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

Hypoparathyroidism Clinical Trial

— NATPARA KAB  

Official title:

Quantitative Testing of Patient and Healthcare Provider Knowledge, Attitudes, and Behavior About NATPARA® (Parathyroid Hormone) for Injection, for Subcutaneous Use

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05556629
• Other study ID #: TAK-834-4008
• Secondary ID: EUPAS48713
• Status: Recruiting
• Start date: September 1, 2015
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1 866 842 5335
• Email: ClinicalTransparency[@]Takeda.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypoparathyroidism

Intervention

Other:
• No Intervention
This is a non-interventional study.

Locations

Country	Name	City	State
United States	Shire-NPS Pharmaceuticals, INC. (Shire now part of Takeda)	Lexington	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Shire	Takeda Development Center Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants and Prescribing Physicians Providing Correct Responses to Questions	All question for key risk message and about NATPARA will be asked through a questionnaire, Participant or prescribing physicians (HCPs) would need to respond true or false to each question based upon understanding and knowledge. Respondents could be participants or HCPs.	Up to approximately 7 years
Secondary	Number of Participants and Prescribing Physicians Providing At Least 80 Percent (%) Correct Responses to Each key Risk Messages	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 one 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.	Up to approximately 7 years
Secondary	Number of Participants and Prescribing Physicians who Demonstrated Understanding of Each key Risk Messages	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.	Up to approximately 7 years

External Links

•   To obtain more information on the study, click here/on this link