Multiple Sclerosis Nervous System Diseases
Conditions
Interventions
Patient participants will receive the following interventions as part of this study:
Cognitive screening (Part 1): A new clinical procedure involving a self-administered, brief online screening tool
Sponsors
Nottinghamshire Healthcare NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 17/05/2024: 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: People with MS: 1.1. Diagnosis of MS 1.2. Aged 18 years or above Part 2: People with MS: 2.1. Aged 18 years or above 2.2. Diagnosis of MS 2.3. Received cognitive screening, and mild or moderate cognitive problems identified (Part 1): Mild or moderate problems will be identified by the clinical team based on the screening scores, the clinical and contextual information collected as part of the cognitive screening, and the patient-clinician conversations on cognitive problems experienced. Thresholds for mild and moderate cognitive problems in people with MS will be defined based on norms (WP6: compared to control participants (people without MS)) and based on previous research (van Dongen et al. 2020) and recommendations on classifications and labelling of neuropsychological assessments (Lezak 1996; Guilmette et al. 2020)*: -Mild cognitive problems: Scores of 1 SD below the mean or lower, and higher than 2 SD below the mean; -Moderate cognitive problems: Scores of 2 SD below the mean or lower, and higher than 2.5 SD below the mean. *People with scores in mild or moderate ranges in either cognitive test (SST and/or WCT) would be considered eligible to participate. Part 3: 3.1. People with MS: People with MS who participated in Part 2. 3.2. Intervention providers: AP/Research Nurses/Assistant OT delivering the NEuRoMS pathway and intervention to people with MS in Part 1 and Part 2. 3.3. Healthcare professionals (HCPs): Healthcare professionals (e.g., neurologists, MS nurse specialists, psychologists, occupational therapists, physiotherapists) delivering the NEuRoMS screening and management pathway to people with MS in Part 1. Part 4: 4.1. People with MS: People with MS who participated in Part 2 4.2. Intervention providers: AP/Research Nurses/Assistant OT delivering the NEuRoMS pathway and intervention to people with MS in Part 1 and Part 2 4.3. HCPs: Healthcare professionals (e.g., neurologists, MS nurse specialists, psychologists, occupational therapists, physiotherapists) delivering the NEuRoMS screening and management pathway to people with MS in Part 1 4.4. Service commissioners: Service commissioners (or similar) working within the Clinical Commissioning Groups or Integrated Care Systems that commission new NHS services. Previous participant 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: People with MS: 1.1. Diagnosis of MS 1.2. Aged 18 years or above Part 2: People with MS: 2.1. Aged 18 years or above 2.2. Diagnosis of MS 2.3. Received cognitive screening, and mild or moderate cognitive problems identified (Part 1): Mild or moderate problems will be identified by the clinical team based on the screening scores, the clinical and contextual information collected as part of the cognitive screening, and the patient-clinician conversations on cognitive problems experienced. Thresholds for m
Exclusion criteria
Exclusion criteria: 1. All participants: Do not have mental capacity to consent to participate in the study. Part 2 participants only: 2.1. Currently receiving neuropsychological intervention for cognitive problems 2.2. Received NEuRoMS intervention during WP2ii or WP3. Part 3 patient participants only: 3.1. Participated in Part 4 interviews. Part 4 patient participants only: 4.1. Participated in Part 3 interviews.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-reported psychological impact of MS on everyday life, measured using the Psychological Subscale of the Multiple Sclerosis Impact Scale (MSIS-Psych; Hobart et al., 2001) at baseline, 3, 6 and 12 months post randomisation. The primary endpoint is at 3 months post-randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcomes for secondary objectives 1a and 1b: 1.1. Participant scores from cognitive screening measures (completed at a single time-point at screening) including an online, self-administered: Symbol Substitution Task (SST), and Word Colour Task (WCT). 1.2. Demographic, clinical features and screening usage information (e.g., time taken to complete the screening, type of device used to complete screening, setting the screening completed at, number of patients who required reminders and extra support, etc.) will be collected as part of cognitive screening (at a single-time point at screening). Outcomes for secondary objective 1c: 1.3. Clinical data collected as part of usual care: Patient scores from the three measures from the Multiple Sclerosis Quality of Life Inventory for self-reported cognitive problems, fatigue and mental health (Ritvo et al., 1997), measured during screening as part of usual care. Outcomes for secondary objectives 2a and 2b: The following secondary outcome measures will be used to capture information about the patient at baseline and to assess outcomes at 3, 6 and 12 months after randomisation: 2.1. Self-reported (subjective) cognitive impairment as measured using the Perceived Deficits Questionnaire – 20-items (PDQ-20) (Sullivan et al., 1990). 2.2. Objective cognitive impairment as measured using the Symbol Substitution Task (SST). Participants’ Part 1 SST scores will be used as baseline, and SST will be repeated at 3-, 6- and 12-month follow-ups. 2.3. Quality of life as measured using the Multiple Sclerosis Impact Scale (MSIS-29; Hobart et al., 2001) and EQ-5D-5L (Herdman et al., 2011). 2.4. Mood as measured using the Patient Health Questionnaire 9-items (PHQ-9; Kroenke et al., 2001); Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006). 2.5. Function as measured using the Nottingham Extended Activities of Daily Living Scale (Nicholl et al., 2002). 2.6. Self-efficacy as measured using the Multiple Sclerosis Self-efficac | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed