Digital Application for Stroke Health (NCT07511868) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Digital Application for Stroke Health
Austria500 participantsStarted 2026-04-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.
✕. Inability to operate the device independently (assistance from a caregiver is acceptable). E.g.:
✕. Inability to speak and read German to a level which allows fully comprehending the meaning of everything that is said and written.