Quantitative Testing of Patient and Healthcare Provider Knowledge, Attitudes, and Behavior About NATPARA® (Parathyroid Hormone) for Injection, for Subcutaneous Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of Participants and Prescribing Physicians Providing Correct Responses to Questions
研究概览
简要总结
This main aim of this study is to check the level of knowledge and assess attitudes and behaviors of both participants and prescribing physicians regarding the risks and safe use of NATPARA. The survey will be done via internet, telephone, or paper and participants will be able to choose the method that is preferred. No study medicines will be provided to patients in this study.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Participant inclusion criteria:
- •Participants who are 18 years of age or older and who have been approved for NATPARA and a part of the SUP Program prior to survey implementation are eligible to participate in the survey.
- •A caregiver may participate in this survey on behalf of a participant who is a part of the SUP Program and who is eligible but unable to complete the survey.
- •Prescribing physician inclusion criteria:
- •HCPs in the United States (US) who can provide a 10-digit NPI number and who are certified in the NATPARA REMS by successfully completing the NATPARA REMS Program Training Module for Prescribing Physicians, including the Knowledge Assessment, and submitting a NATPARA REMS Program Prescribing Physician Enrollment Form are eligible for participation in the survey and a part of the SUP Program.
- •Participant and Prescribing Physician
排除标准
- •Respondents who do not agree to participate in the survey will be excluded.
- •Survey respondents who have been employed or whose immediate family members have been employed by NPS, Shire, Takeda, United BioSource LLC, (UBC), or the Food and Drug Administration (FDA) are not eligible to participate in the survey and will be excluded.
- •Respondents who reported having a conflict of interest will be excluded.
- •Respondents who are not part of the SUP program will be excluded.
- •Participant exclusion criteria:
- •Participants who do not agree to participate in the survey will be excluded.
- •Participants who have opted out of receiving communications will be excluded.
结局指标
主要结局
Number of Participants and Prescribing Physicians Providing Correct Responses to Questions
时间窗: Up to approximately 7 years
All question for key risk message and about NATPARA will be asked through a questionnaire, Participant or prescribing physicians (HCPs) would need to respond true or false to each question based upon understanding and knowledge. Respondents could be participants or HCPs.
次要结局
- Number of Participants and Prescribing Physicians who Demonstrated Understanding of Each key Risk Messages(Up to approximately 7 years)
- Number of Participants and Prescribing Physicians Providing At Least 80 Percent (%) Correct Responses to Each key Risk Messages(Up to approximately 7 years)