NEuRoMS WP4 Definitive RCT & WP5 Implementation Study

• Research type

  Research Study

• Full title

  Neuropsychological Evaluation and Rehabilitation in Multiple Sclerosis (NEuRoMS): A mixed methods pragmatic multicentre Randomised Controlled Trial (RCT) with nested health economic and process evaluations and an implementation study (Phase 3: Work Packages 4 and 5)

• IRAS ID

  325421

• Contact name

  Roshan das Nair

• Contact email

  roshan.dasnair@nottingham.ac.uk

• Sponsor organisation

  Nottinghamshire Healthcare NHS Trust

• Duration of Study in the UK

  3 years, 2 months, 31 days

• Research summary

  Problems with memory, attention, and problem solving (together known as cognitive problems) affect up to 70% of people with multiple sclerosis (MS). These problems are distressing for people with MS, affecting their mood, ability to work, and enjoy social activities. Therefore, treating cognitive problems is a ‘top 10’ research priority in MS. This project aims to develop a clinical pathway to routinely assess people with MS for cognitive problems using brief online tasks (cognitive screening) and provide appropriate support to help them manage these problems (rehabilitation). In this study, we will implement the pathway in seven study sites to evaluate the clinical and cost-effectiveness of the NEuRoMS rehabilitation intervention, and explore the process of implementation of the NEuRoMS screening and management pathway.

  Using a mix of different methodological approaches, we will:

  Part 1. Assess the frequency and extent of cognitive problems in people with MS using collected cognitive screening data.

  Part 2: Recruit 478 people with MS with mild or moderate cognitive problems, who will either receive the NEuRoMS rehabilitation intervention plus usual care (intervention group) or receive usual care only (control group). The brief therapist-led, manualised intervention provides information and strategies to help people cope with their cognitive problems. We will evaluate the clinical and cost-effectiveness of the intervention to reduce the impact of cognitive problems amongst people with MS.

  Part 3: Use observations, questionnaires, and interviews with Part 2 participants and healthcare professionals involved in delivering the pathway and the intervention to understand how the cognitive screening and management pathway and intervention work in practice (process evaluation).
  
  Part 4: Conduct interviews with people with MS, healthcare professionals, intervention providers and service commissioners to understand the processes of implementation in ‘real world’ settings by exploring facilitators and barriers to implementation of the pathway and the intervention.

• REC name

  North West - Greater Manchester West Research Ethics Committee

• REC reference

  23/NW/0272

• Date of REC Opinion

  13 Oct 2023

• REC opinion

  Favourable Opinion