PocDoc Lipids Out-of-Surgery Study

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

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

Study Overview

• Status: Recruiting
• Conditions: Dyslipidemias
• Intervention / Treatment: Diagnostic test: PocDoc

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.

• Study Type: Observational
• Enrollment (Estimated): 8000

Contacts and Locations

• Study Contact: Name: Kiran Roest, PhD; Phone Number: +41799167073; Email: kiran@mypocdoc.com

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB4 0FW
    • Recruiting
    • PocDoc Ltd
    • Contact: Kiran Roest, PhD; Phone Number: 0041799167073; Email: kiran@mypocdoc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PocDoc testing of primary care patients; 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.	Diagnostic test: PocDoc; PocDoc is a digital rapid 5-marker lipid test
Pocdoc testing in the community; 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.	Diagnostic test: PocDoc; PocDoc is a digital rapid 5-marker lipid test
PocDoc testing in workplaces; 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.	Diagnostic test: PocDoc; PocDoc is a digital rapid 5-marker lipid test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate	Number and proportion of individuals contacted who conduct a PocDoc test	Day 1 - one single test done at one timepoint
Achieved response rate	Number and proportion of individuals who conduct a PocDoc test that have dyslipidaemia	Day 1 - one single test done at one timepoint

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PocDoc experience	Number (N) and proportion (%) of individuals reporting a positive experience with the PocDoc testing pathway	Day 1 - one single test done at one timepoint
PocDoc value	c. Number (N) and proportion (%) of individuals reporting improvements vs in surgery testing procedure with regards to convenience, speed of testing, testing process	Day 1 - one single test done at one timepoint

Collaborators and Investigators

• Sponsor: Vital Signs Solutions Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: 325988

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No