Evaluation of a mHealth Platform for Diarrheal Disease Decision-support

Diarrhea Clinical Trial

Official title:

The Evaluation of a mHealth Platform for Diarrheal Disease Decision-support in Hospitals: a Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03154229
• Other study ID #: IRB201601762 - N
• Secondary ID: 1DP5OD019893TW01
• Status: Completed
• Phase: N/A
• Start date: March 11, 2018
• Est. completion date: September 23, 2018

Study information

• Verified date: October 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4975
• Est. completion date: September 23, 2018
• Est. primary completion date: September 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months and older

Eligibility

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.

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))

Related Conditions & MeSH terms

• Diarrhea

Intervention

Other:
• Smartphone-based decision-support
WHO guidelines have been adapted from paper onto a smartphone referred to as a Rehydration Calculator
• Paper-based decision-support
WHO guidelines presented on paper
• Pre-Assessment of practices
Observation of baseline clinical practice.

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)	Dhaka	Dhaka Division

Sponsors (4)

Lead Sponsor	Collaborator
University of Florida	International Centre for Diarrhoeal Disease Research, Bangladesh, John E. Fogarty International Center (FIC), National Institutes of Health (NIH)

Country where clinical trial is conducted

Bangladesh, 

References & Publications (1)

Haque F, Ball RL, Khatun S, Ahmed M, Kache S, Chisti MJ, Sarker SA, Maples SD, Pieri D, Vardhan Korrapati T, Sarnquist C, Federspiel N, Rahman MW, Andrews JR, Rahman M, Nelson EJ. Evaluation of a Smartphone Decision-Support Tool for Diarrheal Disease Management in a Resource-Limited Setting. PLoS Negl Trop Dis. 2017 Jan 19;11(1):e0005290. doi: 10.1371/journal.pntd.0005290. eCollection 2017 Jan. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of IV fluid	The percentage of patients prescribed IV fluid between the paper-based decision-support and the Smartphone decision-support.	Intervention is 3 months per hospital
Secondary	Use of zinc	The percentage of patients under five years prescribed zinc between the paper-based decision-support and the Smartphone decision-support.	Intervention is 3 months per hospital
Secondary	Use of indicated antibiotics	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.	Intervention is 3 months per hospital

External Links

•   Pilot study publication