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

Studies

Study First Submitted Date 2022-12-20
Study First Posted Date 2023-01-03
Last Update Posted Date 2023-06-22
Start Month Year March 4, 2024
Primary Completion Month Year September 5, 2025
Verification Month Year June 2023
Verification Date 2023-06-30
Last Update Posted Date 2023-06-22

Detailed Descriptions

Sequence: 20808217
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.

Conditions

Sequence: 52391683
Name Gaucher Disease
Downcase Name gaucher disease

Id Information

Sequence: 40315405
Id Source org_study_id
Id Value TAK-669-4018

Design Groups

Sequence: 55838489
Title VPRIV® Home Infusion
Description 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.

Keywords

Sequence: 80168462
Name Drug Therapy
Downcase Name drug therapy

Design Outcomes

Sequence: 178194016 Sequence: 178194017 Sequence: 178194018 Sequence: 178194019 Sequence: 178194020 Sequence: 178194021 Sequence: 178194022 Sequence: 178194023
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type other Outcome Type other
Measure Percentage of Participants and Caregivers Aware of Educational Material (EM) Measure Percentage of Participants and Caregivers who Understand the EM Measure Percentage of Participants and Caregivers who Utilize the EM Measure Percentage of Home Infusion Nurses Aware of the EM Measure Percentage of Home Infusion Nurses who Understand the EM Measure Percentage of Home Infusion Nurses who Utilize the EM Measure Usefulness of the EM for Participants and Caregivers Measure Usefulness of the EM for Home Infusion Nurses
Time Frame Day 1 Time Frame Day 1 Time Frame Day 1 Time Frame Day 1 Time Frame Day 1 Time Frame Day 1 Time Frame Day 1 Time Frame Day 1
Description EM includes home infusion guide, infusion diary, and safety and emergency plan. Description EM includes home infusion guide, infusion diary, and safety and emergency plan. Description EM includes home infusion guide, infusion diary, and safety and emergency plan. Description EM includes home infusion guide, infusion diary, and safety and emergency plan. Description EM includes home infusion guide, infusion diary, and safety and emergency plan. Description EM includes home infusion guide, infusion diary, and safety and emergency plan. Description EM includes home infusion guide, infusion diary, and safety and emergency plan. Usefulness will be assessed using the 12-item participant and caregiver questionnaire, and 15-item home infusion nurse questionnaire. Description EM includes home infusion guide, infusion diary, and safety and emergency plan. Usefulness will be assessed using the 12-item participant and caregiver questionnaire, and 15-item home infusion nurse questionnaire.

Browse Conditions

Sequence: 194324371 Sequence: 194324372 Sequence: 194324373 Sequence: 194324374 Sequence: 194324375 Sequence: 194324376 Sequence: 194324377 Sequence: 194324378 Sequence: 194324379 Sequence: 194324380 Sequence: 194324381 Sequence: 194324382 Sequence: 194324383 Sequence: 194324384 Sequence: 194324385
Mesh Term Gaucher Disease Mesh Term Sphingolipidoses Mesh Term Lysosomal Storage Diseases, Nervous System Mesh Term Brain Diseases, Metabolic, Inborn Mesh Term Brain Diseases, Metabolic Mesh Term Brain Diseases Mesh Term Central Nervous System Diseases Mesh Term Nervous System Diseases Mesh Term Metabolism, Inborn Errors Mesh Term Genetic Diseases, Inborn Mesh Term Lipidoses Mesh Term Lipid Metabolism, Inborn Errors Mesh Term Lysosomal Storage Diseases Mesh Term Metabolic Diseases Mesh Term Lipid Metabolism Disorders
Downcase Mesh Term gaucher disease Downcase Mesh Term sphingolipidoses Downcase Mesh Term lysosomal storage diseases, nervous system Downcase Mesh Term brain diseases, metabolic, inborn Downcase Mesh Term brain diseases, metabolic Downcase Mesh Term brain diseases Downcase Mesh Term central nervous system diseases Downcase Mesh Term nervous system diseases Downcase Mesh Term metabolism, inborn errors Downcase Mesh Term genetic diseases, inborn Downcase Mesh Term lipidoses Downcase Mesh Term lipid metabolism, inborn errors Downcase Mesh Term lysosomal storage diseases Downcase Mesh Term metabolic diseases Downcase Mesh Term lipid metabolism disorders
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48524726
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Takeda

Overall Officials

Sequence: 29400958
Role Study Director
Name Study Director
Affiliation Takeda

Central Contacts

Sequence: 12065720
Contact Type primary
Name Takeda Contact
Phone +1-877-825-3327
Email medinfoUS@takeda.com
Role Contact

Eligibilities

Sequence: 30892794
Sampling Method Non-Probability Sample
Gender All
Minimum Age 2 Years
Maximum Age N/A
Healthy Volunteers No
Population 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.
Criteria 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).
Adult True
Child True
Older Adult True

Calculated Values

Sequence: 254135911
Registered In Calendar Year 2022
Were Results Reported False
Has Single Facility False
Minimum Age Num 2
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 6
Number Of Other Outcomes To Measure 2

Designs

Sequence: 30638538
Observational Model Cohort
Time Perspective Cross-Sectional

Links

Sequence: 4404681
Url https://clinicaltrials.takeda.com/study-detail/e895407fd93e49c7?idFilter=%5B%22TAK-669-4018%22%5D
Description To obtain more information on the study, click here/on this link

Responsible Parties

Sequence: 29005148
Responsible Party Type Sponsor

Ipd Information Types

Sequence: 3351836 Sequence: 3351837 Sequence: 3351838 Sequence: 3351839
Name Study Protocol Name Statistical Analysis Plan (SAP) Name Informed Consent Form (ICF) Name Clinical Study Report (CSR)