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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03874143
Other study ID # 001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2016
Est. completion date October 1, 2016

Study information

Verified date March 2019
Source World Vision Canada
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 520
Est. completion date October 1, 2016
Est. primary completion date October 1, 2016
Accepts healthy volunteers No
Gender All
Age group 2 Months to 59 Months
Eligibility Inclusion Criteria:

- children presenting symptoms of illness

Exclusion Criteria:

Study Design


Intervention

Other:
mHealth 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

Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
World Vision Canada Global Affairs Canada, Ministry of Public Health Niger, Ryerson University, World Health Organization

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 30 weeks
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