Clinical trial NCT05556629: A Survey to Assess Participants' and Physicians' Knowledge, Attitudes and Behavior When Using NATPARA
Official title: Quantitative Testing of Patient and Healthcare Provider Knowledge, Attitudes, and Behavior About NATPARA® (Parathyroid Hormone) for Injection, for Subcutaneous Use
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypoparathyroidism
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: Takeda Development Center Americas, Inc.
First posted: 2022-09-27
Enrollment: 200
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 who have been approved for NATPARA and a part of the SUP program prior to survey implementation and prescribing physicians who can provide a 10-digit NPI number and who are certified in the NATPARA REMS by successfully completing the NATPARA REMS program training module for prescribing physicians, including the knowledge assessment, and submitting a NATPARA REMS program prescribing physician enrollment form are eligible for participation in the survey.

Brief summary: This main aim of this study is to check the level of knowledge and assess attitudes and behaviors of both participants and prescribing physicians regarding the risks and safe use of NATPARA. The survey will be done via internet, telephone, or paper and participants will be able to choose the method that is preferred. No study medicines will be provided to patients in this study.


Eligibility criteria: Participant inclusion criteria:

• Participants who are 18 years of age or older and who have been approved for NATPARA and a part of the SUP Program 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 a part of the SUP Program and who is eligible but unable to complete the survey.

Prescribing physician inclusion criteria:

• HCPs in the United States (US) who can provide a 10-digit NPI number and who are certified in the NATPARA REMS by successfully completing the NATPARA REMS Program Training Module for Prescribing Physicians, including the Knowledge Assessment, and submitting a NATPARA REMS Program Prescribing Physician Enrollment Form are eligible for participation in the survey and a part of the SUP Program.

Participant and Prescribing Physician exclusion criteria:

* Respondents who do not agree to participate in the survey will be excluded.
* Survey respondents who have been employed or whose immediate family members have been employed by NPS, Shire, Takeda, United BioSource LLC, (UBC), or the Food and Drug Administration (FDA) are not eligible to participate in the survey and will be excluded.
* Respondents who reported having a conflict of interest will be excluded.
* Respondents who are not part of the SUP program will be excluded.

Participant exclusion criteria:

* Participants who do not agree to participate in the survey will be excluded.
* Participants who have opted out of receiving communications will be excluded.

Primary outcomes:
measure: Number of Participants and Prescribing Physicians Providing Correct Responses to Questions
timeFrame: Up to approximately 7 years
Secondary outcomes:
measure: Number of Participants and Prescribing Physicians Providing At Least 80 Percent (%) Correct Responses to Each key Risk Messages
timeFrame: Up to approximately 7 years
measure: Number of Participants and Prescribing Physicians who Demonstrated Understanding of Each key Risk Messages
timeFrame: Up to approximately 7 years
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Shire-NPS Pharmaceuticals, INC. (Shire now part of Takeda)
state: Massachusetts
Study officials:
affiliation: Shire
name: Study Director
role: STUDY_DIRECTOR
References: