NCT06298487

Brief 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. These workshops are organised outside the hospital environment and supervised by hospital and town professionals in the NOVO zone.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

March 11, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2025

Completed
Last Updated

March 18, 2025

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

March 1, 2024

Last Update Submit

March 14, 2025

Conditions

Keywords

COPDPatient Therapeutic Education (PTE)House of Prevention-Health and Therapeutic Support (MPSAT)City-hospital

Outcome Measures

Primary Outcomes (1)

  • 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

    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)

    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

    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

    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

    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

    At the end of the study, an average of 6 month

Study Arms (2)

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)

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)

Other: Patient questionnaires

Interventions

Patients questionnaires, on paper or online (Microsoft Form) and data collection on patients medical file

Control groupPTE group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pneumology, respiratory rehabilitation and follow-up and rehabilitation care department - Hôpital NOVO

Pontoise, 95300, France

Location

Related Publications (8)

  • 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.

    PMID: 35279265BACKGROUND
  • Fuhrman 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.

    PMID: 20206064BACKGROUND
  • Brinchault 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.

    PMID: 26585876BACKGROUND
  • Roche 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.

    PMID: 18508819BACKGROUND
  • Bourbeau 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.

    PMID: 12622605BACKGROUND
  • Peytremann-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.

    PMID: 18456040BACKGROUND
  • Bischoff 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.

    PMID: 21037270BACKGROUND
  • Belanger 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.

    PMID: 26306793BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dr Bruno PHILIPPE

    Hôpital NOVO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2024

First Posted

March 7, 2024

Study Start

March 11, 2024

Primary Completion

February 7, 2025

Study Completion

February 7, 2025

Last Updated

March 18, 2025

Record last verified: 2024-08

Locations