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Clinical Trials/NCT06620770
NCT06620770
Recruiting
Not Applicable

Impact of the Therapeutic Education Program "living with Chronic Inflammatory Disease Under Biotherapy" on Compliance and Quality of Life of Patients

Groupe Hospitalier de Bretagne Sud1 site in 1 country126 target enrollmentFebruary 14, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Inflammatory Disease
Sponsor
Groupe Hospitalier de Bretagne Sud
Enrollment
126
Locations
1
Primary Endpoint
Scores of the Morisky scale
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Patient therapeutic education programs have been shown to be effective in many specialties, allowing "Improving biological and psychological parameters, allowing patients to improve their health knowledge, therapeutic adherence and sense of personal effectiveness." Several studies have shown that patient knowledge, adherence and satisfaction are better after attending a therapeutic education program.

This multidisciplinary program is presented and offered to all patients with chronic disease treated by subcutaneous biotherapy, followed by dermatologists, rheumatologists and gastroenterologists of the Lorient hospital.

The study aims to demonstrate the benefit of the Patient Therapeutic Education program at GHBS Lorient "living with a chronic inflammatory disease under biotherapy" on treatment adherence, as well as the positive impact on quality of life.

Detailed Description

All patients followed up as part of their chronic disease and treated with subcutaneous biotherapy in the dermatology, rheumatology, hepatotherapygastroenterology, will be offered participation in the therapeutic education program by GHBS specialists. Whether they agree to participate or not, doctors will offer them participation in the IMPEBIO study. Patients treated with subcutaneous biotherapy who do not wish to participate in the program will be included in the control group. Patients treated with subcutaneous biotherapy who wish to participate in this program will be included in the intervention group. The therapeutic education program will begin within 3 months of inclusion. If the patient does not object, the Morisky scale and the SF 12 questionnaire will be given to him. It may be assisted with filling if necessary by a clinical researcher. Patients will first complete the Morisky test, and the quality of life questionnaire SF 12 at inclusion in the IMPEBIO study (J0), then to M6 (6 months), M12 (12 months) and M18 (18 months). These questionnaires will then be retrieved, anonymized and sent to the investigation department. The analysis of questionnaires will not lead to changes in patient management. Estimated time to complete the questionnaires is 10 minutes.

Registry
clinicaltrials.gov
Start Date
February 14, 2025
End Date
March 2028
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Groupe Hospitalier de Bretagne Sud
Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Scores of the Morisky scale

Time Frame: 18 months after inclusion

Comparison of the scores of the Morisky scale in patients with chronic inflammatory disease treated by S/C biotherapy at 18 months after inclusion versus patients who only received nurse consultation.

Secondary Outcomes

  • Scores of the Morisky scale(6 and 12 months after inclusion)
  • SF-12 quality of life questionnaire(6 and 12 and 18 months after inclusion)

Study Sites (1)

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