I10
Conditions
Interventions
Group 1: Intervention group: Oviva Direkt Hypertension (App-based digital
lifestyle intervention) + standard of care
Group 2: Comparison group: standard of care
Sponsors
Oviva AG
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: ? Fulfilling the criteria for essential hypertension, which is an average systolic blood pressure > 135 mmHg measured at rest with validated devices and according to the 2023 ESH Guidelines for the management of arterial hypertension for home-blood pressure monitoring ? Stable antihypertensive treatment for at least three months ? Concurrent use of fewer than 4 antihypertensive drugs ? Treatment goal to reduce systolic blood pressure using a lifestyle intervention ? Valid and working email address, telephone number, and internet access ? Sufficient skill in the German language for participation ? Signed informed consent ? Smartphone available and compatible with the Oviva Direkt app ? Possession of a validated blood pressure monitor ? Motivation and ability to make lifestyle changes
Exclusion criteria
Exclusion criteria: ? Average systolic blood pressure at rest = 180 mmHg ? Patient safety reasons (e.g., breastfeeding, pregnancy, concurrent insulin treatment) ? Cardiovascular event in the last 6 months (e.g., stroke, heart attack, cerebral haemorrhage) ? Severe cognitive and intellectual impairment ? Current or recent participation (within the past 12 months) in a digital lifestyle intervention or clinical investigation targeting blood pressure and/or body weight reduction ? Weight loss >5% in the past 6 months (intentional or unintentional) ? Living in a household with another study participant for a digital lifestyle intervention ? Terminal diagnosis with a life expectancy of less than 24 months ? Planned long-term absence > 3 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean systolic blood pressure measured by home-based blood pressure monitoring at week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| ? Percent change in body weight between baseline and 12 weeks measured by home-based monitoring ? Mean diastolic blood pressure measured by home-based blood pressure monitoring at week 12 ? Change in health-related quality of life between baseline and 12 weeks measured by SF-8 questionnaire ? Change in patient food literacy between baseline and 12 weeks measured by SFLQ questionnaire | — |
Countries
Germany
Contacts
Public ContactAna Mijuskovic
Oviva AG
Outcome results
None listed