Artificial Intelligence + Care Coach Intervention

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05352399
• Other study ID #: 2000032226
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Yale University
• Contact: Cameron Gettel
• Phone: 2037374842
• Email: cameron.gettel[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Artificial Intelligence
• Care Transition
• Caregiver
• Dementia
• Emergencies
• Emergency Department

Intervention

Other:
• NeuViCare application
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.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (4)

Lead Sponsor	Collaborator
Yale University	Emergency Medicine Foundation, National Institute on Aging (NIA), West Health Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 30
Primary	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 30
Primary	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 30
Primary	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 satisfcation, with an overall score range of 10-50 (higher scores suggest increased usability). Administration time is 3-5 minutes. Measured by survey.	Day 30
Secondary	Dementia Knowledge Assessment Scale	The Dementia Knowledge Assessment Scale is a reliable and valid measure of dementia knowledge for health professionals and members of the general public that is capable of elucidating knowledge characteristics across four coherent domains: 1) Causes and Characteristics, 2) Communication and Behaviour, 3) Care Considerations, and 4) Risks and Health Promotion. Statements are true/false for the respondent to answer with scores ranging from 0-21. Administration time is approximately 10-15 minutes. Measured by survey.	Day 30
Secondary	Zarit Caregiver Burden Scale	The Zarit Caregiver Burden Scale consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88. Higher scores indicate greater burden. Administration time is approximately 10-15 minutes. Measured by survey.	Day 30
Secondary	General Self-Efficacy Scale	The General Self-Efficacy Scale is used to evaluate the coping ability of daily living. The measure is 10 items with overall scores ranging from 10-40, with higher scores representing greater self-efficacy. Administration time is approximately 3-5 minutes. Measured by survey.	Day 30
Secondary	Emergency Department revisits	Repeat visit to the ED by electronic health record, supplemented with self-report survey to identify those not with the institution's EDs.	Day 30
Secondary	Hospitalizations	Hospitalizations by electronic health record, supplemented with self-report survey to identify those not with the institution's hospitals.	Day 30