Mild Cognitive ImpairmentCREATE P3NCT07485725
Digital Tools to Support Healthcare Decision Making
A study testing Project 3, Phase 2: Clinical Trial in people with Mild Cognitive Impairment, run by Weill Medical College of Cornell University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Project 3, Phase 2: Clinical Trial
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 May 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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?
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 2 recruiting
- Recruiting
University of Illinois Urbana-Champaign
Champaign, Illinois, 61820
Wendy Rogers, PhD, 217-300-1470, wendyr@illinois.edu
Wendy Rogers, PhD
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Chelsie Burchett, PhD, 646-962-7141, cob2014@med.cornell.edu
Sara Czaja, PhD
- Withdrawn
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: 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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Project 3, Phase 2: Clinical Trial
- Keywords
- Technology
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project 3, Phase 2: Clinical TrialBehavioural
A digital support tool (adapted for this study for Medicare) with a diverse sample of adults age 60+ with and without a cognitive impairment.
| Study group | Role | What they receive |
|---|---|---|
| Sidekick Condition | Experimental | 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). Receives: Behavioral: Project 3, Phase 2: Clinical Trial |
| Usual-Tool Control Condition | Active comparator | 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. Receives: Behavioral: Project 3, Phase 2: Clinical Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately following completion of the task performance session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start4 May 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Sara J Czaja, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485725
- Sponsor's protocol ID
- 23-01025559-03
- Other IDs
- P01AG073090-01A1
- Acronym
- CREATE P3
- Status last verified
- Jul 2026
- First submitted
- 16 Mar 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Tools for Cognitive Support for Health Management Activities for Aging Adults With and Without Mild Cognitive Impairment (Research Project 3)
- ClinicalTrials.gov ID
- NCT07485725
- Acronym / sponsor ID
- CREATE P3 / 23-01025559-03
- Conditions
- Mild Cognitive Impairment
- Keywords
- Technology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 4 May 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sidekick Condition | Experimental | Behavioral: Project 3, Phase 2: Clinical TrialParticipants 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 comparator | Behavioral: Project 3, Phase 2: Clinical TrialParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project 3, Phase 2: Clinical TrialA digital support tool (adapted for this study for Medicare) with a diverse sample of adults age 60+ with and without a cognitive impairment. | Behavioural | Sidekick Condition, Usual-Tool Control Condition |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara J Czaja, PhD principal investigator
Weill Medical College of Cornell University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project 3, Phase 2: Clinical Trial in people with Mild Cognitive Impairment, run by Weill Medical College of Cornell University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chelsie Burchett, PhD (646-962-7141, cob2014@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Project 3, Phase 2: Mean Perceived System Usefulness (time frame: Immediately following completion of the task performance session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.