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CompletedNCT03874143Updated Mar 14, 2019

Clinical Evaluation of the Use of an mHealth Intervention on Quality of Care

An interventional study of mHealth Intervention for Quality of Care in Malaria, Diarrhea and Acute Respiratory Infection, sponsored by World Vision Canada. Completed. Open to participants aged 2 Months to 59 Months. Per ClinicalTrials.gov, last updated 2019-03-14.

Sponsored by World Vision Canada · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 2 years 11 months after the study started (first participant enrolled Mar 2016, registered Feb 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
520
Allocation
Randomized
Ages
2 Months to 59 Months
Sex
All
01

Study summary

Under the World Health Organization's (WHO) integrated community case management (iCCM) Rapid Access Expansion Program (RAcE), World Vision Niger and Canada supported the Niger Ministry of Public Health to implement iCCM in four health districts in Niger in 2013. Community health workers (CHWs), known as Relais Communautaire (RCom), were deployed in their communities to diagnose and treat children under five years of age presenting with diarrhea, malaria and pneumonia and refer children with severe illness to the higher-level facilities. Two of the districts piloted RCom using smartphones equipped with an application to support quality case management and provide good timely clinical data. A two-arm cluster randomized trial assessed the impact of use of the mHealth application mainly on quality of care (QoC), but also on motivation, retention and supervision

02

Conditions studied

  • Malaria
  • Diarrhea
  • Acute Respiratory Infection
03

In context

Respiratory Tract Infections

1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.

This study's enrollment of 520 is above the median of 199 across 698 interventional studies indexed under Respiratory Tract Infections.

Browse Respiratory Tract Infections studies →

Lead sponsor

This is the only study on the registry with World Vision Canada as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 59 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • children presenting symptoms of illness

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
520 participants (actual)

Study arms

  • Experimental
    RCom equipped with a smartphone

    Other: mHealth Intervention for Quality of Care

  • No intervention
    RCom with paper-based system

Interventions

  • OthermHealth Intervention for Quality of Care

    Does use of a specially equipped smartphone make a difference in the diagnosis and treatment by RCom of malaria, pneumonia and diarrhea in children aged 2 to 59 months

06

What researchers measure

Primary outcomes

  1. Quality of Care (QoC) provided by RCom

    The maximum QoC score was 31 points; the score was weighted with two-thirds of the score allocated to screening questions and correct identification of the danger signs and signs/symptoms of serious conditions A perfect score was achieved when RComs asked all 10 health screening questions and correctly classified 4 major danger signs and 6 serious symptoms, made appropriate referral, and provided advice to caregivers.

    Time frame: 30 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03874143
Lead sponsor
World Vision Canada
Collaborators
World Health Organization, Ministry of Public Health Niger, Toronto Metropolitan University, Global Affairs Canada
Responsible party
Sponsor
First posted
Mar 14, 2019
Start date
Mar 1, 2016
Primary completion
Oct 1, 2016
Completion
Oct 1, 2016
Last update
Mar 14, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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