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

Recruiting

• Conditions: Hypoparathyroidism
• Interventions: Other: No Intervention

• Registration Number: NCT05556629
• Lead Sponsor: Shire

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-01
• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NATPARA: Healthcare Provider (Prescribing Physician)	No Intervention	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.
NATPARA: Participants	No Intervention	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants and Prescribing Physicians 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 prescribing physicians (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

Name	Time	Method
Number of Participants and Prescribing Physicians 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.
Number of Participants and Prescribing Physicians 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 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.

Trial Locations

Locations (1)

Shire-NPS Pharmaceuticals, INC. (Shire now part of Takeda); 🇺🇸 Lexington, Massachusetts, United States