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Alzheimer DiseaseThriveNCT05150990

Technology and Family Thriving Study

A study testing Virtual Reality and Video Chat in people with Alzheimer Disease and Dementia, run by University of California, Santa Barbara at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alzheimer Disease, Dementia, Caregiver Burnout
What is being tested?
Virtual Reality and Video Chat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
27 sitesUnited States
Study dates
2 Oct 2021to 16 Mar 2024
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • Do not have an overly negative, aggressive, or abusive relationship with this adult child
  • 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

Who cannot join

  • 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)

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

United States27 sites
  • Stone Hill at Andover

    Andover, Massachusetts, 01810

  • Stonebridge at Burlington

    Burlington, Massachusetts, 01803

  • Belmont Calabasas

    Calabasas, California, 91302

  • Oakmont of Camarillo

    Camarillo, California, 93012

  • Youville House Assisted Living

    Cambridge, Massachusetts, 02138

  • Cadbury Commons

    Cambridge, Massachusetts, 02140

  • Brightview Canton

    Canton, Massachusetts, 02021

  • The Linden at Danvers

    Danvers, Massachusetts, 01923

  • Friendship Manor

    Goleta, California, 93117

  • Ledgewood Bay Assisted Living

    Milford, New Hampshire, 03055

  • Casa Dorinda

    Montecito, California, 93108

  • Brightview North Andover

    North Andover, Massachusetts, 01845

  • Benchmark of Norwood (Clapboardtree)

    Norwood, Massachusetts, 02062

  • Ojai Gables

    Ojai, California, 93023

  • Laurelwood at The Pinehills

    Plymouth, Massachusetts, 02630

  • Autumn Glen at Dartmouth

    Russells Mills, Massachusetts, 02747

  • Garden Court on De La Vina

    Santa Barbara, California, 93101

  • Covenant Living at the Samarkand

    Santa Barbara, California, 93105

  • Gardens on Hope

    Santa Barbara, California, 93105

  • Grace Village Apartments

    Santa Barbara, California, 93105

  • Valle Verde

    Santa Barbara, California, 93105

  • Vista Del Monte

    Santa Barbara, California, 93105

  • Heritage House

    Santa Barbara, California, 93111

  • Maravilla

    Santa Barbara, California, 93111

  • Atterdag Village of Solvang

    Solvang, California, 93463

  • Bayberry at Emerald Court

    Tewksbury, Massachusetts, 01876

  • Carriage House at Lee's Farm

    Wayland, Massachusetts, 01778

Other trials in United States

About this 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

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.

Read the 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.

Being tested
Virtual Reality, Video Chat
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
Medical subject headings
Alzheimer Disease, Dementia, Caregiver Burden, Cognitive Dysfunction, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual RealityBehavioural

    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.

  • Video ChatBehavioural

    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.

Study groups in NCT05150990
Study groupRoleWhat they receive
Virtual RealityExperimentalWeekly activities using virtual reality (Rendever)
Receives: Behavioral: Virtual Reality
Video ChatActive comparatorWeekly activities using video conference (Zoom)
Receives: Behavioral: Video Chat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of Life in Alzheimer's Disease (QOL-AD) - Changes From Baseline (Older Adult)

    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.

    Measured: T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)

  2. Brief Inventory of Thriving (BIT) - Changes From Baseline (Older Adult)

    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.

    Measured: T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)

  3. Positive and Negative Affect Schedule (PANAS) - Changes From Baseline (Older Adult)

    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.

    Measured: T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)

  4. Geriatric Depression Scale (GDS) - Changes From Baseline (Older Adult)

    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.

    Measured: T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)

  5. Mental Health Inventory (MHI) - Changes From Baseline (Older Adult)

    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.

    Measured: T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)

  6. Revised UCLA Loneliness Scale (Short Form) - Changes From Baseline (Older Adult)

    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.

    Measured: T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)

  7. Unidimensional Relationship Closeness Scale - Changes From Baseline (Older Adult)

    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.

    Measured: T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)

  8. Relationship Satisfaction - Changes From Baseline (Older Adult)

    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.

    Measured: T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)

  9. Communal Coping - Changes From Baseline (Older Adult)

    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.

    Measured: T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)

  10. Brief Inventory of Thriving (BIT) - Changes From Baseline (Adult Child)

    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.

    Measured: T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)

  11. Center for Epidemiological Studies Depression Scale Revised Short Form (CESD-R-10) - Changes From Baseline (Adult Child)

    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.

    Measured: T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)

  12. Positive and Negative Affect Schedule (PANAS) - Changes From Baseline (Adult Child)

    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.

    Measured: T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)

  13. Mental Health Inventory (MHI) - Changes From Baseline (Adult Child)

    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.

    Measured: T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)

  14. Perceived Stress Scale (PSS) - Changes From Baseline (Adult Child)

    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.

    Measured: T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)

  15. Caregiver Guilt/Grief Scale - Changes From Baseline (Adult Child)

    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.

    Measured: T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)

  16. Relational Burnout/Load Scale - Changes From Baseline (Adult Child)

    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.

    Measured: T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)

  17. Unidimensional Relationship Closeness Scale - Changes From Baseline (Adult Child)

    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.

    Measured: T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)

  18. Relationship Satisfaction - Changes From Baseline (Adult Child)

    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.

    Measured: T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)

  19. Communal Coping - Changes From Baseline (Adult Child)

    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.

    Measured: T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)

Secondary outcomes (5)
  1. Positive and Negative Affect Schedule (PANAS) - Technology Sessions

    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.

    Measured: Immediately after each of the 4 technology sessions during the intervention (one week apart)

  2. Social and Conversational Engagement - Technology Sessions

    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.

    Measured: Immediately after each of the 4 technology sessions during the intervention (one week apart)

  3. Relationship Satisfaction and Communication Quality - Technology Sessions

    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.

    Measured: Immediately after each of the 4 technology sessions during the intervention (one week apart)

  4. Telepresence and Copresence - Technology Session

    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.

    Measured: Immediately after each of the 4 technology sessions during the intervention (one week apart)

  5. Observational and Computer Coding - Social, Conversational, and Kinesic Engagement - Technology Sessions

    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.

    Measured: Coded from audio and videotapes of each of the 4 technology (intervention) sessions.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2021
  2. Study start2 Oct 2021
  3. Primary completion16 Mar 2024
  4. Study completion16 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Dyads (older adult and adult child) 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)
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05150990
Sponsor's protocol ID
NIH 13336607
Other IDs
R42AG063640-02, 3R42AG063640-03S1
Acronym
Thrive
Status last verified
Jul 2026
First submitted
28 Oct 2021
Last updated
29 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified data and related information will be made available to researchers and data analysts at no cost through NACDA-Open Aging Repository (NACDA-OAR), which is an NIH-funded repository. Quantitative data, codebooks, descriptions of missing data, and any errors will be made available on the site. The data submitted will conform to the NACDA-OAR standards.

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