- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05352399
Artificial Intelligence + Care Coach Intervention
July 16, 2025 updated by: Yale University
Artificial Intelligence + Care Coach Intervention for Persons Living With Dementia and Caregivers
The purpose of this research study is to develop and test an artificial intelligence intervention for emergency department (ED) discharge care transitions experienced by caregivers of older adults with cognitive impairment.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06519
- Yale New Haven Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- age ≥65 years with a diagnosis of dementia within the electronic health record OR new cognitive impairment identified during an ED visit
- be fluent in English or Spanish
- discharge after an ED visit
- possession of a smart device (either a phone, tablet, or computer) that has internet access to utilize and interact with NeuViCare AI services
Exclusion Criteria:
- evidence of delirium, by the 4-AT screening tool
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention (NeuViCare AI)
An anticipated 55 participants will be part of the Intervention arm participants and will engage with NeuViCare AI, including all variations of its 5 components described further below.
|
Intervention arm participants will engage with NeuViCare AI, including all variations of its 5 components: 1) NeuViCare Planner - enables review of ordered tests and external resources recommended by the care provider; 2) NeuViCare Task-Support Service - provides context-sensitive, personalized text-based assistance to help patients' complete care plan captured in the NeuViCare Planner; 3) NeuViCare Resource Advisor - presents trusted, unbiased advice to locate nearby resources listed within their care plan; 4) NeuViCare Advisor - educates and trains Persons Living With Dementia (PLWD) and their care partners at the moment of need; and 5) NeuViCare Community Hub - a safe virtual space which enables care partners to interact with other peer care partners to gain their experiential knowledge and emotional support.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention Appropriateness Measure
Time Frame: Day 7 and 30
|
Appropriateness is defined as the perceived fit, relevance, or compatibility of the innovation for a given setting or consumer, and/or perceived fit of the innovation to address a particular issue or problem.
The measure consists of 4 questions, with an overall score range of 4-20 (higher scores suggest increased appropriateness).
Administration time is 1-2 minutes.
Measured by survey.
|
Day 7 and 30
|
|
Feasibility of Intervention Measure
Time Frame: Day 7 and 30
|
Feasibility is defined as the extent to which a new innovation can be successfully used or carried out within a given setting.
The measure consists of 4 questions, with an overall score range of 4-20 (higher scores suggest increased feasibility).
Administration time is 1-2 minutes.
Measured by survey.
|
Day 7 and 30
|
|
Acceptability of Intervention Measure
Time Frame: Day 7 and 30
|
Acceptability is defined as the perception that a given innovation is agreeable, palatable, or satisfactory.
The measure consists of 4 questions, with an overall score range of 4-20 (higher scores suggest increased acceptability).
Administration time is 1-2 minutes.
Measured by survey.
|
Day 7 and 30
|
|
System Usability Scale
Time Frame: Day 7 and 30
|
Usability encapsulates several aspects including subjective component assessments of effectiveness, efficiency, and satisfaction.
The System Usability Scale consists of 10 questions on effectiveness, efficiency, and satisfaction, with an overall score range of 10-50 (higher scores suggest increased usability).
Administration time is 3-5 minutes.
Measured by survey.
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Day 7 and 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life (QOL) in Alzheimer's Disease (AD) Scale (QOL-AD)
Time Frame: Day 0, 7 and 30
|
Total score range 13-52; higher scores indicate better QOL.
|
Day 0, 7 and 30
|
|
Dyadic Relationship Scale (DRS)
Time Frame: Day 0, 7 and 30
|
DRS to measure strain between the caregiver and recipient within the last 30 days.
Total score range 4-20.
High scores indicate high levels of strain.
|
Day 0, 7 and 30
|
|
Zarit Caregiver Burden Scale
Time Frame: Day 0, 7 and 30
|
The Zarit Caregiver Burden Scale consists of 4 items with the total score ranging between 0-16.
Higher scores indicate greater burden.
Administration time is approximately 10-15 minutes.
Measured by survey.
|
Day 0, 7 and 30
|
|
Fortinsky Caregiver Self-Efficacy Scale
Time Frame: Day 0, 7, and 30
|
Used to evaluate the coping ability of daily living.
The measure has a total score range from 10-100, with higher scores representing greater self-efficacy.
Administration time is approximately 3-5 minutes.
Measured by survey.
|
Day 0, 7, and 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cameron Gettel, Yale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2023
Primary Completion (Actual)
June 30, 2024
Study Completion (Actual)
June 30, 2024
Study Registration Dates
First Submitted
April 18, 2022
First Submitted That Met QC Criteria
April 26, 2022
First Posted (Actual)
April 28, 2022
Study Record Updates
Last Update Posted (Actual)
August 5, 2025
Last Update Submitted That Met QC Criteria
July 16, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000032226
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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