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临床试验/NCT03360019
NCT03360019已完成不适用

Accurate WiFi-Based Localization of Dementia Patients For Caregiver Support: Phase II

University of Florida4 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2021年1月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
4
主要终点
Caregiver Activity Survey

研究概览

简要总结

In this Phase II SBIR project we will enhance a wireless WiFi-based insole that was designed and successfully tested during a Phase I trial with elderly persons with dementia and their caregivers, and then investigate its efficacy in terms of caregiver activity, burden, and quality of life in Phase II. Evaluation will use semi-structured interviews and participant observation data collected from professional and family caregivers of patients with moderate or mild dementia.

详细描述

The efficacy of the Activlink system offering localization information to improve caregiver will be evaluated in two studies. Study 2a will use the insole system with dementia patients residing in skilled or memory care. Data regarding caregiving activity will be collected from their paid professional care providers. Study 2b will use participant localization data collected on 80 independently dwelling mild dementia patients. In this case data will be collected from their unpaid family caregivers. Both studies will result in evaluating the efficacy of the WiFi-based insole to provide caregivers with augmented patient awareness, helping to improve their immediate quality of life by reducing their direct burden of continuous oversight of their person in care.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
21 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Persons With Dementia Resides in memory care or skilled nursing
  • Moderate dementia (MMSE of 10-18)
  • Ambulatory (without or with cane, walker or wheelchair assist)
  • A legal proxy that can provide consent
  • Persons With Dementia Resides in independent living setting in community.
  • Mild dementia (MMSE of 19-25)
  • Ambulatory (without or with cane, walker or wheelchair assist).
  • Has a legal proxy that can provide consent.
  • Care Partners
  • Speaks English
  • Be 21 years of age or over
  • Has at least three times per week direct contact with person with dementia (PWD)
  • Consents to participate in the study

排除标准

  • Is not fluent in written or spoken English
  • Indicate an unwillingness to use the Activlink
  • History of Major Mental Illness for patient or caregiver

结局指标

主要结局

Caregiver Activity Survey

时间窗: week 2

Validated scale requires caregivers to report on amount of time spent caregiving for a particular patient. It has high test-retest reliability. Caregivers will be asked to complete this instrument once every two weeks. The scale describes the total number of minutes spent daily on six different caregiving activities. Therefore the minimum value for each item is 0 and the maximum is 1,440 for each item. Higher scores on each item mean more time spent caregiving.

次要结局

  • Zarit Caregiver Burden Scale(Up to 6 months)
  • AD Quality of Life Scale(up to 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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