Michalski Dominik, Prost Alexander, Handel Till, Schreiber Max, Tylcz Jean-Baptiste, Geisler Daniela, Urban Daniela, Schramm Stephanie, Lippmann Stefan, Gullnick Jenny, Neumuth Thomas, Classen Joseph, Ivanova Galina
Department of Neurology, University of Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.
Innovation Center Computer Assisted Surgery, University of Leipzig, Semmelweisstr. 14, 04103, Leipzig, Germany.
Neurol Res Pract. 2021 Sep 9;3(1):53. doi: 10.1186/s42466-021-00137-w.
Post stroke management has moved into the focus as it represents the only way to secure acute treatment effects in the long term. Due to individual courses, post stroke management appears rather challenging and is hindered by existing barriers between treatment sectors. As a novel concept, the PostStroke-Manager combines digital and sensor-based technology with personal assistance to enable intersectoral cooperation, best possible reduction of stroke-related disability, optimal secondary prevention, and detection of physical and psychological comorbidities.
This prospective single-center observational study aims to investigate the feasibility of the PostStroke-Manager concept in an outpatient setting. Ninety patients who have suffered an ischemic or hemorrhagic stroke or transient ischemic attack will be equipped with a tablet and mobile devices recording physical activity, blood pressure, and electrocardiographic signals. Through a server-based platform, patients will be connected with the primary care physician, a stroke pilot and, if necessary, other specialists who will use web-based platforms. Via the tablet, patients will have access to an application with 10 newly designed components including, for instance, a communication tool, medication schedule, medical records platform, and psychometric screenings (e.g., depression, anxiety symptoms, quality of life, adherence, cognitive impairment). During the 1-year follow-up period, clinical visits are scheduled at three-month intervals. In the interim, communication will be secured by an appropriate tool that includes text messenger, audio, and video telephony. As the primary endpoint, feasibility will be measured by a 14-item questionnaire that addresses digital components, technical support, and personal assistance. The PostStroke-Manager will be judged feasible if at least 50% of these aspects are rated positively by at least 75% of patients. Secondary endpoints include feedback from professionals and longitudinal analyses on clinical and psychometric parameters.
This study will answer the question of whether combined digital and personal support is a feasible approach to post stroke management. Furthermore, the patient perspective gained regarding digital support may help to specify future applications. This study will also provide information regarding the potential use of remote therapies and mobile devices in situations with limited face-to-face contacts.
German Register for Clinical Trials ( DRKS00023213 .), registered 27 April 2021.
中风后的管理已成为焦点,因为它是确保长期急性治疗效果的唯一途径。由于个体病情发展过程不同,中风后的管理颇具挑战性,且受到治疗部门之间现有障碍的阻碍。作为一个新概念,中风后管理系统将数字技术和基于传感器的技术与个人协助相结合,以实现跨部门合作,尽可能降低与中风相关的残疾程度,实现最佳的二级预防,并检测身体和心理合并症。
这项前瞻性单中心观察性研究旨在调查中风后管理系统概念在门诊环境中的可行性。90名曾发生缺血性或出血性中风或短暂性脑缺血发作的患者将配备平板电脑和记录身体活动、血压和心电图信号的移动设备。通过基于服务器的平台,患者将与初级保健医生、一名中风治疗指导人员以及必要时的其他专家建立联系,这些专家将使用基于网络的平台。通过平板电脑,患者可以使用一个包含10个新设计组件的应用程序,例如通信工具、用药时间表、医疗记录平台和心理测评(如抑郁、焦虑症状、生活质量、依从性、认知障碍)。在1年的随访期内,每三个月安排一次临床就诊。在此期间,将通过包括文本信使、音频和视频电话在内的适当工具确保沟通。作为主要终点,可行性将通过一份包含14个条目的问卷进行衡量,该问卷涉及数字组件、技术支持和个人协助。如果至少75%的患者对这些方面中至少50%给予积极评价,则判定中风后管理系统可行。次要终点包括专业人员的反馈以及对临床和心理测评参数的纵向分析。
本研究将回答数字支持与个人支持相结合是否是中风后管理的可行方法这一问题。此外,从患者角度获得的关于数字支持的看法可能有助于明确未来的应用。本研究还将提供有关在面对面接触有限的情况下远程治疗和移动设备潜在用途的信息。
德国临床试验注册中心(DRKS00023213.),于2021年4月27日注册。