Therapeutic education program for patients with chronic inflammatory diseases on biotherapy
Impact of the Therapeutic Education Program "living with Chronic Inflammatory Disease Under Biotherapy" on Compliance and Quality of Life of Patients
This study tests a new education program for patients with chronic inflammatory diseases on biotherapy to see if it helps them understand their treatment better and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Groupe Hospitalier de Bretagne Sud Academic / other |
| Locations | 1 site (Lorient) |
| Trial ID | NCT06620770 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the impact of a therapeutic education program designed for patients with chronic inflammatory diseases who are receiving subcutaneous biotherapy. The program aims to enhance patient knowledge, adherence to treatment, and overall quality of life. Participants will complete the Morisky scale and SF 12 quality of life questionnaire at various intervals over 18 months to assess the program's effectiveness. Patients who choose not to participate will be included in a control group for comparison.
Who should consider this trial
Good fit: Ideal candidates are patients with chronic inflammatory diseases being treated with subcutaneous biotherapy at the Groupe Hospitalier de Bretagne Sud.
Not a fit: Patients who are cognitively impaired or unable to participate in the program due to legal or health restrictions may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve treatment adherence and quality of life for patients with chronic inflammatory diseases.
How similar studies have performed: Previous studies have shown that therapeutic education programs can effectively improve patient knowledge and adherence, suggesting a positive outlook for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All major patients followed up on GHBS for chronic inflammatory disease treated with S/C biotherapy. * Patients not opposed to their participation in the research. * Less than 3 months between inclusion and start of Therapeutic Education Program. Exclusion Criteria: * Subcutaneous injection by another person. * Patients with cognitive impairment. * Persons of legal age who are the subject of a legal protection (safeguarding of justice, curatorship, guardianship), persons deprived of liberty. * Pregnant women. * Persons not covered by social security.
Where this trial is running
Lorient
- Groupe Hospitalier de Bretagne Sud — Lorient, France (Recruiting)
Study contacts
- Principal investigator: Olivier Gall — Groupe Hospitalier de Bretagne Sud
- Study coordinator: Olivier Gall
- Email: o.gall@ghbs.bzh
- Phone: 02 97 06 79 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.