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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Inflammatory Disease
• Intervention / Treatment: Other: questionnaires

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.

• Study Type: Observational
• Enrollment (Estimated): 126

Contacts and Locations

• Study Contact: Name: Olivier Gall; Phone Number: +33 02 97 06 79 11; Email: o.gall@ghbs.bzh
• Study Contact Backup: Name: Pierre BOUJU; Phone Number: +33 02 97 06 75 14; Email: p.bouju@ghbs.bzh

Study Locations

• France
  • Lorient, France, 56100
    • Recruiting
    • Groupe Hospitalier de Bretagne Sud
    • Contact: Pierre BOUJU; Phone Number: +33 02 97 06 75 14; Email: p.bouju@ghbs.bzh
    • Contact: Nolwen Leissen; Phone Number: +33 02 97 06 74 61; Email: n.leissen@ghbs.bzh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All major patients followed up on GHBS for chronic inflammatory disease treated with S/C biotherapy.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients participating in the therapeutic education program; 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.	Other: questionnaires; Morisky and SF12 Questionnaires delivery at inclusion, 6, 12 and 18 months
Patients who do not wish to participate in the therapeutic education program; 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.	Other: questionnaires; Morisky and SF12 Questionnaires delivery at inclusion, 6, 12 and 18 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores of the Morisky scale	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.	18 months after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores of the Morisky scale	Comparison of scores on the Morisky scale in patients with chronic inflammatory disease treated by S/C biotherapy at 6 and 12 months after inclusion versus patients who only received nurse consultation.	6 and 12 months after inclusion
SF-12 quality of life questionnaire	Comparison of the SF-12 quality of life questionnaire in patients at 6, 12 and 18 months after inclusion versus patients who only received nurse consultation.	6 and 12 and 18 months after inclusion

Collaborators and Investigators

• Sponsor: Groupe Hospitalier de Bretagne Sud
• Investigators: Principal Investigator: Olivier Gall, Groupe Hospitalier de Bretagne Sud

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Biotherapy; Therapeutic education program
• Other Study ID Numbers: 56LORC_2023_IMPEBIO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No