Health Monitoring and sOcial Integration environMEnt for Supporting WidE ExTension of Independent Life at HOME (HOMESWEETHOME)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,010
- 试验地点
- 6
- 主要终点
- Quality of life (QoL)
研究概览
简要总结
The clinical evaluation of the HOMESWEETHOME project sets out to assess the long-term effects of continuous assistance offered by the HOMESWEETHOME services to older people living independently. The trial will test the hypothesis that while providing a level of safety equivalent to or better than that enjoyed in older people"s homes, there is a significant positive effect on the quality of life (QoL) and the duration of independently living of older people.
详细描述
The HOMESWEETHOME clinical trial is conducted as a multi-centre randomised control trial (RCT), across four pilot sites. The trial design, analysis and reporting follow the "Revised CONSORT - Consolidated Standards of Reporting Trials - Statement" and subsequent additions to the CONSORT statement.
HOMESWEETHOME services are expected to result in an outcome that is superior to usual care alone in reducing deterioration of health related quality of life and function associated with age and chronic disease. This effect will be measured by assessing different outcomes.
The clinical evaluation of the HOMESWEETHOME project sets out to assess the long-term effects of continuous assistance offered by the HOMESWEETHOME services to older people living independently. The trial will test the hypothesis that while providing a level of safety equivalent to or better than that enjoyed in older people"s homes, there is a significant positive effect on the quality of life (QoL) and the duration of independently living of older people.
The study is conducted in four sites within the European Union, these sites will have the number of participants randomised into Intervention Group and Control Group, as follows:
- Belgium - City of Antwerp 30 + 30
- Catalonia - Town of Badalona 15 + 15
- Ireland - North Eastern Region 30 + 30
- Italy - Town of Latina 30 + 30 The main inclusion criteria for participants" entry into the trial will be based on frailty. Frailty is a concept associated with adverse outcomes such as higher morbidity, more hospitalisations and falls, and a lower quality of life. Furthermore, frailty predicts - better than age - the evolution to disability and death. Participants must also be 65 years or over, and living at home. The main reasons for excluding participants will be based on their physical or mental (in)ability to take part.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 65 years or over.
- •Living at home or in the community, i.e. not in a nursing home, acute or sub-acute clinical or care setting.
- •Scoring "mildly frail" or "moderately frail" in Edmonton Frail Scale (EFS).
排除标准
- •Not willing to participate (e.g. no signing informed consent form).
- •Living situation not suitable for independent living (also including long planned durations of absence from home).
- •Physically, mentally or otherwise unable to use and / or operate HOMESWEETHOME devices / instruments.
- •Unable to administer self-assessment measurements (e.g. monitoring vital signs; questionnaires).
- •Significant impairment of language comprehension or expression (e.g. aphasia).
- •Active medical illness with a significant shortened life expectancy (< 6 months), based on mortality prognosis
- •Living without access to ISDN or ADSL service.
- •Living with another HOMESWEETHOME participant in the same home.
- •Completely dependent on others for the activities of daily living.
结局指标
主要结局
Quality of life (QoL)
时间窗: measurement will be at trial end (t=30 months)
Health related QoL as measured with Health Status Questionnaire Short Form 36 (SF-36) (v2).
次要结局
- Number of hospitalizations(measurement will be at trial midterm (t=15 months).)
- Nursing home admission(measurement will be at trial end (t=30 months).)
- Frailty(measurement will be at trial end (t=30 months))
- Number of accesses to emergency rooms(measurement will be at trial end (t=30 months))
- Geriatric assessment(measurement will be at trial end (t=30 months))
- Clinical Global Impression(measurement will be at trial end (t=30 months))
- Depression and anxiety(measurement will be at trial end (t=30 months))
- Mortality(continous monitoring during trial duration = 30 months.)
- Number of hospitalisations(measurement will be at trial end (t=30 months))