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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05669729

Enrollment

Registered

2023-01-03

Start date

2026-09-30

Completion date

2027-09-30

Last updated

2026-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gaucher Disease

Keywords

Drug Therapy

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.

Detailed description

The participants diagnosed with Gaucher disease receiving VPRIV® home infusion, their caregivers and home infusion nurses were observed in this study. This cross-sectional study will determine and assess the understanding of the educational material (EM), including infusion diary and emergency plan associated with VPRIV® home infusion in participants diagnosed with Gaucher disease, their caregivers and home infusion nurses. The study will recruit approximately 30 participants/caregivers and 30 home infusion nurses. The survey will be conducted through non-nominative web-based questionnaires that will be completed in approximately 10-15 minutes. All participants will be enrolled in a single observational group: • VPRIV® Home Infusion The trial will be conducted in home-based setting in Austria, Belgium, Finland, France, Germany, Italy, the Netherlands, and Spain.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Gaucher disease participants who receive VPRIV® for home infusion and their caregivers. 2. Home infusion nurses administering VPRIV® to participants with Gaucher disease at home.

Exclusion criteria

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).

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants and Caregivers Aware of Educational Material (EM)	Day 1	EM includes home infusion guide, infusion diary, and safety and emergency plan.
Percentage of Participants and Caregivers who Understand the EM	Day 1	EM includes home infusion guide, infusion diary, and safety and emergency plan.
Percentage of Participants and Caregivers who Utilize the EM	Day 1	EM includes home infusion guide, infusion diary, and safety and emergency plan.
Percentage of Home Infusion Nurses Aware of the EM	Day 1	EM includes home infusion guide, infusion diary, and safety and emergency plan.
Percentage of Home Infusion Nurses who Understand the EM	Day 1	EM includes home infusion guide, infusion diary, and safety and emergency plan.
Percentage of Home Infusion Nurses who Utilize the EM	Day 1	EM includes home infusion guide, infusion diary, and safety and emergency plan.

Contacts

CONTACTTakeda Contact

medinfoUS@takeda.com+1-877-825-3327

STUDY_DIRECTORStudy Director

Takeda

Outcome results