NCT03972787

Brief Summary

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:

  • Loneliness and social isolation;
  • Accessibility to and use of technology;
  • Quality of life, mood, and overall well-being; and
  • Caregiver experience?
  • Do particular characteristics of the older adult population influence these impacts?

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

May 24, 2019

Last Update Submit

February 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

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

    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.

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

Other Outcomes (10)

  • Computer Proficiency Questionnaire

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

  • ElliQ Companionship Questionnaire

    Time 2 (follow-up 1, week 9), Time 3 (follow-up 2, week 18)

  • Caregiver Status

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

  • +7 more other outcomes

Study Arms (2)

Proactive Social Robot (Intervention)

EXPERIMENTAL

Participants will have the opportunity to use ElliQ for a total of 8 weeks to determine the impacts of the system on participants' loneliness, mood, technology use, and quality of life.

Device: Proactive social robot

Waitlist Control

NO INTERVENTION

Participants will not receive any intervention for a total of 8 weeks to determine whether any impacts noted for participants' loneliness, mood, technology use, and quality of life are unique to ElliQ or are influenced by other factors.

Interventions

ElliQ, is a new type of robotic technology aimed at reducing loneliness and social isolation in older adults. It differs from other social/companion robots on the market, as it leverages artificial intelligence to create personalized and interactive experiences for the user, while also proactively offering prompts (such as reminding the user to stay hydrated) and suggesting and initiating various activities for the user (such as offering to play a game). This social companion adapts to the personalities and interests of the older adult, creating a personalized experience and recommending content the user may enjoy such as news, music, TED talks, and cognitive games.

Also known as: ElliQ
Proactive Social Robot (Intervention)

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • Individuals who are not an informal caregiver to an ElliQ study participant
  • Lives in the same home as the ElliQ study participant
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jewish Senior Living Group

San Francisco, California, 94112, United States

Location

Baycrest

Toronto, Ontario, M6A 2E1, Canada

Location

Related Publications (17)

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    PMID: 24783377BACKGROUND
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    PMID: 18410815BACKGROUND
  • Smith JM. Toward a better understanding of loneliness in community-dwelling older adults. J Psychol. 2012 May-Jun;146(3):293-311. doi: 10.1080/00223980.2011.602132.

    PMID: 22574422BACKGROUND
  • Mayer JD, Gaschke YN. The experience and meta-experience of mood. J Pers Soc Psychol. 1988 Jul;55(1):102-11. doi: 10.1037//0022-3514.55.1.102.

    PMID: 3418484BACKGROUND
  • Machado L, Thompson LM, Brett CHR. Visual analogue mood scale scores in healthy young versus older adults. Int Psychogeriatr. 2019 Mar;31(3):417-424. doi: 10.1017/S1041610218000996. Epub 2018 Jul 11.

    PMID: 29991360BACKGROUND
  • Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.

    PMID: 18752852BACKGROUND
  • Bowling A, Stenner P. Which measure of quality of life performs best in older age? A comparison of the OPQOL, CASP-19 and WHOQOL-OLD. J Epidemiol Community Health. 2011 Mar;65(3):273-80. doi: 10.1136/jech.2009.087668. Epub 2010 Aug 18.

    PMID: 20719807BACKGROUND
  • Bichescu-Burian D, Cerisier C, Czekaj A, Grempler J, Hund S, Jaeger S, Schmid P, Weithmann G, Steinert T. [Patients with ICD-10 disorders F3 and F4 in psychiatric and psychosomatic in-patient units - who is treated where? : Allocation features from the PfAD study]. Nervenarzt. 2017 Jan;88(1):61-69. doi: 10.1007/s00115-015-0058-9. German.

    PMID: 26842897BACKGROUND
  • Russell DW. UCLA Loneliness Scale (Version 3): reliability, validity, and factor structure. J Pers Assess. 1996 Feb;66(1):20-40. doi: 10.1207/s15327752jpa6601_2.

    PMID: 8576833BACKGROUND
  • Boot WR, Charness N, Czaja SJ, Sharit J, Rogers WA, Fisk AD, Mitzner T, Lee CC, Nair S. Computer proficiency questionnaire: assessing low and high computer proficient seniors. Gerontologist. 2015 Jun;55(3):404-11. doi: 10.1093/geront/gnt117. Epub 2013 Oct 9.

    PMID: 24107443BACKGROUND
  • Kopecek M, Bezdicek O, Sulc Z, Lukavsky J, Stepankova H. Montreal Cognitive Assessment and Mini-Mental State Examination reliable change indices in healthy older adults. Int J Geriatr Psychiatry. 2017 Aug;32(8):868-875. doi: 10.1002/gps.4539. Epub 2016 Jun 29.

    PMID: 27352935BACKGROUND
  • Koskas P, Henry-Feugeas MC, Feugeas JP, Poissonnet A, Pons-Peyneau C, Wolmark Y, Drunat O. The Lawton Instrumental Activities Daily Living/Activities Daily Living Scales: A Sensitive Test to Alzheimer Disease in Community-Dwelling Elderly People? J Geriatr Psychiatry Neurol. 2014 Jun;27(2):85-93. doi: 10.1177/0891988714522694. Epub 2014 Feb 26.

    PMID: 24578460BACKGROUND
  • Jakobsson U, Westergren A, Lindskov S, Hagell P. Construct validity of the SF-12 in three different samples. J Eval Clin Pract. 2012 Jun;18(3):560-6. doi: 10.1111/j.1365-2753.2010.01623.x. Epub 2011 Jan 6.

    PMID: 21210901BACKGROUND
  • Poscia A, Stojanovic J, La Milia DI, Duplaga M, Grysztar M, Moscato U, Onder G, Collamati A, Ricciardi W, Magnavita N. Interventions targeting loneliness and social isolation among the older people: An update systematic review. Exp Gerontol. 2018 Feb;102:133-144. doi: 10.1016/j.exger.2017.11.017. Epub 2017 Dec 2.

    PMID: 29199121BACKGROUND
  • Jones RB, Ashurst EJ, Atkey J, Duffy B. Older people going online: its value and before-after evaluation of volunteer support. J Med Internet Res. 2015 May 18;17(5):e122. doi: 10.2196/jmir.3943.

    PMID: 25986724BACKGROUND
  • Robinson H, Macdonald B, Kerse N, Broadbent E. The psychosocial effects of a companion robot: a randomized controlled trial. J Am Med Dir Assoc. 2013 Sep;14(9):661-7. doi: 10.1016/j.jamda.2013.02.007. Epub 2013 Mar 30.

    PMID: 23545466BACKGROUND
  • Boss L, Kang DH, Branson S. Loneliness and cognitive function in the older adult: a systematic review. Int Psychogeriatr. 2015 Apr;27(4):541-53. doi: 10.1017/S1041610214002749. Epub 2015 Jan 2.

    PMID: 25554219BACKGROUND

Related Links

Study Officials

  • Allison B Sekuler, PhD

    Baycrest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This study is a stratified, parallel, randomized waitlist control study that will be implemented at Baycrest and JSLG/UCSF, 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
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

Study Record Dates

First Submitted

May 24, 2019

First Posted

June 4, 2019

Study Start

March 5, 2019

Primary Completion

January 31, 2020

Study Completion

July 31, 2020

Last Updated

February 5, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations