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Completed

NCT Number: NCT05352399

Artificial Intelligence + Care Coach Intervention

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.

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Key information

Conditions

Dementia Artificial Intelligence Brain Diseases Care Transition Caregiver Central Nervous System Diseases Disease Attributes Emergencies Emergency Department Mental Disorders Nervous System Diseases Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

NeuViCare application

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Emergency Medicine Foundation
  • National Institute on Aging (NIA)

Registry information

Official study title

Artificial Intelligence + Care Coach Intervention for Persons Living With Dementia and Caregivers

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 28, 2022
Registry last updated
Aug 5, 2025

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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