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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое questionnaires
  Morisky and SF12 Questionnaires delivery at inclusion, 6, 12 and 18 months

Первичные конечные точки

• Scores of the Morisky scale [Срок оценки: 18 months after inclusion]

Вторичные конечные точки (2)

• Scores of the Morisky scale [Срок оценки: 6 and 12 months after inclusion]
• SF-12 quality of life questionnaire [Срок оценки: 6 and 12 and 18 months after inclusion]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Франция · 1 центр

• Groupe Hospitalier de Bretagne Sud — Lorient

Идентификаторы

NCT: NCT06620770 · 56LORC_2023_IMPEBIO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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