The PostStroke-Manager – combining mobile, digital and sensor-based technology with personal assistance: protocol of the feasibility study

• Published in: Neurological research and practice Vol. 3; no. 1; p. 53
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: Berlin Springer Nature B.V 09-09-2021; BioMed Central; BMC
• Subjects: Blood pressure; Clinical Trial Protocol; Clinical trials; Cognitive ability; Digital health; Feasibility studies; Hemorrhage; Ischemia; Medical records; Mobile devices; Patients; Physical activity; Post stroke management; Primary care; Quality of life; Quantitative psychology; Secondary prevention; Stroke; Telemedicine; Transient ischemic attack
• ISSN: 2524-3489; 2524-3489
• DOI: 10.1186/s42466-021-00137-w

Abstract
Introduction
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.
Methods
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.
Perspective
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.
Trial registration
German Register for Clinical Trials (
DRKS00023213
.), registered 27 April 2021
.