Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
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
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?
Secondary ID [1] 281054 0
Nil
Universal Trial Number (UTN)
U1111-1133-5869
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain-heart health 287199 0
Condition category
Condition code
Public Health 287527 287527 0 0
Health promotion/education
Cardiovascular 287534 287534 0 0
Normal development and function of the cardiovascular system
Neurological 287535 287535 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 285513 0
Lifestyle
Comparator / control treatment
Intervention #3: The Brain-Heart Health Program
-


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.
Control group
Active

Outcomes
Primary outcome [1] 287769 0
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.
Timepoint [1] 287769 0
Baseline and immediately following completion of the intervention.
Secondary outcome [1] 298807 0
Maintenance of positive lifestyle changes following the completion of the intervention, as assessed using the Health Behaviour Questionnaire.
Timepoint [1] 298807 0
Three months after completion of the intervention.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Detailed in inclusion criteria above.

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)
Computer-generated random numbers.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285840 0
Other Collaborative groups
Name [1] 285840 0
Dementia Collaborative Research Centres - Early Diagnosis and Prevention
Country [1] 285840 0
Australia
Funding source category [2] 285841 0
Charities/Societies/Foundations
Name [2] 285841 0
Bupa Health Foundation
Country [2] 285841 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Alzheimer's Australia
Address
Dr Maree Farrow
98-104 Riversdale Road
Hawthorn, VIC, 3122
Country
Australia
Secondary sponsor category [1] 284662 0
None
Name [1] 284662 0
Address [1] 284662 0
Country [1] 284662 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287862 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 287862 0
Office of Research Integrity
Research Services
Chancelry 10B, Lower Ground Floor
East Road
The Australian National University
Acton, ACT, 0200
Ethics committee country [1] 287862 0
Australia
Date submitted for ethics approval [1] 287862 0
Approval date [1] 287862 0
14/06/2012
Ethics approval number [1] 287862 0
2012/238

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34593 0
Address 34593 0
Country 34593 0
Phone 34593 0
Fax 34593 0
Email 34593 0
Contact person for public queries
Name 17840 0
Elodie O'Connor
Address 17840 0
Alzheimer's Australia
98-104 Riversdale Road
Hawthorn, VIC, 3122
Country 17840 0
Australia
Phone 17840 0
+61 3 9816 5718
Fax 17840 0
Email 17840 0
[email protected]
Contact person for scientific queries
Name 8768 0
Elodie O'Connor
Address 8768 0
Alzheimer's Australia
98-104 Riversdale Road
Hawthorn, VIC, 3122
Country 8768 0
Australia
Phone 8768 0
+61 3 9816 5718
Fax 8768 0
Email 8768 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.