Improving Mental Health and Social Connectivity for Older Adults Through Virtual Reality-Based Social Interventions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 主要终点
- Depressive Symptoms (CES-D)
研究概览
简要总结
The goal of this clinical trial is to evaluate whether a virtual reality (VR) based social platform can improve mental health and social connection for older adults who receive in-home care. Specifically, the study aims to determine if the VR program reduces loneliness, depressive symptoms, and boredom while increasing social connection and well-being among older adult participants. It also explores whether access to the VR program reduces caregiver burden and depressive symptoms for family caregivers.
Researchers will compare an immediate-start group to a waitlist control group to assess whether the VR program improves outcomes compared to standard home care alone. Both groups will eventually receive the intervention. Older adult participants will use a VR headset at home to join group activities three times a week. These sessions include social activities with local peers and live-hosted group activities. A family caregiver or home care professional may be present during sessions if needed for support.
Over a 12-week study period, older adult participants will complete three surveys assessing their mood, social connection, and well-being. Family caregivers of participating older adults are also invited to join an optional caregiver substudy. Caregivers who enroll in the substudy will not participate in the VR activities themselves, but will complete three surveys at the same time points over the 12 weeks to share their own well-being and caregiving experiences.
详细描述
Approximately 90% of older adults in the United States prefer to age in place at home. However, older adults aging at home may experience social isolation and limited opportunities for meaningful social and cognitive engagement, which are associated with depression, cognitive decline, and increased mortality risk. Although home care services are designed to support physical and daily living needs, they may have limited capacity to provide ongoing social and cognitive engagement. The Thrive at Home study tests whether a networked virtual reality (VR) social platform can help address this gap by connecting older adults receiving home care with one another and with residents of nearby senior living communities.
This is a decentralized, randomized controlled trial using a waitlist control design. Two hundred fifty (250) home-dwelling adults aged 65 and older who are receiving in-home care will be enrolled from home care agency offices across approximately 25 U.S. cities. Participants span the cognitive range from unimpaired through moderate dementia, with a Montreal Cognitive Assessment (MoCA) score of 12 or above required for eligibility. Participants are randomized 1:1 to either Group 1 (Immediate Treatment) or Group 2 (Waitlist Control).
Intervention Timeline & Dosing:
- Group 1 (Immediate Treatment): Begins the VR social program within 1-3 weeks after baseline and participates for a 6-week primary intervention period, followed by a 4-week monitoring period during which platform access continues and spontaneous use is tracked.
- Group 2 (Waitlist Control): Continues standard home care alone for the first 6 weeks, and then crosses over to receive an abbreviated 4-week version of the VR social program.
Both arms eventually receive the intervention, protecting participant welfare while preserving a rigorous between-group, standard-of-care comparison at the primary 6-week timepoint. The intervention consists of three VR group activities per week: two local social sessions hosted by a community activity director, and one live, expert-hosted session of the participant's choosing. Sessions are conducted entirely from the participant's home while seated. Participants with a MoCA score below 18, or any participant requiring physical assistance, will have a caregiver or home care professional present during sessions for support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The primary statistician will remain masked until primary outcome analyses are completed.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PRIMARY PARTICIPANTS (OLDER ADULTS):
- •Aged 65 years or older.
- •Living in a private residence and receiving home care services from a participating provider, with services expected to continue for the duration of the study (approximately 4 months).
- •Montreal Cognitive Assessment (MoCA) score of 12 or above.
- •Fluent in English, sufficient to participate in group virtual reality (VR) sessions and complete verbal surveys.
- •Adequate vision and hearing to complete surveys and engage with VR experiences (mild impairments acceptable if corrected).
- •Has a family caregiver or home care professional available to support them at every VR session if the MoCA score is below 18 or the participant cannot physically manipulate the headset independently.
- •FAMILY CAREGIVERS (OPTIONAL SUBSTUDY):
- •Aged 18 years or older.
- •Identifies as the primary family caregiver for an enrolled primary participant (living with or visiting the primary participant at least twice per week).
- •Fluent in English and able to complete online surveys on a personal digital device (e.g., smartphone, laptop, tablet, or computer).
排除标准
- •PRIMARY PARTICIPANTS (OLDER ADULTS):
- •History of severe motion sickness or vertigo.
- •History of seizures or epilepsy.
- •Frequent and distressing hallucinations.
- •Aphasia or other communication barriers preventing verbal participation.
- •Severe disorientation or delirium.
- •Frequent and severe outbursts or emotional dyscontrol, or frequent and severe aggressive tendencies. (Typical sundowning is not exclusionary.)
- •Total vision loss not overcome by VR, or uncorrected hearing impairment that makes group conversation impracticable.
- •Residence in a senior living community or other congregate housing.
- •Presence of a harmful, aggressive, or abusive relationship with a family caregiver living in the home.
- •FAMILY CAREGIVERS (OPTIONAL SUBSTUDY):
- •Presence of an aggressive or abusive relationship with the enrolled primary participant.
研究组 & 干预措施
VR Intervention Group
Participants receive a 6-week VR-based social intervention.
干预措施: Full Virtual Reality Social Intervention (Behavioral)
Waitlist Control Group
Participants receive no VR intervention during the initial 6-week randomized period. Following assessment of the primary outcomes, they receive an abbreviated 4-week VR-based social intervention.
干预措施: Abbreviated Virtual Reality Social Intervention (Behavioral)
结局指标
主要结局
Depressive Symptoms (CES-D)
时间窗: Baseline (T1), Week 7 (T2), Week 12 (T3)
Depressive symptoms are assessed with a modified version of the 20-item Center for Epidemiologic Studies Depression Scale (CES-D). To increase measurement sensitivity, items are rated on a numerical response scale ranging from 0 to 100 rather than the standard 4-point Likert scale. Total scores are calculated as the mean across all 20 items (range: 0 to 100), where higher scores indicate greater depressive symptom severity.
Loneliness (UCLA Loneliness Scale)
时间窗: Baseline (T1), Week 7 (T2), Week 12 (T3)
Loneliness is assessed with a modified version of the 20-item UCLA Loneliness Scale (Version 3). To increase measurement sensitivity, items are rated on a numerical response scale ranging from 0 to 100 rather than the standard 4-point Likert scale. Total scores are calculated as the mean across all 20 items (range: 0 to 100), where higher scores indicate greater subjective loneliness.
Thriving (BIT)
时间窗: Baseline (T1), Week 7 (T2), Week 12 (T3)
Thriving is assessed with a modified version of the 10-item Brief Inventory of Thriving (BIT). To increase measurement sensitivity, the standard 5-point Likert scale is replaced with a 7-point Likert scale for each item. Total scores are calculated as the mean across all 10 items (range: 1 to 7), where higher scores indicate greater thriving.
Boredom (Short Boredom Proneness Scale)
时间窗: Baseline (T1), Week 7 (T2), Week 12 (T3)
Boredom is assessed using a modified Short Boredom Proneness Scale. Items are modified to assess state (vs. trait) boredom. Participants respond to 7 items on a 7-point Likert scale. Total scores are calculated as the mean across all 7 items (range: 1 to 7), where higher scores indicate greater state boredom.
次要结局
- Satisfaction with Home Care Services (CMS HHCAHPS, Adapted)(Baseline (T1), Week 7 (T2), Week 12 (T3))
- Global Cognitive Function (MoCA)(Screening (T0), Week 7 (T2), Week 12 (T3))
- Anxiety Symptoms (GAD-7)(Baseline (T1), Week 7 (T2), Week 12 (T3))
- Global Cognitive Function (MoCA)(Screening (T1), Week 7 (T2), Week 12 (T3))
- Anxiety Symptoms (GAD-7)(Screening (T1), Week 7 (T2), Week 12 (T3))
- Positive and Negative Affect (PANAS)(Baseline (T1), Week 7 (T2), Week 12 (T3))
- Vitality (Subjective Vitality Scale)(Baseline (T1), Week 7 (T2), Week 12 (T3))
- Companionship (PROMIS Companionship)(Baseline (T1), Week 7 (T2), Week 12 (T3))
- Social Connectedness(Baseline (T1), Week 7 (T2), Week 12 (T3))
研究者
Nancy Collins
Professor and Co-Principal Investigator
University of California, Santa Barbara