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Health services research
Protocol
Primary prevention of stroke: randomised controlled pilot trial protocol on engaging everyday activities promoting health
  1. Ann-Helen Patomella1,
  2. Susanne Guidetti1,
  3. Emelie Mälstam1,2,
  4. Christina Eriksson1,
  5. Aileen Bergström1,
  6. Elisabet Åkesson1,
  7. Anders Kottorp1,3,
  8. Eric Asaba1
  1. 1Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden
  2. 2University of Gävle, Faculty of Health and Occupational Studies, Gävle, Sweden
  3. 3Health and Society, University of Malmö, Malmö, Sweden
  1. Correspondence to Dr Ann-Helen Patomella; ann-helen.patomella{at}ki.se

Abstract

Introduction Stroke is a globally common disease that has detrimental effects on the individual and, more broadly, on society. Lifestyle change can contribute to reducing risk factors for stroke. Although a healthy lifestyle has direct benefits, sustaining and incorporating healthy activities into everyday life is a challenge. Engaging everyday activities have the potential to support lifestyle change and to promote sustainable activity patterns. Current healthcare is failing to reduce modifiable risk factors in people at risk, and in addition to current practice, there is a need for systematic and efficient non-pharmacological and non-surgical stroke-prevention strategies. The aim of the pilot study was to increase knowledge about the effects of a prevention programme and its feasibility to promote sustainable and healthy activity patterns among persons at risk of stroke.

Methods and analysis The proposed pilot study will be a two-armed randomised, assessor-blinded, parallel pilot trial. The study will include feasibility data, investigating acceptability and delivery of the intervention. Persons at risk of stroke (n=60) will be included in a mobile phone-supported prevention programme. The 10-week programme will be conducted at primary healthcare clinics, combining group meetings and online resources to support self-management of lifestyle change. Main outcomes are stroke risk, lifestyle habits and healthy activity patterns. Assessments will be performed at baseline and at follow-up (immediately following the end of the programme and at 6 and 12 months). Effects of the programme will be analysed using inferential statistics. Feasibility will be analysed using both qualitative and quantitative methods.

Ethics and dissemination The study has been approved by the Regional Ethical Review Board in Stockholm, Sweden, being granted reference numbers 2015/834-31, 2016/2203-32 and 2019/01444. Study results will be disseminated through peer-review journals and presentations to mixed audiences at regional and international conferences.

Trial registration number NCT03730701.

  • stroke
  • prevention
  • Mhealth
  • primary care
  • stroke risk
  • occupational therapy

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2019-031984

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    Footnotes

    • Contributors A-HP, EA and SG conceived the original idea and outline of the study. EM is implementing the protocol in primary healthcare settings, with oversight and review by A-HP, EA and SG. AK, AB, CE and EÅ contributed to the design of the study. A-HP wrote the study protocol together with EA, SG and AB. All authors discussed and commented on draft versions and approved the final version.

    • Funding This work was funded by grants from Vårdal Foundation, grant number 2014-0108 and from the research school of Health Care Science, Karolinska Institutet. This funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data or decision to submit results.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.