NCT07511868 · NOT YET RECRUITING

Digital Application for Stroke Health

This trial is testing a smartphone app called StrokeApp to see whether it helps stroke and TIA survivors recover and stay healthy after leaving the hospital. Researchers will compare 500 patients using the app alongside standard care versus standard care alone, measuring quality of life at three months. It is a Phase NA trial — this designation typically applies to non-drug device or behavioral studies rather than drug efficacy testing.

Eligibility criteria

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

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-04-06

View full record on ClinicalTrials.gov

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