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

No phase Interventional Mild Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Project 2, Phase 2: Intelligent Adaptive System.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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 2: Phase 1 of the project will yield important information on the feasibility of using technology-based approaches to support everyday activities and cognition for persons with MCI and insight on barriers to the implementation of technology-based interventions. The investigators will also gain understanding of the challenges aging adults with MCI encounter in everyday activities.

In phase 2, akin to Stage 1b, the study will involve pilot testing to evaluate the feasibility, acceptability, and usability of the system (primary outcomes) with a diverse sample of individuals with MCI at each site. Investigators will gather preliminary data on efficacy of the system with respect to secondary outcomes such as cognition, perceptions of memory functioning, social connectivity, social support, loneliness, technology proficiency, and the performance of everyday tasks. Investigators will collect real time data on system use and system adaptations. Investigators will examine potential negative consequences of use of the system, such as decreases in social networks or interactions or negative changes in life space. All assessments will occur in the participants' living environment by trained research assistants. An assessor other than the one who conducted the baseline assessment, will conduct follow-up assessments to minimize bias (i.e., assessors will be blinded to treatment condition).

Project 2 record was originally listed under NCT05811338.

Interventions

  • Behavioral Project 2, Phase 2: Intelligent Adaptive System
    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.

Primary outcome measures

  • 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]
  • Project 2, Phase 2: Perceived System Usability of the CAST Program as measured by the number of times the system was used per day [Time frame: Baseline through 6 months]
  • Project 2, Phase 2: Perceived System Usability of the CAST Program as measured by the number of features used per day [Time frame: Baseline through 6 months]
  • Project 2, Phase 2: Perceived Ease of Use of the CAST Program, assessed using the Perceived Ease of Use Questionnaire [Time frame: 6 months post intervention]
  • Project 2, Phase 2: Perceived System Usefulness of the CAST Program, assessed using the Perceived Usefulness Questionnaire [Time frame: 6-months post intervention]
  • Project 2, Phase 2: Mean scores of participants' perception of CAST program usability and usefulness, assessed using the Usability Metric for user Experience (UMUX-Lite) questionnaire [Time frame: 6-months post intervention]
Secondary outcome measures (5)
  • Project 2, Phase 2: Mean Difference in Score of Social Support and Connectivity Assessed using The Social Connectedness Measure [Time frame: Baseline and 6 month post intervention]
  • Project 2, Phase 2: Mean Difference in Score of Quality of Life, assessed using The Quality of Life Questionnaire [Time frame: Baseline and 6 month post intervention]
  • Project 2, Phase 2: Mean Difference in Score of reported depression, assessed using the Center for Epidemiological Studies-Depression (CES-D) Scale [Time frame: Baseline and 6 month post intervention]
  • Project 2, Phase 2: Mean Difference in score of participants self-reported health, assessed using the 36-Item Short Form Health Survey questionnaire (SF-36 Short Form) [Time frame: Baseline and 6 month post intervention]
  • Project 2, Phase 2: Mean Difference in scores of participants' perceived memory function, assessed using the Perception of Memory Function questionnaire [Time frame: Baseline and 6 month post intervention]

Eligibility criteria

Inclusion criteria

  • 62+ years of age
  • Able to read English at the 6th grade level
  • Have 20/60 vision with or without correction.
  • Clinical diagnosis of mild cognitive impairment (MCI)
  • Subjective cognitive complaints
  • Evidence by clinical evaluation
  • Clinical Dementia Rating Global scale of 0.5-2.0
  • Probable MCI
  • Montreal Cognitive Assessment (MoCA) score of 18-26
  • No major Instrumental activities of daily living (IADL) impairments
  • Geriatric Depression Scale of 4 or Below
  • No diagnosis of dementia

Exclusion criteria

  • Blind or have visual impairments that limit their ability to view the technology.
  • Deaf or have hearing impairments that limit their ability to answer telephone queries.
  • Have a life-limiting/terminal illness
  • Severe motor impairment (e.g., severe tremors or debilitating arthritis in their hands) that impairs ability to speak or use dominant hand
  • Cognitive impairment (MOCA ≤ 25)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Florida State University — Tallahassee
  • University of Illinois Urbana-Champaign — Champaign
  • Weill Cornell Medicine — New York

Identifiers

NCT: NCT07485712 · 23-01025559-02 · P01AG073090-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗