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Evaluation of a mHealth Platform for Diarrheal Disease Decision-support

NCT03154229 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4975

Last updated 2019-10-02

No results posted yet for this study

Summary

The study hypothesis is that clinical decision-support on a smartphone for the management of diarrheal disease will improve the assessment of dehydration, reduce IV fluid usage, and increase guideline adherence for the use of zinc and antibiotics. To test this hypothesis we will conduct a cluster randomized controlled trial in the diarrhea wards of 10 hospitals in Bangladesh. A 6-week pre-intervention period will establish a baseline at all sites, and in the intervention, hospitals will be randomized to use a paper versus smartphone adaptation of the WHO guidelines by the admitting physician. Inclusion criteria are patients 2 months and older that have uncomplicated acute diarrheal disease; estimated enrollment is 7893 patients. The primary outcome measure is use of IV fluids. This project may have broad impact that will include opportunities to provide improved decision-support for the assessment of dehydration, decreased use intravenous fluids and more prudent use of antibiotics.

Conditions

Interventions

OTHER

Smartphone-based decision-support

WHO guidelines have been adapted from paper onto a smartphone referred to as a Rehydration Calculator

OTHER

Paper-based decision-support

WHO guidelines presented on paper

OTHER

Pre-Assessment of practices

Observation of baseline clinical practice.

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • Fogarty International Center of the National Institute of Health

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • Eric J Nelson, MD PhD · University of Florida, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-11
Primary Completion
2018-09-23
Completion
2018-09-23

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03154229 on ClinicalTrials.gov