NCT07430371

Brief Summary

The VR-CARES project is an innovative, collaborative effort that invites dementia care professionals into the design process of a virtual reality platform seeking to mitigate their work-related burden and social isolation by cultivating a virtual community of support. The co-created, caregiver-specific VR platform will serve as a safe, communal space where caregivers can remotely connect with their peers, share fun experiences together, access support, learn self-care and build resilience within a supportive virtual network to enhance their social and mental health and job satisfaction. Central to VR-CARES in the principle of user-led innovation, ensuring that the technology not only serves but is informed and successfully adopted by the very individuals it intends to benefit, an important standard for empathetic and inclusive technology in healthcare.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Mar 2026Oct 2026

First Submitted

Initial submission to the registry

February 5, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

March 11, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

February 5, 2026

Last Update Submit

April 17, 2026

Conditions

Keywords

Virtual Reality Support GroupCaregiver Support GroupPeer SupportDementia Caregiver

Outcome Measures

Primary Outcomes (3)

  • System Usability Scale (SUS) Score

    A 10-item questionnaire measuring subjective usability of the VR technology platforms. To gain more nuanced meaning from the data, items are rated using a numerical response scale with ratio properties and finite anchors, the Global Hedonic Intensity Scale (GHIS), in place of a 5-point categorical scale. The GHIS is a bipolar 100-point sliding scale with -100 representing the most unpleasant personal experience, 0 neutral, and +100 representing the most pleasurable personal experience (Bartoshuk et al., 2004; Lim et al., 2009). Scores of each item are averaged for a total score. To score it traditionally for direct comparison in the literature, scores of each item will be divided back into the 5-point categorical scores, totaled, and multiplied by 2.5 to range from 0 to 100 (Lewis \& Sauro, 2020). Higher scores indicate better usability. A traditionally scored value above 68 is considered above average usability.

    Assessed at mid-point (T2 - 8 weeks, post Rendever social engagement VR platform) and end of study (T3 - 16 weeks, post VR-CARES caregiver support platform). T2 vs. T3 comparison provides usability data for each intervention phase.

  • Mean Change in Caregiver Job Satisfaction

    Job satisfaction will be assessed with the Centers for Medicare and Medicaid Services' (CMS) Nursing Home Employee Satisfaction Survey adapted for home care workers. 34 items make up 4 subsections: job satisfaction, team building and communication, scheduling and staffing, and management and leadership. For more sensitive measurmment of change over time, a bipolar 100-point slider scale is provided to indicate the degree to which one 100% disagrees or 100% agrees with each statement instead of the 5-item Likert response scale typically provided. The total score is the mean of items (range: -100 to +100). To score it traditionally for direct comparison in the literature, scores of each item are divided back into the 5-point Likert scale and averaged. The total score and scores of each subsection will be calculated and analyzed. Higher scores indicate greater job satisfaction. This measure aligns with CMS quality metrics and workforce sustainability priorities for long-term care.

    Assessed at enrollment (T1- baseline), mid-point (T2- 8 weeks, post Rendever social engagement VR platform), and end of study (T3- 16 weeks, post VR-CARES platform) - allows detection of the impact of each intervention phase on job satisfaction change.

  • Mean Change in Caregiver Empowerment

    Caregiver empowerment is assessed with the 13-item Personal Self-Efficacy (PSE) and the 7-item Caregiver Self-Efficacy (CSE) subsections of the Caregiver Empowerment Scale. For more accurate detection of significance and measure of change over time, items are rated using the GHIS bipolar 100-point sliding response scale (-100 labeled as the most unpleasant personal experience, 0 neutral, and +100 representing the most pleasurable personal experience (Bartoshuk et al., 2004; Lim et al., 2009)) in place of a 5-point categorical scale of low to high. Item's scores are averaged for a total score. To score it traditionally for direct comparison in the literature, items' scores are divided back into the 5-point categorical scores, totaled, and multiplied by 2.5 (range: 0-100) (Lewis \& Sauro, 2020). Higher scores indicate greater empowerment and confidence as a caregiver. Caregiver empowerment is a key outcome valued in social engagement interventions.

    Assessed at enrollment (T1- baseline), mid-point (T2- 8 weeks), and end of study (T3- 16 weeks) - allows identification of whether empowerment gains occur during the core social engagement phase, the caregiver-specific program, or accumulate across both.

Secondary Outcomes (16)

  • Adherence to VR-CARES Intervention

    Assessed at end of study (T3 - 16 weeks, post VR-CARES caregiver support platform). Adherence data is collected continuously during the VR-CARES intervention period (weeks 9-16) and summarized at T3.

  • Mean Change in Study-Specific Caregiver Job Satisfaction Items

    Assessed at enrollment (T1 - baseline), mid-point (T2 - 8 weeks), and end of study (T3 - 16 weeks). Three-timepoint assessment allows detection of the impact of each intervention phase on job satisfaction change.

  • Technology Acceptance Model (TAM) Score

    Assessed at mid-point (T2 - 8 weeks, post Rendever social engagement VR platform) and end of study (T3 - 16 weeks, post VR-CARES caregiver support platform).

  • User Experience Questionnaire Short Form (UEQ-S) Score

    Assessed at mid-point (T2 - 8 weeks, post Rendever social engagement VR platform) and end of study (T3 - 16 weeks, post VR-CARES caregiver support platform).

  • User Experience Questionnaire+ (UEQ+) for Voice Assistants Score

    Assessed at mid-point (T2 - 8 weeks) only, post Rendever social engagement VR platform. This measure is specific to Intervention 1 and is not administered at T3.

  • +11 more secondary outcomes

Study Arms (1)

Direct Care Worker Cohort

EXPERIMENTAL
Behavioral: Rendever VR Social Engagement PlatformBehavioral: VR-CARES Platform

Interventions

Participants will be trained how to use Rendever's core VR platform (Engage) and encouraged to use the core social platform independently and with their clients for \~4-8 weeks to build rapport and engage their clients doing fun activities, traveling, visiting personally important places to each other in the VR platform.

Also known as: Rendever Engage
Direct Care Worker Cohort

Participants will use Rendever's newly designed VR-CARES support platform, developed with insights from the first focus group, for 8 weeks. Participants engage with other direct care workers in a virtual community support setting intended to provide supportive resources and content for group social activities and improve wellbeing and job satisfaction for direct care workers.

Also known as: VR-CARES
Direct Care Worker Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Employed by Right at Home and have at least one older adult client with Mild Cognitive Impairment or Alzheimer's Disease or Related Dementia
  • At least 18 years of age
  • Are proficient in English

You may not qualify if:

  • History of seizures, severe vertigo or motion sickness
  • Are unable to see images in the virtual reality headset

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Comfort Keepers Home Care

San Diego, California, 92120, United States

RECRUITING

Rendever, Inc.

Boston, Massachusetts, 02109, United States

RECRUITING

Right at Home

Brighton, Michigan, 48116, United States

RECRUITING

Right at Home

East Lansing, Michigan, 48823, United States

RECRUITING

Right at Home

Novi, Michigan, 48375, United States

RECRUITING

Right at Home

Owosso, Michigan, 48867, United States

RECRUITING

Central Study Contacts

Jennifer Stamps, PhD, PhD

CONTACT

Julia Bandini, PhD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2026

First Posted

February 24, 2026

Study Start

March 11, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

All subject-level clinical data, including, usage data from the Virtual Reality intervention, information collected through focus groups and interviews, and self-reported survey measures on job satisfaction, caregiver burden, mental health, social health and user experience, will be preserved and shared with one exception. The RAND IRB does not allow depositing full interview/group audio or full transcripts to be deposited; however, the codebook, interviewer protocols, and focus group questions will be shared. Shared data will be de-identified, and original data will be securely maintained at the investigator's institution. Data will be shared in accordance with applicable privacy regulations, including HIPAA (if applicable) and institutional data sharing policies. Aggregate demographic data will be provided to enable assessment of sample representativeness.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Data will become available 6 months after publication of primary outcomes and will remain available for a minimum of 5 years through a secure institutional repository. The timeline may be extended or adjusted based on funder requirements, journal policies, or institutional data retention policies.
Access Criteria
Data will be shared under a two-tier distribution system. All data that can be de-identified will be publicly shared as allowed by the informed consents and institutional certification on The Open Science Framework (OSF) website. Data with specific confidentiality risks will not be shared publicly. Data with increased risk of re-identification will be shared under a data-use agreement that clearly establishes user rules to facilitate respondent confidentiality. Proposals should be directed to jennifer@rendever.com and jbandini@rand.org. Priority will be given to proposals that advance caregiver health research, VR intervention science, or workforce retention. Data will be provided in de-identified format via secure file transfer.

Locations