Do Cardiac Health: Advanced New Generation Ecosystem - Phase 2
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Lifestyle
研究概览
简要总结
The Do CHANGE service is designed for cardiac patients who could benefit from lifestyle change and a better disease management. The study aims to support patients with behavior change by providing them with devices and behavioral intervention in order to facilitate long-term behavior change.
详细描述
The focus of the Do CHANGE project is on empowering individuals with high blood pressure, ischemic heart disease or heart failure with tools and services to optimally monitor and manage their real-time health condition and disease. The innovative approach of the Do CHANGE project also involves the patients' surrounding health ecosystem in the process. The traditional difficulties of therapy adherence in a physician-centred care system are radically abandoned and replaced by a patient-centred approach. The approach advocated by Do CHANGE project focuses on the needs of the patient by not only providing them with innovative tools that assess the patient's real-time health condition, but also offer a variety of behavioural alternatives. The main hypothesis of the Do CHANGE project is that patients' disease self-management and lifestyle will improve as compared to self-management of patients who receive the care as usual.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-75 years
- •diagnosed with CAD, HF or HT
- •having at least two of the following risk factors: smoking, positive family history, increased cholesterol, diabetes, sedentary lifestyle, psychosocial risk factors.
- •Patients should also have access to the Internet and have a smartphone (and sufficient knowledge on using personal computer or smartphone)
- •sufficient knowledge of the countries' native language.
- •Additional inclusion criteria for HF patients only is to have a previous diagnosis of systolic or diastolic heart failure and experience HF symptoms (e.g. shortness of breath, chest pain, exhaustion).
排除标准
- •significant cognitive impairments (e.g. dementia)
- •patients who are on the waiting list for heart transplantation
- •life expectancy <1 year
- •life threatening comorbidities (e.g. cancers),
- •a history of psychiatric illness other than anxiety/depression
- •patients who do not have access to internet
- •patients with insufficient knowledge of the local pilot language (Dutch, Chinese and Catalonian).
研究组 & 干预措施
Intervention
Besides the behavior change programme (Do Something Different)
- All patients will receive: Fitbit, Beddit, Care-portal, Do CHANGE app (including dietary habits picture taking), CookiT (smart spatula that monitors cooking behavior)
- patients with heart failure will, in addition to the above mentioned, be offered a weight scale, blood pressure monitor, and FluiT (smart cup to measure fluid intake).
- Patients with hypertension will also be offered a bloodpressure monitor.
Data from these devices will be gathered and visible for patients (in patient portal) and for their health care provider (health care provider portal). In case of negative results the patient will be contacted by their health care provider (usually the cardiologist).
Once every week the patients will be contacted to discuss their progress and will be given feedback about their dietary intake.
干预措施: Do CHANGE (Behavioral)
Care as usual
Patients in this arm will receive care as usual with no restrictions.
结局指标
主要结局
Lifestyle
时间窗: 3 months
Lifestyle change will be measured with the HPLP-II questionnaire which assesses multiple domains of lifestyle. This will make it possible to compare the two groups.
Behavioral flexibility
时间窗: 3 months
With the Do Something Different purpose designed questionnaire changes in behavioral flexibility will be measured. This programme has previously shown to be effective in changing lifestyle behaviors among physically healthy subjects.
Quality of Life (QoL)
时间窗: 3 months
Quality of life will be assessed with the WHOQoL-Bref which is a validated questionnaire and taps into different domains of quality of life.
次要结局
- Satisfaction, usability, and acceptance of the intervention(6 months)
- Health care utilization(6 months)
- Cost effectiveness(6 months)
研究者
Jos Widdershoven
Prof. Dr.
Elisabeth-TweeSteden Ziekenhuis