ISRCTN ISRCTN41564300
DOI https://doi.org/10.1186/ISRCTN41564300
Secondary identifying numbers REGO-2019-2345
Submission date
05/03/2019
Registration date
20/03/2019
Last edited
25/04/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Mr Ryan Trevor Titus Rego
Scientific

Warwick Medical School
University of Warwick
Coventry
CV47AL
United Kingdom

ORCiD logoORCID ID 0000-0003-1361-9366
Phone +44 (0)7462890990
Email ryan.rego@warwick.ac.uk

Study information

Study designObservational longitudinal cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Home
Study typeScreening
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleComparison of traditional diarrhoea measurement methods with microbiological indicators
Study acronymDiarrhoeaMeasurement
Study objectivesThe 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(s)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
Health condition(s) or problem(s) studiedDiarrhoea/enteric infection
InterventionInitially 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 typeOther
Primary outcome measureDiarrhoea prevalence measured through standard survey or enhanced survey at baseline (April 2019) and endline (June/July 2019)
Secondary outcome measuresPathogenic profile measured by microbiological analysis of stool at baseline (April 2019) and endline (June/July 2019)
Overall study start date01/11/2018
Completion date01/08/2019

Eligibility

Participant type(s)Mixed
Age groupMixed
SexBoth
Target number of participants400
Total final enrolment800
Key inclusion criteria1. 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
Key exclusion criteriaHousehold is expecting to relocate/resettle/repatriate in the next 6 months
Date of first enrolment20/03/2019
Date of final enrolment10/04/2019

Locations

Countries of recruitment

  • Bangladesh

Study participating centre

ICDDR,B
68, Shaheed Tajuddin Ahmed Sarani
Dhaka
1212
Bangladesh

Sponsor information

University of Warwick
University/education

RIS, University House
Coventry
CV4 7AL
England
United Kingdom

Phone +44 (0)24 76 524760
Email wmsgrantssupport@warwick.ac.uk
Website warwick.ac.uk
ROR logo "ROR" https://ror.org/01a77tt86

Funders

Funder type

University/education

University of Warwick
Private sector organisation / Universities (academic only)
Alternative name(s)
The University of Warwick, Warwick
Location
United Kingdom

Results and Publications

Intention to publish date01/11/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination plan1. Conference presentation (Water and Health 2019, USA)
2. Manuscript (TBD)
IPD sharing planThe datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file version V2.3 01/04/2019 No No
Results article 01/12/2021 25/04/2022 Yes No

Additional files

ISRCTN41564300_PROTOCOL_V2.3.pdf
Uploaded 01/04/2019

Editorial Notes

25/04/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
01/04/2019: Uploaded protocol (not peer reviewed)
06/03/2019: Trial's existence confirmed by Warwick Biomedical & Scientific Research Ethics Committee.