Validation of Non-Invasive Hemoglobin Measurement Using Optical Method for Anemia Screening Among… (NCT07701499) | Clinical Trial Compass
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Validation of Non-Invasive Hemoglobin Measurement Using Optical Method for Anemia Screening Among Adults in Jakarta
Indonesia200 participantsStarted 2026-07-11
Plain-language summary
Anemia remains a major public health concern and is commonly diagnosed through hemoglobin measurement using capillary or venous blood samples. Although laboratory-based and point-of-care testing methods are widely used, they require blood collection, trained personnel, and may cause discomfort to participants. Non-invasive spectrophotometric technology has emerged as a potential alternative for rapid hemoglobin assessment without blood sampling.
This study aims to evaluate the validity and diagnostic performance of a non-invasive hemoglobin using optical method compared with capillary point-of-care testing (POCT) and venous blood hemoglobin measured using an automated hematology analyzer as the reference standard. A total of 150 adults from Kelurahan Kota Bambu, Jakarta, will undergo non-invasive hemoglobin measurement, capillary blood testing, and venous blood testing during a single study visit.
The study will assess agreement between methods, diagnostic accuracy for anemia detection, and factors that may influence measurement performance. Findings from this study are expected to support the development of convenient, community-based anemia screening strategies and provide evidence for future implementation of non-invasive hemoglobin assessment technologies.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 years and older.
* Residents or community members participating in community health screening activities in Kelurahan Kota Bambu, Jakarta.
* Willing to undergo non-invasive hemoglobin measurement.
* Willing to undergo capillary blood hemoglobin testing using point-of-care testing (POCT).
* Willing to undergo venous blood collection for hematology analyzer examination.
* Able to provide written informed consent.
Exclusion Criteria:
* Active bleeding at the time of examination.
* Severe acute illness requiring urgent medical attention.
* Refusal to undergo finger-prick or venous blood sampling.
* History of severe anxiety, syncope, or adverse reactions related to blood collection procedures.
* Visible infection, wound, or skin lesion at the measurement site.
* Severe hand deformity preventing proper non-invasive measurement.
* Nail polish or artificial nails that cannot be removed before examination.
* Markedly cold hands or poor peripheral perfusion that may interfere with optical measurements.
* Incomplete hemoglobin measurement data from any of the study methods.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Agreement Between Non-Invasive Hemoglobin Measurement and Hematology Analyzer