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; Yoon Kong Loke; William Davison; Katharina Mattishent; George Christopher Fox; Robert Fleetcroft; David Turner; Lee Shepstone; John F Potter

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, Yoon Kong Loke, William Davison, Katharina Mattishent, George Christopher Fox, Robert Fleetcroft, David Turner, Lee Shepstone, John F Potter

University of East Anglia

Research output: Contribution to journal › Article › peer-review

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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.

Original language	English
Article number	e017416
Journal	BMJ Open
Volume	7
Issue number	11
Early online date	28 Nov 2017
DOIs	https://doi.org/10.1136/bmjopen-2017-017416
Publication status	Published - Nov 2017

Bibliographical note

This work was supported by the National Institute for Health Research
(NIHR) under its Research for Patient Benefit Programme (RfPB), grant number
DRF-2013-06-115. The views expressed here are those of the author(s) and not
necessarily those of the NHS, the NIHR or the Department of Health. The study is
sponsored by Research and Development at NNUH. The sponsor did not have a role
in the design or implementation of the study, nor the writing of this protocol.

Keywords

cognitive impairment
dementia
vascular dementia
stroke
TIA

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

Myint, P. K., Loke, Y. K., Davison, W., Mattishent, K., Fox, G. C., Fleetcroft, R., Turner, D., Shepstone, L., & Potter, J. F. (2017). Protocol for a feasibility randomised controlled trial of Screening and Enhanced Risk management for Vascular Event-related Decline in Memory (SERVED Memory). BMJ Open, 7(11), Article e017416. https://doi.org/10.1136/bmjopen-2017-017416

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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.",

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AU - Loke, Yoon Kong

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AU - Mattishent, Katharina

AU - Fox, George Christopher

AU - Fleetcroft, Robert

AU - Turner, David

AU - Shepstone, Lee

AU - Potter, John F

N1 - This work was supported by the National Institute for Health Research (NIHR) under its Research for Patient Benefit Programme (RfPB), grant number DRF-2013-06-115. The views expressed here are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. The study is sponsored by Research and Development at NNUH. The sponsor did not have a role in the design or implementation of the study, nor the writing of this protocol.

PY - 2017/11

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N2 - 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.

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KW - dementia

KW - vascular dementia

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DO - 10.1136/bmjopen-2017-017416

M3 - Article

SN - 2044-6055

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JO - BMJ Open

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M1 - e017416

ER -

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

Abstract

Bibliographical note

Keywords

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