LonelinessNCT03972787
Effects of a Proactive Social Robot for Older Adults in Reducing Loneliness and Social Isolation
A study testing Proactive social robot in people with Loneliness and Mood, run by Baycrest at 2 sites in 2 countries.
Trial 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: 1. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness, Mood, Quality of Life
- What is being tested?
- Proactive social robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 5 Mar 2019to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Show all 15Show fewer
- Is able to hear a finger rub with hearing aids in, if applicable
- Is able to read visual content on a screen
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Jewish Senior Living Group
San Francisco, California, 94112
About this study
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:
- 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?
- Do particular characteristics of the older adult population influence these impacts?
Read the detailed description
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.
Upon completion of the study tasks (i.e., at the final data-collection session at week 18), each participant's study participation will conclude.
Informal Caregivers
Informal caregivers (e.g., family, friends who provide care for the ElliQ user) may also be enrolled in the study to investigate their experiences with the messaging function of the ElliQ system (user and caregiver pairs will be referred to as "dyads" going forward). Of note, users who do not have caregivers can still enroll in the study.
This will be an exploratory study, insofar as eligible and consented informal caregivers will complete a baseline data collection session for participant characterization; they will also have the opportunity to test the ElliQ messaging function for the 2 months while their study partner (i.e., the ElliQ user) tests the ElliQ system. Informal caregivers will have the opportunity to discuss their ElliQ experience, caregiving experience, and their perception of the impacts the ElliQ system and messaging function had on their study partner's social engagement, loneliness, access to technology, and use of different communication methods (e.g., online, in-person, over the phone, etc.). An audio-recorded focus group or interview (where field notes will be taken) will be held with informal caregivers at the end of the ElliQ users' 2-month test/use period (i.e., on or around week 9 for caregivers of users in the intervention group, or on or around week 18 for caregivers of users in the waitlist control group).
The teams at Baycrest and JSLG will follow a similar protocol (for both users and informal caregivers) and will submit applications for ethics approval through the Baycrest Research Ethics Board and University of California, San Francisco (UCSF) Institutional Review Board and the JSLG Research Committee.
Recruitment
Users
For this study, the teams at Baycrest will be recruiting up to 50 participants and JSLG will be recruiting up to 50 participants (i.e., users) at each site, with the aim of recruiting a total of 100 participants. Participants will include residents at Baycrest or JSLG/UCSF, as well as community-dwelling older adults who live within the vicinity of Baycrest or JSLG/UCSF. Recruitment will occur on an ongoing basis at both Baycrest and JSLG.
Recruitment venues
- San Francisco, JSLG in Partnership with UCSF (n=50)
- Baycrest (n=50)
Participant consent will adopt the tenets of the Partnership of Consent Protocol, whereby the prospective participant (or their substitute decision maker, if applicable) will review the consent form with research staff. Consent will be obtained from the prospective participant (or their SDM), if they are able to provide it and can answer the teach-back questions.
Informal Caregivers
Study participants (users) will be asked by the research staff if they have an informal caregiver (e.g., a family member or friend who provides care for them) who might be interested in taking part in the study as well. Those participants who indicate that they do have an informal caregiver who might be interested will be provided with the research staff's contact information to share with their informal caregiver. Interested caregivers who contact the research staff will be provided with more information about the study either over the phone, in person, or over email. Users who do not have informal caregivers can still take part in the study and will not have access to the messaging function.
- Conditions
- Loneliness, Mood, Quality of Life
- Being tested
- Proactive social robot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive social robotDevice
Also called ElliQ
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time 1 (baseline, week 0), Time 2 (follow-up 1, week 9), Time 3 (follow-up 2, week 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start5 Mar 2019
- Primary completion31 Jan 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baycrest
- Sponsor type
- University, hospital or other
- Collaborators
- Jewish Senior Living Group, Intuition Robotics
- Responsible party
- Principal investigator, Dr. Allison B. Sekuler, Baycrest
- Investigators
- Allison B Sekuler, PhD, Principal investigator, Baycrest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972787
- Sponsor's protocol ID
- REB #18-54
- Status last verified
- Feb 2021
- First submitted
- 24 May 2019
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Batchelor-Aselage M, Amella E, Zapka J, Mueller M, Beck C. Research with dementia patients in the nursing home setting: a protocol for informed consent and assent. IRB. 2014 Mar-Apr;36(2):14-20. No abstract available.
PubMed 24783377Hastings SN, George LK, Fillenbaum GG, Park RS, Burchett BM, Schmader KE. Does lack of social support lead to more ED visits for older adults? Am J Emerg Med. 2008 May;26(4):454-61. doi: 10.1016/j.ajem.2007.07.005.
PubMed 18410815Smith 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.
PubMed 22574422Mayer 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.
PubMed 3418484Machado 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.
PubMed 29991360Kroenke 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.
PubMed 18752852Bowling 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.
PubMed 20719807Bichescu-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.
PubMed 26842897Russell 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.
PubMed 8576833Boot 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.
PubMed 24107443Kopecek 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.
PubMed 27352935Koskas 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.
PubMed 24578460Jakobsson 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.
PubMed 21210901Poscia 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.
PubMed 29199121Jones 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.
PubMed 25986724
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Proactive Social Robot for Older Adults in Reducing Loneliness and Social Isolation
- ClinicalTrials.gov ID
- NCT03972787
- Acronym / sponsor ID
- REB #18-54
- Conditions
- Loneliness, Mood, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- BaycrestUniversity, hospital or other
- Collaborators
- Jewish Senior Living Group, Intuition Robotics
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- Do particular characteristics of the older adult population influence these impacts?
Detailed description
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.
Upon completion of the study tasks (i.e., at the final data-collection session at week 18), each participant's study participation will conclude.
Informal Caregivers
Informal caregivers (e.g., family, friends who provide care for the ElliQ user) may also be enrolled in the study to investigate their experiences with the messaging function of the ElliQ system (user and caregiver pairs will be referred to as "dyads" going forward). Of note, users who do not have caregivers can still enroll in the study.
This will be an exploratory study, insofar as eligible and consented informal caregivers will complete a baseline data collection session for participant characterization; they will also have the opportunity to test the ElliQ messaging function for the 2 months while their study partner (i.e., the ElliQ user) tests the ElliQ system. Informal caregivers will have the opportunity to discuss their ElliQ experience, caregiving experience, and their perception of the impacts the ElliQ system and messaging function had on their study partner's social engagement, loneliness, access to technology, and use of different communication methods (e.g., online, in-person, over the phone, etc.). An audio-recorded focus group or interview (where field notes will be taken) will be held with informal caregivers at the end of the ElliQ users' 2-month test/use period (i.e., on or around week 9 for caregivers of users in the intervention group, or on or around week 18 for caregivers of users in the waitlist control group).
The teams at Baycrest and JSLG will follow a similar protocol (for both users and informal caregivers) and will submit applications for ethics approval through the Baycrest Research Ethics Board and University of California, San Francisco (UCSF) Institutional Review Board and the JSLG Research Committee.
Recruitment
Users
For this study, the teams at Baycrest will be recruiting up to 50 participants and JSLG will be recruiting up to 50 participants (i.e., users) at each site, with the aim of recruiting a total of 100 participants. Participants will include residents at Baycrest or JSLG/UCSF, as well as community-dwelling older adults who live within the vicinity of Baycrest or JSLG/UCSF. Recruitment will occur on an ongoing basis at both Baycrest and JSLG.
Recruitment venues
- San Francisco, JSLG in Partnership with UCSF (n=50)
- Baycrest (n=50)
Participant consent will adopt the tenets of the Partnership of Consent Protocol, whereby the prospective participant (or their substitute decision maker, if applicable) will review the consent form with research staff. Consent will be obtained from the prospective participant (or their SDM), if they are able to provide it and can answer the teach-back questions.
Informal Caregivers
Study participants (users) will be asked by the research staff if they have an informal caregiver (e.g., a family member or friend who provides care for them) who might be interested in taking part in the study as well. Those participants who indicate that they do have an informal caregiver who might be interested will be provided with the research staff's contact information to share with their informal caregiver. Interested caregivers who contact the research staff will be provided with more information about the study either over the phone, in person, or over email. Users who do not have informal caregivers can still take part in the study and will not have access to the messaging function.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Proactive Social Robot (Intervention) | Experimental | Device: Proactive social robotParticipants 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. |
| 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proactive social robotAlso: ElliQElliQ, 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. | Device | Proactive Social Robot (Intervention) |
Primary outcome
University of California, Los Angeles Loneliness (UCLA) V3 Scale - Change is Being Assessed
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Background: PubMed 24783377Batchelor-Aselage M, Amella E, Zapka J, Mueller M, Beck C. Research with dementia patients in the nursing home setting: a protocol for informed consent and assent. IRB. 2014 Mar-Apr;36(2):14-20. No abstract available.
- Background: PubMed 18410815Hastings SN, George LK, Fillenbaum GG, Park RS, Burchett BM, Schmader KE. Does lack of social support lead to more ED visits for older adults? Am J Emerg Med. 2008 May;26(4):454-61. doi: 10.1016/j.ajem.2007.07.005.
- Background: PubMed 22574422Smith 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.
- Background: PubMed 3418484Mayer 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.
- Background: PubMed 29991360Machado 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.
- Background: PubMed 18752852Kroenke 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.
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- Statistics Canada. Canada Year Book. 2011.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison B Sekuler, PhD principal investigator
Baycrest
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proactive social robot in people with Loneliness and Mood, run by Baycrest at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
University of California, Los Angeles Loneliness (UCLA) V3 Scale - Change is Being Assessed (time frame: Time 1 (baseline, week 0), Time 2 (follow-up 1, week 9), Time 3 (follow-up 2, week 18)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03972787, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.