Evaluation of a mHealth Platform for Diarrheal Disease Decision-support

Not Applicable

Completed

• Conditions: Diarrhea
• Interventions: Other: Smartphone-based decision-support; Other: Paper-based decision-support; Other: Pre-Assessment of practices

• Registration Number: NCT03154229
• Lead Sponsor: University of Florida

Brief 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.

Detailed Description

Technology is making possible new approaches to overcome old public health challenges. Cellular networks are now ubiquitous in resource-poor settings and offer new opportunities for high-yield interventions for both chronic and acute diseases. We are specifically interested in developing mHealth solutions for diarrheal disease for two reasons. The first reason is that diarrheal disease globally remains the second leading cause of death for children less than 5 years of age. Barriers to combat this problem include poor adherence to guidelines for rehydrating children and outbreaks often outpace current epidemiological tools. The second reason is that diarrheal diseases in a setting like Bangladesh, including cholera outbreaks, are a model system to develop and test mHealth solutions that can be adapted to more complex chronic and acute diseases in Bangladesh and globally.

In partnership with the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b; primary collaborator) and the Institute of Epidemiology, Disease Control, Research (IEDCR) within the Ministry of Health and Family Welfare in Bangladesh, we propose to compare a paper-based versus a smartphone-based decision-support tool in a cluster randomized controlled trial (cRCT) to determine the impact of the method of decision-support on the use of IV fluids (primary outcome) and indicated medications (secondary outcomes). The smartphone tool is an adaptation of the paper-based World Health Organization guidelines, and is called the 'Rehydration Calculator.' The cRCT will be conducted collaboratively between the icddr,b and government hospitals (N=10) in Bangladesh over 4.5 months per site. A 6-week pre-intervention period will establish a baseline at all sites, and in the intervention, hospitals will be randomized to use the paper versus smartphone tool by the admitting physician. Inclusion criteria are patients 2 months and older that have uncomplicated acute diarrheal disease; estimated enrollment is 7893 patients. Standard of care will be practiced at all sites, with the exception of the decision-support tool(s) in the interventional period. 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, decrease intravenous fluid use and improve antibiotic stewardship.

Study Timeline

• Study First Submitted: 2017-05-12
• Study First Submitted QC: 2017-05-12
• Study First Posted: 2017-05-16
• Study Start: 2018-03-11
• Primary Completion: 2018-09-23
• Study Completion: 2018-09-23
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4975

Inclusion Criteria

• Acute uncomplicated diarrhea (less than 7 days with at least 3 loose stools in the last 24 hours)
• Age greater than or equal to two months.

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Exclusion Criteria

• No diarrhea
• Complicated diarrheal disease (e.g. e.g. sepsis, meningitis, convulsions, electrolyte imbalance, myocardial infarction, respiratory failure, chronic kidney disease, severe malnutrition by clinical measures and mid-upper arm circumference (<11.5cm for >= 6 mo to less than 5 years; <11.0 cm for >= 2mo to <6 mo))

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paper-based decision-support	Pre-Assessment of practices	Prior to starting the study, 10 hospitals will be made into 5 pairs. The paper versus smartphone intervention will be randomized to one member of each pair. The study arm will consist of a pre-interventional (6 weeks) followed by an interventional period (12 weeks); this arms will use paper-based decision support at the 5 hospitals designated.
Smartphone-based decision-support	Smartphone-based decision-support	Prior to starting the study, 10 hospitals will be made into 5 pairs. The paper versus smartphone intervention will be randomized to one member of each pair. The study arm will consist of a pre-interventional (6 weeks) followed by an interventional period (12 weeks); this arms will use smartphon-based decision support at the 5 hospitals designated.
Smartphone-based decision-support	Pre-Assessment of practices	Prior to starting the study, 10 hospitals will be made into 5 pairs. The paper versus smartphone intervention will be randomized to one member of each pair. The study arm will consist of a pre-interventional (6 weeks) followed by an interventional period (12 weeks); this arms will use smartphon-based decision support at the 5 hospitals designated.
Paper-based decision-support	Paper-based decision-support	Prior to starting the study, 10 hospitals will be made into 5 pairs. The paper versus smartphone intervention will be randomized to one member of each pair. The study arm will consist of a pre-interventional (6 weeks) followed by an interventional period (12 weeks); this arms will use paper-based decision support at the 5 hospitals designated.

Primary Outcome Measures

Name	Time	Method
Use of IV fluid	Intervention is 3 months per hospital	The percentage of patients prescribed IV fluid between the paper-based decision-support and the Smartphone decision-support.

Secondary Outcome Measures

Name	Time	Method
Use of zinc	Intervention is 3 months per hospital	The percentage of patients under five years prescribed zinc between the paper-based decision-support and the Smartphone decision-support.
Use of indicated antibiotics	Intervention is 3 months per hospital	The percentage of patients prescribed the indicated antibiotic over 2 years of age that have acute watery diarrhea and severe dehydration between the paper-based decision-support and the Smartphone decision-support.

Trial Locations

Locations (1)

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b); 🇧🇩 Dhaka, Dhaka Division, Bangladesh