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Trial registered on ANZCTR


Registration number
ACTRN12615000348550
Ethics application status
Approved
Date submitted
22/01/2015
Date registered
16/04/2015
Date last updated
14/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Use of improved tools for measuring respiratory rate and oxygen saturation among community health workers : Sub-Saharan Africa and Southeast Asia.
Scientific title
Accuracy, usability and acceptability of respiratory rate timers and pulse oximeters when used by community health workers and first level health facility workers to detect the signs of pneumonia in children under five in resource poor settings, as compared to a medical professional counting respiratory rate or using the same pulse oximeter.
Secondary ID [1] 285542 0
BMGF Global Health Grant OPP1054367
Universal Trial Number (UTN)
U1111-1163-3494
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumonia 293360 0
Condition category
Condition code
Respiratory 293635 293635 0 0
Other respiratory disorders / diseases
Infection 294835 294835 0 0
Other infectious diseases
Public Health 294836 294836 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention aims is to identify the most accurate, acceptable, scalable and user-friendly respiratory rate (RR) timers and pulse oximeters (POx) for the detection of pneumonia symptoms by CHWs and FLHFWs in four low-income countries - Cambodia in Southeast Asia and Ethiopia, South Sudan and Uganda in Sub-Saharan Africa.

The accuracy of each device in the hands of CHWs and FLHFWs will be evaluated against three reference standards: medical expert counting (to be referred to as expert counter), a sample of videos of the CHW using the new devices which will be reviewed by a panel of experts and thirdly, an automated monitoring device (Masimo’s Radical-7 device) to obtain RR and oxygen saturation (%SpO2), respectively. A total of up to six new devices will be tested in this way on a sample of up to 300 children in each of the four countries.

To explore the acceptability and usability of the RR counting devices and pulse oximeter devices as perceived by parents, community and FLHFWs in Sub-Saharan Africa and South-East Asia a selection of up to two RR timing/classification devices and one POx device based on minimal clinical performance standards and pile sorting with CHWs and FLHFWs. This will include an evaluation of user perceptions of the devices in routine practice. Conduct qualitative interviews with CHWs and caregivers of children under five on their perceptions and opinions regarding the device(s) used and perform intermittent quality assurance to establish whether healthcare providers’ use of the selected device remains in accordance with the training and is not changing over time.

The nine devices being tested in the study can be grouped into broad device categories as follows:

1. Respiratory Rate Counters - 4 devices

a) Non-automated devices include tools that support the manual counting of chest movements, by indicating when to start and stop counting and in this study the UNICEF ARI timer and counting beads are the two devices being tested.
b) Automated devices support an assisted count, by automating or negating the need for manual counting of each chest movement. Mobile software applications in the category of assisted count work when CHWs tap the screen or press buttons for each chest movement. Mobile phone applications being tested in this study include a simple feature phone app called the respirometer and a SMART phone app called rrate.


2. Pulse Oximeters - 5 devices

a) Handheld Pulse Oximeters tend to be more expensive than Fingertip Pulse Oximeters and are designed for professional rather than for home use. Many of them are suitable for adults, children and young infants, since oxygen is measured using a finger external sensor that can be purchased separately for paediatric and neonatal use. As with fingertip Pulse Oximeters, handheld oximeters show values of SpO2 and pulse rate in different colours on the display, but, in general, they would need additional training of CHWs because they are more complex to operate. In this study two devices will be tested - Lifebox and UTECH.

b) Mobile phone applications In order to measure oxygen saturation in blood through a mobile phone application it is necessary, in addition to a smartphone or iPhone, to also have an external finger sensor. Most of these applications can be downloaded for free; however the price of the phone and the sensor has to be also included when thinking on this approach. Oxygen values of the patient are shown on the display of the phone. In this study one device will be tested - Masimo iSPO2 android pulse oximeter.

c) Fingertip Pulse Oximeters are the most affordable option for measuring oxygen saturation (SpO2) in blood, and almost all of them show values of pulse rate in addition to the SpO2. A selection of fingertip pulse oximeters suitable to be use with children and showing display values in blue and black was conducted. A limitation found within this category is that some of the fingertip pulse oximeters designed for paediatric use have a limited age range of 2 to 13 years old or 15 kg weight and they are therefore not suitable for use with neonates. In this study two devices will be tested - Contec and Devon.

Pairs of devices will be tested and therefore each pair of devices will be tested over a two week period in each country to achieve the required sample size.
Intervention code [1] 290489 0
Early detection / Screening
Comparator / control treatment
For respiratory rate the compararator will be a medical professional or expert counter simultaneously counting the respiratory rate of the patient while the community health worker or first level health facility worker is using the new device to measure the respiratory rate. This comparator will be the main measure but will be supported by along with a sample of video recordings being recorded and subsequently observed by expert respiratory rate counters.
Control group
Active

Outcomes
Primary outcome [1] 293449 0
The primary outcome for the evaluation of respiratory rate timing/classification devices will be:

The difference (or delta) in the, reading of the CHW and the continuous monitor (Masimo Radical 7)
AND
The difference (or delta) in the reading between the expert counter and the continuous monitor.
Timepoint [1] 293449 0
2 months or until the required sample is reached
Primary outcome [2] 293450 0
For the Pulse Oximeter devices the primary outcome will be agreement in SpO2 reading between the CHW/FLHFW and the expert counter. As a back-up SpO2 comparison, the reading from the Masimo’s Radical 7, Pulse Oximeter will be used.
Timepoint [2] 293450 0
Two months or until the required sample size is reached
Secondary outcome [1] 311074 0
Acceptability and usability of new devices by community health workers and first level health facility workers. This will be done using semi-structured qualitative interviews and checklists completed by research assistants as the CHWs use the devices.

Timepoint [1] 311074 0
2 months or until the required sample is reached
Secondary outcome [2] 313695 0
Acceptability of new devices to caregivers. This will be done using semi-structured qualitative interviews with caregivers after the CHWs have conducted their assessments.
Timepoint [2] 313695 0
Two months or until the sample size has been reached.

Eligibility
Key inclusion criteria
A child who fulfils ALL of the following eligibility criteria will be included in this study:
1. Age between 2 months to 59 months
2. Cough or Difficulty in Breathing
3. Caregiver consent.

A young infant who fulfils the following eligibility criteria will be included in this study:
1. Age 0 days to 60 days
2. Caregiver consent.
Minimum age
0 Days
Maximum age
59 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A child with the following criteria will be excluded from this study:
1. Presenting illness of greater than two weeks duration
2. The child having severe dehydration, child with agitation/inconsolable, neck stiffness, active convulsions/fits, unconscious/lethargic, not breastfeeding and vomiting everything
3. Caregiver’s age less than 18 years
4. No Caregiver consent.

A young infant with the following criteria will be excluded from this study:
1. The child having severe dehydration, child with agitation/inconsolable, neck stiffness, active convulsions/fits, unconscious/lethargic, not breastfeeding and vomiting everything
2. Caregiver’s age less than 18 years
3. No Caregiver consent.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study subjects will be:

a) Children 0 to 5 years of age attending medical care/baby clinics/inpatient care at a health facility (e.g. a hospital, health centre). Their caregivers must be over 18 years of age and will be invited to participate in the study.

b) CHWs/FLHFWs involved in the diagnosis and management of pneumonia in children under 5 years in the four study countries, will be systematically selected based on maximum variation in characteristics (literacy, age groups, gender, years of experience and distance to health facility) reflecting the CHW/FLHFW profile in the country. The CHW/FLHFW will be 18 years and over so as to allow them to give written informed consent process to participate in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size calculations are based on precision of the estimated difference between device and expert respiratory count assuming normal distribution (Bland and Altman 2012). A standard deviation of Sd=7 for the difference was obtained in a previous study (Noordam, Barbera Lainez et al. 2014), data not shown. Requiring a maximal total length of the 95% confidence interval of 4 units, the minimal sample size will be 47 per strata for independent observations.

The total sample size in all countries will add up to 2*3*47=282 when stratifying into age groups 0 to 60 days / between 2 and 59 months, and a pairwise division of 7 devices into 3 groups. The sample size is then increased by 50% to n=423 (rounded off to 430) to accommodate potential clustering on CHW level. This would mean a total sample size across all four countries of 1720.

A normal distribution of the mean of the differences could be assumed based on the relatively large sample size (central limit theorem) but differences will be logged if motivated. The selected precision is in the same range as the WHO accepted maximal absolute breathing rate deviance (Malaria Consortium 2014). The sampling design requires each child to be measured by at least two devices (assessed by the CHW/FLHFW) and the expert. Clustering of data on child level is not accounted for in the sample size calculations due to the limited cluster size of 2 observations. Clustering on CHW level might exist. In all countries 20 CHWs and 5 FLHFWs will participate for each set of devices.

In all countries a cluster size averaging (n=2*3*47) + (50%n) = 423 ~ 430/100 = 4.30.. This will require a CHW/FLHFW to observe 4 to 5 children, which is a total of 8 to 10 observations respectively.

The total sample size is increased by 50% to accommodate for clustering in the calculations (mixed model). Clustering will be assessed after data collection, and if no obvious clustering the differences will be assumed to be independent.
As the study is cross sectional, each assessment of the devices tests will be performed at a single time-point per subject.

Regression analysis will be done on continuous (RR rate and SpO2) and dichotomous (fast/normal RR and hypoxemia/no hypoxemia) data to control for confounders like user and patient characteristics, and implementation setting.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/03/2015
Actual
23/03/2015
Date of last participant enrolment
Anticipated
1/01/2016
Actual
1/01/2016
Date of last data collection
Anticipated
Actual
Sample size
Target
1720
Accrual to date
Final
1730
Recruitment outside Australia
Country [1] 6432 0
Cambodia
State/province [1] 6432 0
Rattanakiri
Country [2] 6433 0
Ethiopia
State/province [2] 6433 0
SNNPR
Country [3] 6434 0
Uganda
State/province [3] 6434 0
MPIGI
Country [4] 6435 0
Sudan
State/province [4] 6435 0
NBEG - South Sudan

Funding & Sponsors
Funding source category [1] 290148 0
Charities/Societies/Foundations
Name [1] 290148 0
Bill and Melinda Gates Foundation
Country [1] 290148 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
Malaria Consortium
Address
Development House
56-64 Leonard Street
London EC2A 4LT
Country
United Kingdom
Secondary sponsor category [1] 288858 0
None
Name [1] 288858 0
Address [1] 288858 0
Country [1] 288858 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291856 0
Makerere University IRB Committee
Ethics committee address [1] 291856 0
Ethics committee country [1] 291856 0
Uganda
Date submitted for ethics approval [1] 291856 0
Approval date [1] 291856 0
07/03/2014
Ethics approval number [1] 291856 0
2014-043
Ethics committee name [2] 291857 0
South Sudan IRB, Research and Ethics committee at the Government of South Sudan
Ethics committee address [2] 291857 0
Ethics committee country [2] 291857 0
Sudan
Date submitted for ethics approval [2] 291857 0
Approval date [2] 291857 0
23/05/2014
Ethics approval number [2] 291857 0
Ethics committee name [3] 291858 0
National Ethics Committee for Health Research (NECHR), Ministry of Health
Ethics committee address [3] 291858 0
Ethics committee country [3] 291858 0
Cambodia
Date submitted for ethics approval [3] 291858 0
Approval date [3] 291858 0
12/05/2014
Ethics approval number [3] 291858 0
Ethics committee name [4] 291859 0
Southern Nation Nationalities Peoples' Region Health bureau health research review committee
Ethics committee address [4] 291859 0
Ethics committee country [4] 291859 0
Ethiopia
Date submitted for ethics approval [4] 291859 0
Approval date [4] 291859 0
Ethics approval number [4] 291859 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52282 0
Dr Karin Kallander
Address 52282 0
Malaria Consortium
Development House
56-64 Leonard Street
London EC2A 4LT
Country 52282 0
United Kingdom
Phone 52282 0
+442075490270
Fax 52282 0
Email 52282 0
k.kallander@malariaconsortium.org
Contact person for public queries
Name 52283 0
Kevin Baker
Address 52283 0
Malaria Consortium
Development House
56-64 Leonard Street
London EC2A 4LT
Country 52283 0
United Kingdom
Phone 52283 0
+442075490270
Fax 52283 0
Email 52283 0
k.baker@malariaconsortium.org
Contact person for scientific queries
Name 52284 0
Kevin Baker
Address 52284 0
Malaria Consortium
Development House
56-64 Leonard Street
London EC2A 4LT
Country 52284 0
United Kingdom
Phone 52284 0
+447811266539
Fax 52284 0
Email 52284 0
k.baker@malariaconsortium.org

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePerformance of Four Respiratory Rate Counters to Support Community Health Workers to Detect the Symptoms of Pneumonia in Children in Low Resource Settings: A Prospective, Multicentre, Hospital-Based, Single-Blinded, Comparative Trial.2019https://dx.doi.org/10.1016/j.eclinm.2019.05.013
N.B. These documents automatically identified may not have been verified by the study sponsor.