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

NCT03457519 | Completed DMC

• 1 other identifier: R-ST-POC-1707-07682
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Respiratory Infection

Keywords

ChARM; community health worker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Respiratory rate counting accuracy

  8 months

• Proportion of pneumonia cases detected and treated by CHWs

  8 months

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

  8 months

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

  8 months

• Accuracy in drug management and procurement requests

  8 months

Study Arms (3)

Intervention Group A

ACTIVE COMPARATOR

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)

Intervention Group B

ACTIVE COMPARATOR

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)

Control Group C

NO INTERVENTION

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.

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.

Intervention Group A; Intervention Group B

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Diego Bassani: lead
• Canadian Red Cross: collaborator

Study Sites (2)

iCCM sites

Banamba, Koulikoro, Mali

Location

iCCM Sites

Koulikoro, Mali

Location

Study Officials

• Diego G Bassani, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, International Program Evaluation Unit (IPE), Center for Global Child Health

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: March 7, 2018
• Study Start: March 5, 2018
• Primary Completion: January 21, 2019
• Study Completion: January 21, 2019
• Last Updated: June 25, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: March 2018 - March 2019
• 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

Locations

MA (2)