German Center for Neurodegenerative Diseases, Magdeburg, Germany
Institute of Cognitive Neurology and Dementia Research, Otto von Guericke University Magdeburg, Magdeburg, Germany.
BMJ Open. 2024 Mar 12;14(3):e081159. doi: 10.1136/bmjopen-2023-081159.
Timely diagnosis of mild cognitive impairment (MCI) in Alzheimer's disease is crucial for early interventions, but its implementation is often challenging due to the complexity and time burden of required cognitive assessments. To address these challenges, the usability of new unsupervised digital remote assessment tools needs to be validated in a care context.
This multicentric healthcare research evaluation survey, re.cogni.ze, aims to evaluate physician satisfaction with a remote digital assessment solution (neotivCare) in primary and specialised routine care in Germany. Over a period of 22 months, physicians in different regions of Germany will recommend the application (app) to approximately 1000 patients for a 12-week self-assessment of cognition. The primary endpoint is the evaluation of physicians' and patients' overall satisfaction with neotivCare and with neuropsychological questionnaires/standard procedures using a Likert scale, while secondary endpoints include user-friendliness, qualitative assessment of acceptance and potential improvements on medical routine services. The study also aims to evaluate the proportion of physicians or patients attributing added value to neotivCare compared with standard paper-pencil tests. The study results will provide insights into the feasibility, efficiency and acceptance of new digital tools for MCI diagnosis in routine care. The re.cogni.ze survey will thus provide proof-of-concept information for the implementation of remote digital cognitive assessment apps for MCI into medical routine care.
This study was approved by the ethics committee of the State Medical Association (Landesärztekammer) Baden-Württemberg, (F-2021-161) as the leading committee and nine ethics committees local to the participating healthcare professionals (Lower Saxony, North Rhine, Westphalia-Lippe, Hesse, Bremen, Berlin, University of Göttingen, Charite, University of Rostock). The results can be shared (upon reasonable quest) to improve routine clinical processes and holistic approaches.
及时诊断阿尔茨海默病的轻度认知障碍（MCI）对于早期干预至关重要，但由于所需认知评估的复杂性和时间负担，其实施常常具有挑战性。为了解决这些挑战，需要在护理环境中验证新的无监督数字远程评估工具的可用性。
这项多中心医疗保健研究评估调查，re.cogni.ze，旨在评估德国初级和专科常规护理中医生对远程数字评估解决方案（neotivCare）的满意度。在 22 个月的时间里，德国不同地区的医生将向大约 1000 名患者推荐该应用程序（app），以进行为期 12 周的认知自我评估。主要终点是使用李克特量表评估医生和患者对 neotivCare 以及神经心理学问卷/标准程序的总体满意度，而次要终点包括用户友好性、接受度的定性评估以及对常规医疗服务的潜在改进。该研究还旨在评估与标准纸笔测试相比，医生或患者中有多少人认为 neotivCare 具有附加价值。该研究结果将为新的数字工具在常规护理中用于 MCI 诊断的可行性、效率和可接受性提供深入了解。re.cogni.ze 调查将为远程数字认知评估应用程序在常规医疗护理中用于 MCI 诊断提供概念验证信息。
该研究已获得巴登-符腾堡州州立医师协会（Landesärztekammer）伦理委员会（F-2021-161）的批准，作为主要委员会，以及参与医疗保健专业人员所在的九个地方伦理委员会（下萨克森州、北莱茵州、威斯特法伦-利珀州、黑森州、不来梅、柏林、哥廷根大学、Charité、罗斯托克大学）批准。可以共享（在合理请求的情况下）研究结果，以改善常规临床流程和整体方法。
