An observational study in Focus of Study: Accurate Clinical Measurement and Diagnosis, sponsored by PATH. Recruiting at 2 sites in Kenya. Open to participants aged Up to 59 Months. Per ClinicalTrials.gov, last updated 2023-10-26.
Sponsored by PATH · Observational
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.
Performance and feasibility of photoplethysmograph (PPG)-derived clinical measurement tools (medical device and smartphone-based screening technologies) by primary care providers will be assessed using a type 2 hybrid design to conduct a mixed methods diagnostic accuracy and implementation study.
The diagnostic accuracy study will consist of 3 components to achieve the primary and secondary objectives: 1) a usability assessment of observed user-product interactions and a system usability score, 2) measurement of multimodal PO device performance through comparison against a reference standard, and 3) caregiver/provider acceptability through semi-structured interviews.
The observational implementation (OI) study consists of 3 components to achieve the primary and secondary objectives: 1) a human-centered design workshop, 2) an observational study to evaluate the feasibility of implementing an approved multimodal PO device in clinical care, and 3) semi-structured in-depth interviews to assess provider and caregiver acceptability and adaptation.
The interventions for this study are PPG-derived clinical measurement tools that measure oxygen saturation (SpO2), pulse rate, respiratory rate, and/or temperature. The interventions will also be compared to a reference standard for the different clinical measurements
PATH is the lead sponsor of 113 studies on the registry; 7 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children 0 - 59 months consulting for or reported to have a respiratory illness.
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Exclusion Criteria:
Mixed methods diagnostic accuracy and implementation of multimodal PO
Diagnostic accuracy: Performance of clinical measurement tools
To determine the performance of PPG-derived clinical measurement tools (medical device and smartphone-based screening technologies) compared to an accepted reference standard, among children 0-59 months seeking care at the primary care level.
Time frame: 19 weeks
Observational implementation: multimodal (MM) operational feasibility
To evaluate the operational feasibility of implementing an approved next generation pulse oximeter at the primary care level.
Time frame: 16 weeks
DA: MM Usability
To measure the usability of multimodal PO devices, measuring pulse oximetry and respiratory rate in addition to other relevant clinical measurements, by healthcare providers at the primary care level.
Time frame: 2 weeks
DA: MM Acceptability
To assess the acceptability of multimodal PO devices among healthcare providers and caregivers at the primary care level.
Time frame: 21 weeks
DA: Data repository
To create an open-source data repository for future research on PPG-derived clinical measurement tools for children.
Time frame: 19 weeks
OI: MM/clinical measurement system requirements
To explore future multimodal PO device and smartphone based clinical measurement product concepts and prototypes to further define the user and health system requirements for potential device integration within integrated management of childhood illness (IMCI) care practices, among country stakeholders and healthcare providers.
Time frame: 16 weeks
OI: MM co-design
To co-design integration of an approved multimodal PO device within existing IMCI practices, mapping current and future state workflows, prioritizing outcomes, and determining training needs.
Time frame: 1 week
Plan to share: No
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