NATPARA KAB: A Survey to Assess Participants' and Physicians' Knowledge, Attitudes and Behavior When Using NATPARA
Study Details
Study Description
Brief Summary
This main aim of this study is to check the level of knowledge and assess attitudes and behaviors of both participants and 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| NATPARA: Participants Paticipants 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. |
Other: No Intervention
This is a non-interventional study.
|
| NATPARA: Healthcare Provider (Prescribers) Healthcare provider (HCPs)/Prescriber 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 prescribers, including the knowledge assessment, and submitting a NATPARA REMS Program Prescriber Enrollment Form will participate in the survey via telephone or internet. |
Other: No Intervention
This is a non-interventional study.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants and Prescribers Providing Correct Responses to Questions [Up to approximately 7 years]
All question for key risk message and about NATPARA will be asked through a questionnaire, Participant or prescribers (HCPs) would need to respond true or false to each question based upon understanding and knowledge. Respondents could be participants or HCPs.
Secondary Outcome Measures
- Number of Participants and Prescribers Providing At Least 80 Percent (%) Correct Responses to Each key Risk Messages [Up to approximately 7 years]
The questions will be asked to participants and HCPs will be counted as correct if 80% of the correct responses are provided and not more than 1 incorrect response is provided. In key risk message, general question about NATPARA will be asked, participant or HCPs would need to respond true or false to each question based upon understanding and knowledge. Respondents could be participants or HCPs.
- Number of Participants and Prescribers who Demonstrated Understanding of Each key Risk Messages [Up to approximately 7 years]
Understanding demonstration is defined as respondents who answered 80% or more questions/items in a key risk message correctly. In key risk message, general question about NATPARA will be asked, participants or HCPs would need to respond true or false to each question based upon understanding and knowledge. Respondents could be participants or HCPs.
Eligibility Criteria
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.
Prescriber 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 Prescribers, including the Knowledge Assessment, and submitting a NATPARA REMS Program Prescriber Enrollment Form are eligible for participation in the survey and a part of the SUP Program.
Participant and Prescriber exclusion criteria:
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Respondents who do not agree to participate in the survey will be excluded.
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Survey respondents who have been employed or whose immediate family members have been employed by NPS, Shire, Takeda, UBC, or the Food and Drug Administration (FDA) are not eligible to participate in the survey and will be excluded.
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Respondents who reported having a conflict of interest will be excluded.
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Respondents who are not part of the SUP program will be excluded.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shire-NPS Pharmaceuticals, INC. (Shire now part of Takeda) | Lexington | Massachusetts | United States |
Sponsors and Collaborators
- Shire
Investigators
- Study Director: Study Director, Shire
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- TAK-834-4008
- EUPAS48713