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:
Condition or disease | Intervention/treatment | Phase |
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Loneliness Mood Quality of Life | Device: Proactive social robot | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 54 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention 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) |
Primary Purpose: | Other |
Official Title: | Effects of a Proactive Social Robot for Older Adults in Reducing Loneliness and Social Isolation |
Actual Study Start Date : | March 5, 2019 |
Actual Primary Completion Date : | January 31, 2020 |
Actual Study Completion Date : | July 31, 2020 |
Arm | Intervention/treatment |
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Experimental: Proactive Social Robot (Intervention)
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.
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Device: Proactive social robot
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.
Other Name: ElliQ
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No Intervention: Waitlist Control
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.
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Ages Eligible for Study: | 70 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria (Users):
Exclusion Criteria (Users):
Inclusion Criteria (Informal Caregivers):
Exclusion Criteria (Caregivers):
United States, California | |
Jewish Senior Living Group | |
San Francisco, California, United States, 94112 | |
Canada, Ontario | |
Baycrest | |
Toronto, Ontario, Canada, M6A 2E1 |
Principal Investigator: | Allison B Sekuler, PhD | Baycrest |
Tracking Information | |||||
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First Submitted Date ICMJE | May 24, 2019 | ||||
First Posted Date ICMJE | June 4, 2019 | ||||
Last Update Posted Date | February 5, 2021 | ||||
Actual Study Start Date ICMJE | March 5, 2019 | ||||
Actual Primary Completion Date | January 31, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Effects of a Proactive Social Robot for Older Adults in Reducing Loneliness and Social Isolation | ||||
Official Title ICMJE | Effects of a Proactive Social Robot for Older Adults in Reducing Loneliness and Social Isolation | ||||
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:
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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
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention 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)Primary Purpose: Other |
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Condition ICMJE |
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Intervention ICMJE | Device: Proactive social robot
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.
Other Name: ElliQ
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
54 | ||||
Original Estimated Enrollment ICMJE |
100 | ||||
Actual Study Completion Date ICMJE | July 31, 2020 | ||||
Actual Primary Completion Date | January 31, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria (Users):
Exclusion Criteria (Users):
Inclusion Criteria (Informal Caregivers):
Exclusion Criteria (Caregivers):
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Sex/Gender ICMJE |
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Ages ICMJE | 70 Years and older (Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Canada, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03972787 | ||||
Other Study ID Numbers ICMJE | REB #18-54 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Dr. Allison B. Sekuler, Baycrest | ||||
Study Sponsor ICMJE | Baycrest | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Baycrest | ||||
Verification Date | February 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |