Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06620770
Acronym
IMPEBIO
Enrollment
126
Registered
2024-10-01
Start date
2025-02-14
Completion date
2028-03-31
Last updated
2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Inflammatory Disease

Keywords

Biotherapy, Therapeutic education program

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.

Interventions

OTHERquestionnaires

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

Sponsors

Groupe Hospitalier de Bretagne Sud
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Scores of the Morisky scale18 months after inclusionComparison 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.

Secondary

MeasureTime frameDescription
Scores of the Morisky scale6 and 12 months after inclusionComparison 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.
SF-12 quality of life questionnaire6 and 12 and 18 months after inclusionComparison 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.

Countries

France

Contacts

Primary ContactOlivier Gall
o.gall@ghbs.bzh02 97 06 79 11
Backup ContactPierre Bouju
p.bouju@ghbs.bzh02 97 06 75 14

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026