NCT06620770

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 126 (estimated)
• Sponsor: Groupe Hospitalier de Bretagne Sud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Inflammatory Disease

Interventions

Type	Name	Description
OTHER	questionnaires	Morisky and SF12 Questionnaires delivery at inclusion, 6, 12 and 18 months

Timeline

• Start date: 2025-02-14
• Primary completion: 2027-03-01
• Completion: 2028-03-01
• First posted: 2024-10-01
• Last updated: 2025-03-14

Locations

1 site across 1 country: France