NCT05811338

Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 1

Center for Research and Education on Aging and Technology Enhancement - CREATE V

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

Project 1: The goal of this research project is to examine usability and acceptance of virtual reality (VR) applications and their efficacy with older adults. This highly innovative cross-site Stage 1 Intervention Development Project (NIH (National Institutes of Health) Stage Model) will apply the CREATE systematic approach to the design and evaluation of an immersive VR program, Cognitive Activity Social Technology (CAST), for older adults. The program will provide a suite of virtual cognitive, social and activity engagement applications; and allow for virtual interactions.

Detailed description

Deployment of technology in healthcare and day-to- day activities is increasing and advances in technology such as artificial intelligence (AI) are increasingly aimed at supporting older adults. Yet, aging adults are often ignored in design, and robust research evaluating the usability, safety, and efficacy of these systems with older adults is limited. Even among older technology adopters, rapid changes in technology pose challenges in terms of the constant need for adaptation and continual learning. Further, there remains a lag in uptake among many older adult sub-groups, including ethnic minorities, older cohorts, those of lower socio-economic status, those living in a rural location, or with a cognitive impairment such as Mild Cognitive Impairment (MCI) or Alzheimer's Disease/Alzheimer's Disease Related Dementias (AD/ADRD). The goal of CREATE V is to harness the potential benefits and power of technology to maintain, support, and foster the cognitive, emotional, and physical health of aging adults to enhance independence, well-being, and quality of life. Given that age represents a significant risk factor for cognitive impairments such as MCI and AD/ADRD, and the criticality of cognition to everyday functioning, a thrust of the research investigators planned research is on using emerging technologies to help maintain cognitive health and provide support for those with cognitive impairments. CREATE V has a fresh vision, a focus on emerging technologies, expanded research teams, new populations such as those with cognitive impairments, and technological capabilities. Project 1: Phase 1, akin to NIH Stage 1a, will involve usability testing across the three CREATE sites with older adults, and heuristic analysis to gather information on user preferences, usability problems, implementation, and training protocols. Phase 2, akin to NIH Stage 1b, will involve a cross-site pilot randomized trial with a large and diverse sample of aging adults. Participants will be randomized, following a baseline assessment, to the VR CAST condition or a tablet control condition, where participants will be exposed to similar context in 2d (e.g., online museum tours). Following training on the VR program/tablet, they will use the VR program/tablet in their home for two months. The battery of measures will be re-administered at 1 and 2-months post randomization. Research investigators will collect real time data on use of the VR program/tablet. The planned project will yield significant and timely information on the feasibility of using VR support for older adults, delineate potential mediator and moderators of the benefits of VR, and design guidelines for VR interventions for older adults. Projects 2 and 3 under this grant were originally registered as part of this ClinicalTrials.gov record (NCT05811338), but have since been separated into their own respective ClinicalTrials.gov records.

Conditions

• Mild Cognitive Impairment

Interventions

Type	Name	Description
BEHAVIORAL	Project 1, Phase 2: VR Program for Social, Activity, and Cognitive Engagement	The investigators will apply a systematic approach to the design and evaluation of an immersive Cognitive Activity Social Technology (CAST) VR intervention (using the Oculus Quest 2), that provides aging adults a suite of virtual cognitive, social, and activity engagement applications. The program will allow for virtual interactions (one-on one or groups), cultural, creativity, and educational opportunities, and gaming.

Timeline

• Start date: 2026-07-31
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2023-04-13
• Last updated: 2026-03-18

Locations

3 sites across 1 country: United States