PocDoc Lipids Usability Study for Self-test Use

Not Applicable

Completed

• Conditions: Hyperlipidemias
• Interventions: Diagnostic Test: PocDoc

• Registration Number: NCT06053788
• Lead Sponsor: Vital Signs Solutions Ltd

Brief Summary

This study seeks to expand the approved indication of use for a UKCA approved IVD device. PocDoc lipids is approved for professional use to measure the levels of lipids in a fingerprick blood samples. This study will investigate the usability of the device by untrained lay people in order to expand the device's utility to the self-test setting.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-26
• Primary Completion: 2023-08-01
• Status Verified: 2023-09
• Study Completion: 2023-09-01
• Study First Submitted: 2023-09-06
• Study First Submitted QC: 2023-09-18
• Last Update Submitted: 2023-09-18
• Study First Posted: 2023-09-26
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Signed informed consent form
• Subjects are legally competent and capable to understand character, meaning and consequences of the study
• Subjects own an approved mobile device (these will be available at the time of the study on the PocDoc website and a link will be contained in the PIS)

Exclusion Criteria

• Being unable to give informed consent
• < 18 years or > 85 years
• Legally incompetent
• Language barriers potentially compromising an adequate compliance with study procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PocDoc	PocDoc	All participants given PocDoc device

Primary Outcome Measures

Name	Time	Method
Usability	Day 1 - one single test done at one timepoint	The usability study will pass our acceptance criteria if 95% of the users are able to successfully conduct a PocDoc lipid test, obtaining a result. The PocDoc lipid test is a rapid 5-marker lipid test in lateral flow format that uses a smartphone application to analyse and display the result.; Usability is defined as the ability of an individual to navigate the mobile application steps to conduct the rapid lateral flow test, to take a picture of the image and to navigate to the results page of the application to see their results. A successful test is one where the individual successfully completes all steps and gets their result.

Trial Locations

Locations (1)

Vital Signs Solutions Ltd; 🇬🇧 Cambridge, United Kingdom