Quantitative Testing of Patient and Prescriber Knowledge About GATTEX (Teduglutide) for Injection Safety and Use Information
概览
- 阶段
- 不适用
- 干预措施
- No Intervention
- 疾病 / 适应症
- Short Bowel Syndrome (SBS)
- 发起方
- Takeda
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Number of Participants and Prescribers Providing Correct Responses to Questions
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
The study is about learning and documenting how well participants and physicians understand how to use GATTEX and about potential risks by using a survey (called Knowledge Assessment Survey). This survey, which is conducted every two years, is part of the Gattex Risk Evaluation and Mitigation Strategy (REMS). REMS is a safety program required by the US health authority (FDA) for certain medicines that have serious risks. REMS intends to help reduce these risks while still allowing treatment. The goal is to make sure these medicines are used in the safest way possible. The main aim of this survey is to find out how well participants and physicians understand the checkups and tests (so called monitoring) participants should have while taking GATTEX, and the possible risks or of using GATTEX to treat Short Bowel Syndrome.
The knowledge assessment survey will be done via internet, telephone, or paper and both physicians and participants will be able to choose the method that is preferred.
No study medicines will be provided to participants in this study.
研究者
入排标准
入选标准
- •Participant inclusion criteria:
- •Participants who are 18 years of age and who have taken GATTEX in the 60 days 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 eligible but unable to complete the survey. Note: Participants who have previously participated in a GATTEX Patient Knowledge Assessment Survey, are eligible.
- •Prescriber inclusion criteria:
- •HCPs (adult and pediatric) in the United States who can provide a 10-digit National Provider Identifier (NPI) number and who have prescribed GATTEX at least once regardless of their completion of the voluntary GATTEX REMS training (Prescriber Education Slide Deck) are eligible for participation in the survey. Note: HCPs who have previously participated in a GATTEX Prescriber Knowledge Assessment Survey, are eligible
- •Participant and Prescriber
排除标准
- •Respondents who do not agree to participate in the survey.
- •Respondents who are currently working for and/or whose immediate family members who are currently working for Takeda Pharmaceuticals U.S.A., Inc., NPS Pharmaceuticals, Inc., Shire, UBC, or the Food and Drug Administration (FDA) are not eligible to participate in the survey.
- •Respondents who reported having a conflict of interest.
- •HCPs who have opted out of receiving communications about the GATTEX Prescriber Knowledge Assessment Survey for the current wave
- •Further details associated with respondents who do not meet the exclusion criteria established above, will be provided in the assessment report.
研究组 & 干预措施
GATTEX: Participants
Participants who have taken GATTEX in the 60 days prior to survey implementation are eligible to participate in this Risk Evaluation and Mitigation Strategy (REMS) survey via internet, telephone, and paper.
干预措施: No Intervention
GATTEX: Healthcare Providers (Prescribers)
HCPs (adult and pediatric) in the United States (US) who have prescribed GATTEX at least once regardless of their completion of the voluntary GATTEX REMS training are eligible for participation in this REMS survey via internet, telephone, and paper.
干预措施: No Intervention
结局指标
主要结局
Number of Participants and Prescribers Providing Correct Responses to Questions
时间窗: Up to 18 years
All questions for survey knowledge domain and about GATTEX will be asked through a questionnaire, Participant or 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 Prescribers Providing At Least 80 Percent (%) Correct Responses to Each Survey Knowledge Domains(Up to 18 years)
- Number of Participants and Prescribers who Demonstrated Understanding of Survey Knowledge Domains(Up to 18years)