Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000019404
Ethics application status
Approved
Date submitted
11/12/2015
Date registered
14/01/2016
Date last updated
4/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cool Runnings: A smartphone app-based intervention for educating mothers of young children about hot drink scalds risks and burn first aid.
Scientific title
Cool Runnings: A smartphone app-based intervention aimed at educating and raising awareness about hot beverage scalds and correct burn first aid among mothers of children aged 5-12 months of age.
Secondary ID [1] 288097 0
Nil Known
Universal Trial Number (UTN)
U1111-1177-3874
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Public Health 297055 0
Condition category
Condition code
Injuries and Accidents 297219 297219 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this project is to develop an awareness and prevention program specifically targeting mothers of children aged 5 to 12 months using an smartphone app-based ‘gamified’ platform. During the intervention period (26 weeks) mothers will receive messages about hot drink scald risk factors associated with their child’s age and developmental stage, and the correct burn first aid treatment.
This study will use a Smartphone app-based platform that combines game thinking and game mechanics with behaviour change strategies to increase knowledge and awareness of hot beverage scalds and burns first aid.
The intervention group will receive weekly push notifications from the app asking them to “Play”. Once every three weeks, the ‘game’ will feature one of the nine intervention messages; the format of these messages will be either an infographic, motion graphic or 30-second video. During the other two weeks of the month participants will be given opportunities to participate in activities that continue to engage them. The app will record how often participants open, view and engage with the program. The challenge is to keep participants invested in-between the actual intervention questions. Each time they participate in a ‘game’ they earn points, which means they have a better chance of earning rewards. Participants will accrue points with each full engagement, and once they achieve a certain number of points they will then be eligible to gain a reward. These rewards include iPad minis, shopping vouchers and movie vouchers. Participants in this group will also be able to see a ‘leader board’ so they can monitor their points being accrued and compare their points with other participating mothers.
Intervention code [1] 293404 0
Prevention
Intervention code [2] 293457 0
Behaviour
Comparator / control treatment
Control group: This group will access a slightly different app interface, and will only receive three infographic messages over the six-month intervention period (weeks 4, 10 and 16). Two will be the same messages as the intervention group receives (1. about the leading causes of burns in children and burn first aid, and 2. about sharing the infant's new developmental skills (standing, climbing etc) with grandparents and other caregivers). The third infographic is about childhood injuries in the home. There will be no gamification strategies, prizes or incentives offered to the control group, however they will go in the draw for a prize (an iPad mini) if they complete both the pre and post questionnaires. It is hoped that the potential to win prizes will minimise the loss to attrition. The app will record how often control group participants open, view and engage with the program. At end of the study (after 6 months) the control group will be provided the same information as the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 296807 0
Percentage (%) change in knowledge about the risk of hot beverage scald injuries in young children, using a questionnaire specifically designed for this study.
Timepoint [1] 296807 0
Baseline and post-intervention (6 months)
Secondary outcome [1] 319413 0
Percentage (%) change in knowledge about correct burn first aid, using a questionnaire specifically designed for this study.
Timepoint [1] 319413 0
Baseline and post-intervention (6 months)

Eligibility
Key inclusion criteria
Queensland mothers aged 18+ years of age, who own a smartphone, and who have at least one child aged between 5 and 12 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Anyone who does not fulfil the inclusion criteria. However, because of the method of recruitment (voluntary response to online ad) it is not possible to be 100% confident that all participants fulfil the inclusion criteria.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be assessed for inclusion into the study by an automated computer criterion.. Those who meet the inclusion criteria will be randomised to the intervention or control group using a simple computer-generated randomisation sequence following completion of consent procedures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). Randomisation will also be stratified by maternal age (18 to 28 years; 29 years and above)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:
A cross-sectional study of knowledge and attitudes toward burns first aid in Queensland, (Cuttle et al, 2013) showed that 29% of mothers of children aged 0-4yrs in Brisbane correctly identified appropriate burns first aid (cool running water for 20 mins). Assuming 90% power and alpha = .05, in order to detect a 20% increase in the proportion of mothers who can correctly identify the appropriate burns first aid (type and length) in the intervention group relative to the control group, 240 participants in total are required (120 each in intervention group and control group), with 95% confidence. This will allow detection of improvement in the intervention group from 29-49%, with no improvement in the control group.
In order to determine the proportion of participants who correctly identify the main cause of burns/scalds in children under 4 years, and/or the main age group at risk for burns/scalds, a sample size of 96 is required. This will allow detection of the true proportion in this population with 95%CI and 10% precision (assuming 50% prevalence, the most conservative estimate possible). Further, in order to detect a subsequent increase in knowledge of 20% on both these dimensions for intervention group relative to control group, a total sample size of 240 is required (120 in each group). Assuming 50% loss to follow up in each group, a total sample of 480 is required (240 intervention; 240 control).

Analysis:
Chi-square analyses will be conducted in order to determine whether there is an increase in the proportion of mothers who can correctly identify the appropriate burns first aid (type and length), the main cause of burns/scalds in children under 4 years, and/or the main age group at risk for burns/scalds, in the intervention group relative to the control group. Increase in knowledge can also be considered a categorical variable (increase vs no increase). Cumulative incidence of increased knowledge in the intervention group vs control group can then be calculated, as well as Relative Risk, Absolute Risk, Absolute Risk Reduction, Number Needed to Treat, etc. This will allow examination of the strength and magnitude of the association between the intervention and increased knowledge.
If sample size allows, stratified analyses will be conducted to assess the effect of the intervention in subgroups (eg age groups; SES). As stated earlier, if more participants are successfully recruited, more sophisticated analyses will be completed. For example, if the sample size allows, regression modelling will be completed in order to assess the effect of the intervention while controlling for relevant confounding factors. This is the preferred approach.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/01/2016
Date of last participant enrolment
Anticipated
14/02/2016
Actual
10/02/2016
Date of last data collection
Anticipated
Actual
29/07/2016
Sample size
Target
480
Accrual to date
Final
499
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 292520 0
University
Name [1] 292520 0
Centre for Children's Burns & Trauma Research, University of Queensland
Country [1] 292520 0
Australia
Funding source category [2] 292521 0
Other Collaborative groups
Name [2] 292521 0
Wound Management Innovation Cooperative Research Centre
Country [2] 292521 0
Australia
Primary sponsor type
University
Name
Centre for Chidren's Burns & Trauma Research, University of Queensland
Address
Centre for Child Health Research
62 Graham Street
South Brisbane
QLD 4101
Country
Australia
Secondary sponsor category [1] 291228 0
None
Name [1] 291228 0
N/A
Address [1] 291228 0
N/A
Country [1] 291228 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293997 0
University of Queensland Institutional Human Research Ethics Committee
Ethics committee address [1] 293997 0
Ethics committee country [1] 293997 0
Australia
Date submitted for ethics approval [1] 293997 0
02/11/2015
Approval date [1] 293997 0
07/12/2015
Ethics approval number [1] 293997 0
2015001652

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62038 0
Ms Jacqueline Burgess
Address 62038 0
Centre for Children's Burns & Trauma Research
University of Queensland
Centre for Child Health Research
62 Graham Street,
South Brisbane,
QLD 4101
Country 62038 0
Australia
Phone 62038 0
+61 407789078
Fax 62038 0
Email 62038 0
[email protected]
Contact person for public queries
Name 62039 0
Jacqueline Burgess
Address 62039 0
Centre for Children's Burns & Trauma Research
University of Queensland
Centre for Child Health Research
62 Graham Street,
South Brisbane,
QLD 4101
Country 62039 0
Australia
Phone 62039 0
+61 407789078
Fax 62039 0
Email 62039 0
[email protected]
Contact person for scientific queries
Name 62040 0
Jacqueline Burgess
Address 62040 0
Centre for Children's Burns & Trauma Research
University of Queensland
Centre for Child Health Research
62 Graham Street,
South Brisbane,
QLD 4101
Country 62040 0
Australia
Phone 62040 0
+61 407789078
Fax 62040 0
Email 62040 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCool Runnings - an app-based intervention for reducing hot drink scalds: Study protocol for a randomised controlled trial.2016https://dx.doi.org/10.1186/s13063-016-1521-z
N.B. These documents automatically identified may not have been verified by the study sponsor.