Prospective, randomized, controlled, multicenter pilot study investigating the therapy of increased blood pressure with help of a digital program

Phase 4

• Conditions: I10; I11; I12; I13; Essential (primary) hypertension; Hypertensive heart disease; Hypertensive renal disease; Hypertensive heart and renal disease

• Registration Number: DRKS00031923
• Lead Sponsor: Vantis GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-17
• Study Completion: 2024-07-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

patients with increased blood pressure
- patient understands the patient information and gives written consent for study participation

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- decrease of systolic blood pressure after 13 weeks in practice measurement

Secondary Outcome Measures

Name	Time	Method
- decrease of diastolic blood pressure (BP) for patients with diastolic BP >84mmHg at inclusion<br>- change of resting state heart rate for patients with heart rate >50 at inclusion<br>- change of body mass index (BMI) for patients with BMI > 25<br>- number of patients in target range after 13 weeks<br>- improvement of therapy adherence, measured with the questionnaire Selbstfürsorge des Bluthochdrucks<br>- increase of patient proportion with blood pressure protocol (blood pressure regularly measured and protocoled with a diary at minimum 8 of the last 14 days)<br>- number of unplanned physician visits for cardiovascular complaints