europsychological evaluation and rehabilitation in multiple sclerosis – definitive randomised controlled trial (RCT) and implementation study

Not Applicable

• Conditions: Multiple Sclerosis; Nervous System Diseases

• Registration Number: ISRCTN10285713
• Lead Sponsor: ottinghamshire Healthcare NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-11
• Last Update Posted: 27 May 2024
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 4776

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified