Sample Collection and Instruction Optimization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: First-void urine collection device.
- Who it may be relevant to
- Registry conditions: Instructions for Use, Usability. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
SCIO: Sample Collection and Instruction Optimization
Overview
The aim of this study is to improve the instructions for use and to evaluate the usability of a novel first-void urine collection device.
Detailed description
Participants are asked to try a novel first-void urine collection device and give feedback on the instructions and usability of the device through a questionnaire. Further, only the volume of the collected sample is measured. A first group of 30 participants (15 men and 15 women) will be asked for a one-time visit. If any substantial changes need to be made based on the results of the questionnaire, a second group of 30 participants will be asked to evaluate the adapted version.
Interventions
- Device First-void urine collection device
Use of a first-void urine collection device
Primary outcome measures
- Feedback usability [Time frame: Immediately after use of the first-void urine collection device by participants]
- Feedback instructions for use [Time frame: Immediately after use of the first-void urine collection device by participants]
Secondary outcome measures (1)
- Volume first-void urine collected [Time frame: Baseline (single visit)]
Eligibility criteria
Inclusion criteria
- Naïve to first-void urine collection (standard urine cup is allowed)
- Able to understand the information brochure and what the study is about
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Belgium · 1 center
- University of Antwerp - Centre for the Evaluation of Vaccination — Edegem
Identifiers
NCT: NCT07636668 · B3002026000061