背景:轻度认知障碍(MCI)涉及超出典型年龄相关变化的认知下降,但没有显著的日常活动中断。它可以涵盖各种认知领域,因为MCI的原因是多种多样的。MCI以及常见的共病神经精神疾病如抑郁和焦虑会影响个体的生活质量。早期干预至关重要,计算机认知训练(cCT)是一种既定的治疗方法。本文介绍了NeuroNationMED有效性研究的方案,评估MCI患者的自我管理移动cCT干预(“NeuroNationMED”),以评估认知领域的训练效果,健康能力,神经精神症状,心理健康,和一般的应用程序可用性。
方法:该研究方案提出了一项单盲多中心随机对照试验,该试验将在德国和卢森堡的六个研究中心进行。我们纳入了患有MCI的成年人(现有F06.7ICD-10-GM诊断和TICS≥21和≤32)。干预小组将使用手机,多域CT(“NeuroNationMED”)12周。同时,等待名单对照组将接受标准医疗护理或不接受护理。志愿者的资格将通过电话筛选来确定。基线检查完成后,患者将以2:1的比例随机分配到其中一种实验条件.总的来说,286名参与者将被纳入本研究。主要结果是通过神经心理学评估电池的筛选模块的指标得分来衡量的认知表现的变化。次要结果是认知失败问卷的变化,医院焦虑抑郁量表,Health-49,健康素养问卷,在其他人中。所有主要和次要结果将在基线和分配后12周后进行评估。此外,干预组将接受系统可用性量表的评估,和NeuroNationMED应用程序的训练数据将被分析。
结论:本研究旨在评估移动自给cCT在增强诊断为MCI的个体认知能力方面的有效性。如果调查结果证实了NeuroNationMED应用程序的有效性,由于可及性,它可能会为MCI患者的护理管理带来可能的好处,成本效益,以及它提供的基于家庭的设置。具体来说,cCT程序可以为患者提供个性化的认知训练,教育资源,和放松技巧,使参与者能够在没有进一步监督的情况下在家中独立参与认知训练课程。
背景:德国临床试验注册DRKS00025133。2021年11月5日注册。
BACKGROUND: Mild cognitive impairment (MCI) involves cognitive decline beyond typical age-related changes, but without significant daily activity disruption. It can encompass various cognitive domains as the causes of MCI are diverse. MCI as well as frequent comorbid neuropsychiatric conditions like depression and anxiety affect individuals\' quality of life. Early interventions are essential, and computerized cognitive training (cCT) is an established treatment method. This paper presents the protocol for the NeuroNation MED Effectiveness Study, evaluating the self-administered mobile cCT intervention (\"NeuroNation MED\") in individuals with MCI to assess training effects on cognitive domains, health competence, neuropsychiatric symptoms, psychological well-being, and the general application usability.
METHODS: This study protocol presents a single-blinded multicenter randomized controlled trial that will be carried out in six study centers in Germany and Luxembourg. We included adults with MCI (existing F06.7 ICD-10-GM diagnosis and TICS ≥ 21 and ≤ 32). The intervention group will use a mobile, multi-domain cCT (\"NeuroNation MED\") for 12 weeks. Meanwhile, the wait list control group will receive standard medical care or no care. The eligibility of volunteers will be determined through a telephone screening. After completion of the baseline examination, patients will be randomly assigned to one of the experimental conditions in a 2:1 ratio. In total, 286 participants will be included in this study. The primary outcome is the change of cognitive performance measured by the index score of the screening module of the Neuropsychological Assessment Battery. Secondary outcomes are changes in the Cognitive Failures Questionnaire, Hospital Anxiety and Depression Scale, Health-49, Health Literacy Questionnaire, among others. All of the primary and secondary outcomes will be assessed at baseline and after the 12-week post-allocation period. Furthermore, the intervention group will undergo an assessment of the System Usability Scale, and the training data of the NeuroNation MED application will be analyzed.
CONCLUSIONS: This study aims to assess the effectiveness of a mobile self-administered cCT in enhancing cognitive abilities among individuals diagnosed with MCI. Should the findings confirm the effectiveness of the NeuroNation MED app, it may confer possible benefits for the care management of patients with MCI, owing to the accessibility, cost-effectiveness, and home-based setting it provides. Specifically, the cCT program could provide patients with personalized cognitive training, educational resources, and relaxation techniques, enabling participants to independently engage in cognitive training sessions at home without further supervision.
BACKGROUND: German Clinical Trials Register DRKS00025133. Registered on November 5, 2021.