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VR and Adaptive Technology for Mild Cognitive Impairment
N/A
Waitlist Available
Led By Sara J Czaja, PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-randomization at month 1 and month 2
Awards & highlights
Study Summary
This trial examines the use of virtual reality and adaptive software to provide cognitive and social support to older adults, especially those with mild cognitive impairment. It also looks at how to use technology to help older adults manage their healthcare.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not detailed, participants may experience discomfort using VR technology such as dizziness or nausea. The software tools might also lead to frustration if they don't meet user expectations or if there are technical difficulties.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-randomization at month 1 and month 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-randomization at month 1 and month 2
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Project 1, Phase 2: Mean Difference in Score of CAST Program Intervention Workload, assessed using the NASA Tax Load Index (TLX) Measure
Project 1, Phase 2: Mean Difference in Score of Perceived CAST Program system enjoyment Assessed using The User Experience Questionnaire
Project 1, Phase 2: Mean Difference of Perceived Ease of Use of the CAST Program Assessed using the Perceived Ease of Use Questionnaire
+13 moreSecondary outcome measures
Project 1, Phase 2: Mean Difference in Score of Quality of Life, assessed using The Quality of Life Questionnaire
Project 1, Phase 2: Mean Difference in Score of Social Support and Connectivity Assessed using The Social Connectedness Measure
Project 1, Phase 2: Mean Difference in Score of reported depression, assessed using the Center for Epidemiological Studies-Depression (CES-D) Scale
+7 moreTrial Design
9Treatment groups
Experimental Treatment
Active Control
Group I: Project 3 - Phase 3: DATA ConditionExperimental Treatment1 Intervention
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.
Group II: Project 2 - Phase 2: Active Intervention GroupExperimental Treatment1 Intervention
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.
Group III: Project 1 - Phase 2: VR ProgramExperimental Treatment1 Intervention
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.
Group IV: Project 2 - Phase 2: Waitlist ControlActive Control1 Intervention
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.
Group V: Project 3 - Phase 2: Development of Digital Assistant ToolsActive Control1 Intervention
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.
Group VI: Project 3 - Phase 3: Usual-Tool Control ConditionActive Control1 Intervention
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.
Group VII: Project 3 - Phase 1: Problem Space Specification and Task SelectionActive Control1 Intervention
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.
Group VIII: Project 1 - Phase 1: Development/Refinement of VR program; Usability Testing/Development of TrainingActive Control1 Intervention
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.
Group IX: Project 1 - Phase 2: Tablet Control ConditionActive Control1 Intervention
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?
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,019,635 Total Patients Enrolled
Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,315,045 Total Patients Enrolled
Sara J Czaja, PhDPrincipal InvestigatorWeill Medical College of Cornell University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 60, can read English well, have decent vision with glasses if needed, and my cognitive test score is 23 or lower.I am visually or hearing impaired, have a terminal illness, or severe motor impairment.I am 65 or older, can read English at a 6th grade level, and have at least 20/60 vision with glasses or contacts.I am 62 or older, can read English, have decent vision, mild memory issues without major daily activity impairments, not severely depressed, and no dementia.I have chronic neck pain or an injury that could make wearing a headset uncomfortable.
Research Study Groups:
This trial has the following groups:- Group 1: Project 2 - Phase 2: Waitlist Control
- Group 2: Project 2 - Phase 2: Active Intervention Group
- Group 3: Project 1 - Phase 2: VR Program
- Group 4: Project 3 - Phase 2: Development of Digital Assistant Tools
- Group 5: Project 3 - Phase 3: DATA Condition
- Group 6: Project 3 - Phase 3: Usual-Tool Control Condition
- Group 7: Project 3 - Phase 1: Problem Space Specification and Task Selection
- Group 8: Project 1 - Phase 1: Development/Refinement of VR program; Usability Testing/Development of Training
- Group 9: Project 1 - Phase 2: Tablet Control Condition
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still room to enroll participants in this research project?
"The information present on the clinicaltrials.gov website suggests that this medical trial is not currently recruiting patients, despite its initial posting date of June 1st 2023 and last update occurring on March 30th 2023. However, there are plenty other studies actively seeking participants with 582 trials in total listed by the site."
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What is the aim of this medical experiment?
"The purpose of this trial, from Baseline to 2 months, is to measure the CAST Program's Perceived System Feasibility as indicated by daily usage. Secondary objectives include quantifying Quality Of Life with a 13-item scale ranging 1 - 4 points; measuring depression levels through the Center for Epidemiological Studies-Depression (CES-D) Scale which has 0 - 60 scores; and gauging participants' self reported health using the 36-Item Short Form Health Survey questionnaire (SF-36 Short Form)."
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