Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 3

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Project 3, Phase 3: Intelligent Decision Support Tool

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 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.

Project 3 record was originally listed under NCT05811338.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chelsie Burchett, PhD; Phone Number: 646-962-7141; Email: cob2014@med.cornell.edu
• Study Contact Backup: Name: Xin Lin, PhD; Phone Number: 646-962-7141; Email: xyl4001@med.cornell.edu

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Florida State University
  • Illinois
    • Champaign, Illinois, United States, 61820
      • University of Illinois Urbana-Champaign
      • Contact: Wendy Rogers, PhD; Phone Number: 217-300-1470; Email: wendyr@illinois.edu
      • Principal Investigator: Wendy Rogers, PhD
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine
      • Contact: Chelsie Burchett, MA; Phone Number: 646-962-7141; Email: cob2014@med.cornell.edu
      • Principal Investigator: Sara Czaja, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Project 3 - Phase 1: Problem Space Specification and Task Selection; 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.
No Intervention: Project 3 - Phase 2: Development of Digital Assistant Tools; 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.
Experimental: Project 3 - Phase 3: DATA Condition; 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.	Behavioral: Project 3, Phase 3: Intelligent Decision Support Tool; An innovative intelligent decision tool for health decisions aims at providing health management support for older adults with and without MCI.
Active Comparator: Project 3 - Phase 3: Usual-Tool Control Condition; 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.	Behavioral: Project 3, Phase 3: Intelligent Decision Support Tool; An innovative intelligent decision tool for health decisions aims at providing health management support for older adults with and without MCI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Project 3, Phase 1: Qualitative interview assessment regarding Healthcare Challenges	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.	During one-time condition session at Baseline Assessment
Project 3, Phase 3: Mixed-method assessment of usability challenges assessed using the Usability Metric for User Experience (UMUX-LITE)	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.	During one-time condition session at Baseline Assessment
Project 3, Phase 3: Comprehension and Decision Making Accuracy	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.	During one-time condition session at Baseline Assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Project 3, Phase 3: Comprehension and Decision Making Tool Usability	The Comprehension and Decision making tool will measure participants' perception of technology-based intervention ease of use and usefulness. The Comprehension and Decision making tool measure is to be developed based on projects 1 and 2 of the study.	During one-time condition session at Baseline Assessment

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Sara J Czaja, PhD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Technology
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 23-01025559-03; P01AG073090-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No