Do Cardiac Health: Advanced New Generation Ecosystem
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- Lifestyle
研究概览
简要总结
The primary objective of Do CHANGE is to develop a health ecosystem for integrated disease management of citizens with high blood pressure and patients with ischemic heart disease or heart failure. The system will give them access to a set of personalized health services in a near real-time fashion. This disruptive system will incorporate the behaviour change methods, such as "Do Something Different", in conjunction with new innovative wearable/portable tools that can monitor behaviour and clinical parameters in normal living situations.
详细描述
Patients enrolled for participation will be randomly assigned to the intervention or 'care as usual' group (1:1). Patients assigned to the intervention group will receive a 3 month intervention aiming to enhance self-management and lifestyle.
The intervention will consist out 4 components.
- Behavioral prompts (Do's) from the Do Something Different Programme The Do Something Different Program has previously been developed and evaluated (ref). For the current study, the programme has been adapted to the population of interest (CAD, HF, and HT patients) together with behavioural experts and cardiologists. The program aims to change behavioural habits and increase flexibility and subsequently change habits associated with an unhealthy lifestyle and distress, which are both found to be associated with hypertension and cardiovascular risks. The program has been developed with input from cardiologists , psychologists, and patients. 'Typical' other behavioural risks besides hypertension have been identified and are addressed within the program. To further adapt the program to patient' needs, all patient, prior to starting the program, will be assessed regarding their own functioning, distress, and personality such that the Do's will match their personal habits and challenge them to change.
After assessing patients personality profile the intervention will be provided for 11 weeks. Patients will receive a total of 32 Do's / messages during this period. The Do's will be matched to their personal profile. 2. Care-Portal All patients who are randomized to the intervention group will also receive a Care-Portal (Docobo Ltd.) which will be installed at their home. The Care-Portal will be used to gather ECG data and blood pressure on a daily basis. The Care-Portal will send the physiological data directly to the cardiologist who will be able to access those via an online platform and contact the patient if necessary.
In addition, patients will receive their Do's trough the care-portal. The Care-Portal is a CE-marked device that has previously been successfully used and implemented to support patients with chronic conditions. 3. Blood pressure monitor All patients in the intervention group will receive the digital blood pressure monitor 'UA -767 Plus' which is a CE-marked device for clinical use. Patients will be asked to measure their blood pressure on a daily basis and record the values through the care-portal. 4. Moves App For the future study within the Do CHANGE project, the Do Something Different programme wants to focus on providing 'Contextual Do's' where patients will receive behavioural prompts at the moment that the behaviour takes place. In order to reach this goal getting more insight in patients behavioral patters is of utmost importance. Hence, that data will be gathered within this current study as one of the exploratory objectives using GPS data. This will give more insights and will be used as input for future study. All patients participating in the intervention will be provided with the 'Moves' app that will log their activities anonymously. This information will automatically be available for research purposes only. Patients will not receive any push messages from that app or any feedback.
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)
- •Patients should have sufficient knowledge of the countries' native language.
- •Additional inclusion criteria for HF patients only is to have a left ejection fraction of ≤35% 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)
- •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
干预措施: Do CHANGE (Behavioral)
Care as usual
结局指标
主要结局
Lifestyle
时间窗: 0-6 months
The Health Promoting Lifestyle Questionnaire (HPLP-II) will be administered to evaluate whether patients' subjective perception of lifestyle change has changed.
Behavioural flexibility
时间窗: 6 months
Whether the patients' behavioural flexibility (having a bigger behavioural repertoire which makes it easier to perform alternative behaviours) has increased and thus whether behaviour change (as conceptualized by Do Something Different program) has occurred will be assessed using purpose designed questions by the Do Something Different program.
Quality of life
时间窗: 6 months
Changes in quality of life will be assessed using the WHOQOL-Bref questionnaire. As this is a widely used instrument it will allow the integration of data from different partners.
次要结局
- Usability, acceptance, satisfaction with intervention / tools(3 months)
- Cost-effectiveness(6 months)
研究者
Jos Widdershoven
Prof. Dr.
Elisabeth-TweeSteden Ziekenhuis