Biotherapies and Therapeutic Education in Chronic Inflammatory Rheumatism

Study Overview
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Brief Summary
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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.

Detailed Description
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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) : 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. 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.

Official Title
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Impact of Association of Individual and Group Therapeutic Education Sessions on the Acquisition of Safety Skills by Patients With Chronic Inflammatory Rheumatism (CIR) Treated With Subcutaneous Biotherapy, Compared to Individual Therapeutic Education Sessions Alone

Conditions
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Rheumatoid Arthritis, Spondyloarthritis

Intervention / Treatment
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* Other: Therapeutic education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interventional group<br>M3 (group with 3 to 10 patients) Intensification Biotherapy Education Workshops : Subcutaneous injection education and biotherapy management | Other: Therapeutic education<br>* Individual and group therapeutic education sessions will consist of : acquisition by patient of self-care skills such as performing subcutaneous injection, acquisition by patient of safety skills such as identifying symptoms that should lead to consult general practitioner, and stop treatment ...<br>|
| Placebo Comparator: Control group<br>M3 (individual) Intensification Biotherapy Education: Subcutaneous injection education and biotherapy management. | Other: Therapeutic education<br>* Individual and group therapeutic education sessions will consist of : acquisition by patient of self-care skills such as performing subcutaneous injection, acquisition by patient of safety skills such as identifying symptoms that should lead to consult general practitioner, and stop treatment ...<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Biosecure's score at 6 months after biological treatment initiation | Biosecure questionnaire assesses safety skills regarding infections, vaccinations, and situations of daily life (travel, surgery, pregnancy,…). It's composed of 29 questions about knowledge and 7 scenarios. The response methods are: yes / no / I don't know, with 55 items (score from 0 to 100 points), developed by Therapeutic Education Section of French Society of Rheumatology. | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Biosecure's score at 6 months after biological treatment initiation | Biosecure questionnaire assesses safety skills regarding infections, vaccinations, and situations of daily life (travel, surgery, pregnancy,…). It's composed of 29 questions about knowledge and 7 scenarios. The response methods are: yes / no / I don't know, with 55 items (score from 0 to 100 points), developed by Therapeutic Education Section French Society of Rheumatology. | at 6 months | 
| Number of hospitalizations for infection during the year, collected from patient (tracking book) and in medical file, at the follow-up at M12 | patient tracking book includes type of infection, stop biotherapy, consultation with attending physician, taking antibiotics, hospitalization and validation by treating physician | at 12 months | 
| Number of biotherapy stops and number of visits to physician for infection, collected from patient at M6 and M12 (tracking book) | patient tracking book includes type of infection, stop biotherapy, consultation with attending physician, taking antibiotics, hospitalization and validation by treating physician | at 6 months and 12 months | 
| Type of infections occurring, collected from patient at M6 and M12 (tracking book ) | patient tracking book includes type of infection, stop biotherapy, consultation with attending physician, taking antibiotics, hospitalization and validation by treating physician | at 6 months and 12 months | 
| Coping evaluated by analogical visual scale at M6 and M12 | RAID questionnaire is calculated according to 7 numerical rating scales: pain, functional ability, fatigue, sleep, emotional well-being, physical well-being, and disease management. Each scale is evaluated by a number between 0 and 10. A final RAID score with high values characterize a disturbing state of the patient | at 6 months and 12 months | 
| Psychological well-being evaluated by Analogical visual scale at M6 and M12 by RAID questionnaire. | RAID questionnaire is calculated according to 7 numerical rating scales: pain, functional ability, fatigue, sleep, emotional well-being, physical well-being, and disease management. Each scale is evaluated by a number between 0 and 10. A final RAID score with high values characterize a disturbing state of the patient. | at 6 months and 12 months | 
| Fear about treatment evaluated by FAIR questionnaire at M6 and M12. | FAIR questionnaire (Fear Assessment in Inflammatory Rheumatic diseases) evaluate the levels of fear (side effects of treatment, disease progress,…) and psychological distress in patients, it be included in clinical trial protocols to measure the impact of specific interventions on psychological distress | at 6 months and 12 months | 
| Patient satisfaction evaluated with Patient satisfaction questionnaire | Patient satisfaction questionnaire items are: overall satisfaction of education sessions, quality of content in line with expectations, teaching methods and tools used, course flow, quality of the exchange | at 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic inflammatory rheumatism, biotherapies, therapeutic education, safety skills