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Randomized Controlled Trial
. 2017 Nov 28;7(11):e017416.
doi: 10.1136/bmjopen-2017-017416.

Protocol for a feasibility randomised controlled trial of Screening and Enhanced Risk management for Vascular Event-related Decline in Memory (SERVED Memory)

Phyo Kyaw Myint  1 , Yoon K Loke  2 , William Davison  2 , Katharina Mattishent  2 , George Christopher Fox  2 , Robert Fleetcroft  2 , David Turner  2 , Lee Shepstone  2 , John F Potter  2
Affiliations
Randomized Controlled Trial

Protocol for a feasibility randomised controlled trial of Screening and Enhanced Risk management for Vascular Event-related Decline in Memory (SERVED Memory)

Phyo Kyaw Myint et al. BMJ Open. .

Abstract

Introduction: Stroke is a leading cause of death and disability. The development of dementia after stroke is common. Vascular risk factors (VRF) which contribute to stroke risk can also contribute to cognitive decline, especially in vascular dementia (VaD). There is no established treatment for VaD, therefore strategies for prevention could have major health resource implications. This study was designed to assess whether patients with early cognitive decline after stroke/transient ischaemic attack (TIA) can be easily identified and whether target-driven VRF management can prevent progression to dementia.

Objectives: The primary objective is to establish the feasibility of recruitment and retention of patients with early cognitive decline to a randomised controlled trial of enhanced VRF management. Secondary objectives include: (a) to determine the potential clinical benefit of the intervention; (b) to estimate the sample size for a future definitive multicentre randomised controlled trial; (c) to inform a future economic evaluation; (d) to explore the link between VRF control and the incidence of cognitive impairment on longitudinal follow-up in a UK population after stroke/TIA with current routine management.

Methods: 100 patients with cognitive decline poststroke/TIA will be recruited from stroke services at the Norfolk and Norwich University Hospital. After collection of baseline data, they will be randomised to intervention (3 monthly follow-up with enhanced management) or control (treatment as usual by the general practitioner). At 12 months outcomes (repeat cognitive testing, VRF assessment) will be assessed. A further 100 patients without cognitive decline will be recruited to a parallel observational group from the same site. At 12 months they will have repeat cognitive testing.

Ethics and dissemination: Ethical approval has been granted in England. Dissemination is planned via publication in peer-reviewed medical journals and presentation at relevant conferences.

Trial registration number: 42688361; Pre-results.

Keywords: dementia; stroke; stroke medicine; vascular medicine.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Summary of the study design depicting the flow of participants through the study. Steps detailed include the identification and recruitment of participants, allocation and randomisation into the study arms based on Montreal Cognitive Assessment (MoCA) score, and the timing of intervention and follow-up visits. GP, general practitioner; TIA, transient ischaemic attack.
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References

    1. The Stroke Association. State of the Nation: stroke statistics. 2017. https://www.stroke.org.uk/resources/state-nation-stroke-statistics (accessed 17 Jul 2017).
    1. Myint PK, Sinha S, Luben RN, et al. . Risk factors for first-ever stroke in the EPIC-Norfolk prospective population-based study. Eur J Cardiovasc Prev Rehabil 2008;15:663–9. 10.1097/HJR.0b013e32830fe465 - DOI - PubMed
    1. Kwok CS, Loke YK, Hale R, et al. . Atrial fibrillation and incidence of dementia: a systematic review and meta-analysis. Neurology 2011;76:914–22. 10.1212/WNL.0b013e31820f2e38 - DOI - PubMed
    1. Guyomard V, Metcalf AK, Naguib MF, et al. . Transient ischaemic attack, vascular risk factors and cognitive impairment: a case-controlled study. Age Ageing 2011;40:641–4. 10.1093/ageing/afr079 - DOI - PubMed
    1. Barba R, Martínez-Espinosa S, Rodríguez-García E, et al. . Poststroke dementia: clinical features and risk factors. Stroke 2000;31:1494–501. 10.1161/01.STR.31.7.1494 - DOI - PubMed

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