VR and Adaptive Technology for Mild Cognitive Impairment
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how virtual reality (VR) and smart technology can assist older adults with mild cognitive challenges. Researchers aim to determine if these tools can enhance mental sharpness, social connections, and daily living tasks. The trial includes several components: a VR program for social, activity, and cognitive engagement; adaptive software for personalized support; and digital assistants for managing health tasks. Ideal participants are older adults who have noticed some memory issues but have not been diagnosed with dementia. As an unphased trial, this study provides a unique opportunity for participants to explore innovative technologies that could improve their quality of life.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these technologies are safe for older adults with mild cognitive impairment?
Research has shown that virtual reality (VR) programs can be safe and helpful for older adults with mild cognitive impairment (MCI). Studies indicate that VR can boost memory and attention and assist with brain functions like problem-solving. It is generally well-tolerated, with few side effects reported. Some people might feel dizzy or a bit disoriented after using VR, but these effects are usually mild and temporary.
For the Intelligent Adaptive System, research on similar technologies for older adults with MCI suggests they can be safe and beneficial. These systems use smart technology to adjust to a person's needs, and studies have not found significant safety issues. However, since these systems are relatively new, monitoring for any unexpected problems is important.
Lastly, the Intelligent Decision Support Tool, which uses artificial intelligence, has shown promise in other studies. It helps ensure decisions related to cognitive health are both accurate and safe. While still being tested, it hasn't shown major safety concerns so far.
Overall, these technologies are designed to be safe and easy to use for older adults. However, as with any new technology, reporting any issues or discomfort to the study team is important.12345Why are researchers excited about this trial?
Researchers are excited about the innovative use of VR and adaptive technology for treating mild cognitive impairment because these approaches offer a fresh take on engagement and decision support. Unlike traditional methods that might focus solely on medications or cognitive exercises, these treatments utilize virtual reality for immersive social and cognitive activities, making the experience more engaging and interactive. Moreover, the intelligent adaptive system and decision support tools are designed to tailor the experience to individual needs, potentially enhancing effectiveness by addressing personal preferences and challenges in real-time. This personalized and technologically advanced approach could offer more dynamic and responsive support for cognitive health compared to existing options.
What evidence suggests that this trial's treatments could be effective for mild cognitive impairment?
Research has shown that virtual reality (VR) programs can significantly enhance thinking skills in older adults with mild memory problems. In this trial, participants in the VR Program arm will use VR to boost overall brain function, proving as effective as traditional methods. Reviews suggest that technology-based programs, like the Intelligent Adaptive System tested in another arm of this trial, can improve thinking and self-confidence in individuals with mild memory issues by adapting to each person's needs and providing personalized support. Additionally, the Intelligent Decision Support Tool, part of a separate arm in this trial, uses artificial intelligence to assist older adults in managing their health decisions. Some studies have indicated that these tools effectively predict and track changes in thinking skills.26789
Who Is on the Research Team?
Sara J Czaja, PhD
Principal Investigator
Weill Medical College of Cornell University
Are You a Good Fit for This Trial?
This trial is for older adults, aged 60 and above, who have been clinically diagnosed with mild cognitive impairment (MCI). Participants should be able to read English at a 6th-grade level or higher, have correctable vision of at least 20/60, and score between 18-26 on the MoCA test. It's not suitable for those outside this age range or cognitive ability.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Usability Testing and Development
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.
Pilot Randomized Trial
Participants will be randomized to the VR CAST condition or a tablet control condition, using the VR program/tablet in their home for two months.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Project 1, Phase 2: VR Program for Social, Activity, and Cognitive Engagement
- Project 2, Phase 2: Intelligent Adaptive System
- Project 3, Phase 3: Intelligent Decision Support Tool
Trial Overview
CREATE V includes three projects: A VR program (CAST) for mental and social stimulation; an intelligent adaptive system that adjusts to users' cognitive levels; and a digital assistant tool designed to help manage healthcare tasks. These interventions aim to support cognition in aging individuals with MCI.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Active Control
Participants in the DATA condition, instead of access to a generic digital assistant, will have DATA at their disposal to solve the queries and will be encouraged to use it as the primary resource. Qualitative data on how they use this tool, in isolation and in conjunction with other sources of information, will be collected. Following completion of the problems, as in Phase 2, measures of DATA usability will be collected including usefulness and comprehension associated with each tool, perceived mental workload, and usability with an efficient, two-item test based on the widely used System Usability Scale: UMUX-LITE). The investigators will then conduct an audio-recorded semi-structured exit interview about various perceptions participants had regarding the challenges associated with successfully solving the health-management problems.
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.
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.
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.
The study includes one session that will last approximately 2 - 3 hours. The study involves interactions with digital assistants developed by the research team, the participants will answer structured interview questions regarding their experiences using the system. The researchers will assess the participants' comments along dimensions such as type of information requested, preference for format of information, points of confusion, and likes and dislikes of features, which will form the basis for a prioritized list of features/functions to be modified for the next prototype iteration.
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.
Participants will have access to a generic, non-adapted voice assistant available on a provided tablet. The experimenter will use a standard script that allows for guidance to participants in searching for information relevant to the problems. Participants will indicate when they are ready to move on to the next problem, which will be followed by their assessment of the confidence they have in having solved the problem, their comprehension of the information associated with the problem, their assessment of the usefulness of the available information, and the perceived mental workload they experienced in solving the problem. Investigators will track, code, and analyze participants' online interactions with any websites they use. For each of the three task activity domains, overall performance scores will be computed, as will performance scores for the simpler and more complex problems.
Both the subject matter experts and older adult participants will participate in individual structured interviews for each activity category, 1.5 - 2 hours in length. This qualitative data will provide rich contextualized information regarding the specific needs of older adults for access to services, financial health management, and Medicare.gov services utilization. This data will be used to identify current barriers and facilitators to successful healthcare management that could be targeted by technology solutions and/obtain details of the challenges that are common in each activity category.
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.
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Who Is Running the Clinical Trial?
Weill Medical College of Cornell University
Lead Sponsor
National Institute on Aging (NIA)
Collaborator
Published Research Related to This Trial
Citations
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