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

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 1, Phase 2: VR Program for Social, Activity, and Cognitive Engagement.
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

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
  • Project 1, Phase 2: Perceived System Feasibility of the CAST Program as measured by the number of times used per day [Time frame: Baseline through 2 months]
  • Project 1, Phase 2: Perceived System Feasibility of the CAST Program as measured by the number of features used per day [Time frame: Baseline through 2 months]
  • Project 1, Phase 2: Mean Difference of Perceived Ease of Use of the CAST Program Assessed using the Perceived Ease of Use Questionnaire [Time frame: Post-Randomization at Month 1 and Month 2]
  • Project 1, Phase 2: Mean Difference of Perceived System Usefulness of the CAST Program, assessed using the Perceived Usefulness Questionnaire [Time frame: Post-Randomization at Month 1 and Month 2]
  • Project 1, Phase 2: Mean Difference in Score of CAST Program Intervention Workload, assessed using the NASA Tax Load Index (TLX) Measure [Time frame: Post-Randomization at Month 1 and Month 2]
  • Project 1, Phase 2: Mean Difference in Score of Perceived CAST Program system enjoyment Assessed using The User Experience Questionnaire [Time frame: Post-Randomization at Month 1 and Month 2]
Secondary outcome measures (4)
  • Project 1, Phase 2: Mean Difference in Score of Social Support and Connectivity Assessed using The Social Connectedness Measure [Time frame: Post-Randomization at Month 1 and Month 2]
  • Project 1, Phase 2: Mean Difference in Score of Quality of Life, assessed using The Quality of Life Questionnaire [Time frame: Post-Randomization at the Baseline assessment, Month 1 and Month 2]
  • Project 1, Phase 2: Mean Difference in Score of reported depression, assessed using the Center for Epidemiological Studies-Depression (CES-D) Scale [Time frame: Post randomization at the baseline assessment, month 1 and month 2.]
  • Project 1, 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: Post randomization at the baseline assessment, month 1 and month 2.]

Eligibility criteria

Inclusion criteria

  • 65+ years of age
  • Able to read English at the 6th grade level
  • Have 20/60 vision with or without correction.

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
  • Chronic neck pain/injury that might make the headset uncomfortable

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: NCT05811338 · 23-01025559-01 · P01AG073090-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗