Clinical trial NCT05150990: Technology and Family Thriving Study
Official title: Using Rendever to Improve the Quality of Life of Older Adults With Cognitive Impairments in Senior Living Communities and Their Family Members Who Live at a Distance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Caregiver Burnout
Quality of Life
Mental Health Wellness 1
Loneliness
Family Relationship
Keywords: Virtual reality
Video chat (Zoom)
Technology
Senior living community
Seniors
Older adults
Cognitive impairment
Dementia
Thriving
Quality of Life
Loneliness
Mental health
Caregiver guilt
Caregiver burden
Family relationships
Adult children
Assisted living
Social connection
Lead sponsor: University of California, Santa Barbara
Sponsor class: OTHER
Collaborators: name: Rendever, Inc.
name: National Institute on Aging (NIA)
First posted: 2021-12-09
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two intervention groups (two types of technology): (1) virtual reality, or (2) video chat (active control)
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this project is to test the impact of different forms of technology (virtual reality vs. video chat) on quality of life and family relationships in older adults who reside in senior living communities and an adult child who lives at a distance. The study will also investigate whether responses to the technology and quality of life outcomes depend on older adults' level of cognitive impairment.

Detailed description: Purpose of the clinical trial: The virtual reality (VR) program, Rendever, enables older adults in senior living communities to maintain important family relationships, engage fully with life, and reconnect with their past, regardless of physical location, through its advanced networking and live-streaming capabilities. This project will test the immediate and longer-term impact of the Rendever virtual reality platform (vs. video chat) on the quality of life of residents and their adult children in an experimental design. The study will also investigate whether responses to the technology and quality of life outcomes depend on older adults' level of cognitive impairment.

Participants: Participants will be older adults (age 50+) with mild cognitive impairments (MCI) or mild to moderate Alzheimer's Disease or related dementias (AD/ADRD) who reside in senior living communities, and an adult child who lives at a distance. The resident-adult child dyads (N=192 dyads) will be recruited from 12 senior living communities in the greater Boston area and central California. Residents will participate from their senior living community and adult children will participate from their own home, at least 45 minutes driving distance away.

Study Design and Method: The design is a 2 (Intervention Group: Virtual Reality vs. Active Control) x 2 (Level of Cognitive Impairment: MCI vs. AD/ADRD) x Time (7 time points) design. Dyads will be randomly assigned to an intervention group (Virtual Reality vs. Video Chat Control). Dependent variables will include positive engagement while using the technology, quality of life, psychological and social well-being (loneliness, mental health, thriving, and relationship quality), and caregiver guilt (guilt, stress, and burden) assessed through surveys, interviews, and observational methods.

The experimental intervention will be implemented in a between-group design. Dyads will be randomly assigned to either the Virtual Reality Condition or the active Control Condition (video chat). Participants will complete a baseline survey (T1), followed by four activity sessions once a week for 4 consecutive weeks (T2-T5). Follow-up surveys will be conducted at 1-month (T6) and 3-months (T7) post-intervention. Residents and adult children will also be interviewed briefly after the intervention and at the each follow-up. All sessions will be video and audiotaped. Computerized and human coding will examine positive engagement and interpersonal dynamics while using the technology.

Dyads assigned to the virtual reality (VR) condition will engage in 4 weekly VR sessions that include immersive virtual adventures (e.g., bucket list travel) and reminiscence activities (e.g., virtual life story). Dyads assigned to the control condition will engage in 4 weekly video chat sessions. During these sessions, dyads will engage in conversations that are typical in their daily lives. All other procedures will be identical in the two conditions.

Sample size, recruitment, and statistical power: A power analysis using simulation methods (for multi-level regression models and structural equation models) was used to determine the sample size. A sample size of 192 dyads (96 in each intervention condition) evenly split between cognitive impairment groups (MCI vs. dementia) will achieve a high level of power for detecting the minimal expected effect size. Additional dyads will be recruited to account for attrition.

Statistical analysis: Because data from parent-adult child dyads will be dependent, and because the dyad is the unit of analysis for assignment to experimental conditions, the analysis of quantitative data will utilize linear models designed for nested (clustered) data. Hypothesis testing will be conducted with multi-level, random-effects regression and multi-level structural equation modeling.

Study Aims:

AIM 1: Determine whether virtual reality (vs. control) improves quality of life for residents and their adult children who live at a distance.

AIM 2: Determine whether the positive effects of virtual reality (vs. control) on quality of life depend upon residents' level of cognitive impairment (MCI vs. mild to moderate AD/ADRD).

AIM 3: Determine whether virtual reality (vs. control) reduces caregiver guilt for adult children and whether these effects depend on the adult child's own responses to the technology and their parent's responses to the technology.

Eligibility criteria: Inclusion Criteria for older adults:

* must reside in one of the senior living communities participating in the study
* at least 50 years old
* fluent in English or Spanish
* have MCI or mild to moderate AD/ADRD
* mini-mental state examination (MMSE-2) score between 13 and 27
* have an adult child who lives at least 45 minutes driving distance from the community and is willing to participate with them
* do not have an overly negative, aggressive, or abusive relationship with this adult child

Inclusion Criteria for adult children:

* at least 18 years old
* fluent in English or Spanish,
* live at least 45 minutes driving distance from the residential community
* do not have an overly negative, aggressive, or abusive relationship with their parent

Exclusion Criteria:

* severe AD/ADRD
* history of severe vertigo, hallucinations, or aggression
* severe visual impairment (screening will be conducted to determine if vision is sufficient to participate)

Primary outcomes:
measure: Quality of Life in Alzheimer's Disease (QOL-AD) - changes from Baseline
timeFrame: Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention
measure: Geriatric Depression Scale (GDS) - changes from Baseline
timeFrame: Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention
measure: Revised UCLA Loneliness Scale (short form) - changes from Baseline
timeFrame: Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention
measure: Brief Inventory of Thriving (BIT) - changes from Baseline
timeFrame: Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention
measure: Perceived Stress Scale (PSS) - changes from Baseline
timeFrame: Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention
measure: Positive and Negative Affect Schedule (PANAS) - changes from Baseline
timeFrame: Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention
measure: Mental Health Inventory (MHI) - changes from Baseline
timeFrame: Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention
measure: Center for Epidemiological Studies Depression Scale Revised Short Form (CESD-R-10) - changes from Baseline
timeFrame: Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention
measure: Caregiver Guilt and Grief Scale - changes from Baseline
timeFrame: Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention
measure: Relational Burnout/Load Scale - changes from Baseline
timeFrame: Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention
measure: Unidimensional Relationship Closeness Scale - changes from Baseline
timeFrame: Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention
measure: Communal Coping - changes from Baseline
timeFrame: Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention
measure: Relationship satisfaction - changes from Baseline
timeFrame: Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention
Secondary outcomes:
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Immediately after each of the 4 technology sessions during the intervention (one week apart)
measure: Social and Conversational Engagement
timeFrame: Immediately after each of the 4 technology sessions during the intervention (one week apart)
measure: Relationship satisfaction and Communication Quality
timeFrame: Immediately after each of the 4 technology sessions during the intervention (one week apart)
measure: Telepresence and Copresence
timeFrame: Immediately after each of the 4 technology sessions during the intervention (one week apart)
Other outcomes:
Locations:
city: Calabasas
country: United States
facility: Belmont Calabasas
state: California
city: Camarillo
country: United States
facility: Oakmont of Camarillo
state: California
city: Goleta
country: United States
facility: Friendship Manor
state: California
city: Montecito
country: United States
facility: Casa Dorinda
state: California
city: Ojai
country: United States
facility: Ojai Gables
state: California
city: Santa Barbara
country: United States
facility: Garden Court on De La Vina
state: California
city: Santa Barbara
country: United States
facility: Covenant Living at the Samarkand
state: California
city: Santa Barbara
country: United States
facility: Gardens on Hope
state: California
city: Santa Barbara
country: United States
facility: Grace Village Apartments
state: California
city: Santa Barbara
country: United States
facility: Valle Verde
state: California
city: Santa Barbara
country: United States
facility: Vista Del Monte
state: California
city: Santa Barbara
country: United States
facility: Heritage House
state: California
city: Santa Barbara
country: United States
facility: Maravilla
state: California
city: Solvang
country: United States
facility: Atterdag Village of Solvang
state: California
city: Andover
country: United States
facility: Stone Hill at Andover
state: Massachusetts
city: Burlington
country: United States
facility: Stonebridge at Burlington
state: Massachusetts
city: Cambridge
country: United States
facility: Youville House Assisted Living
state: Massachusetts
city: Cambridge
country: United States
facility: Cadbury Commons
state: Massachusetts
city: Canton
country: United States
facility: Brightview Canton
state: Massachusetts
city: Danvers
country: United States
facility: The Linden at Danvers
state: Massachusetts
city: North Andover
country: United States
facility: Brightview North Andover
state: Massachusetts
city: Norwood
country: United States
facility: Benchmark of Norwood (Clapboardtree)
state: Massachusetts
city: Plymouth
country: United States
facility: Laurelwood at The Pinehills
state: Massachusetts
city: South Dartmouth
country: United States
facility: Autumn Glen at Dartmouth
state: Massachusetts
city: Tewksbury
country: United States
facility: Bayberry at Emerald Court
state: Massachusetts
city: Wayland
country: United States
facility: Carriage House at Lee's Farm
state: Massachusetts
city: Milford
country: United States
facility: Ledgewood Bay Assisted Living
state: New Hampshire
Study officials:
affiliation: University of California, Santa Barbara
name: Tamara Afifi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rendever Co.
name: Kyle Rand, B.A.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Santa Barbara
name: Nancy Collins, PhD
role: PRINCIPAL_INVESTIGATOR
References: