Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
186 participants
INTERVENTIONAL
2021-10-02
2024-03-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dementia Family Caregiver Study
NCT04894006
In-Home Technology for Caregivers of People With Dementia and Mild Cognitive Impairment: Spanish Language Homes
NCT05159596
Telehealth to Reduce Mental Health in Family Caregivers
NCT05696704
VR&R: Providing Caregiver Respite by Managing BPSDs and Improving QoL in People with Dementia Using Immersive VR-Therapy
NCT05867641
Assistive Technology and Reduced Caregiver Burden
NCT05352529
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Virtual Reality
Weekly activities using virtual reality (Rendever)
Virtual Reality
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 Chat
Weekly activities using video conference (Zoom)
Video Chat
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Virtual Reality
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 Chat
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
* History of seizure, severe vertigo, hallucinations, or aggression
* Severe visual impairment (screening will be conducted to determine if vision is sufficient to participate)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rendever, Inc.
INDUSTRY
National Institute on Aging (NIA)
NIH
University of California, Santa Barbara
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nancy Collins
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tamara Afifi, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Santa Barbara
Kyle Rand, B.A.
Role: PRINCIPAL_INVESTIGATOR
Rendever Co.
Nancy Collins, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Santa Barbara
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Belmont Calabasas
Calabasas, California, United States
Oakmont of Camarillo
Camarillo, California, United States
Friendship Manor
Goleta, California, United States
Casa Dorinda
Montecito, California, United States
Ojai Gables
Ojai, California, United States
Garden Court on De La Vina
Santa Barbara, California, United States
Covenant Living at the Samarkand
Santa Barbara, California, United States
Gardens on Hope
Santa Barbara, California, United States
Grace Village Apartments
Santa Barbara, California, United States
Valle Verde
Santa Barbara, California, United States
Vista Del Monte
Santa Barbara, California, United States
Heritage House
Santa Barbara, California, United States
Maravilla
Santa Barbara, California, United States
Atterdag Village of Solvang
Solvang, California, United States
Stone Hill at Andover
Andover, Massachusetts, United States
Stonebridge at Burlington
Burlington, Massachusetts, United States
Youville House Assisted Living
Cambridge, Massachusetts, United States
Cadbury Commons
Cambridge, Massachusetts, United States
Brightview Canton
Canton, Massachusetts, United States
The Linden at Danvers
Danvers, Massachusetts, United States
Brightview North Andover
North Andover, Massachusetts, United States
Benchmark of Norwood (Clapboardtree)
Norwood, Massachusetts, United States
Laurelwood at The Pinehills
Plymouth, Massachusetts, United States
Autumn Glen at Dartmouth
South Dartmouth, Massachusetts, United States
Bayberry at Emerald Court
Tewksbury, Massachusetts, United States
Carriage House at Lee's Farm
Wayland, Massachusetts, United States
Ledgewood Bay Assisted Living
Milford, New Hampshire, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form: Informed Consent for Older Adult (Resident)
Document Type: Informed Consent Form: Informed Consent for Adult Child (Family Member)
Document Type: Informed Consent Form: Informed Consent for Legal Representative
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.