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Learning and Improving Alzheimer's Patient-Caregiver Relationships Via Smart Healthcare Technology

Collaborative Research: Learning and Improving Alzheimer's Patient-Caregiver Relationships Via Smart Healthcare Technology

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04536701
Enrollment
22
Registered
2020-09-03
Start date
2021-02-19
Completion date
2024-12-31
Last updated
2025-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Caregiver Stress Syndrome

Keywords

Alzheimer Disease, Dementia, Caregiving, Smart Health Technology

Brief summary

The purpose of this project is to develop a monitoring, modeling, and interactive recommendation solution (for caregivers) for in-home dementia patient care that focuses on caregiver-patient relationships. This includes monitoring for mood and stress and analyzing the significance of monitoring those attributes to dementia patient care and subsequent behavior dynamics between the patient and caregiver. In addition, novel and adaptive behavioral suggestions at the right moments aims at helping improve familial interactions related to caregiving, which over time should ameliorate the stressful effects of the patient's illness and reduce strain on caregivers. The technical solution consists of a core set of statistical learning based techniques for automated generation of specialized modules required by in-home dementia patient care. There are three main technical components in the solution. The first obtains textual content and prosody from voice and uses advanced machine learning techniques to create classification models. This approach not only monitors patients' behavior, but also caregivers', and infers the underlying dynamics of their interactions, such as changes in mood and stress. The second is the automated creation of classifiers and inference modules tailored to the particular patients and dementia conditions (such as different stages of dementia). The third is an adaptive recommendation system that closes the loop of an in-home behavior monitoring system.

Detailed description

The purpose of this project is to develop a monitoring, modeling, and interactive recommendation solution (for caregivers) for in-home dementia patient care that focuses on caregiver-patient relationships. This includes monitoring for mood and stress and analyzing the significance of monitoring those attributes to dementia patient care and subsequent behavior dynamics between the patient and caregiver. In addition, novel and adaptive behavioral suggestions will be provided to family caregivers via text messages on project Smart phones at the right moments aimed to help improve familial interactions related to caregiving, which over time should ameliorate the stressful effects of the patient's illness and reduce strain on caregivers. The technical solution consists of a core set of statistical learning based techniques for automated generation of specialized modules required by in-home dementia patient care. There are three main technical components in the solution. - The first obtains textual content and prosody from voice and uses advanced machine learning techniques to create classification models. This approach not only monitors patients' behavior, but also caregivers', and infers the underlying dynamics of their interactions, such as changes in mood and stress. - The second is the automated creation of classifiers and inference modules tailored to the particular patients and dementia conditions (such as different stages of dementia). - The third is an adaptive recommendation system that closes the loop of an in-home behavior monitoring system.

Interventions

BEHAVIORALMood Monitoring and Behavioral Recommendation System

The purpose of this project is to develop a monitoring, modeling, and interactive recommendation solution (for caregivers) for in-home dementia patient care that focuses on caregiver-patient relationships. This includes monitoring for mood and stress and analyzing the significance of monitoring those attributes to dementia patient care and subsequent behavior dynamics between the patient and caregiver. In addition, novel and adaptive behavioral suggestions will be provided to family caregivers via text messages on project Smart phones at the right moments aimed to help improve familial interactions related to caregiving, which over time should ameliorate the stressful effects of the patient's illness and reduce strain on caregivers.

Sponsors

University of Virginia
CollaboratorOTHER
The University of Tennessee, Knoxville
CollaboratorOTHER
Ohio State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Longitudinal descriptive

Eligibility

Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

for persons with dementia: * Females and males * Age 60-90 years * Physician documentation of dementia: Alzheimer's disease, vascular, mixed or unspecified type * Community-dwelling (living in the home) * Fluent in English Inclusion criteria for family caregivers: * Age 21 years or older * Informal, unpaid caregiver who resides with the care recipient * Fluent in English * Functioning home Wifi * Scoring above a 3 on the Revised Memory and Behavior Problems Checklist, a clinical cut-off point used to determine caregiver stress.

Exclusion criteria

for persons with dementia: * Presence of acute illness as this could lead to delirium * Alcohol abuse or dependence within the past 2 years (DSM-IV criteria) * History of significant psychiatric illness (e.g., schizophrenia).

Design outcomes

Primary

MeasureTime frameDescription
Depression Anxiety Stress Scale (DASS)Baseline, 4 monthsThe DASS is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress in 3 subscales of 14 items each. The scores of each subscale range from 0-42. These subscales are scored by the addition of the total item scores. Total score is obtained by summing all subscores. Total minimum score: 0; Total maximum score: 126; A higher score indicates higher levels of emotional distress, depression, anxiety and stress. Total: Normal - 0-32; Mild - 33-39; Moderate - 40-49; Severe - 50-57; Extremely severe - 58+ Depression: Normal - 0-9; Mild -10-12; Moderate -13-20; Severe - 21-27; Extremely severe - 28-42 Anxiety: Normal - 0-6; Mild - 7-9; Moderate -10-14; Severe -15-19; Extremely severe - 20-42 Stress: Normal - 0-10; Mild - 11-18; Moderate -19-26; Severe - 27-34; Extremely severe - 35-42
Revised Memory and Behavior Problems Checklist (RMBPC)Baseline, 4 monthsRMBPC 24-item, caregiver-report of observable behavioral problems in dementia patients AND the caregiver's stress reactions to these disturbances. It provides a total score and 3 subscale scores (memory, depression, and disruptive behaviors) and scores for caregiver reactions. Score ranges - Frequency: Total 0-96; Disruptive 0-32; Depressive 0-36; Memory 0-24. Sum items with scores of 0 to 4 on subscales and total. If question score is 9, exclude it from the sum and item count. Sum items for each subscale, compute the mean item score for each subscale by dividing by the number of items included in the sum. Score ranges - Reaction Total 1-96; Disruptive 1-36; Depressive 1-36; Memory 1-24. Include only items with frequency scores of 1 to 4 in the reaction scoring. Compute the mean reaction score by summing reaction scores of these items and then dividing by the number of items included in the sum. A higher score indicates worse outcomes.
Change in Caregiver Emotional ReactivityBaseline, 4 monthsThe 16-item, Difficulties in Emotion Regulation Scale (DERS-16) will be used to measure caregivers' ability to regulate emotions at baseline and end of study. The scale used is the brief version of a theoretically-driven, valid, and reliable self-report tool used to measure difficulties with emotion regulation. The brief version will be more easily administered with the study population and has been shown to be valid and reliable \[41\]. Minimum score: 16; Maximum score: 80. A higher score indicates higher levels of caregiver emotional reactivity.
Five Facet Mindfulness QuestionnaireBaseline, 4 monthsFive Facet Mindfulness Questionnaire 39-item to measure capacity for five different domains of mindfulness practice at baseline and end of study. The five facets include non-reactivity to the inner experience, non-judgment of the inner experience, acting with awareness, observing, and describing internal states. All items are scored with a scale of 1-5. Some items are marked to be reverse scored. All items are scored and summed then divided by the total in each category by the number of items in that category to get an average category score. Each category is summed to calculate the Total then divided by the number of items to get an average item score for each subscale. A higher score indicates higher levels of caregiver capacity for mindfulness practices and better outcomes. Score ranges: Total 1-5; Observing 1-5; Describing 1- 5; Acting with Awareness 1-5; Non-judging 1-5; Nonreactivity 1-5
Change in Caregiver StrainBaseline, 4 monthsModified Caregiver Strain Index (MCSI): It is a 13-item self-report measure that examines both subjective and objective elements of caregiver strain. The MCSI showed excellent inter-item and test-retest reliability and was correlated in expected directions with relevant criteria \[32\]. It has excellent reliability and validity, displays adequate clinical sensitivity, has an established cut-off for determining functional/dysfunctional systems, and has been used successfully on a variety of mental health outcomes \[28\]. We will use a practice tracking worksheet to assess how much the caregivers practice the exercises over the course of the study. Minimum score: 0; Maximum score: 26. High scores indicates higher caregiver strain.
Family Assessment Device (FAD)Baseline, 4 monthsThe FAD is a self-report measure that is given as a set of seven subscales measuring a different dimension of family function. Scores for each dimension (problem solving, communication, roles, affective responsiveness, affective involvement, behavior control, and general functioning) are calculated separately as the mean of the items in that subscale. Scored by summing the endorsed responses (1-4) for each subscale (negatively worded statements are reversed) and dividing by the number of items in each scale. A higher score indicates greater levels of family functioning on all subscales Score Ranges: Total 1-4; Problem Solving 1-5; Communication 1-4; Roles 1-4; Affective Responsiveness 1-6; Affective Involvement 1-7; Behavior Control 1-4; General Functioning 1-4

Countries

United States

Participant flow

Recruitment details

Participants were recruited from a Memory Care Clinic at a large Midwestern academic institution, through social media and self-referral from January 2021 through December 2023.

Pre-assignment details

11 participant dyads (total of 22 participants) completed baseline data collection. 1 dyad withdrew from the study after completing baseline data collection, but did not complete the intervention. While all participants were part of a dyad, only caregiver participants completed surveys and are included in the baseline characteristics data and outcome measures. Baseline Characteristics were not collected for patient participants.

Participants by arm

ArmCount
Dementia/Caregiver Dyad
All dementia/caregiver dyads will have in-home acoustic monitoring to classify mood and will be provided mindfulness-based stress reduction recommendations via a smart phone. Mood Monitoring and Behavioral Recommendation System: The purpose of this project is to develop a monitoring, modeling, and interactive recommendation solution (for caregivers) for in-home dementia patient care that focuses on caregiver-patient relationships. This includes monitoring for mood and stress and analyzing the significance of monitoring those attributes to dementia patient care and subsequent behavior dynamics between the patient and caregiver. In addition, novel and adaptive behavioral suggestions will be provided to family caregivers via text messages on project Smart phones at the right moments aimed to help improve familial interactions related to caregiving, which over time should ameliorate the stressful effects of the patient's illness and reduce strain on caregivers.
11
Total11

Baseline characteristics

CharacteristicDementia/Caregiver Dyad
Age, Continuous60.09 years
STANDARD_DEVIATION 13.52
Caregiver duration34.82 months
STANDARD_DEVIATION 20.26
Caregiving hours/day21.18 hours/day
STANDARD_DEVIATION 6.37
Education Level - Above High School11 participants
Employed outside of home3 participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Married7 participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
2 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
9 Participants
Region of Enrollment
United States
11 participants
Sex: Female, Male
Female
8 Participants
Sex: Female, Male
Male
3 Participants
Veteran Status2 participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 22
other
Total, other adverse events
0 / 22
serious
Total, serious adverse events
0 / 22

Outcome results

Primary

Change in Caregiver Emotional Reactivity

The 16-item, Difficulties in Emotion Regulation Scale (DERS-16) will be used to measure caregivers' ability to regulate emotions at baseline and end of study. The scale used is the brief version of a theoretically-driven, valid, and reliable self-report tool used to measure difficulties with emotion regulation. The brief version will be more easily administered with the study population and has been shown to be valid and reliable \[41\]. Minimum score: 16; Maximum score: 80. A higher score indicates higher levels of caregiver emotional reactivity.

Time frame: Baseline, 4 months

Population: There was 1 participant who did not complete the study.

ArmMeasureValue (MEAN)Dispersion
Baseline - Dementia/Caregiver DyadChange in Caregiver Emotional Reactivity30.55 score on a scaleStandard Deviation 11.85
4 Months Post Baseline - Dementia/Caregiver DyadChange in Caregiver Emotional Reactivity34.3 score on a scaleStandard Deviation 15.7
p-value: 0.3857t-test, 2 sided
Primary

Change in Caregiver Strain

Modified Caregiver Strain Index (MCSI): It is a 13-item self-report measure that examines both subjective and objective elements of caregiver strain. The MCSI showed excellent inter-item and test-retest reliability and was correlated in expected directions with relevant criteria \[32\]. It has excellent reliability and validity, displays adequate clinical sensitivity, has an established cut-off for determining functional/dysfunctional systems, and has been used successfully on a variety of mental health outcomes \[28\]. We will use a practice tracking worksheet to assess how much the caregivers practice the exercises over the course of the study. Minimum score: 0; Maximum score: 26. High scores indicates higher caregiver strain.

Time frame: Baseline, 4 months

Population: There was 1 participant who did not complete the study.

ArmMeasureValue (MEAN)Dispersion
Baseline - Dementia/Caregiver DyadChange in Caregiver Strain14.18 score on a scaleStandard Deviation 5.58
4 Months Post Baseline - Dementia/Caregiver DyadChange in Caregiver Strain15.1 score on a scaleStandard Deviation 6.84
p-value: 0.5368t-test, 2 sided
Primary

Depression Anxiety Stress Scale (DASS)

The DASS is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress in 3 subscales of 14 items each. The scores of each subscale range from 0-42. These subscales are scored by the addition of the total item scores. Total score is obtained by summing all subscores. Total minimum score: 0; Total maximum score: 126; A higher score indicates higher levels of emotional distress, depression, anxiety and stress. Total: Normal - 0-32; Mild - 33-39; Moderate - 40-49; Severe - 50-57; Extremely severe - 58+ Depression: Normal - 0-9; Mild -10-12; Moderate -13-20; Severe - 21-27; Extremely severe - 28-42 Anxiety: Normal - 0-6; Mild - 7-9; Moderate -10-14; Severe -15-19; Extremely severe - 20-42 Stress: Normal - 0-10; Mild - 11-18; Moderate -19-26; Severe - 27-34; Extremely severe - 35-42

Time frame: Baseline, 4 months

Population: There was 1 participant who did not complete the study.

ArmMeasureGroupValue (MEAN)Dispersion
Baseline - Dementia/Caregiver DyadDepression Anxiety Stress Scale (DASS)DASS-Depressive mood8.09 score on a scaleStandard Deviation 5.39
Baseline - Dementia/Caregiver DyadDepression Anxiety Stress Scale (DASS)DASS-Anxiety6 score on a scaleStandard Deviation 5.25
Baseline - Dementia/Caregiver DyadDepression Anxiety Stress Scale (DASS)Total26.27 score on a scaleStandard Deviation 16.46
Baseline - Dementia/Caregiver DyadDepression Anxiety Stress Scale (DASS)DASS-Stress12.18 score on a scaleStandard Deviation 7.31
4 Months Post Baseline - Dementia/Caregiver DyadDepression Anxiety Stress Scale (DASS)DASS-Stress12.6 score on a scaleStandard Deviation 11.74
4 Months Post Baseline - Dementia/Caregiver DyadDepression Anxiety Stress Scale (DASS)Total29.10 score on a scaleStandard Deviation 30.29
4 Months Post Baseline - Dementia/Caregiver DyadDepression Anxiety Stress Scale (DASS)DASS-Anxiety6.5 score on a scaleStandard Deviation 9.23
4 Months Post Baseline - Dementia/Caregiver DyadDepression Anxiety Stress Scale (DASS)DASS-Depressive mood10 score on a scaleStandard Deviation 10.35
Comparison: Total DASS score reported.p-value: 0.444t-test, 2 sided
Comparison: Depressive Mood DASS score reportedp-value: 0.8378t-test, 2 sided
Comparison: Anxiety DASS score reportedp-value: 0.4087t-test, 2 sided
Comparison: Stress DASS score reportedp-value: 0.4124t-test, 2 sided
Primary

Family Assessment Device (FAD)

The FAD is a self-report measure that is given as a set of seven subscales measuring a different dimension of family function. Scores for each dimension (problem solving, communication, roles, affective responsiveness, affective involvement, behavior control, and general functioning) are calculated separately as the mean of the items in that subscale. Scored by summing the endorsed responses (1-4) for each subscale (negatively worded statements are reversed) and dividing by the number of items in each scale. A higher score indicates greater levels of family functioning on all subscales Score Ranges: Total 1-4; Problem Solving 1-5; Communication 1-4; Roles 1-4; Affective Responsiveness 1-6; Affective Involvement 1-7; Behavior Control 1-4; General Functioning 1-4

Time frame: Baseline, 4 months

Population: There was 1 participant who did not complete the study

ArmMeasureGroupValue (MEAN)Dispersion
Baseline - Dementia/Caregiver DyadFamily Assessment Device (FAD)FAD General Functioning2.05 score on a scaleStandard Deviation 0.72
Baseline - Dementia/Caregiver DyadFamily Assessment Device (FAD)FAD Total2.13 score on a scaleStandard Deviation 0.46
Baseline - Dementia/Caregiver DyadFamily Assessment Device (FAD)FAD Problem Solving2.15 score on a scaleStandard Deviation 0.49
Baseline - Dementia/Caregiver DyadFamily Assessment Device (FAD)FAD Communication2.29 score on a scaleStandard Deviation 0.56
Baseline - Dementia/Caregiver DyadFamily Assessment Device (FAD)FAD Roles2.29 score on a scaleStandard Deviation 0.4
Baseline - Dementia/Caregiver DyadFamily Assessment Device (FAD)FAD Affective Responsiveness2.27 score on a scaleStandard Deviation 0.62
Baseline - Dementia/Caregiver DyadFamily Assessment Device (FAD)FAD Affective Involvement2.08 score on a scaleStandard Deviation 0.43
Baseline - Dementia/Caregiver DyadFamily Assessment Device (FAD)FAD Behavior Control1.82 score on a scaleStandard Deviation 0.49
4 Months Post Baseline - Dementia/Caregiver DyadFamily Assessment Device (FAD)FAD Behavior Control1.91 score on a scaleStandard Deviation 0.52
4 Months Post Baseline - Dementia/Caregiver DyadFamily Assessment Device (FAD)FAD General Functioning2.07 score on a scaleStandard Deviation 0.77
4 Months Post Baseline - Dementia/Caregiver DyadFamily Assessment Device (FAD)FAD Roles2.35 score on a scaleStandard Deviation 0.72
4 Months Post Baseline - Dementia/Caregiver DyadFamily Assessment Device (FAD)FAD Total2.20 score on a scaleStandard Deviation 0.59
4 Months Post Baseline - Dementia/Caregiver DyadFamily Assessment Device (FAD)FAD Affective Involvement2.20 score on a scaleStandard Deviation 0.59
4 Months Post Baseline - Dementia/Caregiver DyadFamily Assessment Device (FAD)FAD Problem Solving2.32 score on a scaleStandard Deviation 0.73
4 Months Post Baseline - Dementia/Caregiver DyadFamily Assessment Device (FAD)FAD Affective Responsiveness2.35 score on a scaleStandard Deviation 0.76
4 Months Post Baseline - Dementia/Caregiver DyadFamily Assessment Device (FAD)FAD Communication2.23 score on a scaleStandard Deviation 0.49
Comparison: FAD Total reportedp-value: 0.2845t-test, 2 sided
Comparison: FAD Problem Solving is reportedp-value: 0.1386t-test, 2 sided
Comparison: FAD Communication is reportedp-value: 0.7551t-test, 2 sided
Comparison: FAD Roles is reportedp-value: 0.7213t-test, 2 sided
Comparison: FAD Affective Responsiveness is reportedp-value: 0.3233t-test, 2 sided
Comparison: FAD Affective Involvement is reportedp-value: 0.2832t-test, 2 sided
Comparison: FAD Behavior Control is reportedp-value: 0.6831t-test, 2 sided
Comparison: FAD General Functioning is reportedp-value: 0.6075t-test, 2 sided
Primary

Five Facet Mindfulness Questionnaire

Five Facet Mindfulness Questionnaire 39-item to measure capacity for five different domains of mindfulness practice at baseline and end of study. The five facets include non-reactivity to the inner experience, non-judgment of the inner experience, acting with awareness, observing, and describing internal states. All items are scored with a scale of 1-5. Some items are marked to be reverse scored. All items are scored and summed then divided by the total in each category by the number of items in that category to get an average category score. Each category is summed to calculate the Total then divided by the number of items to get an average item score for each subscale. A higher score indicates higher levels of caregiver capacity for mindfulness practices and better outcomes. Score ranges: Total 1-5; Observing 1-5; Describing 1- 5; Acting with Awareness 1-5; Non-judging 1-5; Nonreactivity 1-5

Time frame: Baseline, 4 months

Population: There was 1 participant who did not complete the study

ArmMeasureGroupValue (MEAN)Dispersion
Baseline - Dementia/Caregiver DyadFive Facet Mindfulness QuestionnaireDescribing3.83 score on a scaleStandard Deviation 0.56
Baseline - Dementia/Caregiver DyadFive Facet Mindfulness QuestionnaireTotal3.48 score on a scaleStandard Deviation 0.58
Baseline - Dementia/Caregiver DyadFive Facet Mindfulness QuestionnaireObserving3.43 score on a scaleStandard Deviation 0.93
Baseline - Dementia/Caregiver DyadFive Facet Mindfulness QuestionnaireActing with Awareness3.17 score on a scaleStandard Deviation 0.9
Baseline - Dementia/Caregiver DyadFive Facet Mindfulness QuestionnaireNon-judging3.55 score on a scaleStandard Deviation 0.91
Baseline - Dementia/Caregiver DyadFive Facet Mindfulness QuestionnaireNonreactivity3.42 score on a scaleStandard Deviation 0.84
4 Months Post Baseline - Dementia/Caregiver DyadFive Facet Mindfulness QuestionnaireNon-judging3.58 score on a scaleStandard Deviation 0.98
4 Months Post Baseline - Dementia/Caregiver DyadFive Facet Mindfulness QuestionnaireActing with Awareness3.23 score on a scaleStandard Deviation 1.14
4 Months Post Baseline - Dementia/Caregiver DyadFive Facet Mindfulness QuestionnaireTotal3.44 score on a scaleStandard Deviation 0.49
4 Months Post Baseline - Dementia/Caregiver DyadFive Facet Mindfulness QuestionnaireNonreactivity3.21 score on a scaleStandard Deviation 0.77
4 Months Post Baseline - Dementia/Caregiver DyadFive Facet Mindfulness QuestionnaireObserving3.44 score on a scaleStandard Deviation 0.96
4 Months Post Baseline - Dementia/Caregiver DyadFive Facet Mindfulness QuestionnaireDescribing3.71 score on a scaleStandard Deviation 0.61
Comparison: Five Facet Mindfulness Questionnaire (FFMQ) total reportedp-value: 0.7213t-test, 2 sided
Comparison: FFMQ Observing reportedp-value: 0.6075t-test, 2 sided
Comparison: FFMQ Describing reportedp-value: 0.4136t-test, 2 sided
Comparison: FFMQ Acting with Awareness reportedp-value: 0.8378t-test, 2 sided
Comparison: FFMQ Nonjudging reportedp-value: 0.7193t-test, 2 sided
Comparison: FFMQ Nonreactivity reportedp-value: 0.4145t-test, 2 sided
Primary

Revised Memory and Behavior Problems Checklist (RMBPC)

RMBPC 24-item, caregiver-report of observable behavioral problems in dementia patients AND the caregiver's stress reactions to these disturbances. It provides a total score and 3 subscale scores (memory, depression, and disruptive behaviors) and scores for caregiver reactions. Score ranges - Frequency: Total 0-96; Disruptive 0-32; Depressive 0-36; Memory 0-24. Sum items with scores of 0 to 4 on subscales and total. If question score is 9, exclude it from the sum and item count. Sum items for each subscale, compute the mean item score for each subscale by dividing by the number of items included in the sum. Score ranges - Reaction Total 1-96; Disruptive 1-36; Depressive 1-36; Memory 1-24. Include only items with frequency scores of 1 to 4 in the reaction scoring. Compute the mean reaction score by summing reaction scores of these items and then dividing by the number of items included in the sum. A higher score indicates worse outcomes.

Time frame: Baseline, 4 months

Population: There was 1 participant who did not complete the study.

ArmMeasureGroupValue (MEAN)Dispersion
Baseline - Dementia/Caregiver DyadRevised Memory and Behavior Problems Checklist (RMBPC)Frequency of Symptoms Total13.27 score on a scaleStandard Deviation 4.22
Baseline - Dementia/Caregiver DyadRevised Memory and Behavior Problems Checklist (RMBPC)Frequency of Disruptive Symptoms3.82 score on a scaleStandard Deviation 2.6
Baseline - Dementia/Caregiver DyadRevised Memory and Behavior Problems Checklist (RMBPC)Frequency of Depressive Symptoms3.09 score on a scaleStandard Deviation 2.59
Baseline - Dementia/Caregiver DyadRevised Memory and Behavior Problems Checklist (RMBPC)Frequency of Memory Symptoms6.36 score on a scaleStandard Deviation 0.92
Baseline - Dementia/Caregiver DyadRevised Memory and Behavior Problems Checklist (RMBPC)Reaction to Symptoms Total26.82 score on a scaleStandard Deviation 17.35
Baseline - Dementia/Caregiver DyadRevised Memory and Behavior Problems Checklist (RMBPC)Reaction to Disruptive Symptoms9.45 score on a scaleStandard Deviation 7.5
Baseline - Dementia/Caregiver DyadRevised Memory and Behavior Problems Checklist (RMBPC)Reaction to Depressive Symptoms7.27 score on a scaleStandard Deviation 8.26
Baseline - Dementia/Caregiver DyadRevised Memory and Behavior Problems Checklist (RMBPC)Reaction to Memory Symptoms10.09 score on a scaleStandard Deviation 6
4 Months Post Baseline - Dementia/Caregiver DyadRevised Memory and Behavior Problems Checklist (RMBPC)Reaction to Memory Symptoms9.1 score on a scaleStandard Deviation 7.19
4 Months Post Baseline - Dementia/Caregiver DyadRevised Memory and Behavior Problems Checklist (RMBPC)Frequency of Symptoms Total10.9 score on a scaleStandard Deviation 5.47
4 Months Post Baseline - Dementia/Caregiver DyadRevised Memory and Behavior Problems Checklist (RMBPC)Reaction to Symptoms Total19.6 score on a scaleStandard Deviation 21.9
4 Months Post Baseline - Dementia/Caregiver DyadRevised Memory and Behavior Problems Checklist (RMBPC)Frequency of Disruptive Symptoms2.4 score on a scaleStandard Deviation 2.95
4 Months Post Baseline - Dementia/Caregiver DyadRevised Memory and Behavior Problems Checklist (RMBPC)Reaction to Depressive Symptoms5 score on a scaleStandard Deviation 8.41
4 Months Post Baseline - Dementia/Caregiver DyadRevised Memory and Behavior Problems Checklist (RMBPC)Frequency of Depressive Symptoms2.1 score on a scaleStandard Deviation 2.38
4 Months Post Baseline - Dementia/Caregiver DyadRevised Memory and Behavior Problems Checklist (RMBPC)Reaction to Disruptive Symptoms5.5 score on a scaleStandard Deviation 7.53
4 Months Post Baseline - Dementia/Caregiver DyadRevised Memory and Behavior Problems Checklist (RMBPC)Frequency of Memory Symptoms6.4 score on a scaleStandard Deviation 0.84
Comparison: Total RMBPC frequency reportedp-value: 0.0508t-test, 2 sided
Comparison: Frequency of disruptive symptoms on RMBP reportedp-value: 0.026t-test, 2 sided
Comparison: Frequency of depressive symptoms on RMBPC reportedp-value: 0.1861t-test, 2 sided
Comparison: Frequency of memory symptoms on RMBPC reportedp-value: 0.9535t-test, 2 sided
Comparison: RMBPC reaction total is reportedp-value: 0.0411t-test, 2 sided
Comparison: RMBPC reaction disruptive symptoms is reportedp-value: 0.0058t-test, 2 sided
Comparison: RMBPC reaction depressive symptoms is reportedp-value: 0.2527t-test, 2 sided
Comparison: RMBPC reaction memory symptomsp-value: 0.3542t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026