Direct Care WorkersVR-CARESNCT07430371
Virtual Reality for Caregiver Assembly, Relief, Empowerment, and Support (VR-CARES)
A study testing Rendever VR Social Engagement Platform and VR-CARES Platform in people with Direct Care Workers and Dementia Caregiver, run by Rendever, Inc. at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Direct Care Workers, Dementia Caregiver, In-Home Care
- What is being tested?
- Rendever VR Social Engagement Platform and VR-CARES Platform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 8 sitesUnited States
- Study dates
- 11 Mar 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employed by an in-home care agency 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
Who cannot join
- History of seizures or severe motion sickness
- Are unable to see images in the virtual reality headset
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Halcyon Home
Austin, Texas, 78759
Rendever, Inc.
Boston, Massachusetts, 02109
Right at Home
Brighton, Michigan, 48116
Right at Home
East Lansing, Michigan, 48823
Right at Home
Novi, Michigan, 48375
Right at Home
Owosso, Michigan, 48867
Right at Home
Salem, Massachusetts, 01970
Comfort Keepers Home Care
San Diego, California, 92120
About this study
Official title: VR-CARES: Feasibility of Virtual Reality for Caregiver Assembly, Relief, Empowerment, and Support to Improve Social Connection, Health, and At-home Dementia Care
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.
Read the detailed description
The escalating demand for home-based caregiving, combined with a high turnover rate and prevalence of stress and burden in this workforce, presents a unique challenge within the healthcare sector. High turnover rates are especially difficult for care recipients with dementia who benefit from consistency. Caregivers are often socially isolated at work due to the intimate care they provide to socially isolated clients. The VR-CARES initiative is an innovative response to these issues built upon Rendever's existing social engagement VR platform and vast content to provide a novel caregiver support virtual reality (VR) platform for dementia caregivers providing in-home care that generates real community and connectivity. Rendever, a pioneer in VR for older adults, enables shared experiences with networked communication technology that overcomes geographical distance, lack of transportation, mobility issues, low vision, or cognitive impairment so they can connect with others for group travel, activities, games, and sharing life stories.
Study Design. The proposed 3-aim project takes a human-centered design approach grounded in an in-depth qualitative understanding of the target population with multiple stages of user feedback to inform an iteratively developed VR platform to support home care workers and to test the feasibility of the resulting VR Caregiver platform with them. The investigators refer to this project as "VR Cares: Virtual Reality for Caregiver Assembly, Relief, Empowerment, and Support to improve social connection, health, and at-home dementia care" (VR CARES). The process followed has been summarized by the IDEAS framework and the Stanford d.school as encompassing 5 phases: "empathize" (understand target population), "define" (identify goals and scope), "ideate" (brainstorm potential solutions), "prototype" (build potential solutions), and "test" (gather feedback from target users).
Participants. The investigators will recruit dementia caregivers (n=30) to participate in pre/post-focus groups/interviews and up to 16 weeks of product use. The investigators will recruit caregivers across the United States who are employed by an in-home care agency. Demographics will be gathered during the screening process to help ensure our study represents the general population of direct care workers with roughly 34% White, 26% Hispanic, 26% Black, and 14% Non-Hispanic Other racial identification. Direct care workers will be at least 18 years of age, proficient in English, and provide care for at least one older adult client living with mild cognitive impairment (MCI) or dementia. Exclusion criteria include extreme motion sickness preventing an individual from participating in VR activities or a history of seizures.
AIM 1: Once enrollment is complete, at Time 1 (T1), the investigators will conduct the baseline survey (Survey #1). A trainer/implementation specialist from Rendever will provide each caregiver with a Rendever social engagement VR system consisting of 2 VR headsets and 1 control tablet and will train them on how to use the basic Rendever engagement platform in VR that will be the backbone of the VR-CARES support platform. During this baseline period, RAND will conduct focus groups/interviews with caregivers to empathize with the target users and gather their insights to ground the development in a behavioral theory with responses to qualitative research questions such as, "How can a VR platform support social gatherings and support groups to help manage stress and improve job satisfaction?". RAND will analyze findings from these focus groups/interviews and share them with the Rendever researchers and Rendever's CTO to inform the development of the VR-CARES platform prototype.
AIM 2: During the ~4-8 weeks Rendever's development team of software engineers builds the platform, the Caregivers will use the core Rendever social engagement VR platform alone and/or with their clients to familiarize themselves with what can be done on the basic platform, allowing them to become familiar with using the basic platform before being introduced to the additional features and capabilities of the VR-CARES platform that will be added to it. This will also allow the researchers to tease out the barriers to use of the basic VR platform versus the barriers to use of the added features of the VR-CARES platform. It also allows us to control for the impact of using Rendever's basic VR engagement platform alone and with clients versus the additional impact of using the VR-CARES platform to engage with other direct care workers for social support.
AIM 3: Following these ~4-8 weeks of development and the caregivers' use of Rendever's basic VR platform with their clients, the caregivers will be sent via email an online survey (Survey #2) and then Rendever will send the VR-CARES platform as an update to their Rendever systems. Rendever's research team will remotely train the caregivers how to use the VR-CARES platform. The caregivers will then begin using the VR-CARES platform with each other to participate in virtual activities, training, and support groups inspired by the first focus group/interview. They will be shown how they can casually meet up with other available caregivers to gather on the virtual back porch to visit, debrief about their day, and choose fun activities to do together in Rendever just for fun and friendship building such as all go on a tour of Rome, hike the Grand Canyon, or swim with Dolphins. They will also participate in a weekly support group centered on self-care and dementia care and offered multiple times to accommodate different schedules. These will be led and moderated by a NAMI (National Alliance on Mental Illness)-certified instructor on Rendever's research team. They will also participate in group activities identified by the pre-focus group/interviews. They may continue to use the basic Rendever VR platform with their clients during this time if they wish.
Following the up to 8 weeks of using the VR-CARES platform with other caregivers, participating caregivers will complete a post-project survey (Survey #3). RAND's research team will conduct a second round of focus groups/interviews with up to 30 caregivers and share the findings with Rendever's research and development teams for further reiteration and VR-CARES platform refinement.
- Conditions
- Direct Care Workers, Dementia Caregiver, In-Home Care, Caregiver Social Support, Peer Support
- Being tested
- Rendever VR Social Engagement Platform, VR-CARES Platform
- Keywords
- Virtual Reality Support Group, Caregiver Support Group, Peer Support, Dementia Caregiver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rendever VR Social Engagement PlatformBehavioural
Also called Rendever Engage
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.
VR-CARES PlatformBehavioural
Also called VR-CARES
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.
| Study group | Role | What they receive |
|---|---|---|
| Direct Care Worker Cohort | Experimental | Not described Receives: Behavioral: Rendever VR Social Engagement Platform; Behavioral: VR-CARES Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Adherence will be defined as the average number of group activities attended during the 8-week VR-CARES intervention period. Attendance will be recorded automatically via the VR-CARES platform for each session. Higher values indicate greater adherence to the VR-CARES intervention.
Measured: 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
Three study-specific items assess caregivers' experiential and emotional dimensions of job satisfaction, complementing the structural job satisfaction domains captured by the CMS Employee Satisfaction Survey (primary outcome), providing a 2-dimensional view of job satisfaction. Items are rated on the Global Hedonic Intensity Scale (GHIS) bipolar 100-point sliding scale (-100 = most unpleasant personal experience, 0 = neutral, +100 = most pleasurable personal experience). The three items are: (1) Overall, how do you feel about the work you do? (2) How would you rate the level of care you provide to clients? (3) How positive, neutral, or negative do you feel about continuing to work at your current home care provider office? Scores are averaged across the three items. Higher scores indicate more positive feelings about caregiving work.
Measured: 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
Technology acceptance is indicated with the 6-item Perceived Usefulness subset of the TAM, one item from the TAM Perceived Ease of Use subset (How pleasant or unpleasant was learning how to use the technology?) and one item from the TAM Attitude of Use subset (All things considered, how do you feel about using the technology?). The numerical GHIS, -100 (most unpleasant experience of your life) to 0 (neutral) to +100 (most pleasant experience of your life) is provided as the response scale (Lim et al., 2009), in place of a 7-point Likert scale. Scores of each item are averaged for a total score. To score it traditionally for direct comparison in the literature, scores of each item are divided back into the 7-point Likert scale scores and averaged. Higher scores indicate better acceptance, perceived usefulness, and adoption likelihood by the target population. TAM provides the adoption and sustainability narrative that complements usability data from the SUS.
Measured: 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
The UEQ-S measures the overall appeal of the technology in two domains and 6 dimensions of user experience: pragmatic quality and hedonic quality. Pragmatic quality refers to the usability, efficiency, and clarity of the technology, while hedonic quality refers to the stimulation, interest, and novelty of it. Each of the 8 items consists of a pair of contrasting attributes (e.g., boring vs. exciting) rated on a 7-point semantic differential scale from -3 to +3. Two additional study-specific items were added: at T2 only, 'confusing for my clients vs. reassuring for my clients'; and at T2 and T3, 'creating more work for me vs. providing relief for me.' These study-specific items capture caregiver-relevant dimensions absent from the standard UEQ-S. Scores for each dimension are averaged. Values between -0.8 and 0.8 represent a neutral evaluation, while values > 0.8 indicate a positive user experience.
Measured: 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
The UEQ+ Type 1 for Voice Assistants measures acceptance and satisfaction of voice interaction with a virtual assistant/chatbot/embodied, AI-powered companion and guide (Nova) within the Rendever social engagement platform that allows conversational control of the technology. 12 items make up 3 subsections of the UEQ+VA: Response Behavior, Response Quality, and Comprehensibility. 12 additional, study-specific items assess the voice assistant's communication and companionship capabilities (e.g., impatient with my clients with dementia vs. patient with my clients with dementia; a poor companion vs. a good companion). Each item consists of a pair of contrasting attributes (e.g., artificial vs. natural) rated on a 7-point semantic differential scale (-3 to +3). Scores for each dimension are averaged. Values between -0.8 and 0.8 represent a neutral evaluation. Values > 0.8 indicate a positive user experience. This measure captures the voice interaction experience unique to intervention 1.
Measured: 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.
User Experience Questionnaire+ (UEQ+) Social Survey Score
Three of the four surveys of the UEQ+ Social Scales for interactive products are used to measure the social dimension of the user experience of the VR-CARES platform. The 3 sub-surveys measure social interaction, social stimulation, and social acceptance enabled by the VR-CARES program for the caregivers. Each of the 13 items consists of a pair of contrasting attributes (e.g., left out by others vs. welcomed by others) rated on a 7-point semantic differential scale from -3 to +3. Scores for each dimension are averaged. Values between -0.8 and 0.8 represent a neutral evaluation, while values > 0.8 indicate a positive social experience by the user. This measure is time-matched exclusively to Intervention 2 (the VR-CARES caregiver support program) and captures the social UX that is unique to that phase.
Measured: Assessed at end of study (T3 - 16 weeks) only, post VR-CARES caregiver support platform. This measure is specific to Intervention 2 and is not administered at T2.
Study-Specific User Experience Scores - Rendever Platform (3 items)
Three study-specific items assess experiential dimensions of the Rendever social engagement platform that are not captured by the standardized UX instruments. Items are rated on the Global Hedonic Intensity Scale (GHIS) bipolar 100-point sliding scale (-100 = most unpleasant personal experience, 0 = neutral, +100 = most pleasurable personal experience). The three items are: (1) What level of enjoyment did you experience when using Rendever by yourself? (2) What level of enjoyment did you experience when using Rendever with your clients? (3) How positive or negative was the impact of using Rendever with clients on your job satisfaction? Item 2 captures the shared-experience dimension that is central to the Rendever platform's value proposition for caregivers and clients. Item 3 directly links the VR experience to the job satisfaction outcome domain. Scores are reported individually and as a mean across all three items.
Measured: Assessed at mid-point (T2 - 8 weeks) only, post Rendever social engagement VR platform. These items are specific to Intervention 1.
Study-Specific User Experience Scores - VR-CARES Platform (12 items)
12 study-specific items assess intervention-relevant dimensions of the VR-CARES platform that aren't captured by standardized UX instruments, such as peer support, training quality, burden and stress relief. Items are rated on the GHIS bipolar 100-point sliding scale (-100 = most unpleasant personal experience, 0 = neutral, +100 = most pleasurable personal experience). Examples of the 12 items: In general, what level of enjoyment did you experience when using the VR-CARES platform? How was VR-CARES at creating new friendships and strengthening relationships between caregivers? How would you rate the group sessions in VR-CARES on relieving job stress? How was the VR-CARES training on caring for clients with dementia? How was VR-CARES at helping you overcome the social isolation that can occur with being a caregiver? Scores are reported individually and as a total mean. Higher scores indicate greater impact and satisfaction with the VR-CARES program.
Measured: Assessed at end of study (T3 - 16 weeks) only, post VR-CARES caregiver support platform. These items are specific to Intervention 2.
Mean Change in Patient Health Questionnaire-4 (PHQ-4)
The PHQ-4 is a 4-item ultra-brief clinical screening tool for depression and anxiety combining the PHQ-2 (depression) and GAD-2 (anxiety) subscales. Participants rate how intensely they have felt symptoms over the past 2 weeks using the 100-point Global Sensory Intensity Scale (GSIS): 0 = Not at All, 100 = as Intensely as the Intensity of the Brightness of the Sun. The total score is the average score of all items: range 0-100, with 25-49 indicating mild symptoms, 50-74 moderate symptoms, and 75-100 severe symptoms. The GSIS is a numerical scale with ratio properties and a universal intensity anchor independent of the domain of the items, allowing accurate measurement of change in score from each intervention and determination of clinical significance free from statistical artifacts of ordinal data. To score it traditionally for direct comparison in the literature, scores are divided back into a 4-point Likert scale and totaled. Lower scores indicate better mental health.
Measured: 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 depression and anxiety.
Mean Change in Mental Health Inventory-5 (MHI-5)
The Mental Health Inventory 5-item Scale will be used to assess general mental health and wellbeing. Items are rated on the 100-point Global Sensory Intensity Scale (GSIS): 0 = Not at All and 100 = as Intensely as the Intensity of the Brightness of the Sun. The total score is the mean of all items (range: 0 to 100). Two items are reverse coded before averaging so that higher means indicate better mental health. The GSIS provides ratio-level measurement with increased sensitivity to detect change and determine significance compared to the original categorical response options.
Measured: 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 changes in general mental health and wellbeing.
Mean Change in PROMIS Companionship Short Form 4a
The PROMIS Companionship Short Form 4a measures perceived availability of friends and companions for positive social interaction. To increase measurement sensitivity while preserving the construct and response framework of the validated instrument, items are rated on a continuous 100-point slider scale ranging from 0% to 100% of the time, with the original 5-point Likert categorical labels retained as reference anchors along the slider: Never (0%), Rarely (25%), Sometimes (50%), Usually (75%), Always (100%). Higher scores indicate greater companionship. Raw scores will also be converted to standard T-scores (mean = 50, SD = 10) referenced to the U.S. general population for normative comparison in the PROMIS Social Relationships Scoring Manual.
Measured: Assessed at mid-point (T2 - 8 weeks) as the baseline measure and end of study (T3 - 16 weeks) as the post-VR-CARES intervention measure.
Mean Change in PROMIS Emotional Support Short Form 6a
The PROMIS Emotional Support Short Form 6a measures perceived availability of someone to talk to about problems, confide in, and turn to for support and understanding. To increase measurement sensitivity while preserving the construct and response framework of the validated instrument, items are rated on a continuous 100-point slider scale ranging from 0% to 100% of the time, with the original 5-point Likert categorical labels retained as reference anchors along the slider: Never (0%), Rarely (25%), Sometimes (50%), Usually (75%), Always (100%). Higher scores indicate greater emotional support. Raw scores will also be converted to standard T-scores (mean = 50, SD = 10) referenced to the U.S. general population for normative comparison in the PROMIS Social Relationships Scoring Manual.
Measured: Assessed at mid-point (T2 - 8 weeks) as the baseline measure and end of study (T3 - 16 weeks) as the post-VR-CARES intervention measure.
Mean Change in Lubben Social Network Scale (LSNS-6)
Social network size and engagement will be assessed using the 6-item Lubben Social Network Scale. Items are rated on a 5-point scale with 1 being the least amount of contacts and 5 being the highest amount of contacts. The total score is the sum of all items (range: 6 to 30), with higher totals representing larger and more engaged social networks. Scores below 12 indicate risk for social isolation. The LSNS-6 captures objective network characteristics that complement the perceived social support measures (PROMIS Companionship and Emotional Support).
Measured: Assessed at mid-point (T2 - 8 weeks) as the baseline measure and end of study (T3 - 16 weeks) as the post-VR-CARES intervention measure.
Mean Change in UCLA Loneliness Scale-3 (ULS-3)
The short form, 3-item version of the UCLA Loneliness Scale will be used to assess loneliness. The three items are adapted to use the 100-point Global Sensory Intensity Scale (GSIS): 0 = No Sensation and 100 = Intense as the Brightness of the Sun. The score is the sum of all items (range: 0 to 300). 0-85 = not lonely, 86-171 = moderately lonely, 172-300 = very lonely. Higher scores indicate greater feelings of loneliness. The ULS-3 provides a loneliness-specific measure not captured by the companionship, emotional support, or social network scales, and its use of the GSIS places it within the psychophysical scaling framework used across the study battery, improving methodological consistency and measurement sensitivity.
Measured: 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 changes in feeling lonely.
Mean Change in Archangels Caregiver Intensity Index
11 items of the Archangels Caregiver Intensity Index assess the intensity and attitudes of caregiving responsibilities. ACII items pertaining to family caregivers (e.g. financial impact on family) were removed. Items evaluate stress, preparedness, ability to cope, and the personal impact of caregiving. To increase measurement sensitivity and maintain consistency with the psychophysical scaling approach used across the study battery, items are rated on the 100-point Global Sensory Intensity Scale (GSIS): 0 = No Sensation and 100 = Intense as the Brightness of the Sun. The total score is the mean of all items (range: 0 to 100). Higher scores indicate greater caregiving burden and intensity. This measure captures the practical demands placed on caregivers and complements the empowerment measures by providing a burden relieving-focused perspective.
Measured: 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 changes in caregiver intensity.
Mean Change in Jefferson Scale of Empathy for Care Professionals (Adapted)
Empathy will be assessed using a 20-item Jefferson Scale of Empathy adapted for Care Professionals (Hojat et al., 2018). Each item will be scored on a bipolar 100-point scale: -100 representing the strongest level of disagreement and +100 representing the strongest level of agreement. Higher scores indicate greater empathy toward clients. This measure assesses whether the social VR interventions, particularly the shared experience and perspective-taking facilitated by VR, influence caregivers' empathic engagement with their clients.
Measured: 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 changes in empathy for care clients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start11 Mar 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Direct Care WorkersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rendever, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), RAND
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430371
- Sponsor's protocol ID
- 1R41AG092119
- Other IDs
- 1R41AG092119
- Acronym
- VR-CARES
- Status last verified
- Aug 2026
- First submitted
- 5 Feb 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VR-CARES: Feasibility of Virtual Reality for Caregiver Assembly, Relief, Empowerment, and Support to Improve Social Connection, Health, and At-home Dementia Care
- ClinicalTrials.gov ID
- NCT07430371
- Acronym / sponsor ID
- VR-CARES / 1R41AG092119
- Conditions
- Direct Care Workers, Dementia Caregiver, In-Home Care, Caregiver Social Support, Peer Support
- Keywords
- Virtual Reality Support Group, Caregiver Support Group, Peer Support, Dementia Caregiver
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rendever, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), RAND
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The escalating demand for home-based caregiving, combined with a high turnover rate and prevalence of stress and burden in this workforce, presents a unique challenge within the healthcare sector. High turnover rates are especially difficult for care recipients with dementia who benefit from consistency. Caregivers are often socially isolated at work due to the intimate care they provide to socially isolated clients. The VR-CARES initiative is an innovative response to these issues built upon Rendever's existing social engagement VR platform and vast content to provide a novel caregiver support virtual reality (VR) platform for dementia caregivers providing in-home care that generates real community and connectivity. Rendever, a pioneer in VR for older adults, enables shared experiences with networked communication technology that overcomes geographical distance, lack of transportation, mobility issues, low vision, or cognitive impairment so they can connect with others for group travel, activities, games, and sharing life stories.
Study Design. The proposed 3-aim project takes a human-centered design approach grounded in an in-depth qualitative understanding of the target population with multiple stages of user feedback to inform an iteratively developed VR platform to support home care workers and to test the feasibility of the resulting VR Caregiver platform with them. The investigators refer to this project as "VR Cares: Virtual Reality for Caregiver Assembly, Relief, Empowerment, and Support to improve social connection, health, and at-home dementia care" (VR CARES). The process followed has been summarized by the IDEAS framework and the Stanford d.school as encompassing 5 phases: "empathize" (understand target population), "define" (identify goals and scope), "ideate" (brainstorm potential solutions), "prototype" (build potential solutions), and "test" (gather feedback from target users).
Participants. The investigators will recruit dementia caregivers (n=30) to participate in pre/post-focus groups/interviews and up to 16 weeks of product use. The investigators will recruit caregivers across the United States who are employed by an in-home care agency. Demographics will be gathered during the screening process to help ensure our study represents the general population of direct care workers with roughly 34% White, 26% Hispanic, 26% Black, and 14% Non-Hispanic Other racial identification. Direct care workers will be at least 18 years of age, proficient in English, and provide care for at least one older adult client living with mild cognitive impairment (MCI) or dementia. Exclusion criteria include extreme motion sickness preventing an individual from participating in VR activities or a history of seizures.
AIM 1: Once enrollment is complete, at Time 1 (T1), the investigators will conduct the baseline survey (Survey #1). A trainer/implementation specialist from Rendever will provide each caregiver with a Rendever social engagement VR system consisting of 2 VR headsets and 1 control tablet and will train them on how to use the basic Rendever engagement platform in VR that will be the backbone of the VR-CARES support platform. During this baseline period, RAND will conduct focus groups/interviews with caregivers to empathize with the target users and gather their insights to ground the development in a behavioral theory with responses to qualitative research questions such as, "How can a VR platform support social gatherings and support groups to help manage stress and improve job satisfaction?". RAND will analyze findings from these focus groups/interviews and share them with the Rendever researchers and Rendever's CTO to inform the development of the VR-CARES platform prototype.
AIM 2: During the ~4-8 weeks Rendever's development team of software engineers builds the platform, the Caregivers will use the core Rendever social engagement VR platform alone and/or with their clients to familiarize themselves with what can be done on the basic platform, allowing them to become familiar with using the basic platform before being introduced to the additional features and capabilities of the VR-CARES platform that will be added to it. This will also allow the researchers to tease out the barriers to use of the basic VR platform versus the barriers to use of the added features of the VR-CARES platform. It also allows us to control for the impact of using Rendever's basic VR engagement platform alone and with clients versus the additional impact of using the VR-CARES platform to engage with other direct care workers for social support.
AIM 3: Following these ~4-8 weeks of development and the caregivers' use of Rendever's basic VR platform with their clients, the caregivers will be sent via email an online survey (Survey #2) and then Rendever will send the VR-CARES platform as an update to their Rendever systems. Rendever's research team will remotely train the caregivers how to use the VR-CARES platform. The caregivers will then begin using the VR-CARES platform with each other to participate in virtual activities, training, and support groups inspired by the first focus group/interview. They will be shown how they can casually meet up with other available caregivers to gather on the virtual back porch to visit, debrief about their day, and choose fun activities to do together in Rendever just for fun and friendship building such as all go on a tour of Rome, hike the Grand Canyon, or swim with Dolphins. They will also participate in a weekly support group centered on self-care and dementia care and offered multiple times to accommodate different schedules. These will be led and moderated by a NAMI (National Alliance on Mental Illness)-certified instructor on Rendever's research team. They will also participate in group activities identified by the pre-focus group/interviews. They may continue to use the basic Rendever VR platform with their clients during this time if they wish.
Following the up to 8 weeks of using the VR-CARES platform with other caregivers, participating caregivers will complete a post-project survey (Survey #3). RAND's research team will conduct a second round of focus groups/interviews with up to 30 caregivers and share the findings with Rendever's research and development teams for further reiteration and VR-CARES platform refinement.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Direct Care Worker Cohort | Experimental | Behavioral: Rendever VR Social Engagement Platform, Behavioral: VR-CARES Platform |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Employed by an in-home care agency 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
Key exclusion criteria (2 listed)
- History of seizures or severe motion sickness
- Are unable to see images in the virtual reality headset
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rendever VR Social Engagement PlatformAlso: Rendever EngageParticipants 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. | Behavioural | Direct Care Worker Cohort |
| VR-CARES PlatformAlso: VR-CARESParticipants 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. | Behavioural | Direct Care Worker Cohort |
Primary outcome
System Usability Scale (SUS) Score
Time frame: 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.
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.
Mean Change in Caregiver Job Satisfaction
Time frame: 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.
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.
Mean Change in Caregiver Empowerment
Time frame: 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.
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.
16 secondary outcomes
Adherence to VR-CARES Intervention
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
User Experience Questionnaire+ (UEQ+) Social Survey Score
Time frame: Assessed at end of study (T3 - 16 weeks) only, post VR-CARES caregiver support platform. This measure is specific to Intervention 2 and is not administered at T2.
Study-Specific User Experience Scores - Rendever Platform (3 items)
Time frame: Assessed at mid-point (T2 - 8 weeks) only, post Rendever social engagement VR platform. These items are specific to Intervention 1.
Study-Specific User Experience Scores - VR-CARES Platform (12 items)
Time frame: Assessed at end of study (T3 - 16 weeks) only, post VR-CARES caregiver support platform. These items are specific to Intervention 2.
Mean Change in Patient Health Questionnaire-4 (PHQ-4)
Time frame: 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 depression and anxiety.
Mean Change in Mental Health Inventory-5 (MHI-5)
Time frame: 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 changes in general mental health and wellbeing.
Mean Change in PROMIS Companionship Short Form 4a
Time frame: Assessed at mid-point (T2 - 8 weeks) as the baseline measure and end of study (T3 - 16 weeks) as the post-VR-CARES intervention measure.
Mean Change in PROMIS Emotional Support Short Form 6a
Time frame: Assessed at mid-point (T2 - 8 weeks) as the baseline measure and end of study (T3 - 16 weeks) as the post-VR-CARES intervention measure.
Mean Change in Lubben Social Network Scale (LSNS-6)
Time frame: Assessed at mid-point (T2 - 8 weeks) as the baseline measure and end of study (T3 - 16 weeks) as the post-VR-CARES intervention measure.
Mean Change in UCLA Loneliness Scale-3 (ULS-3)
Time frame: 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 changes in feeling lonely.
Mean Change in Archangels Caregiver Intensity Index
Time frame: 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 changes in caregiver intensity.
Mean Change in Jefferson Scale of Empathy for Care Professionals (Adapted)
Time frame: 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 changes in empathy for care clients.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Direct Care Workers
Recruiting
The Dream Team: Testing Implementation of a Sleep Intervention for Perinatal Women Delivered by Direct Care Workers
Sleep, Postpartum Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rendever VR Social Engagement Platform and VR-CARES Platform in people with Direct Care Workers and Dementia Caregiver, run by Rendever, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (SUS) Score (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.