Condition category
Infections and Infestations
Date applied
06/03/2019
Date assigned
20/03/2019
Last edited
20/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

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

warwick.ac.uk

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

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

Publication citations

Additional files

Editorial Notes

06/03/2019: Trial’s existence confirmed by IRB