Trial Outcomes & Findings for Artificial Intelligence + Care Coach Intervention (NCT NCT05352399)
NCT ID: NCT05352399
Last Updated: 2025-08-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Day 7 and 30
Results posted on
2025-08-05
Participant Flow
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
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Discontinued intervention
|
6
|
Baseline Characteristics
Artificial Intelligence + Care Coach Intervention
Baseline characteristics by cohort
| Measure |
Intervention (NeuViCare AI)
n=40 Participants
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.
|
|---|---|
|
Age, Continuous
|
82.3 years
STANDARD_DEVIATION 6.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=99 Participants
|
|
Marital Status
Married
|
20 Participants
n=99 Participants
|
|
Marital Status
Divorced
|
4 Participants
n=99 Participants
|
|
Marital Status
Single
|
4 Participants
n=99 Participants
|
|
Marital Status
Widowed
|
12 Participants
n=99 Participants
|
|
Form of cognitive impairment
Diagnosed dementia
|
24 Participants
n=99 Participants
|
|
Form of cognitive impairment
Absence of dementia based on dementia screening score ≥ 2
|
16 Participants
n=99 Participants
|
|
Median number of chronic conditions
|
3 conditions
n=99 Participants
|
|
Emergency Department chief complaint (Most common three)
Fall
|
7 Participants
n=99 Participants
|
|
Emergency Department chief complaint (Most common three)
Altered mental state
|
6 Participants
n=99 Participants
|
|
Emergency Department chief complaint (Most common three)
Syncope
|
5 Participants
n=99 Participants
|
|
Living Situation
Own home
|
10 Participants
n=99 Participants
|
|
Living Situation
With care partner
|
30 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 7 and 30Population: Data presented here is for all caregiver participants that completed the surveys at each time frame.
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.
Outcome measures
| Measure |
Intervention (NeuViCare AI)
n=26 Participants
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.
|
|---|---|
|
Intervention Appropriateness Measure
Day 7
|
15.1 score on a scale
Standard Deviation 3.6
|
|
Intervention Appropriateness Measure
Day 30
|
15.8 score on a scale
Standard Deviation 3.9
|
PRIMARY outcome
Timeframe: Day 7 and 30Population: Data presented here is for all caregiver participants that completed the surveys at each time frame.
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.
Outcome measures
| Measure |
Intervention (NeuViCare AI)
n=26 Participants
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.
|
|---|---|
|
Feasibility of Intervention Measure
Day 7
|
15.1 score on a scale
Standard Deviation 3.1
|
|
Feasibility of Intervention Measure
Day 30
|
15.5 score on a scale
Standard Deviation 3.6
|
PRIMARY outcome
Timeframe: Day 7 and 30Population: Data presented here is for all caregiver participants that completed the surveys at each time frame.
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.
Outcome measures
| Measure |
Intervention (NeuViCare AI)
n=26 Participants
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.
|
|---|---|
|
Acceptability of Intervention Measure
Day 7
|
15.9 score on a scale
Standard Deviation 3.2
|
|
Acceptability of Intervention Measure
Day 30
|
15.8 score on a scale
Standard Deviation 3.9
|
PRIMARY outcome
Timeframe: Day 7 and 30Population: Data presented here is for all caregiver participants that completed the surveys at each time frame.
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.
Outcome measures
| Measure |
Intervention (NeuViCare AI)
n=26 Participants
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.
|
|---|---|
|
System Usability Scale
Day 7
|
30.1 score on a scale
Standard Deviation 3.8
|
|
System Usability Scale
Day 30
|
29.7 score on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Day 0, 7 and 30Population: Data presented here is for all caregiver participants that completed the surveys at each time frame.
Total score range 13-52; higher scores indicate better QOL.
Outcome measures
| Measure |
Intervention (NeuViCare AI)
n=40 Participants
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.
|
|---|---|
|
Quality of Life (QOL) in Alzheimer's Disease (AD) Scale (QOL-AD)
Day 0
|
40.5 score on a scale
Standard Deviation 7.4
|
|
Quality of Life (QOL) in Alzheimer's Disease (AD) Scale (QOL-AD)
Day 7
|
33.8 score on a scale
Standard Deviation 9.2
|
|
Quality of Life (QOL) in Alzheimer's Disease (AD) Scale (QOL-AD)
Day 30
|
36.6 score on a scale
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Day 0, 7 and 30Population: Data presented here is for all caregiver participants that completed the surveys at each time frame.
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.
Outcome measures
| Measure |
Intervention (NeuViCare AI)
n=40 Participants
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.
|
|---|---|
|
Dyadic Relationship Scale (DRS)
Day 0
|
10.7 score on a scale
Standard Deviation 3.9
|
|
Dyadic Relationship Scale (DRS)
Day 7
|
10.4 score on a scale
Standard Deviation 2.6
|
|
Dyadic Relationship Scale (DRS)
Day 30
|
10.8 score on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Day 0, 7 and 30Population: Data presented here is for all caregiver participants that completed the surveys at each time frame.
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.
Outcome measures
| Measure |
Intervention (NeuViCare AI)
n=40 Participants
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.
|
|---|---|
|
Zarit Caregiver Burden Scale
Day 0
|
9.2 score on a scale
Standard Deviation 4.3
|
|
Zarit Caregiver Burden Scale
Day 7
|
9 score on a scale
Standard Deviation 2.1
|
|
Zarit Caregiver Burden Scale
Day 30
|
8.2 score on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Day 0, 7, and 30Population: Data presented here is for all caregiver participants that completed the surveys at each time frame.
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.
Outcome measures
| Measure |
Intervention (NeuViCare AI)
n=40 Participants
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.
|
|---|---|
|
Fortinsky Caregiver Self-Efficacy Scale
Day 0
|
52 score on a scale
Standard Deviation 26.3
|
|
Fortinsky Caregiver Self-Efficacy Scale
Day 7
|
57.6 score on a scale
Standard Deviation 23.1
|
|
Fortinsky Caregiver Self-Efficacy Scale
Day 30
|
65.8 score on a scale
Standard Deviation 17.8
|
Adverse Events
Intervention (NeuViCare AI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place