Plain English Summary
Background and study aims
This study aims to evaluate different methods of measuring infant diarrhoea prevalence in refugee camps and slums. Currently, the accepted method of doing this is by asking parents if their child has had two or more loose or watery stools in the past two weeks. However, this measurement can lead to an incorrect result due to problems with memory, not answering truthfully, or not understanding the question. As an alternative, in this study this method will be tested against more in depth questions and sampling of stool to test for causes of diarrhoea.
Who can participate?
Household with at least one adult over the age of 18 and children under the age of five in the Cox’s bazar refugee camp
What does the study involve?
The study involves selection of 400 households by house to house surveying, recruiting consenting households who have a child under the age of five. Consenting households are initially given a survey on their demographics, health status, and access to care, toilets, and water. Households are then randomly allocated to receive either the enhanced survey or the standard survey. 20 households from each survey who report diarrhoea, and 20 surveys from each survey who don’t report diarrhoea, are also asked to provide stool samples. Stool samples are collected, visually inspected by a researcher for presence of diarrhoea, and sent for laboratory analysis. Households are first surveyed in April, a time with low diarrhoea prevalence; and again in June/July, a time with high diarrhoea prevalence.
What are the possible benefits and risks of participating?
There are no benefits to participating, with no compensation. However, if a participant gives an answer indicating that the child requires medical care, or if stool samples indicate that medical care is required, the carer will be notified. Risks include discomfort with questions being asked, and discomfort collecting stool. Households will be instructed that they are free to stop the survey and withdraw at any time. A small amount of risk results in data being traceable back to participants, however, all measures have been taken to mitigate this – including storing identifiers and data separately; and encryption of all data on a secure server.
Where is the study run from?
University of Warwick (UK) and International Center for Diarrhoeal Disease Research (Bangladesh)
When is the study starting and how long is it expected to run for?
November 2018 to August 2019
Who is funding the study?
University of Warwick (UK)
Who is the main contact?
1. Ryan Rego
ryan.rego@warwick.ac.uk
2. Dr Samuel Watson
s.watson.1@warwick.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Mr Ryan Trevor Titus Rego
ORCID ID
http://orcid.org/0000-0003-1361-9366
Contact details
Warwick Medical School
University of Warwick
Coventry
CV47AL
United Kingdom
+44 (0)7462890990
ryan.rego@warwick.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
REGO-2019-2345
Study information
Scientific title
Comparison of traditional diarrhoea measurement methods with microbiological indicators
Acronym
DiarrhoeaMeasurement
Study hypothesis
The researchers hypothesise that traditional methods of measuring diarrhoea prevalence in infants (asking questions on loose stools in the past two weeks) are plagued by several issues, including recall bias, social desirability, and ascertainment bias. To evaluate this, the researchers are comparing traditional diarrhoea measurement questions against two alternatives: an enhanced questionnaire using pictorial representation, and stool sampling for visual inspection and microbiological analysis.
Ethics approval
1. Approved 27/02/2019 by the Warwick Biomedical & Scientific Research Ethics Committee in the UK, Contact: Emily Dight, Research Support Officer- Governance & Ethics, University House, University of Warwick, Coventry, CV4 7AL, UK, Tel: +44 (0)24 765 73961, Email: E.C.Dight@warwick.ac.uk, ref: REGO-2019-2345
2. This study has also been submitted to the ICDDR,B Ethics Research Committee in Bangladesh
Study design
Observational longitudinal cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Home
Trial type
Screening
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Diarrhoea/enteric infection
Intervention
Initially 400 households will be randomly selected, of which 200 will be randomised by block randomisation to receive the standard survey (standard diarrhoea measurement questions), and 200 to receive the enhanced survey (with pictorial representation). From each arm, 20 households reporting diarrhoea and 20 not reporting diarrhoea will be chosen for stool sampling.
The study will collect baseline data in April 2019, with follow-up in June/July 2019. The study will be taking place in Camp 18 (Balukhali) of the Cox's Bazar refugee camp in Bangladesh.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Diarrhoea prevalence measured through standard survey or enhanced survey at baseline (April 2019) and endline (June/July 2019)
Secondary outcome measures
Pathogenic profile measured by microbiological analysis of stool at baseline (April 2019) and endline (June/July 2019)
Overall trial start date
01/11/2018
Overall trial end date
01/08/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Household has at least one child under the age of five
2. Household has at least one adult over the age of 18
3. Household consents to study
Participant type
Mixed
Age group
Mixed
Gender
Both
Target number of participants
400
Participant exclusion criteria
Household is expecting to relocate/resettle/repatriate in the next 6 months
Recruitment start date
20/03/2019
Recruitment end date
10/04/2019
Locations
Countries of recruitment
Bangladesh
Trial participating centre
ICDDR,B
68, Shaheed Tajuddin Ahmed Sarani
Dhaka
1212
Bangladesh
Sponsor information
Organisation
University of Warwick
Sponsor details
RIS
University House
Coventry
CV4 7AL
United Kingdom
+44 (0)24 76 524760
wmsgrantssupport@warwick.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Warwick
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
1. Conference presentation (Water and Health 2019, USA)
2. Manuscript (TBD)
IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
01/11/2019
Participant level data
Other
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN41564300_PROTOCOL_V2.3.pdf Uploaded 01/04/2019