Biotherapies and Therapeutic Education in Chronic Inflammatory Rheumatism (ERIBIO)

University Hospital, Clermont-Ferrand

Status: Completed

Conditions: Spondyloarthritis; Rheumatoid Arthritis

Treatments: Other: Therapeutic education

Study type: Interventional

Funder types: Other

Identifiers

NCT03838939

2018-A00647-48 (Other Identifier)

CHU-420

Details and patient eligibility

About

The hypothesis is that group interaction associated with individual interviews intensify the acquisition of safety skills compared to individual interviews alone in patients with CIR treated by subcutaneous biotherapies.

Full description

Selection and inclusion of patients will be done by principal investigator of Rheumatology Department. After verification of inclusion and non-inclusion criteria by principal investigator and signature of consent, patients will be randomized by 1: 1 randomization (centralized randomization by statistician into 2 groups at M0) :

1. Experimental group (individual and group therapeutic education )

   • M0 (individual) Educational diagnosis and biotherapy education: "subcutaneous injection education" and "biotherapy management".
   • M3 (group with 3 to 10 patients) Intensification Biotherapy Education: Workshops : "Subcutaneous injection education" and "biotherapy management".
   • M6 (individual presential or by phone) Assessment of security skills and questionnaires.
   • M12 (individual presential or by phone) Assessment of security skills and questionnaires.

2. Control group (individual therapeutic education alone ) :

   • M0 (individual) Educational diagnosis and biotherapy education: "subcutaneous injection education" and "biotherapy management".
   • M3 (individual) Intensification Biotherapy Education: "Subcutaneous injection education" and "biotherapy management".
   • M6 (individual présential or by phone) Assessment of security skills and questionnaires.
   • M12 (individual présential or by phone) Assessment of security skills and questionnaires. Group session proposed.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient age > 18 years old with RA (ACR/EULAR criteria) or SA (ASAS criteria) initiating a first subcutaneous biotherapy.
• Patient able to complete a questionnaire
• Patient giving informed consent.
• Patient covered by social security

Exclusion criteria

• • Patient with disorder of higher mental function or psychiatric disorders.
• Patient previously treated by intravenous biotherapy.
• Protected populations: pregnant women, breastfeeding women, tutorship, trusteeship, deprived of liberty, safeguard of justice.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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120 participants in 2 patient groups, including a placebo group

interventional group

Experimental group

Description:

M3 (group with 3 to 10 patients) Intensification Biotherapy Education Workshops : "Subcutaneous injection education" and "biotherapy management

Treatment:

Other: Therapeutic education

Control group

Placebo Comparator group

Description:

M3 (individual) Intensification Biotherapy Education: "Subcutaneous injection education" and "biotherapy management".

Treatment:

Other: Therapeutic education