Neuropsychological evaluation and rehabilitation in multiple sclerosis
Neuropsychological Evaluation and Rehabilitation in Multiple Sclerosis (NEuRoMS): multicentre feasibility randomised controlled trial and fidelity evaluation (Phase 2: Work Package 3 feasibility study)
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What it measured
Main measures
Part 2 – acceptability, feasibility RCT and fidelity evaluation: 1. Feasibility and suitability of trial procedures based on response rates, trial uptake and the number of dropouts; measured throughout data collection period 2. Feasibility of recruitment: measured throughout the data collection period, as assessed by: 2.1. Appropriateness of eligibility criteria – the number of those referred to
VisionThinking and memoryFeasibility
Other measures (1)
Current secondary outcome measures as of 21/07/2022: Part 1 – testing the cognitive screening pathway: 1. Feasibility of the cognitive screening pathway procedures, measured during screening and throughout Part 1 data collection period, assessed as: 1.1. Number of patients who complete the screening in different settings (online at home, online in-clinic) 1.2. Number of patients who use different
VisionThinking and memoryFatigueMood and sleepQuality of life (reported by participants)Feasibility
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
Inclusion: Current inclusion criteria as of 21/07/2022: All individuals: Able and willing to give consent and able to communicate in English. Participant information sheets can be provided in Welsh upon request but the standardised materials and tests to be used require communication in English since these have not yet been developed for other languages. Part 1 – testing the cognitive screening pathway: People with MS: 1. Diagnosis of MS 2. Aged 18 years or above Part 2 – acceptability, feasibility RCT and fidelity evaluation: People with MS: 1. Diagnosis of MS 2. Received cognitive screening and mild or moderate cognitive problems identified (Part 1) 3. Aged 18 years or above Part 3 – interviews: 1. People with MS: 1.1. People with MS participated in Part 2 2. Intervention providers: 2.1. Assistant Psychologist/Research Nurses/Assistant Occupational Therapist delivering the NEuRoMS intervention to people with MS in Part 2 3. Clinicians: 3.1. Health professionals (e.g., neurologists, MS nurse specialists, psychologists, occupational therapists) delivering the NEuRoMS screening and management pathway to people with MS _____ Previous inclusion criteria: All individuals: Able and willing to give consent and able to communicate in English. Participant information sheets can be provided in Welsh upon request but the standardised materials and tests to be used require communication in English since these have not yet been developed for other languages. Part 1 – testing the cognitive screening pathway: People with MS: 1. Diagnosis of MS 2. Aged 18 years or above Part 2 – acceptability, feasibility RCT and fidelity evaluation: People with MS: 1. Diagnosis of MS 2. Received cognitive screening and mild cognitive problems identified (Part 1) 3. Aged 18 years or above Part 3 – interviews: 1. People with MS: 1.1. People with MS participated in Part 2 2. Intervention providers: 2.1. Assistant Psychologist/Research Nurses/Assistant Occupational Therapist delivering the NEuRoMS intervention to people with MS in Part 2 3. Clinicians: 3.1. Health professionals (e.g., neurologists, MS nurse specialists, psychologists, occupational therapists) delivering the NEuRoMS screening and management pathway to people with MS Exclusion: Part 2 participants only: 1. Currently receiving neuropsychological intervention for cognitive problems 2. Received NEuRoMS intervention during WP2ii All participants: 1. Does not have the mental capacity to consent to take part in the study
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Background and study aims 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. This study 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, the researchers will implement the pathway in three test sites to explore the feasibility of a larger trial, and further refine the pathway. Who can participate? Part 1: Patients aged 18 years or over with MS Part 2: Patients aged 18 years or over with MS who received cognitive screening and have mild or moderate cognitive problems (Part 1) Part 3: Patients with MS who participated in Part 2; assistant psychologists/research nurses/assistant occupational therapists delivering the NEuRoMS intervention to patients with MS in Part 2; health professionals (e.g., neurologists, MS nurse specialists, psychologists, occupational therapists) delivering the NEuRoMS screening and management pathway to people with MS. What does the study involve? Using a mix of different approaches the researchers will: Part 1: Observe how cognitive screening is integrated within routine clinical practice and determine the frequency and extent of cognitive problems in patients with MS. Part 2. Recruit up to 80 patients with mild or moderate cognitive problems, who will be randomly allocated to receive either an intervention or usual care (control group). The brief therapist-led intervention provides information and strategies to help people cope with their cognitive problems. The researchers will evaluate if the way they plan 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. What are the possible benefits and risks of participating? It is not known whether the study will have a direct benefit to participants, but participating means that they may help people with MS in the future. The information from this study will help the researchers decide how to develop this screening and management pathway further in the hope of providing standardised screening and support for cognitive problems in MS. When talking about experiences and issues associated with cognitive problems, people may feel upset. This may also cause some concerns about their own cognitive abilities. If this happens during the cognitive management programme (including the feedback interviews), the clinician or interviewer will be there to talk to through these concerns. Participants will have their contact information in case they feel upset after the session for reasons associated with participation. The screening, cognitive management sessions, interviews and any other aspect of participants’ involvement can stop at any time if they do not wish to continue. A possible disadvantage is that it may inconvenience people to be available at a specific time during the day to attend the cognitive management sessions or interviews. These will be arranged at a time and date that is suitable for participants and can be conducted over the phone or videoconferencing (based on preference). Where is the study run from? This is a multicentre study conducted across three NHS sites in the UK with MS outpatient clinics: 1. Nottingham University Hospitals NHS Trust (UK) 2. Cardiff and Vale University Health Board (UK) 3. Barts Health NHS Trust (UK) When is the study starting and how long is it expected to run for? July 2017 to September 2023 Who is funding the study? National Institute for Health Research (NIHR) (UK) Who is the main contact? Prof Roshan das Nair (Chief Investigator) roshan.dasnair@nottingham.ac.uk Dr Gogem Topcu (Programme Manager) gogem.topcu@nottingham.ac.uk
Papers
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History
Started
Apr 2022
Finished
Sept 2023