Technology and Family Thriving Study

NCT ID: NCT05150990

Last Updated: 2025-07-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-02

Study Completion Date

2024-03-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease Dementia Caregiver Burnout Quality of Life Mental Health Wellness 1 Loneliness Family Relationship

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

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)

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type BEHAVIORAL

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)

Group Type ACTIVE_COMPARATOR

Video Chat

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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


* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rendever, Inc.

INDUSTRY

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of California, Santa Barbara

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nancy Collins

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Oakmont of Camarillo

Camarillo, California, United States

Site Status

Friendship Manor

Goleta, California, United States

Site Status

Casa Dorinda

Montecito, California, United States

Site Status

Ojai Gables

Ojai, California, United States

Site Status

Garden Court on De La Vina

Santa Barbara, California, United States

Site Status

Covenant Living at the Samarkand

Santa Barbara, California, United States

Site Status

Gardens on Hope

Santa Barbara, California, United States

Site Status

Grace Village Apartments

Santa Barbara, California, United States

Site Status

Valle Verde

Santa Barbara, California, United States

Site Status

Vista Del Monte

Santa Barbara, California, United States

Site Status

Heritage House

Santa Barbara, California, United States

Site Status

Maravilla

Santa Barbara, California, United States

Site Status

Atterdag Village of Solvang

Solvang, California, United States

Site Status

Stone Hill at Andover

Andover, Massachusetts, United States

Site Status

Stonebridge at Burlington

Burlington, Massachusetts, United States

Site Status

Youville House Assisted Living

Cambridge, Massachusetts, United States

Site Status

Cadbury Commons

Cambridge, Massachusetts, United States

Site Status

Brightview Canton

Canton, Massachusetts, United States

Site Status

The Linden at Danvers

Danvers, Massachusetts, United States

Site Status

Brightview North Andover

North Andover, Massachusetts, United States

Site Status

Benchmark of Norwood (Clapboardtree)

Norwood, Massachusetts, United States

Site Status

Laurelwood at The Pinehills

Plymouth, Massachusetts, United States

Site Status

Autumn Glen at Dartmouth

South Dartmouth, Massachusetts, United States

Site Status

Bayberry at Emerald Court

Tewksbury, Massachusetts, United States

Site Status

Carriage House at Lee's Farm

Wayland, Massachusetts, United States

Site Status

Ledgewood Bay Assisted Living

Milford, New Hampshire, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Informed Consent for Older Adult (Resident)

View Document

Document Type: Informed Consent Form: Informed Consent for Adult Child (Family Member)

View Document

Document Type: Informed Consent Form: Informed Consent for Legal Representative

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R42AG063640-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

3R42AG063640-03S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIH 13336607

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Caring for the Caregiver Network
NCT03049501 COMPLETED NA
Telephone Support for Dementia Caregivers
NCT00735800 COMPLETED PHASE2