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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-01

Study Completion Date

2031-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Short Bowel Syndrome (SBS)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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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.

No Intervention

Intervention Type OTHER

This is non-interventional study.

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.

No Intervention

Intervention Type OTHER

This is non-interventional study.

Interventions

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No Intervention

This is non-interventional study.

Intervention Type OTHER

Eligibility Criteria

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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.

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No