Feasibility of a mobil, digital and sensor-based technology for secondary prevention, health competence and self-determination in combination with personal assistance after stroke

• Conditions: Stroke; I64; Stroke, not specified as haemorrhage or infarction

• Registration Number: DRKS00023213
• Lead Sponsor: niversität Leipzig, Medizinische Fakultät,Klinik und Poliklinik für Neurologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

age > 18 years
- written informed consent or verbal consent among witnesses
- pre-mRS 0-2 i.e. at most minor impairment before the event
- stable course of stroke or TIA-related clinical and paraclinical parameters, so that discharge from the hospital is possible
- possibility of operation of the digital system and use of the communication elements by the patient (critical parameters are considered to be the presence of a severe neglect or a high degree of hemiparesis or a severe aphasic disorder that does not enable communication)
- residence in the Leipzig area
- consent of the treating general practitioner to participate in the study

Exclusion Criteria

- other illness of competing severity that makes study participation as intended impossible (e.g cancer with a life expectancy of less than one year)
- recognizable inability to use the study-related software or end devices
- presence of a chronic, clinically relevant psychiatric disease before the cerebrovascular event
- pre-existing dementia
- existing qualitative or quantitative disturbance of consciousness
- patients who cannot be followed for one year
- existing or planned pregnancy

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The feasibility of the support system under real-life” conditions should be evaluated by the participants with an integrated questionnaire at the end of the observation period. The questionnaire contains the assessment of the digital and personal support and also of the corresponding digital single modules. The assessment follows a six-stage scale from very large support” to no support”. In addition to that, the patients receive the possibility to formulate their suggestions and desires how to improve the support system as a free text. The system should be evaluated as feasible”, if at least 50% of the single modules are positively rated by at least 75% of the participants.

Secondary Outcome Measures

Name	Time	Method
An unstructured feedback of stroke pilots, general and other practitioners about the feasibility of the support system should help to develop the content and the technical specifications further. Descriptive analyses of the course of psychometric variables, vital parameters, physical limitations and laboratory parameters are intended to provide an insight into the long-term course of the stroke disease. A stratification concerning the diagnostic groups cerebral infarction, cerebral haemorrhage and TIA could help to identify patients with post-hoc analyses, which would have a particularly benefit from the support system. Biomedical analyses of the terminal devices data should form the basis for further and new developments of modern interpretation possibilities of non-invasively available bio signals. In addition, technical analyses of usage behavior and problems encountered in dealing with the use of the digital system are of great importance for the further development of the system.