Golijani-Moghaddam Nima, Dawson David L, Evangelou Nikos, Turton James, Hawton Annie, Law Graham R, Roche Bryan, Rowan Elise, Burge Rupert, Frost Alexandra C, das Nair Roshan
School of Psychology, University of Lincoln, Sarah Swift Building, Brayford Pool, Lincoln, LN6 7TS, UK.
School of Medicine, University of Nottingham, C floor, South Block, Queen's Medical Centre, Nottingham, NG7 2UH, UK.
Pilot Feasibility Stud. 2022 Sep 3;8(1):195. doi: 10.1186/s40814-022-01152-7.
Multiple sclerosis (MS) is a chronic condition of the central nervous system, affecting around 1 in every 600 people in the UK, with 130 new diagnoses every week. Cognitive difficulties are common amongst people with MS, with up to 70% experiencing deficits in higher-level brain functions-such as planning and problem-solving, attention, and memory. Cognitive deficits make it difficult for people with MS to complete everyday tasks and limit their abilities to work, socialise, and live independently. There is a clear need-and recognised research priority-for treatments that can improve cognitive functioning in people with MS. The absence of effective cognitive interventions exacerbates burdens on the services accessed by people with MS-requiring these services to manage sequelae of untreated cognitive deficits, including reduced quality of life, greater disability and dependence, and poorer adherence to disease-modifying treatments. Our planned research will fill the evidence gap through developing-and examining the feasibility of trialling-a novel online cognitive rehabilitation programme for people with MS (SMART). The SMART programme directly trains relational skills (the ability to flexibly relate concepts to one another) based on theory that these skills are critical to broader cognitive functioning.
The primary objective of this study aims to conduct a feasibility study to inform the development of a definitive trial of SMART for improving cognitive functioning in people with MS. The secondary objective is to develop the framework for a cost-effectiveness analysis alongside a definitive trial, and the exploratory objective is to assess the signal of efficacy.
As a feasibility trial, outcomes are unlikely to immediately effect changes to NHS practice. However, this is a necessary step towards developing a definitive trial-and will give us a signal of efficacy, a prerequisite for progression to a definitive trial. If found to be clinically and cost-effective, the latter trial could create a step-change in MS cognitive rehabilitation-improving service delivery and optimising support with limited additional resources.
Registration ID: ClnicalTrials.gov: NCT04975685-registered on July 23rd, 2021.
2.0, 25 November 2021.
多发性硬化症（MS）是一种中枢神经系统的慢性疾病，在英国，每600人中约有1人受其影响，每周有130例新确诊病例。认知困难在MS患者中很常见，高达70%的患者存在高级脑功能缺陷，如计划和解决问题的能力、注意力及记忆力。认知缺陷使MS患者难以完成日常任务，并限制了他们工作、社交和独立生活的能力。显然需要能够改善MS患者认知功能的治疗方法，这也是公认的研究重点。缺乏有效的认知干预措施加剧了MS患者所使用服务的负担，这些服务需要应对未经治疗的认知缺陷所带来的后遗症，包括生活质量下降、残疾和依赖性增加，以及对疾病修正治疗的依从性较差。我们计划开展的研究将通过开发并检验一项针对MS患者的新型在线认知康复计划（SMART）的试验可行性，来填补证据空白。SMART计划基于这样的理论直接训练关联技能（即灵活地将概念相互联系的能力），该理论认为这些技能对更广泛的认知功能至关重要。
本研究的主要目的是进行一项可行性研究，为开展一项确定的SMART试验以改善MS患者的认知功能提供依据。次要目的是为确定性试验制定成本效益分析框架，探索性目的是评估疗效信号。
作为一项可行性试验，结果不太可能立即影响英国国家医疗服务体系（NHS）的实践。然而，这是开展确定性试验的必要步骤，并且会为我们提供疗效信号，这是推进到确定性试验的先决条件。如果发现该试验在临床和成本效益方面可行，后续试验可能会给MS认知康复带来巨大改变，改善服务提供，并在有限的额外资源下优化支持。
注册编号：ClinicalTrials.gov：NCT04975685 - 于2021年7月23日注册。
2.0，2021年11月25日。
