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

Diego Bassani141 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

141

Conditions

Acute Respiratory Infection

Interventions

Children's Automated Respiration Monitor (ChARM)DEVICE

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.

Eligibility

Sex: ALLMin age: 15 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

iCCM sites

Banamba, Koulikoro, Mali

iCCM Sites

Koulikoro, Mali

Outcomes

Primary Outcomes

Acute Respiratory Illness (ARI) Case fatality rate

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

Time frame: 8 months

Secondary Outcomes

Respiratory rate counting accuracy

Respiratory rate is defined as the number of breaths taken per minute

Time frame: 8 months

Proportion of pneumonia cases detected and treated by CHWs

Proportion of pneumonia cases detected by the CHWs that are treated by CHWs

Time frame: 8 months

Proportion of suspected severe pneumonia cases referred by CHWs to the CSCom

Proportion 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

Time frame: 8 months

Proportion of suspected pneumonia cases in the community who sought care from a CHW

Proportion of self-referenced pneumonia cases in the community (via household survey) who report seeking care from a CHW

Time frame: 8 months

Accuracy in drug management and procurement requests

Percent of CHW with no stock-outs in the last 4 months

Time frame: 8 months

Data from ClinicalTrials.gov

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