Center for Research and Education on Aging and Technology Enhancement - CREATE V

Weill Cornell Medicine (WCM)

Status: Not yet enrolling

Conditions: Mild Cognitive Impairment

Treatments: Behavioral: Project 3, Phase 3: Intelligent Decision Support Tool; Behavioral: Project 2, Phase 2: Intelligent Adaptive System; Behavioral: Project 1, Phase 2: VR Program for Social, Activity, and Cognitive Engagement

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05811338

23-01025559

P01AG073090-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,202 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,202 participants in 9 patient groups

Project 1 - Phase 1: Development/Refinement of VR program; Usability Testing/Development of Training

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Project 1, Phase 2: VR Program for Social, Activity, and Cognitive Engagement

Project 1 - Phase 2: Tablet Control Condition

Active Comparator group

Description:

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.

Treatment:

Behavioral: Project 1, Phase 2: VR Program for Social, Activity, and Cognitive Engagement

Project 2 - Phase 2: Active Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Project 2, Phase 2: Intelligent Adaptive System

Project 2 - Phase 2: Waitlist Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Project 2, Phase 2: Intelligent Adaptive System

Project 3 - Phase 1: Problem Space Specification and Task Selection

No Intervention group

Description:

Both the subject matter experts and older adult participants will participate in individual structured interviews for each activity category, 1.5 - 2 hours in length. This qualitative data will provide rich contextualized information regarding the specific needs of older adults for access to services, financial health management, and Medicare.gov services utilization. This data will be used to identify current barriers and facilitators to successful healthcare management that could be targeted by technology solutions and/obtain details of the challenges that are common in each activity category.

Project 3 - Phase 2: Development of Digital Assistant Tools

No Intervention group

Description:

The study includes one session that will last approximately 2 - 3 hours. The study involves interactions with digital assistants developed by the research team, the participants will answer structured interview questions regarding their experiences using the system. The researchers will assess the participants' comments along dimensions such as type of information requested, preference for format of information, points of confusion, and likes and dislikes of features, which will form the basis for a prioritized list of features/functions to be modified for the next prototype iteration.

Project 3 - Phase 3: DATA Condition

Experimental group

Description:

Participants in the DATA condition, instead of access to a generic digital assistant, will have DATA at their disposal to solve the queries and will be encouraged to use it as the primary resource. Qualitative data on how they use this tool, in isolation and in conjunction with other sources of information, will be collected. Following completion of the problems, as in Phase 2, measures of DATA usability will be collected including usefulness and comprehension associated with each tool, perceived mental workload, and usability with an efficient, two-item test based on the widely used System Usability Scale: UMUX-LITE). The investigators will then conduct an audio-recorded semi-structured exit interview about various perceptions participants had regarding the challenges associated with successfully solving the health-management problems.

Treatment:

Behavioral: Project 3, Phase 3: Intelligent Decision Support Tool

Project 3 - Phase 3: Usual-Tool Control Condition

Active Comparator group

Description:

Participants will have access to a generic, non-adapted voice assistant available on a provided tablet. The experimenter will use a standard script that allows for guidance to participants in searching for information relevant to the problems. Participants will indicate when they are ready to move on to the next problem, which will be followed by their assessment of the confidence they have in having solved the problem, their comprehension of the information associated with the problem, their assessment of the usefulness of the available information, and the perceived mental workload they experienced in solving the problem. Investigators will track, code, and analyze participants' online interactions with any websites they use. For each of the three task activity domains, overall performance scores will be computed, as will performance scores for the simpler and more complex problems.

Treatment:

Behavioral: Project 3, Phase 3: Intelligent Decision Support Tool