Digital Application for Stroke Health
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVASCage GmbH
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
StrokeApp
DeviceStrokeApp 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
Other interventionStandard 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.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Standard Care + StrokeAppExperimental treatment 1 intervention
Group B: Standard CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 dischargeSecondary outcomes
1
Health literacy (HLS19-Q12)
Time frame
Secondary outcome parameters will be assessed at 3 months.2
The adherence to medication (MARS-D).
Time frame
Secondary outcome parameters will be assessed at 3 months.3
Self-perceived stress (PPS-10)
Time frame
Secondary outcome parameters will be assessed at 3 months.4
LDL-cholesterol levels
Time frame
Secondary outcome parameters will be assessed at 3 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
VASCage GmbH
Lead sponsor
Medical University Innsbruck
Collaborator
Evaluation Software Development (ESD)
Collaborator
Source ClinicalTrials.gov
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