Mild Cognitive ImpairmentNCT05811338
Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 1
A study testing Project 1 - Phase 2: VR Program for Social, Activity, and Cognitive Engagement and Project 1 - Phase 2: Tablet for Social, Activity, and Cognitive Engagement in people with Mild Cognitive Impairment, run by Weill Medical College of Cornell University at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Project 1 - Phase 2: VR Program for Social, Activity, and Cognitive Engagement and Project 1 - Phase 2: Tablet for Social, Activity, and Cognitive Engagement
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Oct 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 65+ years of age
- Able to read English at the 6th grade level
- Have 20/60 vision with or without correction.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
University of Illinois Urbana-Champaign
Champaign, Illinois, 61820
Wendy Rogers, PhD, 217-300-1470, wendyr@illinois.edu
Wendy Rogers, PhD
Weill Cornell Medicine
New York, New York, 10065
Chelsie Burchett, MA, 646-962-7141, cob2014@med.cornell.edu
Sara Czaja, PhD
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: Center for Research and Education on Aging and Technology Enhancement - CREATE V
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Project 1 - Phase 2: VR Program for Social, Activity, and Cognitive Engagement, Project 1 - Phase 2: Tablet for Social, Activity, and Cognitive Engagement
- Keywords
- Technology
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project 1 - Phase 2: VR Program for Social, Activity, and Cognitive EngagementBehavioural
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.
Project 1 - Phase 2: Tablet for Social, Activity, and Cognitive EngagementBehavioural
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 CAST VR, 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.
| Study group | Role | What they receive |
|---|---|---|
| Project 1 - Phase 2: VR Program | Experimental | 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. Receives: Behavioral: Project 1 - Phase 2: VR Program for Social, Activity, and Cognitive Engagement |
| Project 1 - Phase 2: Active Control Condition | Active comparator | 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 CAST VR, 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. Receives: Behavioral: Project 1 - Phase 2: Tablet for Social, Activity, and Cognitive Engagement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Project 1, Phase 2: Perceived System Feasibility of the CAST Program as measured by the number of days used
The CAST system or tablet feasibility will be assessed by evaluating participants' perception of the features of the system. Real time measures of the CAST system or tablet use will be evaluated, by the number of days used starting from baseline through two months. Measure is to be developed based on phase 1 of the study.
Measured: 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
The CAST system or tablet feasibility will be assessed by evaluating participants' perception of the features of the system. Real time measures of the CAST system or tablet use will be evaluated, using the sum of times the system was used per day or the average starting from baseline through two months. Measure is to be developed based on phase 1 of the study.
Measured: 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
The CAST system or tablet feasibility will be assessed by evaluating participants' perception of the features of the system. Real time measures of the CAST system or tablet use will be evaluated, by number of features used per day, using the sum of numbers of features used per day or the average starting from baseline through two months. Measure is to be developed based on phase 1 of the study.
Measured: 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
Utilizing a 12-item scale (Perceived Ease of Use Questionnaire) which includes two subscales (perceived usefulness and perceived ease of use) with Likert response scales ranging from. 1 (Strongly disagree) - 10 (Strongly agree). The responses to the items are summed for each of the subscales. To assess ease of use, the investigators will evaluate responses to the perceived ease of use subscale. Higher sores indicate perceived ease of use of the CAST program.
Measured: 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
Utilizing a 12-item scale (Perceived Usefulness Questionnaire) which includes two subscales (perceived usefulness and perceived ease of use) with Likert response scales ranging from. 1 (Strongly disagree) - 10 (Strongly agree). Higher sores indicate perceived system usefulness of the CAST program. The responses to the items are summed for each of the subscales.
Measured: 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
The TLX is a measure of perceived workload that assesses six dimensions of workload: Mental, Physical, and Temporal Demands, Frustration, Effort, and Performance. Administering the TLX involves two steps. First, a participant reflects on the task they're being asked to perform and looks at each paired combination of the six dimensions to decide which is more related to their personal definition of workload as related to the task. This results in a user considering 15 paired comparisons. For example, they need to decide whether Performance or Frustration "represents the more important contributor to the workload for the specific task recently performed." The second step involves participants rating each of the six dimensions on scales from Low to High or from Good to Poor. The raw score for each of the six items is multiplied by the weight from step 1 to generate the overall workload score per task.
NASA TLX -- Scores Range from 0 (low work load) - 100 (very high work load)
Measured: 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
The User Experience Questionnaire. A 23-item scale that measures enjoyment and immersion of a virtual reality experience. Eleven items are related to enjoyment - these items will be summed to assess enjoyment, Scores range from 0-11, with 11 indicating greater enjoyment.
Measured: Post-Randomization at Month 1 and Month 2
Secondary outcomes (4)
Project 1, Phase 2: Mean Difference in Score of Social Support and Connectivity Assessed using The Social Connectedness Measure
Scales used to measure two aspects of social isolation: social disconnectedness and perceived isolation, as well as perceived availability of social support.
The Social Connectedness measure is a 15 item scale consisting of 3 sections with different likert response scale. Section 1 is a 4 item scale ranging from 0 - 5 points (20 total points). Section 2 is a 6-item scale ranging from 1 - 3 points (18 total points). Section 3 is a 5-item scale ranging from 1 - 5 points (25 total points). For Section 1, a higher score is reflective of increased connectedness while for Section 2 and 3, a higher score is a reflective of a higher level of disconnectedness. For sections 1-3, a mean difference in score will be calculated.
Measured: 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
Will assess the participant's quality of life by having the participant rate different aspects of their life using one of four words: poor, fair, good, or excellent. They are instructed to think about different aspects of their life, like physical health, energy, family, money, and others to assess their situation in each area.
The Quality of Life questionnaire is a 13-item scale with Likert response scales ranging between 1 and 4 points. The measure's total score can range between 13 - 52 points. A higher total score is reflective of a higher quality of life while a lower score is reflective of a poorer quality of life.
Measured: 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
The CES-D is a self-report depression scale for research in general population. It is a 20 item questionnaire consisting of likert response scales ranging from 0-3 points. The total score range is 0 - 60 points. Higher scores indicate participants have a greater level of self reported depression.
Measured: 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)
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability. The 8 subscales or domains are as follows:
Physical functioning (10 items);
Role limitations due to physical health (4 items); Role limitations due to emotional problems (4 items); Energy/fatigue (4 items); Emotional well-being (5 items); Social functioning (2 items); Pain (2 items); General health (5 items).
Measured: Post randomization at the baseline assessment, month 1 and month 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start31 Oct 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Sara J Czaja, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811338
- Sponsor's protocol ID
- 23-01025559-01
- Other IDs
- P01AG073090-01A1
- Status last verified
- Aug 2026
- First submitted
- 30 Mar 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators plan for resource sharing is based on the National Institutes of Health/National Institute on Aging (NIH/NIA) Data Sharing Policy. The investigators plan, consistent with the NIH goals of data sharing, is to promote use of the rich CREATE database by the larger research community as this will further the impact of CREATE and expand possibilities for collaboration. It will also allow other researchers to expedite the translation of the research findings into knowledge, products, and procedures. Further, the plan is devised to make the data as widely and freely available as possible while at the same time safeguarding the privacy of participants and protecting confidential and proprietary data.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Center for Research and Education on Aging and Technology Enhancement - CREATE V
- ClinicalTrials.gov ID
- NCT05811338
- Acronym / sponsor ID
- 23-01025559-01
- Conditions
- Mild Cognitive Impairment
- Keywords
- Technology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Project 1 - Phase 2: VR Program | Experimental | Behavioral: Project 1 - Phase 2: VR Program for Social, Activity, and Cognitive EngagementTraining 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. |
| Project 1 - Phase 2: Active Control Condition | Active comparator | Behavioral: Project 1 - Phase 2: Tablet for Social, Activity, and Cognitive EngagementParticipants 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 CAST VR, 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 65+ years of age
- Able to read English at the 6th grade level
- Have 20/60 vision with or without correction.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project 1 - Phase 2: VR Program for Social, Activity, and Cognitive EngagementThe 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. | Behavioural | Project 1 - Phase 2: VR Program |
| Project 1 - Phase 2: Tablet for Social, Activity, and Cognitive EngagementParticipants 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 CAST VR, 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. | Behavioural | Project 1 - Phase 2: Active Control Condition |
Primary outcome
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
The CAST system or tablet feasibility will be assessed by evaluating participants' perception of the features of the system. Real time measures of the CAST system or tablet use will be evaluated, by the number of days used starting from baseline through two months. Measure is to be developed based on phase 1 of the study.
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
The CAST system or tablet feasibility will be assessed by evaluating participants' perception of the features of the system. Real time measures of the CAST system or tablet use will be evaluated, using the sum of times the system was used per day or the average starting from baseline through two months. Measure is to be developed based on phase 1 of the study.
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
The CAST system or tablet feasibility will be assessed by evaluating participants' perception of the features of the system. Real time measures of the CAST system or tablet use will be evaluated, by number of features used per day, using the sum of numbers of features used per day or the average starting from baseline through two months. Measure is to be developed based on phase 1 of the study.
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
Utilizing a 12-item scale (Perceived Ease of Use Questionnaire) which includes two subscales (perceived usefulness and perceived ease of use) with Likert response scales ranging from. 1 (Strongly disagree) - 10 (Strongly agree). The responses to the items are summed for each of the subscales. To assess ease of use, the investigators will evaluate responses to the perceived ease of use subscale. Higher sores indicate perceived ease of use of the CAST program.
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
Utilizing a 12-item scale (Perceived Usefulness Questionnaire) which includes two subscales (perceived usefulness and perceived ease of use) with Likert response scales ranging from. 1 (Strongly disagree) - 10 (Strongly agree). Higher sores indicate perceived system usefulness of the CAST program. The responses to the items are summed for each of the subscales.
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
The TLX is a measure of perceived workload that assesses six dimensions of workload: Mental, Physical, and Temporal Demands, Frustration, Effort, and Performance. Administering the TLX involves two steps. First, a participant reflects on the task they're being asked to perform and looks at each paired combination of the six dimensions to decide which is more related to their personal definition of workload as related to the task. This results in a user considering 15 paired comparisons. For example, they need to decide whether Performance or Frustration "represents the more important contributor to the workload for the specific task recently performed." The second step involves participants rating each of the six dimensions on scales from Low to High or from Good to Poor. The raw score for each of the six items is multiplied by the weight from step 1 to generate the overall workload score per task. NASA TLX -- Scores Range from 0 (low work load) - 100 (very high work load)
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
The User Experience Questionnaire. A 23-item scale that measures enjoyment and immersion of a virtual reality experience. Eleven items are related to enjoyment - these items will be summed to assess enjoyment, Scores range from 0-11, with 11 indicating greater enjoyment.
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Yes. The investigators plan for resource sharing is based on the National Institutes of Health/National Institute on Aging (NIH/NIA) Data Sharing Policy. The investigators plan, consistent with the NIH goals of data sharing, is to promote use of the rich CREATE database by the larger research community as this will further the impact of CREATE and expand possibilities for collaboration. It will also allow other researchers to expedite the translation of the research findings into knowledge, products, and procedures. Further, the plan is devised to make the data as widely and freely available as possible while at the same time safeguarding the privacy of participants and protecting confidential and proprietary data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara J Czaja, PhD principal investigator
Weill Medical College of Cornell University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project 1 - Phase 2: VR Program for Social, Activity, and Cognitive Engagement and Project 1 - Phase 2: Tablet for Social, Activity, and Cognitive Engagement in people with Mild Cognitive Impairment, run by Weill Medical College of Cornell University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chelsie Burchett, PhD (646-962-7141, cob2014@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.