Clinical trial NCT06620770: Impact of the Therapeutic Education Program "living with a Chronic Inflammatory Disease Under Biotherapy" on Patient Compliance and Quality of Life
Official title: Impact of the Therapeutic Education Program "living with Chronic Inflammatory Disease Under Biotherapy" on Compliance and Quality of Life of Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Inflammatory Disease
Keywords: Biotherapy
Therapeutic education program
Lead sponsor: Groupe Hospitalier de Bretagne Sud
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All major patients followed up on GHBS for chronic inflammatory disease treated with S/C biotherapy.

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.

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.

Primary outcomes:
measure: Scores of the Morisky scale
timeFrame: 18 months after inclusion
Secondary outcomes:
measure: Scores of the Morisky scale
timeFrame: 6 and 12 months after inclusion
measure: SF-12 quality of life questionnaire
timeFrame: 6 and 12 and 18 months after inclusion
Other outcomes:
Locations:
city: Lorient
country: France
facility: Groupe Hospitalier de Bretagne Sud
Study officials:
affiliation: Groupe Hospitalier de Bretagne Sud
name: Olivier Gall
role: PRINCIPAL_INVESTIGATOR
References: