Focus of Study: Accurate Clinical Measurement and DiagnosisNCT05527990
TIMCIs: A Hybrid Type 2 Study of Next-generation Pulse Oximeters
An observational study of Focus of Study: Accurate Clinical Measurement and Diagnosis, run by PATH at 2 sites in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 59 months
- Conditions the study is for
- Focus of Study: Accurate Clinical Measurement and Diagnosis
- What is being tested?
- Multimodal PO
- Type of treatment
- Medical device
- How many people
- 650 participants
- Where
- 2 sitesKenya
- Study dates
- 20 Mar 2022to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 59 months
- All sexes
- No healthy volunteers
- Child
Study population: Children 0 - 59 months consulting for or reported to have a respiratory illness.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Kenya2 sites, 2 recruiting
- Recruiting
Mathare North Health Center
Nairobi
Ambrose Agweyu
- Recruiting
Ngiri Health Center
Nairobi
Ambrose Agweyu
About this study
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
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.
Read the 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
- Being tested
- Multimodal PO
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal PODevice
Mixed methods diagnostic accuracy and implementation of multimodal PO
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 16 weeks
Secondary outcomes (5)
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.
Measured: 2 weeks
DA: MM Acceptability
To assess the acceptability of multimodal PO devices among healthcare providers and caregivers at the primary care level.
Measured: 21 weeks
DA: Data repository
To create an open-source data repository for future research on PPG-derived clinical measurement tools for children.
Measured: 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.
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start20 Mar 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of Study: Accurate Clinical Measurement and DiagnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- UNITAID, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527990
- Sponsor's protocol ID
- RES-00317
- Status last verified
- Oct 2023
- First submitted
- 30 Aug 2022
- Last updated
- 26 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05527990
- Acronym / sponsor ID
- RES-00317
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- UNITAID, Bill and Melinda Gates Foundation
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children 0 - 59 months consulting for or reported to have a respiratory illness.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal POMixed methods diagnostic accuracy and implementation of multimodal PO | Device | – |
Primary outcome
Diagnostic accuracy: Performance of clinical measurement tools
Time frame: 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
Time frame: 16 weeks
To evaluate the operational feasibility of implementing an approved next generation pulse oximeter at the primary care level.
5 secondary outcomes
DA: MM Usability
Time frame: 2 weeks
DA: MM Acceptability
Time frame: 21 weeks
DA: Data repository
Time frame: 19 weeks
OI: MM/clinical measurement system requirements
Time frame: 16 weeks
OI: MM co-design
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focus of Study: Accurate Clinical Measurement and Diagnosis, run by PATH at 2 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helen Storey, PhD. (510-541-4160, hstorey@path.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy: Performance of clinical measurement tools (time frame: 19 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.