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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change from Baseline Biosecure's score at 6 months after biological treatment initiation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
盲法说明
no masking
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- 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.
研究组 & 干预措施
interventional group
M3 (group with 3 to 10 patients) Intensification Biotherapy Education Workshops : "Subcutaneous injection education" and "biotherapy management
干预措施: Therapeutic education (Other)
Control group
M3 (individual) Intensification Biotherapy Education: "Subcutaneous injection education" and "biotherapy management".
干预措施: Therapeutic education (Other)
结局指标
主要结局
Change from Baseline Biosecure's score at 6 months after biological treatment initiation
时间窗: 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.
次要结局
- 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)
- 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)
- Type of infections occurring, collected from patient at M6 and M12 (tracking book )(at 6 months and 12 months)
- Coping evaluated by analogical visual scale at M6 and M12(at 6 months and 12 months)
- Psychological well-being evaluated by Analogical visual scale at M6 and M12 by RAID questionnaire.(at 6 months and 12 months)
- Patient satisfaction evaluated with Patient satisfaction questionnaire(at 12 month)
- Change from Baseline Biosecure's score at 6 months after biological treatment initiation(at 6 months)
- Fear about treatment evaluated by FAIR questionnaire at M6 and M12.(at 6 months and 12 months)