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临床试验/NCT06307197
NCT06307197Unknown不适用

HAAL: HeAlthy Ageing Eco-system for peopLe With Dementia

Istituto Nazionale di Ricovero e Cura per Anziani1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年10月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
10
试验地点
1
主要终点
Care load of caregivers

研究概览

简要总结

HAAL project aims to test several technological devices in order to improve the quality of life of older people with dementia and their informal and formal caregiver.

详细描述

The HAAL study is a feasibility study. The general objectives of the HAAL project is to be assessed the stress relief at work for formal and informal caregivers, the improvement in the perceived quality of life for informal caregivers and person with dementia, the reduction in case load for the formal caregivers and the increased cost-effectiveness of the HAAL solution in comparison to the available services. The experimentation will be carried out in 3 sites: Italy, The Netherlands and Taiwan. The study consists in a alpha phase (5 older adults with dementia, 5 formal caregivers and 5 formal caregivers) and in a beta phase (10 older adults with dementia, 10 formal caregivers and 10 formal caregivers).

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

入选标准

  • being the caregiver of a person with cognitive impairment or dementia;
  • availability of time to participate;
  • visit the assisted person at least two times at week or live with him/her.

排除标准

  • Lack of written informed consent

研究组 & 干预措施

older adults

Experimental

干预措施: HAAL platform (Device)

结局指标

主要结局

Care load of caregivers

时间窗: baseline, 1, 2, and 3 months later

The burden of the caregiver will be assessed through the ZARIT Burden Interview (ZBI). The ZBI is a caregiver self-report measure, containing 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always).Total score range: 0 to 88. score range 0-21: no to mild burden; score range 21-40: mild to moderate burden; score range 41-60: moderate to severe burden score ≥ 61: severe burden.

次要结局

未报告次要终点

研究者

发起方
Istituto Nazionale di Ricovero e Cura per Anziani
申办方类型
Other
责任方
Sponsor

研究点 (1)

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