跳至主要内容
临床试验/NCT03972787
NCT03972787已完成不适用

Effects of a Proactive Social Robot for Older Adults in Reducing Loneliness and Social Isolation

Baycrest4 个研究点 分布在 2 个国家目标入组 54 人开始时间: 2019年3月5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
54
试验地点
4
主要终点
University of California, Los Angeles Loneliness (UCLA) V3 Scale - Change is Being Assessed

研究概览

简要总结

This project will to evaluate whether a proactive social robot (ElliQ) has an impact on reducing social isolation and loneliness in older adults who are living alone, while also promoting independence and aging in place. To achieve this, the following research questions will be investigated:

  1. How does the use of ElliQ impact the following outcomes in older adults:
  • Loneliness and social isolation;
  • Accessibility to and use of technology;
  • Quality of life, mood, and overall well-being; and
  • Caregiver experience?
  1. Do particular characteristics of the older adult population influence these impacts?

详细描述

Study Design

Users

This study is a stratified, parallel, randomized waitlist control study that will be implemented at Baycrest and the Jewish Senior Living Group (JSLG), in which eligible, consented participants will be randomly allocated to the ElliQ (intervention) group or the waitlist control group following a 1:1 allocation ratio. In light of the potential benefits of ElliQ exposure, the waitlist control group will receive the ElliQ intervention after serving as a comparable contemporary control group for the ElliQ intervention group.

Those in the intervention group will first undergo participant characterization and baseline data collection (time 1; week 0). Shortly after, they will be provided with the ElliQ technology in their homes. They will then trial the device for 8 weeks (weeks 1-8). The 8-week trial will be followed with a post-trial data-collection session (time 2; week 9), where they will be asked to return the ElliQ system. At this time, participants will be asked to complete some of the same measures they completed at time 1, and they will also have the opportunity to take part in a one-time, audio-recorded focus group or interview, where field notes will be taken. Following this, the participants will not have a device from weeks 10-17; on week 18, they will be asked to attend a follow-up session (time 3; week 18), where they will be asked to complete some of the same measures they completed at times 1 and 2.

Those who get assigned to the second (waitlist) condition will attend an initial baseline data-collection session (time 1; week 0), where questionnaires related to participant characteristics and baseline measures will be administered. Participants will then wait for 8 weeks to get the ElliQ device (weeks 1-8). After this 8-week wait, participants will be invited to attend another data-collection session (time 2; week 9), where they will be asked to complete some of the same measures that they completed at time 1. Following this session, participants will trial the device for 8 weeks (weeks 10-17). After the 8-week trial, participants will be asked to attend a post-trial data-collection session (time 3; week 18), where they will return the ElliQ system. Participants will then complete a number of the same measures that were completed at times 1 and 2, and attend a one-time, audio-recorded focus group or interview session, where field notes will be taken.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Older adults aged ≥70 years old and living alone
  • Has minimal exposure to technology on a daily basis
  • Residents of Baycrest or JSLG/UCSF, or community-dwelling older adults who live near Baycrest or JSLG/UCSF
  • Agrees to allow the ElliQ setup team (a member of Baycrest or JSLG/UCSF and Intuition Robotics) to come to their home to install the ElliQ system and to provide training on how to use the system
  • Agrees to have the ElliQ setup team test their existing Wi-Fi in their home or agrees to allow for installation of Wi-Fi in their home for the duration of the study (at no cost to the participant)
  • Is able to speak clearly and be understood, as exemplified by an app such as Siri/Google speech recognition
  • Is able to hear a finger rub with hearing aids in, if applicable
  • Is able to read visual content on a screen

排除标准

  • Is unable to communicate in oral English
  • Is unable to read visual content on a screen
  • Has a history or current diagnosis of major psychiatric conditions, excluding depression
  • Has sensory impairments (e.g., severe auditory or visual impairments) that would impede an individual's ability to interact with the ElliQ system, which features voice-activated technology and the presentation of content on a screen
  • Has a Mini-Mental State Examination (MMSE) score <18
  • Is currently enrolled in another study
  • Inclusion Criteria (Informal Caregivers):
  • Is an informal caregiver (e.g., a family member, friend, etc.) of an ElliQ study participant
  • Lives separately (in a different home) from their study partner (i.e., the ElliQ participant)
  • Has access to an Android Smartphone or iPhone running iOS v. 10 or above through which to access Twilio Messenger
  • Is willing and able to use Twilio Messenger to access the ElliQ messaging function
  • Understands and abides by the terms and conditions of the messaging app (i.e., Twilio messenger) that links to the ElliQ system
  • Is able to speak clearly and in oral English
  • Able to hear audio and see and read content on a screen
  • Exclusion Criteria (Caregivers):
  • Individuals who are not an informal caregiver to an ElliQ study participant
  • Lives in the same home as the ElliQ study participant
  • Does not have access to an Android Smartphone or iPhone running iOS v. 10 or above through which to access Twilio Messenger
  • Is unable or unwilling to use Twilio Messenger to access the ElliQ messaging function
  • Refuses to abide by the terms and conditions of Twilio Messenger
  • Is unable to speak or read in English
  • Is unable to hear audio or see/read content on a screen

结局指标

主要结局

University of California, Los Angeles Loneliness (UCLA) V3 Scale - Change is Being Assessed

时间窗: Time 1 (baseline, week 0), Time 2 (follow-up 1, week 9), Time 3 (follow-up 2, week 18)

The UCLA Loneliness V3 scale is a 20-item scale measuring loneliness and social isolation; it has been validated in older adult populations. For this scale, 11 items are worded negatively to indicate loneliness, while 9 are worded positively (and are reverse scored) to indicate social connectedness. Participants are asked to rate their responses on a 4-point scale, with responses ranging from 1 ("never") to 4 ("often"). The individual items are then tallied and a total score is calculated (range: 20-80). Higher scores indicate higher levels of loneliness. As the primary outcome for this study, the investigators are exploring the impacts of the social robot on participants' self-rated loneliness/social connectedness. This measure is being collected at multiple time points to evaluate whether there is a change observed across loneliness over time.

次要结局

未报告次要终点

研究者

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

Dr. Allison B. Sekuler

Sandra A Rotman Chair in Cognitive Neuroscience; Managing Director and Senior Scientist, Rotman Research Institute; Managing Director, Centre for Aging + Brain Health Innovation; Vice-President Research, Baycrest Health Sciences

Baycrest

研究点 (4)

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