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International Journal of Stroke 18(4)
survey via REDCap to ascertain: (1) download of The App;
(2) use of The App, and (3) additional assistance required for
The App. The App is not deemed a medical device by the
Australian
Therapeutic Goods Administration or New
Zealand's Medsafe due to its focus on health and lifestyle. See
Supplement Material 1 for further details on the App.
The UCG will receive a summary of their risk factors
obtained from the LS7 by e-mail with links online evidencebased
stroke prevention information. They will not be
informed about The App. Loss to follow-up of participants in
both the IG and UCG will be primarily through digital reminders
within the REDCap data collection system. When there is
non-response, study staff, blinded to the intervention arm, will
contact participants by phone or text message, to encourage
participation. To acknowledge the time commitment to the
project, participants also receive at $25 gift card after completing
the baseline and 6-month face-to-face assessments (e.g.
$50 in total). By design, there is limited contact between participants
and study staff in an effort to make the study design
closely aligned with " real-world " conditions.
Outcome assessments
All primary and secondary outcomes are listed in Table 1.
Blinded outcome assessments of cognitive function and
physical measures following informed consent will be conducted
by research assistants face-to-face at 6 months, following
baseline visit and, online assessment (REDCap) at
3 months and 12 months.
Primary outcome
* The primary outcome improved control of risk factors
as measured by the mean difference in the overall
LS7 score (blood pressure, non-fasting cholesterol
and glucose, BMI (weight kg/height m2), smoking,
physical activity, and diet)11 from baseline and
6 months post-randomization between IG and UCG.
Secondary outcomes
* Change in individual LS7 components from baseline
to 6 (all items) and 12 months (lifestyle only). LS7
items are scored as 0 " poor, " 1 " intermediate, " and 2
" ideal " allowing analysis of change in the control of
lifestyle and biomedical risk factors from randomization
to follow-up in IG compared to UCG.
* Quality of life (EQ5D)22 will be used in the costeffectiveness
analyses based on the rationale that
changes in health behaviors and improved selfmanagement
that we have hypothesized may with
use of the app may also improve QoL.24-27 The
EQ5D is widely used in stroke research and enables
comparison with other interventions, and the results
can be converted into utility values in determining a
cost/quality-adjusted life year gained.28
International Journal of Stroke, 18(4)
* Awareness of stroke signs/symptoms and required
action when stroke is suspected.
* Self-report of health professional diagnosis of cardiovascular
events (myocardial infarction, angina,
heart failure, peripheral vascular disease, stroke,
transient ischaemic attack, carotid stenosis, or aortic
aneurysm) at 3, 6, and 12 months with medical
record verification and adjudication by committee
(see data monitoring).
* Adverse events self-reported at 3, 6, and 12 months.
Process and economic evaluation
A mixed methods process evaluation will be carried out
in parallel to the main trial, utilizing surveys and semi-structured
interviews/focus groups (Supplemental Material 1).
Resource use will be gathered from data linkage and questionnaires
(Table 1 and Supplemental Material 1).
Data monitoring
An independent Data Monitoring Committee (DMC) comprising
a qualified medical practitioner, an epidemiologist
and independent statistician will review serious adverse
events and RCT conduct each quarter. The DMC is responsible
for recommendations to the executive committee
regarding stopping or continuing the trial. A cardiovascular
adjudication committee blinded to allocated intervention,
comprising a neurologist and cardiologist, will review
potential cardiovascular events (e.g. stroke and coronary
artery disease) reported at 3, 6, and 12 months.
Sample size estimates
Assuming a 10% drop-out and 10% drop-in rate, 790 participants
(395 IG, 395 UC) will provide 80% power (two-sided
α = 0.05) to detect the difference found in the New Zealand
pilot in the LS7 of ⩾0.40 (SD 1.61) in the IG compared to
0.01 (SD 1.44) in the UCG at 6 months post-randomization.29
As the pilot study recruited 68% of those screened,5 we estimate
screening 1129 people to achieve the sample size.
Statistical analyses
Analyses will be conducted using intention-to-treat (ITT)
principles. Analysis of covariance (ANCOVA) will compare
the difference in change in LS7 at 6 months post-randomization
between the IG and UCG for the primary aim.
Pre-specified sub-group analyses will assess effect modification
by age, sex, residency, baseline absolute/relative
CVD risk, and socioeconomic status.
Mixed effects models will be used to assess changes in
secondary outcomes between the IG and UCGs from baseline
to 3, 6, and 12 months post-randomization. Inferences will be
based on a 5% significance level and two-sided alternatives.
WSO - April 2023

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