Project COMFORT

Overview

Key participant information

Participant code
COMFORT-017
Enrollment date
31 Aug 2025
Clinical site
Vall d’Hebron
Enrollment place
Hospital
Enrolled part
AB
Status
Completed
Study Population Cohort
Pediatrics
QUESTIONNAIRE
Complete

Study Visits

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

5 visits
DatePartType of visitPlaceStatusComments
31 Aug 2025AScreeningHospitalCompletedScreening visit completed. Eligibility confirmed.
07 Sep 2025A1st VisitHospitalCompletedBaseline visit completed. Sample collection performed at clinical site.
28 Sep 2025A2nd VisitNot applicable (N/A)CompletedAd-hoc follow-up visit.
19 Oct 2025A3rd VisitNot applicable (N/A)CompletedAd-hoc follow-up visit.
09 Nov 2025B1st VisitNot applicable (N/A)CompletedFollow-up visit completed. Capillary microsampling at home.

Collections

Blood microsampling and venipuncture collections with associated analyte results

Blood sample collection
07 Sep 2025
A
CapillaryHome
Collector
Nurse
Device type
TAP Micro Select
Analytes
7
Blood sample collection
28 Sep 2025
A
VenousClinic
Collector
Nurse
Device type
—
Analytes
4
Blood sample collection
19 Oct 2025
A
VenousClinic
Collector
Nurse
Device type
—
Analytes
4
Blood sample collection
09 Nov 2025
B
CapillaryHome
Collector
Nurse
Device type
Greiner MiniCollect EDTA
Analytes
4

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 2025-10-17

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 understandDisagree—
B. Study Information and Visit ExperienceB2I felt comfortable asking questions about the studyNot answered—
B. Study Information and Visit ExperienceB3Satisfaction with study visit organisationVery dissatisfied—
B. Study Information and Visit ExperienceB4Convenience of visit schedulingVery satisfied—
B. Study Information and Visit ExperienceB5Study staff treated me respectfullyAgree—
B. Study Information and Visit ExperienceB6I felt comfortable asking questions during the visitDisagree—
B. Study Information and Visit ExperienceB7Satisfaction with answers receivedSatisfied—
B. Study Information and Visit ExperienceB8Visit duration was acceptableStrongly agree—
B. Study Information and Visit ExperienceB9Impact on daily life was acceptableDisagree—
B. Study Information and Visit ExperienceB10I felt comfortable providing feedback on sampling preferencesStrongly disagree—
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)10 (worst 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?Both methods felt similar to me; convenience matters more.—
D. Microsampling Device ExperienceD1The device seemed easy to useStrongly disagree—
D. Microsampling Device ExperienceD2The device caused little or no painStrongly disagree—
D. Microsampling Device ExperienceD3I could use the device at homeAgree—
D. Microsampling Device ExperienceD4Confidence that microsampling could replace conventional blood samplingStrongly agree—
D. Microsampling Device ExperienceD5Problems experienced with the devicePain, Insufficient bloodSmall leakage on the cartridge.
E. Home / Self-Collection ExperienceE1Did you take part in Part A (home self-collection)?No—
E. Home / Self-Collection ExperienceE2Satisfaction with microsampling equipment and materialsSatisfied—
E. Home / Self-Collection ExperienceE3Helpfulness of training materialsUnhelpful—
E. Home / Self-Collection ExperienceE4Confidence using microsampling for self-collectionNeutral—
E. Home / Self-Collection ExperienceE5Self-collection instructions were clearStrongly agree—
E. Home / Self-Collection ExperienceE6I was able to complete sample collection without helpAgree—
E. Home / Self-Collection ExperienceE7I had access to support during self-collectionDisagree—
E. Home / Self-Collection ExperienceE8Time required for collecting and returning samples was acceptableStrongly agree—
E. Home / Self-Collection ExperienceE9Microsampling fitted into my usual routineStrongly disagree—
E. Home / Self-Collection ExperienceE10I felt safe and confident during self-collectionAgree—
E. Home / Self-Collection ExperienceE11Satisfaction with shipping samples back to the labDissatisfied—
F. Training and SupportF1Which support types were helpful?Other—
F. Training and SupportF2Which factors would build your confidence in using microsampling?Online/telephone support, Doctor recommendation, Trying the device first with a healthcare professional—
G. Future PreferencesG1Preferred future blood collection locationNo preference—
G. Future PreferencesG2Willingness to use a microsampling device at home for regular health-related blood samplingNoHappy to do it if instructions remain clear.
G. Future PreferencesG3If you answered Maybe or No, please explainNot answered—