Capillary Sampling in Clinical Populations Undergoing Monitoring

Sponsor
University of Edinburgh
Study ID
NCT07802665
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blood sampling with capillary sampling device(s) — DIAGNOSTIC_TEST
    Blood sampling with capillary sampling device(s)

Study Details

Many people with long-term health conditions require regular blood tests to monitor their disease or medications. These blood tests are usually performed by taking blood from a vein during a hospital or clinic appointment. This can be inconvenient, time-consuming and difficult for some people, particularly those who live far from hospital, have reduced mobility, require frequent tests, or experience anxiety about attending healthcare settings or having blood taken. Capillary blood sampling devices allow people to collect a small blood sample themselves, usually from the upper arm or fingertip, which can then be sent to a laboratory by post. These devices have shown promising results for some blood tests, but there is insufficient evidence of which tests remain accurate when samples are collected at home, posted to the laboratory and subjected to postage conditions and delayed analysis. The CAPSICUM study will compare blood samples collected using patient-operated capillary sampling devices with routine venous blood samples already being taken as part of participants' usual clinical care. We will investigate whether a wide range of blood tests produce similar results using both methods and assess how delayed analysis, postal transport and home collection affect test accuracy. Participants will attend only one study visit, which will take place during a routine clinic appointment. Some participants will also be invited to collect an additional blood sample at home and return it by post, and to complete a brief questionnaire about their experience. The findings from this study will help identify which blood tests can be safely monitored using home capillary blood sampling. This could improve access to blood monitoring, reduce unnecessary hospital visits, make monitoring more convenient for patients, and support the development of safe, evidence-based remote monitoring pathways within the NHS.

Key Dates

First listed
Sep 3, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Patients with kidney disease
  • Arm: Patients with immune-mediated disease
    e.g. ANCA-associated vasculitis or systemic lupus erythematosus
  • Arm: Kidney, kidney-pancreas and islet transplant recipients
  • Arm: Patients with mental health disorders who experience barriers to conventional blood sampling
  • Arm: Children requiring regular blood monitoring

Primary Outcome Measure

For each pre-defined analyte, the mean difference and 95% limits of agreement between paired capillary and venous blood sample results under immediate analysis conditions, assessed against predefined clinically acceptable limits of agreement. [ Time Frame: From enrollment to end of study visit 1 ]

Central Contacts

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