ISRCTN11203922已完成未知
europsychological Evaluation and Rehabilitation in Multiple Sclerosis (NEuRoMS): multicentre feasibility randomised controlled trial and fidelity evaluation (Phase 2: Work Package 3 feasibility study)
ottinghamshire Healthcare NHS Foundation Trust0 个研究点目标入组 2,354 人开始时间: 2021年2月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 2,354
研究概览
简要总结
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35690797/ (added 13/06/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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