UnknownNot Applicable

TIMCIs: A Hybrid Type 2 Study of Next-generation Pulse Oximeters

Kenya650 participantsStarted 2022-03-20

Plain-language summary

This study aims to provide evidence on next-generation clinical measurement tools through a mixed methods diagnostic accuracy and implementation study in Kenya, Senegal, Tanzania, and Uttar Pradesh, India.

Who can participate

Age range

59 Months

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: * Children 0 - 59 months for whom caregivers provide consent to participate in the research study, following completion of clinical consultation * Consulting for a respiratory illness, or reported to have a respiratory illness when attending for a routine visit as an outpatient (e.g., vaccination, growth, or chronic disease monitoring) Exclusion Criteria: * Children in the immediate post-natal period or first day of life * Attending for a consultation related to trauma only (including new and follow-up presentations for burns, injuries, wounds) * Admitted within an inpatient part of the facility (including neonates delivered at the facility admitted with their mother) * Children who are critically ill, requiring emergency treatment, or received a recommendation of immediate referral during clinical consultation

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

Diagnostic accuracy: Performance of clinical measurement tools

Timeframe: 19 weeks

Observational implementation: multimodal (MM) operational feasibility

Timeframe: 16 weeks

Trial details

NCT IDNCT05527990

SponsorPATH

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12

Contact for this trial

Helen Storey, PhD.

510-541-4160 hstorey@path.org

View on ClinicalTrials.gov More Focus of Study: Accurate Clinical Measurement and Diagnosis trials

Who can participate

Age range

59 Months

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.