Evaluation of the Impact of Therapeutic Education Workshops for COPD Patients in the North-West Val d'Oise Area (MPSAT-ETP)

April 3, 2024 updated by: Hôpital NOVO

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Pontoise, France, 95300
        • Recruiting
        • Pneumology, respiratory rehabilitation and follow-up and rehabilitation care department - Hôpital NOVO
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria :

  • 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

Exclusion Criteria :

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PTE group
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)
Other: Patient questionnaires
Patients questionnaires, on paper or online (Microsoft Form) and data collection on patients medical file
Other: Control group
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)
Other: Patient questionnaires
Patients questionnaires, on paper or online (Microsoft Form) and data collection on patients medical file

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the end of the study, an average of 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
At the end of the study, an average of 6 month
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
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
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
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)
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
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
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
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
At the end of the study, an average of 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital NOVO

Investigators

  • Principal Investigator: Dr Bruno PHILIPPE, Hopital Novo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHRD 1023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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