Clinical trial NCT05811338: Center for Research and Education on Aging and Technology Enhancement - CREATE V
Official title: Center for Research and Education on Aging and Technology Enhancement - CREATE V
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Technology
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-04-13
Enrollment: 1202
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Project 2: 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.

Project 3: The goal for this project is to support the cognitive components of older adults' health-management activities through development of digital assistant technology tools tailored to three exemplar healthcare management task activities: accessing support services, managing healthcare finances, and using the health-management tools provided by Medicare.gov. This project will leverage the machine-intelligence expertise of the research investigators collaborators and the research investigators experience in developing and evaluating technologies for supporting the health and wellbeing needs of older adults to harness technology to provide cognitive support to aging adults, including those with Mild Cognitive Impairment (MCI) and lower SES. The project will be comprised of three phases.

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.

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 3: Phase 1 will use a multimethod approach across the three study sites to assess the demands and challenges facing diverse older adults in the performance of the three health- management activities. Techniques include structured focus groups of subject matter experts, cognitive task analysis of existing tools, and process tracing of older adults' task performance.

In Phase 2, investigators will use the knowledge derived from Phase 1, together with an understanding of older adults' cognitive capabilities and limitations, and their needs and preferences, to conduct iterative design of the digital assistant tools and evaluate their effectiveness and perceived usability using older adults with and without cognitive impairments and diverse in technology skills.

In Phase 3, investigators will do a comparative assessment of the digital assistant tools for the three health-management activities (4 problems in each domain) by randomizing a cross-site sample of 240 participants, with and without MCI, varying in age, ethnicity/race, SES, and technology experience, to novel tool and control conditions, assessing efficacy and usability of the novel tools. The project will yield important information on how best to design technology aids to provide cognitive support for health decision making.

Outcome measures for Projects 2 and 3 will be determined based on the conclusion of Project 1.

Eligibility criteria: Inclusion Criteria:

Project 1:

* 65+ years of age
* Able to read English at the 6th grade level
* Have 20/60 vision with or without correction.

Project 2:

* 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

Project 3:

* 60+ years of age
* Able to read English at the 6th grade level
* Have 20/60 vision with or without correction.
* MoCA score of 23 or lower

Exclusion Criteria:

All Projects:

* 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

Project 1:

- Chronic neck pain/injury that might make the headset uncomfortable

Project 2:

- Cognitive impairment (MOCA ≤ 25)

Primary outcomes:
measure: Project 1, Phase 2: Perceived System Feasibility of the CAST Program as measured by the number of days used
timeFrame: Baseline through 2 months
measure: Project 1, Phase 2: Perceived System Feasibility of the CAST Program as measured by the number of times used per day
timeFrame: Baseline through 2 months
measure: Project 1, Phase 2: Perceived System Feasibility of the CAST Program as measured by the number of features used per day
timeFrame: Baseline through 2 months
measure: Project 1, Phase 2: Mean Difference of Perceived Ease of Use of the CAST Program Assessed using the Perceived Ease of Use Questionnaire
timeFrame: Post-Randomization at Month 1 and Month 2
measure: Project 1, Phase 2: Mean Difference of Perceived System Usefulness of the CAST Program, assessed using the Perceived Usefulness Questionnaire
timeFrame: Post-Randomization at Month 1 and Month 2
measure: Project 1, Phase 2: Mean Difference in Score of CAST Program Intervention Workload, assessed using the NASA Tax Load Index (TLX) Measure
timeFrame: Post-Randomization at Month 1 and Month 2
measure: Project 1, Phase 2: Mean Difference in Score of Perceived CAST Program system enjoyment Assessed using The User Experience Questionnaire
timeFrame: Post-Randomization at Month 1 and Month 2
measure: Project 2, Phase 2: Perceived System Usability of the CAST Program as Measured by the number of times used per day
timeFrame: Baseline through 6 months
measure: Project 2, Phase 2: Perceived System Usability of the CAST Program as measured by the number of times the system was used per day
timeFrame: Baseline through 6 months
measure: Project 2, Phase 2: Perceived System Usability of the CAST Program as measured by the number of features used per day
timeFrame: Baseline through 6 months
measure: Project 2, Phase 2: Perceived Ease of Use of the CAST Program, assessed using the Perceived Ease of Use Questionnaire
timeFrame: 6 months post intervention
measure: Project 2, Phase 2: Perceived System Usefulness of the CAST Program, assessed using the Perceived Usefulness Questionnaire
timeFrame: 6-months post intervention
measure: 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
timeFrame: 6-months post intervention
measure: Project 3, Phase 1: Qualitative interview assessment regarding Healthcare Challenges
timeFrame: During one-time condition session at Baseline Assessment
measure: Project 3, Phase 3: Mixed-method assessment of usability challenges assessed using the Usability Metric for User Experience (UMUX-LITE)
timeFrame: During one-time condition session at Baseline Assessment
measure: Project 3, Phase 3: Comprehension and Decision Making Accuracy
timeFrame: During one-time condition session at Baseline Assessment
Secondary outcomes:
measure: Project 1, Phase 2: Mean Difference in Score of Social Support and Connectivity Assessed using The Social Connectedness Measure
timeFrame: Post-Randomization at Month 1 and Month 2
measure: Project 1, Phase 2: Mean Difference in Score of Quality of Life, assessed using The Quality of Life Questionnaire
timeFrame: Post-Randomization at the Baseline assessment, Month 1 and Month 2
measure: Project 1, Phase 2: Mean Difference in Score of reported depression, assessed using the Center for Epidemiological Studies-Depression (CES-D) Scale
timeFrame: Post randomization at the baseline assessment, month 1 and month 2.
measure: 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)
timeFrame: Post randomization at the baseline assessment, month 1 and month 2.
measure: Project 2, Phase 2: Mean Difference in Score of Social Support and Connectivity Assessed using The Social Connectedness Measure
timeFrame: Baseline and 6 month post intervention
measure: Project 2, Phase 2: Mean Difference in Score of Quality of Life, assessed using The Quality of Life Questionnaire
timeFrame: Baseline and 6 month post intervention
measure: Project 2, Phase 2: Mean Difference in Score of reported depression, assessed using the Center for Epidemiological Studies-Depression (CES-D) Scale
timeFrame: Baseline and 6 month post intervention
measure: 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)
timeFrame: Baseline and 6 month post intervention
measure: Project 2, Phase 2: Mean Difference in scores of participants' perceived memory function, assessed using the Perception of Memory Function questionnaire
timeFrame: Baseline and 6 month post intervention
measure: Project 3, Phase 3: Comprehension and Decision Making Tool Usability
timeFrame: During one-time condition session at Baseline Assessment
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
city: Champaign
country: United States
facility: University of Illinois Urbana-Champaign
state: Illinois
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Sara J Czaja, PhD
role: PRINCIPAL_INVESTIGATOR
References: