Trial Review

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
ACTRN12618000277246
Ethics application status
Approved
Date submitted
14/02/2018
Date registered
22/02/2018
Date last updated
26/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Be Prepared for Being Outside: can new technology improve sun protection behaviours in adults?
Scientific title
Be Prepared for Being Outside: a feasibility study testing an app to improve sun protection behaviours in the healthy adult population in Queensland.
Secondary ID [1] 293984 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sunburn 306496 0
sun exposure 306497 0
Condition category
Condition code
Public Health 305600 305600 0 0
Health promotion/education
Cancer 305795 305795 0 0
Malignant melanoma
Cancer 305797 305797 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this feasibility study is to make engaging sun protection health messages and test them in populations who are regularly outdoors. There will be three user groups that tailored messages will be generated for: 1) athletes, coach or support staff; 2) spectators; or 3) general population. We will construct a Brisbane and Gold coast specific version of the SunVisor app for smartphones, tablets and smartwatches to provide sun-protective messages during April 2018. The SunVisor app will broadcast real-time-weather data, including temperature, humidity, and UV level. Personalised messages (via push notifications) will be delivered through the app with the aim to decrease risk of sunburn and allow people spending time outdoors to adequately prepare and respond to conditions.

This is a 1-arm intervention. We will explore if the impact of the intervention differs for sub-groups (user groups, gender, age, skin types). This study similar to an umbrella trial will take participants with the same demographic data (user group, gender, age) and assign them to different intervention messages.

Arm 1:
To enrol in the project, interested participants must first contact the research team and they will be sent an online participant information and consent form, asked to confirm consent online (tick box) and proceed to complete a 10-15 minute baseline survey. The baseline survey will ask demographic details, skin type, and regular sun protection practices. Once the baseline survey is completed online, they will be directed to download the app (called the SunVisor app). The participants will be asked to use the app for 2 weeks. Participants will be asked to go about their everyday activities whilst using the app, and engage in the app as they see fit. Participants will be asked to allow push notifications, so they receive the daily messages. Participants will receive one message a day for the 2-week intervention period, but can use the app as many times as they like to use its core weather functions. During the install process questions will be used to allocate the user into their specific groups, questions will also be used to determine gender, age and how sensitive their skin is to UV enabling personalized messages to be developed. Software algorithms will work at the back-end of the app to process the weather data into three categories based on the World Health Organisation Guidelines 1) Extreme, Very High, High, 2) Moderate and 3) Low). The app will allow tailored messages (via app push notifications) with the aim to decrease risk of sunburn. The message content via the app notifications will vary between the three user groups, but all main app features will remain the same. An example of message content for the Athlete user group during Extreme weather would be “Training today? Head to the air-conditioned gym - extreme high UV forecasted” and for the low weather category “Great day for a swim session outside while the sun is away”. Email will also be collected at enrollment so we can send an evaluation survey in the week following the study to determine satisfaction with the app and messages, and identify any barriers to use. The evaluation survey will take 10-15 minutes to complete. Participants will also be asked about their sun exposure practices and rates of sunburn during the 2 weeks of app use. Participants who complete all the study procedures may choose to enter a prize draw to win one of 5 x $100 gift vouchers. Participants will be directed to the prize draw entry (optional) after completing the evaluation survey. Metric data will be collected via the app such as number of downloads, uninstalls, retention rate, daily active users, frequency of app sessions and app rating will also be collected and analysed.
Intervention code [1] 300258 0
Prevention
Intervention code [2] 300259 0
Behaviour
Intervention code [3] 300260 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304723 0
satisfaction with use of device/technology/messages (Using questionnaire designed specifically for this study)
Timepoint [1] 304723 0
Evaluation Survey (single assessment conducted up to 2 weeks post completion of intervention)
Secondary outcome [1] 342938 0
Feasibility of intervention (retention of participants)
Timepoint [1] 342938 0
Evaluation Survey (single assessment conducted up to 2 weeks post completion of intervention)
Secondary outcome [2] 343401 0
barriers to uptake of intervention
Timepoint [2] 343401 0
Evaluation Survey (single assessment conducted up to 2 weeks post completion of intervention)

Eligibility
Key inclusion criteria
males and females 18+, Understand sufficient English; cognitive ability for consent; own a private mobile phone with internet access to be able to use the SunVisor app. Users in the athlete group should participate in outdoor sport on a routine basis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous melanoma; organ transplant recipients and individuals taking medications that induce skin photosensitivity.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Counts and percentages will be used to analyse the baseline and evaluation survey data. Metric data will be collected via the app such as number of downloads, uninstalls, retention rate, daily active users, frequency of app sessions and app rating will also be collected and analysed.

We plan to acquire 100 people to participate. It is expected that 115 will participate in the study with an approximate 15% attrition rate due to failing to meet eligibility criteria or participate during the expected days. The 15% attrition rate is based on our previous research study.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/04/2018
Actual
1/04/2018
Date of last participant enrolment
Anticipated
1/05/2018
Actual
1/05/2018
Date of last data collection
Anticipated
31/05/2018
Actual
31/05/2018
Sample size
Target
115
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 298614 0
University
Name [1] 298614 0
Queensland University of Technology
Country [1] 298614 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
60 Musk Avenue, Kelvin Grove, QLD 4059
Country
Australia
Secondary sponsor category [1] 297776 0
None
Name [1] 297776 0
Address [1] 297776 0
Country [1] 297776 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299573 0
Queensland University of Tecnology Human Ethics Committee
Ethics committee address [1] 299573 0
60 Musk Ave, Kelvin Grove, Brisbane, Queensland, 4059
Ethics committee country [1] 299573 0
Australia
Date submitted for ethics approval [1] 299573 0
13/02/2018
Approval date [1] 299573 0
12/03/2018
Ethics approval number [1] 299573 0
1800000182

Summary
Brief summary
This feasibility study is aiming to test the SunVisor app and messages to determine its effectiveness before it can be applied to a randomised controlled trial setting. The app aims to improve sun protection strategies and reduce sunburn incidence. We plan to recruit up to 115 participants to test the feasibility and satisfaction with the app. Participants will be asked to use the app for a two week period and receive a daily sun protection message. Participants will be asked to complete a evaluation survey after the
2 week intervention period to assess satisfaction with the app and messages.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80886 0
Dr Elke Hacker
Address 80886 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 80886 0
Australia
Phone 80886 0
+61 7 3138 9674
Fax 80886 0
Email 80886 0
[email protected]
Contact person for public queries
Name 80887 0
Dr Elke Hacker
Address 80887 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 80887 0
Australia
Phone 80887 0
+61 7 3138 9674
Fax 80887 0
Email 80887 0
[email protected]
Contact person for scientific queries
Name 80888 0
Dr Elke Hacker
Address 80888 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 80888 0
Australia
Phone 80888 0
+61 7 3138 9674
Fax 80888 0
Email 80888 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
No additional documents have been identified.