Project COMFORT

Overview

Key participant information

Participant code
COMFORT-047
Enrollment date
23 Oct 2025
Clinical site
Karolinska Hospital
Enrollment place
Not applicable (N/A)
Enrolled part
AB
Status
Withdrawn
Study Population Cohort
Pediatrics
QUESTIONNAIRE
Complete

Study Visits

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

7 visits
DatePartType of visitPlaceStatusComments
23 Oct 2025AScreeningHospitalWithdrawnScreening visit completed. Eligibility confirmed.
30 Oct 2025A1st VisitHospitalWithdrawnBaseline visit completed. Sample collection performed at clinical site.
20 Nov 2025A2nd VisitHealth Primary CareWithdrawnAd-hoc follow-up visit.
11 Dec 2025A3rd VisitHospitalWithdrawnAd-hoc follow-up visit.
01 Jan 2026B1st VisitNot applicable (N/A)WithdrawnFollow-up visit completed. Capillary microsampling at home.
22 Jan 2026B2nd VisitHospitalWithdrawnAd-hoc follow-up visit.
12 Feb 2026B3rd VisitNot applicable (N/A)WithdrawnAd-hoc follow-up visit.

Collections

Blood microsampling and venipuncture collections with associated analyte results

Blood sample collection
30 Oct 2025
A
VenousClinic
Collector
Phlebotomist
Device type
—
Analytes
4
Blood sample collection
20 Nov 2025
A
VenousClinic
Collector
Caregiver
Device type
—
Analytes
7
Blood sample collection
11 Dec 2025
A
CapillaryHome
Collector
Caregiver
Device type
Capitainer B
Analytes
3
Blood sample collection
01 Jan 2026
B
VenousClinic
Collector
Nurse
Device type
—
Analytes
5
Blood sample collection
22 Jan 2026
B
VenousClinic
Collector
Participant
Device type
—
Analytes
6
Blood sample collection
12 Feb 2026
B
VenousClinic
Collector
Phlebotomist
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 2025-12-14

Complete
SECTIONQ #QuestionAnswerComments / Free-text
A. Previous Experience with MicrosamplingA1Had you heard about blood microsampling before this study?Yes—
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 easy—
A. Previous Experience with MicrosamplingA5Previous difficulties experiencedDevice malfunction, Insufficient sample, BruisingDevice was awkward to position.
B. Study Information and Visit ExperienceB1Study information was easy to understandStrongly disagree—
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 schedulingSatisfied—
B. Study Information and Visit ExperienceB5Study staff treated me respectfullyDisagree—
B. Study Information and Visit ExperienceB6I felt comfortable asking questions during the visitAgree—
B. Study Information and Visit ExperienceB7Satisfaction with answers receivedNot answered—
B. Study Information and Visit ExperienceB8Visit duration was acceptableStrongly disagree—
B. Study Information and Visit ExperienceB9Impact on daily life was acceptableNeutral—
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)10 (worst pain)—
C. Conventional Sampling vs Microsampling ExperienceC2Pain rating for microsampling device collection (0-10)9—
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?Not answered—
D. Microsampling Device ExperienceD1The device seemed easy to useNeutral—
D. Microsampling Device ExperienceD2The device caused little or no painAgree—
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 deviceDevice error—
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 materialsNeutral—
E. Home / Self-Collection ExperienceE4Confidence using microsampling for self-collectionStrongly disagree—
E. Home / Self-Collection ExperienceE5Self-collection instructions were clearDisagree—
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 acceptableDisagree—
E. Home / Self-Collection ExperienceE9Microsampling fitted into my usual routineAgree—
E. Home / Self-Collection ExperienceE10I felt safe and confident during self-collectionAgree—
E. Home / Self-Collection ExperienceE11Satisfaction with shipping samples back to the labNeutral—
F. Training and SupportF1Which support types were helpful?Video tutorial, Telephone/online support, Printed instructionsNurse walked me through the steps.
F. Training and SupportF2Which factors would build your confidence in using microsampling?Doctor recommendation, Trying the device first with a healthcare professional, 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 samplingYes—
G. Future PreferencesG3If you answered Maybe or No, please explainNot answered—