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Trial registered on ANZCTR
Registration number
ACTRN12612000886886
Ethics application status
Approved
Date submitted
17/08/2012
Date registered
21/08/2012
Date last updated
22/08/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
eHealth Tools for Improving Brain-Heart Health in the Australian Community
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Scientific title
In Australian adults, are an interactive website and a smartphone application more effective than an information-based website in health behaviour change related to brain-heart health, at one month and four month follow-ups?
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Secondary ID [1]
281054
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Nil
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Universal Trial Number (UTN)
U1111-1133-5869
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Brain-heart health
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Condition category
Condition code
Public Health
287527
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0
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Health promotion/education
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Cardiovascular
287534
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0
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Normal development and function of the cardiovascular system
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Neurological
287535
287535
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0
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Studies of the normal brain and nervous system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention #1: BrainyApp
BrainyApp is a mobile device application designed to raise awareness of the link between brain and heart health, and to help users make positive lifestyle changes. Users complete a Brain Health Survey and then engage in the recommended activities to improve in areas where they have scored poorly. The duration of the intervention is four weeks, and the frequency of use is at the participants' discretion.
Intervention #2: The Brain-Heart Health+ Program
The Brain-Heart Health+ Program is an interactive web-based program designed to raise awareness of the link between brain and heart health, and to help users make positive lifestyle changes. Users complete a Brain Health Survey and then complete a series of online modules in order to improve in areas where they have scored poorly. The Brain-Heart Health+ Program is also designed to provide users with an overview of the scientific evidence supporting the link between brain and heart health, as well as giving users practical tips, resources, and updates. The duration of the intervention is four weeks, and the frequency of use is at the participants' discretion.
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Intervention code [1]
285513
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Lifestyle
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Comparator / control treatment
Intervention #3: The Brain-Heart Health Program
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The Brain-Heart Health Program is an information-based website designed to inform users of the link between brain and heart health, and to provide the scientific evidence supporting this link. The duration of the control treatment is four weeks, and the frequency of use is at the participants' discretion.
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Control group
Active
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Outcomes
Primary outcome [1]
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Positive behaviour change across a range of lifestyle factors (alcohol use, blood pressure, body weight, cholesterol, diabetes, diet, mental activity, physical activity, smoking, and social activity), assessed using the Health Behaviour Questionnaire, which was designed specifically for this research project.
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Assessment method [1]
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Timepoint [1]
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Baseline and immediately following completion of the intervention.
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Secondary outcome [1]
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Maintenance of positive lifestyle changes following the completion of the intervention, as assessed using the Health Behaviour Questionnaire.
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Assessment method [1]
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Timepoint [1]
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Three months after completion of the intervention.
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Eligibility
Key inclusion criteria
1. Be aged over eighteen
2. Speak English
3. Have daily access to an internet-enabled mobile phone or tablet, email, and internet
4. Be healthy enough to undertake physical exercise
5. Not have a psychiatric or neurological condition
6. Not have previously engaged with the evaluation tools
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Detailed in inclusion criteria above.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
10/09/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Other Collaborative groups
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Name [1]
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Dementia Collaborative Research Centres - Early Diagnosis and Prevention
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Address [1]
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Centre for Research on Ageing, Health and Wellbeing
The Australian National University
Canberra, ACT, 0200
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Country [1]
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Australia
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Funding source category [2]
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Charities/Societies/Foundations
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Name [2]
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Bupa Health Foundation
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Address [2]
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600 Glenferrie Road
Hawthorn, VIC, 3122
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Country [2]
285841
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
Alzheimer's Australia
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Address
Dr Maree Farrow
98-104 Riversdale Road
Hawthorn, VIC, 3122
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
284662
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Address [1]
284662
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Country [1]
284662
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Australian National University Human Research Ethics Committee
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Ethics committee address [1]
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Office of Research Integrity
Research Services
Chancelry 10B, Lower Ground Floor
East Road
The Australian National University
Acton, ACT, 0200
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Ethics committee country [1]
287862
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Australia
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Date submitted for ethics approval [1]
287862
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Approval date [1]
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14/06/2012
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Ethics approval number [1]
287862
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2012/238
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Summary
Brief summary
This project aims to evaluate a range of eHealth (i.e. healthcare using the internet; e.g. websites, apps) tools that have been designed to raise awareness of the link between brain and heart health and to help people make positive lifestyle changes.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Elodie O'Connor
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Address
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Alzheimer's Australia
98-104 Riversdale Road
Hawthorn, VIC, 3122
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Country
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Australia
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Phone
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+61 3 9816 5718
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Elodie O'Connor
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Address
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Alzheimer's Australia
98-104 Riversdale Road
Hawthorn, VIC, 3122
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Country
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Australia
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Phone
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+61 3 9816 5718
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Fax
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Email
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[email protected]
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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.
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