About this trial
Stroke is a leading cause of death and long-term disability worldwide. Despite substantial advances in acute stroke care, there remains a lack of evidence-based digital solutions to support patients after hospital discharge. This study evaluates the effectiveness of a digital health application (StrokeApp) designed to support patients with ischemic or hemorrhagic stroke or transient ischemic attack (TIA) in secondary prevention and recovery.
In this multicenter, randomized, controlled, open-label trial, 500 patients will be assigned in a 1:1 ratio to receive either standard care alone or standard care in combination with StrokeApp. The primary objective is to assess the impact of the application on health-related quality of life three months after discharge. Secondary and exploratory outcomes include health literacy, medication adherence, vascular risk factors, health-related behaviors, psychosocial outcomes, long-term recovery up to twelve months, as well as safety and user experience.
Eligibility criteria
Qualifiers
Male or female patient (biological sex) ≥18 years at the time of consent
Hospitalization for acute ischemic stroke, acute haemorrhagic stroke or TIA
Necessary Technical Equipment (smartphone or tablet computer) and skills
Able to provide informed consent
Disqualifiers
Cerebral infarction due to cerebral venous thrombosis (CVT)
Severe Psychiatric Conditions
Severe pre-existing cognitive impairment
Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) or other patients where salt restriction is harmful.
Trial design
Treatments tested in this trial
- StrokeApp
- Standard care
Treatment groups
Sponsors and collaborators
VASCage GmbH
Lead sponsor
Medical University Innsbruck
Collaborator
Evaluation Software Development (ESD)
Collaborator