Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 2

Part of paid clinical trials in Tallahassee, Florida.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT07485712
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 2, Phase 2: Intelligent Adaptive System — BEHAVIORAL
    An innovative intelligent adaptive software package aimed at providing social and cognitive support to older adults with MCI. The system will be designed to adapt to the needs and abilities of the user.

Study Details

The goal of this Stage 1 (NIH Stage Model) Intervention Development cross-site project is to develop, using a user-centered design approach, and evaluate an innovative intelligent adaptive software package aimed at providing cognitive and social support and engagement to older adults with mild cognitive impairment (MCI). The system will be designed to adapt to the needs and abilities of the user. The investigator's goal is to develop a unique and highly innovative technology tool that can provide adaptive support to aging individuals with MCI, even as cognition might deteriorate further. Speech data collected as part of an embedded reminiscence feature will advance fundamental knowledge of how speech and language production data might serve as an early indicator of cognitive decline.

Key Dates

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

Study Design

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

Arms

  • Experimental: Project 2 - Phase 2: Active Intervention Group
    Participants will receive a tablet with the adaptive program and be provided with internet service following the baseline assessment. Participants will receive a 3-day training in their home that will include basic tablet/internet training and training on the features of the system. The training will also encompass a module on internet etiquette and security against potential spam and fraud. Participants will be provided with practice tasks in between sessions. Participants will be provided with a "hands-on" performance assessment at the end of the second session and concepts/procedures that are problematic will be reviewed.
  • Active Comparator: Project 2 - Phase 2: Waitlist Control
    Participants will receive a 3-day training in their home. Participants will also receive a tablet, internet support for 12 months and training. This will include instructions for accessing content pertaining to the research study.

Primary Outcome Measure

Project 2, Phase 2: Perceived System Usability of the CAST Program as Measured by the number of times used per day [ Time Frame: Baseline through 6 months ]

Central Contacts

Locations (3)

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

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