NEuRoMS Work Package 2i Observational Study
Research type
Research Study
Full title
Neuropsychological Evaluation and Rehabilitation in Multiple Sclerosis (NEuRoMS): Refining the screening and management pathway in routine clinical practice (Phase 1: Work Package 2i Observational Study)
IRAS ID
276570
Contact name
Roshan das Nair
Contact email
Sponsor organisation
Nottinghamshire Healthcare NHS Trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 7 months, 31 days
Research summary
Summary of Research
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 neuropsychological evaluation pathway, to routinely screen/assess all people with MS for cognitive problems attending NHS MS clinics (see https://neuroms.org/ for more information). In this smaller study, we will implement the pathway in three test sites. Using an observational study method, we will observe the frequency and degree of cognitive problems in people with MS. Three control sites will also be recruited to help us evaluate the impact of the pathway on people’s mood and beliefs about their coping abilities.People with MS will initially be approached by their MS clinics with an information sheet about the study. Those interested in taking part, will be asked to access a weblink where their consent will be sought for the study. Participants will then provide some demographic information and complete two questionnaires asking about their mood and perceived ability to cope with their MS using an online system (additional face-to-face/telephone support and paper copies of the questionnaires will be made available). We will ask participants to repeat the questionnaires 2-weeks and 4-weeks later. Those participants at the test sites will also receive the neuropsychological evaluation pathway (set of tasks to help identify and manage cognitive problems) after the baseline questionnaires. Questionnaire scores will be compared between the those who received the new pathway and those who did not to look at the impact this has on people with MS.
Summary of Results
Why did we run the study?
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. There have been calls for better screening and monitoring of cognitive problems in people with MS. As part of the NEuRoMS project, we developed a cognitive screening tool (a brief puzzle and some questionnaires on cognition, mood and fatigue) to routinely screen all people with MS for cognitive problems attending NHS MS clinics (see https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbY5nI6jxkVrl1Yd8WvYre8k-3DXauk_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YK9LyXShKRUUEDqxjf2GypmhTY4Koc4WCwzbtVBB-2BSMP4G39OnRaL-2FsLq6FpewkRrCnRCmsEAabSoAmXtwUAfzNSmSN3O2E1AtXfbqWk9DvVKgzWrzTV0bLnzHPI6ktsRU2J8QiTvleQlvBr9PmFyTwLatgU4ZpzN2H7RFEs1-2Ba8g-3D-3D&data=05%7C02%7Cgmwest.rec%40hra.nhs.uk%7C5d365ef70d0d4bd8ec1a08dbfc9ee87b%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638381531654824197%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=42T%2BoV5rHLcIUwYx5amzERvKqlpTgUODy5vkokLLBaw%3D&reserved=0 for more information).Some clinicians, however, have raised concerns that cognitive screening could negatively affect peoples’ mood. Therefore, we conducted this study to help us understand the potential impact of online screening on mood (depression and anxiety) and beliefs about their coping abilities (self-efficacy).
What did the study involve?
The study was conducted across seven NHS sites with MS clinics. Three of these sites rolled out the cognitive screening as part of their normal services. We called this group the ‘screened’ sites. The remaining four sites did not roll out the screening and were our ‘non-screened’ control sites.Participants in both sites completed questionnaires asking about their mood and perceived ability to cope with their MS. They repeated the same questionnaires 2-weeks and 4-weeks later. Those participants at the screened sites also completed the cognitive screening after the first set of questionnaires.
Questionnaire scores were then compared between those who completed the screening and those who did not at the three time points to see whether cognitive screening had an impact on people with MS, and to see if there was a change over time between screened and non-screened groups.
What did we find?
• Peoples’ mood and self-efficacy were no different between either group (screened vs non-screened) at any time point. This suggests that screening people with MS for cognitive problems using the NEuRoMS online screening tool does not make peoples’ mood worse immediately after screening 2 and 4 weeks later, and does not affect their perceived ability to cope with MS.
• The three screened sites have screened more than 3,500 people with MS with "no adverse events" reported in relation to the NEuRoMS cognitive screening(which means there were nothing unfavourable or unintended that occurred) . Therefore, our online cognitive screening appears safe to be used within routine services.What are we going to do with the results?
The NEuRoMS cognitive screening is now part of the standard clinical care for people with MS in London, Cardiff and Nottingham, and will soon be rolled out in Leeds, Lincoln, Newcastle and Sheffield.REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
20/NW/0080
Date of REC Opinion
20 Apr 2020
REC opinion
Further Information Favourable Opinion