Thursday, July 7, 2022

Personalised knowledge to reduce the risk of stroke (PERKS-International): protocol for a randomised controlled trial

 Where is the much more important research?

Personalised knowledge to 100% recovery

I would never approve research like this, the whole point of stroke research is to get survivors recovered. This is just a lazy way to get published. 

Shit there are multiple stroke risk calculators out there already, making it mobile is not addressing an unmet need. My parents could never have figured out a cell phone much less an app on that cell phone, which would be the market for such an app.

  • stroke risk calculator (24 posts to February 2011) And none of these had me at anything other than low risk, because they can't tell how unstable your plaque is. 

Personalised knowledge to reduce the risk of stroke (PERKS-International): protocol for a randomised controlled trial

First Published June 30, 2022 Research Article 

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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