Short Bowel Syndrome (SBS)
Conditions
Brief summary
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.
Interventions
OTHERNo Intervention
This is non-interventional study.
Sponsors
Takeda
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants and Prescribers Providing Correct Responses to Questions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants and Prescribers Providing At Least 80 Percent (%) Correct Responses to Each Survey Knowledge Domains | Up to 18 years | 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. |
| Number of Participants and Prescribers who Demonstrated Understanding of Survey Knowledge Domains | Up to 18years | 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. |
Countries
United States
Contacts
CONTACTTakeda Contact
STUDY_DIRECTORStudy Director
Takeda
Outcome results
None listed