Project COMFORT

Overview

Key participant information

Participant code
COMFORT-041
Enrollment date
17 Aug 2025
Clinical site
Málaga Biomedicine
Enrollment place
Hospital
Enrolled part
AB
Status
Completed
Study Population Cohort
Cardiovascular disease
QUESTIONNAIRE
Complete

Study Visits

Details of participatnt visits in Part A and/or Part B

7 visits
DatePartType of visitPlaceStatusComments
17 Aug 2025AScreeningHospitalCompletedScreening visit completed. Eligibility confirmed.
24 Aug 2025A1st VisitHospitalCompletedBaseline visit completed. Sample collection performed at clinical site.
14 Sep 2025A2nd VisitHealth Primary CareCompletedAd-hoc follow-up visit.
05 Oct 2025A3rd VisitHealth Primary CareCompletedAd-hoc follow-up visit.
26 Oct 2025B1st VisitNot applicable (N/A)CompletedFollow-up visit completed. Capillary microsampling at home.
16 Nov 2025B2nd VisitHealth Primary CareCompletedAd-hoc follow-up visit.
07 Dec 2025B3rd VisitNot applicable (N/A)CompletedAd-hoc follow-up visit.

Collections

Blood microsampling and venipuncture collections with associated analyte results

Blood sample collection
24 Aug 2025
A
VenousClinic
Collector
Participant
Device type
—
Analytes
7
Blood sample collection
14 Sep 2025
A
CapillaryHome
Collector
Nurse
Device type
Hemaspot SE
Analytes
7
Blood sample collection
05 Oct 2025
A
VenousClinic
Collector
Phlebotomist
Device type
—
Analytes
3
Blood sample collection
26 Oct 2025
B
VenousClinic
Collector
Nurse
Device type
—
Analytes
5
Blood sample collection
16 Nov 2025
B
VenousClinic
Collector
Participant
Device type
—
Analytes
4
Blood sample collection
07 Dec 2025
B
VenousClinic
Collector
Caregiver
Device type
—
Analytes
5

Adverse Events

Reported adverse events during the study

No adverse events reported

This participant has no adverse events recorded during the study.

Medical profile

Past medical history and conditions

Coming soon

Past medical history, conditions, medications and allergies will appear here once the ETL feed is connected.

Usability Questionnaire

Participant responses — surveyed on 2025-09-07

Complete
SECTIONQ #QuestionAnswerComments / Free-text
A. Previous Experience with MicrosamplingA1Had you heard about blood microsampling before this study?No—
A. Previous Experience with MicrosamplingA2Name of the microsampling device previously knownNot answered—
A. Previous Experience with MicrosamplingA3Number of previous usesNot answered—
A. Previous Experience with MicrosamplingA4Ease of previous useNot answered—
A. Previous Experience with MicrosamplingA5Previous difficulties experiencedNot answered—
B. Study Information and Visit ExperienceB1Study information was easy to understandNeutral—
B. Study Information and Visit ExperienceB2I felt comfortable asking questions about the studyStrongly agree—
B. Study Information and Visit ExperienceB3Satisfaction with study visit organisationDissatisfied—
B. Study Information and Visit ExperienceB4Convenience of visit schedulingDissatisfied—
B. Study Information and Visit ExperienceB5Study staff treated me respectfullyNeutral—
B. Study Information and Visit ExperienceB6I felt comfortable asking questions during the visitStrongly agree—
B. Study Information and Visit ExperienceB7Satisfaction with answers receivedNeutral—
B. Study Information and Visit ExperienceB8Visit duration was acceptableNeutral—
B. Study Information and Visit ExperienceB9Impact on daily life was acceptableDisagree—
B. Study Information and Visit ExperienceB10I felt comfortable providing feedback on sampling preferencesAgree—
C. Conventional Sampling vs Microsampling ExperienceC1Pain rating for conventional venous blood sampling (0-10)9—
C. Conventional Sampling vs Microsampling ExperienceC2Pain rating for microsampling device collection (0-10)0 (no pain)—
C. Conventional Sampling vs Microsampling ExperienceC3Preferred blood collection method if given a choiceMicrosampling—
C. Conventional Sampling vs Microsampling ExperienceC4Why did you choose this preferred method?Microsampling caused noticeably less discomfort and was faster to perform.—
D. Microsampling Device ExperienceD1The device seemed easy to useStrongly disagree—
D. Microsampling Device ExperienceD2The device caused little or no painDisagree—
D. Microsampling Device ExperienceD3I could use the device at homeNeutral—
D. Microsampling Device ExperienceD4Confidence that microsampling could replace conventional blood samplingDisagree—
D. Microsampling Device ExperienceD5Problems experienced with the devicePain—
E. Home / Self-Collection ExperienceE1Did you take part in Part A (home self-collection)?No—
E. Home / Self-Collection ExperienceE2Satisfaction with microsampling equipment and materialsNeutral—
E. Home / Self-Collection ExperienceE3Helpfulness of training materialsHelpful—
E. Home / Self-Collection ExperienceE4Confidence using microsampling for self-collectionNeutral—
E. Home / Self-Collection ExperienceE5Self-collection instructions were clearAgree—
E. Home / Self-Collection ExperienceE6I was able to complete sample collection without helpDisagree—
E. Home / Self-Collection ExperienceE7I had access to support during self-collectionStrongly disagree—
E. Home / Self-Collection ExperienceE8Time required for collecting and returning samples was acceptableStrongly disagree—
E. Home / Self-Collection ExperienceE9Microsampling fitted into my usual routineNeutral—
E. Home / Self-Collection ExperienceE10I felt safe and confident during self-collectionNot answered—
E. Home / Self-Collection ExperienceE11Satisfaction with shipping samples back to the labVery dissatisfied—
F. Training and SupportF1Which support types were helpful?Video tutorial, In-person explanation—
F. Training and SupportF2Which factors would build your confidence in using microsampling?Tutorial videos, Online/telephone support—
G. Future PreferencesG1Preferred future blood collection locationAt home—
G. Future PreferencesG2Willingness to use a microsampling device at home for regular health-related blood samplingMaybeHappy to do it if instructions remain clear.
G. Future PreferencesG3If you answered Maybe or No, please explainNot answered—