SMART LIVING HOMES - WHOLE INTERVENTIONS DEMONSTRATOR FOR PEOPLE AT HEALTH AND SOCIAL RISKS
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Health Related Quality of Life (cancer patients only)
研究概览
简要总结
The main objective of the Project is to create a GATEKEEPER, that connects healthcare providers, businesses, entrepreneurs, elderly citizens and the communities they live in, in order to originate an open, trust-based arena for matching ideas, technologies, user needs and processes, aimed at ensuring healthier independent lives for the ageing populations. By 2022, GATEKEEPER will be embodied in an open source, European, standard-based, interoperable and secure framework available to all developers, for creating combined digital solutions for personalised early detection and interventions that (i) harness the next generation of healthcare and wellness innovations; (ii) cover the whole care continuum for elderly citizens, including primary, secondary and tertiary prevention, chronic diseases and co-morbidities; (iii) straightforwardly fit "by design" with European regulations, on data protection, consumer protection and patient protection (iv) are subjected to trustable certification processes; (iv) support value generation through the deployment of advanced business models based on the VBHC paradigm.
GATEKEEPER will demonstrate its value by scaling up, during a 42-month work plan, towards the deployment of solutions that will involve ca 40.000 elderly citizens, supply and demand side (authorities, institutions, companies, associations, academies) in 8 regional communities, from 7 EU member states. Recently 3 Asian pilots have been added as a result of the Open Calls.
The achievement of the overall objective is supported by the following, among others, specific objective: To execute a series of PILOTS to demonstrate the effect, benefit, value and scalability of the GATEKEEPER solutions around REFERENCE USE CASES COVERING PRIMARY, SECONDARY and TERTIARY PREVENTION, initially deployed in 8 regions of 7 European countries.
The Cyprus pilot mainly focuses on the early detection of the condition worsening of cancer and dementia patients by monitoring whether the use of technology can trigger appropriate management, thereby reducing the need for higher acuity care, and even, at times, improving survival by supporting demand-driven solutions through high-quality health mobile systems.
详细描述
Primary Outcome The Primary Objective of the proposed pilot will be the improved Health-Related Quality of Life (HRQoL) for patients participating in the full intervention and limited intervention groups compared to patients in the control group.
It is hypothesized that the improvement will he higher for the full intervention group patients compared to the limited intervention group patients.
Secondary Objectives
The secondary outcomes are measured as follows:
- Secondary Objective for patients: includes improved parameters of patients participating in the full and limited intervention groups associated with the improvement in disease self-management; symptom burden; motivation; mobility; sleep hygiene; depression and anxiety.
- Secondary Objective for caregivers: includes improved parameters of caregivers participating in the full and limited intervention groups associated with caregiver burden; depression and anxiety.
- Secondary Objective for healthcare professionals: includes improved parameters of healthcare professionals before and after introducing technology associated with anxiety and technology acceptance.
- Secondary Objective for technology evaluation: includes the feasibility, usability and acceptability of the technology used by patients, caregivers and healthcare professionals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The patients, research assistants, nurses, social workers, physiotherapists and psychologists responsible for data collection will not have access to the information of which group (control or intervention) the participant is.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Health Related Quality of Life (cancer patients only)
时间窗: Baseline and follow up at 6 weeks
EORTC QLQ C-30 is a cancer health-related quality-of-life questionnaire that has been widely validated and used in clinical trials and investigations using PROs for individual patient management. It is composed of both multi-item scales and single-item measures. The QLQ-C30 will be administered at admission and at 6 weeks. It is hypothesized that the improvement will he higher for the full intervention group patients compared to the limited intervention group patients.
Health status (dementia patients only)
时间窗: Baseline and follow up at 6 weeks
EQ-5D is a standardised measure of health status to provide a simple, generic measure of health for clinical and economical appraisal. The EQ-5D provides a simple descriptive profile and a single summary index value for health status. The EQ-5D will be administered at admission and at 6 weeks.
次要结局
- System Usability(Follow up at 6 weeks)
- Symptom burden (cancer patients only)(Baseline and follow up at 6 weeks)
- Cognitive decline (dementia patients only)(Baseline and follow up at 6 weeks)
- Depression (dementia patients only)(Baseline and follow up at 6 weeks)
- Technology acceptance (healthcare professionals only)(Baseline and follow up at 6 weeks)
- Anxiety (cancer patients only)(Baseline and follow up at 6 weeks)
- Anxiety (dementia patients only)(Baseline and follow up at 6 weeks)
- Depression (cancer patients only)(Baseline and follow up at 6 weeks)
- System Feasibility(Follow up at 6 weeks)
- Depression (caregivers only)(Baseline and follow up at 6 weeks)
- Anxiety (caregivers only)(Baseline and follow up at 6 weeks)
- Cognitive function (dementia patients only)(Baseline and follow up at 6 weeks)
- Caregiver burden (caregivers only)(Baseline and follow up at 6 weeks)
研究者
Angelos Kassianos
Lecturer
Cyprus University of Technology