- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03874143
Clinical Evaluation of the Use of an mHealth Intervention on Quality of Care
March 11, 2019 updated by: World Vision Canada
Clinical Evaluation of the Use of an mHealth Intervention on Quality of Care Provided by Community Health Workers in Southwest Niger
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
520
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 months to 4 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- children presenting symptoms of illness
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RCom equipped with a smartphone
|
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
|
No Intervention: RCom with paper-based system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Care (QoC) provided by RCom
Time Frame: 30 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2016
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
February 26, 2019
First Submitted That Met QC Criteria
March 11, 2019
First Posted (Actual)
March 14, 2019
Study Record Updates
Last Update Posted (Actual)
March 14, 2019
Last Update Submitted That Met QC Criteria
March 11, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001 (NavyGHB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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