Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000376448
Ethics application status
Approved
Date submitted
18/03/2016
Date registered
23/03/2016
Date last updated
2/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Mobile Applications to Reduce Risk of Stroke
Scientific title
A pilot randomised controlled trial to evaluate the Stroke Riskometer mobile phone application to improve stroke risk awareness and reduce risk of stroke and cardiovascular disease
Secondary ID [1] 288793 0
None
Universal Trial Number (UTN)
Trial acronym
MARS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 298057 0
Condition category
Condition code
Public Health 298218 298218 0 0
Health promotion/education
Stroke 298219 298219 0 0
Haemorrhagic
Stroke 298238 298238 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After participants are randomised into the intervention (Stroke Riskometer) group, a study RA will contact them and they will be provided a link to download the Stroke Riskometer Pro application on their mobile device. If required, they will be guided through the installation process to ensure that the app is working correctly on their device. After this they will be instructed to open and use the app as they see fit. Participants will not be instructed on how many times they should use the app/how often to use it to determine "real world" usage. The application requires the user to answer 20 health and lifestyle related questions, after which it provides them with a 5 and 10 year risk of stroke. In addition, the users applicable risk factors are identified, and the management section of the app provides additional information on these risk factors and the steps the user can take to minimise their impact. At the end of the study, participants will be asked how often they used the application, as well as their general thoughts about the utility of the application.
Intervention code [1] 294239 0
Prevention
Intervention code [2] 294240 0
Behaviour
Intervention code [3] 294241 0
Lifestyle
Comparator / control treatment
Those in the control group will continue to receive usual care (as applicable). Usual care for this study is defined as any ongoing care they were receiving at the start of the study, or any new health care interventions prescribed by their health professional while they were enrolled in the study.
Control group
Active

Outcomes
Primary outcome [1] 297720 0
Change from baseline in awareness about stroke risk and associated stroke risk factors. Participants will be asked to identify stroke symptoms and risk factors - and the percentage change in correct responses will be calculated.
Timepoint [1] 297720 0
6 months post baseline
Secondary outcome [1] 322010 0
Change from baseline in stroke risk. Participants complete the Stroke Riskometer questionnaire to measure their absolute 5 and 10 year stroke risk, and any change in the risk between baseline and follow-ups are measured.
Timepoint [1] 322010 0
6 months post baseline
Secondary outcome [2] 322058 0
Change in health behaviours related to stroke risk factors. Changes in the Life's Simple 7 health behaviour score are recorded to determine change in behaviour related to modifiable risk factors associated with stroke.
Timepoint [2] 322058 0
6 months post baseline
Secondary outcome [3] 322059 0
Determine feasibility of a full-scale RCT using the same intervention. A semi-structured qualitative interview will be used to ask participants about the acceptability of the intervention. This, in addition to the findings of the pilot trial will be used to inform the feasibility of conducting a full scale trial to investigate the efficacy of the Stroke Riskometer app as tool for primary stroke prevention
Timepoint [3] 322059 0
6 months post baseline

Eligibility
Key inclusion criteria
(1) those screened with by their GP with at least 2 modifiable stroke risk factors identified; (2) those who own a Smartphone; (3) those who give informed consent to participate in the study.
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
previous history of stroke, diagnosis of life-threatening conditions (as determined by GP), significant cognitive impairment or other conditions deemed unsuitable by their GP to participate in this research (e.g., psychiatric disorders, alcoholism).

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2016
Actual
1/08/2016
Date of last participant enrolment
Anticipated
1/05/2017
Actual
23/12/2016
Date of last data collection
Anticipated
30/06/2017
Actual
21/06/2017
Sample size
Target
50
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 7711 0
New Zealand
State/province [1] 7711 0

Funding & Sponsors
Funding source category [1] 293153 0
Government body
Name [1] 293153 0
Ministry of Tertiary Education, Skills and Employment funding reveived by Brain CoRE
Country [1] 293153 0
New Zealand
Primary sponsor type
Individual
Name
Prof Valery Feigin
Address
AUT University
90 Akoranga Drive
Northcote 0627
Auckland
Country
New Zealand
Secondary sponsor category [1] 291953 0
None
Name [1] 291953 0
Address [1] 291953 0
Country [1] 291953 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294651 0
Health and Disabilities Ethics Committee
Ethics committee address [1] 294651 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 294651 0
New Zealand
Date submitted for ethics approval [1] 294651 0
31/03/2016
Approval date [1] 294651 0
14/04/2016
Ethics approval number [1] 294651 0
16/STH/36

Summary
Brief summary
Stroke is a devastating yet highly preventable disease. There are about 9000 strokes every year in New Zealand, 30% of which are fatal in the first year and a further 70% of survivors are left with some level of disability. While the prevalence of behavioural and other modifiable risk factors of cardiovascular disease (CVD) including stroke has reached epidemic proportions worldwide, there is evidence that modifying health behaviours is feasible, improves health outcomes, reduces healthcare costs and can reduce an individual’s risk of stroke by about 70%. However, the level of public awareness of stroke, its risk factors, and how to manage them is low, particularly in communities with low socioeconomic status, in ethnic minority groups and in rural areas. Preventing the occurrence of these conditions will allow individuals and their families to live longer, healthier and more productive lives. If shown to be effective, the Stroke Riskometer will improve people’s awareness about their risk of stroke, and enable better health behaviour to minimise their chances of having one.
This study aims to conduct a pilot randomised clinical trial to test the efficacy of the Stroke Riskometer mobile application (which was a validated tool developed by AUT University) at improving participants’ awareness about stroke risk factors, and any corresponding changes in health behaviour. The pilot trial will also inform on feasibility issues such as recruitment, acceptability of the intervention, and design and timeframes of the full-scale trial. The findings of the study will also inform power calculations to determine the sample size for the full-scale trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64486 0
Prof Valery Feigin
Address 64486 0
AUT University
90 Akoranga Drive,
Northcote 0627
Auckland
Country 64486 0
New Zealand
Phone 64486 0
+64 9 921 9999 ext 9166
Fax 64486 0
Email 64486 0
[email protected]
Contact person for public queries
Name 64487 0
Mr Rohit Bhattacharjee
Address 64487 0
AUT University
AA254, 90 Akoranga Drive
Northcote 0627
Auckland
Country 64487 0
New Zealand
Phone 64487 0
+ 64 9 921 9999 ext 7126
Fax 64487 0
Email 64487 0
[email protected]
Contact person for scientific queries
Name 64488 0
Mr Rohit Bhattacharjee
Address 64488 0
AUT University
AA254, 90 Akoranga Drive
Northcote 0627
Auckland
Country 64488 0
New Zealand
Phone 64488 0
+64 9 921 9999 ext 7126
Fax 64488 0
Email 64488 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
EmbaseMobile technology for primary stroke prevention a proof-of-concept pilot randomized controlled trial.2019https://dx.doi.org/10.1161/STROKEAHA.118.023058
N.B. These documents automatically identified may not have been verified by the study sponsor.