NCT06258005

PocDoc Lipids Out-of-Surgery Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,256 (actual)
• Sponsor: Vital Signs Solutions Ltd · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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: 1. 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 2. Enable increase in "treat to target" and move more patients from low / medium intensity statin onto high intensity, which reduces risk of CVD events 3. 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.

Conditions

• Dyslipidemias

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PocDoc	PocDoc is a digital rapid 5-marker lipid test

Timeline

• Start date: 2023-06-23
• Primary completion: 2024-09-01
• Completion: 2025-01-01
• First posted: 2024-02-14
• Last updated: 2025-01-17

Locations

1 site across 1 country: United Kingdom