Project COMFORT

Overview

Key participant information

Participant code
COMFORT-045
Enrollment date
19 Dec 2025
Clinical site
Karolinska Hospital
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

7 visits
DatePartType of visitPlaceStatusComments
19 Dec 2025AScreeningHospitalCompletedScreening visit completed. Eligibility confirmed.
26 Dec 2025A1st VisitHospitalCompletedBaseline visit completed. Sample collection performed at clinical site.
16 Jan 2026A2nd VisitNot applicable (N/A)CompletedAd-hoc follow-up visit.
06 Feb 2026A3rd VisitHospitalCompletedAd-hoc follow-up visit.
27 Feb 2026B1st VisitNot applicable (N/A)CompletedFollow-up visit completed. Capillary microsampling at home.
20 Mar 2026B2nd VisitHospitalCompletedAd-hoc follow-up visit.
10 Apr 2026B3rd VisitNot applicable (N/A)CompletedAd-hoc follow-up visit.

Collections

Blood microsampling and venipuncture collections with associated analyte results

Blood sample collection
26 Dec 2025
A
VenousClinic
Collector
Nurse
Device type
—
Analytes
4
Blood sample collection
16 Jan 2026
A
VenousClinic
Collector
Nurse
Device type
—
Analytes
5
Blood sample collection
06 Feb 2026
A
CapillaryClinic
Collector
Phlebotomist
Device type
Hemaspot SE
Analytes
5
Blood sample collection
27 Feb 2026
B
CapillaryHome
Collector
Phlebotomist
Device type
Whatman 903 PSC
Analytes
3
Blood sample collection
20 Mar 2026
B
VenousClinic
Collector
Participant
Device type
—
Analytes
4
Blood sample collection
10 Apr 2026
B
CapillaryHome
Collector
Caregiver
Device type
Greiner MiniCollect EDTA
Analytes
7

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 2026-01-28

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 organisationNeutral—
B. Study Information and Visit ExperienceB4Convenience of visit schedulingSatisfied—
B. Study Information and Visit ExperienceB5Study staff treated me respectfullyStrongly agree—
B. Study Information and Visit ExperienceB6I felt comfortable asking questions during the visitStrongly agree—
B. Study Information and Visit ExperienceB7Satisfaction with answers receivedVery satisfied—
B. Study Information and Visit ExperienceB8Visit duration was acceptableStrongly agree—
B. Study Information and Visit ExperienceB9Impact on daily life was acceptableStrongly disagree—
B. Study Information and Visit ExperienceB10I felt comfortable providing feedback on sampling preferencesDisagree—
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)7—
C. Conventional Sampling vs Microsampling ExperienceC3Preferred blood collection method if given a choiceConventional blood sampling—
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 useDisagree—
D. Microsampling Device ExperienceD2The device caused little or no painStrongly agree—
D. Microsampling Device ExperienceD3I could use the device at homeStrongly agree—
D. Microsampling Device ExperienceD4Confidence that microsampling could replace conventional blood samplingAgree—
D. Microsampling Device ExperienceD5Problems experienced with the devicePain, Insufficient bloodNo issues noted.
E. Home / Self-Collection ExperienceE1Did you take part in Part A (home self-collection)?Yes—
E. Home / Self-Collection ExperienceE2Satisfaction with microsampling equipment and materialsNot answered—
E. Home / Self-Collection ExperienceE3Helpfulness of training materialsUnhelpful—
E. Home / Self-Collection ExperienceE4Confidence using microsampling for self-collectionStrongly agree—
E. Home / Self-Collection ExperienceE5Self-collection instructions were clearDisagree—
E. Home / Self-Collection ExperienceE6I was able to complete sample collection without helpStrongly disagree—
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 acceptableAgree—
E. Home / Self-Collection ExperienceE9Microsampling fitted into my usual routineStrongly disagree—
E. Home / Self-Collection ExperienceE10I felt safe and confident during self-collectionStrongly agree—
E. Home / Self-Collection ExperienceE11Satisfaction with shipping samples back to the labSatisfied—
F. Training and SupportF1Which support types were helpful?In-person explanation, Printed instructions, OtherPrinted booklet was particularly useful.
F. Training and SupportF2Which factors would build your confidence in using microsampling?Tutorial videos—
G. Future PreferencesG1Preferred future blood collection locationNo preference—
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—