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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00031923
Enrollment
100
Registered
2023-05-17
Start date
2023-05-09
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I10 I11 I12 I13

Interventions

Group 1: intervention group: app "Vantis | Bluthochdruck" and care as usual Group 2: control group: care as usual

Sponsors

Vantis GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime frame
- decrease of systolic blood pressure after 13 weeks in practice measurement

Secondary

MeasureTime 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

Public ContactMaximilian Rödel

Vantis GmbH

studien@vantis-health.com+49 (0)89 6931 44840

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 5, 2026