ISRCTN10285713进行中（未招募）Unknown
europsychological Evaluation and Rehabilitation in Multiple Sclerosis (NEuRoMS): A mixed methods pragmatic multicentre Randomised Controlled Trial (RCT) with nested health economic and process evaluations and an implementation study (Phase 3: Work Packages 4 and 5)
ottinghamshire Healthcare NHS Foundation Trust0 个研究点目标入组 4,776 人开始时间: 2024年3月11日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,776
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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.
- •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.
- •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
排除标准
- •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.
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