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

Launched by SHIRE · Sep 23, 2022

Keywords

ClinConnect Summary

This clinical trial is looking to understand how well both patients and doctors know about NATPARA, a medication used to treat hypoparathyroidism, a condition where the body does not produce enough parathyroid hormone. The researchers want to learn about people’s thoughts and behaviors regarding the safe use of this medication. Participants will complete a survey that they can take online, over the phone, or on paper, depending on what they prefer. It's important to note that no medications will be given to participants in this study.

To be eligible for the survey, participants must be at least 18 years old and be approved to use NATPARA as part of a specific program called the SUP Program. Caregivers can also help fill out the survey for those who are eligible but unable to do it themselves. Doctors who prescribe NATPARA and have completed the necessary training can also take part. However, anyone who cannot agree to participate, has conflicts of interest, or is not part of the SUP Program will not be able to join. This study is currently accepting participants, and it aims to improve knowledge and safety around the use of NATPARA for everyone involved.

Gender

ALL

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.