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)

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.

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Project 3, Phase 2: Clinical Trial

Detailed Description

The overarching goal of the project is to enable diverse older adults, including those of lower SES or with cognitive impairments (e.g., MCI), to achieve their health goals by supporting the cognitive components of health-management activities, through development of digital assistant technology tools. Tool development will be guided by an understanding of the preferences, needs, and cognitive capabilities and limitations of older adults. Each of the CREATE sites will lead efforts. CREATE resources will be used to maximal potential through utilization of the machine learning and artificial intelligence expertise of our partners at the WCM site for support of the development of digital assistant technology tools for medicare. Importantly, data collection related to development and evaluation of the tools for each of the task activities will occur at all sites to maximize the design of the cognitive support tools and the generalizability of the findings.

Clinical Trial, the primary objective is focused on evaluating the feasibility, acceptability and usability of the SideKick digital support tool (adapted for this study for Medicare) with a diverse sample of adults age 60+ with and without a cognitive impairment. This is a feasibility trial. The study design is a pilot RCT. Following a baseline assessment, participants will be randomized into a Medicare.gov Condition or the SideKick condition. Participants will complete a series of queries related to Medicare enrollment and plan selection (that vary in complexity) using medicare.gov or Sidekick. Their performance and perceptions (e.g., challenges, usability, usefulness, etc.) will be evaluated upon completion of the queries.

This clinical trial was originally registered as part of NCT05811338.

• Study Type: Interventional
• Enrollment (Estimated): 120
• 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: Sophie Park; Phone Number: 646-962-7141; Email: sep4008@med.cornell.edu

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Withdrawn
      • Florida State University
  • Illinois
    • Champaign, Illinois, United States, 61820
      • Recruiting
      • 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
      • Recruiting
      • Weill Cornell Medicine
      • Principal Investigator: Sara Czaja, PhD
      • Contact: Chelsie Burchett, PhD; Phone Number: 646-962-7141; Email: cob2014@med.cornell.edu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.
• 6th 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.

Exclusion Criteria:

• 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?

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sidekick Condition; Participants 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).	Behavioral: Project 3, Phase 2: Clinical Trial; A digital support tool (adapted for this study for Medicare) with a diverse sample of adults age 60+ with and without a cognitive impairment.
Active Comparator: Usual-Tool Control Condition; Participants 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.	Behavioral: Project 3, Phase 2: Clinical Trial; A digital support tool (adapted for this study for Medicare) with a diverse sample of adults age 60+ with and without a cognitive impairment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

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 (Actual): May 4, 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): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 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