NEuRoMS Work Package 3 Feasibility Study

• Research type

  Research Study

• Full title

  Neuropsychological Evaluation and Rehabilitation in Multiple Sclerosis (NEuRoMS): Multicentre Feasibility Randomised Controlled Trial and Fidelity Evaluation (Phase 2: Work Package 3 Feasibility Study)

• IRAS ID

  287115

• Contact name

  Roshan das Nair

• Contact email

  roshan.dasnair@nottingham.ac.uk

• Sponsor organisation

  Nottinghamshire Healthcare NHS Trust

• ISRCTN Number

  ISRCTN11203922

• Duration of Study in the UK

  1 years, 0 months, 31 days

• Research summary

  Study 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 for people with MS. The NEuRoMS (Neuropsychological Evaluation and Rehabilitation in Multiple Sclerosis) 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. In this smaller study, we will implement the pathway in three test sites to explore the feasibility of a larger trial, and further refine the pathway.

  Using a mix of different methodological approaches we will:

  Part 1. Observe how cognitive screening is integrated within routine clinical practice and determine the frequency and extent of cognitive problems in people with MS

  Part 2. Recruit 60 participants with mild cognitive problems, who will either receive an intervention or usual care (control group). The brief therapist-led intervention provides information and strategies to help people cope with their cognitive problems. We will evaluate if the way we planned to do the study is feasible.

  Part 3. Conduct interviews with people with multiple sclerosis and clinicians involved in delivering the pathway to understand their experiences and identify potential barriers and revisions.

  See https://neuroms.org/ for more information.

  Lay summary of study results:
  Why did we run the study?
  This study was part of NEuRoMS (Neuropsychological Evaluation and Rehabilitation in Multiple Sclerosis; https://www.neuroms.org/ , a programme of research which includes several smaller studies. NEuRoMS aims to improve our ability to detect cognitive problems in people with MS and help them manage these problems. Cognitive problems refer to problems with memory, attention and problem solving. These problems can be distressing for people with MS, affecting mood, work, and the ability to enjoy social activities.

  NEuRoMS has developed a screening tool (a set of computerised tasks) to routinely assess all people with MS for cognitive problems, and offers a brief cognitive support programme for those with mild or moderate cognitive problems.

  In this feasibility study, we explored whether the cognitive support programme was acceptable to people with MS and whether it was feasible to carry out a larger study to test its clinical and cost-effectiveness. Now that we have shown that NEuRoMS is acceptable and feasible, we will offer the cognitive support programme to several hundred people across the UK in a larger study.

  What did we find?
  • Participants, clinicians and therapists were satisfied that the cognitive support programme was helpful and met their expectations.
  • There was a “signal of efficacy”, meaning that our cognitive support programme has the potential to produce positive impact on people’s wellbeing.
  • The cognitive support programme can be delivered as planned.
  • The training of NEuRoMS therapists worked well, and they were able to competently deliver the programme.
  • Participants felt our study methods and procedures were appropriate and easy to follow, and the information provided was sufficient and clear.

  What have we done with the results?
  The feasibility study has enabled us to test out our research methods, which have now been carried forward into the much bigger study. We have also made a number of improvements based on what we have learnt from the feasibility study. A large NEuRoMS study is currently underway to assess the clinical and cost-effectiveness of the cognitive support programme.

• REC name

  North West - Greater Manchester West Research Ethics Committee

• REC reference

  20/NW/0454

• Date of REC Opinion

  13 Jan 2021

• REC opinion

  Further Information Favourable Opinion