Blood sample collection
06 Aug 2025
VenousClinic
- Collector
- Caregiver
- Device type
- —
- Analytes
- 5
Overview
Key participant information
Participant code
COMFORT-048
Enrollment date
30 Jul 2025
Clinical site
Málaga Biomedicine
Enrollment place
Not applicable (N/A)
Enrolled part
B
Status
Lost to follow-up
Study Population Cohort
Elderly
QUESTIONNAIRE
Incomplete
Study Visits
Details of participatnt visits in Part A and/or Part B
| Date | Part | Type of visit | Place | Status | Comments |
|---|---|---|---|---|---|
| 30 Jul 2025 | B | Screening | Hospital | Lost to follow-up | Screening visit completed. Eligibility confirmed. |
| 06 Aug 2025 | B | 1st Visit | Not applicable (N/A) | Lost to follow-up | Follow-up visit completed. Capillary microsampling at home. |
| 27 Aug 2025 | B | 2nd Visit | Not applicable (N/A) | Lost to follow-up | Ad-hoc follow-up visit. |
| 17 Sep 2025 | B | 3rd Visit | Not applicable (N/A) | Lost to follow-up | Ad-hoc follow-up visit. |
Collections
Blood microsampling and venipuncture collections with associated analyte results
B
Blood sample collection
27 Aug 2025
VenousClinic
- Collector
- Phlebotomist
- Device type
- —
- Analytes
- 7
Blood sample collection
17 Sep 2025
CapillaryHome
- Collector
- Nurse
- Device type
- Greiner MiniCollect EDTA
- Analytes
- 3
| Collection | Collection type | Collection place | Collector | Device type | Part | Analytes | Action |
|---|---|---|---|---|---|---|---|
Blood sample collection Details 06 Aug 2025 | Venous | Clinic | Caregiver | — | B | 5 | Open |
Blood sample collection Details 27 Aug 2025 | Venous | Clinic | Phlebotomist | — | B | 7 | Open |
Blood sample collection Details 17 Sep 2025 | Capillary | Home | Nurse | Greiner MiniCollect EDTA | B | 3 | Open |
Adverse Events
Reported adverse events during the study
| Date | Part | Visit | Severity | Device related | Action |
|---|---|---|---|---|---|
| 07 Aug 2025 | B | Other | Severe | No |
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 2025-09-18
| SECTION | Q # | Question | Answer | Comments / Free-text |
|---|---|---|---|---|
| A. Previous Experience with Microsampling | A1 | Had you heard about blood microsampling before this study? | No | — |
| A. Previous Experience with Microsampling | A2 | Name of the microsampling device previously known | Not answered | — |
| A. Previous Experience with Microsampling | A3 | Number of previous uses | Not answered | — |
| A. Previous Experience with Microsampling | A4 | Ease of previous use | Not answered | — |
| A. Previous Experience with Microsampling | A5 | Previous difficulties experienced | Not answered | — |
| B. Study Information and Visit Experience | B1 | Study information was easy to understand | Neutral | — |
| B. Study Information and Visit Experience | B2 | I felt comfortable asking questions about the study | Agree | — |
| B. Study Information and Visit Experience | B3 | Satisfaction with study visit organisation | Very satisfied | — |
| B. Study Information and Visit Experience | B4 | Convenience of visit scheduling | Very dissatisfied | — |
| B. Study Information and Visit Experience | B5 | Study staff treated me respectfully | Disagree | — |
| B. Study Information and Visit Experience | B6 | I felt comfortable asking questions during the visit | Agree | — |
| B. Study Information and Visit Experience | B7 | Satisfaction with answers received | Dissatisfied | — |
| B. Study Information and Visit Experience | B8 | Visit duration was acceptable | Agree | — |
| B. Study Information and Visit Experience | B9 | Impact on daily life was acceptable | Agree | — |
| B. Study Information and Visit Experience | B10 | I felt comfortable providing feedback on sampling preferences | Strongly agree | — |
| C. Conventional Sampling vs Microsampling Experience | C1 | Pain rating for conventional venous blood sampling (0-10) | 10 (worst pain) | — |
| C. Conventional Sampling vs Microsampling Experience | C2 | Pain rating for microsampling device collection (0-10) | Not answered | — |
| C. Conventional Sampling vs Microsampling Experience | C3 | Preferred blood collection method if given a choice | Microsampling | — |
| C. Conventional Sampling vs Microsampling Experience | C4 | Why did you choose this preferred method? | I am used to venous sampling and trust the technique more. | — |
| D. Microsampling Device Experience | D1 | The device seemed easy to use | Not answered | — |
| D. Microsampling Device Experience | D2 | The device caused little or no pain | Strongly disagree | — |
| D. Microsampling Device Experience | D3 | I could use the device at home | Disagree | — |
| D. Microsampling Device Experience | D4 | Confidence that microsampling could replace conventional blood sampling | Not answered | — |
| D. Microsampling Device Experience | D5 | Problems experienced with the device | Other | — |
| E. Home / Self-Collection Experience | E1 | Did you take part in Part A (home self-collection)? | No | — |
| E. Home / Self-Collection Experience | E2 | Satisfaction with microsampling equipment and materials | Satisfied | — |
| E. Home / Self-Collection Experience | E3 | Helpfulness of training materials | Neutral | — |
| E. Home / Self-Collection Experience | E4 | Confidence using microsampling for self-collection | Strongly agree | — |
| E. Home / Self-Collection Experience | E5 | Self-collection instructions were clear | Strongly agree | — |
| E. Home / Self-Collection Experience | E6 | I was able to complete sample collection without help | Disagree | — |
| E. Home / Self-Collection Experience | E7 | I had access to support during self-collection | Not answered | — |
| E. Home / Self-Collection Experience | E8 | Time required for collecting and returning samples was acceptable | Not answered | — |
| E. Home / Self-Collection Experience | E9 | Microsampling fitted into my usual routine | Strongly disagree | — |
| E. Home / Self-Collection Experience | E10 | I felt safe and confident during self-collection | Disagree | — |
| E. Home / Self-Collection Experience | E11 | Satisfaction with shipping samples back to the lab | Not answered | — |
| F. Training and Support | F1 | Which support types were helpful? | In-person explanation | Video tutorial answered most of my doubts. |
| F. Training and Support | F2 | Which factors would build your confidence in using microsampling? | Not answered | — |
| G. Future Preferences | G1 | Preferred future blood collection location | No preference | — |
| G. Future Preferences | G2 | Willingness to use a microsampling device at home for regular health-related blood sampling | Yes | — |
| G. Future Preferences | G3 | If you answered Maybe or No, please explain | Not answered | — |
Legal
Consent and withdrawal information
Date of consent
27 Jul 2025
Date of withdrawal
28 Sep 2025
Withdraw reason
Unable to attend follow-up visits