Children's Automated Respiration Monitor (ChARM) for Child Pneumonia Diagnosis by Community Health Workers in Mali
Condition: Acute Respiratory Infection
MeSH terms: Pneumonia; Respiratory Tract Infections
Study type: Interventional

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
    

Intervention name(s): Children's Automated Respiration Monitor (ChARM)
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Diagnostic
Keywords: ChARM; community health worker