An Integrated Care Platform Based on the Monitoring of Older Individual Intrinsic Capacity for Inclusive Health (CAREUP)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Change in acceptability of the CAREUP platform
研究概览
简要总结
The objective of this study is to assess the usability and acceptance of the CAREUP solution in improving the quality of life at home of the older adults. The CAREUP solution is a platform that collects data from different tools such as tablets, smartwatches, ambient sensors, iHealth weight scale, and Digital Hand Dynamometer.
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详细描述
The objective of this study is to assess the usability and acceptance of the CAREUP solution at home in primary (older adults), secondary (informal caregivers) and tertiary (doctors and geriatrics) end users. The CAREUP solution is a platform that collects data from different tools such as tablets, smartwatches, ambient sensors, iHealth weight scale, and Digital Hand Dynamometer. The study will comprehends two phases: a pre-pilot and pilot phases.The pre-pilot phase will test new user interfaces and games with 5 older adult (primary users) and 5 informal caregiver (secondary) in each site (Italy, Romania, Austria) for at least 1 week. This phase will only focus on primary endpoints (usability and acceptance). The pilot phase will investigate platform usability, acceptance and efficiency of developed Intrinsic Capacity (IC) evaluation algorithms, reliability and security. At least 30 primary and 15 secondary and some tertiary users (doctors and geriatrics) will be enrolled in each country (Italy, Romania, Austria) for 12 months. This phase will focus on both primary and secondary endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •Live independently in their home in rural or urban areas;
- •In good physical and cognitive status;
- •Able to stand and walk unaided;
- •Availability to sign the Informed Consent;
- •Ability to use smartphones/tablets independently.
排除标准
- •Use of active implant or not-implant medical devices;
- •Allergy to nickel components;
- •Lack of written informed consent;
- •Acute or untreated medical problems such as history of syncopal episodes, epilepsy and vertigo not controlled pharmacologically; serious dysfunction of the autonomic system; severe behavioural syndromes not compensated by drugs; concurrent neurological diseases; severe systemic diseases with life expectancy < 1 year;
- •A myocardial infarction or stroke within 6 months;
- •Painful arthritis, spinal stenosis, amputation, painful foot lesions or neuropathy limiting balance and mobility;
- •Uncontrolled hypertension;
- •Pacemaker or implantable cardioverter defibrillator;
- •Diagnosis of mild and or/advanced Parkinson's disease or other neuromuscular disorder;
- •Diagnosis of mild and/or advance cognitive impairments
- •Metastatic cancer or immunosuppressive therapy;
- •Significant visual or hearing impairment
研究组 & 干预措施
older adults
Elderly adults who live independently in their own home in rural or urban areas.
干预措施: CAREUP platform (Device)
结局指标
主要结局
Change in acceptability of the CAREUP platform
时间窗: baseline and 12 months later
Acceptability will be assess by an ad hoc structured questionnaire of 10 questions to collect data about like and dislike of the Careup platform.
Change in usability of the CAREUP platform
时间窗: baseline and 12 months later
The System Usability Scale (SUS) is a reliable tool for measuring usability. It consists of a10 item questionnaire with five response options for respondents from 'Strongly agree' to 'Strongly disagree'.
次要结局
- Change in Mood(baseline, 6 and 12 months later)
- Change in Quality of Life(baseline, 6 and 12 months later)
- Change in Physical Performance(baseline, 6 and 12 months later)