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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGroupe Hospitalier de Bretagne Sud

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • questionnaires

    Other intervention

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

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Patients participating in the therapeutic education program1 intervention
Group B: Patients who do not wish to participate in the therapeutic education program1 intervention

Trial outcomes

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.

Time frame
18 months after inclusion

Secondary outcomes

1

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.

Time frame
6 and 12 months after inclusion
2

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.

Time frame
6 and 12 and 18 months after inclusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.