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| Name | Class |
|---|---|
| Canadian Red Cross | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
• Be currently providing iCCM services on a full-time basis to the populations they are serving.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Diego G Bassani, PhD | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| iCCM sites | Banamba | Koulikoro | Mali | |||
| iCCM Sites |
Plan to share Study Protocol and Clinical Study Reports with local study partners with the purposes of future decisions on future CHW training
March 2018 - March 2019
Study Protocol and Clinical Study Reports will be shared with local partners - Mali Red Cross, Canadian Red Cross and Mali Ministry of Health
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 5, 2018 | Apr 6, 2018 | Prot_001.pdf |
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.
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| 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 |
| Koulikoro |
| Mali |