Clinical trial NCT05527990: TIMCIs: A Hybrid Type 2 Study of Next-generation Pulse Oximeters
Official title: A Study of Next-generation Pulse Oximeters to Support the Integrated Management of Childhood Illnesses in Primary Care Settings. A Mixed Methods Type 2 Effectiveness-implementation Study Measuring the Performance and Feasibility, of Multimodal Pulse Oximeter Devices by Primary Care Providers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Focus of Study: Accurate Clinical Measurement and Diagnosis
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: UNITAID
name: Bill and Melinda Gates Foundation
First posted: 2022-09-06
Enrollment: 650
Sex: ALL
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children 0 - 59 months consulting for or reported to have a respiratory illness.

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

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic accuracy: Performance of clinical measurement tools
timeFrame: 19 weeks
measure: Observational implementation: multimodal (MM) operational feasibility
timeFrame: 16 weeks
Secondary outcomes:
measure: DA: MM Usability
timeFrame: 2 weeks
measure: DA: MM Acceptability
timeFrame: 21 weeks
measure: DA: Data repository
timeFrame: 19 weeks
measure: OI: MM/clinical measurement system requirements
timeFrame: 16 weeks
measure: OI: MM co-design
timeFrame: 1 week
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Mathare North Health Center
city: Nairobi
country: Kenya
facility: Ngiri Health Center
Study officials:
References: