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

Part of paid clinical trials in Tallahassee, Florida.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT05811338
Status
Not Yet Recruiting

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Conditions

  • Mild Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Project 1, Phase 2: VR Program for Social, Activity, and Cognitive Engagement — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
312 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Project 1 - Phase 1: Development/Refinement of VR program; Usability Testing/Development of Training
    The study includes one session that will last approximately 2 - 3 hours. The study involves completing some questionnaires that gather background demographic information and a structured needs assessment interview to gather information on user preferences, usability problems, implementation and training protocols.
  • Experimental: Project 1 - Phase 2: VR Program
    Training will occur over 3 days and be conducted by research investigators in the participants' homes. Training will include training on the proper placement of the headset, the viewing lens, system headphones, and safety guidelines. The research investigator will aid in the set-up of the VR system in the home, which will be pre-loaded with applications, and will recommend an area to use the system to ensure a safe play area free of obstacles. Participants will be provided with practice tasks between training sessions. Participants will be provided with a "hands-on" performance assessment at the beginning of the second session and concepts/procedures that are problematic will be reviewed. Participants will be contacted one-week post training to determine if they are having any problems by study investigators. Following training, participants will use the CAST VR program and tablet at will, though encouraged to use it at least three times per week for 20 minutes.
  • Active Comparator: Project 1 - Phase 2: Tablet Control Condition
    Training will occur over 3 days and be conducted by research investigators in the participants' homes. Participants in the control condition will receive a tablet, internet support for 2 months and training (including training on cybersecurity). This will include instructions for accessing content similar to, but in 2-D, so less immersive than that included in the VR program (e.g., virtual museum tours, One click, etc.). Participants will complete all assessments and will be provided with an Android tablet that has a 10.1" display, built in modem, and a front facing camera. Research investigators are providing people with tablets for standardization. Research Assessor (RA) Training, Certification and Treatment Fidelity. At follow-up assessments, assessors and data analysts will be blinded to treatment condition.

Primary Outcome Measure

Project 1, Phase 2: Perceived System Feasibility of the CAST Program as measured by the number of days used [ Time Frame: Baseline through 2 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Florida State UniversityTallahasseeFlorida32306-
University of Illinois Urbana-ChampaignChampaignIllinois61820
Wendy Rogers, PhD
[email protected]
217-300-1470
Wendy Rogers, PhD (PRINCIPAL_INVESTIGATOR)
Weill Cornell MedicineNew YorkNew York10065
Chelsie Burchett, MA
[email protected]
646-962-7141
Sara Czaja, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Florida State University· Tallahassee, FLUniversity of Illinois Urbana-Champaign· Champaign, ILWeill Cornell Medicine· New York, NY

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