Plain English Summary
Background and study aims
With diarrhoea being one of the two most significant causes of death in children under five, collection of accurate data on diarrhoea prevalence is of paramount importance. However, collecting this data has been proven difficult. Standard questions used to asses diarrhoea, asking if a child has had diarrhoea two or more times in the past two weeks, has been seen to suffer from recall bias, social desirability, high cost of data collection, and Hawthorne effects. To address this, we will study the impact of shortening recall period to 24 hours, including a multi-level questionnaire, and altering incentive level. We will do this while collecting data using mobile phone text messaging.
Who can participate?
Households selected will have at least one child under the age of five, live in the study area, and have access to mobile phones.
What does the study involve?
Participants will be randomised into one of eight cohorts. Each cohort, at random order, will be subjected to every possible combination of incentive (no incentive or TZS1000 incentive), recall period (two week or 24 hour), and questionnaire type (standard question or three level). Over eight two-week rounds of data collection, participants will receive surveys on diarrhoea as per their randomisation, and will be remunerated and incentivised as necessary.
What are the possible benefits and risks of participating?
Possible harms of the study surround discomfort with questions being asked, however, participants are free to withdraw at any time. Further, there is small risk of a breach of confidentiality. To address this, data is kept separately from identifiers, and all data are encrypted. There are no direct benefits, however, if a participant reports a medically concerning symptom, they will be referred to a local clinic.
Where is the study run from?
UN-Habitat Regional Office for Africa and the Arab States, Nairobi (Kenya)
When is the study starting and how long is it expected to run for?
Data collection will begin in April 2019 and end in August 2019.
Who is funding the study?
University of Warwick, UK
Who is the main contact?
Ryan Rego (ryan.rego@warwick.ac.uk) and Samuel Watson (s.watson.1@warwick.ac.uk)
Trial website
Contact information
Type
Scientific
Primary contact
Mr Ryan Rego
ORCID ID
http://orcid.org/0000-0003-1361-9366
Contact details
Warwick Medical School
University of Warwick
Warwick
CV4 7AL
United Kingdom
+44 07462890990
ryan.rego@warwick.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
REGO2018-2148
Study information
Scientific title
Pilot testing of a parent record of child health
Acronym
SMSdiarrhoea
Study hypothesis
This study aims to evaluate several hypothesises aimed at improving traditional diarrhoea measurement methods, asking if a child has had two or more loose or watery stool in the past two weeks. These are:
- Reducing the recall threshold from two weeks to 24 hours will decrease prevalence
- The use of a three point scale asking further questions on number of schools, treatment, and blood will result in lower prevalence than the standard measure
- That response rates vary over time
- That incentive alters response rate and data quality
Ethics approval
Approved 12/01/2018, Warwick Biomedical & Scientific Research Ethics Committee (University House, University of Warwick, Coventry, CV4 7AL; E.C.Dight@warwick.ac.uk; 024 765 73961), ref: REGO-2018-2148
Study design
Individual level crossover factorial randomised controlled trial
Primary study design
Observational
Secondary study design
Individual level crossover factorial RCT
Trial setting
Community
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
Differing recall periods; questionnaire types; and incentive levels for diarrhoea surveys.
Initially, households will be randomised into one of eight cohorts using block randomisation. At every two week periods, cohorts will switch into new surveying strategies. These strategies are unique combinations of recall period (two week or 24 hour); questionnaire type (three level or one level); and incentive level (no incentive or some incentive). All surveys will take place by mobile phone text messaging, and all cohorts will experience all combinations of treatments at any time - through a random sequence. This study will ake place in slums around Mwanza, Tanzania.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Diarrhoea Prevalence through the use of a mobile phone survey. This will take place at pre-set time points either daily or every two weeks for a period of 16 weeks.
Secondary outcome measures
Trends in diarrhoea prevalence over time
Overall trial start date
01/04/2018
Overall trial end date
01/11/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Resides in the enumeration area
2. Has a child under five
3. Has access to mobile phone
4. Consents to study
Participant type
Carer
Age group
Mixed
Gender
Both
Target number of participants
150
Total final enrolment
141
Participant exclusion criteria
1. Child under five is exclusively breast fed
2. Does not have their own mobile phone (e.g. shares phone or no access to phone)
Recruitment start date
15/03/2019
Recruitment end date
01/04/2019
Locations
Countries of recruitment
Tanzania
Trial participating centre
UN-Habitat
UN-HABITAT Regional Office for Africa and the Arab States
P.O. Box 30030, GPO
Nairobi
00100
Kenya
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
Universities (academic only)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Conference presentation (Water and Health 2019, USA) and planned publication in a high-impact peer-reviewed journal
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.
Intention to publish date
01/12/2019
Participant level data
Other
Basic results (scientific)
Publication list
2020 results in https://pubmed.ncbi.nlm.nih.gov/32605536/ (added 30/06/2020)