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

Acute Respiratory Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03457519
• Other study ID #: R-ST-POC-1707-07682
• Status: Completed
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: January 21, 2019

Study information

• Verified date: June 2019
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: January 21, 2019
• Est. primary completion date: January 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Pneumonia
• Respiratory Tract Infections

Intervention

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.

Locations

Country	Name	City	State
Mali	iCCM sites	Banamba	Koulikoro
Mali	iCCM Sites	Koulikoro

Sponsors (2)

Lead Sponsor	Collaborator
Diego Bassani	Canadian Red Cross

Country where clinical trial is conducted

Mali, 

Outcome

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