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

Primary Purpose

Acute Respiratory Infection

Status

Completed

Phase

Not Applicable

Locations

Mali

Study Type

Interventional

Intervention

Children's Automated Respiration Monitor (ChARM)

About this trial

This is an interventional diagnostic trial for Acute Respiratory Infection focused on measuring ChARM, community health worker

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

iCCM sites
iCCM Sites

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention Group A

Intervention Group B

Control Group C

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Respiratory rate counting accuracy

Respiratory rate is defined as the number of breaths taken per minute

Proportion of pneumonia cases detected and treated by CHWs

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

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

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

Accuracy in drug management and procurement requests

Percent of CHW with no stock-outs in the last 4 months

Full Information

NCT ID

NCT03457519

First Posted

December 14, 2017

Last Updated

June 21, 2019

Sponsor

Diego Bassani

Collaborators

Canadian Red Cross

1. Study Identification

Unique Protocol Identification Number

NCT03457519

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

March 5, 2018 (Actual)

Primary Completion Date

January 21, 2019 (Actual)

Study Completion Date

January 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Diego Bassani

Collaborators

Canadian Red Cross

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Respiratory Infection

Keywords

ChARM, community health worker

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

141 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group A

Arm Type

Active Comparator

Arm Description

Arm Title

Intervention Group B

Arm Type

Active Comparator

Arm Description

Arm Title

Control Group C

Arm Type

No Intervention

Arm 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.

Intervention Type

Device

Intervention Name(s)

Children's Automated Respiration Monitor (ChARM)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Acute Respiratory Illness (ARI) Case fatality rate

Description

Acute Respiratory Illness (ARI) Case fatality rate defined as number of deaths from respiratory infections among children diagnosed with respiratory infections

Time Frame

8 months

Secondary Outcome Measure Information:

Title

Respiratory rate counting accuracy

Description

Respiratory rate is defined as the number of breaths taken per minute

Time Frame

8 months

Title

Proportion of pneumonia cases detected and treated by CHWs

Description

Proportion of pneumonia cases detected by the CHWs that are treated by CHWs

Time Frame

8 months

Title

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

Description

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

Time Frame

8 months

Title

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

Description

Proportion of self-referenced pneumonia cases in the community (via household survey) who report seeking care from a CHW

Time Frame

8 months

Title

Accuracy in drug management and procurement requests

Description

Percent of CHW with no stock-outs in the last 4 months

Time Frame

8 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Diego G Bassani, PhD

Organizational Affiliation

University of Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

iCCM sites

City

Banamba

State/Province

Koulikoro

Country

Mali

Facility Name

iCCM Sites

City

Koulikoro

Country

Mali

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

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

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