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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 55
- 主要终点
- Quality of Life in Alzheimer's Disease (QOL-AD) - Changes From Baseline (Older Adult)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Virtual Reality
Weekly activities using virtual reality (Rendever)
干预措施: Virtual Reality (Behavioral)
Video Chat
Weekly activities using video conference (Zoom)
干预措施: Video Chat (Behavioral)
结局指标
主要结局
Quality of Life in Alzheimer's Disease (QOL-AD) - Changes From Baseline (Older Adult)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Telepresence and Copresence - Technology Session(Measured after the first technology session (Week 1 of the intervention))
- Positive and Negative Affect Schedule (PANAS) - Technology Sessions(Immediately after each of the 4 technology sessions during the intervention (one week apart))
- Social and Conversational Engagement - Technology Sessions(Immediately after each of the 4 technology sessions during the intervention (one week apart))
- Relationship Satisfaction and Communication Quality - Technology Sessions(Immediately after each of the 4 technology sessions during the intervention (one week apart))
- Telepresence and Copresence - Technology Session(Immediately after each of the 4 technology sessions during the intervention (one week apart))
- Observational and Computer Coding - Social, Conversational, and Kinesic Engagement - Technology Sessions(Coded from audio and videotapes of each of the 4 technology (intervention) sessions.)
研究者
Nancy Collins
Professor
University of California, Santa Barbara