DyslipidemiasNCT06258005
PocDoc Lipids Out-of-Surgery Study
An observational study of Dyslipidemias, run by Vital Signs Solutions Ltd at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- PocDoc
- How many people
- 4,256 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Jun 2023to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Being unable to give informed consent
- < 18 years or > 85 years
- Legally incompetent
- Language barriers potentially compromising an adequate compliance with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- Lipid testing for high-risk individuals on existing CVD register who have not attended in-surgery appointments
- Footfall lipid testing conducted in pharmacy or at community events
- Corporate wellness lipid testing performed by employers for employees as part of an organised corporate wellness check
Read the 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:
- 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
- Enable increase in "treat to target" and move more patients from low / medium intensity statin onto high intensity, which reduces risk of CVD events
- 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.
- Conditions
- Dyslipidemias
- Being tested
- PocDoc
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PocDocDiagnostic test
PocDoc is a digital rapid 5-marker lipid test
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: PocDoc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Number and proportion of individuals contacted who conduct a PocDoc test
Measured: 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
Measured: Day 1 - one single test done at one timepoint
Secondary outcomes (2)
PocDoc experience
Number (N) and proportion (%) of individuals reporting a positive experience with the PocDoc testing pathway
Measured: Day 1 - one single test done at one timepoint
PocDoc value
- Number (N) and proportion (%) of individuals reporting improvements vs in surgery testing procedure with regards to convenience, speed of testing, testing process
Measured: Day 1 - one single test done at one timepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start23 Jun 2023
- Primary completion1 Sep 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vital Signs Solutions Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258005
- Sponsor's protocol ID
- 325988
- Status last verified
- Jan 2025
- First submitted
- 5 Feb 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roest K, Kelly C, Marshall T, Whales E, Taylor L, Hatfield R, Bunyan K, Dawson L, Roest S, Newton J. Rapid community "Healthy Heart" screening to identify people at high risk of cardiovascular events. PLoS One. 2026 Sep 29;21(9):e0358999. doi: 10.1371/journal.pone.0358999. eCollection 2026.
PubMed 42809611
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PocDoc Lipids Study for Increasing Out-of-Surgery Lipid Testing
- ClinicalTrials.gov ID
- NCT06258005
- Acronym / sponsor ID
- 325988
- Conditions
- Dyslipidemias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,256 participants (actual)
- Lead sponsor
- Vital Signs Solutions LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Lipid testing for high-risk individuals on existing CVD register who have not attended in-surgery appointments
- Footfall lipid testing conducted in pharmacy or at community events
- 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:
- 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
- Enable increase in "treat to target" and move more patients from low / medium intensity statin onto high intensity, which reduces risk of CVD events
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PocDoc testing of primary care patients | – | Diagnostic Test: PocDocThere 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. |
| Pocdoc testing in the community | – | Diagnostic Test: PocDocProviding 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. |
| PocDoc testing in workplaces | – | Diagnostic Test: PocDocProviding 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- Being unable to give informed consent
- < 18 years or > 85 years
- Legally incompetent
- Language barriers potentially compromising an adequate compliance with study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PocDocPocDoc is a digital rapid 5-marker lipid test | Diagnostic test | PocDoc testing in workplaces, PocDoc testing of primary care patients, Pocdoc testing in the community |
Primary outcome
Overall response rate
Time frame: Day 1 - one single test done at one timepoint
Number and proportion of individuals contacted who conduct a PocDoc test
Achieved response rate
Time frame: Day 1 - one single test done at one timepoint
Number and proportion of individuals who conduct a PocDoc test that have dyslipidaemia
2 secondary outcomes
PocDoc experience
Time frame: Day 1 - one single test done at one timepoint
PocDoc value
Time frame: Day 1 - one single test done at one timepoint
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Derived from this study: PubMed 42809611Roest K, Kelly C, Marshall T, Whales E, Taylor L, Hatfield R, Bunyan K, Dawson L, Roest S, Newton J. Rapid community "Healthy Heart" screening to identify people at high risk of cardiovascular events. PLoS One. 2026 Sep 29;21(9):e0358999. doi: 10.1371/journal.pone.0358999. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemias, run by Vital Signs Solutions Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: Day 1 - one single test done at one timepoint). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06258005, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025; AzTrials last refreshed its copy on 30 Oct 2026.