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临床试验/NCT05063045
NCT05063045已完成不适用

Development and Preliminary Effects of Smart Cloth Care System for Persons With Dementia

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Time UP and Go

研究概览

简要总结

The purpose of this study is to develop and examine the preliminary effects of a smart cloth care system for facilitating family caregiving for persons with dementia in the home setting. This will be a three-year study, with the first two years to explore the feasibility of such a smart cloth care system and the third year to pilot test its effects. During the third year, a quasi experimental design will be implemented and the outcomes of caregivers and persons with dementia will be followed for 6 months.

详细描述

The purpose of this study is to develop and examine the preliminary effects of a smart cloth care system for facilitating family caregiving for persons with dementia in the home setting. A smart-care model, using smart clothing with a remote monitoring system, was developed to assist home-nursing care. Older persons with dementia are asked to wear a smart vest, which contained a coin-size monitor in a hidden inner pocket. Sensors are installed in bedrooms and living areas to receive signals from the smart clothing. Alarm at door, emergency button and smoke detector are also installed. The signals and emergency information are transmitted to the mobile phones of responsible home care nurses, who have downloaded an app to their phones. After the home care nurse receive a sensor signal, she would then give feedback to family caregivers about the care receiver, including emergency calls, frequent getting up at night, staying in the bathroom for more than 30 minutes, inadequate or abnormal activity level, not moving during the day for more than 2 hours, leaving the house alone, and a sensor being disconnected from the system. Based on information and signals from smart-care sensors, home care nurses will discuss caregiving activities and planning with family caregivers.Participants were asked to wear smart clothing for at least 4 days/week for 6 months. A home care research nurse will visit the home setting to assess it for sensor installation and suggest environmental modifications for potential hazards. A second visit will be made by an engineer with the research nurse to install the sensors. The research nurse visit the participants' homes once a week during the first month and once every month from the second to third month after the sensor installation to conduct in-home interventions and resolve problems using the smart-care system.

During the first two years, this smart cloth care system will be developed. During the third year. The investigators plan to recruit at least 60 participants and randomize them into an intervention group (N=30) that receives the smart cloth care model and a control group (N=30) that receives usual care. Patient and caregiver outcomes will be followed every two months for a period of 6 months after the smart cloth care system has been implemented. Finally Intention-to-treat and hierarchical linear models will be used to analyze the results.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Older persons were included by these criteria:
  • age 60 or older diagnosed with dementia, or received surgery for a hip fracture could walk independently or with assistance living with family members in northern Taiwan.
  • Family caregivers were included by these criteria:
  • 20 years old responsible for providing direct care or supervising care received by the patient.

排除标准

  • Terminal ill Living in institution

结局指标

主要结局

Time UP and Go

时间窗: six months after installation

Time spends while stand from an armed chair, walk for three meters and come back to sit down

Barthel Activity of Daily Living Scale

时间窗: six months after installation

dependency in activities of daily living, 0-100, higher score indicate better activities of daily living.

IADL self-care ability

时间窗: six months after installation

dependency in instrumental activities of daily living

cognitive function

时间窗: six months after installation

Mini-Mental State Examination

Preparedness scale

时间窗: six months after installation

caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness

Medical Outcome Short Form-36

时间窗: six months after installation

Health-related quality of life, from 0-100, higher score representing better health related quality of life

Centre for epidemiological Studies Depression Scale

时间窗: six months after installation

caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms

caregiver balance scale

时间窗: six months after installation

caregiving balance between competing needs, 0-3, higher score indicate more balanced

Caregiver Medical Outcome Short Form-36

时间窗: six months after installation

caregiver health-related quality of life, from 0-100, higher score representing better health related quality of life

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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