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NCT07511868Not yet recruiting

Digital Application for Stroke Health

Evaluating a Digital Health Application for Post-stroke Care and Vascular Risk Factor Management - a Multicenter Randomized Controlled Clinical Investigation

Source: ClinicalTrials.gov · Last updated 6 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
500 (estimated)
First submitted
30 Mar 2026
Start date
1 Apr 2026
Primary completion date
31 Dec 2026
Lead sponsor
VASCage GmbH
Diseases
Stroke
NCT number
NCT07511868

What you commit to

  • Study type: Interventional
  • Planned participants: 500
  • From 1 Apr 2026 to the primary completion date, 31 Dec 2026
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.:
    • Severe apraxia,
    • Severe Motor Disabilities,
    • Severe Visual Impairment
    • Severe Communication Barriers (e.g. Severe Aphasia, Severe Dysarthria)

Other

  • Inability to speak and read German to a level which allows fully comprehending the meaning of everything that is said and written.
  • Women of childbearing potential not willing to adopt effective contraceptive measures during the clinical investigation
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Graz, Clinical Department of General Neurology
Coordinator of this site? Confirm its status
GrazAustriaUnknown status
Medical University of Innsbruck, Department of Neurology
Coordinator of this site? Confirm its status
InnsbruckAustriaUnknown status
Johannes Kepler University Linz, University Hospital for Neurology
Coordinator of this site? Confirm its status
LinzAustriaUnknown status
Pyhrn-Eisenwurzen Klinikum, Department of Neurology
Coordinator of this site? Confirm its status
SteyrAustriaUnknown status
University Hospital Tulln, Clinical Department of Neurology
Coordinator of this site? Confirm its status
TullnAustriaUnknown status
St. John's Hospital, Vienna Department of Neurology
Coordinator of this site? Confirm its status
ViennaAustriaUnknown status
Salzkammergut Klinikum Vöcklabruck, Department of Neurology
Coordinator of this site? Confirm its status
VöcklabruckAustriaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.