DiarrheaNCT03154229
Evaluation of a mHealth Platform for Diarrheal Disease Decision-support
A study testing Smartphone-based decision-support, Paper-based decision-support and Pre-Assessment of practices in people with Diarrhea, run by University of Florida at 1 site in Bangladesh.
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. Read more about this study
- Who is it for?
- Ages 2 months and older
- Conditions the study is for
- Diarrhea
- What is being tested?
- Smartphone-based decision-support, Paper-based decision-support and Pre-Assessment of practices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,975 participants
- Where
- 1 siteBangladesh
- Study dates
- 11 Mar 2018to 23 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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))
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka, Dhaka Division, 1212
About this study
Official title: The Evaluation of a mHealth Platform for Diarrheal Disease Decision-support in Hospitals: a Cluster Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Diarrhea
- Being tested
- Smartphone-based decision-support, Paper-based decision-support, Pre-Assessment of practices
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-based decision-supportOther
WHO guidelines have been adapted from paper onto a smartphone referred to as a Rehydration Calculator
Paper-based decision-supportOther
WHO guidelines presented on paper
Pre-Assessment of practicesOther
Observation of baseline clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Paper-based decision-support | Active comparator | 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. Receives: Other: Paper-based decision-support; Other: Pre-Assessment of practices |
| Smartphone-based decision-support | Active comparator | 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. Receives: Other: Smartphone-based decision-support; Other: Pre-Assessment of practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of IV fluid
The percentage of patients prescribed IV fluid between the paper-based decision-support and the Smartphone decision-support.
Measured: Intervention is 3 months per hospital
Secondary outcomes (2)
Use of zinc
The percentage of patients under five years prescribed zinc between the paper-based decision-support and the Smartphone decision-support.
Measured: Intervention is 3 months per hospital
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.
Measured: Intervention is 3 months per hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start11 Mar 2018
- Primary completion23 Sep 2018
- Study completion23 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 4,975 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Eric J Nelson, MD PhD, Principal investigator, University of Florida, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154229
- Sponsor's protocol ID
- IRB201601762 - N
- Other IDs
- 1DP5OD019893, TW010182 [Pending]
- Status last verified
- Oct 2019
- First submitted
- 12 May 2017
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28103233Khan 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.
PubMed 33328057
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of a mHealth Platform for Diarrheal Disease Decision-support in Hospitals: a Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03154229
- Acronym / sponsor ID
- IRB201601762 - N
- Conditions
- Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,975 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Study start
- 11 Mar 2018 (actual)
- Primary completion
- 23 Sep 2018 (actual)
- Study completion
- 23 Sep 2018 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Paper-based decision-support | Active comparator | Other: Paper-based decision-support, Other: Pre-Assessment of practicesPrior 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 comparator | Other: Smartphone-based decision-support, Other: Pre-Assessment of practicesPrior 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. |
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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))
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone-based decision-supportWHO guidelines have been adapted from paper onto a smartphone referred to as a Rehydration Calculator | Other | Smartphone-based decision-support |
| Paper-based decision-supportWHO guidelines presented on paper | Other | Paper-based decision-support |
| Pre-Assessment of practicesObservation of baseline clinical practice. | Other | Paper-based decision-support, Smartphone-based decision-support |
Primary outcome
Use of IV fluid
Time frame: Intervention is 3 months per hospital
The percentage of patients prescribed IV fluid between the paper-based decision-support and the Smartphone decision-support.
2 secondary outcomes
Use of zinc
Time frame: Intervention is 3 months per hospital
Use of indicated antibiotics
Time frame: Intervention is 3 months per hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Background: PubMed 28103233Haque 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.
- Derived from this study: PubMed 33328057Khan 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.
- Pilot study publicationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric J Nelson, MD PhD principal investigator
University of Florida, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-based decision-support, Paper-based decision-support and Pre-Assessment of practices in people with Diarrhea, run by University of Florida at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of IV fluid (time frame: Intervention is 3 months per hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03154229, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.