Haemorrhagic Stroke, Ischaemic Stroke, Transient Ischemic Attack (TIA)
Conditions
Keywords
Digital Health Application, Post Stroke, Medical Device, App, stroke aftercare
Brief 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.
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.
Interventions
DEVICEStrokeApp
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.
OTHERStandard 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.
Sponsors
VASCage GmbH
Medical University Innsbruck
Evaluation Software Development (ESD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame |
|---|---|
| Health literacy (HLS19-Q12) | Secondary outcome parameters will be assessed at 3 months. |
| The adherence to medication (MARS-D). | Secondary outcome parameters will be assessed at 3 months. |
| Self-perceived stress (PPS-10) | Secondary outcome parameters will be assessed at 3 months. |
| LDL-cholesterol levels | Secondary outcome parameters will be assessed at 3 months. |
| HbA1c levels below 7.5% in patients with diabetes at baseline | Secondary outcome parameters will be assessed at 3 months. |
| Average systolic office blood pressure level | Secondary outcome parameters will be assessed at 3 months. |
| Physical activity (IPAQ) | Secondary outcome parameters will be assessed at 3 months. |
| Number of cigarettes smoked per day | Secondary outcome parameters will be assessed at 3 months. |
| Diet (MEPA) | Secondary outcome parameters will be assessed at 3 months. |
| Alcohol consumption (AUDIT-C) | Secondary outcome parameters will be assessed at 3 months. |
| Sleep quality (VAS) | Secondary outcome parameters will be assessed at 3 months. |
| Average hours of sleep per night (self-reported) | Secondary outcome parameters will be assessed at 3 months. |
| Symptoms of Anxiety (HADS-A) | Secondary outcome parameters will be assessed at 3 months. |
| Symptoms of Depression (HADS-D) | Secondary outcome parameters will be assessed at 3 months. |
| The patient's return to life after discharge (questionnaire) at 3 months. | Secondary outcome parameters will be assessed at 3 months. |
| Fatigue (VAS) | Secondary outcome parameters will be assessed at 3 months. |
| Overall quality of life (VAS) | 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) | Secondary outcome parameters will be assessed at 3 months. |
Countries
Austria
Contacts
CONTACTMuriel Harloff, M.Sc.
CONTACTPetr Simurda
Outcome results
None listed