Neuropsychological evaluation and rehabilitation in multiple sclerosis (NEuRoMS): protocol for a mixed-methods, multicentre feasibility randomised controlled trial

Pilot and Feasibility Studies

On behalf of the NEuRoMS Collective¹  Kimberley Allen-Philbey²  Klaus Schmierer²  Paul Leighton³  Paul Bradley⁴  Emma C. Tallantyre⁵  Roshan das Nair⁶  Gogem Topcu⁶  Jacqueline R. Mhizha-Murira⁶  Nikos Evangelou⁶  Clare Bale⁷  James Turton⁷  Zoë Hoare⁸  Nia Goulden⁸  Avril Drummond⁹  Laura Smith^1,10  Deborah Fitzsimmons^1,11  Andrea Stennett^1,12 

[1] ;Centre for Neuroscience, Surgery and Trauma, Barts and the London School of Medicine and Dentistry, The Blizard Institute, Queen Mary University of London;Centre of Evidence Based Dermatology, School of Medicine, University of Nottingham;Department of Neurology, Cardiff and Vale University Health Board;Division of Psychological Medicine and Clinical Neurosciences, School of Medicine, Cardiff University;Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham;Multiple Sclerosis Patient and Public Involvement Group;North Wales Organisation for Randomised Trials in Health Clinical Trials Unit, Bangor University;School of Health Sciences, University of Nottingham;School of Psychology, Keynes College, University of Kent;Swansea Centre for Health Economics, School of Health and Social Care, Faculty of Medicine, Health and Life Sciences, Swansea University;Wolfson Institute of Population Health, Queen Mary University of London;

关键词: Multiple sclerosis;    Cognition;    Cognitive screening;    Rehabilitation;    Feasibility study;    Randomised controlled trial;   

DOI  :  10.1186/s40814-022-01073-5

来源: DOAJ

【 摘 要 】

Abstract Background Cognitive problems affect up to 70% of people with multiple sclerosis (MS), which can negatively impact mood, ability to work, and quality of life. Addressing cognitive problems is a top 10 research priority for people with MS. Our ongoing research has systematically developed a cognitive screening and management pathway (NEuRoMS) tailored for people with MS, involving a brief cognitive evaluation and rehabilitation intervention. The present study aims to assess the feasibility of delivering the pathway and will inform the design of a definitive randomised controlled trial (RCT) to investigate the clinical and cost-effectiveness of the intervention and eventually guide its clinical implementation. Methods The feasibility study is in three parts. Part 1 involves an observational study of those who receive screening and support for cognitive problems, using routinely collected clinical data. Part 2 is a two-arm, parallel group, multicentre, feasibility RCT with a nested fidelity evaluation. This part will evaluate the feasibility of undertaking a definitive trial comparing the NEuRoMS intervention plus usual care to usual care only, amongst people with MS with mild cognitive problems (n = 60). In part 3, semi-structured interviews will be undertaken with participants from part 2 (n = 25), clinicians (n = 9), and intervention providers (n = 3) involved in delivering the NEuRoMS cognitive screening and management pathway. MS participants will be recruited from outpatient clinics at three UK National Health Service hospitals. Discussion Timely screening and effective management of cognitive problems in MS are urgently needed due to the detrimental consequences of cognitive problems on people with MS, the healthcare system, and wider society. The NEuRoMS intervention is based on previous and extant literature and has been co-constructed with relevant stakeholders. If effective, the NEuRoMS pathway will facilitate timely identification and management of cognitive problems in people with MS. Trial registration ISRCTN11203922 . Prospectively registered on 09.02.2021.

【 授权许可】

Unknown