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PocDoc Lipids Usability Study for Self-test Use

Primary Purpose

Hyperlipidemias

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
PocDoc
Sponsored by
Vital Signs Solutions Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hyperlipidemias

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vital Signs Solutions Ltd

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PocDoc

Arm Description

All participants given PocDoc device

Outcomes

Primary Outcome Measures

Usability
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.

Secondary Outcome Measures

Full Information

First Posted
September 6, 2023
Last Updated
September 18, 2023
Sponsor
Vital Signs Solutions Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT06053788
Brief Title
PocDoc Lipids Usability Study for Self-test Use
Official Title
PocDoc Lipids Usability Study for Self-test Use
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 26, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
September 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vital Signs Solutions Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PocDoc
Arm Type
Experimental
Arm Description
All participants given PocDoc device
Intervention Type
Diagnostic Test
Intervention Name(s)
PocDoc
Intervention Description
Point of care digital lipid test
Primary Outcome Measure Information:
Title
Usability
Description
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.
Time Frame
Day 1 - one single test done at one timepoint

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Vital Signs Solutions Ltd
City
Cambridge
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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PocDoc Lipids Usability Study for Self-test Use

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