Personalized knowledge to reduce the risk of stroke (PERKS-International): Protocol for a randomized controlled trial

Seana L Gall; Valery Feigin; Amanda G Thrift; Timothy J Kleinig; Dominique A Cadilhac; Derrick A Bennett; Mark R Nelson; Tara Purvis; Shabnam Jalili-Moghaddam; Gemma Kitsos; Rita Krishnamurthi

doi:10.1177/17474930221113430

Personalized knowledge to reduce the risk of stroke (PERKS-International): Protocol for a randomized controlled trial

Int J Stroke. 2023 Apr;18(4):477-483. doi: 10.1177/17474930221113430. Epub 2022 Jul 22.

Authors

Affiliations

¹ Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.
² National Institute of Stroke and Applied Neurosciences, Auckland University of Technology, Auckland, New Zealand.
³ Epidemiology and Prevention Division, Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, VIC, Australia.
⁴ Department of Medicine, The University of Adelaide, Adelaide, SA, Australia.
⁵ Department of Neurology, Royal Adelaide Hospital, Adelaide, SA, Australia.
⁶ Translational Public Health and Evaluation Division, Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, VIC, Australia.
⁷ Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
⁸ Medical Research Council Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.

PMID: 35770887
DOI: 10.1177/17474930221113430

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 personalized 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-randomization.

Methods and design: PERKS-International is a Phase III, multicentre, prospective, pragmatic, open-label, single-blinded endpoint, two-arm randomized controlled trial (RCT). Inclusion criteria are as follows: 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 (seven individual items: blood pressure, cholesterol, glucose, body mass index (BMI), smoking, physical activity, and diet) from baseline to 6 months post-randomization 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-randomization.

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; epidemiology; intervention; prevention; protocols; risk factors.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Clinical Trials, Phase III as Topic
Diet
Humans
Multicenter Studies as Topic
Myocardial Infarction*
Quality of Life
Randomized Controlled Trials as Topic
Risk Factors
Stroke* / epidemiology
Stroke* / prevention & control

Associated data

ANZCTR/ACTRN12621000211864