Multiple sclerosis Nervous System Diseases Multiple sclerosis
Conditions
Interventions
Current intervention as of 21/07/2022:
Patients with mild or moderate cognitive problems will be randomly allocated to receive either an intervention plus usual care or usual care only (control group)
Sponsors
Nottinghamshire Healthcare NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 the trial who meet the eligibility criteria and the number of those eligible who expressed interest in the trial 2.2. Success of recruitment strategy – recruitment rate recorded as the number of eligible patients who consent to participate in the trial within the trial recruitment period, and the number of patients who decline to participate (including reasons for non-participation) 2.3. Retention rates assessed as the number of participants who consent to participate that remain in the trial by 6-month follow-up 3. Appropriateness of self-report clinical and health economics measures at three data collection time points (baseline, 3-month and 6-month follow-up), as assessed by: completion rates, rate of return of online/postal questionnaires, level of missing data and completeness of measures, number of participants requiring reminders and extra telephone support to complete the measures and content of contacts between service providers/researchers and patient participants 4. Patient preference for different versions/formats of the outcome data collection tools, measured at three time points (baseline, 3-month and 6-month follow-up), as assessed by: the number completed via paper/online/telephone, the number and types of reminders participants required to complete the tools, data completeness (the number of missing data), the number of participants who complete 3-month and 6-month follow-up measures. 5. Fidelity of the intervention, measured throughout data collection period, as assessed by: 5.1. The accuracy of intervention delivery recording and quality of intervention d | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 devices to complete the screening (e.g., tablet, mobile phone, laptop) 1.3. Time taken to complete the screening (in minutes) 1.4. Number of patients who require reminders and extra support (telephone/in-clinic) to complete the screening 1.5. Number and content of contacts between service providers and patient-participants. 2. Patient scores from the cognitive screening measures: a version of the Stroop task (Word Colour Task; WCT) and/or a version of the Symbol Digit Modalities Test (Symbol Substitution Task; SST), and three measures from the Multiple Sclerosis Quality of Life Inventory for self-reported cognitive problems, fatigue and mental health, measured during screening as part of usual care. Part 2 - patient-centred outcomes: In addition to feasibility outcomes (primary outcomes), the following measures will also be used to capture information about the patient at baseline and to assess outcomes at 3- and 6-months after randomisation: 1. Cognitive impairment is assessed using the Perceived Deficits Questionnaire at baseline, 3-month, and 6-month follow-up 2. Quality of life is assessed using the Multiple Sclerosis Impact Scale (MSIS-29) and EQ-5D-5L at baseline, 3-month, and 6-month follow-up 3. Mood is assessed using the Patient Health Questionnaire-9, Generalized Anxiety Disorder-7 scale, and Whooley Questions for depression screening at baseline, 3-month, and 6-month follow-up 4. Functional ability is assessed using the Nottingham Extended Activities of Daily Living Scale at baseline, 3-month, and 6-month follow-up 5. Self-efficacy is assessed using the Multipl | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed