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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypoparathyroidism
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Takeda Contact; Phone Number: +1 866 842 5335; Email: ClinicalTransparency@takeda.com

Study Locations

• United States
  • Massachusetts
    • Lexington, Massachusetts, United States
      • Recruiting
      • Shire-NPS Pharmaceuticals, INC. (Shire now part of Takeda)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants who have been approved for NATPARA and a part of the SUP program prior to survey implementation and prescribing physicians 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NATPARA: Participants; 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.	Other: No Intervention; This is a non-interventional study.
NATPARA: Healthcare Provider (Prescribing Physician); 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.	Other: No Intervention; This is a non-interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Shire
• Collaborators: Takeda Development Center Americas, Inc.
• Investigators: Study Director: Study Director, Shire

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 27, 2022

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hypoparathyroidism
• Other Study ID Numbers: TAK-834-4008; EUPAS48713 (Registry Identifier: ENCePP (EU PAS))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No