NCT07170826

Brief Summary

Chronic inflammatory rheumatic diseases (CIRD), like all chronic somatic disease, can impair self-esteem and self-image in affected individuals. Numerous studies conducted in this population have confirmed this fact. Therapeutic patient education (TPE) programs aim to help patients acquire self-care and adaptive skills. However, there is a near-total absence of workshops specifically dedicated to self-image in TPE programs for CIRD. Such educational interventions have shown their effectiveness in contexts such as cancer and obesity. Our study aims to evaluate their effectiveness for patients with CIR.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
30mo left

Started Oct 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress20%
Oct 2025Oct 2028

First Submitted

Initial submission to the registry

August 28, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

September 12, 2025

Status Verified

August 1, 2025

Enrollment Period

2.8 years

First QC Date

August 28, 2025

Last Update Submit

September 5, 2025

Conditions

Chronic Inflammatory Rheumatic Diseases

Keywords

Chronic Inflammatory Rheumatic diseasesTherapeutic patient education

Outcome Measures

Primary Outcomes (1)

  • To evaluate a therapeutic patient education intervention focused on self-image in patients with chronic inflammatory rheumatic diseases

    Multidimensional Body-Self Relations Questionnaire (MBSRQ)

    3 months following completion of the 'self-image' module

Secondary Outcomes (4)

  • To evaluate a therapeutic patient education intervention on each domain of self-image

    3 months following completion of the 'self-image' module

  • To evaluate a therapeutic patient education intervention focused on self-image in relation to self-esteem.

    3 months following completion of the 'self-image' module

  • To evaluate a therapeutic patient education intervention focused on self-image in relation to quality of life.

    3 months following completion of the 'self-image' module

  • To explore body image in patients after participating in therapeutic education workshops on self-image.

    4 months following completion of the 'self-image' module

Interventions

Self questionnaireOTHER

Rosenberg Scale, SF36, MBRSQ

interviewOTHER

Semi-structured individual interviews

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The target population will consist of patients with RIC (rheumatoid arthritis, spondyloarthritis, psoriatic arthritis) participating in the ETP programme

You may qualify if:

  • Age ≥ 18 years
  • Suffering from chronic inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis, psoriatic arthritis)
  • Having agreed to follow the therapeutic education programme offered by the department as part of routine care
  • Not opposed to participating in the research

You may not qualify if:

  • People who do not speak or read French
  • Current pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cochin - Service de rhumatologie -27 rue du Faubourg St Jacques

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Marie Laure TOURNEUR, Marie Laure

    AP-HP - Hôpital Cochin - Service de rhumatologie.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Laure TOURNEUR, Therapeutic education nurse

CONTACT

01 58 41 26 58marie-laure.tourneur@aphp.fr

Aline DECHANET, Project advisor

CONTACT

aline.dechanet@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2025

First Posted

September 12, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

September 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)