A Survey to Assess Participants', Caregivers', and Nurses' Use and Understanding of Educational Material on Velaglucerase Alfa (VPRIV) Home Infusion

Study Overview
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Brief Summary
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The main purpose of this survey is to determine participants', caregivers', and nurses' understanding and use of educational material (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
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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.

Official Title
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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

Conditions
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Gaucher Disease

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Gaucher disease participants who receive VPRIV® for home infusion and their caregivers. 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).

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VPRIV® Home Infusion<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy