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

Diego Bassani

Status: Completed

Conditions: Acute Respiratory Infection

Treatments: Device: Children's Automated Respiration Monitor (ChARM)

Study type: Interventional

Funder types: Other

Identifiers

NCT03457519

R-ST-POC-1707-07682

Details and patient eligibility

About

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.

Full 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

Enrollment: 141 patients

Sex: All

Ages: 15 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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141 participants in 3 patient groups

Intervention Group A

Active Comparator group

Description:

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.

Treatment:

Device: Children's Automated Respiration Monitor (ChARM)

Intervention Group B

Active Comparator group

Description:

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.

Treatment:

Device: Children's Automated Respiration Monitor (ChARM)

Control Group C

No Intervention group

Description:

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.