Rather than actually doing the difficult work of solving stroke you went down the lazy route of prevention. Anyone coming to me with such research wouldn't stay employed in stroke very long. My risk of stroke was incredibly small yet I had one because my Dad's doctor didn't tell him to have his kids tested for carotid artery problems when he was diagnosed with 80% blockage. Yes, mine was totally preventable but none of the stroke risk calculators look for that risk.
Personalised knowledge to reduce the risk of stroke (PERKS-International): protocol for a randomised controlled trial
Abstract
Abstract
Rationale
Theoretically, most strokes could be prevented through the management of modifiable risk factors. The Stroke Riskometer™ mobile phone application (hereon ‘The App’) uses an individual’s data to provide personalised information and advice to reduce their risk of stroke.
Aims
To determine the effect of The App on a combined cardiovascular risk score (Life’s Simple 7®, LS7) of modifiable risk factors at 6 months post-randomisation.
Methods and design
PERKS-International is a Phase III, multicentre, prospective, pragmatic, open-label, single-blinded endpoint, 2-arm randomised controlled trial (RCT). Inclusion criteria are: age ≥35 and ≤75 years; ≥2 LS7 risk factors; smartphone ownership; no history of stroke/myocardial infarction/cognitive impairment/terminal illness. The intervention group (IG) will be provided with The App and the usual care group (UCG) is provided with generic online information about risk factors, but not be informed about The App. Face-to-face assessments will be conducted at baseline and 6 months, and online at 3 and 12 months. The RCT includes a process and economic evaluation.
Study outcomes and sample size
The primary outcome is a difference in the mean change in LS7 (7 individual items: blood pressure, cholesterol, glucose, body mass index [BMI], smoking, physical activity and diet) from baseline to 6 months post-randomisation with intention-to-treat analysis. Secondary outcomes include: change in individual LS7 items, quality of life; stroke awareness, adverse events; health service use; and costs. Based on pilot data, 790 participants (395 IG, 395 UCG) will be required to provide 80% power (two sided α=0.05) to detect a mean difference in the LS7 of ≥0.40 (SD 1.61) in IG compared to 0.01 (SD 1.44) in the UCG at 6 months post-randomisation.
Discussion
Stroke is largely preventable. This study will provide evidence of the effectiveness of a mobile app to reduce stroke risk.
Trial registration
ACTRN12621000211864
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