- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05150990
Technology and Family Thriving Study (Thrive)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Calabasas, California, United States, 91302
- Belmont Calabasas
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Camarillo, California, United States, 93012
- Oakmont of Camarillo
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Goleta, California, United States, 93117
- Friendship Manor
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Montecito, California, United States, 93108
- Casa Dorinda
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Ojai, California, United States, 93023
- Ojai Gables
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Santa Barbara, California, United States, 93101
- Garden Court on De La Vina
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Santa Barbara, California, United States, 93105
- Covenant Living at the Samarkand
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Santa Barbara, California, United States, 93105
- Gardens on Hope
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Santa Barbara, California, United States, 93105
- Grace Village Apartments
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Santa Barbara, California, United States, 93105
- Valle Verde
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Santa Barbara, California, United States, 93105
- Vista Del Monte
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Santa Barbara, California, United States, 93111
- Heritage House
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Santa Barbara, California, United States, 93111
- Maravilla
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Solvang, California, United States, 93463
- Atterdag Village of Solvang
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Massachusetts
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Andover, Massachusetts, United States, 01810
- Stone Hill at Andover
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Burlington, Massachusetts, United States, 01803
- Stonebridge at Burlington
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Cambridge, Massachusetts, United States, 02138
- Youville House Assisted Living
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Cambridge, Massachusetts, United States, 02140
- Cadbury Commons
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Canton, Massachusetts, United States, 02021
- Brightview Canton
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Danvers, Massachusetts, United States, 01923
- The Linden at Danvers
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North Andover, Massachusetts, United States, 01845
- Brightview North Andover
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Norwood, Massachusetts, United States, 02062
- Benchmark of Norwood (Clapboardtree)
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Plymouth, Massachusetts, United States, 02630
- Laurelwood at The Pinehills
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Russells Mills, Massachusetts, United States, 02747
- Autumn Glen at Dartmouth
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Tewksbury, Massachusetts, United States, 01876
- Bayberry at Emerald Court
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Wayland, Massachusetts, United States, 01778
- Carriage House at Lee's Farm
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New Hampshire
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Milford, New Hampshire, United States, 03055
- Ledgewood Bay Assisted Living
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 (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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Virtual Reality
Weekly activities using virtual reality (Rendever)
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Older adults (residents of senior living communities) 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 include immersive virtual adventures (e.g., bucket list travel) and reminiscence activities (e.g., virtual life story).
Adult children participate remotely from their own homes.
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Active Comparator: Video Chat
Weekly activities using video conference (Zoom)
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Older adults (residents of senior living communities) engage in four 20-minute video chat sessions (via the Zoom platform) with their adult child each week for 4 consecutive weeks.
Adult children participate remotely from their own homes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Quality of Life in Alzheimer's Disease (QOL-AD) - Changes From Baseline (Older Adult)
Time Frame: 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.
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T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
|
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Brief Inventory of Thriving (BIT) - Changes From Baseline (Older Adult)
Time Frame: 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.
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T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
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Positive and Negative Affect Schedule (PANAS) - Changes From Baseline (Older Adult)
Time Frame: 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.
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T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
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Geriatric Depression Scale (GDS) - Changes From Baseline (Older Adult)
Time Frame: 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.
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T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
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Mental Health Inventory (MHI) - Changes From Baseline (Older Adult)
Time Frame: 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.
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T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
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Revised UCLA Loneliness Scale (Short Form) - Changes From Baseline (Older Adult)
Time Frame: 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.
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T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
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Unidimensional Relationship Closeness Scale - Changes From Baseline (Older Adult)
Time Frame: 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.
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T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
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Relationship Satisfaction - Changes From Baseline (Older Adult)
Time Frame: 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.
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T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
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Communal Coping - Changes From Baseline (Older Adult)
Time Frame: 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.
|
T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
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Brief Inventory of Thriving (BIT) - Changes From Baseline (Adult Child)
Time Frame: 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.
|
T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
|
|
Center for Epidemiological Studies Depression Scale Revised Short Form (CESD-R-10) - Changes From Baseline (Adult Child)
Time Frame: 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.
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T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
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Positive and Negative Affect Schedule (PANAS) - Changes From Baseline (Adult Child)
Time Frame: 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.
|
T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
|
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Mental Health Inventory (MHI) - Changes From Baseline (Adult Child)
Time Frame: 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.
|
T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
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Perceived Stress Scale (PSS) - Changes From Baseline (Adult Child)
Time Frame: 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.
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T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
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Caregiver Guilt/Grief Scale - Changes From Baseline (Adult Child)
Time Frame: 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.
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T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
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Relational Burnout/Load Scale - Changes From Baseline (Adult Child)
Time Frame: T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
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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.
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T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
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Unidimensional Relationship Closeness Scale - Changes From Baseline (Adult Child)
Time Frame: 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.
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T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
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Relationship Satisfaction - Changes From Baseline (Adult Child)
Time Frame: 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.
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T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
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Communal Coping - Changes From Baseline (Adult Child)
Time Frame: 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.
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T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positive and Negative Affect Schedule (PANAS) - Technology Sessions
Time Frame: Immediately after each of the 4 technology sessions during the intervention (one week apart)
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Positive and negative emotions experienced during the technology sessions (completed by both the older adult and adult child).
Rated on a scale from 1 to 5, and separate indices 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 sessions.
Higher positive emotion and lower negative emotion indicate a more favorable response during the technology session.
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Immediately after each of the 4 technology sessions during the intervention (one week apart)
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Social and Conversational Engagement - Technology Sessions
Time Frame: Immediately after each of the 4 technology sessions during the intervention (one week apart)
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Self-reported social and conversational engagement during the technology sessions will be assessed using items developed specifically for this study, based on findings from a pilot study.
The items assess experiences such as learning something new, reminiscing, and sharing special moments (completed by both the older adult and adult child), with responses rated on a 5-point scale from 1 to 5. Items are averaged across the four-week intervention period to generate overall engagement scores across the intervention sessions.
Higher scores indicate greater enjoyment and a more favorable response during the technology sessions.
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Immediately after each of the 4 technology sessions during the intervention (one week apart)
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Relationship Satisfaction and Communication Quality - Technology Sessions
Time Frame: Immediately after each of the 4 technology sessions during the intervention (one week apart)
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Multiple items are designed to assess features of relationship connection during the remote family sessions (completed by both the older adult and adult child).
Items are rated on a scale from 1 to 5. Subscales include (a) relational connection and (b) relational strain.
Scores will be averaged across the intervention period (4 weeks) to obtain an overall score of relational connection and strain during the technology sessions.
Higher connection and lower strain scores indicate a more favorable response during the technology sessions.
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Immediately after each of the 4 technology sessions during the intervention (one week apart)
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Telepresence and Copresence - Technology Session
Time Frame: Immediately after each of the 4 technology sessions during the intervention (one week apart)
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Self-reported ratings of immersion during the technology sessions will be completed by both the older adult and the adult child.
Items were adapted for this project based on a pilot study and will assess experiences such as feeling like they are in the same room and interacting face-to-face.
Responses will be rated on a scale from 1 to 5, where higher scores indicate greater immersion and co-presence.
Finally, item ratings will be averaged across the four-week intervention period to generate overall composite scores for each item.
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Immediately after each of the 4 technology sessions during the intervention (one week apart)
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Observational and Computer Coding - Social, Conversational, and Kinesic Engagement - Technology Sessions
Time Frame: Coded from audio and videotapes of each of the 4 technology (intervention) sessions.
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To supplement the self-reports, trained raters will evaluate video and audio recordings of the sessions for conversational, emotional, and kinesic (physical) engagement.
Human-coded items will use a 1-to-5 scale, with higher scores representing greater involvement.
Subscales for older adults will measure (a) reminiscence, (b) conversational engagement, (c) conversational lead, (d) positive emotions, (e) active emotions, and (f) kinesic engagement; subscales for adult children will measure only (a) reminiscence, (b) conversational engagement, and (c) conversational lead.
Additionally, an automated computer program will evaluate older adults' kinesic engagement, yielding metrics from 0 to 1 (higher values indicating greater physical engagement).
All subscales and metrics will be averaged across the four-week intervention to generate overall composite engagement scores.
|
Coded from audio and videotapes of each of the 4 technology (intervention) sessions.
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Collaborators and Investigators
Investigators
- Principal Investigator: Tamara Afifi, PhD, University of California, Santa Barbara
- Principal Investigator: Kyle Rand, B.A., Rendever Co.
- Principal Investigator: Nancy Collins, PhD, University of California, Santa Barbara
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Behavioral Symptoms
- Neurocognitive Disorders
- Cognition Disorders
- Tauopathies
- Neurodegenerative Diseases
- Stress, Psychological
- Behavior
- Personal Satisfaction
- Caregiver Burden
- Cognitive Dysfunction
- Alzheimer Disease
- Dementia
- Psychological Well-Being
Other Study ID Numbers
- NIH 13336607
- R42AG063640-02 (U.S. NIH Grant/Contract)
- 3R42AG063640-03S1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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