Haemorrhagic StrokeDASHNCT07511868
Digital Application for Stroke Health
A study testing StrokeApp in people with Haemorrhagic Stroke and Ischaemic Stroke, run by VASCage GmbH at 7 sites in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemorrhagic Stroke, Ischaemic Stroke, Transient Ischemic Attack (TIA)
- What is being tested?
- StrokeApp
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 7 sitesAustria
- Study dates
- 1 Apr 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 17Show fewer
- Severe Motor Disabilities,
- Severe Visual Impairment
- Severe Communication Barriers (e.g. Severe Aphasia, Severe Dysarthria)
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Austria7 sites
Medical University of Graz, Clinical Department of General Neurology
Graz, Styria, 8010
Markus Kneihsl, +43 316 385-82984, markus.kneihsl@medunigraz.at
Daniela Pinter, +43 316 385 31215, daniela.pinter@medunigraz.at
Medical University of Innsbruck, Department of Neurology
Innsbruck, Tyrol, 6020
Michael Knoflach, +43 512 504 81697, Michael.knoflach@i-med.ac.at
Michael Knoflach
Johannes Kepler University Linz, University Hospital for Neurology
Linz, Upper Austria, 4021
Raimund Helbok, +43 5 7680 83 - 6811, raimund.helbok@kepleruniklinikum.at
Elke Bach, +43 5 7680 87 - 29215, elke.bach@kepleruniklinikum.at
Pyhrn-Eisenwurzen Klinikum, Department of Neurology
Steyr, Upper Austria, 4400
Michael Guger, +43 5 055466-25702, Michael.Guger@ooeg.at
Jasmine Cichlinski, +43 50 55466-25702, jasmine.cichlinski@ooeg.at
University Hospital Tulln, Clinical Department of Neurology
Tulln, Lower Austria, 3430
St. John's Hospital, Vienna Department of Neurology
Vienna, State of Vienna, 1020
Stefan Krebs, +43 1 21121 3240, Stefan.krebs@meduniwien.at
Lisa Kaindl, +43 1 21121 3240, lisa.kaindl@bbwien.at
Salzkammergut Klinikum Vöcklabruck, Department of Neurology
Vöcklabruck, Upper Austria, 4840
Nenad Mitrovic, +43 5 055471-25750, Nenad.Mitrovic@ooeg.at
Agnes Linortner, +43 50 554 71-23496, agnes.linortner@ooeg.at
About this study
Official title: Evaluating a Digital Health Application for Post-stroke Care and Vascular Risk Factor Management - a Multicenter Randomized Controlled Clinical Investigation
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.
Read the detailed description
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.
- Being tested
- StrokeApp, Standard care
- Keywords
- Digital Health Application, Post Stroke, Medical Device, App, stroke aftercare
- Medical subject headings
- Hemorrhagic Stroke, Ischemic Stroke, Ischemic Attack, Transient, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StrokeAppDevice
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 careOther
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 group | Role | What they receive |
|---|---|---|
| Standard Care + StrokeApp | Experimental | 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. Receives: Device: StrokeApp |
| Standard Care | Active comparator | 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. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months after hospital discharge
Secondary outcomes (18)
Health literacy (HLS19-Q12)
Measured: Secondary outcome parameters will be assessed at 3 months.
The adherence to medication (MARS-D).
Measured: Secondary outcome parameters will be assessed at 3 months.
Self-perceived stress (PPS-10)
Measured: Secondary outcome parameters will be assessed at 3 months.
LDL-cholesterol levels
Measured: Secondary outcome parameters will be assessed at 3 months.
HbA1c levels below 7.5% in patients with diabetes at baseline
Measured: Secondary outcome parameters will be assessed at 3 months.
Average systolic office blood pressure level
Measured: Secondary outcome parameters will be assessed at 3 months.
Physical activity (IPAQ)
Measured: Secondary outcome parameters will be assessed at 3 months.
Number of cigarettes smoked per day
Measured: Secondary outcome parameters will be assessed at 3 months.
Diet (MEPA)
Measured: Secondary outcome parameters will be assessed at 3 months.
Alcohol consumption (AUDIT-C)
Measured: Secondary outcome parameters will be assessed at 3 months.
Sleep quality (VAS)
Measured: Secondary outcome parameters will be assessed at 3 months.
Average hours of sleep per night (self-reported)
Measured: Secondary outcome parameters will be assessed at 3 months.
Symptoms of Anxiety (HADS-A)
Measured: Secondary outcome parameters will be assessed at 3 months.
Symptoms of Depression (HADS-D)
Measured: Secondary outcome parameters will be assessed at 3 months.
The patient's return to life after discharge (questionnaire) at 3 months.
Measured: Secondary outcome parameters will be assessed at 3 months.
Fatigue (VAS)
Measured: Secondary outcome parameters will be assessed at 3 months.
Overall quality of life (VAS)
Measured: 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)
Measured: Secondary outcome parameters will be assessed at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemorrhagic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VASCage GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University Innsbruck, Evaluation Software Development (ESD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511868
- Sponsor's protocol ID
- C_2_BC.3-0059_014
- Acronym
- DASH
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Digital Health Application for Post-stroke Care and Vascular Risk Factor Management - a Multicenter Randomized Controlled Clinical Investigation
- ClinicalTrials.gov ID
- NCT07511868
- Acronym / sponsor ID
- DASH / C_2_BC.3-0059_014
- Keywords
- Digital Health Application, Post Stroke, Medical Device, App, stroke aftercare
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- VASCage GmbHUniversity, hospital or other
- Collaborators
- Medical University Innsbruck, Evaluation Software Development (ESD)
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care + StrokeApp | Experimental | Device: StrokeAppParticipants 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. |
| Standard Care | Active comparator | Other: Standard careParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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.:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StrokeAppStrokeApp 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. | Device | Standard Care + StrokeApp |
| Standard careStandard 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. | Other | Standard Care |
Primary outcome
Health-related quality of life (EQ VAS)
Time frame: 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).
18 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StrokeApp in people with Haemorrhagic Stroke and Ischaemic Stroke, run by VASCage GmbH at 7 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muriel Harloff, M.Sc. (+43 512 554435 13, muriel.harloff@vascage.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (EQ VAS) (time frame: 3 months after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.