NCT06258005

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,256

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 23, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

1.2 years

First QC Date

February 5, 2024

Last Update Submit

January 15, 2025

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • PocDoc experience

    Day 1 - one single test done at one timepoint

  • PocDoc value

    Day 1 - one single test done at one timepoint

Study Arms (3)

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 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 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

Interventions

PocDocDIAGNOSTIC_TEST

PocDoc is a digital rapid 5-marker lipid test

PocDoc testing in workplacesPocDoc testing of primary care patientsPocdoc testing in the community

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • Being unable to give informed consent
  • \< 18 years or \> 85 years
  • Legally incompetent
  • Language barriers potentially compromising an adequate compliance with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PocDoc Ltd

Cambridge, CB4 0FW, United Kingdom

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2024

First Posted

February 14, 2024

Study Start

June 23, 2023

Primary Completion

September 1, 2024

Study Completion

January 1, 2025

Last Updated

January 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)