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Artificial Intelligence + Care Coach Intervention

Primary Purpose

Dementia, Caregiver, Emergency Department

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NeuViCare application
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yale New Haven HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention (NeuViCare AI)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
Hospitalizations
Hospitalizations by electronic health record, supplemented with self-report survey to identify those not with the institution's hospitals.

Full Information

First Posted
April 18, 2022
Last Updated
May 4, 2023
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT05352399
Brief Title
Artificial Intelligence + Care Coach Intervention
Official Title
Artificial Intelligence + Care Coach Intervention for Persons Living With Dementia and Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Caregiver, Emergency Department, Artificial Intelligence, Care Transition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention (NeuViCare AI)
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
NeuViCare application
Intervention Description
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 Outcome Measure Information:
Title
Intervention Appropriateness Measure
Description
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.
Time Frame
Day 30
Title
Feasibility of Intervention Measure
Description
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.
Time Frame
Day 30
Title
Acceptability of Intervention Measure
Description
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.
Time Frame
Day 30
Title
System Usability Scale
Description
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.
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Dementia Knowledge Assessment Scale
Description
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.
Time Frame
Day 30
Title
Zarit Caregiver Burden Scale
Description
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.
Time Frame
Day 30
Title
General Self-Efficacy Scale
Description
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.
Time Frame
Day 30
Title
Emergency Department revisits
Description
Repeat visit to the ED by electronic health record, supplemented with self-report survey to identify those not with the institution's EDs.
Time Frame
Day 30
Title
Hospitalizations
Description
Hospitalizations by electronic health record, supplemented with self-report survey to identify those not with the institution's hospitals.
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cameron Gettel
Phone
2037374842
Email
cameron.gettel@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cameron Gettel
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cameron Gettel
Phone
717-228-7759
Email
cameron.gettel@yale.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Artificial Intelligence + Care Coach Intervention

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