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

NCT06620770 | Recruiting

• 1 other identifier: 56LORC_2023_IMPEBIO
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Inflammatory Disease

Keywords

Biotherapy; Therapeutic education program

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Scores of the Morisky scale

  6 and 12 months after inclusion

• SF-12 quality of life questionnaire

  6 and 12 and 18 months after inclusion

Study Arms (2)

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

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

Interventions

questionnaires OTHER

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Groupe Hospitalier de Bretagne Sud: lead

Study Sites (1)

Groupe Hospitalier de Bretagne Sud

Lorient, 56100, France

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Olivier Gall

  Groupe Hospitalier de Bretagne Sud

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier Gall

CONTACT

02 97 06 79 11; o.gall@ghbs.bzh

Pierre Bouju

CONTACT

02 97 06 75 14; p.bouju@ghbs.bzh

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 1, 2024
• Study Start: February 14, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

FR (1)