Project COMFORT

Overview

Key participant information

Participant code
COMFORT-029
Enrollment date
27 Aug 2025
Clinical site
Palacký Olomouc
Enrollment place
Hospital
Enrolled part
AB
Status
Completed
Study Population Cohort
Pediatrics
QUESTIONNAIRE
Incomplete

Study Visits

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

6 visits
DatePartType of visitPlaceStatusComments
27 Aug 2025AScreeningHospitalCompletedScreening visit completed. Eligibility confirmed.
03 Sep 2025A1st VisitHospitalCompletedBaseline visit completed. Sample collection performed at clinical site.
24 Sep 2025A2nd VisitHospitalCompletedAd-hoc follow-up visit.
15 Oct 2025B1st VisitNot applicable (N/A)CompletedFollow-up visit completed. Capillary microsampling at home.
05 Nov 2025B2nd VisitHospitalCompletedAd-hoc follow-up visit.
26 Nov 2025B3rd VisitHealth Primary CareCompletedAd-hoc follow-up visit.

Collections

Blood microsampling and venipuncture collections with associated analyte results

Blood sample collection
03 Sep 2025
A
CapillaryClinic
Collector
Phlebotomist
Device type
Tasso mini
Analytes
3
Blood sample collection
24 Sep 2025
A
CapillaryClinic
Collector
Phlebotomist
Device type
Hemaspot SE
Analytes
7
Blood sample collection
15 Oct 2025
B
CapillaryHome
Collector
Nurse
Device type
Tasso mini
Analytes
5
Blood sample collection
05 Nov 2025
B
VenousClinic
Collector
Caregiver
Device type
—
Analytes
4
Blood sample collection
26 Nov 2025
B
VenousClinic
Collector
Participant
Device type
—
Analytes
4

Adverse Events

Reported adverse events during the study

DatePartVisitSeverityDevice relatedAction
12 Oct 2025BVisit 3MildPossible

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 2025-10-15

Incomplete
SECTIONQ #QuestionAnswerComments / Free-text
A. Previous Experience with MicrosamplingA1Had you heard about blood microsampling before this study?Not answered—
A. Previous Experience with MicrosamplingA2Name of the microsampling device previously knownNot answered—
A. Previous Experience with MicrosamplingA3Number of previous uses0—
A. Previous Experience with MicrosamplingA4Ease of previous useVery difficult—
A. Previous Experience with MicrosamplingA5Previous difficulties experiencedPainMild pain only.
B. Study Information and Visit ExperienceB1Study information was easy to understandAgree—
B. Study Information and Visit ExperienceB2I felt comfortable asking questions about the studyDisagree—
B. Study Information and Visit ExperienceB3Satisfaction with study visit organisationNot answered—
B. Study Information and Visit ExperienceB4Convenience of visit schedulingNot answered—
B. Study Information and Visit ExperienceB5Study staff treated me respectfullyNot answered—
B. Study Information and Visit ExperienceB6I felt comfortable asking questions during the visitStrongly disagree—
B. Study Information and Visit ExperienceB7Satisfaction with answers receivedSatisfied—
B. Study Information and Visit ExperienceB8Visit duration was acceptableStrongly disagree—
B. Study Information and Visit ExperienceB9Impact on daily life was acceptableStrongly disagree—
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)Not answered—
C. Conventional Sampling vs Microsampling ExperienceC2Pain rating for microsampling device collection (0-10)5—
C. Conventional Sampling vs Microsampling ExperienceC3Preferred blood collection method if given a choiceNo preferenceEither option works for me.
C. Conventional Sampling vs Microsampling ExperienceC4Why did you choose this preferred method?Not answered—
D. Microsampling Device ExperienceD1The device seemed easy to useNot answered—
D. Microsampling Device ExperienceD2The device caused little or no painStrongly disagree—
D. Microsampling Device ExperienceD3I could use the device at homeNot answered—
D. Microsampling Device ExperienceD4Confidence that microsampling could replace conventional blood samplingAgree—
D. Microsampling Device ExperienceD5Problems experienced with the deviceNot answered—
E. Home / Self-Collection ExperienceE1Did you take part in Part A (home self-collection)?Yes—
E. Home / Self-Collection ExperienceE2Satisfaction with microsampling equipment and materialsSatisfied—
E. Home / Self-Collection ExperienceE3Helpfulness of training materialsVery unhelpful—
E. Home / Self-Collection ExperienceE4Confidence using microsampling for self-collectionAgree—
E. Home / Self-Collection ExperienceE5Self-collection instructions were clearDisagree—
E. Home / Self-Collection ExperienceE6I was able to complete sample collection without helpNot answered—
E. Home / Self-Collection ExperienceE7I had access to support during self-collectionStrongly agree—
E. Home / Self-Collection ExperienceE8Time required for collecting and returning samples was acceptableNot answered—
E. Home / Self-Collection ExperienceE9Microsampling fitted into my usual routineNeutral—
E. Home / Self-Collection ExperienceE10I felt safe and confident during self-collectionStrongly agree—
E. Home / Self-Collection ExperienceE11Satisfaction with shipping samples back to the labNot answered—
F. Training and SupportF1Which support types were helpful?Other, Printed instructions, Telephone/online supportNurse walked me through the steps.
F. Training and SupportF2Which factors would build your confidence in using microsampling?Tutorial videos, Doctor recommendation—
G. Future PreferencesG1Preferred future blood collection locationAt a pharmacy—
G. Future PreferencesG2Willingness to use a microsampling device at home for regular health-related blood samplingNot answered—
G. Future PreferencesG3If you answered Maybe or No, please explainNot answered—