Children's Automated Respiration Monitor (ChARM) for Child Pneumonia Diagnosis by Community Health Workers in Mali
- Conditions
- Acute Respiratory Infection
- Interventions
- Device: Children's Automated Respiration Monitor (ChARM)
- Registration Number
- NCT03457519
- Lead Sponsor
- Diego Bassani
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 141
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• 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.
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• 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group A Children's Automated Respiration Monitor (ChARM) 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: The Children's Respiration Monitor (also known as ChARM) device is routinely used to diagnose Pneumonia cases but in this study it will be used as a self-monitoring and teaching aide for strengthening CHWs skills. Intervention Group B Children's Automated Respiration Monitor (ChARM) 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. Intervention: The Children's Respiration Monitor (also known as ChARM) device is routinely used to diagnose Pneumonia cases but in this study it will be used as a self-monitoring and teaching aide for strengthening CHWs skills.
- Primary Outcome Measures
Name Time Method Acute Respiratory Illness (ARI) Case fatality rate 8 months Acute Respiratory Illness (ARI) Case fatality rate defined as number of deaths from respiratory infections among children diagnosed with respiratory infections
- Secondary Outcome Measures
Name Time Method Proportion of suspected pneumonia cases in the community who sought care from a CHW 8 months Proportion of self-referenced pneumonia cases in the community (via household survey) who report seeking care from a CHW
Accuracy in drug management and procurement requests 8 months Percent of CHW with no stock-outs in the last 4 months
Respiratory rate counting accuracy 8 months Respiratory rate is defined as the number of breaths taken per minute
Proportion of pneumonia cases detected and treated by CHWs 8 months Proportion of pneumonia cases detected by the CHWs that are treated by CHWs
Proportion of suspected severe pneumonia cases referred by CHWs to the CSCom 8 months 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
Trial Locations
- Locations (2)
iCCM Sites
🇲🇱Koulikoro, Mali
iCCM sites
🇲🇱Banamba, Koulikoro, Mali