A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey)

Официальное название

Quantitative Testing of Patient and Prescriber Knowledge About GATTEX (Teduglutide) for Injection Safety and Use Information

Обзор

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.

Вмешательства

• Другое No Intervention
  This is non-interventional study.

Первичные конечные точки

• Number of Participants and Prescribers Providing Correct Responses to Questions [Срок оценки: Up to 18 years]

Вторичные конечные точки (2)

• Number of Participants and Prescribers Providing At Least 80 Percent (%) Correct Responses to Each Survey Knowledge Domains [Срок оценки: Up to 18 years]
• Number of Participants and Prescribers who Demonstrated Understanding of Survey Knowledge Domains [Срок оценки: Up to 18years]

Критерии участия

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 exclusion criteria:

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 1 центр

• Takeda Pharmaceuticals, U.S.A., Inc. — Cambridge

Идентификаторы

NCT: NCT05561647 · TAK-633-4008 · EUPAS48716

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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