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

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 Overview

• Status: Completed
• Conditions: Acute Respiratory Infection
• Intervention / Treatment: Device: Children's Automated Respiration Monitor (ChARM)

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

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mali
  • Koulikoro, Mali
    • iCCM Sites
  • Koulikoro
    • Banamba, Koulikoro, Mali
      • iCCM Sites

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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: 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.	Device: Children'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.
Active Comparator: 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. 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.	Device: Children'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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory rate counting accuracy	Respiratory rate is defined as the number of breaths taken per minute	8 months
Proportion of pneumonia cases detected and treated by CHWs	Proportion of pneumonia cases detected by the CHWs that are treated by CHWs	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	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	8 months
Accuracy in drug management and procurement requests	Percent of CHW with no stock-outs in the last 4 months	8 months

Collaborators and Investigators

• Sponsor: Diego Bassani
• Collaborators: Canadian Red Cross
• Investigators: Principal Investigator: Diego G Bassani, PhD, University of Toronto

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2018
• Primary Completion (Actual): January 21, 2019
• Study Completion (Actual): January 21, 2019

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 21, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: community health worker; ChARM
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Respiratory Tract Infections
• Other Study ID Numbers: R-ST-POC-1707-07682

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Plan to share Study Protocol and Clinical Study Reports with local study partners with the purposes of future decisions on future CHW training
• IPD Sharing Time Frame: March 2018 - March 2019
• IPD Sharing Access Criteria: Study Protocol and Clinical Study Reports will be shared with local partners - Mali Red Cross, Canadian Red Cross and Mali Ministry of Health
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No