Digital Tools to Support Healthcare Decision Making
CREATE P3
Technology Tools for Cognitive Support for Health Management Activities for Aging Adults With and Without Mild Cognitive Impairment (Research Project 3)
2 other identifiers
interventional
120
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 our collaborators and our 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2026
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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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
May 4, 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
July 8, 2026
July 1, 2026
1.1 years
March 16, 2026
July 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Project 3, Phase 2: Mean Perceived System Usefulness
Participants' perception of the usefulness of the system with 7 items with 3 subscales, included workload, trust, and usability. The Workload subscale will be computed from the average of a. the mental effort and b. the physical effort responses. Average c,d,e for the trust scale, and average f,g for a usability scale. Higher scores indicated higher workload, higher trust, and higher usability.
Immediately following completion of the task performance session
Project 3, Phase 2: Sum of Performance Accuracy
Accuracy will be evaluated based on whether the participants provided the accurate answer for each query (0=incorrect and 1=correct). Accuracy is summed across 12 queries with possible scores ranging from 0-12, higher scores indicate higher accuracy.
Immediately following completion of the task performance session
Study Arms (2)
Sidekick Condition
EXPERIMENTALParticipants will be given a brief introduction to Large Language Models, how they can be used to solve queries, and introduced to Sidekick. Some simple example queries will be used to demonstrate its use, how to construct prompts, and to illustrate the nature of Sidekick's responses. Participants will also be instructed about different degrees of specificity of information and other customization features of Sidekick and how to use responses as a springboard for iterative prompting (sequential queries).
Usual-Tool Control Condition
ACTIVE COMPARATORParticipants will be asked to open the medicare.gov website. They will be shown the basic structure of the homepage and the distinctions between tabs on the website. Examples of information that can be obtained from these different tabs will be demonstrated. Navigation between different parts of the website will also be demonstrated.
Interventions
A digital support tool (adapted for this study for Medicare) with a diverse sample of adults age 60+ with and without a cognitive impairment.
Eligibility Criteria
You may qualify if:
- Some internet proficiency is required; participants will need to answer Yes to the following:
- Can you use the Internet to access a website, for example, amazon.com?
- Can you use search engines like Google to search for information on the Internet?
- English speaking.
- th grade literacy.
- Aged 60 or older.
- TICS-m with a score between 22-37 for MCI and \>37 for normal.
- Able to read from a newspaper.
You may not qualify if:
- blindness
- deafness (inability to engage in telephone screening due to hearing difficulties)
- terminal illness
- severe motor impairments (e.g., severe tremors or debilitating arthritis in the hands),
- TICS-m \<22.
- All Phase 1 study participants (interview and observational study): have you ever participated in a study that interviewed you about your experience with Medicare or asked you to search for Medicare information?
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
- TRIPLE
- Who Masked
- PARTICIPANT, 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
May 4, 2026
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
July 8, 2026
Record last verified: 2026-07
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.