concerning PTE workshops organised in a city/hospital setting
Time frame: At the end of the study, an average of 6 month
Results and safety
The study was stopped early (reason given: There is no longer any point in continuing the research, as the objectives and evaluation criteria defined in the protocol are now being evaluated in everyday practice.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Background: PubMed 35279265Adeloye D, Song P, Zhu Y, Campbell H, Sheikh A, Rudan I; NIHR RESPIRE Global Respiratory Health Unit. Global, regional, and national prevalence of, and risk factors for, chronic obstructive pulmonary disease (COPD) in 2019: a systematic review and modelling analysis. Lancet Respir Med. 2022 May;10(5):447-458. doi: 10.1016/S2213-2600(21)00511-7. Epub 2022 Mar 10.
- Background: PubMed 20206064Fuhrman C, Delmas MC; pour le groupe epidemiologie et recherche clinique de la SPLF. [Epidemiology of chronic obstructive pulmonary disease in France]. Rev Mal Respir. 2010 Feb;27(2):160-8. doi: 10.1016/j.rmr.2009.08.003. Epub 2010 Jan 19. French.
- Background: PubMed 26585876Brinchault G, Diot P, Dixmier A, Goupil F, Guillais P, Gut-Gobert C, Leroyer C, Marchand-Adam S, Meurice JC, Morel H, Person C, Cavailles A. [Comorbidities of COPD]. Rev Pneumol Clin. 2015 Dec;71(6):342-9. doi: 10.1016/j.pneumo.2015.09.009. Epub 2015 Nov 14. French.
- Background: PubMed 18508819Roche N, Zureik M, Soussan D, Neukirch F, Perrotin D; Urgence BPCO (COPD Emergency) Scientific Committee. Predictors of outcomes in COPD exacerbation cases presenting to the emergency department. Eur Respir J. 2008 Oct;32(4):953-61. doi: 10.1183/09031936.00129507. Epub 2008 May 28.
- Background: PubMed 12622605Bourbeau J, Julien M, Maltais F, Rouleau M, Beaupre A, Begin R, Renzi P, Nault D, Borycki E, Schwartzman K, Singh R, Collet JP; Chronic Obstructive Pulmonary Disease axis of the Respiratory Network Fonds de la Recherche en Sante du Quebec. Reduction of hospital utilization in patients with chronic obstructive pulmonary disease: a disease-specific self-management intervention. Arch Intern Med. 2003 Mar 10;163(5):585-91. doi: 10.1001/archinte.163.5.585.
- Background: PubMed 18456040Peytremann-Bridevaux I, Staeger P, Bridevaux PO, Ghali WA, Burnand B. Effectiveness of chronic obstructive pulmonary disease-management programs: systematic review and meta-analysis. Am J Med. 2008 May;121(5):433-443.e4. doi: 10.1016/j.amjmed.2008.02.009.
- Background: PubMed 21037270Bischoff EW, Hamd DH, Sedeno M, Benedetti A, Schermer TR, Bernard S, Maltais F, Bourbeau J. Effects of written action plan adherence on COPD exacerbation recovery. Thorax. 2011 Jan;66(1):26-31. doi: 10.1136/thx.2009.127621. Epub 2010 Oct 30.
- Background: PubMed 26306793Belanger A, Hudon C, Fortin M, Amirall J, Bouhali T, Chouinard MC. Validation of a French-language version of the health education impact Questionnaire (heiQ) among chronic disease patients seen in primary care: a cross-sectional study. Health Qual Life Outcomes. 2015 May 24;13:64. doi: 10.1186/s12955-015-0254-0.
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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.
Dr Bruno PHILIPPE principal investigator
Hôpital NOVO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient questionnaires in people with COPD, run by Hôpital NOVO 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 7 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: stopped early, as of the sponsor's last update on 18 Mar 2025. 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 was stopped early (reason given: There is no longer any point in continuing the research, as the objectives and evaluation criteria defined in the protocol are now being evaluated in everyday practice.). Results are not available in the source record.
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?
Evaluation of the overall impact of the PTE workshops offered by the MPSAT on patients' knowledge, skills, attitudes and behaviours with regard to COPD management and care (time frame: At the end of the study, an average of 6 month). 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 NCT06298487, which also lists 8 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 18 Mar 2025.