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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06258005
Other study ID # 325988
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 23, 2023
Est. completion date December 1, 2024

Study information

Verified date May 2024
Source Vital Signs Solutions Ltd
Contact Kiran Roest, PhD
Phone +41799167073
Email kiran@mypocdoc.com
Is FDA regulated No
Health authority
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 December 1, 2024
Est. primary completion date September 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

Study Design


Related Conditions & MeSH terms


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
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