Capillary Sampling in Clinical Populations Undergoing Monitoring
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6+
SponsorUniversity of Edinburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be attending a routine clinical appointment during which venous blood sampling is planned as part of standard clinical care for disease monitoring or therapeutic drug monitoring.
Be willing and able to undertake capillary blood sampling independently or with appropriate assistance.
Be aged ≥18 years of age.
Have capacity to provide written informed consent.
Disqualifiers
Inability or unwillingness to provide informed consent, or, for paediatric participants, absence of parental or legal guardian consent or age-appropriate assent where applicable.
Skin disease, infection, injury, or other local factors at the intended sampling site that would make capillary blood collection unsafe or impractical.
Known allergy or hypersensitivity to any materials used in the capillary blood sampling devices.
Inability to undertake the capillary sampling procedures independently or with appropriate assistance.
Trial population
A maximum of 1000 participants will be recruited. The study aims to include approximately 200 participants from each of five clinical populations in which regular blood monitoring forms part of routine care and where remote capillary blood sampling has the potential to improve access to monitoring or patient experience: * Patients with kidney disease * Patients with immune-mediated disease * Kidney, kidney-pancreas and islet transplant recipients * Patients with mental health disorders requiring regular blood monitoring * Children attending paediatric services who require regular blood monitoring
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood sampling with capillary sampling device(s)
Diagnostic testBlood sampling with capillary sampling device(s)
Treatment groups
1,000 Participants
are divided into 5 treatment groupsGroup A: Patients with kidney disease1 intervention
Group B: Patients with immune-mediated disease1 intervention
Group C: Kidney, kidney-pancreas and islet transplant recipients1 intervention
Group D: Patients with mental health disorders who experience barriers to conventional blood sampling1 intervention
Group E: Children requiring regular blood monitoring1 intervention
Trial outcomes
Primary outcomes
1
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 1Secondary outcomes
1
Mean difference and 95% limits of agreement following delayed analysis (24-48 hours).
Time frame
From enrollment to end of study visit 12
Mean difference and 95% limits of agreement following delayed analysis after exposure to temperatures representative of routine postal transport.
Time frame
Enrollment to end of study visit 13
Mean difference and 95% limits of agreement following unsupervised patient-led home collection and postal return.
Time frame
Enrollment to end of study visit 14
Proportion of successful capillary sample collections and proportion of samples unsuitable for laboratory analysis, by analyte, patient group and sampling device.
Time frame
Enrollment to end of study visit 1Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: