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Children's Automated Respiration Monitor (ChARM) for Child Pneumonia Diagnosis by Community Health Workers in Mali

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03457519
Enrollment
141
Registered
2018-03-07
Start date
2018-03-05
Completion date
2019-01-21
Last updated
2019-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Infection

Keywords

ChARM, community health worker

Brief summary

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.

Detailed description

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. 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- November 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- November 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- November 2018. CHW and Field Monitor In-depth interviews - November 2018 Data analysis and report writing - December 2018-January 2019

Interventions

DEVICEChildren's Automated Respiration Monitor (ChARM)

The Philips CHARM (children's automatic respiratory monitor) is specifically designed to detect pneumonia in low resource areas. The lightweight measuring device sits on a child's or infant's chest, secured by a strap and measures respiration rate (fast breathing) through an ingenious algorithm. In this study ChARM will be used as a self monitoring and teaching aide by the CHWS.

Sponsors

Canadian Red Cross
CollaboratorOTHER
Diego Bassani
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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- November 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): March- November 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- November 2018.

Eligibility

Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
Yes

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. * 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.

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

Design outcomes

Primary

MeasureTime frameDescription
Acute Respiratory Illness (ARI) Case fatality rate8 monthsAcute Respiratory Illness (ARI) Case fatality rate defined as number of deaths from respiratory infections among children diagnosed with respiratory infections

Secondary

MeasureTime frameDescription
Respiratory rate counting accuracy8 monthsRespiratory rate is defined as the number of breaths taken per minute
Proportion of pneumonia cases detected and treated by CHWs8 monthsProportion of pneumonia cases detected by the CHWs that are treated by CHWs
Proportion of suspected severe pneumonia cases referred by CHWs to the CSCom8 monthsProportion of all suspected severe pneumonia cases identified by the CHWs (based on presence of fever and increased respiratory rates for age) referred by CHWs to the CSCom
Proportion of suspected pneumonia cases in the community who sought care from a CHW8 monthsProportion of self-referenced pneumonia cases in the community (via household survey) who report seeking care from a CHW
Accuracy in drug management and procurement requests8 monthsPercent of CHW with no stock-outs in the last 4 months

Countries

Mali

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026