A Survey to Assess Participants' and Physicians' Knowledge, Attitudes and Behavior When Using NATPARA (NATPARA KAB)

Shire

Status: Completed

Conditions: Hypoparathyroidism

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT05556629

TAK-834-4008

EUPAS48713 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

200 participants in 2 patient groups

NATPARA: Participants

Description:

Participants who have been approved for NATPARA and a part of the special use program (SUP) prior to survey implementation will participate in the survey via telephone or internet.

Treatment:

Other: No Intervention

NATPARA: Healthcare Provider (Prescribing Physician)

Description:

Healthcare provider (HCPs)/Prescribing physician who can provide a 10-digit National Provider Identifier (NPI) number and who are certified in the NATPARA risk evaluation and mitigation strategy (REMS) by successfully completing the NATPARA REMS program training module for prescribing physicians, including the knowledge assessment, and submitting a NATPARA REMS Program Prescriber Enrollment Form will participate in the survey via telephone or internet.

Treatment:

Other: No Intervention