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

Groupe Hospitalier de Bretagne Sud

Status: Enrolling

Conditions: Chronic Inflammatory Disease

Treatments: Other: questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT06620770

56LORC_2023_IMPEBIO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

126 participants in 2 patient groups

Patients participating in the therapeutic education program

Description:

Patients treated with subcutaneous biotherapy who wish to participate in the therapeutic education program will be included in the intervention group. This program will begin within 3 months of inclusion. An initial meeting with a nurse allows for a shared educational assessment. The other days are planned monthly with groups of up to 6 people. A discussion around biotherapies is established by a doctor-nurse pair on theoretical and practical questions. In a second step, questions around nutrition are addressed with the dietician. Mealtime is also a time for discussion with professionals and the group of patients. The third workshop is led by a physical activity teacher. A nurse and a patient partner lead a time dedicated to fatigue management in the form of practical exercises that can be easily reproduced at home.

Treatment:

Other: questionnaires

Patients who do not wish to participate in the therapeutic education program

Description:

Patients treated with subcutaneous biotherapy who do not wish to participate in the therapeutic education program will be included in the control group. Patients will be followed by their physicians as usual.

Treatment:

Other: questionnaires