PocDoc Lipids Out-of-Surgery Study

Dyslipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06258005
• Other study ID #: 325988
• Status: Recruiting
• Start date: June 23, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: February 2024
• Source: Vital Signs Solutions Ltd
• Contact: Kiran Roest, PhD
• Phone: +41799167073
• Email: kiran[@]mypocdoc.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: June 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Diagnostic Test:
• PocDoc
PocDoc is a digital rapid 5-marker lipid test

Locations

Country	Name	City	State
United Kingdom	PocDoc Ltd	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
Vital Signs Solutions Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate	Number and proportion of individuals contacted who conduct a PocDoc test	Day 1 - one single test done at one timepoint
Primary	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	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
Secondary	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