NCT05352399

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

March 20, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 5, 2025

Completed
Last Updated

August 5, 2025

Status Verified

July 1, 2025

Enrollment Period

1.3 years

First QC Date

April 18, 2022

Results QC Date

June 24, 2025

Last Update Submit

July 16, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Intervention Appropriateness Measure

    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

    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

    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

    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.

    Day 7 and 30

Secondary Outcomes (4)

  • Quality of Life (QOL) in Alzheimer's Disease (AD) Scale (QOL-AD)

    Day 0, 7 and 30

  • Dyadic Relationship Scale (DRS)

    Day 0, 7 and 30

  • Zarit Caregiver Burden Scale

    Day 0, 7 and 30

  • Fortinsky Caregiver Self-Efficacy Scale

    Day 0, 7, and 30

Study Arms (1)

Intervention (NeuViCare AI)

EXPERIMENTAL

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.

Other: NeuViCare application

Interventions

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.

Intervention (NeuViCare AI)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- evidence of delirium, by the 4-AT screening tool

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

DementiaEmergencies

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Cameron Gettel
Organization
Yale School of Medicine

Study Officials

  • Cameron Gettel

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2022

First Posted

April 28, 2022

Study Start

March 20, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

August 5, 2025

Results First Posted

August 5, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations