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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTakeda

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial population

Participants and prescriber who have completed Wave 8 of the GATTEX Knowledge Assessment Survey will be observed in this REMS survey.

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • No Intervention

    Other intervention

    This is non-interventional study.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: GATTEX: Participants1 intervention
Group B: GATTEX: Healthcare Providers (Prescribers)1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants and Prescribers Providing Correct Responses to Questions

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.

Time frame
Up to 18 years

Secondary outcomes

1

Number of Participants and Prescribers Providing At Least 80 Percent (%) Correct Responses to Each Survey Knowledge Domains

The questions will be asked to participants and HCPs and will be counted as correct if 80% of the correct responses are provided and not more than 1 incorrect response is provided. In each survey knowledge domain, general questions about GATTEX will be asked; participants or HCPs would need to respond true or false to each question based upon understanding and knowledge. Respondents could be participants or HCPs.

Time frame
Up to 18 years
2

Number of Participants and Prescribers who Demonstrated Understanding of Survey Knowledge Domains

Understanding demonstration is defined as respondents who answered 80% or more questions/items in a survey knowledge domain correctly. In each survey knowledge domain, general questions about GATTEX will be asked, and participants or HCPs would need to respond true or false to each question based upon understanding and knowledge. Respondents could be participants or HCPs.

Time frame
Up to 18years

Other outcomes

Sponsors and contacts

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