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临床试验/NCT06170528
NCT06170528已完成不适用

ARUA-ALZ - Connecting Audio and Radio Sensing Systems to Improve Care at Home for ADRD

Florida State University2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2022年11月16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
9
试验地点
2
主要终点
Usability of use of the AURA_ALZ system will be determined

研究概览

简要总结

The purpose of this study is to address the unmet care needs and reduce the care burdens for persons with ADRD (Alzheimer's Disease and Alzheimer's Disease Related Dementias) and their caregivers by providing monitoring of daily activities and gestures using audio and radio sensing, providing voice-based reminders intervention.

In phase 1, dyads will participate in two focus groups will take 60 minutes per each. In Phase 2, AURA_ALZ (connecting Audio and Radio Sensing Systems-Alzheimer's Disease) will deployed for two weeks at participants' home. At the end of the two weeks, usability, acceptability of the use of the system will be measured.

详细描述

The purpose of this study is to reduce the care burdens of people with mild cognitive impairment or mild dementia and their caregivers using Fitbit watches and Amazon Echo devices. Couples will be both recruited and provided with consent forms that explain the study.

In the first phase, after the informed consent, selected dyads will participate in two focus groups will take 60 minutes per each. For this, a research staff will schedule a zoom meeting and then will show the short introduction video regarding Alexa and Fitbit, lists of voice interaction with Alexa, and lists of Fitbit conversation. After this, each dyad will participate in one focus groups interview.

In the second phase, a researcher will visit each dyad's home to set up Amazon Echo and Fitbit. The research staff will train participants in use of the Amazon Echo device and Fitbit. A web camera will be set up in the living room. This visit will take about three hours. The camera will run for three hours, and then be removed from the home setting. Two routers, the Amazon echo, Fitbit watch and iPad will remain in the home for two weeks. Signals from two routers will capture activities. Couples will contact the researcher with questions. During the two weeks data on movement, sitting, lying, walking, drinking, eating, falls, washing face, brushing teeth, and location data of the patients as detected by the WIFI router. Daily reminders will be given through the voice assisted ECHO system for routine activities of daily living including time to eat, taking medication, etc. At the end of the two-week study period, measurements will be made on usability, acceptability of the use of the system. Participants will be compensated with another $50.00 gift card for completing this phase of the study.

There are minimal risks in performing the research procedures that consist of a survey, interview, and testing feasibility of the device. However, PI will continuously monitor any harms or discomfort from participants.

Data reporting: Information the investigators learn about participants in this study will be handled in a confidential manner, within the limits of the law. If investigators publish the results of the study in a scientific journal or book, no participants will be identified. The Institutional Review Board and other groups that have the responsibility of monitoring research may want to see study records which identify the participants as a subject in this study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To be included, dyads of persons with ADRD and their family caregivers must meet the following criteria:
  • 1 person must be diagnosed with ADRD from a physician. Caregivers must self-report that their person's dementia diagnosis from a physician and self-report Global Deterioration Scale (GDS) rating for care recipients to determine stage of dementia. Eligible participants must characterize their person's ADRD symptoms as fitting with Stages 3 and 4 (defined as mild cognitive impairment to mild dementia of Alzheimer's type),
  • at least 1 caregiver living in the same household for at least 4 hours per day for at least the past 6 months,
  • both individuals within the dyads be at least 18 years of age,
  • both individuals within the dyads have sufficient vision and speaking capabilities to use a voice-enabled system, and
  • both individuals within the dyads live in a community setting in Tallahassee or assisted living setting inTallahassee.
  • Exclusion Criteria,
  • Person is diagnosed with Moderate and Sever ADRD
  • No caregivers living in the same household
  • Both individuals with less 18 years of age
  • Both individuals within the dyads have language barriers

排除标准

  • 未提供

结局指标

主要结局

Usability of use of the AURA_ALZ system will be determined

时间窗: At two weeks after deployment of system

Usability Scale (rating from 1 to 5 with the higher score is better)adapted for the evaluation of AURA-ALZ will be administered to assess the usability of AURA-ALZ.

Acceptability of use of the AURA_ALZ system will be determined

时间窗: At two weeks after deployment of system

Interviews will be conducted with all study participants to ask about their acceptability of the AURA-ALZ system

Feasibility of use of the AURA_ALZ system will be determined

时间窗: At two weeks after deployment of system

Feasibility will be determined by the retention rates.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jing Wang

FSU Site Principal Investigator

Florida State University

研究点 (2)

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