TIMCIs: A Hybrid Type 2 Study of Next-generation Pulse Ox... | NCT05527990

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

NCT05527990

Sponsor

PATH

Status

Unknown status

Last Update Posted

Oct 26, 2023Actual

Enrollment

650Estimated

Phase

Not provided

Conditions

Focus of Study: Accurate Clinical Measurement and Diagnosis

Interventions

Multimodal PO

Countries

Kenya

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2022Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Aug 30, 2022

First Submission Date that Met QC Criteria

Sep 1, 2022

First Posted Date

Sep 6, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2023

Last Update Posted Date

Oct 26, 2023Actual

Name	Class
UNITAID	OTHER
Bill and Melinda Gates Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

650Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multimodal PO	Device	Mixed methods diagnostic accuracy and implementation of multimodal PO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	16 weeks

Secondary Outcomes

Measure	Description	Time Frame
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.	2 weeks
DA: MM Acceptability

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

59 Months

Standard Ages

Child

Study Population

Children 0 - 59 months consulting for or reported to have a respiratory illness.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Helen Storey, PhD.	Contact	510-541-4160		hstorey@path.org
Megan Horlacher	Contact	7345365674		mhorlacher@path.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mathare North Health Center	Recruiting	Nairobi			Kenya

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004194	Disease

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided