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International Journal of Stroke 18(4)
Discussion: Stroke is largely preventable. This study will provide evidence of the effectiveness of a mobile app to reduce
stroke risk.
Trial registration: ACTRN12621000211864.
Keywords
Stroke, prevention, protocols, epidemiology, risk factors, intervention
Received: 10 April 2022; accepted: 14 June 2022
Introduction and rationale
The rising number of people affected by stroke is due to
increases in life expectancy but also changes in the prevalence
of stroke risk factors.1 Primary prevention is the most
effective solution to reduce the burden of stroke.2 Targets
for primary prevention are well-known; INTERSTROKE
investigators reported that 90% of strokes could be
accounted for by 10 modifiable risk factors.3 Populationlevel
data from numerous countries demonstrate persistently
high prevalence of stroke risk factors,4 suggesting an
urgent need for new primary prevention strategies.
There is growing evidence of the feasibility and effectiveness
of mobile technologies to improve health, including
results of our pilot randomized controlled trial (RCT).5
Auckland University of Technology (AUT) in New Zealand
have developed the free Stroke RiskometerTM Pro application
(hereon " The App " ) that uses an individual's demographics,
health, and lifestyle data to provide absolute and
relative risk of stroke. The App's stroke risk calculation algorithm
was validated against the established Framingham
Stroke Risk Score and QStroke and found to have comparable
stroke risk prediction.6 The App incorporates several
evidence-based tools to promote behavior change aligned
with internationally recognized stroke prevention guidelines.7
These include (1) provision of feedback on absolute
risk of stroke within the next 5-10 years and relative risk
with those of a person of the same age and sex without risk
factors to motivate behavior change; (2) employment of tailored
self-management strategies including goal setting to
engage the person in behavior modification; (3) information
on stroke risk factors and warning signs aligned with the
internationally relevant Face, Arm, Speech, Time (FAST)
international mass media campaign; (4) reminders, known as
" push notifications, " to prompt users to achieve their goals
that have been shown to increase adherence to programs;8
and (5) the ability to track and visualize individual risk factors
over time. Mobile technologies are widely accessible
and promising approach to enhance primary stroke prevention
strategies.9 However, there is limited evidence of their
efficacy for changing health behaviors to prevent stroke.10
Our primary aim is to determine the efficacy of The App
in improving the Life's Simple 7 (LS7)11 score comprising
lifestyle and biomedical risk factors compared to the usual
care at 6 months post-randomization.
International Journal of Stroke, 18(4)
Methods
Design
Knowledge to reduce the risk of Stroke (PERKSInternational)
is a Phase III, prospective, pragmatic, openlabel,
single-blinded end-point, 2-arm, RCT
being
undertaken in Australia (Hobart, Tasmania; Melbourne,
Victoria; Adelaide, South Australia) and New Zealand
(Auckland, Hamilton). Mobile network coverage is high in
all locations (>96% of population). The protocol is presented
in accordance with the Standard Protocol Items:
Recommendations for Interventional Trials (SPIRIT)12 and
mHealth evidence reporting and assessment (mERA) guidelines
(see Supplemental Material 1).13
Participant eligibility
Participants will be recruited through advertising (Australia
and New Zealand) and General practice clinics (New
Zealand).
Inclusion criteria:
* Aged between 35 and 75 years (inclusive).
* ⩾2 " poor " LS7 risk factors.11
* No cognitive impairment (Montreal Cognitive
Assessment (MoCA) score ⩾26).14
* Own smartphone.
* Speaks English.
Exclusion criteria:
* History of stroke, myocardial infarction, or terminal
illness (self-report with verification through medical
records).
* Participating in another RCT.
* Family/household members of existing participants.
Screening is conducted online using REDCap: https://redcap.utas.edu.au/surveys/?s=M7N8DHFE3J.
Potential participants
are sent an e-mail via REDCap with links to (1)
online booking system for the face-to-face baseline assessment
for biomedical risk factors (Supplemental Table 1)
and (2) questionnaires for demographic, health, and lifestyle
questions (Supplemental Material 2).
https://redcap.utas.edu.au/surveys/?s=M7N8DHFE3J https://redcap.utas.edu.au/surveys/?s=M7N8DHFE3J
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