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Clinical 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. 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? 2. Do particular characteristics of the older adult population influence these impacts?


Clinical Trial 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 1. San Francisco, JSLG in Partnership with UCSF (n=50) 2. 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


Related Conditions & MeSH terms


NCT number NCT03972787
Study type Interventional
Source Baycrest
Contact
Status Completed
Phase N/A
Start date March 5, 2019
Completion date July 31, 2020

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