Focus of Study: Accurate Clinical Measurement and Diagnosis
Conditions
Brief 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.
Detailed description
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
Interventions
DEVICEMultimodal PO
Mixed methods diagnostic accuracy and implementation of multimodal PO
Sponsors
UNITAID
Bill and Melinda Gates Foundation
PATH
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 59 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy: Performance of clinical measurement tools | 19 weeks | 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. |
| Observational implementation: multimodal (MM) operational feasibility | 16 weeks | To evaluate the operational feasibility of implementing an approved next generation pulse oximeter at the primary care level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DA: Data repository | 19 weeks | To create an open-source data repository for future research on PPG-derived clinical measurement tools for children. |
| DA: MM Usability | 2 weeks | 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. |
| OI: MM co-design | 1 week | 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. |
| OI: MM/clinical measurement system requirements | 16 weeks | 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. |
| DA: MM Acceptability | 21 weeks | To assess the acceptability of multimodal PO devices among healthcare providers and caregivers at the primary care level. |
Countries
Kenya
Contacts
Primary ContactHelen Storey, PhD.
Backup ContactMegan Horlacher
Outcome results
None listed