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

Topcu, Gogem; Smith, Laura; Mhizha-Murira, Jacqueline R; Goulden, Nia; Hoare, Zoë; Drummond, Avril; Fitzsimmons, Deborah; Evangelou, Nikos; Schmierer, Klaus; Tallantyre, Emma C; Leighton, Paul; Allen-Philbey, Kimberley; Stennett, Andrea; Bradley, Paul; Bale, Clare; Turton, James; das Nair, Roshan; On behalf of the NEuRoMS Collective

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.

Citation

Topcu, G., Smith, L., Mhizha-Murira, J. R., Goulden, N., Hoare, Z., Drummond, A., Fitzsimmons, D., Evangelou, N., Schmierer, K., Tallantyre, E. C., Leighton, P., Allen-Philbey, K., Stennett, A., Bradley, P., Bale, C., Turton, J., das Nair, R., & On behalf of the NEuRoMS Collective. (2022). Neuropsychological evaluation and rehabilitation in multiple sclerosis (NEuRoMS): protocol for a mixed-methods, multicentre feasibility randomised controlled trial. Pilot and Feasibility Studies, 8(1), Article 123. https://doi.org/10.1186/s40814-022-01073-5

• Journal Article Type: Article
• Acceptance Date: May 17, 2022
• Online Publication Date: Jun 11, 2022
• Publication Date: Jun 11, 2022
• Deposit Date: May 19, 2022
• Publicly Available Date: Jun 11, 2022
• Journal: Pilot and Feasibility Studies
• Electronic ISSN: 2055-5784
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 8
• Issue: 1
• Article Number: 123
• DOI: https://doi.org/10.1186/s40814-022-01073-5
• Keywords: Multiple Sclerosis, cognition, cognitive screening, rehabilitation, feasibility study, randomised controlled trial
• Public URL: https://nottingham-repository.worktribe.com/output/8135415
• Publisher URL: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-022-01073-5
• Additional Information: Received: 13 November 2021; Accepted: 17 May 2022; First Online: 11 June 2022; : ; : The North West — Greater Manchester West Research Ethics Committee (REC) has given approval for the study (Reference number: 20/NW/0454, date: 13 Jan 2021). Substantial amendments that require review by the REC will not be implemented until the REC and Health Research Authority has granted approval. The ISRCTN will be notified of protocol modifications. Study participants will be notified of protocol modifications where appropriate.; : Not applicable; : The authors declare that they have no competing interests.