Evaluation of a mHealth Platform for Diarrheal Disease Decision-support
The Evaluation of a mHealth Platform for Diarrheal Disease Decision-support in Hospitals: a Cluster Randomized Controlled Trial
3 other identifiers
interventional
4,975
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2017
CompletedFirst Posted
Study publicly available on registry
May 16, 2017
CompletedStudy Start
First participant enrolled
March 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2018
CompletedOctober 2, 2019
October 1, 2019
7 months
May 12, 2017
October 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Use of zinc
Intervention is 3 months per hospital
Use of indicated antibiotics
Intervention is 3 months per hospital
Study Arms (2)
Paper-based decision-support
ACTIVE COMPARATORPrior 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
ACTIVE COMPARATORPrior 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.
Interventions
WHO guidelines have been adapted from paper onto a smartphone referred to as a Rehydration Calculator
Observation of baseline clinical practice.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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))
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka, Dhaka Division, 1212, Bangladesh
Related Publications (2)
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.
PMID: 28103233BACKGROUNDKhan AI, Mack JA, Salimuzzaman M, Zion MI, Sujon H, Ball RL, Maples S, Rashid MM, Chisti MJ, Sarker SA, Biswas D, Hossin R, Bardosh KL, Begum YA, Ahmed A, Pieri D, Haque F, Rahman M, Levine AC, Qadri F, Flora MS, Gurka MJ, Nelson EJ. Electronic decision support and diarrhoeal disease guideline adherence (mHDM): a cluster randomised controlled trial. Lancet Digit Health. 2020 May;2(5):e250-e258. doi: 10.1016/S2589-7500(20)30062-5.
PMID: 33328057DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric J Nelson, MD PhD
University of Florida, USA
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2017
First Posted
May 16, 2017
Study Start
March 11, 2018
Primary Completion
September 23, 2018
Study Completion
September 23, 2018
Last Updated
October 2, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share