PocDoc Lipids Out-of-Surgery Study

Vital Signs Solutions

Status: Completed

Conditions: Dyslipidemias

Treatments: Diagnostic Test: PocDoc

Study type: Observational

Funder types: Industry

Identifiers

NCT06258005

325988

Details and patient eligibility

About

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

Full 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.

Enrollment: 4,256 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

4,256 participants in 3 patient groups

PocDoc testing of primary care patients

Description:

There are significant numbers of patients in primary care who should be given annual lipid checks who are not receiving them. PocDoc is a digital rapid 5-marker lipid panel that uses a smartphone as a diagnostic reader. PocDoc tests will be offered to patients overdue their annual lipid check either in surgery, in the community or in their own home.

Treatment:

Diagnostic Test: PocDoc

Pocdoc testing in the community

Description:

Providing lipid testing in community settings such as in pharmacy may offer a more attractive solution to consumers. This hypothesis will be tested by offering PocDoc lipid tests in a community setting.

Treatment:

Diagnostic Test: PocDoc

PocDoc testing in workplaces

Description:

Providing lipid testing as part of a health wellness screen in employees workplaces in may offer an attractive solution to consumers needing their lipid levels check. This hypothesis will be tested by offering PocDoc lipid tests as part of corporate wellness screens.

Treatment:

Diagnostic Test: PocDoc