Survey on knowledge and attitudes about NATPARA use
Quantitative Testing of Patient and Healthcare Provider Knowledge, Attitudes, and Behavior About NATPARA® (Parathyroid Hormone) for Injection, for Subcutaneous Use
This study is trying to understand what patients and doctors know and think about using NATPARA to treat hypoparathyroidism.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Locations | 1 site (Lexington, Massachusetts) |
| Trial ID | NCT05556629 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the knowledge, attitudes, and behaviors of participants and prescribing physicians regarding the safe use of NATPARA for treating hypoparathyroidism. The survey will be conducted through various methods, including internet, telephone, or paper, allowing participants to choose their preferred mode of response. No medications will be provided, as the focus is solely on gathering information about the understanding and perceptions of NATPARA among those involved in its use.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have been approved for NATPARA and are part of the SUP Program.
Not a fit: Patients who do not agree to participate in the survey or are not part of the SUP Program may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of NATPARA's safe use, potentially leading to improved patient outcomes.
How similar studies have performed: While this approach is observational and focuses on knowledge assessment, similar studies have shown that understanding patient and physician perspectives can lead to improved treatment adherence and outcomes.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Lexington, Massachusetts
- Shire-NPS Pharmaceuticals, INC. (Shire now part of Takeda) — Lexington, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Takeda Contact
- Email: ClinicalTransparency@Takeda.com
- Phone: +1 866 842 5335
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.