Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 3
2 other identifiers
interventional
600
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2026
CompletedFirst Posted
Study publicly available on registry
March 20, 2026
CompletedStudy Start
First participant enrolled
April 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
March 20, 2026
March 1, 2026
1.1 years
March 16, 2026
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Project 3, Phase 3: Comprehension and Decision Making Tool Usability
During one-time condition session at Baseline Assessment
Study Arms (4)
Project 3 - Phase 1: Problem Space Specification and Task Selection
NO INTERVENTIONBoth 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 INTERVENTIONThe 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
EXPERIMENTALParticipants 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.
Project 3 - Phase 3: Usual-Tool Control Condition
ACTIVE COMPARATORParticipants 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.
Interventions
An innovative intelligent decision tool for health decisions aims at providing health management support for older adults with and without MCI.
Eligibility Criteria
You may qualify if:
- Project 1:
- + years of age
- Able to read English at the 6th grade level
- Have 20/60 vision with or without correction.
- Project 2:
- + 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
- +7 more criteria
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Florida State University
Tallahassee, Florida, 32306, United States
University of Illinois Urbana-Champaign
Champaign, Illinois, 61820, United States
Weill Cornell Medicine
New York, New York, 10065, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sara J Czaja, PhD
Weill Medical College of Cornell University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2026
First Posted
March 20, 2026
Study Start
April 30, 2026
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
March 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- 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.
- 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.
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.