DRKS00034348招募中3 期
Randomised, controlled trial to evaluate the effectiveness of Oviva Direkt in reducing blood pressure in patients with hypertension - HYPE
Oviva AG0 个研究点目标入组 134 人开始时间: 2024年6月10日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 134
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •? 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
排除标准
- •? 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
研究者
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