Clinical trial NCT06258005: PocDoc Lipids Out-of-Surgery Study
Official title: PocDoc Lipids Study for Increasing Out-of-Surgery Lipid Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemias
Lead sponsor: Vital Signs Solutions Ltd
Sponsor class: INDUSTRY
First posted: 2024-02-14
Enrollment: 4256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals in the primary prevention setting who have not previously had a cardiovascular event such as a heart attack or stroke as well as individuals in the secondary prevention setting who have had previous cardiovascular events.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall response rate
timeFrame: Day 1 - one single test done at one timepoint
measure: Achieved response rate
timeFrame: Day 1 - one single test done at one timepoint
Secondary outcomes:
measure: PocDoc experience
timeFrame: Day 1 - one single test done at one timepoint
measure: PocDoc value
timeFrame: Day 1 - one single test done at one timepoint
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: PocDoc Ltd
Study officials:
References: