DementiaNCT05352399
Artificial Intelligence + Care Coach Intervention
A study testing NeuViCare application in people with Dementia and Caregiver, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Caregiver, Emergency Department
- What is being tested?
- NeuViCare application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- evidence of delirium, by the 4-AT screening tool
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06519
About this study
Official title: 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.
- Being tested
- NeuViCare application
- Medical subject headings
- Dementia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuViCare applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: NeuViCare application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 7 and 30
Secondary outcomes (4)
Quality of Life (QOL) in Alzheimer's Disease (AD) Scale (QOL-AD)
Total score range 13-52; higher scores indicate better QOL.
Measured: Day 0, 7 and 30
Dyadic Relationship Scale (DRS)
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.
Measured: Day 0, 7 and 30
Zarit Caregiver Burden Scale
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.
Measured: Day 0, 7 and 30
Fortinsky Caregiver Self-Efficacy Scale
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.
Measured: Day 0, 7, and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start20 Mar 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Emergency Medicine Foundation
- Responsible party
- Sponsor
- Investigators
- Cameron Gettel, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352399
- Sponsor's protocol ID
- 2000032226
- Status last verified
- Jul 2025
- First submitted
- 18 Apr 2022
- Last updated
- 5 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence + Care Coach Intervention for Persons Living With Dementia and Caregivers
- ClinicalTrials.gov ID
- NCT05352399
- Acronym / sponsor ID
- 2000032226
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Emergency Medicine Foundation
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Posted 5 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention (NeuViCare AI) | Experimental | Other: NeuViCare applicationAn 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- evidence of delirium, by the 4-AT screening tool
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuViCare applicationIntervention 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. | Other | Intervention (NeuViCare AI) |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
Quality of Life (QOL) in Alzheimer's Disease (AD) Scale (QOL-AD)
Time frame: Day 0, 7 and 30
Dyadic Relationship Scale (DRS)
Time frame: Day 0, 7 and 30
Zarit Caregiver Burden Scale
Time frame: Day 0, 7 and 30
Fortinsky Caregiver Self-Efficacy Scale
Time frame: Day 0, 7, and 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cameron Gettel principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuViCare application in people with Dementia and Caregiver, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Appropriateness Measure (time frame: Day 7 and 30). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.