Learning and Improving Alzheimer's Patient-Caregiver Relationships Via Smart Healthcare Technology
Primary Purpose
Alzheimer Disease, Caregiver Stress Syndrome
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mood Monitoring and Behavioral Recommendation System
Sponsored by
About this trial
This is an interventional other trial for Alzheimer Disease focused on measuring Alzheimer Disease, Dementia, Caregiving, Smart Health Technology
Eligibility Criteria
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).
Sites / Locations
- The Ohio State University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dementia/Caregiver Dyad
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in Acoustic Monitoring/Mood Classifier
The acoustic monitoring will occur for 1 month to establish baseline interactions between the family caregiver and the persons with dementia. Acoustic monitoring and text message recommendations will occur over the subsequent 3 months.
Change in Caregiver Depression, Anxiety and Stress
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. The DASS was constructed not merely as another set of scales to measure conventionally defined emotional states, but to further the process of defining, understanding, and measuring the ubiquitous and clinically significant emotional states usually described as depression, anxiety and stress. As the scales of the DASS have been shown to have high internal consistency and to yield meaningful discriminations in a variety of settings, the scales should meet the needs of both researchers and clinicians who wish to measure current state or change in state over time (e.g., in the course of treatment) on the three dimensions of depression, anxiety and stress. Minimum score: 0; Maximum score: 168; A higher score indicates higher levels of depression, anxiety and stress.
Change in Caregiver reaction to dementia behaviors
The Revised Memory and Behavior Problems Checklist (RMBPC) is a 24-item, caregiver-report measure of observable behavioral problems in dementia patients and the caregiver's stress reactions to these behavioral disturbances. The instrument provides a total score and 3 subscale scores for patient behavioral problems (memory-related, depression, and disruptive behaviors) and corresponding scores for caregiver reactions to each of these. Overall scale internal consistency of the instrument is reported as .84 for patient behavior and .90 for caregiver reaction and the instrument has confirmed validity through comparison of instrument scores with measures of depression, cognitive impairment, and caregiver burden Minimum score: 0; Maximum score: 120. A higher score indicates higher levels of caregiver reaction to dementia behaviors.
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.
Change in caregiver capacity for mindfulness practice
Caregivers will be asked to complete the 39-item Five Facet Mindfulness Questionnaire to measure their 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. The questionnaire has good reliability and validity Minimum score: 39; Maximum score: 195. A higher score indicates higher levels of caregiver capacity for mindfulness practices.
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.
Change in Family Functioning
Family Assessment Device (FAD): The FAD is a self-report measure that is given as a set of seven subscales of varied length. Each subscale measures 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. The information obtained through the FAD allows for the elucidation of the structure and organization of the family system, as well as the identification of common patterns of interaction among family members. The FAD is heavily used in research related to the function of family systems, and it has demonstrated excellent validity and reliability in both non-clinical and clinical populations. Minimum score:0 ; Maximum score: 212. A higher score indicates greater levels of family functioning.
Change in Mood Classifier System Feasibility
Determine the accuracy of dementia/caregiver dyad mood classification using the acoustic monitoring system. Percentage of agreement between participant identified mood (via self-report) and mood classifier system identified mood (via acoustic monitoring).
Change in Recommendation System Feasibility
Determine the functionality of the text message recommendation system. Percentage of recommendations that are implemented at time of message delivery. Identification of common reasons for improper implementation.
Change in Recommendation System Acceptability
Determine usefulness of behavioral recommendation messages as reported by caregivers via surveys and interviews. Participants will rate behavioral recommendations on a scale from 0(not useful)-10(very useful). A high score indicates the recommendation was very useful for them. Participants will also participate in an interview at study of completion (average of 4 months) to discuss how useful and acceptable the recommendations were for them.
Change in Caregiver Loneliness
Measure of caregiver self-reported loneliness via 0(none)-10(highest) scale. A high score indicates greater levels of loneliness.
Change in Caregiver Self-Reported Physical Health
Measure of caregiver self-reported physical health via 0(none)-10(highest) scale. A low score indicates poor self-reported physical health.
Change in Caregiver Self-Reported Emotional Health
Measure of caregiver self-reported emotional health via 0(none)-10(highest) scale. A low score indicates poor self-reported emotional health.
Secondary Outcome Measures
Full Information
NCT ID
NCT04536701
First Posted
August 19, 2020
Last Updated
April 19, 2023
Sponsor
Ohio State University
Collaborators
University of Virginia, The University of Tennessee, Knoxville
1. Study Identification
Unique Protocol Identification Number
NCT04536701
Brief Title
Learning and Improving Alzheimer's Patient-Caregiver Relationships Via Smart Healthcare Technology
Official Title
Collaborative Research: Learning and Improving Alzheimer's Patient-Caregiver Relationships Via Smart Healthcare Technology
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 19, 2021 (Actual)
Primary Completion Date
April 15, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
University of Virginia, The University of Tennessee, Knoxville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Caregiver Stress Syndrome
Keywords
Alzheimer Disease, Dementia, Caregiving, Smart Health Technology
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Longitudinal descriptive
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dementia/Caregiver Dyad
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mood Monitoring and Behavioral Recommendation System
Intervention 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.
Primary Outcome Measure Information:
Title
Change in Acoustic Monitoring/Mood Classifier
Description
The acoustic monitoring will occur for 1 month to establish baseline interactions between the family caregiver and the persons with dementia. Acoustic monitoring and text message recommendations will occur over the subsequent 3 months.
Time Frame
Through study completion, average of 4 months
Title
Change in Caregiver Depression, Anxiety and Stress
Description
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. The DASS was constructed not merely as another set of scales to measure conventionally defined emotional states, but to further the process of defining, understanding, and measuring the ubiquitous and clinically significant emotional states usually described as depression, anxiety and stress. As the scales of the DASS have been shown to have high internal consistency and to yield meaningful discriminations in a variety of settings, the scales should meet the needs of both researchers and clinicians who wish to measure current state or change in state over time (e.g., in the course of treatment) on the three dimensions of depression, anxiety and stress. Minimum score: 0; Maximum score: 168; A higher score indicates higher levels of depression, anxiety and stress.
Time Frame
Baseline, 4 months
Title
Change in Caregiver reaction to dementia behaviors
Description
The Revised Memory and Behavior Problems Checklist (RMBPC) is a 24-item, caregiver-report measure of observable behavioral problems in dementia patients and the caregiver's stress reactions to these behavioral disturbances. The instrument provides a total score and 3 subscale scores for patient behavioral problems (memory-related, depression, and disruptive behaviors) and corresponding scores for caregiver reactions to each of these. Overall scale internal consistency of the instrument is reported as .84 for patient behavior and .90 for caregiver reaction and the instrument has confirmed validity through comparison of instrument scores with measures of depression, cognitive impairment, and caregiver burden Minimum score: 0; Maximum score: 120. A higher score indicates higher levels of caregiver reaction to dementia behaviors.
Time Frame
Baseline, 4 months
Title
Change in caregiver emotional reactivity
Description
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
Title
Change in caregiver capacity for mindfulness practice
Description
Caregivers will be asked to complete the 39-item Five Facet Mindfulness Questionnaire to measure their 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. The questionnaire has good reliability and validity Minimum score: 39; Maximum score: 195. A higher score indicates higher levels of caregiver capacity for mindfulness practices.
Time Frame
Baseline, 4 months
Title
Change in Caregiver Strain
Description
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
Title
Change in Family Functioning
Description
Family Assessment Device (FAD): The FAD is a self-report measure that is given as a set of seven subscales of varied length. Each subscale measures 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. The information obtained through the FAD allows for the elucidation of the structure and organization of the family system, as well as the identification of common patterns of interaction among family members. The FAD is heavily used in research related to the function of family systems, and it has demonstrated excellent validity and reliability in both non-clinical and clinical populations. Minimum score:0 ; Maximum score: 212. A higher score indicates greater levels of family functioning.
Time Frame
Baseline, 4 months
Title
Change in Mood Classifier System Feasibility
Description
Determine the accuracy of dementia/caregiver dyad mood classification using the acoustic monitoring system. Percentage of agreement between participant identified mood (via self-report) and mood classifier system identified mood (via acoustic monitoring).
Time Frame
Daily through study completion, average of 4 months
Title
Change in Recommendation System Feasibility
Description
Determine the functionality of the text message recommendation system. Percentage of recommendations that are implemented at time of message delivery. Identification of common reasons for improper implementation.
Time Frame
Daily through study completion, average of 4 months
Title
Change in Recommendation System Acceptability
Description
Determine usefulness of behavioral recommendation messages as reported by caregivers via surveys and interviews. Participants will rate behavioral recommendations on a scale from 0(not useful)-10(very useful). A high score indicates the recommendation was very useful for them. Participants will also participate in an interview at study of completion (average of 4 months) to discuss how useful and acceptable the recommendations were for them.
Time Frame
Daily through study completion, average of four months
Title
Change in Caregiver Loneliness
Description
Measure of caregiver self-reported loneliness via 0(none)-10(highest) scale. A high score indicates greater levels of loneliness.
Time Frame
Daily through study completion, average of four months
Title
Change in Caregiver Self-Reported Physical Health
Description
Measure of caregiver self-reported physical health via 0(none)-10(highest) scale. A low score indicates poor self-reported physical health.
Time Frame
Daily through study completion, average of four months
Title
Change in Caregiver Self-Reported Emotional Health
Description
Measure of caregiver self-reported emotional health via 0(none)-10(highest) scale. A low score indicates poor self-reported emotional health.
Time Frame
Daily through study completion, average of four months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen M Rose, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33576064
Citation
Rose KM, Coop Gordon K, Schlegel EC, Mccall M, Gao Y, Ma M, Lenger KA, Ko E, Wright KD, Wang H, Stankovic J. Smarthealth technology study protocol to improve relationships between older adults with dementia and family caregivers. J Adv Nurs. 2021 May;77(5):2519-2529. doi: 10.1111/jan.14714. Epub 2021 Feb 11.
Results Reference
derived
Learn more about this trial
Learning and Improving Alzheimer's Patient-Caregiver Relationships Via Smart Healthcare Technology
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