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
- 120
- 试验地点
- 3
- 主要终点
- Project 2, Phase 2: Perceived System Usability of the CAST Program as Measured by the number of times used per day
研究概览
简要总结
The goal of this Stage 1 (NIH Stage Model) Intervention Development cross-site project is to develop, using a user-centered design approach, and evaluate an innovative intelligent adaptive software package aimed at providing cognitive and social support and engagement to older adults with mild cognitive impairment (MCI). The system will be designed to adapt to the needs and abilities of the user. The investigator's goal is to develop a unique and highly innovative technology tool that can provide adaptive support to aging individuals with MCI, even as cognition might deteriorate further. Speech data collected as part of an embedded reminiscence feature will advance fundamental knowledge of how speech and language production data might serve as an early indicator of cognitive decline.
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 2: Phase 1 of the project will yield important information on the feasibility of using technology-based approaches to support everyday activities and cognition for persons with MCI and insight on barriers to the implementation of technology-based interventions. The investigators will also gain understanding of the challenges aging adults with MCI encounter in everyday activities.
In phase 2, akin to Stage 1b, the study will involve pilot testing to evaluate the feasibility, acceptability, and usability of the system (primary outcomes) with a diverse sample of individuals with MCI at each site. Investigators will gather preliminary data on efficacy of the system with respect to secondary outcomes such as cognition, perceptions of memory functioning, social connectivity, social support, loneliness, technology proficiency, and the performance of everyday tasks. Investigators will collect real time data on system use and system adaptations. Investigators will examine potential negative consequences of use of the system, such as decreases in social networks or interactions or negative changes in life space. All assessments will occur in the participants' living environment by trained research assistants. An assessor other than the one who conducted the baseline assessment, will conduct follow-up assessments to minimize bias (i.e., assessors will be blinded to treatment condition).
Project 2 record was originally listed under NCT05811338.
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
- •62+ years of age
- •Able to read English at the 6th grade level
- •Have 20/60 vision with or without correction.
- •Clinical diagnosis of mild cognitive impairment (MCI)
- •Subjective cognitive complaints
- •Evidence by clinical evaluation
- •Clinical Dementia Rating Global scale of 0.5-2.0
- •Probable MCI
- •Montreal Cognitive Assessment (MoCA) score of 18-26
- •No major Instrumental activities of daily living (IADL) impairments
- •Geriatric Depression Scale of 4 or Below
- •No diagnosis of dementia
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
- •Cognitive impairment (MOCA ≤ 25)
研究组 & 干预措施
Project 2 - Phase 2: Waitlist Control
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.
干预措施: Project 2, Phase 2: Intelligent Adaptive System (Behavioral)
Project 2 - Phase 2: Active Intervention Group
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.
干预措施: Project 2, Phase 2: Intelligent Adaptive System (Behavioral)
结局指标
主要结局
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 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 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: 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 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 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.
次要结局
- 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 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 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 scores of participants' perceived memory function, assessed using the Perception of Memory Function questionnaire(Baseline and 6 month post intervention)