Digital Application for Stroke Health

NCT07511868 · tracked via the Priya Life Science Austria tracker

Sponsor

VASCage GmbH

Phase

Not applicable

Started

2026-04-01

Last updated

2026-04-06

Condition(s) studied

Haemorrhagic StrokeIschaemic StrokeTransient Ischemic Attack (TIA)

Investigational drug(s) / intervention(s)

StrokeAppStandard care

StrokeApp: StrokeApp is a smartphone/tablet-based medical application designed to support patients following ischemic stroke, hemorrhagic stroke, or transient ischemic attack (TIA). The application is installed on the patient's personal device during hospitalization and includes structured onboarding. It provides educational content on stroke and secondary prevention, medication and appointment reminders, and tools for documenting health-related parameters. Patients complete electronic patient-reported outcomes (ePROs) at predefined time points. Optional daily tracking features and automated feedback support adherence to treatment recommendations and promote health-related behavior change. The application is used for up to 12 months in addition to standard care.

Standard care: Standard post-stroke care according to clinical guidelines, including routine inpatient management and structured outpatient follow-up approximately three months after discharge. No digital application is provided.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Health-related quality of life (EQ VAS) — 3 months after hospital discharge
Health-related quality of life measured using the EQ Visual Analogue Scale (EQ VAS), a standardized instrument assessing the participant's self-rated health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).

Trial sites (7)

Facility	City	Region
University Hospital Tulln, Clinical Department of Neurology	Tulln	Lower Austria
St. John's Hospital, Vienna Department of Neurology	Vienna	State of Vienna
Medical University of Graz, Clinical Department of General Neurology	Graz	Styria
Medical University of Innsbruck, Department of Neurology	Innsbruck	Tyrol
Johannes Kepler University Linz, University Hospital for Neurology	Linz	Upper Austria
Pyhrn-Eisenwurzen Klinikum, Department of Neurology	Steyr	Upper Austria
Salzkammergut Klinikum Vöcklabruck, Department of Neurology	Vöcklabruck	Upper Austria

More VASCage GmbH trials in Austria

Stroke-Card Registry Active, not recruiting

Exploratory Study on the Potential Cross-System Effects of BCI-FES Hand Therapy on Dysphagia and Aphasia in Chronic Stroke Patients Recruiting

Predication of Arterial Stiffness in Healthy Adults by Oral Health and Chewing Assessments Recruiting

Innsbruck Health Promotion Program Recruiting

Functional Mitochondrial Analysis PBMCs Active, not recruiting

Other trials for the same condition

Exploratory Study on the Potential Cross-System Effects of BCI-FES Hand Therapy on Dysphagia and Aphasia in Chronic Stroke Patients Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07511868 on ClinicalTrials.gov ↗ ← All trials in Austria