- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07170826
- Original Trial
Evaluation of a Therapeutic Education Program on Self-image in Patients With Chronic Inflammatory Rheumatic Diseases (IMAG'RIC)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A chronic disease is a long-term, progressive illness that affects the daily life of the person affected. The onset of the disease is a major upheaval, a moment of rupture between a before and an after. Physical functions and appearance can be altered by the disease (deformities, stiffness… in the case of rheumatic diseases) and by treatments.
According to Schilder, body image is "the way our body appears to ourselves." It can be defined as the set of perceptions, emotions, and thoughts related to appearance. It consists of perceptions but also of representations and feelings, which are built and evolve throughout the individual's experience. It is not limited to physical appearance and properties. It is the foundation of identity.
The disease affects the body, but also has an impact on self-perception, self-esteem, and even identity.
The literature highlights the importance of using qualitative research in addition to quantitative methods to grasp the full complexity of body image.
Despite the progress and effectiveness of treatments, recent studies showed that patients with chronic inflammatory rheumatic diseases (CIRD) have an unsatisfactory, disturbed body image. Literature data also reveal that self-esteem and quality of life in this population are lower than in the general population.
Most studies focused on the consequences of the disease, and very few on the actions taken to address these difficulties encountered by patients, even though such actions are recommended.
Therapeutic patient education (TPE) is support offered to the patient and their relatives so they can take ownership of their disease. TPE is a comprehensive approach that meets the patient's needs and aims to maintain and/or improve quality of life with the illness.
Most therapeutic education workshops related to self-image are proposed in the context of cancer, psychiatric disorders, or obesity. Body image is rarely the direct subject of a workshop in programs aimed at patients with CIRD.
A few studies on the impact of image consulting workshops have been conducted in oncology, but very few in the context of other diseases, including rheumatic conditions. Existing studies show an improvement in self-image, self-esteem, and quality of life after educational interventions, thus a real benefit for patients.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marie Laure TOURNEUR, Therapeutic education nurse
- Phone Number: +33 01 58 41 26 58
- Email: marie-laure.tourneur@aphp.fr
Study Contact Backup
- Name: Aline DECHANET, Project advisor
- Email: aline.dechanet@aphp.fr
Study Locations
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-
Île-de-France Region
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Paris, Île-de-France Region, France, 75014
- Hôpital Cochin - Service de rhumatologie -27 rue du Faubourg St Jacques
-
Contact:
- Marie Laure TOURNEUR
- Phone Number: +33 01 58 41 26 58
- Email: marie-laure.tourneur@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- People who do not speak or read French
- Current pregnancy
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate a therapeutic patient education intervention focused on self-image in patients with chronic inflammatory rheumatic diseases
Time Frame: 3 months following completion of the 'self-image' module
|
Multidimensional Body-Self Relations Questionnaire (MBSRQ)
|
3 months following completion of the 'self-image' module
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate a therapeutic patient education intervention on each domain of self-image
Time Frame: 3 months following completion of the 'self-image' module
|
Measurement of each subscale of the Multidimensional Body-Self Relations Questionnaire (MBSRQ)
|
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.
Time Frame: 3 months following completion of the 'self-image' module
|
Rosenberg Self-Esteem Scale before participation : min = 10, max=40
|
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.
Time Frame: 3 months following completion of the 'self-image' module
|
Measurement of the quality of life score using the SF-36 questionnaire
|
3 months following completion of the 'self-image' module
|
|
To explore body image in patients after participating in therapeutic education workshops on self-image.
Time Frame: 4 months following completion of the 'self-image' module
|
Data from individual qualitative interviews (inductive approach).
|
4 months following completion of the 'self-image' module
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Marie Laure TOURNEUR, Marie Laure, AP-HP - Hôpital Cochin - Service de rhumatologie.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP250978
- IDRCB (Other Identifier: 2024-A00519-38)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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