Children's Automated Respiration Monitor (ChARM) for Child Pneumonia Diagnosis by Community Health Workers in Mali: Innovating ChARM's Role in Supervision, Training and Diagnosis, a Cluster Randomized Control Trial
Phase: NA
Conditions: Acute Respiratory Infection
Sponsor: Diego Bassani

ChARM Research Study / Malian and Canadian Red Cross / Ministry of Health / 2018 Mali / Grand Challenges Canada  Page 1 
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Project Title: 
 
Children’s Automated Respiration Monitor (ChARM) for child pneumonia diagnosis by Community Health 
Workers in Mali: Innovating ChARM’s role in supervision, training and diagnosis, a cluster randomized control trial 
Principal Investigators:  
 
Mary Thompson 
Health Advisor, Global Health Unit, International Operations, Canadian Red Cross  
 
Dr. Diego G. Bassani 
Director, International Program Evaluation Unit (IPE), Center for Global Child Health 
Epidemiologist, Pediatric Medicine Division, Hospital for Sick Children 
Assistant Professor of Pediatrics, Faculty of Medicine, University of Toronto 
 
 
Emails:  mary.thompson@redcross.ca & diego.bassani@sickkids.ca 
 
Addresses and Telephones:  
 
Mary Thompson 
Global Health Unit, International Operations, Canadian Red Cross 
170 Metcalfe St, Ottawa, Ontario, K2P 2P2 
613-314-8430 (cell) 
 
Dr. Diego Bassani 
Center for Global Child Health, Peter Gilgan Centre for Research and Learning 
686 Bay Street, Toronto, Ontario, M5G 0A4 
416-813-7654 extension: 303033 
 
 
Study Location: Koulikoro and Banamba districts, Koulikoro region, Mali 
 
Proposed project dates:  December 2017 – December 2018 
 
 
 
 

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Project Summary 
Title 
Children’s Automated Respiration Monitor (ChARM) for child pneumonia diagnosis by 
Community Health Workers in Mali: Innovating ChARM’s role in supervision, training 
and diagnosis, a cluster randomized control trial 
Short Title 
Children’s Automated Respiration Monitor (ChARM) for child pneumonia diagnosis by 
Community Health Workers in Mali  
Clinicaltrials.gov 
NCT03457519 
Design 
Cluster Randomized Pragmatic Parallel Trial 
Study Duration 
Intervention Group A - Community Health Workers (CHWs) (Basic training in CHW 
curriculum, ChARM training and 8-month application of the ChARM device, self-
monitoring, direct observation and review of CHW routine monthly reports and drug 
supply sheets): 8 months,  March-December 2018.  
 
Intervention Group B - Community Health Workers  (Basic training in CHW 
curriculum, ChARM training and 4-month application of the ChARM device, self-
monitoring, direct observation and review of CHW routine monthly reports and drug 
supply sheets): 8 months,–  March- December 2018.  
 
Control Group C - Community Health Workers (Basic training in CHW curriculum, 
direct observation and CHW routine monthly reports and drug supply sheets): 8 months,  
–  March- December 2018.  
 
CHW and Field Monitor In-depth interviews –  December 2018  
 
Data analysis and report writing –  December -January 2018 
Study site 
Koulikoro and Banamba districts in Koulikoro Region, Mali 
Primary Objective 
The primary objective of this study is to estimate the impact of a self-monitoring tool 
(ChARM), used as a teaching/monitoring device, on the CHWs respiratory rate 
counting accuracy when assessing children under the age of 5 years with suspected 
pneumonia symptoms.  
Study Intervention 
Basic training on ChARM device and application of the device on children under five 
with suspected pneumonia symptoms.  
Primary Outcome 
Acute Respiratory Illness (ARI) Case fatality rate  
Secondary 
Outcomes 
Respiratory rate counting accuracy 
Proportion of pneumonia cases detected and treated by CHWs 
Proportion of suspected severe pneumonia cases referred by CHWs to the CSCom 
Proportion of suspected pneumonia cases in the community who sought care from a 
CHW  
Accuracy in drug management and procurement requests 
# of CHWs 
Intervention Group A: approximately 49 (1/3 of the CHWs, randomly selected) 
Intervention Group B: approximately 49 (1/3 of the CHWs, randomly selected) 
Control Group C: approximately 50 (1/3 of the CHWs, randomly selected) 
Main Inclusion 
Criteria 
 
Be currently providing iCCM services on a full-time basis to the populations they 
are serving. 
 
Have completed the Malian Ministry of Health basic community health care worker 
training provided as part of the 2016-2020 Strengthening Maternal, Newborn and 
Child Health project.  

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 
Are using a device (a respiratory timer) as part of their basic MoH training package, 
or have a cell phone to use to count the respiratory rates of children under five with 
suspected symptoms of pneumonia.  
 
Be willing to participate in a trial to study the impact of using ChARM as a self-
monitoring tool to improve the capacity to detect pneumonia. 
Main Exclusion 
Criteria 
 
CHWs in conflict ridden geographical areas within the district or not, providing 
consistent services on a full-time basis to the populations they are serving. 
 
CHWs not willing to participate in the trial. 
 
CHWs who do not have a device (watch, respiratory timer or cell phone) to support 
measurement of respiratory rates and who are not routinely counting respiratory 
rate to diagnose suspected pneumonia. 
 
CHWs who did not complete the MoH basic training for CHWs provided through 
the 2016-2020 Strengthening Maternal, Newborn and Child Health program. 
Main Study 
Procedures  
 
In-service trainings of community health care workers on : 
o Using the ChARM device to assess the respiratory rate in children under the age 
of 5 years with suspected pneumonia.  
o Using the ChARM device to self-monitor competency in counting respiratory 
rates in children under the age 5 years with suspected pneumonia.  
 
In-depth interviews (IDI) to assess the effectiveness of ChARM as a self-
monitoring tool and its potential to scale up.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
Acronyms....................................................................................................................................................... 4 
1. 
Title........................................................................................................................................................ 6 
2. 
Trial Registration ................................................................................................................................... 6 
3. 
Protocol version .................................................................................................................................... 6 
4. 
Funding .................................................................................................................................................. 6 
5. 
Roles and Responsibilities ..................................................................................................................... 6 
6. 
Background and Rationale ..................................................................................................................... 7 
7. 
Objective ............................................................................................................................................... 8 
8. 
Trial Methodology and Sample Size ...................................................................................................... 8 
9. 
Randomization .................................................................................................................................... 11 
10. 
Study Setting ................................................................................................................................... 11 
11. 
Study Duration ................................................................................................................................ 11 
12. 
Participant Eligibility Criteria and Enrolment ................................................................................... 12 
13. 
Intervention Groups ........................................................................................................................ 13 
14. 
Control Group .................................................................................................................................. 14 
15. 
Study Trainers .................................................................................................................................. 14 
16. 
Data Collection ................................................................................................................................ 14 
17. 
Data Processing and analysis ........................................................................................................... 16 
18. 
Field Supervision and Quality Control ............................................................................................. 17 
19. 
Data Safety Monitoring ................................................................................................................... 17 
20. 
Ethical Approval, Consent Process, Confidentiality, and Safety ...................................................... 17 
Annexes: ...................................................................................................................................................... 20 
Annex 1: CHWs Tools .............................................................................................................................. 20 
Annex 2 : ChARM Training Material ........................................................................................................ 20 
Annex 3 : Consent Forms ........................................................................................................................ 20 
Annex 4 : Questions for the In-depth interviews .................................................................................... 21 
List of Figures  
Figure I: RCT Flow Figure Chart ...............................................................................................................10 
Figure II: Study Districts Profile ................................................................................................................... 11 
Figure III: Timeline of the Trial………………………………………………………………………………………………………………. 19 
 
 

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Acronyms  
ARI 
 
Acute Respiratory Illness 
ChARM  
Children’s Automated Respiration Monitor 
CHW 
 
Community Health Worker 
CRC 
 
Canadian Red Cross 
CSCom  
Centre de santé communautaire (Community Health Centre, in English) 
CSRef  
Centre de santé de référence  
DSMB  
Data and safety monitoring board 
DTC 
 
Directeur Technique du Centre (Technical Director of Health Centre, in English) 
FMPOS 
Faculté de Médecine, de Pharmacie et d'Odonto-Stomatologie de Mali (Faculty of Medicine, 
Pharmacy, Odonotology and Stomatology of Mali, in English) 
HH 
 
Household 
iCCM 
 
Integrated Community Case Management 
IDI 
 
In-depth interviews 
IPE 
 
International Program Evaluation  
ITT 
 
Intention to treat 
MNCH  
Maternal, Newborn and Child Health 
MoH 
 
Ministry of Health 
MRC 
 
Mali Red Cross 
ODK 
 
Open Data Kit 
PEC 
 
Prise en charge (Case management, in English) 
PI 
 
Principal Investigator 
RCT 
 
Randomized Control Trial 
REB 
 
Research Ethics Board 
RRT 
 
Respiratory Rate Timer 
SickKids 
The Hospital for Sick Children (Toronto, Canada) 
TCPS 2   
Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans, 2nd edition  
UNICEF 
United Nations Children’s Fund WHO 
 
World Health Organization 

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1. Title 
 
Children’s Automated Respiration Monitor (ChARM) for child pneumonia diagnosis by Community Health 
Workers in Mali: Innovating ChARM’s role in supervision, training and diagnosis, a cluster randomized control trial 
 
2. Trial Registration                                                                                                                                   
NCT03457519 
3. Protocol Version  
Version 2 – March 05, 2018  
4.   Funding 
 
Grand Challenges Canada grant to the Canadian Red Cross 
Program officer: Lindsay Angelow (Lindsay.Angelow@redcross.ca) 
5. Roles and Responsibilities 
 
Names, affiliations, and roles of protocol contributors 
 
Role 
Name 
Institution 
Principal Investigator 
Mary Thompson 
Canadian Red Cross 
Co-Principal Investigator 
Diego G. Bassani 
The Hospital for Sick Children 
Study Coordinator  
Liliose Niyitegeka 
Canadian Red Cross, Mali Delegation 
Project Manager                                   
Thierry Nkurabagaya 
Canadian Red Cross, Mali Delegation 
 
Principal Investigator:  Mary Thompson  
Address:           
 
Canadian Red Cross, Suite 300 
                           
170 Metcalfe, Ottawa, ON, K2P 2P2, Canada 
Email:                    
mary.thompson@ redcross.ca 
Phone:                   
613-314-8430 
 
Co-Principal Investigator: Dr. Diego G. Bassani 
Address  
 
686 Bay Street, Toronto, ON, M5G 0A4, Canada 
Email:                      
diego.bassani@sickkids.ca 
Phone:                       
416-813-7654 extension: 303033 
Assistant (if applicable):    Nadine Francis     Assistant email: nadine.francis@sickkids.ca 
 
Project Manager:   
Dr. Thierry Nkurabagaya 
Address:                   
Canadian Red Cross delegation office, at the Mali Red Cross Headquarters 
                                
Djélibougou, Rue 261, Porte02, Route Koulikoro, Bamako, Mali 
Email:  
     
thierry.nkurababaya@redcross.ca  
Phone:  
      
(+223) 79 99 22 15 
 
Budget/Finance Contact: Evelyne Kakana  
Address:                   
Canadian Red Cross, Suite 300 
                                 
170 Metcalfe, Ottawa, ON, K2P 2P2, Canada 
Email:  
     
evelyne.kakana@redcross.ca 
 
Phone:  
     
613-740-9708 

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Role of study sponsors  
 
Study Sponsors (Canadian Red Cross and The Hospital for Sick Children):  
• 
Overall responsibility for study design  
• 
Collection, management, analysis, and interpretation of data 
• 
Writing of the report; and the decision to submit the report for publication, including having joint ultimate 
authority over any of these activities 
• 
Pre-intervention implementation of CHWs trainings in the MoH basic curriculum in program area 
1. Background and Rationale  
 
Globally, pneumonia accounts for 16% of all deaths of children under 5 years oldi. In sub-Saharan African (SSA) 
countries it causes approximately 750 000 child deaths per year in. In Mali, about 900,000 pneumonia episodes occur 
in children under 5 years of age annually, leading to almost 8,000 deaths.ii Pneumonia accounts for 2% of under-five 
deaths in Mali, but only 38% of children under five presenting with symptoms of pneumonia are taken to an 
appropriate health provider. In line with the World Health Organization (WHO) guidelines, increasingly, the first point 
of contact with the health care system for people seeking care for pneumonia symptoms is through community health 
care workers (CHWs)iii.  Aware that access to accurate diagnosis, treatment and appropriate referral determines a 
child's survival the Mali Ministry of Health (MoH) introduced Integrated Community Case Management (iCCM) in 
2007, authorizing community health workers (CHWs) to diagnose and treat pneumonia, malaria, diarrhoea and 
malnutrition in children under five.iv  Research has suggested that community case management of pneumonia, if 
properly implemented, could reduce under-five deaths from pneumonia by 70%v. 
 
In 2012, WHO and UNICEF published a joint statement that supported iCCM as “an essential strategy that can both 
foster equity and contribute to sustained reduction in child mortality” and identified fast breathing as the key 
presenting symptom for diagnosing and treating pneumonia using the iCCM strategyvi. WHO has set the threshold for 
respiratory rate (respiratory rate per minute) in infants less than 2 months at a respiratory rate of 60 per minute, for 
children 2 to 12 months at a respiratory rate of 50 per minute and for children 1 to 5 years at a respiratory rate of 40 
per minutevii and includes these guidelines in its Integrated Management of Childhood Illness (IMCI) handbook widely 
used as the technical guidelines at the community level of careviii. Studies demonstrate that there is evidence to show 
that, when well-trained, CHWs can adequately manage pneumonia cases at the community levelix. However, when 
training is deficient CHWs’ skills in measuring respiratory rates and accurately classifying pneumonia remain a 
challengex xi xii.   
 
In Mali, as part of their basic training, CHWs are trained to detect suspected pneumonia cases using video, practice 
sessions and their basic training manual. Algorithms used for diagnosis developed in the 1980s include assessing 
danger signs in children with a cough, counting respiratory rates, and observing chest in drawing to classify respiratory 
illnessxiii. These algorithms correspond with WHO’s definition of presenting symptoms for pneumonia: cough and/or 
difficult breathing, with or without fever, the presence of either fast breathing or lower chest wall in- drawing where 
the child’s chest moves in or retracts during inhalation.xiv Because counting respiratory rate by observing the chest, by 
using a stethoscope or putting one’s hand on an abdomen has been shown to have conflictive resultsxv, both WHO and 
UNICEF recommend respiratory rate timers (RRTs) as a CHW diagnostic tool for pneumonia at the community level. 
There are several studies that have demonstrated that these tools can be used successfully by CHWs trained to use 
themxvi. However, study results cautioned that for CHWs to be able to easily and accurately classify pneumonia cases 
additional practice in counting respiratory rates and simple job aides would be necessaryxvii xviii. 
 
Pneumonia is the number one cause of under-five deaths in Mali and case fatality rates can exceed 20%, but in 2013, 
of the 231,548 reported pneumonia cases only 20% were treated by CHWs. The quality of community health workers’ 
diagnostic skills can influence how communities accept and use these workers. Poor competency in CHWs to correctly 
count respiratory rate, a key indicator for pneumonia detection, puts CHWs and their patients at risk of frequently 
misdiagnosing pneumonia and over prescription of antibiotics. The need for strong CHW competency to correctly 
count respiratory rate for a quick and accurate detection of pneumonia is evident.   
 

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The challenge for many countries implementing iCCM is a lack of funding to provide consistent supervision, refresher 
courses and feedbacks, putting at risk the populations CHWs are placed to serve. In 2014, only 63% of routine 
supervisory visits to assess CHW skills in Mali were reported to be completedxix. Supportive supervision has been a 
continuous reported gap in ICCM and studies have demonstrated the correlation between strong supervision and 
improved CHW performancexx xxi. Research shows that the access to mHealth tools, for CHWs working in remote 
areas and having access to consistent training and supervision, can help improve the effectiveness of the services they 
providexxii. 
 
Royal Philips’ 2015 pledge to Every Woman, Every Child includes improved pneumonia diagnosis and treatment in 
low resource countries. To this end, Phillips invented the Children’s Automated Respiratory Monitor (ChARM), a 
low cost device for low skilled health workers. Clinical tests have concluded that ChARM is an acceptable alternate 
diagnostic tool for identifying fast breathing among <5 children, which may have potential for use at point-of-care 
by low-skilled community health workers in low resource countries xxiii The proposed study will test whether or not 
the Children’s Automated Respiratory Monitor (ChARM) can be successfully used as a tool to help CHWs self-
monitor and improve their competency to count respiratory rate accurately, diagnose pneumonia cases correctly and 
determine whether to treat or refer a child under 5. By applying the ChARM device on the child, and at the same time 
counting the child’s respiratory rate themselves, the CHWs can carry out an accurate real time assessment of their 
breath counting skills. This randomized cluster trial will evaluate ChARM’s potential as a teaching/monitoring tool to 
support CHWs skill improvement in the diagnosis and treatment of children under 5 with symptoms of suspected 
pneumonia. 
2. Objective 
 
The primary objective of this study is to estimate the impact of a self-monitoring tool (ChARM), used as a 
teaching/monitoring device, on the CHWs respiratory rate counting accuracy when assessing children under the age 
of 5 years with suspected pneumonia symptoms.  
 
The study is embedded in a 2016-2020 Maternal, Newborn and Child Health (MNCH) program in Mali funded by 
Global Affairs Canada; in partnership with the Malian and Canadian Red Cross Societies, the Mali Ministry of Health 
and the SickKids Centre for Global Child Health. The embedded nature of the study reduces project costs. 
3. Trial Methodology and Sample Size 
 
Methodology:  
 
The study is designed as a community based, cluster randomized, pragmatic, intervention trial.  It will be conducted 
within the existing 2016-2020 project structure.  Specifically, the intervention will evaluate the potential of the 
ChARM device to improve CHWs competency in counting respiratory rate and diagnose pneumonia more accurately 
in children under 5 years presenting with symptoms in remote areas.   
 
Sample Size:  
Within the 2016-2020 Strengthening Maternal, Newborn and Child Health program 441 CHWs have been trained 
using the Ministry of Health curriculum to diagnose pneumonia in children under 5 by monitoring the respiratory rate 
visually using a timer. Counting respiratory rates visually using a timer is part of the MoH protocol for CHWs 
providing care to all children under 5 years of age seeking consultations presenting with symptoms of a cough and/or 
cold.  
The study will be implemented in two (Banamba and Koulikoro) of the six districts the MNCH project is targeting. 
Of the 441 community health workers involved, 148 will participate in the study, 75 in Banamba and 73 in Koulikoro. 
This represents 34% of the 411 CHWs in the 2016-2020 program implementation area. In each of the two districts, 
1/3 CHWs will be randomly assigned to intervention group A (monitoring the respiratory rate visually using a timer 
and the ChARM device for 8 months), 1/3 will be randomly assigned to intervention group B (monitoring the 
respiratory rate using both visual counting with a timer and the ChARM device for 4 months, followed by monitoring 

ChARM Research Study / Malian and Canadian Red Cross / Ministry of Health / 2018 Mali / Grand Challenges Canada  Page 9 
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the respiratory rate visually using a timer only for the next 4 months) and 1/3 of the CHWs will be assigned to group 
C (monitoring the respiratory rate visually using a timer only). This group will not be trained in ChARM nor use the 
device during the study).The CHWs will be randomly assigned to the following groups prior to the intervention. 
Intervention and control groups are: 
 
Intervention Group A: CHWs trained in ChARM and using ChARM as a self-monitoring tool for 8 months while 
counting respiratory rate of children under 5 visually using a timer. 
 
Intervention Group B: CHWs trained in ChARM and using ChARM as a self-monitoring tool for 4 months while 
counting respiratory rate of children under 5 visually using a time; then discontinue using ChARM and continue 
to monitor the respiratory rate visually using a timer only for the remaining 4 months. 
 
Control Group C: CHWs who did not receive the ChARM training and will be monitoring the respiratory rate of 
children under 5 visually using a timer only, as per the MoH traditional training.  
 
Throughout the study 3 independent Field Monitors will follow each group’s participants in both Banamba and 
Koulikoro (i.e. one Field Monitor will follow 1/2 CHWs in Group A in Banamba and 1/2 CHWs in Group A 
Koulikoro; the Field Monitors responsible for Groups B and C will also follow one study group each, in both areas).  
The Field Monitors will be responsible for both testing the accuracy of the CHWs’ ability to count respiratory rate 
and for collecting data during the study from the CHW reports and drug records. The Field Monitors will receive the 
same training as the CHWs in the Intervention Groups A and B, and additional training on data collection and 
observation protocol. The Field Monitor will test the CHWs’ capacity to count respiratory rate during three intervals:  
 
Before the ChARM training 
 
4 months after initiating the use of the ChARM device 
 
8 months after initiating the use of the ChARM device (which corresponds to 4 months after the ChARM 
device will be discontinued for group B). 
 
At each of the three measures, the Field Monitor will test CHWs on their visual respiratory rate counting capacity 
using a timer against the ChARM automated readings and review supporting data sources. To maintain the study 
observation periods comparable, and save on the additional logistics costs, the intervention will be rolled out in 
Koulikoro 1 month after it has been rolled out in Banamba. Therefore, for the 2nd and 3rd direct observation the Field 
Monitors will begin first in Banamba and then one month later in Koulikoro. This will allow time for the Field 
Monitors to carry out the site visits required for each district for each of the measurements (approximately 24 visits 
per Field Monitor per district). As a result, the 2nd and 3rd measure for Groups A and B and C in Banamba will be at 4 
months and 8 months, and the same groups in Koulikoro will be measured one month later, but still at 4 and 8 months. 
 
The qualitative evaluation will be undertaken only in the Intervention Groups A and B using In-depth Interviews 
(IDIs) with CHWs, Field Monitors and the Technical Director of the Health centre responsible for the CHWs. In 
total 25 IDIs will be carried out. The Study Coordinator will be responsible for supporting the research and 
qualitative researcher who will be carrying out the IDIs.  In total, anticipated number of IDIs are:  
 
Field Monitors - 3 IDIs, one interview with each one 
 
Technical Director of Health Centre (Directeur Technique du Centre/CSCom) (DTCs) – 10  IDIs (5 in 
Banamba and 5 in Koulikoro) 
 
Community Health Workers – 12 IDIs 
 
 
 
 
 

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Basic MoH training
148 CHWs in Banamba and Koulikoro 
districts.
Intervetion group A - 49 CHWs 
in Banamba and  Koulikoro  will 
self-monitor their ability to count 
breaths using both a  timer and 
the ChARM device. 
4 months
Self-monitoring data , direct 
observation and data collection 
on breath counts, diagnosis and 
treatment  from monthly reports 
and supporting data soutrces. 
8 months
Self-monitoring data , direct 
observation and data collection 
on breath counts, diagnosis and 
treatment  from monthly reports 
and supporting data soutrces. IDI 
with selected CHWs. 
Intervention Group B  - 49 CHWs 
in Banamba and  Koulikoro  will 
self-monitor their ability to count 
breaths using both a  timer and 
the ChARM device. 
4 months
Self-monitoring data , direct 
observation and data collection  
on breath counts, diagnosis and 
treatment  from monthly reports 
and supporting data soutrces.
8 months
Direct observation and data 
collection  on breath counts, 
diagnosis and treatment  from 
monthly reports and supporting 
data sources. IDI with selected 
CHWs. 
Control Group C - 50 CHWs 
in Banamba and  Koulikoro  who 
will count breaths visually using a  
timer only. 
4 months
Direct observation and data 
collection  on breath counts, 
diagnosis and treatment  from 
monthly reports and suporting 
data sources. 
8 months
Direct observation and data 
collection  on breath counts, 
diagnosis and treatment  from 
monthly reports and supporting 
data sources.

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4. Randomization 
 
An epidemiologist not directly involved in the research project will perform randomization of clusters. Due to the 
nature of the intervention, blinding is not possible, however to ensure reduced measurement bias, data on the effect of 
the intervention will be collected by independent data collectors; not involved in the intervention delivery. The unit 
of randomization will be the community health worker.  
5. Study Setting 
 
The trial will take place in the iCCM sites in 2 districts (Banamba and Koulikoro) in the Koulikoro region in Mali.  
These sites were selected because of their proximity to each other, similarity in the number of CHWs working in each 
district and because both districts are part of the larger 2016-2020 CRC program to improve care seeking practices 
and utilization of CHWs in the diagnosis and treatment of pneumonia, malaria and diarrhoea. Political stability and 
availability of population and health facility data from the CRC program baseline survey in 2016 were also taken into 
account.  
 
Koulikoro Region is the second-most-western region of Mali. It covers an area of 90,120 km2 with an estimated 
population of 2,418,305 and a density of 26.83 people per square Km of land area as of 2009. Field operations for the 
study will be managed and coordinated by a Research Coordinator in Mali hired as part of the Canadian Red Cross 
locally supported staff.   
 
Cluster Definition 
A cluster is defined as the population to which a CHW is providing health services in areas more than 5 kilometers 
from a Centre de Santé Communautaire (CSCom).  One community health worker is assigned to 1500 people 
(approximately 250 households dispersed across up to 3 villages).  
Figure II: Study Districts Profile 
*Districts 
*Total 
Population 
*No. of 
HH 
*Urban 
*Rural 
 
*Women 
15-49  
years 
 
**Total    
CSComs 
 
 
***Total 
CHWs 
 
**Total No. of 
children 
under five in  
2016 who are 
covered by 
CHW sites 
 
***MRC 
Volunteers 
(Villages) 
Banamba 
191,005 
28,278 
- 
191,005 
37,850 
18 
75 
18,301 
339 (107) 
Koulikoro 
210,611 
33,068 
41,602 
169,009 
44,390 
20 
73 
13,957 
258 (101) 
*4th General Housing and Population Census of Mali (RGPH), November 2011 
** Ministry of Health, Mali 
*** Mali Red Cross (MRC) 
 
6. Study Duration 
 
Phase I: (4 months)  
 
The first phase of the study (the baseline testing, training and rollout of the intervention) will take place in March-
June 2018. (For logistic purposes, the study will roll out in both districts at a one month interval).  All 148 CHWs 
from the two districts will have their breath counting capacity assessed against the ChARM automated reading.  
Monthly reports, consultation/referral forms, and the drug supply forms for all participating CHWs will be reviewed 
and the data will be abstracted for study purposes, and the number of pneumonia cases treated and/or referred will be 
documented.  

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CHWs randomized to intervention Groups A and B will be trained to use the ChARM device and in data collection 
requirements (filling out the self-monitoring sheet and getting consent from caregivers of children under 5). For the 4 
months of Phase 1, CHWs in Intervention Groups A and B will count the respiratory rate of all children under five 
presenting with symptoms of cough or cold, using the timer and visual counting simultaneously with the ChARM 
device.  Group C will count the respiratory rate using visual counting with the timer only.  
 
Phase II: (4 months)  
 
The second phase of the study will take place from July-November 2018. In the first month of this phase Field Monitor 
will retest CHWs for the 2nd time in all groups on their breath counting capacity against the ChARM automated reading 
and record results. The Field Monitor will also review the CHW monthly reports, consultation/referral forms, the drug 
supply forms, as well as the self-monitoring forms filled in by the CHWs. (Please see Annex 1 for a copy of all forms). 
 
During Phase II, Group A will continue to count the respiratory rate of all children under five presenting with 
symptoms of cough and/or cold, simultaneously using the timer and visual counting and the ChARM device.  
However, once Group B is tested, the CHWs in that group will stop using ChARM and will start to count respiratory 
rate using only the visual counting measured by the timer. Group C will continue to count respiratory rate using only 
visual counting measured by the timer.  
 
An interim analysis of the data from Phase II will be undertaken by an independent researcher (to be chosen by the 
DSMB) once testing has been completed in the three groups.  
 
Phase III: (4 months)  
 
This phase has three main activities. The first is the 3rd testing by Field Monitors of CHWs in all groups of their breath 
counting capacity against the ChARM automated reading and the recording of results.  The Field Monitors will also 
review the CHW monthly reports, consultation/referral forms, the drug supply forms, as well as the self-monitoring 
forms filled in by the CHWs.  
 
Once retested, CHWs in Group A will stop using ChARM and will start to count respiratory rate only using the visual 
counting measured by the timer. CHWs in Groups B and C will continue to count respiratory rate; only using visual 
counting measured by the timer.  
 
The second activity will be qualitative research in the form of in-depth interviews. In each district, in-depth interviews 
with participants from Group A and B CHWs working at 5, 10 and 15 kilometres from their associated CSComs will 
be held to better understand their perception of working with ChARM and its value as a self-monitoring tool and their 
perspective on whether it is something they would recommend the MoH add to its CHW curriculum.  
 
In addition, in-depth interviews with the three Field Monitors and a sample of the Technical Director of Health Centre 
(Directeur Technique du Centre/CSCom) (DTCs) from the CSComs associated with the CHWs will be conducted. 
The IDIs will focus on their perceptions on the effectiveness of ChARM as a tool to improve CHWs accuracy in 
diagnosing pneumonia and referring complicated cases to the CSCom, and whether the ChARM tool has potential to 
be scaled up and made part of the MoH curriculum is also something that will be examined.  
 
The third activity will be the analysis of quantitative and qualitative data from Phase III by Sickkids in preparation for 
developing the final study report.   
 
The timeline of the study can be seen in Figure IV: Timeline of the Trial. 
 
1. 
7. Participant Eligibility Criteria and Enrolment 
 
All CHWs within the project area of Koulikoro and Banamba will be eligible for enrollment in this study.  

ChARM Research Study / Malian and Canadian Red Cross / Ministry of Health / 2018 Mali / Grand Challenges Canada  Page 13 
Version 2, March 05, 2018 
 
 
 
Inclusion Criteria:  
1. Be currently providing iCCM services on a full time basis to the populations they are serving. 
2. Have completed the Malian Ministry of Health basic community health care worker training provided as part of 
the 2016-2020 Strengthening Maternal, Newborn and Child Health program.  
3. Are using a device (a respiratory timer as part of their basic MoH training package) to count the respiratory rates 
of children under five with suspected symptoms of pneumonia. 
4. Be willing to participate in a trial to study the impact of using ChARM as a self-monitoring tool to improve their 
capacity to detect pneumonia. 
 
Exclusion Criteria: 
1. CHWs in conflict ridden geographical areas within the region or not providing consistent services on a full time 
basis to the populations they are serving. 
2. CHWs not willing to participate in a trial to assess the impact of using ChARM as a self-monitoring tool to 
improve their capacity to detect pneumonia. 
3. CHWs who do not have a device (a respiratory timer) to measure respiratory rate and who are not routinely 
counting respiratory rate to diagnose suspected pneumonia. 
4. CHWs who did not complete the MoH basic training for CHWs provided through the 2016-2020 Strengthening 
Maternal, Newborn and Child Health program. 
  
Enrollment 
 
1. Approval from the Ministry of Health Mali and the Regional Directorate of Health, Koulikoro will be obtained 
to enroll CHWs providing iCCM services in the districts of Koulikoro and Banamba in the study.  
2. Subsequently the local study coordinator will visit the MoH district level staff and share the letters of approval 
from the MoH and regional directorate with the facilities responsible for the CHWs working in the Banamba and 
Koulikoro districts to formalize the enrollment.  
3. All consenting women and men seeking care from the CHW for a child under 5 presenting with symptoms of 
pneumonia (i.e. cough and/or cold) will be invited to provide consent and enroll in the study. 
8. Intervention Groups 
The intervention is a training in ChARM device offered to CHWs providing iCCM services to children under-five in 
the districts of Banamba and Koulikoro.  
Once all CHWs in the two districts have been randomized into the three groups and had their breath counting skill 
tested using ChARM as a global measure, the CHWs randomized to Groups A and B will receive a  1-day training on 
the ChARM device. During the training, CHWs in intervention groups will learn how to use the ChARM device as a 
self-monitoring tool by comparing the respiratory rate they count visually when using the timer against ChARM’s 
automated read-out during assessment of all children under-5 years presenting with symptoms of pneumonia (cough 
and/or cold). CHWs will be instructed to record the two measurements on the self-monitoring sheet and to continue 
to record the child`s respiratory rates, treatment and referrals on the MoH forms they routinely fill out.  
All CHWs in Groups A and B will use the both ChARM and visual breath counting using the timer for the first 4 
months of the study. In the case of a discrepancy where there is enough variation that the CHW visual counts using a 
timer and the ChARM reading would put the child in different categories (i.e. rapid or non-rapid respiration) then the 
CHW will be instructed to use the ChARM reading for filling the section on the MoH form for Individual Case 
Management of a Sick Child (Fiche Individuelle de Prise en Charge de l’Enfant Malade – PEC) form. (Annex 1).  
 
In the fifth month the Field Monitor will retest CHWs in Groups A and B, using the ChARM device as a global 
measure. The Field Monitor will also review the CHW monthly reports, PEC consultation/referral forms, drug supply 
forms, and the self-monitoring forms filled in by the CHWs.  
 

ChARM Research Study / Malian and Canadian Red Cross / Ministry of Health / 2018 Mali / Grand Challenges Canada  Page 14 
Version 2, March 05, 2018 
 
 
For months 5 – 8, CHWs randomized to Group A will continue to use ChARM as a self-monitoring tool, continue to 
count respiratory rate visually using a timer and to compare and record the two measurements.  Group B CHWs will 
discontinue using ChARM and only count respiratory rate visually using a timer.  Both groups will continue to record 
the child`s respiratory rates, treatment and referrals on the MoH forms they routinely fill out. 
9. Control Group 
 
All CHWS in the three groups received training on the basic CHW curriculum given by the Ministry of Health as off 
August 2017. In the training, they all received respiratory timers and were trained to count respiratory rate using those 
timers through classroom instruction, videos, and hands on practice in a health facility setting.  
 
The control group (Group C) composed of 1/3 of the CHWs in Banamba and 1/3 of the CHWs in Koulikoro will have 
completed the basic MoH training, but will not receive the additional ChARM training or receive the device. 
Throughout the study Group C will count respiratory rate visually using a timer only and record the child`s respiratory 
rates, treatment and referrals on the MoH forms they routinely fill out when assessing and treating a child presenting 
with symptoms of pneumonia. The Field Monitor for Group C in both districts will measure their breath counting 
competency, using the ChARM device as a global measure following the same testing intervals as the intervention 
groups A and B.  
10. Study Trainers 
 
The Intervention trainer for demonstrating how to count respiratory rates will be selected according to the following 
criteria: 
a. 
A pediatrician from the Ministry of Health  
b. Preferably a resident of the intervention district (Koulikoro and Banamba) 
 
The ChARM trainer will be selected according to the following criteria: 
a. 
A medical professional practicing in Mali who has been trained in using the ChARM device either by a 
representative of the manufacturer personally or through the instructional material developed by the 
manufacturer (Annex 2) 
 
The Field Monitors for the three groups will be selected according to the following criteria:  
a. 
A practicing health professional in Mali who has participated in the training given by the pediatrician to count 
respiratory rate visually using a timer.  
b. A practicing health professional who will have participated in the training on how to use ChARM given by 
the ChARM trainer. 
c. 
Is in agreement to be available over a 10-month period in order to carry out 3 observations, of CHWs, record 
results and gather supporting data from routine forms filled out by the CHWs. 
 
The Qualitative Researcher will be selected based on the following criteria: 
1. 
       a. A Malian national fluent in French and the local language of Bambara. 
2. 
       b. Previous experience in conducting in-depth interviews (IDI) with people working at the community 
level. 
 
11. Data Collection 
 
Logistics 
 
16.1. Field Monitors  
 
The Field Monitors (described above) will be responsible to collect data at three different time periods, before the 
intervention, 4 months after the intervention begins and 8 months after the intervention begins.  There will be one 
Field Monitor each for Groups A, B and C who will cover those groups in both districts. They will be practicing health 

ChARM Research Study / Malian and Canadian Red Cross / Ministry of Health / 2018 Mali / Grand Challenges Canada  Page 15 
Version 2, March 05, 2018 
 
 
professionals and have participated in the 1-day ChARM training in which they will receive in-depth understanding 
of the required data collection forms and the ChARM device. Field Monitors will conduct 3 site visits to test the 
CHWs respiratory rate counting ability using a timer against the ChARM automated reading and record both readings. 
They will review and document the number of cases assessed for pneumonia, treated and/or referred by CHWs during 
the three testing periods.  
 
Data Collection  
 
i) 
Quantitative Data Collection:  
 
Written informed consent will be taken from participating Community Health Workers in the Intervention and Control 
Groups, and from parents and caregivers of all children under five who will have their respiratory rates counted using 
the ChARM device. It will be made clear that eligible participants are under no obligation to participate in this study. 
In addition, the time burden associated with being involved in this study will be clearly outlined during the consent 
process.  
 
Data from the CHW self-monitoring sheets filled out by Intervention Groups A and B will be reviewed and 
documented by the Field Monitor.  The Field Monitor will also measure all CHWs respiratory rate counting capacity 
using ChARM as a global standard and collect routine CHW data three times during the study. This routine data is 
found in both the CHW monthly reports and the consultation/referral forms. Data from drug supply forms filled out 
by CHWs will also be collected to identify any variations that may occur due to more accurate pneumonia diagnosis 
by CHWs as a result of using ChARM and to triangulate this data with the consultation forms and other sections of 
the monthly report.  
 
ii) Qualitative Data Collection:  
 
Qualitative data collection will only take place in the intervention Groups A and B. Written, informed consent will 
be taken from CHWs, Field Monitors and MoH Technical Director of Health Centre (Directeur Technique du 
Centre/CSCom) participating in in-depth interviews. (Consent Forms - Annex 3, Questions for In-depth interviews - 
Annex 4).  
 
Outcomes: 
 
Primary outcome:  
Acute Respiratory Illness (ARI) Case fatality rate  
 
Secondary outcomes: 
Respiratory rate assessment accuracy 
Proportion of pneumonia cases detected and treated by CHWs 
Proportion of suspected severe pneumonia cases referred by CHWs to the CSCom 
Proportion of suspected cases of pneumonia in the community who sought care from a CHW  
Accuracy in drug management and procurement requests 
 
Sample size:  
48 clusters with average size of 50 suspected ARI cases per cluster per arm (over 8 months) are sufficient to detect a 
30% reduction in the ARI case-fatality rate (from 20% at baseline), with 80% power and 5% significance. Differences 
in all secondary outcomes are powered above 80% within this sample size.  
iCCM Curriculum Training: Intervention & Control sites 
Participants: CHWs in Koulikoro and Banamba districts (n=148)  

ChARM Research Study / Malian and Canadian Red Cross / Ministry of Health / 2018 Mali / Grand Challenges Canada  Page 16 
Version 2, March 05, 2018 
 
 
Time frame: Completed as part of CRC program implementation in Mali (December 2016 – August 2017)  
Responsibility: CRC/MoH Mali Trainers 
Training Material: Ministry of Health iCCM curriculum for CHWs –18-day curriculum including classroom 
instruction and hands on training.  
 
Intervention Training: Intervention sites  
Participants: CHWs in Koulikoro (n≅49) and Banamba (n≅49) districts.  
Time Frame: After iCCM curriculum training; 9 months–1month for training CHWs in ChARM and 8 months for 
monitoring. 
Responsibility: External Trainers and Study coordinator  
 
A. CHWs trained in ChARM and the self-monitoring data collection format.  
B. Submission of regular MoH monthly reports, consultation referral forms, drug supply forms.  
C. In-depth interviews for CHWs, Field Monitor and the Technical Director of Health Centres (Directeur 
Technique du Centre/CSCom) on their perception of ChARM tool and recommendations for future use 
as a teaching tool and/or scale up by the MoH. 
 
Control Sites 
CHWs in Koulikoro and Banamba districts (n=49)  
Time frame: 8 months–including initial measurement of respiratory rate counts using a timer against ChARM`s 
automated reading and subsequently repeating the measurement twice during the study.  
A. Pneumonia diagnosis as per usual practice of visually counting respiratory rate using a respiratory timer.  
B. Submission of regular monthly reports, consultation/referral reports and drug supply reports for review by 
Field Monitors.   
 
12. Data Processing and analysis 
 
Data (described in section 16) will be collected on  paper by the Field Monitors.  Data will be entered in the ChARM 
database by the field monitors and study coordinator, after the data is  entered it will be checked for consistency and/or 
missing responses. Inconsistencies and/or omissions will be flagged and communicated to interviewers for 
clarification.   
 
The data entry forms, databases and interface will be developed using ODK. The data entry forms will employ range 
and consistency checks and logical skips to improve interview efficiency and minimize data entry errors. Special 
arrangements will be made to enforce referential integrity of the database so that all data tables are related to each 
other.   
 
The trial data will be analyzed as “Intention to treat” (ITT). 
  
After successful completion of data transfer agreements between the Academic Partner in Mali and SickKids, de-
identified data will be transferred to SickKids using the SickKids-based secure online file transfer protocol managed 
by the Research Information Technology team at SickKids. Once the data have arrived at SickKids, it will be secured 
behind the SickKids firewall, which is backed up by the hospital system (SickKids server/cloud). Data will be 
encrypted and will only be made available to Dr. Diego Bassani and his SickKids’ research personnel who have 
successfully completed the TCPSII Course on Research Ethics training and have been added to the REB application 
for this study. For quantitative data analysis STATA version 13 and for qualitative data analysis Nvivo will be used. 

ChARM Research Study / Malian and Canadian Red Cross / Ministry of Health / 2018 Mali / Grand Challenges Canada  Page 17 
Version 2, March 05, 2018 
 
 
13. Field Supervision and Quality Control 
 
An in-country project team composed of a part-time Study coordinator and three Field Monitor, with support from the 
project team, will coordinate project activities. The Study coordinator will assist with the training of Community 
Health Workers in the intervention and control clusters along with three Field Monitors and the CRC/MRC program 
staff. The project team will also be responsible for all the logistics and monitoring support of project activities and the 
Study coordinator will be responsible for the overall oversight.  
 
The Field Monitors will be responsible for ensuring quality control in data collection as well as maintain close liaison 
with the Community Health Workers and the field project staff to have access to project data if necessary. They will 
also ensure timely and accurate  paper data transfer from field to the Study coordinator who will also have overall 
responsibility for the on-ground management and supervision of the trial.  
 
14. Data Safety Monitoring  
 
A data and safety monitoring board (DSMB) will be convened with three individuals, Dr. Shaun Morris, at the 
Hospital for Sick Children, Dr. Poma Hachimi, Mali, Dr. Traore Bintou Sangare, Mali, with expertise in the clinical 
area of the trial and Nadia Akseer, a Biostatistician at the Hospital for Sick Children. The DSMB will have the 
mandate of making an independent, fully informed assessment of the progress of the trial. It will make 
recommendations to the trial PI as to whether to continue, amend or terminate the trial. The DSMB will be 
provided de-identified data at 2nd and 6th month of data collection. The identity of study groups will be masked 
unless the DSMB determines that the identities of the groups are necessary for their decision making. The DSMB 
may also make recommendations / escalate issues to the REB at SickKids (primary organization) and Comité 
d'éthique de la Faculté de Médecine, de Pharmacie et d'Odonto-Stomatologie de Mali (FMPOS). 
 
Function / Responsibilities of the DSMB: 
• Assess and monitor the trial from an ethical perspective 
• Assess the quality and completeness of interim data 
• Review recruitment and participant retention data 
• Review protocol and deviations from the Standard Operating Procedures 
• Review any individual events considered significant 
• Make recommendations regarding trial continuation, amendments or termination 
• Assess the need for stopping the trial prematurely based on strong evidence of unintended harm or external  
   evidence for all or any of the following. 
a) Failure to adhere to the research protocol and non-compliance with goals for recruitment and retention.  
b) Any factors that might affect the study outcome or compromise the confidentiality of the trial data (such as 
protocol violations, unmasking, etc.); and, 
c) Factors external to the study such as scientific or therapeutic developments that may impact participant safety or 
the ethics of the study. 
 
15. Ethical Approval, Consent Process, Confidentiality, and Safety 
 
Ethical Approval 
 
The study proposal will be submitted for ethical approval to Comité d'éthique de la Faculté de Médecine, de Pharmacie 
et d'Odonto-Stomatologie de Mali (FMPOS), and the Research Ethics Board at The Hospital for Sick Children, 
Toronto, Canada.  Subsequent to this approval, consent and agreement to participate will be obtained from the regional 
and district health departments of Koulikoro and Banamba in Koulikoro, Mali. 
 
Participant Consent 
 

ChARM Research Study / Malian and Canadian Red Cross / Ministry of Health / 2018 Mali / Grand Challenges Canada  Page 18 
Version 2, March 05, 2018 
 
 
Written informed consent will be obtained from mothers and/or fathers of children under five at the time of their 
consultation with the CHW. If the mother is not able to give consent, her husband or other adult family member present 
will be invited to give consent to participate in the study. The CHW will explain risks and benefits to potential enrollees 
and participants will be informed that they have the right to withdraw from the study at any time and that there are no 
penalties from doing this and this will not in any way affect their ability to receive any health care services.  
 
Ethical issues, Benefits and Safety 
 
Caregivers of children will be free to consent to participate or not in the study. Community Health Workers will 
explain that children with rapid respiratory rates will be treated on site if no complicating factors are observed, but 
that if there are complicating factors, children will be referred and/or treated at the next level of care. Anonymity of 
caregivers, their children and the community health workers and data will be ensured.  
 
The ChARM training will be conducted in such a way that the community health workers do not feel vulnerable or 
persecuted in any way. 
 
Overall, improved quality of neonatal and child care in diagnosing and treating Pneumonia are the anticipated benefits 
of this study which outweigh the risks in this study.  Health care providers and families can refuse or are free to 
withdraw at any time from participating in the study and no penalties will arise from this refusal.  
 
Confidentiality 
 
Information obtained during this study will only be transferred in an anonymized form. The national and international 
regulatory agencies and sponsoring agencies may request access to the medical or other confidential records of 
participating subjects, but the identity of subjects will remain confidential.  The final study report with aggregate 
anonymized data will be shared with the Minister of Health-Mali, without identifying the individual CHWs. All study 
records will be kept confidential in keeping with the stipulated requirements by the ethics boards of the Hospital for 
Sick Children and Ethics Committee of the Faculty of Medicine, Pharmacy, Odontology and Somatology of Mali 
(FMPOS). 
 
 

ChARM Research Study / Malian and Canadian Red Cross / Ministry of Health / 2018 Mali / Grand Challenges Canada  Page 19 
Version 2, March 05, 2018 
 
 
Figure III: Timeline of the Trial 
 
Month of Study - Number 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
Month of Study - Name 
 
J 
F 
M 
A 
M 
J 
J 
A 
S 
O 
N 
D 
Cluster Randomization 
X 
 
 
 
 
 
 
 
 
 
 
 
 
MOU – Koulikoro Regional Health 
Directorate 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Orientation of CSCom District 
Technical Coordinator 
X 
 
 
 
 
 
 
 
 
 
 
 
 
In-Country Study Team 
identification 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Training of Study Team 
 
X 
 
 
 
 
 
 
 
 
 
 
 
1ST data collection of all CHWs 
 
 
X 
 
 
 
 
 
 
 
 
 
 
Training of CHWs in Intervention 
Groups A and B in ChARM 
 
 
X 
 
 
 
 
 
 
 
 
 
 
Groups A and B initiate use of 
ChARM 
 
 
X 
 
 
 
 
 
 
 
 
 
 
2nd data collection of all CHWs in 
Banamba 
 
 
 
 
 
 
X 
 
 
 
 
 
 
2nd data collection of all CHWs in 
Koulikoro 
 
 
 
 
 
 
 
X 
 
 
 
 
 
Interim data analysis 
 
 
 
 
 
 
 
X 
 
 
 
 
 
3rd data collection of all  CHWs in 
Banamba 
 
 
 
 
 
 
 
 
 
 
X 
 
 
3rd data collection of all  CHWs in 
Koulikoro 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Individual in-depth interviews in 
Banamba 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Individual in – depth interviews in 
Koulikoro 
 
 
 
 
 
 
 
 
 
 
 
 
X 
In-depth interviews with Field 
Monitors and MoH DTCs 
 
 
 
 
 
 
 
 
 
X 
 
 
 
Quarterly reporting 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Final data analysis 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
Preparation of Final report 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
 
 
 

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Version 2, March 05, 2018 
 
 
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