An interventional study of StrokeApp and Standard care in Haemorrhagic Stroke, Ischaemic Stroke and Transient Ischemic Attack (TIA), sponsored by VASCage GmbH. Not yet recruiting at 7 sites in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by VASCage GmbH · Not applicable, Interventional, and Supportive care
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.
This study evaluates the clinical effectiveness, usability, and safety of a digital health application (StrokeApp) designed to support patients following ischemic stroke, hemorrhagic stroke, or transient ischemic attack (TIA) during the post-acute phase of care.
The StrokeApp is a mobile medical application classified as a Class IIa medical device and is currently in the pivotal phase of clinical development. It is intended to complement standard care by supporting secondary prevention and self-management. Core functionalities include the provision of structured educational content, medication and appointment reminders, tools for documenting health-related parameters, and the collection of electronic patient-reported outcomes (ePROs). In addition, the application offers optional tracking features and automated feedback to support adherence to recommended health behaviors.
The study is conducted as a multicenter, randomized, controlled, open-label clinical trial. Participants are enrolled during hospitalization for the index event and randomized in a 1:1 ratio to receive either standard care alone or standard care in combination with StrokeApp. The application is installed on the participant's personal mobile device during the hospital stay. Participants receive structured onboarding, including training on core functionalities and data entry. A reinforcement session is conducted prior to discharge to ensure independent use.
Following discharge, participants in the intervention group use the application over a period of up to twelve months. During this time, they are prompted to complete ePROs at predefined intervals and may optionally use daily tracking functions. The application delivers reminders, educational material, and automated feedback based on user input. Technical support is available throughout the study period if needed.
Study procedures and follow-up assessments are aligned with routine clinical practice. Data are collected through a combination of on-site visits, remote contacts, and electronic questionnaires. Participants in the control group follow the same visit schedule but complete patient-reported outcomes using web-based tools rather than the application.
The study includes both short-term and long-term follow-up. Data collected during the study include patient-reported outcomes, clinical parameters obtained as part of routine care, and application usage data in the intervention group. Usage data include frequency of access, completion of questionnaires, and interaction with app features, enabling assessment of engagement and adherence.
Safety is evaluated throughout the study by systematic documentation of adverse events and serious adverse events. Although the application is considered low risk, monitoring is performed to identify any potential unintended effects associated with its use, including issues related to usability, misunderstanding of content, or changes in healthcare utilization.
In addition to patient-centered outcomes, the study includes an assessment of physician perspectives regarding the usability and perceived benefit of the application in routine care. This component aims to provide insights into the feasibility of integrating digital health applications into established clinical workflows.
Overall, this study is designed to generate clinical evidence on the role of a digital health application in supporting post-stroke management under real-world conditions, including its integration into standard care pathways and its potential to support sustained patient engagement in secondary prevention.
233 studies on the registry are indexed under Hemorrhagic Stroke; 93 are open to participants now.
This study's planned enrollment of 500 is above the median of 58 across 156 interventional studies indexed under Hemorrhagic Stroke.
Browse Hemorrhagic Stroke studies →VASCage GmbH is the lead sponsor of 12 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Inability to operate the device independently (assistance from a caregiver is acceptable). E.g.:
Patients who are considered to be part of the vulnerable population:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive standard post-stroke care in accordance with clinical guidelines plus access to the StrokeApp. The application is installed during hospitalization and includes structured onboarding. It provides educational content, medication and appointment reminders, electronic patient-reported outcomes (ePROs), and optional tracking of health-related parameters. Participants may use the app for up to 12 months following discharge and receive automated feedback and reminders to support secondary prevention and self-management.
Device: StrokeApp
Participants receive standard post-stroke care in accordance with clinical guidelines, including routine outpatient follow-up. Participants complete study-related assessments, including patient-reported outcomes, via web-based tools but do not have access to the StrokeApp.
Other: Standard care
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 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.
Health-related quality of life (EQ VAS)
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).
Time frame: 3 months after hospital discharge
Health literacy (HLS19-Q12)
Time frame: Secondary outcome parameters will be assessed at 3 months.
The adherence to medication (MARS-D).
Time frame: Secondary outcome parameters will be assessed at 3 months.
Self-perceived stress (PPS-10)
Time frame: Secondary outcome parameters will be assessed at 3 months.
LDL-cholesterol levels
Time frame: Secondary outcome parameters will be assessed at 3 months.
HbA1c levels below 7.5% in patients with diabetes at baseline
Time frame: Secondary outcome parameters will be assessed at 3 months.
Average systolic office blood pressure level
Time frame: Secondary outcome parameters will be assessed at 3 months.
Physical activity (IPAQ)
Time frame: Secondary outcome parameters will be assessed at 3 months.
Number of cigarettes smoked per day
Time frame: Secondary outcome parameters will be assessed at 3 months.
Diet (MEPA)
Time frame: Secondary outcome parameters will be assessed at 3 months.
Alcohol consumption (AUDIT-C)
Time frame: Secondary outcome parameters will be assessed at 3 months.
Sleep quality (VAS)
Time frame: Secondary outcome parameters will be assessed at 3 months.
Average hours of sleep per night (self-reported)
Time frame: Secondary outcome parameters will be assessed at 3 months.
Symptoms of Anxiety (HADS-A)
Time frame: Secondary outcome parameters will be assessed at 3 months.
Symptoms of Depression (HADS-D)
Time frame: Secondary outcome parameters will be assessed at 3 months.
The patient's return to life after discharge (questionnaire) at 3 months.
Time frame: Secondary outcome parameters will be assessed at 3 months.
Fatigue (VAS)
Time frame: Secondary outcome parameters will be assessed at 3 months.
Overall quality of life (VAS)
Time frame: Secondary outcome parameters will be assessed at 3 months.
Health related quality of life (EQ-5D-3L overall health utility score calculated from individual 3-level components using rescaled European visual analogue scale weights)
Time frame: Secondary outcome parameters will be assessed at 3 months.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2026; primary completion for Dec 2026, 8 months later.
Of 75 non-industry interventional studies with no phase under Hemorrhagic Stroke, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 57. This study's planned 8 months is below that.
Counting every sponsor, half of 89 studies reached it within 36 months; a quarter within 14 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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