Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000809134
Ethics application status
Approved
Date submitted
11/04/2019
Date registered
4/06/2019
Date last updated
4/06/2019
Date data sharing statement initially provided
4/06/2019
Date results provided
4/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Diabetes Online Risk Assessment (DORA) Project: Assessment of acceptability of the provision of video versus text risk feedback information following diabetes online risk assessment using AUSDRISK survey.
Scientific title
Assessment of acceptability of the provision of video versus text risk feedback information following diabetes online risk assessment using AUSDRISK survey in Australian adults aged 35 years and over
Secondary ID [1] 297953 0
none
Universal Trial Number (UTN)
Trial acronym
DORA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 312350 0
Condition category
Condition code
Metabolic and Endocrine 310911 310911 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be screened online using the AUSDRISK survey. Those classified as high risk will be accepted into the study and randomly assigned to either the TEXT or VIDEO feedback groups. The text group will receive information about the meaning of a high risk score and recommendation to see their GP. This is in line with current practice on Australian state and federal diabetes association websites. The video group will receive a specifically designed short (max 2 minute) vignette of someone same gender and similar age discussing their high risk score and actions taken to reduce their risk. Participants will complete screening survey, baseline survey (before intervention), 1 month and 3 month follow up surveys. Outcome measures are: (1) follow up with GP to discuss their risk and further testing if required, (2) changes to dietary and lifestyle behaviours at follow up. Participants may review their text or video information at any time by accessing the study website. No action is required by the participant other than completion of follow up surveys to provide feedback on the text or video risk information provided. Overdue one month and three month follow up surveys are followed up by research staff.
Text information provided to participants:
The total points from your risk assessment have been calculated and your score shows that you may be at HIGH or VERY HIGH risk of type 2 diabetes. It is important to acknowledge that this is a risk rating, and is NOT a diagnosis of type 2 diabetes.
So what does this risk mean?
A high or very high risk rating means that genetic factors and current lifestyle factors are currently placing you at a higher risk of developing type 2 diabetes within the next 5 years.
• At medium risk - approximately one person in every 30 classified as medium risk will develop diabetes.
• At high risk - approximately one person in every 14 classified as high risk will develop diabetes.
• At very high risk - approximately one person in every 3 classified as very high risk will develop diabetes.
Factors which increase your risk of type 2 diabetes
• Genetic factors: such as age, gender, ethnicity, region of birth and family history are all genetic factors that contribute towards your risk of developing type 2 diabetes. These are the factors you cannot change, so it is important to concentrate on the lifestyle behaviours to reduce your risk.
• Lifestyle factors: such as high blood glucose, smoking, high blood pressure, fruit and vegetable intake, physical activity, weight and waist circumference influence your risk of developing type 2 diabetes.
Adopting healthy lifestyle behaviours, weight management, exercise and healthy eating make a significant impact on risk reduction now and into the future.

What you should do next…
Given that the risk assessment indicates that you are at an elevated risk of type 2 diabetes, the DORA Project recommends you make an appointment with your doctor to further discuss your risk. Your doctor will be in the best position to know your current health status and risk factors and recommend changes you may need make to reduce your risk.
As mentioned, it is important to acknowledge that this is a risk rating only based on your responses, and is NOT a diagnosis of type 2 diabetes. A diagnosis can only be made by a medical professional following further testing.
The DORA website Library also contains a letter which you may print and take to your doctor which explains the DORA Project and the method used to arrive at the risk rating. The Library also contains links to website with credible health information.
Intervention code [1] 314174 0
Prevention
Comparator / control treatment
The text group is the control group. Information provided to participants is in line with current practice by those screening high risk on state and federal diabetes and health website.
Control group
Active

Outcomes
Primary outcome [1] 319733 0
Acceptability of the content and nature of the text or video risk information received - as determined by the feedback survey. Survey designed for study.
Timepoint [1] 319733 0
Feedback survey provided to participant immediately after viewing text or video risk information.
Primary outcome [2] 319928 0
The extent to which the risk rating information provided to the participant motivated the participant to follow up with their GP or other health professional. Survey questions designed for study.
Timepoint [2] 319928 0
1m or 3m
Secondary outcome [1] 369342 0
Dietary behaviour change following high risk rating at baseline. Dietary pattern intakes of all food groups are collected in the baseline, 1m and 3m surveys. Outcome will be assessed based on change in these reported intakes - based on reduced unhealthy intake and increased healthy intakes. Dietary intakes information collected using study-specific questionnaire.
Timepoint [1] 369342 0
1m and 3m

Eligibility
Key inclusion criteria
Live in Australia
Aged 35 years or over
Not previously diagnosed with type 1 or 2 diabetes
Access to computer
Read and speak English
screened High risk on AUSDRISK survey during registration
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under 35 years of age
Previous diagnosis of type 1 or 2 diabetes

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled 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)
website auto allocation - equal allocation to either of 2 groups in blocks of 6.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/08/2018
Date of last participant enrolment
Anticipated
Actual
12/11/2018
Date of last data collection
Anticipated
Actual
7/04/2019
Sample size
Target
300
Accrual to date
Final
500
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 302474 0
University
Name [1] 302474 0
Central Queensland University
Country [1] 302474 0
Australia
Primary sponsor type
University
Name
Central Queensland University
Address
Bruce Highway
North Rockhampton QLD 4701
Country
Australia
Secondary sponsor category [1] 302373 0
None
Name [1] 302373 0
Address [1] 302373 0
Country [1] 302373 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303137 0
CQUniversity Human Research Ethics Committee (CQUHREC)
Ethics committee address [1] 303137 0
Ethics committee country [1] 303137 0
Australia
Date submitted for ethics approval [1] 303137 0
01/11/2017
Approval date [1] 303137 0
30/11/2017
Ethics approval number [1] 303137 0
HE17/10-176

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

Contacts
Principal investigator
Name 92598 0
Dr Susan Williams
Address 92598 0
Central Queensland University, Building 7, Bruce Highway, North Rockhampton, Queensland 4701
Country 92598 0
Australia
Phone 92598 0
+61 0749232213
Fax 92598 0
Email 92598 0
[email protected]
Contact person for public queries
Name 92599 0
Susan Williams
Address 92599 0
Central Queensland University, Building 7, Bruce Highway, North Rockhampton, Queensland 4701
Country 92599 0
Australia
Phone 92599 0
+61 0749232213
Fax 92599 0
Email 92599 0
[email protected]
Contact person for scientific queries
Name 92600 0
Susan Williams
Address 92600 0
Central Queensland University, Building 7, Bruce Highway, North Rockhampton, Queensland 4701
Country 92600 0
Australia
Phone 92600 0
+61 0749232213
Fax 92600 0
Email 92600 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Summary data will be available


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
EmbaseWhat is the effectiveness of a personalised video story after an online diabetes risk assessment? A Randomised Controlled Trial.2022https://dx.doi.org/10.1371/journal.pone.0264749
N.B. These documents automatically identified may not have been verified by the study sponsor.