Center for Research and Education on Aging and Technology Enhancement - CREATE V
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 108
- 试验地点
- 3
- 主要终点
- Project 1, Phase 2: Perceived System Feasibility of the CAST Program as measured by the number of days used
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •65+ years of age
- •Able to read English at the 6th grade level
- •Have 20/60 vision with or without correction.
排除标准
- •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
研究组 & 干预措施
Project 1 - Phase 2: Active Control Condition
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.
干预措施: Project 1 - Phase 2: Tablet for Social, Activity, and Cognitive Engagement (Behavioral)
Project 1 - Phase 2: VR Program
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.
干预措施: Project 1 - Phase 2: VR Program for Social, Activity, and Cognitive Engagement (Behavioral)
结局指标
主要结局
Project 1, Phase 2: Perceived System Feasibility of the CAST Program as measured by the number of days used
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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 2, Phase 2: Perceived Ease of Use of the CAST Program, assessed using the Perceived Ease of Use Questionnaire
时间窗: 6 months post intervention
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.
Project 3, Phase 1: Qualitative interview assessment regarding Healthcare Challenges
时间窗: During one-time condition session at Baseline Assessment
Analysis of interview transcripts will identify common themes that will be the target of technology-based support. The general script for interviews with older adults will start with a) demographics and medical history; (b) health management strategies - current approaches for monitoring and managing chronic conditions and maintaining general wellness; (c) current use, awareness of, openness to, and concerns about technologies for health management; (d) general challenges experienced and barriers to successful health management. Investigators will then have sections of the interview script tailored to the three activity categories: access to services; financial health management, and Medicare utilization.
Project 1, Phase 2: Mean Difference of Perceived System Usefulness of the CAST Program, assessed using the Perceived Usefulness Questionnaire
时间窗: 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
时间窗: 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 3, Phase 3: Mixed-method assessment of usability challenges assessed using the Usability Metric for User Experience (UMUX-LITE)
时间窗: During one-time condition session at Baseline Assessment
User testing will have participants "think aloud" as they solve healthcare problems, and data will be coded for frustration and specific challenges experienced. The investigators will also use classic usability measures, for example, UMUX-LITE. The Usability Metric for User Experience (UMUX-Lite) is a two-item Likert scale used for the subjective assessment of an application's perceived usability. On a 7 point scale, with 0 being strongly disagree and 6 being strongly agree, higher scores are reflective of a greater satisfaction with the system.
Project 1, Phase 2: Mean Difference in Score of Perceived CAST Program system enjoyment Assessed using The User Experience Questionnaire
时间窗: 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.
Project 2, Phase 2: Perceived System Usability of the CAST Program as Measured by the number of times used per day
时间窗: Baseline through 6 months
The CAST system or tablet usability 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 using the sum of times the system was used per day or the average, starting from baseline through six months. Measure is to be developed based on phase 1 of the study.
Project 2, Phase 2: Perceived System Usability of the CAST Program as measured by the number of features used per day
时间窗: Baseline through 6 months
The CAST system or tablet usability 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 six months. Measure is to be developed based on phase 1 of the study.
Project 2, Phase 2: Mean scores of participants' perception of CAST program usability and usefulness, assessed using the Usability Metric for user Experience (UMUX-Lite) questionnaire
时间窗: 6-months post intervention
Will assess participants' perception of technology-based intervention ease of use and usefulness. The Usability Metric for User Experience (UMUX-Lite) is a two-item Likert scale used for the subjective assessment of an application's perceived usability. On a 7- point scale, with 0 being strongly disagree and 6 being strongly agree, higher scores are reflective of a greater satisfaction with the system. The scoring range is from 0 to 14. A higher accumulated score is representative of a higher perception of usability.
Project 2, Phase 2: Perceived System Usability of the CAST Program as measured by the number of times the system was used per day
时间窗: Baseline through 6 months
The CAST system or tablet usability 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 six months. Measure is to be developed based on phase 1 of the study.
Project 2, Phase 2: Perceived System Usefulness of the CAST Program, assessed using the Perceived Usefulness Questionnaire
时间窗: 6-months post intervention
Will assess participants' perception of technology-based intervention usefulness. 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. 0 (Strongly disagree) - 4 (Strongly agree). Higher sores indicate perceived ease of use of the CAST program. The responses to the items are summed for each of the subscales.
Project 3, Phase 3: Comprehension and Decision Making Accuracy
时间窗: During one-time condition session at Baseline Assessment
For hypothetical healthcare challenges participants will be presented with, they will afterward be tested on their comprehension of important terms, and their decision-making accuracy will be evaluated, for participants with and without access to novel technology tools developed as part of this project. The comprehension and decision making accuracy measure is to be developed based on projects 1 and 2 of the study.
次要结局
- Project 1, Phase 2: Mean Difference in Score of Social Support and Connectivity Assessed using The Social Connectedness Measure(Post-Randomization at 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(Post randomization at the baseline assessment, month 1 and month 2.)
- Project 2, Phase 2: Mean Difference in Score of Social Support and Connectivity Assessed using The Social Connectedness Measure(Baseline and 6 month post intervention)
- Project 2, 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)(Baseline and 6 month post intervention)
- Project 2, Phase 2: Mean Difference in Score of Quality of Life, assessed using The Quality of Life Questionnaire(Baseline and 6 month post intervention)
- Project 2, Phase 2: Mean Difference in Score of reported depression, assessed using the Center for Epidemiological Studies-Depression (CES-D) Scale(Baseline and 6 month post intervention)
- Project 1, Phase 2: Mean Difference in Score of Quality of Life, assessed using The Quality of Life Questionnaire(Post-Randomization at the Baseline assessment, Month 1 and Month 2)
- Project 2, Phase 2: Mean Difference in scores of participants' perceived memory function, assessed using the Perception of Memory Function questionnaire(Baseline and 6 month post intervention)
- 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)(Post randomization at the baseline assessment, month 1 and month 2.)
- Project 3, Phase 3: Comprehension and Decision Making Tool Usability(During one-time condition session at Baseline Assessment)