Trial Outcomes & Findings for Learning and Improving Alzheimer's Patient-Caregiver Relationships Via Smart Healthcare Technology (NCT NCT04536701)

Last Updated: 2025-05-06

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

Baseline, 4 months

Results posted on

2025-05-06

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Baseline STARTED	22
Baseline COMPLETED	22
Baseline NOT COMPLETED	0
4 Weeks Post Baseline STARTED	20
4 Weeks Post Baseline COMPLETED	20
4 Weeks Post Baseline NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dementia/Caregiver Dyad n=11 Participants 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.
Age, Continuous	60.09 years STANDARD_DEVIATION 13.52 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants
Education Level - Above High School	11 participants n=5 Participants
Employed outside of home	3 participants n=5 Participants
Married	7 participants n=5 Participants
Veteran Status	2 participants n=5 Participants
Caregiving hours/day	21.18 hours/day STANDARD_DEVIATION 6.37 • n=5 Participants
Caregiver duration	34.82 months STANDARD_DEVIATION 20.26 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 4 months

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

Outcome measures

Outcome measures
Measure	Baseline - Dementia/Caregiver Dyad n=11 Participants 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.	4 Months Post Baseline - Dementia/Caregiver Dyad n=10 Participants 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.
Depression Anxiety Stress Scale (DASS) Total	26.27 score on a scale Standard Deviation 16.46	29.10 score on a scale Standard Deviation 30.29
Depression Anxiety Stress Scale (DASS) DASS-Depressive mood	8.09 score on a scale Standard Deviation 5.39	10 score on a scale Standard Deviation 10.35
Depression Anxiety Stress Scale (DASS) DASS-Anxiety	6 score on a scale Standard Deviation 5.25	6.5 score on a scale Standard Deviation 9.23
Depression Anxiety Stress Scale (DASS) DASS-Stress	12.18 score on a scale Standard Deviation 7.31	12.6 score on a scale Standard Deviation 11.74

PRIMARY outcome

Timeframe: Baseline, 4 months

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

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.

Outcome measures

Outcome measures
Measure	Baseline - Dementia/Caregiver Dyad n=11 Participants 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.	4 Months Post Baseline - Dementia/Caregiver Dyad n=10 Participants 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.
Revised Memory and Behavior Problems Checklist (RMBPC) Frequency of Symptoms Total	13.27 score on a scale Standard Deviation 4.22	10.9 score on a scale Standard Deviation 5.47
Revised Memory and Behavior Problems Checklist (RMBPC) Frequency of Disruptive Symptoms	3.82 score on a scale Standard Deviation 2.60	2.4 score on a scale Standard Deviation 2.95
Revised Memory and Behavior Problems Checklist (RMBPC) Frequency of Depressive Symptoms	3.09 score on a scale Standard Deviation 2.59	2.1 score on a scale Standard Deviation 2.38
Revised Memory and Behavior Problems Checklist (RMBPC) Frequency of Memory Symptoms	6.36 score on a scale Standard Deviation 0.92	6.4 score on a scale Standard Deviation 0.84
Revised Memory and Behavior Problems Checklist (RMBPC) Reaction to Symptoms Total	26.82 score on a scale Standard Deviation 17.35	19.6 score on a scale Standard Deviation 21.90
Revised Memory and Behavior Problems Checklist (RMBPC) Reaction to Disruptive Symptoms	9.45 score on a scale Standard Deviation 7.50	5.5 score on a scale Standard Deviation 7.53
Revised Memory and Behavior Problems Checklist (RMBPC) Reaction to Depressive Symptoms	7.27 score on a scale Standard Deviation 8.26	5 score on a scale Standard Deviation 8.41
Revised Memory and Behavior Problems Checklist (RMBPC) Reaction to Memory Symptoms	10.09 score on a scale Standard Deviation 6.00	9.1 score on a scale Standard Deviation 7.19

PRIMARY outcome

Timeframe: Baseline, 4 months

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

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.

Outcome measures

Outcome measures
Measure	Baseline - Dementia/Caregiver Dyad n=11 Participants 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.	4 Months Post Baseline - Dementia/Caregiver Dyad n=10 Participants 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.
Change in Caregiver Emotional Reactivity	30.55 score on a scale Standard Deviation 11.85	34.3 score on a scale Standard Deviation 15.70

PRIMARY outcome

Timeframe: Baseline, 4 months

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

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

Outcome measures

Outcome measures
Measure	Baseline - Dementia/Caregiver Dyad n=11 Participants 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.	4 Months Post Baseline - Dementia/Caregiver Dyad n=10 Participants 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.
Five Facet Mindfulness Questionnaire Total	3.48 score on a scale Standard Deviation 0.58	3.44 score on a scale Standard Deviation 0.49
Five Facet Mindfulness Questionnaire Observing	3.43 score on a scale Standard Deviation 0.93	3.44 score on a scale Standard Deviation 0.96
Five Facet Mindfulness Questionnaire Describing	3.83 score on a scale Standard Deviation 0.56	3.71 score on a scale Standard Deviation 0.61
Five Facet Mindfulness Questionnaire Acting with Awareness	3.17 score on a scale Standard Deviation 0.90	3.23 score on a scale Standard Deviation 1.14
Five Facet Mindfulness Questionnaire Non-judging	3.55 score on a scale Standard Deviation 0.91	3.58 score on a scale Standard Deviation 0.98
Five Facet Mindfulness Questionnaire Nonreactivity	3.42 score on a scale Standard Deviation 0.84	3.21 score on a scale Standard Deviation 0.77

PRIMARY outcome

Timeframe: Baseline, 4 months

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

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.

Outcome measures

Outcome measures
Measure	Baseline - Dementia/Caregiver Dyad n=11 Participants 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.	4 Months Post Baseline - Dementia/Caregiver Dyad n=10 Participants 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.
Change in Caregiver Strain	14.18 score on a scale Standard Deviation 5.58	15.1 score on a scale Standard Deviation 6.84

PRIMARY outcome

Timeframe: Baseline, 4 months

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

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

Outcome measures

Outcome measures
Measure	Baseline - Dementia/Caregiver Dyad n=11 Participants 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.	4 Months Post Baseline - Dementia/Caregiver Dyad n=10 Participants 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.
Family Assessment Device (FAD) FAD Roles	2.29 score on a scale Standard Deviation 0.40	2.35 score on a scale Standard Deviation 0.72
Family Assessment Device (FAD) FAD Affective Responsiveness	2.27 score on a scale Standard Deviation 0.62	2.35 score on a scale Standard Deviation 0.76
Family Assessment Device (FAD) FAD Affective Involvement	2.08 score on a scale Standard Deviation 0.43	2.20 score on a scale Standard Deviation 0.59
Family Assessment Device (FAD) FAD Behavior Control	1.82 score on a scale Standard Deviation 0.49	1.91 score on a scale Standard Deviation 0.52
Family Assessment Device (FAD) FAD General Functioning	2.05 score on a scale Standard Deviation 0.72	2.07 score on a scale Standard Deviation 0.77
Family Assessment Device (FAD) FAD Total	2.13 score on a scale Standard Deviation 0.46	2.20 score on a scale Standard Deviation 0.59
Family Assessment Device (FAD) FAD Problem Solving	2.15 score on a scale Standard Deviation 0.49	2.32 score on a scale Standard Deviation 0.73
Family Assessment Device (FAD) FAD Communication	2.29 score on a scale Standard Deviation 0.56	2.23 score on a scale Standard Deviation 0.49

Adverse Events

Dementia/Caregiver Dyad

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

Dr. Karen Rose

Ohio State University

Phone: 614-292-4844

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60