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| ID | Type | Description | Link |
|---|---|---|---|
| P01AG073090-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Project 1 - Phase 1: Development/Refinement of VR program; Usability Testing/Development of Training | No 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. | |
| 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. |
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| Project 1 - Phase 2: Tablet Control Condition | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Project 1, Phase 2: VR Program for Social, Activity, and Cognitive Engagement | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chelsie Burchett, PhD | Contact | 646-962-7141 | cob2014@med.cornell.edu | |
| Sophie Park | Contact | 646-962-7141 | sep4008@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sara J Czaja, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida State University | Tallahassee | Florida | 32306 | United States | ||
| University of Illinois Urbana-Champaign |
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.
The data from research projects will be made available no later than acceptance of publication of the main findings from the final data set. There is no end date to access the data from the research projects.
The investigators agree to share the data with researchers working under an institution with Federal Wide Assurance who agree to a data sharing agreement that stipulates protection of participant privacy and data confidentiality, acknowledgement of CREATE, that the data will be used for research purposes only, and that the data will not be transferred to other users. The computerized data will include raw data, derived variables, all necessary documentation as described in the National Archive of Computerized Data on Aging depositor agreement. All data will be de-identified. The investigators will follow the guides published by the US Department of Health and Human Services in this respect. Each data set will include data documentation to ensure that others can use the data set and to minimize confusion. Information about where and how to locate and access the data will be available in any publications and presentations authored by CREATE investigators.
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| 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. | 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) | 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. | Post-Randomization at Month 1 and Month 2 |
| 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. | 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. | 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). | Post randomization at the baseline assessment, month 1 and month 2. |
| Champaign |
| Illinois |
| 61820 |
| United States |
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| Weill Cornell Medicine | New York | New York | 10065 | United States |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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