Quantitative Testing of Patient and Healthcare Provider Knowledge, Attitudes, and Behavior About NATPARA® (Parathyroid Hormone) for Injection, for Subcutaneous Use

Shire1 个研究点分布在 1 个国家目标入组 200 人2015年9月1日

适应症Hypoparathyroidism

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Hypoparathyroidism
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
状态: 已完成
最后更新: 3个月前

概览研究者入排标准结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2015年9月1日

结束日期

2025年11月30日

最后更新

3个月前

研究类型

Observational

性别

All

研究者

发起方

Shire

责任方

Sponsor

入排标准

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)