Collaborative Research: Learning and Improving Alzheimer's Patient-Caregiver Relationships Via Smart Healthcare Technology
Phase: NA
Conditions: Alzheimer Disease, Caregiver Stress Syndrome
Sponsor: Ohio State University

Official Title: Learning and Improving Alzheimer's Patient-
Caregiver Relationships Via Smart Healthcare 
Technology 
NCT Number: NCT04536701 
Document Name: Study Protocol 
Document Date: 3/4/2022 
 
 
 

     IRB Protocol Number: 2019B0406 
               IRB Approval date: Pending 
     Version:      03/04/2022  
 
 
2 
 
 
 
 
Research Protocol 
 
 
Collaborative Research: Learning and Improving Alzheimer's Patient-Caregiver Relationships 
via Smart Healthcare Technology.  
 
I. Objectives  
The purpose of this project is to develop a monitoring, modeling, and interactive recommendation 
solutions (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 Smartphones 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. 
 
II. 
Background and Rationale 
Over 80% of people with Alzheimer's disease or a related dementia are cared for in their home 
environments by family members. Family caregivers often report increased anxiety and 
depression, and many forego their own health needs as the demands of being a family caregiver 
are sustained over many years. These demands can be stressful and poor preexisting family 
relationships can exacerbate this burden over time. Behavioral responses to stress, as exhibited 
through problematic behaviors in persons with ADRD, have been linked to higher levels of 
caregiver stress. It is also known that poor interactions between patient and caregiver increase 
the difficulty of providing care: when reactivity is heightened, a stress response ensues and a 
downward cascade of maladaptive behaviors and emotions is elicited. Monitoring physiological 
reactivity between patient and caregiver could signal when problematic interactions might occur. 
Just-in-time or even predictive recommendations in those moments could improve these 
interactions and reduce strain on caregivers. 

     IRB Protocol Number: 2019B0406 
               IRB Approval date: Pending 
     Version:      03/04/2022  
 
 
3 
 
 
To conduct the proposed research, a sensing and recommendation platform is required that can 
detect mood and stress during interactions between caregivers and patients, and that can issue 
just-in-time recommendations to caregivers. Our approach is to employ smart phones with 
microphones and speakers, in-situ microphones, and iPads or laptops to collect affective states 
from voice and provide recommendations using multiple modalities (text and voice). Smart 
phones will be used for automated recommendations of mindfulness training provided to the 
caregivers. This set of equipment will be used to provide the information required by the 
statistical learning modules as well as for the recommendation generation. A base station, and 
cloud storage and computation will also be used. All data uploaded to the cloud is encrypted and 
anonymized by participant ID. The mapping from a person to the participant ID will be kept in a 
separate secure location to protect security and privacy.  
A number of human physiological parameters correlate with mood and respond in the presence 
of stress, such as voice, skin conductance and pupil diameter. Capturing human voice or speech 
is generally less obtrusive than capturing other stress sensitive physiological signals, which 
require on-body sensing equipment and might also introduce safety concerns. As we focus on 
modeling and improving patient-caregiver relationships, we will build on sensing capability in 
acoustic events for monitoring patient and caregiver moods, stress and their vocal interactions. 
As the demands of caregiving for a person with ADRD escalate, many families struggle to 
maintain healthy relationships with each other, which directly leads to intensified stress on 
family caregivers. The stress on caregivers, in turn, exacerbates the disease and condition of 
ADRD patients. Therefore, detecting and modeling stress in caregivers, and providing them with 
just-in-time training and recommendations becomes crucial. It is a notorious difficult challenge 
to detect stress from voice, but our approach is to apply novel machine learning techniques that 
combine multi-instance learning and transfer learning. We have shown these techniques work 
well for detecting anxiety from voice [25], and propose to now apply this to stress detection. 
The end-goals of our research are to provide real-time objective behavior monitoring to reduce 
in-home patient care cost and to improve the quality of interactions between persons with ADRD 
and their family caregivers. To achieve the goals, only passively recording what happened for 
posterior analysis and response is insufficient; real-time recommendation becomes necessary and 
beneficial to both patients and caregivers. For caregivers, this helps them improve their relation 
with patient, and may provide them with new insights of how their actions and reactions to their 
loved one with dementia can either calm or escalate a situation. Furthermore, from a system 
development perspective, patient’s and caregiver’s responses to the system’s output, e.g., 
monitoring data, recommendations, become an invaluable source of supervision for us and the 
back-end automated system to further refine the deployed classifiers and control pipelines. 
 
III. 
Procedures 
A. 
Research Design 
The research design used in this project is a single-group, longitudinal design. All study 
participants will receive the interventions. Therefore, randomization is not occurring in this 
project and there is no control group.  

     IRB Protocol Number: 2019B0406 
               IRB Approval date: Pending 
     Version:      03/04/2022  
 
 
4 
 
 
This project focuses on building a behavior monitoring and recommendation system for in-
home dementia patient care. In the front-end, a flexible sensing and communication platform 
will support the proposed monitoring, analytics, and recommendation tasks. In the back-end, we 
focus on multi-modal behavior monitoring with a special emphasis on patient and caregiver 
vocal events, and the behavior dynamics between them. In particular we focus on detecting 
mood and stress in a personalized and real-time manner. 
To conquer sparsity issue in statistical model training and enable rapid deployment of analytical 
models, we will develop solutions based on transfer learning [22, 23, 6], such that the labeled 
instances and learned models can be shared across patients and monitoring scenarios. This 
further facilitates scalable deployment of our proposed in-home monitoring system. 
To fully address these project goals, we will provide caregivers with brief, face-to-face or 
virtual training on the recommendations that our system will generate for them. These training 
sessions will take place in-person—in their own home or at the Ohio State University depending 
on which setting is easiest for them—or via telephone or Zoom call. They will be trained by a 
graduate research assistant (GRA) who will be supervised by Gordon (via Skype) and Dr. Rose 
(on site). Recommendations will be personalized to include the caregiver’s preferred name (e.g., 
Jane or Mrs. Smith), as this is found to enhance the efficacy [1]. Although we describe a 
proposed outline of the training in more detail below, we will engage in a one-month data 
gathering and baseline assessment phase before we implement this training with caregivers. 
Information that we gather will be used to refine and better target the training described here 
before implementation. For example, if we learn that most difficult interactions occur during the 
dinner hour, we might adapt the training to more specifically focus on behaviors around feeding 
or eating. Based on the literature regarding problematic caregiver-patient interactions, four types 
of recommendations will initially be generated when the system indicates that the caregiver-
patient might be experiencing high levels of arousal in proximity with each other.  
Before we send one of the specific recommendations, we will text the caregiver to insure that 
the care recipient is safe and is not experiencing acute medical changes. In this text, we will 
recommend that the caregiver contact the primary care physician (if not urgent) or dialing 911 
(if urgent).  
The first category of reminders would be to take a brief time-out from the interaction, which 
also has been demonstrated in multiple studies on dyadic interactions to be effective in 
ameliorating problematic exchanges and reducing emotional reactivity [9, 5, 34].We will use the 
time-out method described in [9] and the caregiver will again be given training from GRA in 
this technique.  
The second category are reminders to practice breathing awareness, which has a long history in 
the treatment of anxiety and stress, and is an effective and brief strategy to reduce physiological 
and emotional arousal both in non-clinical and clinical populations [34,35]. The GRA will go 
over this strategy with the caregiver by explaining the rationale behind this technique using 
exercises from the UCLA Mindful Awareness research center (see http://marc.ucla.edu/mindful-
meditations) and then will practice the breathing skill with the caregiver until they have a good 
sense of how to do it. 

     IRB Protocol Number: 2019B0406 
               IRB Approval date: Pending 
     Version:      03/04/2022  
 
 
5 
 
 
The third category of reminders would be to engage in a brief mindfulness exercise that focuses 
on non-judgment and acceptance. Mindfulness strategies have been shown to reduce stress in 
caregiver populations [19,27] and more general studies have indicated that mindfulness reduces 
emotional reactivity and improves communication [19, 16, 27, 17]. Additionally, two RCTs 
indicate that brief psychoeducation on mindfulness and self-guided practice using online 
exercises significantly reduce depression and anxiety [30, 29], and a very brief intervention 
involving training in mindfulness and ecological momentary assessment strategies, which is 
similar to this project’s methodology, significantly increased mindfulness skills [24]. In 
particular, awareness and acceptance strategies have been shown to be particularly effective in 
reducing anxiety and stress [19, 30]. The GRA will explain the rationale for this exercise and 
demonstrate it using transcripts from the UCLA Mindful Awareness research center. 
Mindfulness has been shown to be an effective technique in reducing emotional dysregulation in 
dyadic conflict [17]. They will again receive training from the GRA on this exercise and will be 
referred to the UCLA Mindful Awareness Center website to practice these exercise (or give an 
audio CD to them if they do not have access to the internet). We will recommend that they 
practice it daily as much as possible.  
The fourth category of reminders are strategies that problem solve on how to manage the 
patients if they are agitated, restless, or are disengaged, which are based on recommendations to 
modify the environment provided by the “Savvy Caregiver” program. This program is a product 
of our study consultant, Dr. Kenneth Hepburn [12, 13], and based upon addressing unmet needs 
and a lowered stress threshold in persons with ADRD. At the first study visit, caregivers will be 
provided with information regarding the need to address potentially unmet basic care the 
recipient needs, such as toileting and hunger, and will be asked to identify 3-4 pleasant activities 
they could engage their loved one with ADRD in if they become agitated, restless, or 
disengaged. Examples of this include taking a walk, looking at photo albums together, 
gardening, listening to pleasurable music together, etc. These activities are individualized, based 
on the interests of the individual persons with ADRD. Caregivers would receive a text 
recommendation to identify unmet needs or to engage their loved one in one of their pre-
identified pleasurable activities to decrease agitation, stress, and to improve mood. 
Individualized, social activities are found to be efficacious and cost-effective in redirecting a 
person with ADRD and to decreasing disruptive behaviors [33,11,15]. Caregivers will receive a 
handouts on all of these five strategies. 
B. 
Sample 
The study sample will be drawn from eligible patients receiving treatment either at the Center for 
Cognitive and Memory Disorders clinic at Ohio State University or at community-based settings. 
For recruitment from community-based settings, the Center for Clinical and Translational 
Science (CCTS) will upload a paid advertisement for this study on Facebook and/or Instagram, a 
social media platform. The advertisement will lead potential participants to the Caregiver 
Research Study website (https://studysearch.osumc.edu/studies/2837/) and provide detailed 
information of this research. CCTS will be also affiliated with other organizations and State 
agencies providing caregiving or ADRD resources; the uploaded post on CCTS Facebook and/or 
Instagram will be shared with the organizations. The duration of the first social media 

     IRB Protocol Number: 2019B0406 
               IRB Approval date: Pending 
     Version:      03/04/2022  
 
 
6 
 
 
advertisement will take two weeks and it may be renewed depending on progress on recruitment. 
Data from these clinics indicate that several thousand patients with AD and family members 
have received care and supportive services from these clinics in the past year. We plan to enroll 
up to 50 participants with AD and their family caregivers (1 caregiver per participant with AD) 
during the study to achieve a sample of N=30 dyads as attrition rates of up to 50% are reported in 
the literature. Given the history of the number of persons with AD who receive care through 
these clinics, the applicant is confident an adequate sample size can be obtained. At each 3-
month interval, recruitment goals will be assessed. Potential study participants (persons with AD 
and family caregivers) will be given information regarding the proposed study and will be given 
a consent form to take home and read. Because this is a single-group study design, there is no 
randomization and no control group.  
A member of the study team will follow up with the potential participants to answer any 
questions that they may have regarding the study via telephone at a mutually agreed upon time. 
If the potential participants decide to enroll in the study, the study coordinator will make an 
appointment to visit with the potential participants at their home to gain written, informed 
consent. At this first visit, the study coordinator will answer any questions that the potential 
participants have regarding the study. In AD study participants, surrogate assent will be obtained, 
if needed.  
The inclusion criteria for this study are as follows. For persons with dementia: 
1) Females and males; 2) age 60-99 years; 3) physician documentation of dementia: Alzheimer’s 
disease, vascular, mixed or unspecified type; 4) community-dwelling (living in the home); and 5) 
fluent in English. 
For family caregivers: 1) age 21 years or older; 2) informal, unpaid caregiver who resides with 
the care recipient; 3) fluent in English; 4) functioning home Wifi; and 5) scoring above a 3 on the 
Revised Memory and Behavior Problems Checklist, a clinical cut-off point used to determine 
caregiver stress [24]. And the exclusion criteria are that persons with dementia: 1) presence of 
acute illness as this could lead to delirium; 2) alcohol abuse or dependence within the past 2 
years (DSM-IV criteria); 3) history of significant psychiatric illness (e.g., schizophrenia). 
C. 
Measurement/Instrumentation 
The specific instruments we will use in our evaluation include:  
1) San Diego Capacity to Consent form: In order to determine the capacity for consent, we will 
use the University Of California San Diego Brief Assessment Of Capacity to Consent (UBACC). 
This form takes less than 5 minutes to complete and psychometric testing showed that scores 
greater than 14.5 were 89% sensitive and 100% specific for determining capacity to consent for 
research [40] 
2) Demographic form/Medical History form. Demographic form will be used to record 
participant demographics (e.g., age, gender, ethnicity, time of dementia diagnosis, and months of 
caregiving experience, caregiving hours per day). Medical history form includes current 

     IRB Protocol Number: 2019B0406 
               IRB Approval date: Pending 
     Version:      03/04/2022  
 
 
7 
 
 
medications and co-morbidities. Both are for purpose of describing the study sample. This 
instrument will be administered at baseline and is completed by the caregiver. 
3) Cognitive status. The Telephone Interview of Cognitive Status (TICS) will be administered 
over the phone to determine cognitive status. The instrument has been shown to be clinically 
relevant and comparable to the Mini-Mental State Examination [30]. Higher scores on the TICS 
indicate higher cognitive functioning. This instrument will be administered to the subject with 
ADRD at the screening visit after consent is obtained. AD8 will be administered to ONLY those 
participants recruited from a community-based setting. This brief measure screens for changes in 
cognitive function related to dementia as opposed to changes due to normal aging. This scale 
shows desirable sensitivity (.74-.85) and specificity (.84-.86) [43]. There are eight questions on 
this scale, and answers to the questions are dichotomous: yes or no. Scoring is measured by 
calculating the number of items answered as “yes, a change [44].” The Range of scores is from 0 
to 8. A score of 2 or greater indicates the individual’s cognitive decline is likely dementia related 
[44]. The AD8 scale will be used in place of physician documentation of ADRD in the 
community-based setting. 
4) Caregiver assessment of disruptive behaviors and the impact of these behaviors on caregivers. 
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 [31].  
5) Depressive symptoms, anxiety, and stress:  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 [36-38]. 
6) Caregiver Strain: Modified Caregiver Strain Index 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. 

     IRB Protocol Number: 2019B0406 
               IRB Approval date: Pending 
     Version:      03/04/2022  
 
 
8 
 
 
Patient behavior is affected by caregiver responses, and caregiver responses are in turn 
influenced by both patient behavior and the historical context of their relationship [10, 14, 18, 7]. 
Critical and hostile responses on the part of the caregiver are associated with increases in patient 
dementia symptoms [8]; thus, if we can reduce caregiver’s frustration and criticism, we expect 
this will reduce escalation of negative interactions, reduce caregiver burden and stress over time, 
and in turn decrease patient stress and physiological reactivity. We will assess the quality of the 
caregiver-patient relationship and caregiver stress and burden before beginning the study. 
7) Family Assessment Device: 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 [39]. 
8) Caregiver Emotion Regulation and Mindfulness: 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]. Additionally, 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 [42]. 
D. 
Detailed study procedures 
There are two important research questions this study aims to address: 1) how to generate 
effective and accurate recommendations; and 2) how to adapt the recommendation generation 
according to patients’ and caregivers’ feedback. To the best of our knowledge, no existing in-
home health monitoring system provides this capability, instead recommendations are developed 
in an ad-hoc manner and generated ahead of time and independently of the interaction dynamics. 
Due to the nature of dementia disease and the consideration of patient safety, we will only study 
recommendations for caregivers. But the technical solutions we examined here are general, and 
can be applied to other health recommendation scenarios. We should note that we are not 
replacing medical care; study participants (e.g., caregivers) will be provided information to seek 
help from their regular healthcare provider or emergency services as needed. 
The proposed collaborative research will take place over four years and will follow the outlined 
timeline: 
Year One: In the first year, focus will be on building the front-end monitoring architecture. In-
suite sensing and monitoring components will be built and customized for collecting the 

     IRB Protocol Number: 2019B0406 
               IRB Approval date: Pending 
     Version:      03/04/2022  
 
 
9 
 
 
participants’ vocal and psychological signals. Joint acoustic signal analysis and text mining 
algorithms will be explored. At this stage of single module development, offline dataset will be 
used for evaluation purpose. A study consultant, will also assist the study team in developing and 
pilot-testing a checklist to assess for fidelity of the educational training we deliver to caregiver 
participants. 
Year Two: We will be working on system integration and unit test of the intergraded 
components in the system. In the meanwhile, from the second half of year two, we will start 
recruiting patients for our system deployment and evaluation purpose. The PI and research 
assistant will work with the recruitment clinic to consent and enroll the pilot patients, collect 
study data, and will be on-call to answer caregiver questions as they may arise. We set “5-7 
patients enrolled per month” as our recruitment milestone, and thus it takes about 2 months to 
recruit 8-10 patients for phase 1 pilot study and about 4 months to recruit 25 patients for phase 2 
system evaluation. 
Fidelity checks will be performed , and retraining of GRAs will be performed based upon results 
of fidelity checks. The study team will meet weekly to ensure that recruitment and caregiver 
trainings are proceeding smoothly and to problem-solve with staff if necessary. 
Year Three: According to our evaluation plan, we will start our second phase 4-month pilot 
evaluation at the beginning of year three (one month for constructing baseline measurement and 
three months for controlled studies). All personnel will work together to conduct the pilot study 
and collect feedback from real patients and clinician experts to refine the system design in an 
iterative way. Fidelity checks will be performed and Re-training of GRAs will be performed by 
based upon results of fidelity checks. 
In particular, we will conduct the patient clinical interviews, and will work with an expert 
clinical panel to obtain feedback on the system. The caregiver interviews will be analyzed for the 
specifics of how the recommendation affects the caregiver-care recipient family dynamic. The 
monitored data, system’s automated prediction results will be analyzed, and the system design 
and implementation revised and updated according to the patients’ and clinician experts’ 
feedback. Upon finishing the pilot study, we will start our phase 2 system-level evaluation, 
which will last 18 months. Note, before we start the phase 2 evaluation, we would have around 2 
to 4 months period to adjust to unexpected delays/barriers in algorithm design, system 
development, or patient recruitment. We will make sure everything is planned and on schedule 
before we move onto the phase 2 system level evaluation. 
Year Four: The second phase of system level evaluation will be undertaken based on the 
information and lessons learned from phase one. This will include new technical solutions, 
refined computational models and system deployment designs. All personnel will work together 
to conduct full system evaluation. We will collaborate with clinicians in the two study sites at 
Ohio State University Medical Center the in our user study Clinicians, will help us recruit 
patients for participation and provide feedback on the system development. 
Our general plan is that by the end of this project, we will have a deployed practical system for 
the proposed in-home dementia patient care, and it will be ready for future clinical trial on larger 
and more diverse populations. All PIs will work very closely with the students on all the research 

     IRB Protocol Number: 2019B0406 
               IRB Approval date: Pending 
     Version:      03/04/2022  
 
 
10 
 
 
topics, aiming at regular publications in major conferences/journals. We will provide 
programming interfaces to the algorithms developed in this project, e.g., activity recognition and 
joint acoustic signal and text analysis, transfer learning and multi-task learning algorithms, and 
interactive feedback modeling and recommendation generation, through the developed system.  
 
Study Visits: 
Screening: Potential participants will be recruited from the geriatrics/internal medical clinic and 
the Center for Cognitive and Memory Disorders clinic at The Ohio State University as well as 
from community-based settings across Ohio state. The community sample will be obtained 
through Facebook posts by CCTS. The uploaded post on Facebook will be shared with other 
organizations and State agencies providing caregiving or ADRD resources. Communications 
made to the community will use the same language as the brochure provided to individuals in the 
Memory Clinic setting. Following screening for inclusion and exclusion criteria, potential 
participants will be contacted regarding their interest in the study. A study brochure will be given 
to the potential participants and, if they are interested in participating, a follow-up telephone call 
appointment will be made to review the study and to answer any questions the participants may 
have. If they are interested in participating, an appointment for a home visit or telephone/Zoom 
call will be scheduled at a mutually-agreed upon time. Prior to visit one participants will provide 
verbal consent/assent via telephone/Zoom. If participants provide verbal consent they will be 
asked to sign either an in-person or electronic consent (via REDCap) form at the time of visit 
one. 
Participants will be in the study for up to four months from the time of consent to the time of 
final study data collection and interview. However, the overall study duration may be longer than 
the planned duration (4 months), depending on the interview schedule for you.There will be 
either 4 study visits at your home or 4 telephone or video calls and each will take approximately 
30 – 135 minutes. 
 
Visit 1: The study information brochure and the study consent forms will be reviewed in person, 
via video call, or via telephone with the potential study participants. Written, informed consent 
will be obtained for both the family caregiver and the persons with dementia. If informed consent 
is unable to be obtained for the person with dementia based upon their scores on the Capacity to 
Consent instrument, their surrogate decision-maker will provide informed consent and assent for 
the person with dementia will be ascertained by the study team member. If willing, participants 
will be asked to sign for consent electronically using a REDCap link sent via email. In REDCap 
participants will provide electronic signatures on the consent form indicating they agree to 
participate in this study. Following the consenting procedure, the acoustic monitor (microphone) 
and accompanying laptop computer (for transferring the acoustic data to the Cloud for translation 
processes to occur) will be placed in the participant’s home at the location that is amenable to the 
study participants.  We anticipate this will be the kitchen/dining area and the living room areas of 
the home as many interactions occur in these locations. No acoustic monitoring will occur in any 
areas of the house that they do not wish to have a microphone placed. A 5-minute audio 

     IRB Protocol Number: 2019B0406 
               IRB Approval date: Pending 
     Version:      03/04/2022  
 
 
11 
 
 
recording will be obtained from the caregiver and person with dementia. The recording will be 
uploaded to the recommender system to generate a person ID for vocal recognition during the 
study. 
The acoustic monitoring will occur for up to 1 month to establish baseline interactions between 
the family caregiver and the persons with dementia. A Smart Phone will be given to the 
caregiver for use during the study period for the purpose of receiving recommendations and 
providing feedback through daily and weekly online surveys. Written and verbal instructions on 
the use of the acoustic monitoring and the Smart Phone will be provided to study participants. 
There are no steps that participants need to follow to maintain the equipment, other than keeping 
the microphone and laptop plugged in to an electric outlet and recharging the Smart Phone. We 
will also ensure the internet connection via Wifi is enabled.  
The following surveys will be administered via paper and pencil forms or RedCap to the family 
caregiver: 
1. DASS 
2. DERS-16 
3. Five Facet Mindfulness Questionnaire 
4. Revised Memory and Behaviors Problem Checklist  
5. Modified Caregiver Strain Index 
6. Family Assessment Device 
7. An emergency plan will be formulated with the family caregiver to further reinforce that 
our study is not a substitute for their seeking medical care for themselves or for their 
loved one with dementia.  
 
For dementia study participants, we will administer these surveys: 
1. AD8 (for participants from community-based settings only) 
2. TICS 
 
During Visit 1, research personnel will prompt the family caregiver to establish an emergency 
plan. This plan is meant to reinforce use of previously established procedures or create 
procedures to be used in the event of an emergency. Research personnel will stress that the study 
equipment is not monitored and is not capable of contacting emergency services and should not 
be used for such activity. Examples of an emergency plan could include, but are not limited to, 
notifying a healthcare provider, calling 911, or calling another family member. Caregivers will 
be reminded periodically to follow the procedures of their emergency plan in the event of any 
emergency. 
We anticipate Visit 1 will take between 90-135 minutes. 
Between visits 1 and 2, participants will complete a short survey about their experience 
deploying the study equipment in their home. The questionnaire will take about five to ten 
minutes to complete. 
Visit 2:  Upon completion of the first two weeks to one month of baseline data collection, the 
trained Graduate Research Assistant will visit the study participants in their homes or set up a 

     IRB Protocol Number: 2019B0406 
               IRB Approval date: Pending 
     Version:      03/04/2022  
 
 
12 
 
 
virtual meeting via Zoom or telephone to educate the participants regarding the text messages 
they will be receiving from the study team when stressful situations are identified. The Graduate 
Research Assistant will also train caregivers on how to perform mindfulness-based activities. A 
standardized training guide will be used for all participants by the trained GRAs. During the 
visit, a principal investigator (PI) may monitor whether the stress management education is 
delivered as intended (i.e., intervention fidelity check) with no recordings. Retraining of GRAs 
may be performed based upon the results of fidelity checks. Caregivers will be asked to select 
personal preferences for messages and helpful reminders they will receive in the text messages 
that would prompt their understanding of the text messages received from a pre-set list of 
choices. Additionally, family caregivers will be taught to respond to the daily and weekly 
feedback surveys regarding their use of the text messages. 
Acoustic monitoring and text message recommendations will occur until study end. Trained 
GRAs will communicate with the family caregiver regarding any difficulties they are 
encountering with the acoustic monitoring and/or the text message recommendations they are 
receiving.  We will send a text message within an hour after each recommendation is sent to a 
caregiver for the caregiver to tell us if he/she implemented the recommendation (yes or no) and 
to provide feedback on how helpful the recommendation was (not helpful at all – very helpful, 
using a 1-5 star rating). We will send morning text messages that contain a reminder for 
caregivers to follow their emergency plan in the event of any emergency, a prompt for self-
reflection and setting a self-care goal, and encouraging words. We will send evening text 
messages to follow-up on their self-care goal and inquire about any recommendations that did 
not receive a response during the day. Additionally, we will text caregivers weekly and will ask 
them to rate the overall helpfulness of the recommendations (1-5 stars, as above). At each one 
month interval, participants will receive $50 each, or $100 per dyad, for their time and attention 
to the study protocol. 
We anticipate Visit 2 will take 60 minutes. 
 
Visit 3: The Graduate Research Assistant will visit the caregiver in his/her home or set up a 
virtual meeting via Zoom or telephone approximately one month after the recommendation 
system is initiated. Visit 3 will allow the research personnel to reinforce study training—
including use of the smartphone, how to respond to text messages, and mindfulness techniques—
and troubleshoot any issues that the caregiver may be experiencing. 
We anticipate Visit 3 to take 30-45 minutes. 
 
Visit 4: At the completion of the study, a trained GRA will visit the participant’s home to collect 
the end of study measures, pay participants, and collect all study equipment. Additionally, 
interviews with participants regarding their feedback of the study procedures will be conducted 
and we will collect feedback via Smart Phones regarding the recommendations and their 
usability and acceptability. The interview that occurs during the course of the study will be video 
or audio recorded via Zoom and transcribed verbatim. The interview will take approximately 60 
to 90 minutes. During the interview, all the recordings will be saved and retained in REDCap 

     IRB Protocol Number: 2019B0406 
               IRB Approval date: Pending 
     Version:      03/04/2022  
 
 
13 
 
 
until they are transcribed. The transcribed interview data will also be saved in REDCap and the 
recordings from the interview will then be destroyed. The identified information of participants 
who take part in the interview will be confidential. Caregivers will also have the option to 
complete end of study surveys and interviews virtually and place the study equipment in a 
container for the GRA to pick up outside the home. Caregivers will be given a checklist of items 
to gather and place in the study container. 
We anticipate Visit 4 will take 60 to 90 minutes.  
 
COVID-19 Procedures: 
As a result of new COVID-19 guidelines and restrictions for in-person gatherings, steps have 
been taken to allow for virtual participant training, equipment installation, and data collection. 
Participant training and data collection may occur via Zoom video call or telephone and step-by-
step equipment installation guides will be included in packaged study equipment, to be delivered 
or dropped off at participant homes. These steps remove the need for study personnel to enter 
participant homes. The consenting process will begin via telephone prior to Visit 1, with 
participants giving verbal consent over the telephone. The informed consent document will be 
delivered to participants with study equipment. Participants will provide written informed 
consent on this document and return to research personnel using “contact-free” techniques. 
 
Personal information will be stored for five years following the completion of the study, per 
OSU guidelines.  
 
Potential Risks to Human Subjects. The potential risks for this study are minimal but 
important. Participants may have anxiety and believe their privacy is being invaded from having 
their daily interactions being monitored. Participants will be reminded that there is no video 
capture of their activities, so that private activities, such as bathing, toileting, dressing, are not 
seen. There is a risk that abusive situations may be detected. If this is suspected, the PI (Rose) 
will be contacted, an assessment would be made and a follow-up plan will be developed that may 
include contacting a family member, contacting their healthcare provider, going to the 
Emergency Room, and/or reporting to the Department of Human Services Dependent Adult 
hotline in the county of residence. The consent form will address this issue. Participants will be 
reminded that participating in this study does not substitute for or replace their normal healthcare 
services, and that our project is not intended to be an emergency service of any kind. During the 
first study visit, caregivers will be asked to outline an emergency plan to reinforce that our 
project is not an emergency health provider. We will work with the caregiver to write an 
emergency plan for what they would do if an emergency did occur, such as calling their 
daughter, going to the Emergency Department, etc. Additionally, caregivers will be given 
information regarding mental health and caregiving resources available in the county and state of 
residence. 

     IRB Protocol Number: 2019B0406 
               IRB Approval date: Pending 
     Version:      03/04/2022  
 
 
14 
 
 
There is a potential of increased burden for caregivers from completing the surveys. Care has 
been taken to use instruments that have established, acceptable psychometric properties and are 
parsimonious. Caregivers will be assured they can stop completing the questionnaires at any time 
and finish at a later time or not finish at all with no adverse consequences. It has been our 
experience that caregivers welcome the opportunity to discuss difficulties they face and are eager 
to find solutions.  
Our team will install all acoustic sensors in participants’ homes OR participants will follow a 
detailed installation guide to allow for “contact-free” installation as this is simple and should take 
less than 60 minutes, which includes validating that the system is working. A research team 
member will check- in with the subjects each week that they are in the study and go to their 
homes to troubleshoot as needed. As the acoustic sensors used are not worn there is no risk of 
electrical interference and there is no risk related to interference with pacemakers, implanted 
electrical defibrillators, insulin pumps, or other invasive devices. Our team will provide 
caregiver participants with Smart Phones for use for study purposes only. We will train the 
caregivers on how to use the phone to receive text messages and to respond to daily and weekly 
surveys. 
 
Planned procedures to protect against or minimize potential risks. The study will begin only 
after approval by the Institutional Review Board at participating universities. All investigators 
and graduate assistants associated with the study will complete required IRB training for the 
protection of human subjects prior to the beginning of the study. Potential participants will have 
a full explanation of the study, and those agreeing to participate will sign the consent form and 
be enrolled in the study. Exclusion criteria have been specified to protect the safety of 
participants. 
Survey data for this study will be stored electronically in the centralized data storage server 
maintained by the College of Nursing at Ohio State University. Only IRB-approved research 
team members will have access to the stored data through a secure login. The College of 
Nursing provides secure file storage for research projects. 
At Ohio State University:  
• This server runs Windows Server 2012R2 and is only used to host research files.  No 
unnecessary services are running.  (No IIS, SQL, MS Office, FTP.  Details available 
upon request.) 
• The Windows operating system is kept up to date by weekly, automatic updates from 
Microsoft. 
• The physical server is housed in a secure room within Newton Hall.  Only pertinent IT 
staff and the building coordinator have keys to access this room. 
• Electronic access to the research server is restricted to the college LAN or VPN by a 
Cisco ASA 5510 firewall.  Access from the internet without VPN is not allowed.   
• Electronic access is further restricted by the on-host Windows Firewall. 

     IRB Protocol Number: 2019B0406 
               IRB Approval date: Pending 
     Version:      03/04/2022  
 
 
15 
 
 
• User access is tightly controlled, by request only.  New users must be cleared by the 
College of Nursing Associate Dean for Research. 
• Permissions to individual folders and subfolders are managed individually.  Users only 
have access to folders of projects in which they are directly involved.  All changes are 
submitted in writing.   
• Permissions are audited annually by IT in collaboration with the folder/study owner.    
• The administrator account for the server has a non-standard password and has been 
disabled.   
• All user accounts connecting to the server are domain accounts and are authenticated 
through a domain controller.  Accounts are automatically locked out for 30 minutes after 
5 invalid attempts. 
• User access and system information is logged and exported to a central event logging 
server. 
 
Acoustic data will be uploaded and transferred directly to the University of Virginia to Drs. 
Stankovic and Wang, for their analyses and storage.  
 
 
At the University of Virginia: The Department of Computer Science provides extensive 
computing and communications resources in support of its activities at the University of 
Virginia. The Department provides a shared compute infrastructure of Linux x64 86 (primarily) 
and Solaris Niagara systems made up of interactive servers and batch scheduled (PBS) compute 
clusters. The department provides a transparent desktop environment (to match the shared 
infrastructure) and instructional labs as well. The department employs a systems group to help 
support this infrastructure and provide project specific IT support and infrastructure 
development as needed. The department’s central storage facility, a Hitachi G200 disk array, is 
protected by RAID 5, and served by Linux/ZFS servers. It is backed up to the University Data 
Center every 12 hours. A Fortinet firewall blocks 'ssh' attempts and 'ping' scans from non-UVA 
subnets. This blocks around 1.2 million attempts per day. The access control policy to the 
Department’s computational services is as follows, 
1. The CS Department issues accounts to faculty, students, staff, visitors and research 
collaborators who are actively working in the department. 
2. CS Department accounts are authenticated against a Windows Active Directory server. 
3. Login ids are valid for Linux desktops and servers as well as Windows desktops. 
4. Special purpose 'project' accounts are created for group use, but these accounts do not 
permit interactive login. 
5. Users who do not have an active, official affiliation with the department must have a 
faculty sponsor for their account; sponsors will be asked to renew their sponsorship for 
each account yearly. 

     IRB Protocol Number: 2019B0406 
               IRB Approval date: Pending 
     Version:      03/04/2022  
 
 
16 
 
 
6. Graduate students are issued accounts when they matriculate to the university, and are 
removed when they depart. 
7. Undergraduate students are issued accounts via helpdesk requests from a faculty 
member who is sponsoring the account. 
8. System staff accounts are maintained for one month after a staff member has separated 
from the department; staff accounts are treated in a similar fashion to student accounts; a 
current faculty member may continue to sponsor the staff account, subject to the annual 
renewal. 
9. Faculty are issued accounts as soon as they have joined the university, and are retained 
for one month after they separate from the university. If they have an ongoing research 
or instructional relationship with the department, another faculty member may sponsor 
their account, subject to annual renewal. 
10. The user is notified that their account is scheduled for deletion. They have one month to 
backup or copy off any data they wish to retain from our systems. 
11. Deleted account home directories are not archived. 
12. Websites created by faculty or students off the Dept's web page will be removed on the 
same schedule as that for account deletion. 
13. Users receiving new accounts must abide by the Acceptable Use Policy. 
Protection of confidentiality.  Confidentiality of all participant identifiable information and data 
will be maintained. Participants will be informed of their rights to privacy and confidentiality on 
the study consent form. The consent form includes IRB-approved information on the Health 
Insurance Privacy and Portability Act Protection of Human Subjects (HIPPA) regulations. All 
participants will be assigned numbers for identification purposes that will be used on all study 
materials and computer files. Data collected in the study will be de-identified upon study 
completion and may be used in future research or studies without additional consent. 
The participant consent encounter will be conducted using a REDCap-based electronic consent 
form. The consent form has been developed in REDCap, a secure, web-based, HIPAA-
compliant, data collection platform with a user management system allowing project owners to 
grant and control varying levels of access to data collection instruments and data (e.g. read only, 
de-identified-only data views) for other users. Potential participants will participate in the 
consent process by: 
Self-initiated access of consent forms on personal portable electronic devices using posted QR 
codes or web-links on study posters, brochures, or websites. Self-initiated accessing of consent 
forms may occur at The Ohio State University campus or at home. 
For self-initiated consent, contact information will be provided (email and phone) for prospective 
participants to contact a member of the study team with questions, prior to consent. 
Participant signatures will be obtained using a typed name and electronic signature via mouse. 
Upon completion of the consent encounter, participants will be provided with a copy of the 
consent document by printing a pdf copy of the consent form. 
The recordings from the interview during the study will be saved and retained in REDCap until 
they are transcribed. The transcribed interview data will also be saved in REDCap and the 

     IRB Protocol Number: 2019B0406 
               IRB Approval date: Pending 
     Version:      03/04/2022  
 
 
17 
 
 
recordings from the interview will then be destroyed. The identified information of participants 
who take part in the interview will be confidential. 
Project monitoring. The PIs will have responsibility for verifying the completeness of the 
collected data and will ensure compliance with all study requirements. The PI (Rose) will verify 
that a signed informed consent is available for all patients and will check the battery of measures 
for completeness. 
Infection control protocol. Entering and exiting participant homes introduces risk of 
transmission of infectious processes. Study participants are at increased risk of infection; 
therefore, the research personnel will take extra precautions to protect against transmission of 
infectious processes. Efforts have been made to limit in-person contact with participants. Visits 
1-4 will be conducted either in-person or virtually and participants will have the option to place 
study equipment outside their home for retrieval by the GRA.  
When in-person contact is unavoidable research personnel will adhere to the following 
procedures: 
Pre-Visit: 
Check their temperature prior to leaving the College and/or their home for a visit. Team member 
temperatures, along with the visit date, shall be documented the study folder. Any team member 
presenting with a fever will stay home from work and absolutely not be in contact with 
participants. Clean and sanitize any equipment to be brought in to the home. 
 
Visit: 
During the visit, research team members will wear gloves for any physical contact with a 
participant. Where possible, team members will maximize the distance between them and 
participants.  Hands will be washed before and after visits, and common sense measures such as 
covering sneezes or coughs will be used.  
 
Post-Visit: 
Disinfecting equipment is already standard procedure, but due to heightened risk these cleanings 
will be documented. We are employing a simple log with the date, participant ID from the visit, 
and the name of the team member cleaning the equipment.  
 
 
COVID-19 precautions. Additional precautions will be taken to control the spread of the 
coronavirus until widespread vaccination of the general public has occurred. In addition to the 
above infection control measures, the study team will monitor and document any of their own 
symptoms consistent with coronavirus and will self-quarantine and not conduct any study visits 
for at least 14 days. Additionally, research personnel will screen study participants prior to 
scheduling a home visit and determine the need to delay the visit. The following screening tool 
will be used to determine the need for a delay.  

     IRB Protocol Number: 2019B0406 
               IRB Approval date: Pending 
     Version:      03/04/2022  
 
 
18 
 
 
 
If a participant answers yes to questions 2+3, 7, 8, or 9 (symptom questions), scheduling visits 
with the participant will be delayed for at least 14 days per Ohio State’s current self-quarantine 
and monitoring guidelines. If a participant answers yes to any of the travel questions, a holistic, 
case-by-case risk assessment should be conducted. For now, our lab is recommending a two 
week delay for the following: 
1) Direct contact with an individual diagnosed with COVID-19. 
2) Any individual who: 
a. Meets the recommended Ohio State guidelines for self-quarantine (e.g. travel to a 
level 3 country). 
b. Has had direct contact with an individual meeting the recommended Ohio State 
guidelines for self-quarantine (e.g. travel to a level 3 country). 
Any individual who answers yes to any of the symptom questions above (2+3, 7, 8, 9). 

     IRB Protocol Number: 2019B0406 
               IRB Approval date: Pending 
     Version:      03/04/2022  
 
 
19 
 
 
Potential benefits of the proposed research to the subjects and others. The potential benefit 
of this study is improving home-based dementia care. If the findings from our study support we 
can sense and report caregiver/care recipient patterns of behavior that may add to stress and 
mood changes in the dyad, we will have data to support the development and implementation of 
additional interventions to assist caregivers in providing in-home care. These passive, wireless 
sensors have the potential to collect valid, reliable data in a more normal environment, home 
settings, without the need for research assistants to be present. Thus, the science to examine 
clearly the linkages between caregiver and care recipient behavioral changes will be advanced in 
significant ways, with the potential to intervene more effectively on these distressing symptoms. 
Monetary incentives. As payment for their time and attention to the elements of the study 
protocol, all families will receive $300 at the completion of the 3-month end of measurement of 
outcomes, in $100/monthly increments. 
Importance of the Knowledge to Be Gained. There may be immediate benefit to the subjects 
participating in the study, although we do not guarantee this, as family caregivers will be given 
specific knowledge and helpful reminders to mitigate potentially problematic behaviors 
regarding care of their loved one with ADRD. If successful, the knowledge gained will be 
important because of its substantial potential to enhance the treatment of difficult to manage, 
prevalent, and burdensome care problems of persons with ADRD, increasing their quality of life, 
reducing caregiver burden, delaying or reducing institutionalization, and decreasing the costs of 
caring for persons with AD in the future. 
E. 
Internal Validity 
The purpose of this study is primarily to establish feasibility and test the model. If we can 
establish that our system reduces emotional reactivity and that patient and caregiver self-reported 
and observed outcomes improve over time compared to an individualized baseline period, we 
will have established justification for a more comprehensive design that will more fully test this 
system against a credible alternative. 
Thus, the caregivers will fill out the measures provided to them and then their interactions with 
the patients will be monitored for a month to establish a baseline of functioning. We will assess 
levels of reactivity during caregiver-patient interactions and the time it takes for them to return to 
their own baseline. At the end of the one-month assessment period, the caregiver will be brought 
in for training on the recommendations, after which they will receive recommendations when the 
system detects emotional reactions when the caregiver and patient are with each other. The 
recommendations will be personalized over time. Effectiveness of the recommendations will be 
assessed by examining whether the recommendations reduce the frequency and intensity of the 
negative patient-caregiver interactions and the time required for reactivity to return to baseline in 
real time, as assessed by information recorded by the monitoring system. Effectiveness also will 
be assessed by monitoring change in the self-report measures during the baseline period 
compared to the period in which the caregiver is receiving the recommendations. 
At the end of the 3-month period, we will conduct individual interviews with caregiver 
participants to gather their feedback regarding the recommendations and their suggestions for 
improvement (e.g., mindfulness and environmental modification training, text messages, timing 
of messages). The interviews that occur during the course of the study will be video or audio 

     IRB Protocol Number: 2019B0406 
               IRB Approval date: Pending 
     Version:      03/04/2022  
 
 
20 
 
 
recorded via Zoom and transcribed verbatim. The data will be summarized and categorized and 
will inform future work in this area. 
The PI will train the GRAs on all aspects of the study protocol. To ensure fidelity of the 
mindfulness training recommendations, a checklist for assessing the fidelity of delivery of 
mindfulness/environmental modification caregiver training will be developed. 
The PI will conduct GRA training for the mindfulness/environmental modification caregiver 
training recommendations. The GRAs will need to achieve a minimum of 90% success in the 
fidelity assessment before they will be able to train caregiver study participants. Retraining of 
GRAs will be offered to address any deficits. The results of these fidelity checks will be shared 
with the study team. If fidelity checks fall below 90%, retraining of GRAs will be undertaken by 
the PI’s. 
Participant dyads will be compensated $300 at the completion of the 3-month end of 
measurement of outcomes, in $100/monthly increments; they may opt out at any time in the 
period of study. 
 
 
IV.  Bibliography 
 
 
[1] Melissa T Baysari, Amina Tariq, Richard O Day, and Johanna I Westbrook. Alert override as 
a habit- ual behavior–a new perspective on a persistent problem. Journal of the American 
Medical Informatics Association, 24(2):409–412, 2017. 
[2] Louis Burgio, Alan Stevens, Delois Guy, David L Roth, and William E Haley. Impact of two 
psychoso- cial interventions on white and african american family caregivers of individuals with 
dementia. The Gerontologist, 43(4):568–579, 2003. 
[3] Kate Cavanagh, Alasdair Churchard, Pufﬁn OHanlon, Thomas Mundy, Phoebe Votolato, 
Fergal Jones, Jenny Gu, and Clara Strauss. A randomised controlled trial of a brief online 
mindfulness- based intervention in a non-clinical population: Replication and extension. 
Mindfulness, pages 1–15, 2017. 
[4] Kate Cavanagh, Clara Strauss, Francesca Cicconi, Natasha Grifﬁths, Andy Wyper, and 
Fergal Jones. A randomised controlled trial of a brief online mindfulness-based intervention. 
Behaviour research and therapy, 51(9):573–578, 2013. 
[5] Kristina Coop Gordon, Patricia NE Roberson, Jessica A Hughes, Alexander M Khaddouma, 
Geeta K Swamy, Devon Noonan, Alicia M Gonzalez, Laura Fish, and Kathryn I Pollak. The 
effects of a couples-based health behavior intervention during pregnancy on latino couples 
dyadic satisfaction postpartum. Family process, 2018. 
[6] Wenyuan Dai, Qiang Yang, Gui-Rong Xue, and Yong Yu. Boosting for transfer learning. In 
Proceedings of the 24th international conference on Machine learning, pages 193–200. ACM, 
2007. 
[7] Lauren N DeCaporale-Ryan, Ann M Steffen, Samuel J Marwit, and Thomas M Meuser. 
Dementia spousal caregivers and past transgressions: Measuring and understanding forgiveness 
experiences. Journal of Women & Aging, 28(6):510–520, 2016. 

     IRB Protocol Number: 2019B0406 
               IRB Approval date: Pending 
     Version:      03/04/2022  
 
 
21 
 
 
[8] SF Doris, Timothy Kwok, Jacky Choy, and David J Kavanagh. Measuring the expressed 
emotion in chinese family caregivers of persons with dementia: Validation of a chinese version 
of the family attitude scale. International journal of nursing studies, 55:50–59, 2016. 
[9] Norman B Epstein and Donald H Baucom. Enhanced cognitive-behavioral therapy for 
couples: A contextual approach. American Psychological Association, 2002. 
[10] Lawrence Fisher and Morton A Lieberman. The effects of family context on adult offspring 
of patients with alzheimer’s disease: A longitudinal study. Journal of Family Psychology, 
10(2):180, 1996. 
[11] Laura N Gitlin, Nancy Hodgson, Eric Jutkowitz, and Laura Pizzi. The cost-effectiveness of 
a non- pharmacologic intervention for individuals with dementia and family caregivers: the 
tailored activity program. The American Journal of Geriatric Psychiatry, 18(6):510–519, 2010. 
[12] Kenneth Hepburn, Marsha Lewis, Jane Tornatore, Carey Wexler Sherman, and Karin 
Lindstrom Bre- mer. The savvy caregiver program: the demonstrated effectiveness of a 
transportable dementia care- giver psychoeducation program. Journal of gerontological 
nursing, 33(3):30–36, 2007. 
[13] Kenneth W Hepburn, Marsha Lewis, Laura Nelson Kirk, Suzanne Narayan, Bruce 
Center, Karin Lind- strom Bremer, and Jane Tornatore. Partners in caregiving: A 
psychoeducation program affecting dementia family caregivers’ distress and caregiving 
outlook. Clinical Gerontologist, 29(1):53–69, 2006. 
[14] Alison M Heru, Christine E Ryan, and Asma Iqbal. Family functioning in the caregivers of 
patients with dementia. International journal of geriatric psychiatry, 19(6):533–537, 2004. 
[15] Claire Hulme, Judy Wright, Tom Crocker, Yemi Oluboyede, and Allan House. Non-
pharmacological approaches for dementia that informal carers might try or access: a systematic 
review. International journal of geriatric psychiatry, 25(7):756–763, 2010.  
[16] Susanne M Jones and Wesley Hansen. The impact of mindfulness on supportive 
communication skills: Three exploratory studies. Mindfulness, 6(5):1115–1128, 2015. 
[17] Alexander Khaddouma and Kristina Coop Gordon. Mindfulness and young adult dating 
relationship stability: a longitudinal path analysis. Mindfulness, pages 1–14, 2018. 
[18] DMW Kriegsman, BWJH Penninx, and J Th M Van Eijk. Chronic disease in the elderly and 
its impact on the family: A review of the literature. Family Systems Medicine, 12(3):249, 1994. 
[19] Emily K Lindsay, Shinzen Young, Joshua M Smyth, Kirk Warren Brown, and J David 
Creswell. Ac- ceptance lowers stress reactivity: Dismantling mindfulness training in a 
randomized controlled trial. Psychoneuroendocrinology, 87:63–73, 2018. 
[20] Patricia Marino, Alyssa DePasquale, and Jo Anne Sirey. Cognitive behavior therapy with 
mindfulness and acceptance skills for the treatment of older adults. Clinical Case Studies, 
14(4):262–273, 2015. 
[21] S. Ostwald, K. Hepburn, W. Caron, W. Burns, and R. Mantell. A randomized 
psychoeducational intervention for caregivers of persons with dementia. The Gerontologist, 
39(3):299–309, 1999. 
[22] Sinno Jialin Pan and Qiang Yang. A survey on transfer learning. Knowledge and Data 
Engineering, IEEE Transactions on, 22(10):1345–1359, 2010. 
[23] Rajat Raina, Alexis Battle, Honglak Lee, Benjamin Packer, and Andrew Y Ng. Self-taught 
learning: transfer learning from unlabeled data. In Proceedings of the 24th international 
conference on Machine learning, pages 759–766. ACM, 2007. 

     IRB Protocol Number: 2019B0406 
               IRB Approval date: Pending 
     Version:      03/04/2022  
 
 
22 
 
 
[24] Aimee C Ruscio, Christine Muench, Emily Brede, Jessica MacIntyre, and Andrew J Waters. 
Adminis- tration and assessment of brief mindfulness practice in the ﬁeld: a feasibility study 
using ecological momentary assessment. Mindfulness, 7(4):988–999, 2016. 
[25] Asif Salekin, Jeremy Eberle, Jeffrey Glenn, Bethany Teachman, and John Stankovic. A 
weakly super- vised learning framework for detecting social anxiety and depression. In 
Proceedings of the ACM on Interactive, Mobile, Wearable and Ubiquitous Technologies, 2018. 
[26] Douglas W. Scharre, Shu-Ing Chang, Robert A. Murden, James Lamb, David Q. 
Beversdorf, Maria Kataki, Haikady N. Nagaraja, and Robert A. Bornstein. Self-Administered 
Gerocognitive Examination (SAGE): A Brief Cognitive Assessment Instrument for Mild 
Cognitive Impairment (MCI) and Early Dementia. Alzheimer Disease and Associated Disorders, 
24(1):64–71. 2010. 
[27] Susan Slatyer, Mark Craigie, Brody Heritage, Sue Davis, and Clare Rees. Evaluating the 
effectiveness of a brief mindful self-care and resiliency (mscr) intervention for nurses: a 
controlled trial. Mindful- ness, pages 1–13, 2017. 
[28] Laura Staccini, Elena Tomba, Silvana Grandi, and Gabor I Keitner. The evaluation of 
family func- tioning by the family assessment device: A systematic review of studies in adult 
clinical populations. Family process, 54(1):94–115, 2015. 
[29] Patrick R Steffen and Michael J Larson. A brief mindfulness exercise reduces 
cardiovascular reactivity during a laboratory stressor paradigm. Mindfulness, 6(4):803–811, 
2015. 
[30] Fong, T. G. et al. Telephone interview for cognitive status: Creating a crosswalk with the 
Mini-Mental State Examination. Alzheimers Dement 5, 492–497 (2009). 
[31] Linda Teri, Paula Truax, Rebecca Logsdon, Jay Uomoto, Steven Zarit, and Peter P 
Vitaliano. Assessment of behavioral problems in dementia: the revised memory and behavior 
problems checklist. Psychology and aging, 7(4):622, 1992. 
[32] Megan Thornton and Shirley S Travis. Analysis of the reliability of the modiﬁed caregiver 
strain index. The Journals of Gerontology Series B: Psychological Sciences and Social Sciences, 
58(2):S127–S132, 2003. 
[33] Kristine Yaffe and Tina Hoang. Nonpharmacologic treatment and prevention strategies for 
dementia.CONTINUUM: Lifelong Learning in Neurology, 19(2, Dementia):372–381, 2013. 
[34] David H Barlow. Clinical handbook of psychological disorders: A step-by-step treatment 
manual. Guilford publications, 2014. 
[35] Lloyd Lalande, Robert King, Matthew Bambling, and Robert D Schweitzer. An 
uncontrolled clinical trial of guided respiration mindfulness therapy (grmt) in the treatment of 
depression and anxiety. Journal of Contemporary Psychotherapy, 47(4):251–258, 2017. 
[36] Lovibond, S.H. & Lovibond, P.F. (1995).  Manual for the Depression Anxiety Stress Scales. 
(2nd. Ed.) Sydney: Psychology Foundation.  ISBN 7334-1423-0. 
[37] Page, A.C. Hooke, G.R.; & Morrison, D.L. (2007).  Psychometric properties of the 
Depression Anxiety Stress Scales (DASS) in depressed clinical samples.  British Journal of 
Clinical Psychology. 46, 283-297. 
[38] Gloster, A.T., Rhoades, H.M., Novy, D., Klotsche, J., Senior, A., Kunik, M., Wilson, N. & 
Stanley, M.A. (2008).  Psychometric properties of the Depression Anxiety and Stress Scale-21 in 
older primary care patients.  Journal of Affective Disorders, 110, 248-259. 

     IRB Protocol Number: 2019B0406 
               IRB Approval date: Pending 
     Version:      03/04/2022  
 
 
23 
 
 
[39]  Epstein, N. B., Baldwin, L. M., & Bishop, D. S. (1983). The McMaster family assessment 
device. Journal of marital and family therapy, 9(2), 171-180. 
[40] Jeste DV1, Palmer BW, Appelbaum PS, Golshan S, Glorioso D, Dunn LB, Kim K, Meeks 
T, Kraemer HC.  (2007). A new brief instrument for assessing decisional capacity for clinical 
research. Archives of General Psychiatry, 64(8), 966-974. 
[41] Bjureberg, J., Ljótsson, B., Tull, M. T., Hedman, E., Sahlin, H., Lundh, L.-G., Bjärehed, J., 
DiLillo, D., Messman-Moore, T., Gumpert, C. H., & Gratz, K. L. (2016). Development and 
Validation of a Brief Version of the Difficulties in Emotion Regulation Scale: The DERS-16. 
Journal of Psychopathology and Behavioral Assessment, 38(2), 284–296. 
https://doi.org/10.1007/s10862-015-9514-x 
[42] Baer, R. A., Smith, G. T., Hopkins, J., Krietemeyer, J., & Toney, L. (2016). Using Self-
Report Assessment Methods to Explore Facets of Mindfulness: Assessment. 
https://doi.org/10.1177/1073191105283504 
[43] Galvin, J. E., Roe, C. M., Powlishta, K. K., Coats, M. A., Muich, S. J., Grant, E., Miller, J. 
P., Storandt, M., & Morris, J. C. (2005). The AD8: A brief informant interview to detect 
dementia. Neurology, 65(4), 559–564. https://doi.org/10.1212/01.wnl.0000172958.95282.2a 
[44] Alzheimer’s Association. (n.d.). AD8 dementia screening interview. 
https://www.alz.org/media/Documents/ad8-dementia-screening.pdf