Evaluating a Digital Health Application for Post-stroke Care and Vascular Risk Factor Management - a Multicenter Randomized Controlled Clinical Investigation
Sponsor: VASCage GmbH
Trial Details
| Condition | Haemorrhagic Stroke, Ischaemic Stroke, Transient Ischemic Attack (TIA) |
| Intervention | StrokeApp; Standard care |
| Phase | NA |
| Status | Not_yet_recruiting |
| Participants | 500 |
| Est. Completion | 31 Dec 2026 |
| Last Updated | 6 Apr 2026 |
Primary Outcome
Health-related quality of life (EQ VAS)
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: 1. Male or female patient (biological sex) ≥18 years at the time of consent 2. Hospitalization for acute ischemic stroke, acute haemorrhagic stroke or TIA 3. Necessary Technical Equipment (smartphone or tablet computer) and skills 4. Able to provide informed consent Exclusion Criteria: 1. Cerebral infarction due to cerebral venous thrombosis (CVT) 2. Severe Psychiatric Conditions 3. Severe pre-existing cognitive impairment 4. Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) or other patients where salt restriction is harmful. 5. Inability to operate the device independently (assistance from a caregiver is acceptable). E.g.: * Severe apraxia, * Severe Motor Disabilities, * Severe Visual Impairment * Severe Communication Barriers (e.g. Severe Aphasia, Severe Dysarthria) 6. Inability to speak and read German to a level which allows fully comprehending the meaning of everything that is said and written. 7. Women of childbearing potential not willing to adopt effective contraceptive measures during the clinical investigation 8. Patients who are considered to be part of the vulnerable population: * Persons unable to give consent * Minors * Persons performing military service * persons detained by court or official order or accommodated in accordance with the Accommodation Act, Federal Law Gazette No. 155/1990 * Pregnant or breastfeeding women
Trial Sites
🇦🇺 Australian Sites (7)
Countries
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