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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Emergency Medicine Foundation | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QOL) in Alzheimer's Disease (AD) Scale (QOL-AD) | Total score range 13-52; higher scores indicate better QOL. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
- evidence of delirium, by the 4-AT screening tool
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| Name | Affiliation | Role |
|---|---|---|
| Cameron Gettel | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06519 | United States |
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This was a caregiver-focused study. Although both persons living with cognitive impairment (PLWCI) and their care partners were approached during the recruitment process, only care partners were considered enrolled participants. All baseline and outcome measures, including self-efficacy and burden assessments, were collected solely from enrolled care partners.
The reported enrollment number and participant flow reflect the number of care partners enrolled, not the number of dyads or PLWCI. No s
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention (NeuViCare AI) | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention (NeuViCare AI) | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data presented here is for all caregiver participants that completed the surveys at each time frame. | Posted | Mean | Standard Deviation | score on a scale | Day 7 and 30 |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention (NeuViCare AI) | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cameron Gettel | Yale School of Medicine | 717-228-7759 | cameron.gettel@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 11, 2023 | Jun 22, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 29, 2023 | Jun 22, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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|
| 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. | 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. | Day 0, 7, and 30 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Marital Status | Count of Participants | Participants |
|
| Form of cognitive impairment | Count of Participants | Participants |
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| Median number of chronic conditions | Median | Inter-Quartile Range | conditions |
|
| Emergency Department chief complaint (Most common three) | Count of Participants | Participants |
|
| Living Situation | Count of Participants | Participants |
|
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|
| 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. | Data presented here is for all caregiver participants that completed the surveys at each time frame. | Posted | Mean | Standard Deviation | score on a scale | Day 7 and 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. | Data presented here is for all caregiver participants that completed the surveys at each time frame. | Posted | Mean | Standard Deviation | score on a scale | Day 7 and 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 satisfaction, with an overall score range of 10-50 (higher scores suggest increased usability). Administration time is 3-5 minutes. Measured by survey. | Data presented here is for all caregiver participants that completed the surveys at each time frame. | Posted | Mean | Standard Deviation | score on a scale | Day 7 and 30 |
|
|
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| Secondary | Quality of Life (QOL) in Alzheimer's Disease (AD) Scale (QOL-AD) | Total score range 13-52; higher scores indicate better QOL. | Data presented here is for all caregiver participants that completed the surveys at each time frame. | Posted | Mean | Standard Deviation | score on a scale | Day 0, 7 and 30 |
|
|
|
| Secondary | 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. | Data presented here is for all caregiver participants that completed the surveys at each time frame. | Posted | Mean | Standard Deviation | score on a scale | Day 0, 7 and 30 |
|
|
|
| Secondary | 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. | Data presented here is for all caregiver participants that completed the surveys at each time frame. | Posted | Mean | Standard Deviation | score on a scale | Day 0, 7 and 30 |
|
|
|
| Secondary | 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. | Data presented here is for all caregiver participants that completed the surveys at each time frame. | Posted | Mean | Standard Deviation | score on a scale | Day 0, 7, and 30 |
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| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
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| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Day 30 |
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| Day 30 |
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| Day 30 |
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| Day 30 |
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