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Recruiting NCT07485725

Digital Tools to Support Healthcare Decision Making

No phase Interventional Mild Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Project 3, Phase 2: Clinical Trial.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Project 3, Phase 2: Mean Perceived System Usefulness [Time frame: Immediately following completion of the task performance session]
  • Project 3, Phase 2: Sum of Performance Accuracy [Time frame: Immediately following completion of the task performance session]

Eligibility criteria

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?

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Florida State University — Tallahassee
  • University of Illinois Urbana-Champaign — Champaign
  • Weill Cornell Medicine — New York

Identifiers

NCT: NCT07485725 · 23-01025559-03 · P01AG073090-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗