Technology and Family Thriving Study
- Conditions
- DementiaAlzheimer DiseaseQuality of LifeCaregiver BurnoutMental Health Wellness 1LonelinessFamily Relationship
- Registration Number
- NCT05150990
- Lead Sponsor
- University of California, Santa Barbara
- 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 (ADRD) who reside in senior living communities and an adult child who lives at a distance. The resident-adult child dyads (target 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. 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 quality of life, psychological and social well-being (loneliness, mental health, thriving, and relationship quality), caregiver guilt (guilt, stress, and burden), and positive engagement while using the technology. Outcomes will be 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 for exploratory purposes (to determine if any effects of the technology are sustained over time). Residents and adult children will also be interviewed briefly after the intervention and at 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 (accounting for expected 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 186
Not provided
- Severe AD/ADRD (MMSE-2 score < 13)
- History of seizure, severe vertigo, hallucinations, or aggression
- Severe visual impairment (screening will be conducted to determine if vision is sufficient to participate)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Quality of Life in Alzheimer's Disease (QOL-AD) - Changes From Baseline (Older Adult) T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention) QOL-AD (R.G. Logsdon, 1996) is a 13-item self-report measure of quality of life (completed by older adult participants). (As a secondary outcome, adult children also reported on their parents' quality of life). Items are rated on a 4-point scale: 1 = Poor, 2 = Fair, 3 = Good, 4 = Excellent. The total score is the mean of all items (range: 1 to 4). Higher scores indicate greater quality of life.
Brief Inventory of Thriving (BIT) - Changes From Baseline (Older Adult) T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention) An 11-item measure of thriving adapted from the Brief Inventory of Thriving (BIT) and the Comprehensive Inventory of Thriving (CIT; Su, R., Tay, L., \& Diener, E., 2014). This measure provides a holistic view of positive functioning (completed by older adults and adult children). Items are rated on a 5-point scale: 1 = Strongly Disagree, 2 = Disagree, 3 = Neither Agree nor Disagree, 4 = Agree, 5 = Strongly Agree. The total score is the average of the 11 items (range: 1 to 5). Higher scores indicate a greater sense of thriving.
Positive and Negative Affect Schedule (PANAS) - Changes From Baseline (Older Adult) T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention) This scale includes 12 items from the longer PANAS (Watson, Clark, \& Tellegen, 1988), which measures two primary dimensions of mood. (Completed by older adults and adult children.) Participants rate the extent to which they experienced positive and negative emotions over the past week. Each item is rated on a 5-point scale: 1 = Not at all, 2 = A little, 3 = Moderately, 4 = Quite a lot, 5 = Extremely. Separate subscale scores are calculated for positive emotion (6 items) and negative emotion (6 items) by averaging responses within each set (range: 1 to 5). Higher scores on the positive emotion subscale reflect greater positive mood during the past week, indicating better well-being. Higher scores on the negative emotion subscale reflect greater negative mood, indicating poorer well-being.
Geriatric Depression Scale (GDS) - Changes From Baseline (Older Adult) T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention) GDS (Sheikh, J.I., \& Yesavage, J.A., 1986) is a 15-item self-report measure of depression (completed by older adult participants). 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.
Mental Health Inventory (MHI) - Changes From Baseline (Older Adult) T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention) The MHI includes 5 items from the longer MHI (McHorney, Ware, \& Raczek, 1993) to assess depression, anxiety, and vitality during the past week (completed by older adults and adult children). Items are rated on a 6-point scale: 1= None of the time, 2= A little of the time, 3 = Some of the time, 4 = A good bit of the time, 5 = Most of the time, 6 = All of the time. The total score is the average of all 8 items, some reverse-scored (range: 1 to 6). Higher scores indicate better mental health.
Revised UCLA Loneliness Scale (Short Form) - Changes From Baseline (Older Adult) T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention) 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). Items are rated on a 4-point scale: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often. The total score is the mean of the 4 items (range: 1 to 4). Higher scores indicate greater loneliness.
Unidimensional Relationship Closeness Scale - Changes From Baseline (Older Adult) T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention) Relationship closeness is assessed with 4 items from the Unidimensional Relationship Closeness Scale (Dibble, Levine, \& Park, 2011). (Completed by older adults and adult children). 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. The total score is the average of the 4 items (range: 1 to 7). Higher scores indicate greater relationship closeness.
Relationship Satisfaction - Changes From Baseline (Older Adult) T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention) Global relationship satisfaction is assessed with 3 items adapted from Huston et al.'s (1986) relationship satisfaction scale (completed by older adults and adult children). 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 (range: 1 to 6). Higher scores indicate greater relationship satisfaction.
Communal Coping - Changes From Baseline (Older Adult) T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention) Communal coping is assessed with 3 items reflecting feelings of unity when combatting stress (Afifi et al., 2019). (Completed by older adults and adult children.) Items are rated on a 5-point scale: 1 = Strongly disagree, 2 = Disagree, 3 = Neutral, 4 = Agree, 5 = Strongly agree. The total score is the average of the 3 items (range: 1 to 5). Higher scores indicate a greater sense of communal coping.
Brief Inventory of Thriving (BIT) - Changes From Baseline (Adult Child) T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention) An 11-item measure of thriving adapted from the Brief Inventory of Thriving (BIT) and the Comprehensive Inventory of Thriving (CIT; Su, R., Tay, L., \& Diener, E., 2014). This measure provides a holistic view of positive functioning (completed by older adults and adult children). Items are rated on a 5-point scale: 1 = Strongly Disagree, 2 = Disagree, 3 = Neither Agree nor Disagree, 4 = Agree, 5 = Strongly Agree. The total score is the average of the 11 items (range: 1 to 5). Higher scores indicate a greater sense of thriving.
Center for Epidemiological Studies Depression Scale Revised Short Form (CESD-R-10) - Changes From Baseline (Adult Child) T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention) The 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 adult children). Participants are asked to report how they felt during the past week. 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 = Most or all of the time. The total score is the mean of the 10 items, some reverse-scored (range: 0 to 3). Higher scores reflect more depressive symptoms, worse mental health.
Positive and Negative Affect Schedule (PANAS) - Changes From Baseline (Adult Child) T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention) This scale includes 12 items from the longer PANAS (Watson, Clark, \& Tellegen, 1988), which measures two primary dimensions of mood. (Completed by older adults and adult children.) Participants rate the extent to which they experienced positive and negative emotions over the past week. Each item is rated on a 5-point scale: 1 = Not at all, 2 = A little, 3 = Moderately, 4 = Quite a lot, 5 = Extremely. Separate subscale scores are calculated for positive emotion (6 items) and negative emotion (6 items) by averaging responses within each set (range: 1 to 5). Higher scores on the positive emotion subscale reflect greater positive mood during the past week, indicating better well-being. Higher scores on the negative emotion subscale reflect greater negative mood, indicating poorer well-being.
Mental Health Inventory (MHI) - Changes From Baseline (Adult Child) T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention) The MHI includes 5 items from the longer MHI (McHorney, Ware, \& Raczek, 1993) to assess depression, anxiety, and vitality during the past week (completed by older adults and adult children). Items are rated on a 6-point scale: 1 = None of the time, 2 = A little of the time, 3 = Some of the time, 4 = A good bit of the time, 5 = Most of the time, 6 = All of the time. The total score is the average of all 8 items, some reverse-scored (range: 1 to 6). Higher scores indicate better mental health.
Perceived Stress Scale (PSS) - Changes From Baseline (Adult Child) T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention) The PSS short form (completed by adult children) 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. The total score is the average of the 4 items, some reverse-scored (range: 1 to 5). Higher scores indicate greater perceived stress.
Caregiver Guilt/Grief Scale - Changes From Baseline (Adult Child) T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention) This scale (completed by adult children) 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. The total score is the average of the 13 items (range: 1 to 5). Higher scores indicate greater caregiver guilt/grief.
Relational Burnout/Load Scale - Changes From Baseline (Adult Child) T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention) Relational burnout/load is assessed with 6 items from the Relational Load Scale (Afifi et al., 2019). (Completed by adult children.) Items are rated on a 5-point scale: 1 = Strongly disagree, 2 = Disagree, 3 = Neutral, 4 = Agree, 5 = Strongly agree. The total score is the average of the 6 items, some reverse-scored (range: 1 to 5). Higher scores indicate a greater sense of relational load/burnout.
Unidimensional Relationship Closeness Scale - Changes From Baseline (Adult Child) T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention) Relationship closeness is assessed with 4 items from the Unidimensional Relationship Closeness Scale (Dibble, Levine, \& Park, 2011). (Completed by older adults and adult children.) 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. The total score is the average of the 4 items (range: 1 to 7). Higher scores indicate greater relationship closeness.
Relationship Satisfaction - Changes From Baseline (Adult Child) T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention) Global relationship satisfaction is assessed with 3 items adapted from Huston et al.'s (1986) relationship satisfaction scale (completed by older adults and adult children). Items are rated on a 6-point scale: 1 = Not at all, 2 = A little, 3 = Somewhat, 4 = Very, 5 = Almost completely, 6 = Completely. The total score is the average of the 3 items (range: 1 to 6). Higher scores indicate greater relationship satisfaction.
Communal Coping - Changes From Baseline (Adult Child) T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention) Communal coping is assessed with 3 items reflecting feelings of unity when combatting stress (Afifi et al., 2019). (Completed by older adults and adult children.) Items are rated on a 5-point scale: 1 = Strongly disagree, 2 = Disagree, 3 = Neutral, 4 = Agree, 5 = Strongly agree. The total score is the average of the 3 items (range: 1 to 5). Higher scores indicate a greater sense of communal coping.
- Secondary Outcome Measures
Name Time Method Positive and Negative Affect Schedule (PANAS) - Technology Sessions Immediately after each of the 4 technology sessions during the intervention (one week apart) 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. Higher positive emotion and lower negative emotion indicate a more favorable response during the technology session.
Social and Conversational Engagement - Technology Sessions Immediately after each of the 4 technology sessions during the intervention (one week apart) Social and conversational engagement during the technology sessions will be evaluated using items developed specifically for this study, based on findings from a pilot study. Higher scores indicate greater engagement. Engagement scores will be averaged over the four-week intervention period to generate an overall engagement measure. In addition to self-reports, objective coders will analyze video and audio recordings of the sessions to assess conversational and emotional engagement. Kinesic (physical) engagement of the older adult will be evaluated both by trained raters and an automated computer program.
Relationship Satisfaction and Communication Quality - Technology Sessions Immediately after each of the 4 technology sessions during the intervention (one week apart) 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.
Telepresence and Copresence - Technology Session Measured after the first technology session (Week 1 of the intervention) Rating of engagement and immersion during the technology session (older adult and adult child). Items were written for this project based on a pilot study. Higher scores represent greater telepresence and co-presence. Due to time limitations, this measure is completed only during the first technology session.
Trial Locations
- Locations (27)
Belmont Calabasas
🇺🇸Calabasas, California, United States
Oakmont of Camarillo
🇺🇸Camarillo, California, United States
Friendship Manor
🇺🇸Goleta, California, United States
Casa Dorinda
🇺🇸Montecito, California, United States
Ojai Gables
🇺🇸Ojai, California, United States
Garden Court on De La Vina
🇺🇸Santa Barbara, California, United States
Covenant Living at the Samarkand
🇺🇸Santa Barbara, California, United States
Gardens on Hope
🇺🇸Santa Barbara, California, United States
Grace Village Apartments
🇺🇸Santa Barbara, California, United States
Valle Verde
🇺🇸Santa Barbara, California, United States
Scroll for more (17 remaining)Belmont Calabasas🇺🇸Calabasas, California, United States