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

500 Participants
are divided into 2 treatment groups

Locations

7
University Hospital Tulln, Clinical Department of Neurology3430, TullnLower Austria, Austria
St. John's Hospital, Vienna Department of Neurology1020, ViennaState of Vienna, Austria
Medical University of Graz, Clinical Department of General Neurology8010, GrazStyria, Austria
Medical University of Innsbruck, Department of Neurology6020, InnsbruckTyrol, Austria

Sponsors and collaborators

VASCage GmbH

Lead sponsor

Medical University Innsbruck

Collaborator

Evaluation Software Development (ESD)

Collaborator