A Survey to Assess Participants' and Physicians' Knowledge, Attitudes and Behavior When Using GATTEX

Recruiting

• Conditions: Short Bowel Syndrome (SBS)
• Interventions: Other: No Intervention

• Registration Number: NCT05561647
• Lead Sponsor: Takeda

Brief Summary

The main aim of this study is to document the level of knowledge and assess attitudes and behaviors of both participants and physicians regarding the risks and safe use of GATTEX. The 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-01
• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-09-28
• Study First Posted: 2022-09-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GATTEX: Participants	No Intervention	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 for up to 10 years via internet, telephone, and paper.
GATTEX: Healthcare Providers (Prescribers)	No Intervention	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 for up to 10 years via internet, telephone, and paper.

Primary Outcome Measures

Name	Time	Method
Number of Participants and Prescribers Providing Correct Responses to Questions	Up to 10 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 Outcome Measures

Name	Time	Method
Number of Participants and Prescribers Providing At Least 80 Percent (%) Correct Responses to Each Survey Knowledge Domains	Up to 10 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 10 years	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.

Trial Locations

Locations (1)

Shire-NPS Pharmaceuticals, INC.; 🇺🇸 Lexington, Massachusetts, United States