Pilot Study of Information and Communication Technology Solutions for Hypertension Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Changes in blood pressure
研究概览
简要总结
The goal of this clinical trial is to understand whether the adoption of digital solutions by healthcare professionals and patients improves the management of patients with high blood pressure.
The main questions it aims to answer are:
- are these digital solutions feasible and well accepted by patients?
- can these solutions, compared to standard care, allow a better hypertension control in patients with high blood pressure?
Participants randomised to one of the two intervention arms will be asked to adopt the digital solutions that include a smartphone app and 2 devices for blood pressure and body weight measurement that will be connected to the app.
Researchers will compare patients randomised in the two intervention groups with patients randomised to standard care (control group)
详细描述
The study falls within the scope of the HSMonitor project, a pre-commercial tender for the development of telematics solutions aimed at optimising patient health status and disease management. Specifically, the aim of this study is to test whether the adoption of HSMonitor solutions by healthcare professionals and patients improves the management of patients with high blood pressure.
This will be a randomised controlled trial where patients with hypertension will be randomised either to one of the two digital solutions or to standard care.
The present pilot study is planned to be carried out within the framework of the EU project HSMonitor - Pre-commercial Procurement of innovative ICT-enabled monitoring to improve health status and optimize hypertension care (Grant Agreement Nr. 856698).
The two solutions are referred to as:
- Solution 1 - HSmartBPM (developed by a supplier consortium led by GNOMON)
- Solution 2 - HyperHealth (developed by a supplier consortium led by TECH4CARE)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with essential hypertension (>140/90 mmHg or normal BP with antihypertensive treatment)
- •Basic ICT knowledge and ability to access the internet at home and on mobile devices
- •ability to provide written informed consent, giving informed consent.
- •written informed consent
排除标准
- •inability to consent
- •chronic renal replacement therapy (haemodialysis, peritoneal dialysis or transplantation) or if, at baseline, there is a history of active malignancy within the last five years
- •pregnancy
- •illiterate
- •younger than 18 years
- •being a prisoner
- •being institutionalized
- •the patient is mentally or psychiatrically ill
- •the patient has barriers to understand the implications of participation to the study
- •the patient is critically ill or dying
- •the patient is extremely poor
- •the patient has a learning disability
- •the patient is sedated or unconscious
- •the patient is a refugee with no permanent permission to stay
- •the patient does not have a good command of the language
- •the patient has problems in cognitive, juridical, and deferential dimensions
结局指标
主要结局
Changes in blood pressure
时间窗: 2 and 6 months
The changes in systolic and diastolic blood pressure
次要结局
- The user satisfaction measured with VAS(2 and 6 months)