I10
Conditions
Interventions
Group 1: Oviva Direkt Hypertension (app-based digital lifestyle intervention) + care-as-usual for 24 weeks
Group 2: Care-as-usual for 24 weeks
Sponsors
Oviva AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
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 (i.e., same dose and type of medication) for at least 3 months prior to screening - Concurrent use of fewer than 4 antihypertensive drugs - Willing and motivated to use a lifestyle intervention to reduce systolic blood pressure - Valid and working email address, telephone number, and internet access and willing to maintain these for the duration of the trial - Sufficient skill in the German language for participation - Signed informed consent - Ability to use a smartphone or tablet - Smartphone available and compatible with the Oviva Direkt App - Access to a blood pressure monitor
Exclusion criteria
Exclusion criteria: - Average systolic blood pressure at rest = 180 mmHg - Currently pregnant, breastfeeding or planning to become pregnant during the next 6 months - Current and ongoing multiple daily insulin injections or use of rapid-acting insulin via a pump (once or twice daily injections of long-acting insulin are accepted) - Significant cardiovascular event in the last 6 months prior to screening (e.g., stroke, heart attack, cerebral haemorrhage) - Severe cognitive and intellectual impairment - Current use of Oviva Direkt Bluthochdruck - Having started treatment with a GLP-1 agonist or SGLT-2 inhibitor in the 6 months prior to screening, or (planned) during the trial - Other significant medication changes that could impact blood pressure or body weight in the 3 months prior to screening, or (planned) during the trial - Active oncological treatment - Severe, active psychiatric disease (e.g. eating disorder, bipolar disorder, schizophrenia, alcohol or drug abuse) - Living in a household with a person currently participating in a lifestyle intervention - Terminal diagnosis with a life expectancy of less than 24 months - Planned absence during the planned period of trial participation that may affect data collection - Participating in another clinical trial of an investigational drug or device - Dependence on the sponsor or investigator (e.g. employees of the sponsor or a trial site and their family members) - Any other reason which, in the opinion of the investigator, may put the participant at risk because of participation in the trial or bias trial results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change of systolic blood pressure from baseline to after 24 weeks measured by HBPM (Home Blood Pressure Monitoring) in the intervention group compared to the control group | — |
Secondary
| Measure | Time frame |
|---|---|
| - Mean change of diastolic blood pressure from baseline to after 24 weeks measured by HBPM in the intervention group compared to the control group - Mean change of the Mental Component Summary (MCS) of HRQoL between baseline and after 24 weeks measured by the SF-12 questionnaire score in the intervention group compared to the control group - Mean change in patient activation between baseline and after 24 weeks measured by the PAM-13 in the intervention group compared to the control group | — |
Countries
Germany
Outcome results
None listed