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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03154229 |
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Date of registration:
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12/05/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluation of a mHealth Platform for Diarrheal Disease Decision-support
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Scientific title:
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The Evaluation of a mHealth Platform for Diarrheal Disease Decision-support in Hospitals: a Cluster Randomized Controlled Trial |
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Date of first enrolment:
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March 11, 2018 |
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Target sample size:
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4975 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03154229 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Bangladesh
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Contacts
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Name:
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Eric J Nelson, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Florida, USA |
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Key inclusion & exclusion criteria
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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))
Age minimum:
2 Months
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diarrhea
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Intervention(s)
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Other: Smartphone-based decision-support
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Other: Paper-based decision-support
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Other: Pre-Assessment of practices
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Primary Outcome(s)
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Use of IV fluid
[Time Frame: Intervention is 3 months per hospital]
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Secondary Outcome(s)
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Use of indicated antibiotics
[Time Frame: Intervention is 3 months per hospital]
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Use of zinc
[Time Frame: Intervention is 3 months per hospital]
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Secondary ID(s)
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IRB201601762 - N
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TW010182 [Pending]
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1DP5OD019893
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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