Evaluation of the Effectiveness of the Abatacept (Orencia®) IV and SC Patient Alert Cards in Patients With Rheumatoid Arthritis in European Economic Area Countries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 25
- 主要终点
- HCP survey: Mean total score for correct responses
研究概览
简要总结
The purpose of the study is to determine a) if the implementation of abatacept (Orencia®) patient alert card (PAC) resulted in effective understanding of key safety messages and b) if the degree of understanding of key safety messages is associated with improved clinical and safety outcomes.
详细描述
3 sub studies: 2 Cross-Sectional and 1 retrospective chart review
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient survey (cohort 1):
- •Patients has taken abatacept within the previous 3 months for rheumatoid arthritis
- •Patient is 18 years of age or over
- •HCP survey (cohort 2):
- •a) Physician or nurses working in rheumatology centers, with at least 1 patient taking abatacept in the previous 6 months for rheumatoid arthritis (by prescribing, administering or by follow up)
- •Retrospective chart review study (cohort 3):
- •Patient survey questionnaire completed , Informed Consent Form (ICF) signed
排除标准
- •Patient survey:
- •Patient has participated in a clinical trial for their arthritis in the previous 12 months
- •Currently an employee of BMS
- •HCP survey:
- •Physicians or nurse who have recruited patients for the Patient survey
- •Currently an employee of BMS
结局指标
主要结局
HCP survey: Mean total score for correct responses
时间窗: Day 1
Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of associated with abatacept treatment
时间窗: At patient enrolment
Patient survey: Proportion of patients treated with abatacept who have received the PAC
时间窗: At patient enrolment
Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of allergic reactions associated with abatacept treatment
时间窗: At patient enrolment
Patient survey: Mean total score for correct responses
时间窗: At patient enrolment
Patient survey: Proportion of patients who have utilised the PAC, and the extent of its use
时间窗: At patient enrolment
Patient survey: Proportion of patients treated with abatacept who are aware of the existence of the PAC
时间窗: At patient enrolment
Patient survey: Mean scores for correct responses for questions grouped by objectives
时间窗: At patient enrolment
Objectives: distribution, awareness, utility, utilization and knowledge
HCP survey: Proportion of HCPs who prescribe or administer abatacept in rheumatology centers who are aware of the PAC
时间窗: Day 1
HCP survey: Proportion of HCPs' who have utilized the PAC, and the extent of its use
时间窗: Day 1
HCP survey: Levels of HCPs' knowledge and comprehension related to the important identified risks of infections and the need to screen for specific infection prior to initiating or administering abatacept
时间窗: Day 1
Retrospective chart review study (clinical outcome study): Proportion of infections leading to hospitalization
时间窗: Approximately 3 months
HCP survey: Mean scores for correct responses for questions grouped by objectives
时间窗: Day 1
Objectives: distribution, awareness, utility, utilization and knowledge
次要结局
- Major determinants of patients knowledge of the key messages contained in the abatacept IV, Subcutaneous (SC) formulation PACs among patients(At patient enrolment)
- Determinants of Health Care Professional (HCP) understanding, Implementation regarding key messages contained in the PAC based on data collected in the abatacept IV and SC formulation PACs among HCPs(Day 1)
- Major determinants of understanding the key messages contained in the abatacept IV, SC formulation PACs among patients(At patient enrolment)
- Major determinants of implementation regarding the key messages contained in the abatacept IV, SC formulation PACs among patients(At patient enrolment)
- Retrospective chart review study (clinical outcome study): Proportion of patients with results of any test to screen for Tuberculosis (TB) prior to administration of therapy of abatacept(Upto 8 years)
- Retrospective chart review study (clinical outcome study): Proportion of patients with results of any test to screen for viral hepatitis before administration of therapy with abatacept(Upto 8 years)
- Retrospective chart review study (clinical outcome study): Mean time from infection (symptom onset) to receiving medical attention(Upto 8 years)