Randomised, controlled trial to evaluate the effectiveness of Oviva Direkt in reducing blood pressure in patients with hypertensio
- Conditions
- I10Essential (primary) hypertension
- Registration Number
- DRKS00034348
- Lead Sponsor
- Oviva AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 134
? 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
? 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean systolic blood pressure measured by home-based blood pressure monitoring at week 12
- Secondary Outcome Measures
Name Time Method ? Percent change in body weight between baseline and 12 weeks measured by home-based monitoring <br>? Mean diastolic blood pressure measured by home-based blood pressure monitoring at week 12 <br>? Change in health-related quality of life between baseline and 12 weeks measured by SF-8 questionnaire <br>? Change in patient food literacy between baseline and 12 weeks measured by SFLQ questionnaire