A Cross-sectional Study Among Patients in Canada to Assess Awareness and Knowledge of the Fibristal Patient Alert Card
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Allergan
- 试验地点
- 1
- 主要终点
- Percentages of patients with correct responses to the knowledge related questions based on the contents of the Fibristal Patient Alert Card.
研究概览
简要总结
This is a non-interventional, cross-sectional survey study to evaluate the effectiveness of the Additional Risk Minimization Measures for Fibristal among Patients in Canada.
详细描述
Data will be collected via web-based data capture and paper surveys depending on patient preference. The survey will be conducted in a single wave over 6 months. All data will be maintained in compliance with local regulations.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who have received Fibristal within 6 months of completing the survey.
- •Patients who have provided permission to share their responses in aggregate with Health Canada.
- •Patients who have provided informed consent for their participation in the survey.
排除标准
- •Patients who participated in the cognitive pre-testing of the survey questionnaire to be used for the study.
- •Patients who have been direct employees of Allergan, ICON, Health Canada, or Professional Targeted Marketing (PTM) within the past year.
结局指标
主要结局
Percentages of patients with correct responses to the knowledge related questions based on the contents of the Fibristal Patient Alert Card.
时间窗: 18 - 24 months
Correct responses to knowledge-related questions (i.e, potential of fibristal to cause liver injury, signs and symptoms of liver problems, and what to do in case of signs and symptoms of liver problems.)
次要结局
- Percentage of patients that recall their HCPs' ordering of required liver function tests in accordance with the recommendations in the aRMM/CPM(18 - 24 months)
- Percentages of patients that recall recieving and using the Fibristal Patient Alert Card(18 - 24 months)