I10 I11 I12 I13
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - patients with increased blood pressure - patient understands the patient information and gives written consent for study participation
Exclusion criteria
Exclusion criteria: - no compatible smartphone available or lacking knowledge of smartphone usage - insufficient understanding of the offered language (German) - start of study participation in another clinical study after inclusion in the present study - participation in a lifestyle-related rehabilitation, or device-based blood pressure therapy, or such a rehabilitation/therapy has been conducted in the last 2 months - critical or unstable health status - dependency or employment relation to the sponsor or investigator - prior usage of a comparable digital therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - decrease of systolic blood pressure after 13 weeks in practice measurement | — |
Secondary
| Measure | Time frame |
|---|---|
| - decrease of diastolic blood pressure (BP) for patients with diastolic BP >84mmHg at inclusion - change of resting state heart rate for patients with heart rate >50 at inclusion - change of body mass index (BMI) for patients with BMI > 25 - improvement of therapy adherence, measured with the questionnaire "Selbstfürsorge des Bluthochdrucks" - number of days with measured and protocolled blood pressure in last 14 days - number of unplanned physician visits for cardiovascular complaints | — |
Countries
Germany
Contacts
Vantis GmbH