Technology and Family Thriving Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Alzheimer Disease, Dementia, Caregiver Burnout, Quality of Life, Mental Health Wellness 1, Loneliness, Family Relationship

Intervention / Treatment
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* Behavioral: Virtual Reality
* Behavioral: Video Chat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for older adults: must reside in one of 12 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality<br>Weekly activities using virtual reality (Rendever) | Behavioral: Virtual Reality<br>* Older adults (residents of senior living communities) will engage in four 20-minute virtual reality activities (via the Rendever platform) with their adult child each week for 4 consecutive weeks. The 4 sessions will include immersive virtual adventures (e.g., bucket list travel) and reminiscence activities (e.g., virtual life story). Adult children will be participating remotely from their own homes.<br>|
| Active Comparator: Video Chat<br>Weekly activities using video conference (Zoom) | Behavioral: Video Chat<br>* Older adults (residents of senior living communities) will engage in four 20-minute video chat sessions (via the Zoom platform) with their adult child each week for 4 consecutive weeks. Adult children will be participating remotely from their own homes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life in Alzheimer's Disease (QOL-AD) - changes from Baseline | QOL-AD (R.G. Logsdon, 1996) is a 13-item self-report measure of quality of life (completed by older adult and adult child informant, who reports on parent's quality of life). Items are rated on a 4-point scale: Poor = 1, Fair = 2, Good = 3, Excellent = 4. Total score is the sum of all items (range: 13 to 54). Higher scores indicate greater quality of life. | Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention | 
| Geriatric Depression Scale (GDS) - changes from Baseline | GDS (Sheikh, J.I., & Yesavage, J.A., 1986) is a 15-item self-report measure of depression (completed by older adult). Items are rated Yes or No and are scored 1 if the response reflects depressive symptoms. Total score is the sum of all items (range: 0 to 15). Higher scores indicate greater depression. | Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention | 
| Revised UCLA Loneliness Scale (short form) - changes from Baseline | The short form of the Revised UCLA Loneliness Scale (Hughes, Waite, Hawkley, & Cacioppo, 2008) is a 4-item scale widely used in field research with older adults, and adapted from the original scale (Russell D, Peplau LA, Cutrona CE, 1980). (Completed by the older adult and the adult child.) Items are rated on a 4-point scale: 1=Never, 2=Rarely, 3=Sometimes, 4=Often. Total score is the sum of the 4 items (range: 4 to 16). Higher scores indicate greater loneliness. | Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention | 
| Brief Inventory of Thriving (BIT) - changes from Baseline | BIT (Su, R., Tay, L., & Diener, E., 2014) is a 10-item self-report measure of thriving (completed by the older adult and adult child). Items are rated on a 5-point scale: 1= Strongly Disagree, 2=Disagree, 3 = Neither Agree nor Disagree, 4 = Agree, 5=Strongly Agree. Total score is the average of the 10 items (range: 1 to 5). Higher scores indicate greater sense of thriving. | Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention | 
| Perceived Stress Scale (PSS) - changes from Baseline | The PSS short form (completed by older adult and adult child) is a 4-item scale adapted from the longer PSS (Cohen, Kamarck, & Mermelstein, 1983). Items are rated on a 5-point scale: 1=Never, 2=Almost never, 3=Sometimes, 4=Fairly often, 5=Very often. Total score is the average of the 4 items, some reverse-scored (range: 1 to 5). Higher scores indicate greater perceived stress. | Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention | 
| Positive and Negative Affect Schedule (PANAS) - changes from Baseline | This scale includes 17-items from the longer PANAS (Watson, Clark, & Tellegen (1988). (Completed by the older adult and adult child.) Participants rate the degree to which they experienced positive and negative emotions during the past week. Items are rated on a 5-point scale: 1=Not at all, 2=A little, 3=Moderately, 4=Quite a lot, 5=Extremely. Separate scores are computed for positive and negative emotion. Higher scores indicate greater positive/negative affect. | Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention | 
| Mental Health Inventory (MHI) - changes from Baseline | The MHI includes 8 items from the longer MHI (McHorney, Ware, & Raczek, 1993) to assess depression, anxiety, and vitality during the past week (completed by the older adult and adult child). Items are rated on a 5-point scale: 1= None of the time, 2= A little of the time, 3=some of the time, 4=most of the time, 5= All of the time. Total score is the average of all 8 items, some reverse-scored (range: 1 to 5). Higher scores indicate better mental health. | Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention | 
| Center for Epidemiological Studies Depression Scale Revised Short Form (CESD-R-10) - changes from Baseline | CESD-R-10 (Björgvinsson, Kertz, Bigda-Peyton, McCoy, Aderka,2013) is a 10-item measure of depressive symptoms adapted from the longer CESD (completed by the adult child). Items are rated on a 4-point scale: 0=Rarely or none of the time, 1=Some or a little of the time, 2=Occasionally or a moderate amount of the time, 3=All of the time. Total score is the sum of the 10 items, some reverse-scored (range: 0 to 30). | Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention | 
| Caregiver Guilt and Grief Scale - changes from Baseline | This scale (completed by the adult child) includes 13-items adapted from the caregiver guilt and grief scales (Wells, Jorm, Jordan, & Lefroy, 1990). Items are rated on a 5-point scale: 1= Not at all, 2=A little, 3=A moderate amount, 4=A lot, 5=Almost unbearably. Total score is the average of the 13 items (range: 1 to 5). Higher scores indicate greater caregiver guilt/grief. | Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention | 
| Relational Burnout/Load Scale - changes from Baseline | Relational burnout/load is assessed with 5 items from the Relational Load Scale (Afifi et al., 2019). (Completed by the adult child.) Items are rated on a 5-point scale: 1=Strongly disagree 2=Disagree, 3=Neutral, 4=Agree, 5=Strongly agree. Total score is the average of the 6 items, some reverse-scored (range: 1 to 5). Higher scores indicate greater sense of relational load/burnout. | Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention | 
| Unidimensional Relationship Closeness Scale - changes from Baseline | Relationship closeness is assessed with 4-items from the Unidimensional Relationship Closeness Scale (Dibble, Levine, & Park, 2011). (Completed by the older adult and adult child). Items are rated on a 7-point scale: 1=Strongly disagree, 2=Disagree, 3=Somewhat disagree, 4=Neutral, 5=Somewhat agree, 6=Agree, 7=Strong Agree. Total score is the average of the 4 items (range: 1 to 7). Higher scores indicated greater relationship closeness. | Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention | 
| Communal Coping - changes from Baseline | Communal coping is assessed with 3 items assessing feelings of unity when combatting stress (Afifi et al., 2019). Items are rated on a 5-point scale: 1=Strongly disagree 2=Disagree, 3=Neutral, 4=Agree, 5=Strongly agree. Total score is the average of the 3 items. Higher scores indicate greater sense of communal coping. | Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention | 
| Relationship satisfaction - changes from Baseline | Global relationship satisfaction is assessed with 3 items adapted from Huston et al.'s (1986) relationship satisfaction scale (completed by the older adult and adult child). Items are rated on a 6-point scale: 1=not at all, 2=A little, 3=Somewhat, 4=Very, 5= Almost completely, 6=Completely. Total scores are the average of the 3 items (rage: 1 to 6). Higher scores indicate greater relationship satisfaction. | Baseline (1-week Pre-intervention), 1-week Post-intervention, 1-month Post-intervention, 3-months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Affect Schedule (PANAS) | Positive and negative emotions experienced during the technology session (older adult and adult child). Rated on a scale from 1 to 5, and separate indexes are computed for positive emotion and negative emotion. Higher scores represent greater positive and negative emotion. Scores will be averaged across the intervention period (4 weeks) for overall measures of positive/negative affect experienced during the intervention. | Immediately after each of the 4 technology sessions during the intervention (one week apart) | 
| Social and Conversational Engagement | Rating of social engagement during the technology session (older adult and adult child). Items written for this study based on the funded pilot study. Higher scores represent greater engagement. Scores will be averaged across the intervention period (4 weeks) for an overall score of engagement during the intervention. | Immediately after each of the 4 technology sessions during the intervention (one week apart) | 
| Relationship satisfaction and Communication Quality | Multiple items designed to assess features of relationship quality (older adult and adult child). Higher scores represent greater satisfaction and communication quality. Scores will be averaged across the intervention period (4 weeks) for an overall score of relationship satisfaction and communication quality during the technology sessions, during the intervention period. | Immediately after each of the 4 technology sessions during the intervention (one week apart) | 
| Telepresence and Copresence | Rating of engagement and immersion during the technology session (older adult and adult child). Items written for this study based on the funded pilot study. Higher scores represent greater telepresence and co-presence. Scores will be averaged across the intervention period (4 weeks) for an overall score of telepresence and copresence experienced during the technology sessions. | Immediately after each of the 4 technology sessions during the intervention (one week apart) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older adults, Virtual reality, Video chat (Zoom), Technology, Senior living community, Seniors, Cognitive impairment, Dementia, Thriving, Quality of Life, Loneliness, Mental health, Caregiver guilt, Caregiver burden, Family relationships, Adult children, Assisted living, Social connection