A Survey to Assess Participants', Caregivers', and Nurses' Use and Understanding of Educational Material on Velaglucerase Alfa (VPRIV) Home Infusion
A Survey Among Patients, Caregivers and Home Infusion Nurses Based in the European Union to Assess Their Awareness and Understanding of Educational Materials Supporting VPRIV® Infusion at Home
1 other identifier
observational
60
0 countries
N/A
Brief Summary
The main purpose of this survey is to determine participants', caregivers', and nurses' understanding and use of educational materials (EM) on VPRIV home treatment. EM includes an infusion diary and guide and an emergency plan related to VPRIV infusion given at home for Gaucher disease. The survey is conducted in European countries. Data will be collected directly from participants, caregivers, and nurses in form of a questionnaire, electronic or paper.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2026
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2022
CompletedFirst Posted
Study publicly available on registry
January 3, 2023
CompletedStudy Start
First participant enrolled
September 30, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
Study Completion
Last participant's last visit for all outcomes
September 30, 2027
April 18, 2025
April 1, 2025
9 months
December 20, 2022
April 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Percentage of Participants and Caregivers Aware of Educational Material (EM)
EM includes home infusion guide, infusion diary, and safety and emergency plan.
Day 1
Percentage of Participants and Caregivers who Understand the EM
EM includes home infusion guide, infusion diary, and safety and emergency plan.
Day 1
Percentage of Participants and Caregivers who Utilize the EM
EM includes home infusion guide, infusion diary, and safety and emergency plan.
Day 1
Percentage of Home Infusion Nurses Aware of the EM
EM includes home infusion guide, infusion diary, and safety and emergency plan.
Day 1
Percentage of Home Infusion Nurses who Understand the EM
EM includes home infusion guide, infusion diary, and safety and emergency plan.
Day 1
Percentage of Home Infusion Nurses who Utilize the EM
EM includes home infusion guide, infusion diary, and safety and emergency plan.
Day 1
Other Outcomes (2)
Usefulness of the EM for Participants and Caregivers
Day 1
Usefulness of the EM for Home Infusion Nurses
Day 1
Study Arms (1)
VPRIV® Home Infusion
Participants diagnosed with Gaucher disease will receive VPRIV® home infusion, administered by their caregivers and home infusion nurses will participate in the survey and complete the non-nominative web-based questionnaires on Day 1.
Eligibility Criteria
This study will recruit Gaucher disease participants receiving VPRIV® home infusion, their caregivers and home infusion nurses who administer VPRIV® infusion at home in European countries.
You may qualify if:
- Gaucher disease participants who receive VPRIV® for home infusion and their caregivers.
- Home infusion nurses administering VPRIV® to participants with Gaucher disease at home.
You may not qualify if:
- Potential respondents will be excluded if they have conflicts of interest with the survey (e.g., if they are employed by regulatory bodies, or pharmaceutical industry).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2022
First Posted
January 3, 2023
Study Start (Estimated)
September 30, 2026
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
April 18, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- 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.
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.