Balance Right in Multiple Sclerosis (BRiMS): a guided self-management programme to reduce falls and improve quality of life, balance and mobility in people with secondary progressive multiple sclerosis: a protocol for a feasibility randomised controlled trial

H. Gunn, J. Andrade, L. Paul, L. Miller, S. Creanor, C. Green, J. Marsden, P. Ewings, M. Berrow, J. Vickery, A. Barton, B. Marshall, J. Zajicek, J.A. Freeman

    Research output: Contribution to journalArticle

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    Abstract

    Background
    Impaired mobility is a cardinal feature of multiple sclerosis (MS) and is rated by people with MS as their highest priority. By the secondary progressive phase, balance, mobility and physical activity levels are significantly compromised; an estimated 70% of people with secondary progressive MS fall regularly. Our ongoing research has systematically developed ‘Balance Right in MS’ (BRiMS), an innovative, manualised 13-week guided self-management programme tailored to the needs of people with MS, designed to improve safe mobility and minimise falls. Our eventual aim is to assess the clinical and cost effectiveness of BRiMS in people with secondary progressive MS by undertaking an appropriately statistically powered, multi-centre, assessor-blinded definitive, randomised controlled trial. This feasibility study will assess the acceptability of the intervention and test the achievability of running such a definitive trial.

    Methods/design
    This is a pragmatic multi-centre feasibility randomised controlled trial with blinded outcome assessment. Sixty ambulant people with secondary progressive MS who self-report two or more falls in the previous 6 months will be randomly allocated (1:1) to either the BRiMS programme plus usual care or to usual care alone. All participants will be assessed at baseline and followed up at 15 weeks and 27 weeks post-randomisation.

    The outcomes of this feasibility trial include:
    Feasibility outcomes, including trial recruitment, retention and completion
    Assessment of the proposed outcome measures for the anticipated definitive trial (including measures of walking, quality of life, falls, balance and activity level)
    Measures of adherence to the BRiMS programme
    Data to inform the economic evaluation in a future trial
    Process evaluation (assessment of treatment fidelity and qualitative evaluation of participant and treating therapist experience)
    Discussion
    The BRiMS intervention aims to address a key concern for MS service users and providers. However, there are several uncertainties which need to be addressed prior to progressing to a full-scale trial, including acceptability of the BRiMS intervention and practicality of the trial procedures. This feasibility trial will provide important insights to resolve these uncertainties and will enable a protocol to be finalised for use in the definitive trial.
    Original languageEnglish
    Article number26
    Number of pages12
    JournalPilot and Feasibility Studies
    Volume27
    Issue number4:26
    DOIs
    Publication statusPublished - 27 Jul 2017

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    Chronic Progressive Multiple Sclerosis
    Self Care
    Multiple Sclerosis
    Randomized Controlled Trials
    Quality of Life
    Uncertainty
    Cost-Benefit Analysis
    Outcome Assessment (Health Care)
    Feasibility Studies
    Random Allocation
    Running
    Self Report
    Walking

    Keywords

    • multiple sclerosis
    • fall prevention
    • mobility

    Cite this

    Gunn, H. ; Andrade, J. ; Paul, L. ; Miller, L. ; Creanor, S. ; Green, C. ; Marsden, J. ; Ewings, P. ; Berrow, M. ; Vickery, J. ; Barton, A. ; Marshall, B. ; Zajicek, J. ; Freeman, J.A. / Balance Right in Multiple Sclerosis (BRiMS): a guided self-management programme to reduce falls and improve quality of life, balance and mobility in people with secondary progressive multiple sclerosis: a protocol for a feasibility randomised controlled trial. In: Pilot and Feasibility Studies. 2017 ; Vol. 27, No. 4:26.
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    abstract = "BackgroundImpaired mobility is a cardinal feature of multiple sclerosis (MS) and is rated by people with MS as their highest priority. By the secondary progressive phase, balance, mobility and physical activity levels are significantly compromised; an estimated 70{\%} of people with secondary progressive MS fall regularly. Our ongoing research has systematically developed ‘Balance Right in MS’ (BRiMS), an innovative, manualised 13-week guided self-management programme tailored to the needs of people with MS, designed to improve safe mobility and minimise falls. Our eventual aim is to assess the clinical and cost effectiveness of BRiMS in people with secondary progressive MS by undertaking an appropriately statistically powered, multi-centre, assessor-blinded definitive, randomised controlled trial. This feasibility study will assess the acceptability of the intervention and test the achievability of running such a definitive trial.Methods/designThis is a pragmatic multi-centre feasibility randomised controlled trial with blinded outcome assessment. Sixty ambulant people with secondary progressive MS who self-report two or more falls in the previous 6 months will be randomly allocated (1:1) to either the BRiMS programme plus usual care or to usual care alone. All participants will be assessed at baseline and followed up at 15 weeks and 27 weeks post-randomisation.The outcomes of this feasibility trial include:Feasibility outcomes, including trial recruitment, retention and completionAssessment of the proposed outcome measures for the anticipated definitive trial (including measures of walking, quality of life, falls, balance and activity level)Measures of adherence to the BRiMS programmeData to inform the economic evaluation in a future trialProcess evaluation (assessment of treatment fidelity and qualitative evaluation of participant and treating therapist experience)DiscussionThe BRiMS intervention aims to address a key concern for MS service users and providers. However, there are several uncertainties which need to be addressed prior to progressing to a full-scale trial, including acceptability of the BRiMS intervention and practicality of the trial procedures. This feasibility trial will provide important insights to resolve these uncertainties and will enable a protocol to be finalised for use in the definitive trial.",
    keywords = "multiple sclerosis, fall prevention, mobility",
    author = "H. Gunn and J. Andrade and L. Paul and L. Miller and S. Creanor and C. Green and J. Marsden and P. Ewings and M. Berrow and J. Vickery and A. Barton and B. Marshall and J. Zajicek and J.A. Freeman",
    note = "Acceptance date from journal webpage Funding This study is funded by the NIHR Health Technology Assessment Programme (14/176/12), United Kingdom. This article presents independent research. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The sponsor of this clinical study is the Plymouth Hospitals NHS Trust, Devon, England, UK.",
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    Balance Right in Multiple Sclerosis (BRiMS): a guided self-management programme to reduce falls and improve quality of life, balance and mobility in people with secondary progressive multiple sclerosis: a protocol for a feasibility randomised controlled trial. / Gunn, H.; Andrade, J.; Paul, L.; Miller, L.; Creanor, S.; Green, C.; Marsden, J.; Ewings, P.; Berrow, M.; Vickery, J.; Barton, A.; Marshall, B.; Zajicek, J.; Freeman, J.A.

    In: Pilot and Feasibility Studies, Vol. 27, No. 4:26, 26, 27.07.2017.

    Research output: Contribution to journalArticle

    TY - JOUR

    T1 - Balance Right in Multiple Sclerosis (BRiMS): a guided self-management programme to reduce falls and improve quality of life, balance and mobility in people with secondary progressive multiple sclerosis: a protocol for a feasibility randomised controlled trial

    AU - Gunn, H.

    AU - Andrade, J.

    AU - Paul, L.

    AU - Miller, L.

    AU - Creanor, S.

    AU - Green, C.

    AU - Marsden, J.

    AU - Ewings, P.

    AU - Berrow, M.

    AU - Vickery, J.

    AU - Barton, A.

    AU - Marshall, B.

    AU - Zajicek, J.

    AU - Freeman, J.A.

    N1 - Acceptance date from journal webpage Funding This study is funded by the NIHR Health Technology Assessment Programme (14/176/12), United Kingdom. This article presents independent research. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The sponsor of this clinical study is the Plymouth Hospitals NHS Trust, Devon, England, UK.

    PY - 2017/7/27

    Y1 - 2017/7/27

    N2 - BackgroundImpaired mobility is a cardinal feature of multiple sclerosis (MS) and is rated by people with MS as their highest priority. By the secondary progressive phase, balance, mobility and physical activity levels are significantly compromised; an estimated 70% of people with secondary progressive MS fall regularly. Our ongoing research has systematically developed ‘Balance Right in MS’ (BRiMS), an innovative, manualised 13-week guided self-management programme tailored to the needs of people with MS, designed to improve safe mobility and minimise falls. Our eventual aim is to assess the clinical and cost effectiveness of BRiMS in people with secondary progressive MS by undertaking an appropriately statistically powered, multi-centre, assessor-blinded definitive, randomised controlled trial. This feasibility study will assess the acceptability of the intervention and test the achievability of running such a definitive trial.Methods/designThis is a pragmatic multi-centre feasibility randomised controlled trial with blinded outcome assessment. Sixty ambulant people with secondary progressive MS who self-report two or more falls in the previous 6 months will be randomly allocated (1:1) to either the BRiMS programme plus usual care or to usual care alone. All participants will be assessed at baseline and followed up at 15 weeks and 27 weeks post-randomisation.The outcomes of this feasibility trial include:Feasibility outcomes, including trial recruitment, retention and completionAssessment of the proposed outcome measures for the anticipated definitive trial (including measures of walking, quality of life, falls, balance and activity level)Measures of adherence to the BRiMS programmeData to inform the economic evaluation in a future trialProcess evaluation (assessment of treatment fidelity and qualitative evaluation of participant and treating therapist experience)DiscussionThe BRiMS intervention aims to address a key concern for MS service users and providers. However, there are several uncertainties which need to be addressed prior to progressing to a full-scale trial, including acceptability of the BRiMS intervention and practicality of the trial procedures. This feasibility trial will provide important insights to resolve these uncertainties and will enable a protocol to be finalised for use in the definitive trial.

    AB - BackgroundImpaired mobility is a cardinal feature of multiple sclerosis (MS) and is rated by people with MS as their highest priority. By the secondary progressive phase, balance, mobility and physical activity levels are significantly compromised; an estimated 70% of people with secondary progressive MS fall regularly. Our ongoing research has systematically developed ‘Balance Right in MS’ (BRiMS), an innovative, manualised 13-week guided self-management programme tailored to the needs of people with MS, designed to improve safe mobility and minimise falls. Our eventual aim is to assess the clinical and cost effectiveness of BRiMS in people with secondary progressive MS by undertaking an appropriately statistically powered, multi-centre, assessor-blinded definitive, randomised controlled trial. This feasibility study will assess the acceptability of the intervention and test the achievability of running such a definitive trial.Methods/designThis is a pragmatic multi-centre feasibility randomised controlled trial with blinded outcome assessment. Sixty ambulant people with secondary progressive MS who self-report two or more falls in the previous 6 months will be randomly allocated (1:1) to either the BRiMS programme plus usual care or to usual care alone. All participants will be assessed at baseline and followed up at 15 weeks and 27 weeks post-randomisation.The outcomes of this feasibility trial include:Feasibility outcomes, including trial recruitment, retention and completionAssessment of the proposed outcome measures for the anticipated definitive trial (including measures of walking, quality of life, falls, balance and activity level)Measures of adherence to the BRiMS programmeData to inform the economic evaluation in a future trialProcess evaluation (assessment of treatment fidelity and qualitative evaluation of participant and treating therapist experience)DiscussionThe BRiMS intervention aims to address a key concern for MS service users and providers. However, there are several uncertainties which need to be addressed prior to progressing to a full-scale trial, including acceptability of the BRiMS intervention and practicality of the trial procedures. This feasibility trial will provide important insights to resolve these uncertainties and will enable a protocol to be finalised for use in the definitive trial.

    KW - multiple sclerosis

    KW - fall prevention

    KW - mobility

    U2 - 10.1186/s40814-017-0168-1

    DO - 10.1186/s40814-017-0168-1

    M3 - Article

    VL - 27

    JO - Pilot and Feasibility Studies

    JF - Pilot and Feasibility Studies

    SN - 2055-5784

    IS - 4:26

    M1 - 26

    ER -