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NCT Number: NCT07485725

Digital Tools to Support Healthcare Decision Making

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University, Tallahassee, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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?

Treatment and study plan

Project 3, Phase 2: Clinical Trial

Behavioral

A digital support tool (adapted for this study for Medicare) with a diverse sample of adults age 60+ with and without a cognitive impairment.

Primary outcomes

  1. Project 3, Phase 2: Mean Perceived System Usefulness

    Time frame: Immediately following completion of the task performance session

    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.

  2. Project 3, Phase 2: Sum of Performance Accuracy

    Time frame: Immediately following completion of the task performance session

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chelsie Burchett, PhD

CONTACT

[email protected]

646-962-7141

Sophie Park

CONTACT

[email protected]

646-962-7141

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Technology Tools for Cognitive Support for Health Management Activities for Aging Adults With and Without Mild Cognitive Impairment (Research Project 3)

Acronym: CREATE P3

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 20, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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