Clinical trial NCT05561647: A Survey to Assess Participants' and Physicians' Knowledge, Attitudes and Behavior When Using GATTEX
Official title: Quantitative Testing of Patient and Prescriber Knowledge, Attitudes, and Behavior About GATTEX (Teduglutide) for Injection Safety and Use Information
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Short Bowel Syndrome (SBS)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-09-30
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants and prescriber who have completed Wave 7 of the GATTEX participant KAB Survey will be observed in this REMS survey.

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.


Eligibility 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 patient who is eligible but unable to complete the survey. Note: Participants who have previously participated in a GATTEX Patient Knowledge, Attitudes and Behavior (KAB) 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 HCP KAB 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 HCP KAB 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.

Primary outcomes:
measure: Number of Participants and Prescribers Providing Correct Responses to Questions
timeFrame: Up to 10 years
Secondary outcomes:
measure: Number of Participants and Prescribers Providing At Least 80 Percent (%) Correct Responses to Each Survey Knowledge Domains
timeFrame: Up to 10 years
measure: Number of Participants and Prescribers who Demonstrated Understanding of Survey Knowledge Domains
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Shire-NPS Pharmaceuticals, INC.
state: Massachusetts
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: