Mobile Technology for Primary Stroke Prevention

A Proof-of-Concept Pilot Randomized Controlled Trial

Rita Krishnamurthi, PhD; Leigh Hale, PhD; Suzanne Barker-Collo, PhD; Alice Theadom, PhD;
Rohit Bhattacharjee, MSc; Ann George, MSc; Bruce Arroll, PhD; Annamarie Ranta, MD, PhD;
Debra Waters, PhD; Denise Wilson, PhD; Peter Sandiford, MBChB, PhD; Seana Gall, PhD;
Priyakumari Parmar, PhD; Derrick Bennett, PhD; Valery Feigin, MD, PhD

Background and Purpose—Feasibility of utilizing the Stroke Riskometer App (App) to improve stroke awareness and
modify stroke risk behaviors was assessed to inform a full randomized controlled trial.
Methods—A parallel, open-label, 2-arm prospective, proof-of-concept pilot randomized controlled trial. Participants were
randomized to usual care/control or App intervention group and assessed at baseline, 3, and 6 months. The App measures
stroke risk and provides information on management of risk factors. Participants were aged >19 years with at least 2
modifiable stroke risk factors identified, no prior stroke, and owned a smartphone.
Results—Fifty participants (24 control, 26 App) were recruited from 148 eligible participants. Retention in the trial was
87%. Mean cardiovascular health (Life’s Simple 7) improved by 0.36 (95% CI, −2.10 to 1.38) in the App group compared
with 0.01 (95% CI, −1.34 to 1.32) in controls (P=0.6733).
Conclusions—These findings support a full randomized controlled trial to test the effectiveness of the Stroke Riskometer
for primary stroke prevention.
Clinical Trial Registration—URL: www.anzctr.org.au. Unique Identifier: ACTRN12616000376448.   
(Stroke. 2019;50:196-198. DOI: 10.1161/STROKEAHA.118.023058.)
Key Words: awareness ◼ primary prevention ◼ risk factors ◼ smartphones ◼ stroke

S
Downloaded from http://ahajournals.org by on February 22, 2020

troke is the second leading cause of death and disability
globally1 yet is highly preventable.2 Current primary
stroke prevention strategies are not universally adopted, and,
therefore, not sufficiently effective.3 Smartphone mobile
applications are increasingly used to elicit behavior change
for disease prevention.4, 5 There is no current evidence on use
of smartphone mobile applications to specifically address the
multiple risk factors associated with overall risk of stroke.
The Stroke Riskometer App (App) was developed as a
novel, evidence-based, validated6 tool to address these gaps in
primary stroke prevention.3, 7, 8 We present findings from a pilot
randomized controlled trial designed to gather information on
feasibility of the App and key metrics for a full randomized
controlled trial and to obtain preliminary efficacy data.
Methods
The data that support the findings of this study are available from the
corresponding author on reasonable request.
Study Design
We performed a parallel, open-label, 2-arm prospective, proof-of-con-
cept pilot randomized controlled trial. The trial arms were: (1) usual
care (control; participants not actively informed the App); and (2) Stroke
Riskometer Pro Intervention Group (App). The study had ethical ap-
proval Health and Disability Ethics Committee (number 16/STH/36),
Auckland University of Technology Ethics Committee (number
16/241). Potential participants were identified from patient databases
by general practitioner clinic staff. Inclusion criteria: aged >19 years,
with at least 2 modifiable stroke risk factors; own a smartphone; and
who give informed consent to participate. Exclusion criteria: previous
history of stroke, diagnosed conditions deemed unsuitable by their
GP. The age of the population used to validate the algorithm was 20
to 90 years, encapsulating those at risk. The contribution of stroke
risk factors differs in those under 20 years of age, and the algorithm
is not an informative predictor of stroke beyond the age of 90 years.
For 7 months, 50 participants (24 control, 26 App) were recruited
(Figure 1). Although 148 eligible participants were referred to us by
the general practitioner clinic, 60 of these did not respond to phone
calls and messages from the research team. Stratified minimization
randomization was used to balance the groups for age (<65, 65+) and

Received June 13, 2018; final revision received October 4, 2018; accepted October 24, 2018.
From the National Institute for Stroke and Applied Neurosciences, Faculty of Health and Environmental Studies (RK., A.T., R.B., A.G., P.P., V.F.) and Taupua
Waiora Centre for Māori Health Research, School of Public Health and Psychosocial Studies (D.W.), Auckland University of Technology, New Zealand;
Department of Medicine, School of Physiotherapy, University of Otago, Dunedin, New Zealand (L.H.); School of Psychology (S.B.-C.), Department of General
Practice and Healthcare, School of Population Health (B.A.), and School of Population Health (P.S.), University of Auckland, New Zealand; Department of
Medicine, University of Otago, Wellington, New Zealand (A.R.); Department of Neurology, Wellington Hospital, Wellington, New Zealand (A.R.); ; Department
of Medicine, School of Physiotherapy, University of Otago, Dunedin, New Zealand (D.W.); Waitemata District Health Board, Auckland, New Zealand;
University of Auckland, New Zealand (P.S.); Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia (S.G.); and Clinical Trial
Service Unit and Epidemiological Studies Unit (CTSU), Nuffield Department of Population Health, University of Oxford, United Kingdom (D.B.).
Correspondence to Valery L Feigin, MD, PhD, National Institute for Stroke and Applied Neurosciences, School of Rehabilitation and Occupation
Studies, School of Public Health and Psychosocial Studies, Faculty of Health and Environmental Studies, Auckland University of Technology, N Shore
Campus, AA254, 90 Akoranga Dr, Northcote 0627, Private Bag 92006, Auckland 1142, New Zealand. Email valery.feigin@aut.ac.nz
© 2018 American Heart Association, Inc.
Stroke is available at https://www.ahajournals.org/journal/str DOI: 10.1161/STROKEAHA.118.023058

196
 Krishnamurthi et al   Mobile Technology for Primary Stroke Prevention   197

Figure 1. Flowchart of participant recruitment.

Trial profile of participant recruitment and ran-
domization. App indicates Stroke Riskometer
App.

sex. Persons who were discovered not to be able to use smartphone
mobile applications were excluded before randomization.
Assessments were conducted face-to-face or by telephone at
baseline, 3 and 6 months by a research assistant blinded to group allo-
cation. Measures were obtained from medical records, study-initiated
blood tests, or otherwise self-reported. Physical measurements, such
as cholesterol levels and blood pressure, were obtained from medical
records where available or otherwise self-reported. At the 6-month
follow-up, all participants were provided with a blood test form for
blood glucose and cholesterol measures. Weight and height were self-
reported at baseline and recorded in person at the 6-month follow-up.
App group participants were provided a link to the iTunes App Store
or Google Play to download the app.
Information on recruitment rate, implementation and uptake
of the App, assessment and outcome measure completion rate, and
frequency of withdrawals and loss to follow-up were obtained. The
Life’s Simple 7 metric (LS7) was used to measure differences in car-
diovascular health9, 10 between control and App groups at 6 months
Downloaded from http://ahajournals.org by on February 22, 2020
CI, 0.32–2.49; P=0.8241). At 6 months, the proportion of
those showing awareness of ≥2 symptoms increased in App
by 13% but decreased by 8% in Control.
Discussion
Recruitment was feasible, and the App had a reasonable uptake
as an intervention, with overall positive feedback. Participants
provided suggestions for improvements on utility or ease of
use, and we observed some positive lifestyle behavior changes
(eg, diet, number of cigarettes smoked). As some measures,
such as blood pressure, height, weight have considerable var-
iability with self-report, we propose standardized recordings
by researchers to increase reliability and validity. The fre-
quency of contact should also be balanced between groups.

postrandomisation. Stroke awareness was assessed using open-ended Table.  Baseline Participant Characteristics
questions at baseline and 6 months.
App, Control,
Statistical Analysis Risk Factor Categories n=26 (%) n=24 (%)
Demographic and risk factor profiles for the App and control groups
were analyzed. A general linear model was used to compare dif- Age, y Mean (SD) 47 (14) 43 (14)
ference in LS7 change at 6 months postrandomisation between the
Baseline LS7 Mean (SD) 5.84 (2.10) 6.29 (2.24)
groups. α=0.05 (2-sided) was used to indicate statistical significance.
score
Analyses were conducted using intention to treat principles.
Age groups, y 20–29 4 (15.4) 4 (16.7)
Results 30–39 4 (15.4) 7 (29.2)
Fifty participants (60% female) were recruited from over 7 40–49 10 (38.5) 5 (20.8)
months (Figure 1). Of these, 26 were randomized to the App
50–59 2 (7.7) 6 (25)
and 24 to control. There were no significant differences in
baseline characteristics between groups (Table). The overall 60+ 6 (23.1) 2 (8.3)
recruitment rate was 72% (50/69), and overall retention in Sex Female 15 (57.7) 15 (62.5)
the trial at 6 months was 84% (42 of 50 randomized study
Ethnicity European 8 (30.8) 5 (20.8)
participants).
Owning a smartphone did not always translate to being Maori 7 (26.9) 4 (16.7)
able to download and use the App. Participant feedback Pacific 6 (23.1) 6 (25)
showed that 79% of participants found using the App and Asian 4 (15.4) 5 (20.8)
knowing their risk factors motivated them to take action to
Other 1 (3.8) 4 (16.7)
reduce their risk. The LS7 score in the control group changed
from 6.29 (SD, 2.24) at baseline to 6.30 (SD, 2.13) at 6 Education Up to high school 10 (38.5) 10 (41.7)
months, an increase of 0.01 (SD, 1.44) points (P=0.9900; 95% Tertiary education 16 (61.5) 14 (58.3)
CI, −1.34 to 1.32). The LS7 score in App changed from 5.84
Employed Full-time/part-time 18 (69.2) 17 (70.8)
(SD, 2.10) at baseline to 6.20 (SD, 2.83), an increase of 0.36
(SD, 1.61; 95% CI, −2.10 to 1.38) points at the 6-month fol- Retired/unemployed/other 8 (30.8) 7 (29.2)
low-up (P=0.6733; Figure 2). There was no significant differ- Previous use Yes 25 (96.2) 20 (83.3)
ence in the total LS7 score change from baseline to 6 months of health apps
between the app and usual care groups (odds ratio, 0.89; 95% App indicates Stroke Riskometer App; and LS7, Life’s Simple 7 metric.
 198  Stroke  January 2019
Figure 2. Changes in Life’s Simple 7 (LS7) scores from baseline to 6 mo.
Shows changes in LS7 score from baseline to 6 months a 0.01 increase
seen in controls) and a 0.36 point increase in (Stroke Riskometer App
[App] intervention group).
Conclusions
Our findings showed the Stroke Riskometer App in a full ran-
domized controlled trial for stroke prevention is feasible in a
high-income country with diverse ethnic groups. The signifi-
cant overlap between risk factors for stroke and other noncom-
municable diseases11, 12 means primary prevention programs
Downloaded from http://ahajournals.org by on February 22, 2020
may also contribute to reducing these other noncommunicable
diseases.
Acknowledgments
We acknowledge the research participants and research assistants.
Sources of Funding
This study was funded by Brain Research Centre of Research
Excellence of New Zealand. Dr Gall received research funding from
the National Heart Foundation of Australia.
Disclosures
Dr Feigin declares that Auckland University of Technology owns the
Stroke Riskometer app. The other authors report no conflicts.
References
1. Feigin VL, Abajobir AA, Abate KH, Abd-Allah F, Abdulle AM, Abera
SF, et al. Global, regional, and national burden of neurological disorders
during 1990–2015: A systematic analysis for the global burden of di-
sease study 2015. Lancet Neurol. 2017;16:877–897.
2. Feigin VL, Roth GA, Naghavi M, Parmar P, Krishnamurthi R, Chugh S,
et al; Global Burden of Diseases, Injuries and Risk Factors Study 2013
and Stroke Experts Writing Group. Global burden of stroke and risk fac-
tors in 188 countries, during 1990-2013: a systematic analysis for the
Global Burden of Disease Study 2013. Lancet Neurol. 2016;15:913–924.
doi: 10.1016/S1474-4422(16)30073-4
3. Feigin VL, Norrving B, Mensah GA. Primary prevention of cardiovas-
cular disease through population-wide motivational strategies: insights
from using smartphones in stroke prevention. BMJ Global Health.
2017;2:e000306
4. Schoeppe S, Alley S, Van Lippevelde W, Bray NA, Williams SL, Duncan
MJ, et al. Efficacy of interventions that use apps to improve diet, physical
activity and sedentary behaviour: a systematic review. Int J Behav Nutr
Phys Act. 2016;13:127. doi: 10.1186/s12966-016-0454-y
5. Gandhi S, Chen S, Hong L, Sun K, Gong E, Li C, et al. Effect of mo-
bile health interventions on the secondary prevention of cardiovas-
cular disease: systematic review and meta-analysis. Can J Cardiol.
2017;33:219–231. doi: 10.1016/j.cjca.2016.08.017
6. Parmar P, Krishnamurthi R, Ikram MA, Hofman A, Mirza SS, Varakin
Y, et al; Stroke RiskometerTM Collaboration Writing Group. The Stroke
Riskometer™ App: validation of a data collection tool and stroke risk
predictor. Int J Stroke. 2015;10:231–244. doi: 10.1111/ijs.12411
7. Feigin VL, Krishnamurthi R, Bhattacharjee R, Parmar P, Theadom A,
Hussein T, et al; RIBURST Study Collaboration Writing Group. New
strategy to reduce the global burden of stroke. Stroke. 2015;46:1740–
1747. doi: 10.1161/STROKEAHA.115.008222
8. Meschia JF, Bushnell C, Boden-Albala B, Braun LT, Bravata DM,
Chaturvedi S, et al; American Heart Association Stroke Council; Council
on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology;
Council on Functional Genomics and Translational Biology; Council on
Hypertension. Guidelines for the primary prevention of stroke: a state-
ment for healthcare professionals from the American Heart Association/
American Stroke Association. Stroke. 2014;45:3754–3832. doi:
10.1161/STR.0000000000000046
9. Kulshreshtha A, Vaccarino V, Judd SE, Howard VJ, McClellan WM,
Muntner P, et al. Life’s Simple 7 and risk of incident stroke: the rea-
sons for geographic and racial differences in stroke study. Stroke.
2013;44:1909–1914. doi: 10.1161/STROKEAHA.111.000352
10. Folsom AR, Yatsuya H, Nettleton JA, Lutsey PL, Cushman M, Rosamond
WD; ARIC Study Investigators. Community prevalence of ideal car-
diovascular health, by the American Heart Association definition, and
relationship with cardiovascular disease incidence. J Am Coll Cardiol.
2011;57:1690–1696. doi: 10.1016/j.jacc.2010.11.041
11. The Lancet Neurology. The shared burden of stroke and dementia.
Lancet Neurol. 2016;15:891
12. Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, et al;
INTERHEART Study Investigators. Effect of potentially modifiable
risk factors associated with myocardial infarction in 52 countries (the
INTERHEART study): case-control study. Lancet. 2004;364:937–952.
doi: 10.1016/S0140-6736(04)17018-9