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OpenTrials
Completed

NCT Number: NCT06258005

PocDoc Lipids Out-of-Surgery Study

This study seeks to improve access to lipid testing in out-of-surgery locations using PocDoc, a UKCA approved IVD device that measures a full 5 marker lipid panel using a smartphone or tablet. The study will investigate whether PocDoc can close the gap in people not tested by exploring 3 new out-of-surgery methods:

1. Lipid testing for high-risk individuals on existing CVD register who have not attended in-surgery appointments 2. Footfall lipid testing conducted in pharmacy or at community events 3. Corporate wellness lipid testing performed by employers for employees as part of an organised corporate wellness check

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

PocDoc Ltd

Cambridge, CB4 0FW, United Kingdom

About this study

Lipid testing in out-of-surgery (OOS) locations using a digital lipid measuring device called PocDoc promises to increase access to lipid testing and cardiovascular disease health assessment. PocDoc lipids comprises a smartphone-compatible disposable microchip test strip which uses proprietary colorimetric microfluidic technology to accurately detect lipid biomarkers from a droplet of blood. PocDoc Lipids Professional was launched in 2022 to enable professional users to perform lipid screens as part of lifestyle or preventative healthcare screens. The investigator's hypothesise that providing easier, more cost-effective access to lipid testing at scale, without patients having to attend the GP surgery could:

  • Identify previously unidentified patients (including key "hard to reach" cohorts) who have elevated lipid levels and get them into a lipid lowering clinical pathway which reduces risk of CVD event
  • Enable increase in "treat to target" and move more patients from low / medium intensity statin onto high intensity, which reduces risk of CVD events
  • Identify more cases of undiagnosed FH and getting those patients into a lipid lowering pathway

The SBRI 21 Phase 3 program is funding this collaborative project in partnership with SMASH PCN and AHSN NENC with the objective of increasing access to lipid testing in those geographies.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consent indicated from within PocDoc app
  • 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 the central team will verify individuals have appropriate mobile devices before PocDoc tests are sent to them)

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

Treatment and study plan

PocDoc

Diagnostic Test

PocDoc is a digital rapid 5-marker lipid test

Primary outcomes

  1. Overall response rate

    Time frame: Day 1 - one single test done at one timepoint

    Number and proportion of individuals contacted who conduct a PocDoc test

  2. Achieved response rate

    Time frame: Day 1 - one single test done at one timepoint

    Number and proportion of individuals who conduct a PocDoc test that have dyslipidaemia

Secondary outcomes

  1. PocDoc experience

    Time frame: Day 1 - one single test done at one timepoint

    Number (N) and proportion (%) of individuals reporting a positive experience with the PocDoc testing pathway

  2. PocDoc value

    Time frame: Day 1 - one single test done at one timepoint

    c. Number (N) and proportion (%) of individuals reporting improvements vs in surgery testing procedure with regards to convenience, speed of testing, testing process

Sponsors and collaborators

Lead sponsor

Vital Signs Solutions Ltd

Industry

Registry information

Official study title

PocDoc Lipids Study for Increasing Out-of-Surgery Lipid Testing

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Feb 14, 2024
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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