Rheumatoid Arthritis, Spondyloarthritis
Conditions
Keywords
chronic inflammatory rheumatism, biotherapies, therapeutic education, safety skills
Brief summary
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
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.
Interventions
OTHERTherapeutic education
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 ...
Sponsors
University Hospital, Clermont-Ferrand
French Society of Rheumatology
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
no masking
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Biosecure's score at 6 months after biological treatment initiation | at 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Biosecure's score at 6 months after biological treatment initiation | at 6 months | 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. |
| Number of hospitalizations for infection during the year, collected from patient (tracking book) and in medical file, at the follow-up at M12 | at 12 months | patient tracking book includes type of infection, stop biotherapy, consultation with attending physician, taking antibiotics, hospitalization and validation by treating physician |
| Number of biotherapy stops and number of visits to physician for infection, collected from patient at M6 and M12 (tracking book) | at 6 months and 12 months | patient tracking book includes type of infection, stop biotherapy, consultation with attending physician, taking antibiotics, hospitalization and validation by treating physician |
| Type of infections occurring, collected from patient at M6 and M12 (tracking book ) | at 6 months and 12 months | patient tracking book includes type of infection, stop biotherapy, consultation with attending physician, taking antibiotics, hospitalization and validation by treating physician |
| Coping evaluated by analogical visual scale at M6 and M12 | at 6 months and 12 months | 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 |
| Psychological well-being evaluated by Analogical visual scale at M6 and M12 by RAID questionnaire. | at 6 months and 12 months | 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. |
| Fear about treatment evaluated by FAIR questionnaire at M6 and M12. | at 6 months and 12 months | 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 |
| Patient satisfaction evaluated with Patient satisfaction questionnaire | at 12 month | 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORFrançoise FAYET
University Hospital, Clermont-Ferrand
Outcome results
None listed