Clinical trial NCT03972787: Effects of a Proactive Social Robot for Older Adults in Reducing Loneliness and Social Isolation
Official title: Effects of a Proactive Social Robot for Older Adults in Reducing Loneliness and Social Isolation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loneliness
Mood
Quality of Life
Lead sponsor: Baycrest
Sponsor class: OTHER
Collaborators: name: Jewish Senior Living Group
name: Intuition Robotics
First posted: 2019-06-04
Enrollment: 54
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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:

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?

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

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.

Eligibility criteria: Inclusion Criteria (Users):

* 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

Exclusion Criteria (Users):

* 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

Primary outcomes:
measure: University of California, Los Angeles Loneliness (UCLA) V3 Scale - Change is Being Assessed
timeFrame: Time 1 (baseline, week 0), Time 2 (follow-up 1, week 9), Time 3 (follow-up 2, week 18)
Secondary outcomes:
Other outcomes:
measure: Computer Proficiency Questionnaire
timeFrame: Time 1 (baseline, week 0), Time 2 (follow-up 1, week 9), Time 3 (follow-up 2, week 18)
measure: ElliQ Companionship Questionnaire
timeFrame: Time 2 (follow-up 1, week 9), Time 3 (follow-up 2, week 18)
measure: Caregiver Status
timeFrame: Time 1 (baseline, week 0), Time 2 (follow-up 1, week 9), Time 3 (follow-up 2, week 18)
measure: Duke's Social Support Index (DSSI)
timeFrame: Time 1 (baseline, week 0), Time 2 (follow-up 1, week 9), Time 3 (follow-up 2, week 18)
measure: Old People's Quality of Life-Brief (OPQOL-Brief)
timeFrame: Time 1 (baseline, week 0), Time 2 (follow-up 1, week 9), Time 3 (follow-up 2, week 18)
measure: Brief Mood Introspection Scale (BMIS)
timeFrame: Time 1 (baseline, week 0), Time 2 (follow-up 1, week 9), Time 3 (follow-up 2, week 18)
measure: Visual Analog Mood Scale (VAMS)
timeFrame: Time 1 (baseline, week 0), Time 2 (follow-up 1, week 9), Time 3 (follow-up 2, week 18)
measure: Personal Health Questionnaire-8 (PHQ-8)
timeFrame: Time 1 (baseline, week 0), Time 2 (follow-up 1, week 9), Time 3 (follow-up 2, week 18)
measure: Focus group/interview guide - Users
timeFrame: Post-intervention (follow-up 1, week 9 for the group receiving the intervention first; follow-up 2, week 18 for the group receiving the intervention second)
measure: Focus group/interview guide - Caregivers
timeFrame: Post-intervention (follow-up 1, week 9 for the group receiving the intervention first; follow-up 2, week 18 for the group receiving the intervention second)
Locations:
city: San Francisco
country: United States
facility: Jewish Senior Living Group
state: California
city: Toronto
country: Canada
facility: Baycrest
state: Ontario
Study officials:
affiliation: Baycrest
name: Allison B Sekuler, PhD
role: PRINCIPAL_INVESTIGATOR
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