A Proactive Health Monitoring Intervention for Dementia Caregivers: The eNeighbor
Phase: NA
Conditions: Dementia, Alzheimer Disease
Sponsor: University of Minnesota

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 0 of 48 
Template Revised On: 11/1/2021      
 
 
 
Title Page for ClinicalTrials.gov protocol upload: 
A Proactive Health Monitoring Intervention for 
Dementia Caregivers: The eNeighbor 
9/11/23; Protocol approval 9/20/23 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 1 of 48 
Template Revised On: 11/1/2021      
ANCILLARY REVIEWS 
DO NOT DELETE.  Submit the completed checklist below with your protocol. 
Which ancillary reviews do I need and when do I need them? 
Refer to HRP-309 for more information about these ancillary reviews. 
Select yes or 
no 
Does your study… 
If yes… 
Impact on 
IRB Review 
☐ Yes 
☒  No 
 
Include Gillette resources, staff 
or locations 
Gillette Scientific review and Gillette 
Research Administration approval is 
required.  Contact: 
research@gillettechildrens.com   
Required 
prior to IRB 
submission 
☐ Yes 
☒  No 
Involve Epic, or Fairview 
patients, staff, locations, or 
resources? 
The Fairview ancillary review will be 
assigned to your study by IRB staff 
Contact: ancillaryreview@Fairview.org 
Approval 
must be 
received 
prior to IRB 
committee/ 
designated 
review.   
 
Consider 
seeking 
approval 
prior to IRB 
submission. 
☐ Yes 
☒   No 
Include evaluation of drugs, 
devices, biologics, tobacco, or 
dietary supplements or data 
subject to FDA inspection? 
STOP – Complete the Medical Template 
Protocol (HRP-590) 
 
The regulatory ancillary review will be 
assigned to your study by IRB staff 
Contact: medreg@umn.edu  
See 
https://policy.umn.edu/research/indide  
☐ Yes 
☒   No 
Require Scientific Review? Not 
sure? See guidance in the 
Investigator Manual (HRP-
103).      
ONLY REQUIRED      BIOMEDICAL 
RESEARCH REVIEWED BY FULL 
COMMITTEE 
☐ Yes 
☒  No 
Relate to cancer patients, 
cancer treatments, cancer 
screening/prevention, or 
tobacco? 
Complete the CPRC application process.  
Contact: ccprc@umn.edu  
☐ Yes 
☒  No 
Include the use of radiation? 
(x-ray imaging, 
radiopharmaceuticals, external 
beam or brachytherapy) 
 
Complete the AURPC Human Use 
Application and follow instructions on 
the form for submission to the AURPC 
committee. 
Contact: barmstro@umn.edu  
Approval 
from these 
committees 
must be 
received 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 2 of 48 
Template Revised On: 11/1/2021      
☐ Yes 
☒  No 
Use the Center for Magnetic 
Resonance Research (CMRR) 
as a study location? 
Complete the CMRR pre-IRB ancillary 
review  
Contact: ande2445@umn.edu  
prior to IRB 
approval;  
 
These 
groups 
each have 
their own 
application 
process.  
☐ Yes 
☒  No 
Include the use of 
recombinant or synthetic 
nucleic acids, toxins, or 
infectious agents? 
STOP – Complete the Medical Template 
Protocol (HRP-590) 
☐ Yes 
☒  No 
Include the use of human fetal 
tissue, human embryos, or 
embryonic stem cells? 
STOP – Complete the Medical Template 
Protocol (HRP-590) 
☒   Yes 
☐ No 
Include PHI or are you 
requesting a HIPAA waiver? 
If yes, HIPCO will conduct a review of this 
protocol. 
Contact: privacy@umn.edu  
☐ Yes 
☒  No 
Use data from CTSI Best 
Practices Integrated 
Informatics Core (BPIC) 
Formerly the AHC Information 
Exchange (AHC-IE)? 
The Information Exchange ancillary 
review will be assigned to your study by 
IRB staff 
Contact: bpic@umn.edu  
Approval 
must be 
received 
prior to IRB 
approval. 
 
These 
groups do 
not have a 
separate 
application 
process but 
additional 
information 
from the 
study team 
may be 
required. 
 
☐ Yes 
☒  No 
Use the Biorepository and 
Laboratory Services to collect 
tissue for research? 
STOP – Complete the Medical Template 
Protocol (HRP-590)  
The BLS ancillary review will be 
assigned to your study by IRB staff. 
Contact: Jenny Pham 
Pham0435@umn.edu 
☐ Yes 
☒  No 
Have a PI or study team 
member with a conflict of 
interest? 
The CoI ancillary review will be 
assigned to your study by IRB staff 
Contact: becca002@umn.edu  
☒  Yes 
☐ No 
Need to be registered on 
clinicaltrials.gov? 
If you select “No” in ETHOS, the 
clinicaltrials.gov ancillary review will be 
assigned to your study by IRB staff 
Contact: kmmccorm@umn.edu  
☐ Yes 
☒   No 
Require registration in 
OnCore? 
If you select “No” or “I Don’t Know” in 
ETHOS, the OnCore ancillary review will 
be assigned to your study by IRB staff 
Contact: oncore@umn.edu  
Does not 
affect IRB 
approval. 
 
 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 3 of 48 
Template Revised On: 11/1/2021      
PROTOCOL COVER PAGE 
Protocol Title 
A Proactive Health Monitoring Intervention for Dementia 
Caregivers: The eNeighbor 
Principal 
Investigator/Faculty 
Advisor 
Name: Joseph E. Gaugler, PhD 
Department: School of Public Health 
Telephone Number: 612-626-2485 
Email Address: gaug0015@umn.edu 
Student Investigator 
Name: N/A 
Current Academic Status (Student, Fellow, Resident): N/A 
   
Department: N/A 
Telephone Number: N/A 
Institutional Email Address: N/A 
Scientific Assessment 
Nationally-based, federal funding organizations 
Version 
Number/Date: 
Modification #42, 9/11/23 
 
 
 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 4 of 48 
Template Revised On: 11/1/2021      
REVISION HISTORY 
 
Revision # 
Version Date 
Summary of Changes 
Consent Change? 
#37 
01/24/2022 
Updated protocol to newest IRB social 
template 
No 
#38 
N/A 
Staff update only 
No 
#39 
9/26/22 
Updated plan to share study results 
with participants; staff update 
No 
#40 
N/A 
Re-upload to IRB system of 9.26.22 
protocol associated with mod 39  
No 
#41 
10/20/22 
Updated to clarify permission to 
follow up procedures; removal of 
reference to “appendix” items from 
earlier protocol formatting; inclusion 
of opportunity to provide SSNs per 
consent form 
No, follow-up 
permissions only 
#42 
9/11/23 
Update to clarify data sharing based 
on consultation with archive 
No 
 
 
 
 
 
 
 
 
 
 
 
 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 5 of 48 
Template Revised On: 11/1/2021      
 
Table of Contents 
1.0 
Objectives .............................................................................................................................. 7 
2.0 
Background ............................................................................................................................ 8 
3.0 
Study Endpoints/Events/Outcomes .................................................................................... 10 
4.0 
Study Intervention(s)/Interaction(s) ................................................................................... 12 
5.0 
Procedures Involved ............................................................................................................ 13 
6.0 
Data Banking ....................................................................................................................... 20 
7.0 
Sharing of Results with Participants................................................................................... 21 
8.0 
Study Duration..................................................................................................................... 21 
9.0 
Study Population ................................................................................................................. 21 
10.0 
Vulnerable Populations ....................................................................................................... 22 
11.0 
Number of Participants ....................................................................................................... 24 
12.0 
Recruitment Methods ......................................................................................................... 24 
13.0 
Withdrawal of Participants................................................................................................. 25 
14.0 
Risks to Participants ............................................................................................................ 26 
15.0 
Incomplete Disclosure or Deception ................................................................................... 26 
16.0 
Potential Benefits to Participants ....................................................................................... 26 
17.0 
Statistical Considerations.................................................................................................... 26 
18.0 
Health Information and Privacy Compliance ..................................................................... 30 
19.0 
Confidentiality ..................................................................................................................... 33 
20.0 
Provisions to Monitor the Data to Ensure the Safety of Participants ............................... 34 
21.0 
Compensation for Research-Related Injury........................................................................ 38 
22.0 
Consent Process ................................................................................................................... 38 
23.0 
Setting .................................................................................................................................. 42 
24.0 
Multi-Site Research ............................................................................................................. 42 
25.0 
Coordinating Center Research ............................................................................................ 42 
26.0 
Resources Available............................................................................................................. 42 
27.0 
References ........................................................................................................................... 43 
 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 6 of 48 
Template Revised On: 11/1/2021      
ABBREVIATIONS/DEFINITIONS 
ADRD: Alzheimer’s disease or a related dementia 
AD: Alzheimer’s disease 
TLHA: The Lutheran Home Association 
ADLs: Activities of daily living 
AHRQ: Agency for Healthcare Research & Quality 
SPM: Stress Process Model 
RCT: Randomized controlled trial 
PI: Principal Investigator 
NIH: National Institutes of Health 
AA: Alzheimer’s Association 
SLUMS: St. Louis University Mental Status 
MBA: Minnesota Board on Aging 
CAB: Community Advisory Board 
PWML: Person with Memory Loss 
LAR: Legally authorized representative 
DNT: Director of Nursing and Technology 
RC: Research Coordinator 
ICER: Incremental cost-effectiveness ratio 
ISM: Independent study monitor 
DSM: Data & Safety Monitoring 
 
 
 
 
 
 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 7 of 48 
Template Revised On: 11/1/2021      
1.0 
Objectives 
Purpose: Sensor-based technologies that operate remotely and are non-invasive could assist 
family caregivers monitor the daily function of persons with Alzheimer’s disease or a related 
dementia (ADRD). The eNeighbor technology platform includes a combination of remote sensors 
that are located in key areas of a person with ADRD’s home (e.g., bed, medicine cabinet or 
refrigerator doors, toilet, living rooms). Such sensors can immediately communicate any function 
that is outside of an expected threshold for the person with ADRD to both a family caregiver and 
a care professional (e.g., nurse care manager).  The goal of the remote health monitoring 
technology such as eNeighbor is to prevent negative health transitions such as falls or wandering 
events, and thus provides a more proactive intervention model than many clinical protocols that 
are currently delivered to family caregivers of persons with ADRD.  The Lutheran Home 
Association, a non-profit long-term care provider located in Belle Plaine, Minnesota, has 
deployed eNeighbor in residential and home settings the past 5 years. 
The objective of this 5-year demonstration project is to build on the work of The Lutheran Home 
Association and conduct an embedded experimental mixed methods evaluation to determine the 
efficacy of the eNeighbor technology in improving outcomes among persons with ADRD living in 
the community and their family caregivers.   
In collaboration with a 15-member Community Advisory Board that includes community care 
providers, healthcare organizations, and ADRD caregivers themselves, the proposed 5-year 
project will build on the current efforts of TLHA to evaluate eNeighbor remote monitoring 
technology for persons with ADRD living in the community and their family caregivers. We 
anticipate that the successful completion of the project aims will position the eNeighbor as an 
innovative, stakeholder-centric service that offers robust support for family caregivers of persons 
with ADRD in the community.   
 
The Specific Aims are as follows: 
 
1) To determine the efficacy of remote sensor technology over an 18-month period for 100 
persons with ADRD and their caregivers randomly assigned to an eNeighbor treatment condition 
when compared to 100 usual care controls. We hypothesize: 
Hx. 1) Significant (p < .05) improvements in caregiver self-efficacy and sense of competence in 
managing a relative’s ADRD; 
Hx. 2) Significant reductions in caregiver distress (e.g., subjective stress, or feelings of 
emotional fatigue and role entrapment; depressive symptoms);  
Hx. 3) Significant delay of or reductions in health transitions (falls, wandering) and service 
utilization (hospitalizations, nursing home admission) for persons with ADRD; and 
Hx. 4) Greater cost-effectiveness associated with a person with ADRD’s health service use. 
 
2) To “embed” evaluation components: a) during the randomized controlled evaluation through 
the administration of open-ended survey items to all ADRD caregivers in the eNeighbor 
treatment condition every 6 months to examine the utility of the remote health monitoring 
technology; and b) at the conclusion of the 18-month evaluation by purposively sampling 15 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 8 of 48 
Template Revised On: 11/1/2021      
ADRD caregivers who reported positive acceptance on the embedded qualitative and quantitative 
6-, 12-, and 18-month system reviews and 15 ADRD caregivers who reported low acceptance on 
the embedded qualitative and quantitative 6-, 12-, and 18-month system reviews to participate in 
semi-structured interviews. The interviews will help the research team determine why the health 
monitoring intervention was or was not efficacious; and  
 
3) To engage stakeholders on a quarterly basis throughout the 5-year project with the goal of 
enhancing the utility (via community-based participatory approaches)67 and stakeholder-
relevance of eNeighbor implementation and evaluation for family caregivers of persons with 
ADRD.  
    
2.0 
Background 
 
2.1 Significance of Research Question/Purpose:  
 
Alzheimer’s disease or a related dementia (ADRD) is extremely challenging to manage and 
treat due to complexities in detection, interacting symptoms, and length of progression.1 Because 
persons with dementia rely heavily on informal (i.e., unpaid) sources of care, the prevalence of 
Alzheimer’s disease (AD) has a staggering effect on families. In 2013, 80% of the 5.2 million 
persons with AD in the United States (U.S.) were cared for by a family member and 15.4 million 
individuals provided unpaid care to a person with ADRD.1 There is no one consistent definition of 
caregiving, but in its most global sense caregiving refers to attending to an individual’s health 
needs. More specific definitions emphasize that caregiving includes provision of assistance with 
one or more activities of daily living (such as bathing, dressing, transferring).2,3 In the dementia 
context, caregiving can extend to the management of symptoms such as memory loss, behavioral 
disruptions, and similar concerns. The typical AD caregiver in the U.S. is female, 48 years of age 
(suggesting multiple role responsibilities in addition to family care) and assists a relative who is 78 
years old.4 A well-established literature demonstrates the adverse effects of ADRD care on family 
members including impaired physical health and immune system response,5-7 financial strain,4 
degradation in social well-being, and increased prevalence of depression, anxiety, or other 
negative mental health symptoms.8,9 With the accumulation of evidence demonstrating the 
physical, financial, social, and psychological risks of dementia family care, a series of clinical 
interventions have been developed and evaluated. Meta-analyses and systematic reviews 
suggest moderate overall benefits of these interventions for ADRD caregivers and their care 
recipients.1,5,10-12  
 
Although family members of persons with dementia are willing to utilize technology to improve 
their respective caregiving situations, few studies have determined whether various technologies 
can help families alleviate negative outcomes for caregivers of persons with ADRD.13-20 Among 
the potential benefits of technological interventions is the ability to assist family caregivers of 
persons with ADRD regardless of geographical distance, which is in contrast to standard ADRD 
caregiver interventions where treatment is often delivered face-to-face to family caregivers in 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 9 of 48 
Template Revised On: 11/1/2021      
need. Technology-based interventions also have the potential to overcome another barrier to 
ADRD caregiver interventions: that of time and scheduling.21 Family members can often utilize 
and benefit from various types of technology-based interventions at any time, thus making these 
approaches asynchronous. Technology interventions evaluated include telephone-based 
approaches (conference calls among family members of persons with ADRD, automated 
telephone messages and support, respite calls for persons with ADRD) and computer or internet-
based strategies (e.g., DVD-based delivery of education and support, online discussion boards, 
electronic reminders, computer-based encyclopedias and information resources, online decision-
making support).22 While technology interventions for ADRD caregivers have shown some 
promise, small samples, inconsistent measurement, and lack of high quality randomized 
controlled evaluations suggest the need for further research.15,23-36 
 
The proposed demonstration project will advance scientific knowledge, technical capability, and 
clinical practice as they pertain to ADRD caregiver interventions. Although research on family 
caregiving has served as a platform for multidisciplinary research,37,38 a critical gap in this 
literature is the lack of randomized controlled studies that evaluate advanced, low-cost, high 
potential technologies to alleviate the stressors and other negative outcomes associated with 
everyday ADRD care. The proposed project will be one of very few clinical trials that evaluate the 
efficacy of home-based sensor technologies on actual user outcomes (e.g., family caregivers, 
older adults) in a real world environment using an experimental design.19,22 Specifically, 
Healthsense, Inc. has developed a suite of remote monitoring tools called the eNeighbor, and the 
Lutheran Home Association (TLHA: a non-profit, long-term care provider) has been implementing 
eNeighbor in residential care settings and home environments in Minnesota and Wisconsin as 
part of its routine services offered over the past 5 years. The overarching objective of eNeighbor 
is to lower the cost of care, increase independence of disabled older persons, and enhance 
quality of life for chronically disabled older persons and their family caregivers by allowing older 
persons to remain in their homes safely for as long as possible.  
 
2.2 Preliminary Data:  
 
A number of case studies and survey research efforts establish the feasibility of the eNeighbor 
remote sensor technology in various residential and community-based long-term care settings 
and its potential to prevent falls, medical emergencies, and similar negative health events.65 An 
oft-repeated sentiment of users and family caregivers is that the technology represents a 
“godsend”66 with no adverse events reported. The feasibility of eNeighbor has been further 
established with dementia caregivers in home settings through peer-reviewed pilot research by 
the study consultant, Jennifer Kinney, PhD (who has expertise in studying health technology for 
ADRD caregivers as PI; R21 AG029224).14-16 Using a controlled design, Kinney and colleagues14 
enrolled 28 individuals who were caring for a co-resident family member with dementia (13 
spouses, 15 adult children). When compared to baseline, intervention group caregivers ranked 
meaningful activity and enjoyment as significantly more important than usual care controls at 
follow-up. Qualitative interviews were used to supplement and elaborate upon the quantitative 
findings; specifically, several caregivers reported adaptation to the constant presence of the 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 10 of 48 
Template Revised On: 11/1/2021      
eNeighbor technology in the weeks immediately following installation. As one caregiver stated, 
“For the first few weeks I thought about it every time I opened something. I thought about it 
being recorded, but now I haven’t been thinking about it anymore.” The importance of control 
also became more salient as caregivers came to trust the eNeighbor technology: “You had asked 
if we wanted a monitor on the front door and I said never, but then the other day he actually 
tried to get out the door. It happened to be locked and he couldn’t figure it out. I’ve never 
noticed that before. Now we want the monitor.” Cumulatively, these preliminary studies suggest 
the potential and the feasibility of eNeighbor for ADRD caregivers.   
  
 
2.3 Existing Literature:  
 
The eNeighbor directly aligns with components of quality chronic disease care as proposed by 
healthcare experts and the Agency for Healthcare Research & Quality (AHRQ).39-42 The eNeighbor 
and its integrated, remote sensor technology platform aims to prevent negative health 
transitions (i.e., falls, wandering) by allowing for a method of continuous monitoring and ongoing 
communication between the ADRD caregiver and a nurse care manager. The eNeighbor also 
allows for the appropriate management of chronic disease by episode instead of by health care 
professional encounter (e.g., regular visits to a primary care provider, emergency room visits), 
again resulting in a more proactive intervention approach. The remote monitoring platform of 
eNeighbor also allows chronic care to occur across locations as opposed to solely in formal 
medical settings. For these reasons, the eNeighbor intervention differentiates itself from many 
existing ADRD caregiver interventions which are often premised on crisis management (e.g., 
components of a psychosocial or clinical intervention are enacted only after a problem occurs, 
such as a wandering event or behavioral disruption).  
 
This innovative dimension also becomes apparent when compared to other assistive devices, 
which do not provide person-centered, dynamic, time-sensitive information on older persons’ 
functional behaviors. Specifically, eNeighbor uses complex algorithms that allow for the 
identification of routine function of the older adult and whether behaviors occur within or 
outside expected thresholds to trigger further health intervention. Current assistive devices such 
as bed alarms provide some degree of monitoring assistance, but are more oriented around crisis 
management rather than prevention (and existing evidence is not clear on the efficacy of these 
approaches). Similarly, while assistive supports such as hand rails may offer the least expensive 
solution, they are not able to provide real-time, monitoring data that is personalized to older 
persons at-risk. The potential of health monitoring technology such as eNeighbor is also 
increased due to the increasingly lowered costs associated with sensors and sensor maintenance. 
As the costs of these technologies decrease along with the concurrent increase in availability of 
cellular and broadband connectivity in U.S. households (see below), it is anticipated that health 
monitoring technology use will become more prevalent in caregiving households.  
 
Health care experts have emphasized the need to better utilize technology to enhance care 
management, track patient outcomes, and effectively administer treatments.43 While much is 
made of the promise of electronic health records or other technological advances, it remains 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 11 of 48 
Template Revised On: 11/1/2021      
fairly unknown whether they (or other technological aids)24-33 are actually effective for 
populations such as ADRD caregivers.44-47 A comprehensive review identified evidence 
demonstrating efficacy of health information technology in various chronic disease conditions to 
facilitate person-centered care as well as barriers to feasibility and utility, but no high quality 
studies existed demonstrating the efficacy of such technology for dementia family caregivers.48 
The proposed R18 demonstration will attempt to address this gap by examining the efficacy of 
health monitoring technology for persons with ADRD and their family caregivers to establish it as 
an evidence-based, innovative protocol.  
 
A key component to this project is the integration of stakeholders’ voices throughout the 
evaluation process. An active Community Advisory Board will serve in a collaborative capacity; it 
will engage with the PI on various research-related procedures, identify additional key open-
ended questions to guide the process and outcome evaluation, explore barriers and facilitators to 
how health monitoring technology is delivered and utilized by persons with ADRD and their 
family caregivers, and assist in refining the evaluation design and dissemination to guide ongoing 
development along with the research team. Such engagement will be critical to ensuring that the 
benefits of health monitoring technology for persons with ADRD and their caregivers has high 
relevance for stakeholders.  
 
The development and evaluation of the eNeighbor is grounded in a well-established conceptual 
model that has been used to successfully evaluate the efficacy of interventions for ADRD family 
caregivers.49-51 The Stress Process Model (SPM) has been used extensively to study the 
manifestation of negative outcomes in dementia caregiving.52-55 The SPM is based on the 
mechanism of “proliferation,” where the emotional stress of care provision to a person with 
dementia (primary stress) spreads to other life domains which are then posited to negatively 
influence global caregiving outcomes such as caregiver mental health or the person with ADRD’s 
institutionalization. Psychosocial resources or formal service use may help stem stress 
proliferation and protect ADRD caregivers from negative outcomes.53 
 
The conceptual framework for the proposed project integrates constructs from the SPM. Context 
of care variables are conceptualized as key covariates; context of care considers key 
sociodemographic and background characteristics that may influence outcomes for persons with 
ADRD or their family caregivers. Similarly, resource variables such as perceptions of 
socioemotional support and community-based service use are considered as covariates in the 
eNeighbor conceptual model that could potentially alleviate negative outcomes. A final set of 
covariates considered in our conceptual model include primary objective stressors, or indices of 
dementia severity that may require greater day-to-day care provision on the part of family 
members. The proposed conceptual model positions eNeighbor as a key resource; the remote 
sensor technology of eNeighbor for dementia caregivers is hypothesized to independently and 
directly: improve caregiver self-efficacy and competence, reduce caregiver distress (subjective 
stress and depressive symptoms), delay or reduce negative health transitions for the person 
with ADRD (falls, wandering), and delay or reduce the person with ADRD’s service utilization 
(residential care placement, hospitalization). The SPM is aligned with conceptualizations of 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 12 of 48 
Template Revised On: 11/1/2021      
intervention effectiveness in the health information technology literature, suggesting that 
utilizing the SPM is appropriate when evaluating the efficacy of eNeighbor.56  
 
3.0 
Study Endpoints/Events/Outcomes 
3.1 Primary Endpoint/Event/Outcome: Caregiver self-efficacy and competence 
3.2 Secondary Endpoint(s)/Event(s)/Outcome(s): Caregiver distress (subjective stress 
and depressive symptoms), negative health transitions for person with ADRD (falls, 
wandering), service utilization of person with ADRD (residential care placement, 
hospitalization). 
4.0 
Study Intervention(s)/Interaction(s) 
 
4.1 Description: The home-based sensor technology of eNeighbor relies on multiple, non-invasive 
and safe remote monitors that can alert family caregivers and/or health professionals to 
potentially negative situations that lead to adverse outcomes (e.g., wandering, falls, incomplete 
activity of daily living tasks). The eNeighbor core system includes four unobtrusive motion 
sensors that are placed in a living room, bedroom, bathroom, and an entryway that can detect 
motion in a room to verify daily activity (and do not include a microphone or camera). These 
motion sensors operate jointly and exchange information to help identify significant changes in 
movement or function and can be used to detect urgent needs for help among persons with 
ADRD such as a fall. Three contact sensors can detect whether a door or cabinet is opened or 
closed (often placed on a front door, refrigerator, or medicine cabinet); these sensors can 
measure whether the person with ADRD is accessing important areas of the home and can help 
to determine if basic care plans are followed or activities of daily living (ADLs) are performed as 
expected. A toilet sensor is also mounted inside a tank that can monitor flushes. A bed occupancy 
sensor is placed between the mattress and box spring that can monitor time in and out of bed for 
the person with ADRD, as such occupancy routines can help to detect potential early stage 
symptoms of a number of health conditions (e.g., night time rest is frequently interrupted due to 
pain).  
 
Alerts are sent to the family caregiver as well as a nurse care manager that monitors the real-time 
information generated by the eNeighbor sensors. An example monitoring event could occur as 
follows: a motion sensor detects the person with ADRD has entered a bathroom. Once the person 
with ADRD enters the bathroom, the motion and toilet sensors’ timers are set at 10 minutes to 
determine whether any motion occurs in the bathroom or the toilet is wet or dry. If the motion or 
toilet sensors in the bathroom do not detect any activity within 10 minutes (or another 
household sensor detects activity in some other area of the home), an action alert is sent to 
notify the caregiver and nurse care manager that an expected ADL-using the bathroom-did not 
take place. eNeighbor sensors operate according to self-adapting thresholds (e.g., time expected 
to complete a given ADL) that can be set by the family caregiver or the nurse care manager upon 
installation of the system; if the person with ADRD is outside the normal timing threshold, the 
eNeighbor sensors will then alert the family caregiver and nurse care manager.   
 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 13 of 48 
Template Revised On: 11/1/2021      
The technology platform of eNeighbor relies on wireless infrastructure that allows for remote 
monitoring via alerts that are communicated to the family caregiver’s or nurse care manager’s 
personal computers or handheld devices. eNeighbor also includes a private care coordination and 
socialization tool for the family caregiver of the person with ADRD through the MyHealthsense 
web portal. MyHealthsense provides scheduled reports to the family caregiver and the nurse care 
manager that summarizes eNeighbor sensor activity and links this information to the person with 
ADRD’s electronic health record. In this manner, primary care providers can review the person 
with ADRD’s daily function.  
 
5.0 
Procedures Involved 
5.1 Study Design:  
Mixed methods is generally defined as the collection and analysis of both quantitative and 
qualitative data that links these two forms of data concurrently, sequentially, or embedded one 
into another.57,58 Among the various rationales for conducting mixed methods research are: a) to 
better understand a research problem by converging numeric trends from quantitative data and 
specific details from qualitative data; and b) to obtain statistical, quantitative data from a sample 
of a population and use them to identify individuals who may expand on the empirical results 
through qualitative findings.59 Few evaluations of ADRD caregiver interventions have combined 
qualitative and quantitative data to obtain a greater understanding of why certain protocols are 
beneficial or not. For these reasons, an embedded experimental mixed methods design will be 
utilized for the proposed demonstration. An embedded experimental mixed methods design 
combines the collection and analysis of qualitative data within a traditional randomized 
controlled trial (RCT) design; the collection of the embedded qualitative data may occur prior to, 
during, or after the 
RCT.57, p. 90 The 
embedded 
experimental design 
will assist the 
research team 
examine the process 
of eNeighbor’s 
implementation 
during the conduct 
of the RCT and 
determine why and 
how the eNeighbor 
worked or did not 
for ADRD caregivers 
following the 
completion of the 
RCT (see Figure 
1).57,60-63 
Randomized Controlled Evaluation
Procedure
1.  Baseline interview
2.  Random assignment 
3.  Bi-annual follow-up over 18 months
4. Key outcomes: 
a) Caregiver efficacy, competence, and distress 
b) Person with ADRD negative health transitions 
and service utilization; 
c) Cost effectiveness 
QUAN
Baseline/
Pre-eNeighbor® 
interview (Months 3-36)
QUAN
Follow-up interviews 
(biannually over 18 months) 
(Months 8-55)
eNeighbor
Intervention
Product
-Growth curve models
-Cox proportional hazards
-Cost-effectiveness ratios
Embedded Process Evaluation
qual + quan
Bi-annual open-ended and 
close-ended survey items 
over 1.5 years to examine 
eNeighbor utility
Product
-Descriptive statistics
-Thematic analysis
Stratified 
purposive 
sample: 
Rate of change 
in stress
(n = 20 increase)
(n = 20 decrease)
QUAL
Semi-structured 
interviews to determine 
mechanisms of 
eNeighbor benefit
(Months 22-55)
Embedded 
Post-Eval.
Interviews
Product
-Thematic analysis
Point of Interface/Mixed Methods Analysis (Months 56-60)
Procedure
-Integration of findings from randomized controlled evaluation with embedded components to 
examine points of convergence or divergence as to how and why eNeighbor® is effective
Product
-Matrices and cross tabulations of empirical results and identified categories and themes
Figure 1.  Embedded experimental mixed methods design.

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 14 of 48 
Template Revised On: 11/1/2021      
5.2 Study Procedures:  
Recruitment. The Principal Investigator (PI) or research coordinators (RCs) will initiate email, 
telephone, or mail contact with ADRD caregivers on the University of Minnesota Caregiver 
Registry (IRB# 1007S85812) or others recruited by the PI (see above) who potentially meet the 
project inclusion criteria. In addition, the PI or RCs will ask professional caregivers on the Registry 
to identify potential ADRD caregivers for recruitment purposes (this will also occur via the various 
other recruitment and outreach activities noted above). During initial enrollment contacts, the PI 
or RCs will describe the eNeighbor monitoring system, explain study procedures, and invite 
potential ADRD caregivers to participate. Caregivers will be offered the opportunity to ask any 
questions about the study procedures. The Telephone and Email script will be utilized. = 
 
These recruitment efforts will be facilitated by the Minnesota Board on Aging (MBA), the 
Minnesota-North Dakota Alzheimer’s Association regional office, and other organizations. The 
MBA will help us promote this study through Area Agencies on Aging, many of which serve ethnic 
and racially diverse older adults as well rural ADRD caregivers. Specifically, the Information Sheet 
will be distributed to the MBA and associated Area Agencies on Aging in Minnesota, the 
Minnesota-North Dakota Alzheimer’s Association, or other organizations to distribute to family 
members or family members of clients that these organizations serve. The Information Sheet is 
also used as the basis for any other advertising efforts or by other organizations who wish to 
reach out to their clients and families regarding this opportunity. Finally, a Letter to Families can 
be sent to organizations if they wish to distribute to their clients or family members of clients. 
 
Additional recruitment efforts may occur, on an as-needed basis, via the PI’s or RC’s community 
outreach efforts. The PI, via the annual Caring for a Person with Memory Loss conference (see 
https://www.sph.umn.edu/events-calendar/caring-for-person-with-memory-loss-conference/) 
and a number of other community presentations, will have the opportunity to recruit potential 
participants. Following an overview of the study procedures, the PI or RC will provide interested 
participants with a Documentation of Permission form to complete, which will provide the PI and 
research team members to contact the potential participant to determine eligibility and proceed 
with enrollment. If independent living settings or similar residential providers are willing to 
collaborate with the research team to identify potential participants, we ask them to: a) 
distribute via email or print the study flyer, information sheet, letter to families, and/or other 
recruitment information to announce the study and its availability; b) approach residents or 
family members to discuss the study, and if there is interest, obtain permission for Dr. Gaugler or 
his team to follow-up and contact them to initiate the recruitment and enrollment procedure; 
and c) setting liaisons will simply forward potentially interested family members’ contact 
information to Dr. Gaugler to do so. 
 
Eligibility screening. If caregivers agree to participate, the PI or RC will initiate a brief screening 
procedure. The following inclusion criteria will be applied for persons with ADRD: 1) English 
speaking; 2) physician diagnosis or recognition of ADRD (e.g., Alzheimer’s disease, Lewy Body 
disease, fronto-temporal dementia, or stroke/vascular dementia; mild cognitive impairment); 3) 
not currently receiving care or case management services; and 4) 55 years of age and over. 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 15 of 48 
Template Revised On: 11/1/2021      
Caregivers of persons with ADRD must: 1) speak English; 2) be 21 years of age and over; 3) self-
identify as someone who provides help to the person with ADRD because of their cognitive 
impairments; 4) self-identify as the person most responsible for providing hands-on care to the 
person with ADRD or sharing that role with someone else (i.e., the “primary” family caregiver, 
which can include highly involved kin or non-kin of persons with ADRD; those who share care 
responsibilities are also eligible); 5) plan to, or ideally wish to, remain in the area for at least 18 
months in order to reduce possible loss to follow-up; and 6) indicate a willingness and need to 
use eNeighbor. To determine eligibility, the E-Neighbor Screening Form will be administered 
either in-person over the telephone by the PI or RC to determine and identify eligible persons 
with ADRD and their family caregivers.   
 
Enrollment/Consent and Assent 
Within two weeks following the completion of eligibility screening, consent/assent procedures 
and baseline interviews will be scheduled within 2 weeks for eligible caregivers. Signed informed 
consent from the eligible family caregiver will take place. Signed informed consent will be offered 
in-person, via mail, or if deemed most convenient to the family caregiver, via an online consent 
form. 
 
If a legally authorized representative (LAR) for the person with ADRD is identified other than the 
family caregiver, we will also obtain signed consent from this individual. For the purposes of 
efficiency, we will offer an online consent form to review and approve. All online consent and 
HIPAA forms will be administered via the secure University of Minnesota Google Docs 
application. 
In addition to administering informed consent forms to family caregivers and LARs, we will 
additionally provide HIPAA forms (either in-person or via mail and online formats) for the family 
caregiver and LAR to review and sign. To complete this procedure, the Family Caregiver Consent 
Form, the LAR Consent Form, and the HIPAA form will be utilized.  
 
Following the securing of consent of primary caregivers and LARs, Verbal Assent of persons with 
ADRD will take place (see supplemental documents uploaded to IRB). While ideally this may take 
place simultaneously with the consent procedures above, there may be a delay in time (hopefully 
no more than several days) between when consent is secured from family caregivers and LARs 
and assent of the person with ADRD. 
 
Baseline 
As soon as possible following the completion of consent, HIPAA, and verbal assent, the baseline 
survey/interview will take place. The survey/interview will ask the family caregiver to complete a 
survey that will ask questions about the family caregiver, the person with ADRD, and the person 
with ADRD’s and family caregiver’s memory loss’ emotional, psychological, physical health, the 
caregiver’s confidence about their care situation. The survey/interview we will also ask the family 
caregiver about various health events that the person with ADRD may have experienced. The 
baseline survey can occur in-person, in the family caregiver’s home, Mayo Building at the 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 16 of 48 
Template Revised On: 11/1/2021      
University of Minnesota, or another location of the family caregiver’s choosing. A mail survey, 
telephone interview, or online survey will also be arranged if that is easier for the family 
caregiver. If the caregiver elects to complete the online version of the survey, the survey link will 
be emailed to the caregiver. To complete this procedure, the Baseline eNeighbor Survey will be 
utilized. 
 
Treatment/Intervention Period 
Following the completion of baseline interviews, ADRD caregivers will be randomly assigned to an 
eNeighbor treatment condition that receives the multi-sensor, remote monitoring system or an 
attention control group. Randomization (participant is assigned to either the treatment or control 
condition) will be completed via an a priori list generated from http://randomizer.org by the PI. 
The PI will inform the ADRD caregiver of their randomization status within 2-3 days following 
completion of the baseline interviews.  
 
The PI or research coordinators will call caregivers in the control group 48 hours following 
assignment to the usual care control group to address any questions they may have and to thank 
them for being part of the study and volunteering their time if no response from the participant 
in the usual care group is received following randomization). Group allocation (either attention 
control or treatment condition) will be based solely on their a priori randomization assignment 
number. The PI or research coordinators will then inform the ADRD caregiver of her/his group 
assignment within 2 days of baseline survey completion. 
 
Following ADRD caregivers’ enrollment into the proposed project and within 2 weeks of 
randomization to the eNeighbor treatment condition, the Director of Nursing and Technology 
(DNT) will schedule a visit at the home of the person with ADRD and the enrolled family 
caregiver. The DNT will oversee all system maintenance (battery changes, troubleshoot in 
instances where there is a loss of system contact), establish arrangements for other care services 
that are needed for the person with ADRD in instances of eNeighbor alerts or other health-
related transitions, and develop and monitor a care plan with the family caregiver to ensure that 
it is effectively followed.  
 
An initial Needs Assessment takes place to determine the best use and deployment of the 
eNeighbor remote sensor technology in the person with ADRD’s home. The assessment begins 
with an identification of risk factors that suggest the need for remote health monitoring (e.g., the 
person with ADRD lives alone and has little supervision; the caregiver needs support; the person 
with ADRD has a history of falls or the caregiver has concerns with falls) as well as the use of 
other monitoring systems such as Safe Return™ or a similar device. The DNT will then discuss the 
results of the needs assessment with the ADRD caregiver and review how the remote monitoring 
system works, that the eNeighbor does not include cameras or microphones, is secure, and is 
private, and that the system learns the normal activities of the person with ADRD and alerts both 
the family caregiver and the DNT if something appears unusual (e.g., absence of expected ADL 
behaviors). Following this operational overview, the DNT will summarize the secure and 
password-protected MyHealthsense website, which is used by the family caregiver or other 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 17 of 48 
Template Revised On: 11/1/2021      
trusted family members and friends to coordinate and share information regarding appointments 
or the well-being of the person with ADRD. The remote monitoring system will then be installed 
in the person with ADRD’s home and the expected performance thresholds and daily routines will 
be programmed. The DNT will monitor sensor performance throughout the duration of the 
project, and if these sensors are damaged or become inoperable, she will replace these sensors 
as needed free of charge. 
 
A particularly important aspect of eNeighbor is its configuration in homes with varying broadband 
internet service.  If broadband services are available at the person with ADRD’s home, connection 
of the sensors involves the simple addition of a wireless router which connects with the existing 
broadband modem in the person with ADRD’s home (and is included in the remote sensor 
package that will be supported by the proposed project). If broadband is not available, the 
current project will support connectivity for the person with ADRD’s home via purchase of this 
service as a “bundle” through an existing telephone or cable TV plan. In the instance the family 
caregiver does not wish to utilize broadband service options for the purposes of eNeighbor, the 
proposed project will support a low data rate cellular service plan that supports only eNeighbor 
functions. The quality of data collection is identical across cellular or broadband modalities. The 
DNT will then share paper versions of the alert system reports generated by the MyHealthsense 
website.  
 
To address environmental diversity, the DNT will collect information on the approximate square 
footage of the house; number of bedrooms and bathrooms; distances between primary 
bathroom (e.g., the one used to shower/bathe in), living room area (e.g., where television or the 
majority of similar leisure activity takes place), and entryway; and number of levels in the home.  
 
The Needs Assessment form and utilization data collected by the DNT based on the 
Healthsense/eNeighbor remote health sensor system will be securely transferred to Dr. Gaugler 
and RC via a secure University of Minnesota Box file transfer procedure. Any hard copy Needs 
Assessment forms or similar utilization data will be maintained in a locked file cabinet at The 
Lutheran Home Association. As one of the analyses proposed will focus on the 
individualization/customization of the eNeighbor system for each family as well as variable 
utilization data based on the alerts issued by the remote monitoring system and follow-up 
contacts by the DNT, these utilization data will be collected throughout the 18-month evaluation 
period for each caregiver and person with ADRD. 
 
5.3 
Follow-Up:  
 
Follow-up will continue until Month 55, resulting in a 53-month data collection period. Eligible 
ADRD caregivers will be interviewed/surveyed at baseline and every 6 months thereafter for up 
to 18 months. Six-month follow-up interviews/surveys will be completed by the PI or research 
coordinators for all participants in the treatment and control conditions. The selected measures  
have strong psychometric properties, sensitivity to change, and clinical relevance in the 
evaluation of remote health monitoring technology as established in the stress process and 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 18 of 48 
Template Revised On: 11/1/2021      
related conceptual models. Caregivers will complete the proposed measures at each time point 
(context of care items will be collected at baseline only). Baseline and follow-up interviews will 
take place at a location and in a format that is convenient to ADRD caregivers (at the University of 
Minnesota Delaware Clinical Research Unit, the ADRD caregivers’ home or through online, 
telephone or mail formats if desired). Each follow-up interview is expected to take approximately 
45 minutes to complete. Information from the follow-up surveys will also be utilized to complete 
the E-Neighbor Disposition Form at each follow-up interval. As the information on the Disposition 
form is available from the follow-up surveys, the PI or RCs can extract and complete the 
Disposition form following the completion each 6-, 12-, and 18-month survey. 
 
In general, a call will be placed to every participant near the time when the survey is sent out. For 
participants who are a part of the control group, this call will serve as a time to check-in, and also 
make these participants feel connected to the research study. A monthly check-in call/attempt 
will be placed to those in the eNeighbor treatment group, as a means to confirm that the 
eNeighbor sensor system is functioning properly.  
 
Furthermore, we will administer a verbal permission/modified assent procedure prior to or 
following each 6-month interview/survey (i.e., 6 months, and 12 months) for those in the 
eNeighbor treatment group (unless care recipient passed, moved to a care facility, had sensor 
system removed).  
 
The rationale for this approach is that since persons with dementia in the control group do not 
engage in any way with the research procedures or researchers themselves following baseline 
(i.e., family caregivers complete all surveys), assent is likely not needed in such circumstances as 
participants in the control group are essentially participating in a family caregiving study. As 
persons with memory loss in the treatment condition are experiencing the installation and 
operation of the eNeighbor remote monitoring system in their homes, ongoing permission is 
necessary for these individuals for the duration of the study follow-up period (i.e., 6 months, and 
12 months; note: by the 18-month follow-up surveys/interviews the study procedures are 
complete and no further assent is needed).  
 
Specifically, verbal assent of persons with Alzheimer’s disease or a related dementia (ADRD) (oral 
only) will take place for those in the eNeighbor treatment condition over the telephone (unless 
the family caregiver has requested an in-person interview). Family caregivers may also (and are 
encouraged to) join the telephone call via a conference connection, another land line, or speaker 
phone to help facilitate the assent process and effectively communicate with the person with 
memory loss if needed. If a dissenting behavior or agitation is exhibited by the person with 
memory loss, a conversation with the caregiver alone should take place, to determine if this 
behavior related to the eNeighbor system is common. If it is common, then the verbal dissent 
should be noted and the DNT should be contacted immediately to schedule removal of the 
sensor technology. This will also occur after any adverse/negative reaction to the eNeighbor 
remote monitoring system.  
 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 19 of 48 
Template Revised On: 11/1/2021      
When calling, the staff will defer to caregiver preference in circumstances where the caregiver 
prefers to provide permission for follow up instead of staff speaking with the care recipient 
directly either due to severity of memory loss issues (e.g., the care recipient does not remember 
that the sensors are even in the home) or for another reason. In these circumstances, the staff 
will ask the caregiver if the caregiver and/or care recipient are still agreeable to continue their 
participation in the study and use of the sensor system. If they agree, staff will sign a follow-up 
assent/permission form, thus providing permission for continuation of study procedures (e.g. 
sensor system use). While the staff is available for any questions that may come up during the 
call, the full assent form is not read over the phone during these follow-up permission calls. 
 
Several steps will enhance retention in the proposed study. The research coordinator or PI will 
complete confirmation calls or emails 1-4 days prior to a scheduled interview or survey, will 
contact ADRD caregivers within 24 hours of a missed interview to reschedule, and will update 
participants’ contact information as needed throughout the project. For those in the eNeighbor 
treatment condition, the DNT will contact the caregiver 3-4 days following the installation of 
sensors to ensure the system is operating appropriately and to troubleshoot any issues. In 
addition, the DNT will follow-up with treatment participants on a monthly basis to further 
monitor the overall operation of the eNeighbor sensor system, address issues/concerns of the 
caregiver, and troubleshoot any issues related to the remote health monitoring system. 
 
We will take several steps to address attrition bias. If a person with ADRD has moved into a 
residential long-term care facility or has died, caregiver follow-up interviews will include queries 
determining when these events occurred. Regular follow-up will continue in order to collect as 
much information on outcome variables that are appropriate (i.e., intention to treat principle). 
Per the consent form, participants will have the opportunity to provide a Social Security Number 
for the care recipient to study staff (over the phone) during/at the end of the study. Participants 
may also choose to opt out of this. At the conclusion of the project, Thank You cards will be 
mailed to all participants to ensure rapport.  
 
Treatment fidelity. Monthly system reviews will take place through system reports generated 
by the Director of Nursing and Technology. The MyHealthsense portal can also track how often 
the ADRD caregiver or others utilize the care coordination resources of MyHealthsense. The PI or 
research coordinator will also determine the degree to which participants apply the eNeighbor 
monitoring tool to their everyday care situations. An online or mail survey of close-ended, Likert-
scale items to determine eNeighbor’s acceptability by ADRD caregivers as well as multiple open-
ended questions will be administered to all ADRD caregivers in the eNeighbor treatment 
condition at the 6-, 12-, and 18-month interview intervals. The open-ended responses will 
provide qualitative data as to the reasons why family caregivers felt the health monitoring 
technology of eNeighbor was or was not easy to utilize (e.g., “Why or how was the health 
monitoring technology easy or difficult to use?” The identification of these barriers or facilitators 
will be considered when examining ADRD caregivers’ perceptions of eNeighbor’s design, delivery, 
and ease of use. 
 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 20 of 48 
Template Revised On: 11/1/2021      
Final Study Visit/Survey.  
The final study visit will operate similar to the other follow-up interviews/surveys. Following 
completion of the final 18-month assessment, participants in the treatment group will be 
informed of the conclusion of the study and the need to remove the health monitoring sensors. 
However, available eNeighbor sensor packages purchased for this demonstration project will also 
be offered to the control group on a first-come, first-serve basis at the conclusion of the 
randomized control trial evaluation phase as stated in the consent form. If the eNeighbor system 
is found to have an overall negative effect (specifically, the eNeighbor system results in greater 
emotional stress or depressive symptoms on the part of the caregiver) then the eNeighbor 
system will not be offered on a first-come, first-serve basis for those in the control group. The 
latter is now included to provide additional clarification in the consent form. For those not 
selected but who desire the health monitoring technology, the project team will work with 
Healthsense to determine if discounts are available and applicable.   
 
Post-evaluation semi-structured interviews. Thirty semi-structured interviews with ADRD 
caregivers in the e-Neighbor treatment condition will take place. These interviews will take place 
a month after completion of the final 18-month follow-up interview for selected participants. The 
PI and Dr. Garcia (the Co-I) will identify 15 ADRD caregivers who indicated positive acceptance on 
the embedded qualitative and quantitative 6-, 12-, and 18-month system reviews and 15 ADRD 
caregivers who reported low acceptance on the embedded qualitative and quantitative 6-, 12-, 
and 18-month system reviews.  
 
A stratified purposive sampling approach will also be applied; the PI and Dr. Garcia will 
purposively identify ADRD caregivers of varying kin relationship (spouse vs. adult child), dementia 
severity (middle versus late stage dementia symptomatology), caregiver gender, and racial or 
ethnic background to participate in the post-RCT semi-structured interviews.  
 
The open-ended responses of the semi-structured interviews will provide in-depth information 
on the reasons why dementia caregivers felt the eNeighbor remote sensor technology did or did 
not reduce ADRD caregivers’ distress, help to manage persons’ with ADRD daily function, or 
prevent negative health transitions and service use for persons with ADRD. The PI and research 
coordinators will schedule and conduct the semi-structured interviews and will digitally record 
each interview. Audio recordings will be transcribed by a professional transcriptionist into a 
Microsoft Word file which will then be uploaded to nVivo for subsequent analysis.  
 
6.0 
Data Banking 
6.1 Storage and Access: The original intention was to make the datasets generated 
and/or analyzed publically available upon completion of primary or secondary 
outcome analyses. However, in consultation with the Institute for Social Research at 
the University of Michigan, which houses the National Archive of Computerized Data 
on Aging (NACDA), it was determined that the language in the consent forms (which 
were originally developed at the outset of the project in 2014) did not support data 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 21 of 48 
Template Revised On: 11/1/2021      
sharing of any sort. The datasets generated and analyzed during the current study 
are not, and will not be, publicly available as originally planned. According to the 
study’s consent forms, data can only be viewed and analyzed by the principal 
investigator’s research team. 
6.2 Data: Only de-identified data will be stored, but not publically shared [see section 
6.1].  
7.0 
Sharing of Results with Participants 
7.1   Sharing of Results with Participants: We will create a summary page and brief videos 
highlighting study results/findings for participants.  
8.0 
Study Duration 
8.1 ADRD caregivers will participate in the study for 18-months; the total project 
duration is 5 years (3/31/2014-3/30/2019). A project timeline is below: 
 
Months 
1-3 
Months 
4-12 
Months 
13-55 
Months 
55-60 
Data management processes, team training 
● 
○ 
○ 
○ 
Project and Community Advisory Board meetings 
● 
● 
● 
● 
Recruitment of ADRD caregivers (n = 200) 
○ 
● 
● 
○ 
Home installation and training of e-Neighbor 
 
● 
● 
○ 
Baseline, 6-, 12-, and 18-month data collection 
 
● 
● 
● 
Embedded treatment fidelity/process evaluation 
 
● 
● 
● 
Embedded post-RCT semi-structured interviews 
 
 
● 
● 
Quantitative, qualitative, and mixed analysis 
 
 
● 
● 
Dissemination 
 
 
 
● 
NOTE: ADRD = Alzheimer’s disease or a related dementia; RCT = randomized controlled trial; 
● = primary focus; ○ = ongoing but less intensive  
 
9.0 
Study Population 
 
9.1 
Inclusion Criteria:  
The following inclusion criteria will be applied for 200 persons with ADRD: 1) English 
speaking; 2) physician diagnosis of ADRD (Alzheimer’s disease, Lewy Body disease, fronto-
temporal dementia, or stroke/vascular dementia; mild cognitive impairment only); 3) not 
currently receiving care or case management services; and 4) 55 years of age and over. 
Caregivers of persons with ADRD must: 1) speak English; 2) be 21 years of age and over; 3) 
self-identify as someone who provides help to the person with ADRD because of their 
cognitive impairments; 4) self-identify as the person most responsible for providing 
hands-on care to the person with ADRD; 5) plan to remain in the area for at least 18 
months in order to reduce possible loss to follow-up; and 6) indicate a willingness to use 
eNeighbor.   

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 22 of 48 
Template Revised On: 11/1/2021      
9.2 Exclusion Criteria: Anyone who does not fit the inclusion criteria will be excluded.  
9.3 Screening: If caregivers agree to participate, the PI or research coordinators will 
initiate a brief screening procedure applying the inclusion criteria above. 
10.0 Vulnerable Populations 
10.1 
Vulnerable Populations:  
Population / Group 
Identify whether any of the 
following populations will be 
primary focus of the research 
(targeted), included but not the 
focus of the research or excluded 
from participation in the study.  
Children 
Excluded 
Pregnant women/fetuses/neonates 
included but not the focus 
Prisoners 
Excluded 
Adults lacking capacity to consent 
and/or adults with diminished 
capacity to consent, including, but 
not limited to, those with acute 
medical conditions, psychiatric 
disorders, neurologic disorders, 
developmental disorders, and 
behavioral disorders 
Primary focus of the research 
Non-English speakers 
Excluded 
Those unable to read (illiterate) 
Excluded 
Employees of the researcher 
Excluded 
Students of the researcher 
Excluded 
Undervalued or disenfranchised 
social group 
included but not the focus 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 23 of 48 
Template Revised On: 11/1/2021      
Active members of the military 
(service members), DoD personnel 
(including civilian employees) 
included but not the focus 
Individual or group that is 
approached for participation in 
research during a stressful situation 
such as emergency room setting, 
childbirth (labor), etc. 
Excluded 
Individual or group that is 
disadvantaged in the distribution of 
social goods and services such as 
income, housing, or healthcare. 
included but not the focus 
Individual or group with a serious 
health condition for which there are 
no satisfactory standard treatments. 
included but not the focus 
Individual or group with a fear of 
negative consequences for not 
participating in the research (e.g. 
institutionalization, deportation, 
disclosure of stigmatizing behavior). 
Excluded 
Any other circumstance/dynamic 
that could increase vulnerability to 
coercion or exploitation that might 
influence consent to research or 
decision to continue in research. 
Excluded 
 
10.2 
Additional Safeguards:  
All participants in the above table that are listed as “included but not the focus” 
could be included in the study by chance. However, these vulnerable groups are 
not sought out during recruitment and we do not ask potential participants if they 
belong to one of the above groups or not. Thus, extra safeguards are not put in 
place to protect these groups since we would not know if they were included in 
the research or not. Given our study population of interest, it is unlikely for 
participants to be a part of the groups listed as “included but not the focus,” 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 24 of 48 
Template Revised On: 11/1/2021      
besides adults lacking the capacity to consent or have a diminished capacity to 
consent which is addressed below.  
Adults lacking the capacity to consent or have a diminished capacity to consent are 
one of the primary groups of participants to be recruited to the study. Specific 
safeguards to protect this population include signing of a consent form by the 
caregiver or a LAR (Legally Authorized Representative). Additionally, the person 
with memory loss either consents or assents to the research based on their SLUM 
and Capacity to Consent scores – see more detail in the consent section below.  
10.3 If research includes potential for direct benefit to participant, provide rationale for 
any exclusions indicated in the table above: 
Some individuals in the above vulnerable groups are excluded because they are not 
our population of interest (i.e. ADRD does not impact children) or because 
participating in such research would potentially be risky for them.  
 
11.0 Number of Participants 
11.1 Number of Participants to be Consented:  
We aim to enroll 200 ADRD caregivers and 200 individuals with ADRD in our study. 
12.0 Recruitment Methods 
 
12.1 Recruitment Process:   
 
The Principal Investigator (PI) will initiate email, telephone, or mail contact with ADRD caregivers 
on the University of Minnesota Caregiver Registry (IRB# 1007S85812) or others recruited by the 
PI or research coordinators via various advertisements, community presentations, and other 
outreach/enrollment efforts who potentially meet the project inclusion criteria. In addition, the 
PI or research coordinators will ask professional caregivers on the Registry to identify potential 
ADRD caregivers for recruitment purposes.  
 
12.2 Source of Participants:   
 
Dr. Gaugler has created a University of Minnesota Caregiver Registry that includes family and 
professional caregivers who have participated in his free annual community education 
conference, “Caring for a Person with Memory Loss” (CPWML). Approximately 200-350 persons 
attend each CPWML conference. Attendees are invited to complete a brief form which enrolls 
them in the Registry and gives Dr. Gaugler and his research staff permission to contact and invite 
them to participate in his studies. We will periodically send project recruitment materials to 
members of the caregiver registry. 
 
In addition to general recruitment assistance, the PI or research coordinators will ask professional 
care providers in the Registry (many of whom provide care to under-represented older persons) 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 25 of 48 
Template Revised On: 11/1/2021      
to identify ADRD caregivers of diverse ethnic or racial origin and geographic location to enhance 
the inclusion of AHRQ Priority Populations. These recruitment efforts will be facilitated by the 
Minnesota Board on Aging (MBA), the Minnesota-North Dakota Alzheimer’s Association regional 
office, and other community organizations. For example, the MBA will help us promote this study 
through Area Agencies on Aging, many of which serve ethnic and racially diverse older adults as 
well rural ADRD caregivers. Cumulatively, these various outreach efforts are expected to result in 
a sample that includes approximately 40 diverse and under-represented ADRD caregivers (20% of 
the sample). Additional recruitment efforts will take place via advertisements in local print, radio, 
and internet media sources including websites of local and national organizations.  
 
12.3 
Identification of Potential Participants:   
 
Family and professional caregivers on The University of Minnesota Caregiver Registry (IRB# 
1007S85812) have provided permission for Dr. Gaugler or his research team to contact them 
to invite them to participate in his ongoing or future research projects. Other enrollment 
procedures will rely on participants to contact Dr. Gaugler or the research coordinators if 
they are interested; this will also protect participants’ privacy. 
 
During initial enrollment contacts, the PI or research coordinators will describe the 
eNeighbor monitoring system, explain study procedures, and invite potential ADRD 
caregivers to participate. Caregivers will be offered the opportunity to ask any questions 
about the study procedures. If caregivers agree to participate, the PI or research coordinators 
will initiate a brief screening procedure applying the inclusion criteria above. Participants will 
self-identify in response to recruitment efforts.  
 
The PI and research coordinators will be in first contact with potential participants. 
Additionally, professional care providers in the Registry may promote this study and 
therefore be the first contact with potential participants. Potential participants will not be 
identified using medical records or other source of protected records.  
12.4 Recruitment Materials: See materials submitted in ETHOS.  
12.5 Payment: Participants are not compensated for participating in the study.  
13 Withdrawal of Participants 
13.1 
Withdrawal Circumstances:   
We will emphasize to all participants that they do not have to complete any question they do 
not want to answer, and that the interview may be terminated at any time according to their 
wishes. We will stress to ADRD caregivers that their decision to discontinue the study will in 
no way affect the services they are receiving from the University of Minnesota or other 
entities. If a participant wishes to withdraw from the study because they are no longer 
interested in participating or they are no longer able to participate, we will follow the 
procedures described below.  

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 26 of 48 
Template Revised On: 11/1/2021      
 
13.2 
Withdrawal Procedures:  
 
In instances where ADRD caregivers wish to withdraw from the study we will determine and 
document the reason for study withdrawal, and if the caregiver agrees we will administer 
regular, brief surveys (either online or over the telephone) to collect data on outcome 
variables (identical to the regular follow-up interviews/surveys).  
 
13.3 
Termination Procedures:   
In instances where ADRD caregivers are terminated from the study, we will determine and 
document the reason for termination and ask the caregiver to return the eNeighbor system 
(if applicable). We would not send the caregiver any follow-up surveys/interviews.  
 
14 Risks to Participants 
14.1 Foreseeable Risks:   
The consideration of need is potentially stressful, and thus there are possible 
psychological risks for the caregiver a relative with Alzheimer’s disease and related 
dementia (ADRD). Since the research team has considerable experience providing 
psychosocial support to dementia caregivers on various research protocols, serious 
psychological risks are unlikely to occur. The potential social or legal risks for the 
participants relate only to possible violations of confidentiality. As noted above, 
Healthsense, Inc. as instituted a robust and secure data privacy system for the remote 
health monitoring technology. 
14.2 Reproduction Risks: Not applicable 
14.3 Risks to Others: Not applicable  
15 Incomplete Disclosure or Deception 
15.1 Incomplete Disclosure or Deception: Not applicable 
16 Potential Benefits to Participants 
16.1.1 Potential Benefits: There are no direct benefits of participating in the study.  
17 Statistical Considerations 
17.1 Data Analysis Plan:  
Intensive longitudinal analysis procedures (growth curve modeling) will be utilized to 
capitalize on the randomized design and the multiple waves of data that will be collected.  
17.2 Power Analysis:   
The number of ADRD caregivers to be enrolled to address study hypotheses was 
determined using power analysis procedures that take into account the hierarchical 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 27 of 48 
Template Revised On: 11/1/2021      
analytic design of the study.68 In this framework, the researcher identifies the Type I error 
rate (e.g., p < .05) to differentiate between a null and alternative test hypothesis, a 
suitable level of statistical power (.80 is considered an excellent power value), and the 
expected difference between the two study groups in order to determine the number of 
ADRD caregivers to enroll into the project. We sought a sample size that would be 
sufficient to detect a group difference of 0.50 standard deviation units. This is considered 
to be a “medium” effect size69 and is a reasonable benchmark to evaluate the efficacy of a 
new behavioral intervention in comparison to an attention control condition. Using these 
specifications, a sample size of 200 ADRD caregivers (factoring in the anticipated 20% 
attrition rate) was found sufficient. As noted in various recommendations for mixed 
methods sampling, 30 participants is considered an adequate sample size for semi-
structured interview protocols to ensure the richness and depth of open-ended data 
collected.70,71  
17.3 Statistical Analysis:  
Analysis of Specific Aim1: Tests of Hypotheses 1-3.  
Data available at baseline, 6 months, 12 months, and 18 months will allow for individual growth 
curve models that examine change in ADRD caregiver outcomes.72,73 Multilevel analysis 
approaches are available that support growth curve modeling. In this context, growth curve 
modeling is an example of a 2-stage modeling process consisting of 1) a within-subjects model 
across time; and 2) a between-subjects model that incorporates caregiver and person with ADRD 
covariates.74,75 The primary independent variable in the proposed investigation consists of an 
indicator variable for random assignment into the eNeighbor treatment condition or the 
attention care control. IBM SPSS Statistics 2176 will be used to conduct these analyses, as it 
supports multilevel and growth curve modeling procedures. Dr. Gaugler, the PI, has extensive 
experience conducting longitudinal and growth curve analyses in his prior research on ADRD 
caregiving.46,80,81,88 
 
Our proposed analyses will provide in-depth tests of Hypotheses 1 and 2 and partially test 
Hypothesis 3 (i.e., rates of change in ADRD caregivers’ self-efficacy, competence, subjective 
stress, depressive symptoms, and frequency of negative health transitions and service use). In 
one set of outcome evaluations, the baseline value will be included as a covariate, and time will 
be “centered” at 6-months post-baseline. This scales the intercept effect to be a main effect of 
eNeighbor group assignment and allows the eNeighbor treatment and the attention control 
groups to have different 6-, 12-, and 18-month change trajectories, or an expanded eNeighbor 
treatment*time interaction effect. After establishing that the individual growth parameter 
estimates have significant variance around the mean trajectories of change in key dependent 
variables, an eNeighbor treatment vs. attention care control group indicator will be added as the 
key independent variable to predict intercepts and rates of change in outcomes. Additional 
analyses will determine if covariates (e.g., stress process model covariates including context of 
care indicators, primary objective stressors, and resources) significantly vary across the 
eNeighbor treatment and attention control groups at baseline and over time via growth curve 
modeling procedures. If statistically significant variations between the eNeighbor treatment and 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 28 of 48 
Template Revised On: 11/1/2021      
control groups are found, initial status and rate of change parameters for these covariates will be 
included in all tests to provide additional statistical control.  
 
Cox proportional hazard survival analyses will determine whether participation in the eNeighbor 
treatment group results in significantly less time to nursing home admission (e.g., admission into 
a 24-hour nursing home facility for at least 90 days), overnight hospitalization, emergency room 
use, and negative health transitions (falls, wandering) when compared to persons with ADRD in 
the attention control group (Specific Aim 1/Hypothesis 3). The Cox proportional hazards model is 
defined as the product of an unknown function of time and the exponent of a linear combination 
of risk variables. eNeighbor treatment vs. attention control group membership will be the 
independent variable of interest in the test of Hypothesis 3; time to nursing home admission, 
overnight hospitalization, emergency room use, and occurrence of a fall or a wandering event will 
serve as the dependent variables. Date of randomization will serve as baseline. Additional 
variables will serve as covariates, including time-invariant and time-varying measurements of 
stress process covariates. Likelihood ratio tests and partial odds ratios will be examined in order 
to determine the degree to which these variables explain the observed effects of eNeighbor on 
time to dependent variable occurrence.  
 
Variations in eNeighbor Use and Setting 
Empirical treatment fidelity data and context of care measures that assess heterogeneity in the 
use of eNeighbor within the treatment condition (e.g., frequency and duration of sensor alerts 
and myHealthsense website use; diverse home characteristics) will be included as a series of 
additional Specific Aim 1 analyses. These analyses will explore the effects of variations in 
eNeighbor use on the outcomes hypothesized above for persons with ADRD and their family 
caregivers.  
 
Specific Aim 1/Hypothesis 4 
The cost-effectiveness of the remote monitoring technology intervention will be assessed by 
comparing costs of implementation and healthcare utilization between persons with ADRD in the 
treatment condition and those in the attention control. The analysis will be conducted from the 
perspective of the payer (i.e., the public). Costs in the numerator of the incremental cost-
effectiveness ratio (ICER) will be determined by identifying the differences in Medicare and 
Medicaid expenditures for persons with ADRD across the eNeighbor treatment and attention 
control groups using aggregated (“rolled up”) Medicare and Medicaid claims matched to the 
individual participant by Social Security number for the 18 months of participation. Because the 
differences in costs derive from a randomized trial, an evaluation of the difference in mean costs 
can determine significance. In addition, the direct costs of the intervention will be included as the 
cost of the remote sensor hardware, staff time (i.e., the Director of Nursing and Technology, who 
will track her hourly effort related to monitoring eNeighbor activities and assisting ADRD 
caregivers over a 1.5-year period), and installation costs over the 18-month study period. 
 
The differences in effectiveness included in the denominator of the ICER will be measured using 5 
ADRD caregiver and person with ADRD outcome measures: a) the standard cut-point of 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 29 of 48 
Template Revised On: 11/1/2021      
“moderate or higher” burden on the Zarit Burden Interview;77 b) the standard cut-point of “major 
depression” on the Center for Epidemiological Studies Depression scale;78 c) fall (occurred or 
not); d) wandering event (occurred or not); e) nursing home admission (placed or not); f) 
hospitalization (overnight use or not); and g) emergency room use (used or not). Significant 
differences in cost will be investigated. Sensitivity analysis will be performed where parameter 
uncertainty exists. Where possible, evaluation of these ICERs will be based on comparisons in 
prior literature to determine the overall costs and effectiveness of eNeighbor.  
 
Analysis: Specific Aim 2 
Specific Aim 2 analyses will primarily focus on thematic content analysis of open-ended data to 
examine eNeighbor utility and mechanisms of benefit. As noted by experienced methodologists, 
systematic reading and rereading of qualitative content and hand coding of a significant 
proportion of this content is necessary in order to develop an understanding of meanings in their 
conversational or observational contexts.79,80 Specifically, the PI and research coordinator with 
the help of Dr. Garcia (Co-Investigator) will independently develop coding categories together 
with descriptors (via hand-coding and NVivo) and will generate a shared coding scheme that will 
reflect the primary categories of the transcription. Through repetition of this procedure, a 
consensus perspective on appropriate coding categories and themes will be modified and 
developed. These themes will provide insights as to the eNeighbor’s implementation and use 
(i.e., treatment fidelity/process evaluation embedded component) and mechanisms of benefit 
(i.e., semi-structured interview embedded component). 
 
Grounded theory techniques described by Morse81 and Strauss and Corbin79 will guide the 
analyses of qualitative data in Specific Aim 2. These approaches allow participants to construct 
meanings, perceptions, and behaviors from their own vantage points. All open-ended data 
collected will be first read by the PI and the research coordinator to identify textual elements that 
emerge repeatedly (i.e., codes); these codes will then be clustered into larger categories that are 
later used to construct major thematic elements from the text (with the use of nVivo 10 analytic 
software). During weekly meetings in the analysis phase of the proposed project, the PI and 
research coordinator along with Dr. Garcia will discuss their own identified codes to reach a 
consensus about specific codes, categories, and themes that emerge from the qualitative data 
(these decisions will be noted in an audit trail). In addition, patterns that link particular themes 
will be identified and discussed in successive meetings between the PI, research coordinator, and 
Dr. Garcia to identify more complex processes of eNeighbor use or health monitoring 
technology’s pathways to benefit for persons with ADRD and their family caregivers. During 
monthly team meetings, the development of codes, categories, and themes will be reviewed with 
the project Consultants to yield any additional input into these project components. The multiple 
team meetings and discussions will allow for an exploration of alternative interpretations of the 
qualitative data and will also provide a check regarding the quality and richness of the data 
collected during the embedded mixed methods components. Additional mixed methods 
analyses57,58 will take place. The thematic codes and categories of implementation/use and 
mechanisms of benefit will be cross-tabulated with the empirical data from the randomized 
controlled evaluation to determine whether the findings diverge, converge, or highlight pathways 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 30 of 48 
Template Revised On: 11/1/2021      
toward additional questions and analysis.57 This comparative, mixed method analysis approach 
may suggest that those who reported greater decreases in subjective stress during health 
monitoring technology use may indicate certain themes more often than ADRD caregivers who 
report greater increases in stress. 
 
Specific Aim 3 Analysis Plan 
Brief background data will be collected from Community Advisory Board (CAB) members 
(sociodemographics, professional experience, duration of dementia care, etc.). Analyses of these 
descriptive quantitative data will include descriptive statistics such as frequency tables, means, 
and other univariate statistics.  Additional strategies will include thematic content analysis of 
open-ended data (e.g., meeting discussions) as described above. Analysis of CAB meeting open-
ended data will help us to identify the main themes related to how health monitoring technology 
can be designed, delivered, and evaluated to achieve the greatest utility for persons with ADRD 
and their family caregivers.  
 
Planned Interim Analyses 
Not applicable; if these are done, they will be conducted at the 6-, 12-, and 18-month intervals; 
given how the qualitative data component of the mixed methods research design is structured, 
these findings will not be fully available until the final months of the 5-year project. 
  
17.4 Data Integrity:  
Data will be anonymized approximately 3-5 years following the completion of this project. 
Specific data collection methods and types are described in detail earlier. The de-
identified data will be kept indefinitely.   
18 Health Information and Privacy Compliance 
18.1 
Select which of the following is applicable to your research: 
☐ My research does not require access to individual health information and 
therefore assert HIPAA does not apply.   
☒  I am requesting that all research participants sign a HIPCO approved HIPAA 
Disclosure Authorization to participate in the research (either the standalone 
form or the combined consent and HIPAA Authorization). 
☐ I am requesting the IRB to approve a Waiver or an alteration of research 
participant authorization to participate in the research. 
Appropriate Use for Research:  
☐ An external IRB (e.g. Advarra) is reviewing and we are requesting use of the 
authorization language embedded in the template consent form in lieu of the U 
of M stand-alone HIPAA Authorization.  Note: External IRB must be serving as 
the privacy board for this option. 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 31 of 48 
Template Revised On: 11/1/2021      
 
18.2 
Identify the source of Private Health Information you will be using for your 
research (Check all that apply)   
☐ I will use the Informatics Consulting Services (ICS) available through CTSI (also 
referred to as the University's Information Exchange (IE) or data shelter) to pull 
records for me 
☒   I will collect information directly from research participants. 
☐ I will use University services to access and retrieve records from the Bone 
Marrow Transplant (BMPT) database, also known as the HSCT (Hematopoietic 
Stem Cell Transplant) database. 
☐ I will pull records directly from EPIC. 
☐ I will retrieve record directly from axiUm / MiPACS 
☐ I will receive data from the Center for Medicare/Medicaid Services  
☐ I will receive a limited data set from another institution  
☐ Other.  Describe:  
18.3 
Explain how you will ensure that only records of patients who have agreed to have 
their information used for research will be reviewed. 
18.4 
Approximate number of records required for review: 
N/A; not reviewing records.  
18.5 
Please describe how you will communicate with research participants during the 
course of this research.  Check all applicable boxes 
☐ This research involves record review only. There will be no communication with 
research participants. 
☐ Communication with research participants will take place in the course of 
treatment, through MyChart, or other similar forms of communication used 
with patients receiving treatment.  
☒  Communication with research participants will take place outside of treatment 
settings. If this box is selected, please describe the type of communication and 
how it will be received by participants. When participants consent or assent to 
participating in the research, they are asked whether or not they agree to 
communicate with the research team via unencrypted email. If a participant 
does not agree to communicate this way, the team can send encrypted emails 
to participants.  
18.6 
Access to participants 
The participants consent or assent to providing information to the research 
team for research purposes only.  

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 32 of 48 
Template Revised On: 11/1/2021      
18.7 Location(s) of storage, sharing and analysis of research data, including any links to 
research data (check all that apply).   
☐ In the data shelter of the Information Exchange (IE)  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In the Bone Marrow Transplant (BMT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) Database  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In REDCap (recap.ahc.umn.edu)  
 ☐ Store 
☐ Analyze 
☐ Share 
☒  In Qualtrics (qualtrics.umn.edu) 
 ☒  Store 
☐ Analyze 
☒  Share 
☐ In OnCore (oncore.umn.edu)  
 ☐ Store 
☐ Analyze 
☐ Share 
☒  In the University’s Box Secure Storage (box.umn.edu) 
 ☒  Store 
☐ Analyze 
☒  Share 
☒  In an AHC-IS supported server. Provide folder path, location of server and IT 
Support Contact: 
S:\Public_Health_Center-on-Aging_Gaugler\A Proactive Health Monitoring 
Intervention for Dementia Caregivers The eNeighbor 
IT Support Contact: Troy Karkula karku003@umn.edu 
 ☒  Store 
☒  Analyze 
☒  Share 
☐ In an AHC-IS supported desktop or laptop.  
Provide UMN device numbers of all devices: 
 ☐ Store 
☐ Analyze 
☐ Share 
☒  Other. Online survey data will be collected and stored in Google Forms. 
Indicate if  data will be collected, downloaded, accessed, shared or stored using a 
server, desktop, laptop, external drive or mobile device (including a tablet computer 
such as an iPad or a smartform (iPhone or Android devices) that you have not 
already identified in the preceding questions 
☐I will use a server not previously listed to collect/download research data 
☐I will use a desktop or laptop not previously listed 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 33 of 48 
Template Revised On: 11/1/2021      
☐I will use an external hard drive or USB drive (“flash” or “thumb” drives) not 
previously listed  
☐I will use a mobile device such as an tablet or smartphone not previously listed 
 
18.8 Consultants. Vendors. Third Parties. Data will be collected and stored by 
MyHealthsense. MyHealthsense provides scheduled reports to the family caregiver 
and the nurse care manager that summarizes eNeighbor sensor activity and links 
this information to the person with ADRD’s electronic health record 
Additionally, Production Transcripts is a professional transcription service that will 
be used to transcribe audio recordings of qualitative interviews. Audio recordings 
will be securely uploaded to their secure website and the transcripts will be securely 
shared with the research team once completed.   
18.9 Links to identifiable data: N/A 
 
18.10 Sharing of Data with Research Team Members. Data will be shared with research 
team members using Box, AHC Server, Google Forms, and Qualtrics.  
 
18.11 
Storage of Documents. Paper forms of the data will be located in a locked file 
cabinet in D350 Mayo (the PI’s research office) only accessible to the PI, research 
coordinators, and other approved research staff. Unless the data are being filed or 
accessed, these cabinets will remain locked. All electronic data will be maintained on the 
PI’s office computer and the shared project folder. Per University of Minnesota and AHC-
IS data security guidelines, all data on the PI’s computer in D350 Mayo and the research 
coordinators’ computers (located in D351 Mayo) are protected by strong password only 
accessible to the PI, research coordinators, or the Co-Investigators for data analysis 
purposes. 
 
18.12 
Disposal of Documents: The data will be maintained on the PI’s and research 
coordinators’ computers and in the secure project folder for approximately 2-3 years, 
which is the time anticipated it will take to disseminate any and all research papers or 
presentations from these data. Data will be anonymized approximately 3-5 years 
following the completion of this project. 
19 Confidentiality 
 
19.1 Data Security:   
 
All information obtained from the participants will remain strictly confidential and will not be 
released except at the express written request of the study participant. All electronic data will be 
maintained on Dr. Gaugler’s office computer and the shared project folder. Per University of 
Minnesota and the Academic Health Center-Information Systems data security guidelines, all 
data on Dr. Gaugler’s computer in D350 Mayo and the research staff’s computers (located in 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 34 of 48 
Template Revised On: 11/1/2021      
D351 Mayo) are protected by strong password only accessible to Dr. Gaugler or the research 
team. The data will be maintained on Dr. Gaugler’s research team’s computers and on the secure 
project folder for approximately 2-3 years which is the time anticipated it will take to disseminate 
any and all research papers or presentations from these data. Similarly, paper forms of the data 
will be located in a locked file cabinet in D351 Mayo (Dr. Gaugler’s research office suite) only 
accessible to the research team. Unless the data are being filed or accessed, these cabinets will 
remain locked. 
 
With respect to private information entered into the online portal of the eNeighbor 
myHealthsense site, the design of the system includes a structure of permissions with password 
protection to limit access to material so only ADRD caregivers, invited family members or health 
care professionals, the research staff (the PI or research coordinators), and the Director of 
Nursing and Technology can view sensitive information.   
 
All of Dr. Gaugler’s staff are required to use VPN and Remote Desktop Connection to access study 
data stored on the secure server, and to save all study-related data on the same folder; they are 
not to download, view, or save any project-related data on their personal laptops or any mobile 
data storage device. 
 
A copy of the consent form or other research study related documents will not be placed in a 
participant’s medical, employment, or educational records.  
20 Provisions to Monitor the Data to Ensure the Safety of Participants 
20.11 Data Integrity Monitoring.  
Dr. Gaugler (the PI) and the research coordinators will have primary responsibility 
for managing all study data. Research assistants who work under the supervision of 
Dr. Gaugler in the Families and LTC Projects at the University of Minnesota may also 
enter, clean, and assist the PI and research coordinators manage data as appropriate 
during the course of the project.  
 
Data will be derived from surveys/interviews with ADRD caregivers (an online, 
telephone, or mail survey option will be offered to interested caregivers). Additional 
open-ended data will be collected during quarterly CAB meetings and follow-up 
surveys/interviews (the latter if needed). The Principal Investigator (PI) and research 
coordinators will be responsible for all data collection procedures. The Director of 
Nursing and Technology (DNT; Sharon Blume; Kristen Werner) will also generate 
monthly usage reports on eNeighbor system use to facilitate our analysis of process 
of use.  
 
Names and contact information are included in the Registry, and the PI and research 
coordinators will plan on creating a tracking file for the purposes of interview 
reminders and completion of the various data collection procedures. However, it is 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 35 of 48 
Template Revised On: 11/1/2021      
important to note that in the data analysis files, no identifying information will be 
entered or included. 
 
All electronic data will be maintained on the PI’s office computer, research 
coordinators computers, and the shared project folder. Per University of Minnesota 
and AHC-IS data security guidelines, all data on the PI’s and research coordinators’ 
computers in D350/D351 Mayo are protected by strong password only accessible to 
the PI, research coordinator, or the Co-Investigators for data analysis purposes. The 
data will be maintained on the PI’s and research coordinators’ computers and in the 
secure project folder for approximately 2-3 years, which is the time anticipated it 
will take to disseminate any and all research papers or presentations from these 
data. Similarly, paper forms of the data will be located in a locked file cabinet D351 
Mayo (the PI’s research office suite) only accessible to the PI, research coordinators, 
research assistants, and other approved research staff. Unless the data are being 
filed or accessed, these cabinets will remain locked.  
 
Per email communication with David Norman of AHC-IS Server Operations, 8/28/13, 
based on the PI’s inquiry regarding data security of the SoN secure data servers: 
 
“Although we do have some servers running with hardware encryption, the bulk of 
our servers do not have it. The Nursing shared and Nursing User servers are two that 
do not run hardware encryption. With that said, I just want to reassure you that your 
data is safe and secure. I have attached a document that details the AHC-
Information Systems server standards for you to review if you wish.”  
 
“Hardware encryption only beneficial if a physical hard drive is stolen. If you have an 
AHC-IS supported laptop, for example, we require hardware encryption. This is 
prevent someone who may have stolen a laptop from connecting your laptop hard 
drive in to another computer and accessing the data. With servers and server 
storage, this works differently.  
 
“First off, the servers and associated storage are stored in an enterprise class data 
center which is physically restricted and monitored and is not on campus. Second, all 
your data is stored on various large scale storage appliances. Data is written to these 
appliances not to a single hard drive, but across potentially hundreds. If an individual 
were to somehow get one of these hard drives, it would be useless to them. This is 
because they would not be able to access your data because they won’t have 
enough of your data to reconstruct your files because they are written across all 
those drives. 
 
“If you have a IRB or research requirement that requires hardware encryption, we 
do have a few servers running hardware encryption that may be available depending 
on how much storage you need. Please let me know. 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 36 of 48 
Template Revised On: 11/1/2021      
 
Thank you, 
 
Mike Norman 
AHC-IS Server Operations” 
 
20.12 Data Safety Monitoring.  
As this project will pose minimal risks to study participants the Principal 
Investigator (PI), Dr. Gaugler, will serve as the primary monitoring entity of this 
study. The proposed study involves no invasive procedures and there will be no 
physical risks to study participants.   
 
Additional monitoring support will be provided by the Independent Study Monitor 
(ISM), Dr. Ann Garwick, PhD, RN, LP, LMFT, FAAN. Dr. Garwick is Professor, Senior 
Executive Associate Dean for Research, Cora Meidl Siehl Endowed Chair in Nursing 
Research, and Director of Center for Child and Family Health Promotion Research 
in the University of Minnesota School of Nursing. Dr. Garwick has provided data 
monitoring support and oversight to Dr. Gaugler previous 5-year R01 project 
evaluating a comprehensive psychosocial intervention for adult child caregivers of 
persons with dementia (R01 AG022066) as well two projects funded by the Eli Lily 
Company.  
In addition to ongoing review of protocol and human subjects research 
compliance during weekly project meetings with staff (see Project Timeline), the 
PI will generate an annual report starting at the conclusion of Year 2.   
If a caregiver is in crisis because of their care situation or some other reason, Dr. 
Gaugler, with the permission, we will then contact the appropriate resource 
person in an external agency (e.g., the Alzheimer’s Association). Based on the 
research team’s experience working with their caregiving families, we expect no 
or very few such instances to occur. If a member of the research team does 
identify neglect or other potentially inappropriate care practices, the state senior 
abuse hotline will be contacted to protect the rights of persons with dementia 
and their families.  
Annual audit reports. The responsibility of Dr. Gaugler (who also has oversight for 
the data management and analysis of the project) will include the production of 
an audit report that will highlight the results of the audit analysis as well as study 
progress. In addition, Dr. Gaugler will provide information on any deviations from 
the approved protocol (e.g., deviations in adhering to study eligibility criteria), 
error rates, and any other issues related to the progress of the study. The ISM will 
review the audit report to ensure ongoing quality control, and will work with Dr. 
Gaugler, if needed, to ascertain if audited cases deviate from the approved study 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 37 of 48 
Template Revised On: 11/1/2021      
protocol. In instances of adverse events occurring (see below), the ISM, the AHRQ 
project officer, and the University of Minnesota IRB will be notified immediately. 
The audit reports will include the following: 
1. Table of contents 
2. Narrative/trial summary 
a. Summary of main findings 
b. Discussion of issues or problems 
c. Report preparation procedures 
3. Study description 
a. Project organizational chart, personnel 
b. Brief statement of purpose of trial 
c. Projected timetable and schedule 
4. Study administration 
a. Recruitment and participant status 
i. Figure 1: Enrollment by year or month of study 
b. Forms status 
i. Status of forms (e.g., consent, completing of screener, baseline assessment 
battery, etc.) 
 
Reporting Adverse Events and Unanticipated Problems 
In addition to ongoing monitoring of protocol and human subjects compliance and 
reporting and the production of quarterly case audits to the ISM, Dr. Gaugler will 
generate safety reports on an ongoing basis that will list adverse events, serious 
events, unexpected events, events related to or associated with the intervention, 
and the potential causality of the intervention to the event for each participant if 
they occur. Taken from the September 2002 National Institutes of Mental Health 
policy on Data and Safety Monitoring in Clinical Trials and the Guidance on 
Reporting Adverse Events to Institutional Review Board for NIH-Supported 
Multicenter Trials (as suggested in the Policy of the National Institute of Nursing 
Research for Data and Safety Monitoring of Clinical Trials), the definition of each 
event is as follows: 
 
Adverse event. Any untoward medical occurrence in a patient or clinical 
investigation participant which does not necessarily have to have a causal 
relationship with the treatment. An adverse event can therefore be any 
unfavorable and unintended sign (including an abnormal laboratory finding, for 
example), symptom, or disease temporally associated with the use of [an 
intervention], whether or not considered related to the [interventions]. 
Serious adverse event. Any adverse experience that results in any of the following 
outcomes: death, a life threatening experience, inpatient hospitalization, a 
persistent or significant disability/incapacity, or a congenital anomaly/birth defect. 
Important medical events that may not result in death, be life threatening, or 
require hospitalization, may be considered a serious adverse drug experience 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 38 of 48 
Template Revised On: 11/1/2021      
when based upon appropriate medical judgment, they may require medical or 
surgical intervention to prevent one of the outcomes listed in this definition. 
Unexpected. Any adverse experience, the specificity or severity of which is not 
consistent with the risks information described in the [protocol or consent 
documents]. 
Related to (or associated with) the intervention. There is a reasonable possibility 
that the experience may have been caused by the intervention. 
Causality. A reasonable possibility that the product is etiologically related to the 
adverse event. Causality assessment includes, for example, assessment of 
temporal relationships, dechallenge/rechallenge information, association with (or 
lack of association with) underlying disease, presence (or absence) of a more likely 
cause, plausibility, etc.  
 
In the instance of an adverse event, Dr. Gaugler will classify whether the event is 
unexpected, adverse, or seriously adverse, whether the event is unexpected or 
related to the intervention, and what potentially caused the event. Dr. Gaugler will 
review study-related data on an ongoing basis and will alert the ISM, University of 
Minnesota IRB, and the AHRQ program officer as well as AHRQ (via the DSM 
report) if these events occur. Specifically, the PI will utilize an adverse event form 
that will provide detail on the occurrence (who, what, when, where, why if 
relevant) of any adverse, serious adverse, unexpected/unanticipated event and 
whether these events were related to the remote health monitoring technology.  
 
As part of his professional service, the PI serves as editor-in-chief for the Journal of 
Applied Gerontology and sits on an additional three editorial boards of leading 
journals in gerontology. This proximity to cutting-edge research on family 
caregiving interventions, in addition to his regular review of the literature he 
conducts to support his various dissemination efforts, will allow the PI to assess 
developments and issues related to the use of technology tools for ADRD 
caregivers. If these developments reveal any potential threats to participate safety 
or other concerns that require protocol modification, these issues will be 
addressed in the annual DSM reports provided to the ISM and the University of 
Minnesota IRB. 
 
21 Compensation for Research-Related Injury 
21.1.1 Compensation for Research-Related Injury: N/A 
21.1.2 Contract Language: N/A 
22 Consent Process 
22.1 Consent Process (when consent will be obtained):  
Within two weeks following the completion of eligibility screening, consent/assent procedures 
and baseline interviews will be scheduled within 2 weeks for eligible caregivers. Signed informed 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 39 of 48 
Template Revised On: 11/1/2021      
consent from the eligible family caregiver will take place. Signed informed consent will be offered 
in-person, via mail, or if deemed most convenient to the family caregiver, via an online consent 
form. The following IRB approved script will also be administered either in-person or via the 
telephone in instances where a participating caregiver wishes to complete the consent form via 
mail or online. 
 
“We are examining the effectiveness of health monitoring technology for family caregivers of 
persons with memory loss, and we are asking whether you would be interested in helping us with 
this project. We expect that this technology can help feel family caregivers feel more secure and 
confident about their relative’s care, will experience reduced stress, and can help their relative 
stay at home longer.  
 
“We are asking you to sit down with me to first review and sign the consent form and also to 
have your relative complete a brief cognitive screening procedure and then complete verbal 
assent to complete this project. Over the next few days you will be randomly assigned, like the 
flip of a coin to the group that receives the health monitoring technology system for your relative 
or the usual care control group. If you are in the group that receives health monitoring 
technology, we will ask you to work with the Director of Nursing Technology to conduct a visit to 
the home where your relative with memory loss lives to install the health monitoring technology 
and learn how to use it. If you are selected to receive health monitoring technology, I will be 
contacting you monthly to complete some checklists to see how the sensors are working for you 
and your relative, and then at 6-, 12-, and 18-months to complete a survey and some additional 
open-ended questions. Everyone will also be asked to help us complete interviews at 6-, 12-, and 
18-months. For those assigned to the health monitoring group, we may ask you near the end of 
the project to sit down with me for around an hour or so to see how well the health monitoring 
system worked for you or your relative. Also, if you are selected to not receive the health 
monitoring technology, at the end of this project <mention how long until the end of the project> 
we will offer the technology to you for free on a first-come, first-serve basis.   
 
“How does this sound? Is this something you might be interested in helping us out with? <if no, 
then the PI or RC will thank them and end the interview process>” 
 
We will add the following questions to ascertain comprehension of participants: 
 “Explain to me what we are asking you to do as part of this project.” 
 “What are some of the challenges you think will come up if you decide to participate?” 
 “Let’s review how the eNeighbor system works, and then you can ask me questions about 
it.” 
 “Do you have any other questions about your privacy and confidentiality, your rights as a 
research participant, or any other aspect of participation that I can try and help answer?” 
 
If a legally authorized representative (LAR) for the person with ADRD is identified other than the 
family caregiver, we will also obtain signed consent from this individual. For the purposes of 
efficiency, we will offer an online consent form to review and approve. All online consent and 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 40 of 48 
Template Revised On: 11/1/2021      
HIPAA forms will be administered via the secure University of Minnesota Google Docs 
application. 
In addition to administering informed consent forms to family caregivers and LARs, we will 
additionally provide HIPAA forms (either in-person or via mail and online formats) for the family 
caregiver and LAR to review and sign. To complete this procedure, the Family Caregiver Consent 
Form, the LAR Consent Form, and the HIPAA form will be utilized.  
22.2 Waiver or Alteration of Consent Process (when consent will not be obtained, 
required information will not be disclosed, or the research involves deception): N/A 
22.3 Waiver of Written/Signed Documentation of Consent (when written/signed consent 
will not be obtained):  N/A 
22.4 Non-English Speaking Participants:  N/A; only English speaking participants are 
eligible for the study.  
22.5 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 years of 
age):  N/A; participants must be 21 years of age or over. 
22.6 Cognitively Impaired Adults, or adults with fluctuating or diminished capacity to 
consent:  
Persons with memory loss who receive a score of 20 or above on the brief St. Louis 
University Mental Status examination (SLUMS; moderate/mild cognitive 
impairment; possible introductory script, transcribed from 
http://www.youtube.com/watch?v=P32_zvyXTw8), signed verbal assent to continue 
with the research procedures will be collected. If a person with ADRD scores below 
20 on the SLUMS, verbal assent only will be obtained.  
For remote/telephone consent procedures, the Capacity to Consent Form would be 
used; if a person with memory loss scores over 14.5 on this tool, we would ask them 
to complete a person with memory loss (PWML) version of the consent and HIPAA 
forms, guiding them to do so over the telephone. If PWMLs score below 14.5, the 
PWML would complete oral assent to participate. Consent of the family caregiver 
will then take place (note: if the family caregiver is not the power of attorney/legally 
authorized representative of the person with ADRD, then signed consent must be 
obtained from that person as well; if multiple family members of the person with 
ADRD wish to participate in the data collection procedures outlined below they may 
do so, but signed consent is necessary from each participating family caregiver). See 
next section, 22.7, for more details. 
22.7 Adults Unable to Consent: 
22.7.1.1 Permission: Permission is gathered from primary caregivers or LARs.  
22.7.1.2 Assent:  
 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 41 of 48 
Template Revised On: 11/1/2021      
Following the securing of consent of primary caregivers and LARs, Verbal Assent of 
persons with ADRD will take place. While ideally this may take place 
simultaneously with the consent procedures above, there may be a delay in time 
(hopefully no more than several days) between when consent is secured from 
family caregivers and LARs and assent of the person with ADRD. For those 
individuals who receive a score of 20 or above on the brief St. Louis University 
Mental Status examination (SLUMS; moderate/mild cognitive impairment; possible 
introductory script, transcribed from 
http://www.youtube.com/watch?v=P32_zvyXTw8), signed verbal assent to 
continue with the research procedures will be collected. If a person with ADRD 
scores below 20 on the SLUMS, verbal assent only as well as consent of the 
caregiver (and, if necessary, the LAR) will take place. In this circumstance, the PI or 
RCs will print the name of the person with memory loss (PWML), then sign and 
date the assent form. In instances where the person with memory loss (PWML) 
declines the SLUMS, the PI or RC will ask the PWML to sign and date the verbal 
assent form. In some instances, the PWML may wish to sign and date a consent 
form as well as HIPAA form; they may do so if they wish and in such instances this 
will substitute for a signed verbal assent form. If the PWML is absent from the 
consent meeting (e.g., is asleep) or is non-communicative or non-verbal, the PI or 
RCs should not attempt to obtain verbal assent, but instead determine whether 
the PWML is exhibiting behaviors that suggest agitation or disagreement with 
participation (e.g., see Batchelor-Assage et al., 2014 for approach to do so). If this 
is not the case, then consent and HIPAA forms signed by the caregiver/LAR is 
sufficient for enrollment. 
 
Furthermore, we will administer a verbal permission procedure prior to or 
following each 6-month interview/survey (i.e., 6 months, and 12 months) for those 
in the eNeighbor treatment group (unless care recipient passed, moved to a care 
facility, had sensor system removed). The rationale for this approach is that since 
persons with dementia in the control group do not engage in any way with the 
research procedures or researchers themselves following baseline (i.e., family 
caregivers complete all surveys), obtaining this permission at follow-up is likely not 
needed as participants in the control group are essentially participating in a family 
caregiving study. As persons with memory loss in the treatment condition are 
experiencing the installation and operation of the eNeighbor remote monitoring 
system in their homes, ongoing verbal permission is necessary for these individuals 
for the duration of the study follow-up period (i.e., 6 months, and 12 months; 
note: by completion of the 18-month follow-up surveys/interviews the study 
procedures are complete and no further assent is needed). The follow up 
permission procedures consist of an attempted call to the caregiver and/or care 
recipient to ensure their permission for ongoing study involvement (i.e. sensor 
system use). Staff document this ongoing permission obtained on an assent form, 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 42 of 48 
Template Revised On: 11/1/2021      
with the date, but do not read the full form during this follow-up procedure. If a 
participant is unable to reach, staff document this in the tracking system. 
23 Setting 
 
23.1 Research Sites: The research team will conduct research in the D350 Mayo office suite. 
Research procedures will therefore take place in this location unless otherwise specified, such as 
in a participant’s home or over the phone. The Community Advisory Board is described in section 
17 under the “Specific Aim 3 Analysis Plan” heading.  
23.1 International Research: N/A; not applicable  
23.2 Community Based Participatory Research: N/A; not applicable 
24 Multi-Site Research 
N/A; not applicable 
25 Coordinating Center Research 
N/A; not applicable 
26 Resources Available 
26.1 Resources Available:  
The Principal Investigator (PI), Joseph E. Gaugler, PhD, has a long track-record of 
conducting research on the longitudinal ramifications of dementia caregiving and 
designing, implementing, and evaluating randomized controlled evaluations of ADRD 
caregiver interventions (see attached Biosketch). He is serving or has served as PI on 
multiple AHRQ, National Institutes of Health (NIH), and Alzheimer’s Association (AA) grant 
projects addressing these issues in the past decade (NIH: K02 AG029480R01, R01 
AG022066, R21 AG026525, R03 AG20786, R03 CA099515; AA: NIRG-00-2249, IIRG-02-
3567; R01 HS013181). He has built on these well-established research foci to apply 
everyday technologies to assist family and formal caregivers assist persons with dementia 
(AHRQ: R03 HS020948; R43 NR010642 as Co-Investigator; R44 AG023451-02 as 
Consultant). As part of his current 5-year K02 project (AG029480) Dr. Gaugler has spent 
the last 5 years obtaining expertise in mixed methods research and is the founder and 
director of the Mixed Methods Interdisciplinary Graduate Group at the University of 
Minnesota.64 As part of his academic appointment in The School of Public Health, Dr. 
Gaugler will have the necessary time to devote to the proposed project. The teaching load 
is flexible and based on external support for Dr. Gaugler’s research time. Service 
expectations include standard membership on School of Public Health and university 
committees. Due to the advantageous research environment provided by The School of 
Public Health, Dr. Gaugler can devote up to 95% of his time to research projects and he 
will have the necessary effort available to make the current project a success.  
Dr. Gaugler’s secure suite in the Mayo Building includes his own office, three other 
connected office spaces, a meeting room, and a file area that house nine of his research 
team members (e.g., two research coordinators, five graduate research assistants, and 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 43 of 48 
Template Revised On: 11/1/2021      
two additional research assistants). Dr. Gaugler’s office suites are equipped with secure 
computers (including the necessary statistical software), two printers (including one 
color), web cameras, telephone access, and ample secure file space to conduct the 
proposed study. The computers have LAN access. Dr. Gaugler’s suite is a private location 
to conduct research participant interviews when needed as well as collect and manage 
any related human subjects research data. 
 
Kathleen Buckwalter, PhD, RN, FAAN, Consultant, is recognized internationally for her 
research in geropsychiatric nursing, particularly interventions for behavioral and 
psychological symptoms in persons with dementia and their formal (long-term care staff) 
and family caregivers (R01 NR03234, NIA/Rural Aging Center; Administration on Aging, 
NIMH; Alzheimer’s Association, Division of Nursing, DHHS; NINR F33 award, all as PI). Her 
extensive expertise will facilitate the dissemination of the evaluation results to 
appropriate scientific and clinical venues.  
Bonnie Westra, PhD, RN, FAAN, FACMI (Co-Investigator) will provide health informatics 
expertise in the effective delivery, use, and evaluation of eNeighbor. She is a member of 
the Minnesota e-Health Advisory Board, the American Medical Informatics Association 
Board, and co-chairs the Alliance for Nursing Informatics. She will assist the research team 
in addressing facilitators and barriers to installation, utilization, and evaluation of the 
eNeighbor.  
 
The Lutheran Home Association (TLHA) of Belle Plaine, MN has utilized the eNeighbor 
wellness and communication monitoring system within congregate, independent living, 
and home settings throughout Minnesota and Wisconsin for over five years. The Director 
of Nursing and Technology of TLHA, Melissa Mewes, has begun to establish experience in 
providing nursing care management and technical oversight of the eNeighbor in TLHA’s 
residential and community settings. TLHA will collaborate with the research team to 
purchase, install, and implement eNeighbor for the purposes of the proposed evaluation 
(see Letters of Support).  
 
The research team also includes George Demiris, PhD, FACMI, Consultant, who lends 
extensive expertise in health informatics and information technology in chronic disease. 
Dr. Demiris is currently the PI of an NINR R01 project (NR012213) that will test 
interventions for family caregivers of hospice patients that are delivered through tele-
health. His expertise in these “smart home” applications will directly facilitate the 
implementation, evaluation, and analysis of how and why eNeighbor benefits persons 
with ADRD and their family caregivers.  
 
 
27 References 
 
1. Alzheimer's Association. 2013 alzheimer's disease facts and figures. Alzheimers Dement. 
2013;9(2):208-245. doi: 10.1016/j.jalz.2013.02.003; 10.1016/j.jalz.2013.02.003. 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 44 of 48 
Template Revised On: 11/1/2021      
2. Gaugler JE, Kane RL, Kane RA. Family care for older adults with disabilities: Toward more 
targeted and interpretable research. Int J Aging Hum Dev. 2002;54(3):205-231. 
3. Schulz R, Quittner AL. Caregiving through the life-span: Overview and future directions. Health 
Pscyhol. 1998;17:107-111. 
4. Liu W, Gallagher-Thompson D. Impact of dementia caregiving: Risks, strains, and growth. In: 
Qualls SH, Zarit SH, eds. Aging families and caregiving. Hoboken, NJ: John Wiley & Sons, Inc.; 
2009:85-112. 
5. Vitaliano PP, Zhang J, Scanlan JM. Is caregiving hazardous to one's physical health? A meta-
analysis. Psychological Bulletin. 2003;129:946-972. 
6. Schulz R, Beach SR. Caregiving as a risk factor for mortality: The caregiver health effects study. 
JAMA. 1999;282:2215-2260. 
7. Kiecolt-Glaser JK, Glaser R, Gravenstein S, Malarkey WB, Sheridan J. Chronic stress alters the 
immune response to influenza virus vaccine in older adults. Proc Natl Acad Sci U S A. 
1996;93(7):3043-3047. 
8. Sorensen S, Duberstein P, Gill D, Pinquart M. Dementia care: Mental health effects, 
intervention strategies, and clinical implications. Lancet Neurol. 2006;5(11):961-973. 
9. Pinquart M, Sorensen S. Associations of stressors and uplifts of caregiving with caregiver 
burden and depressive mood: A meta-analysis. J Gerontol B Psychol Sci Soc Sci. 2003;58(2):P112-
28. 
10. Logsdon RG, McCurry SM, Teri L. Evidence-based psychological treatments for disruptive 
behaviors in individuals with dementia. Psychol Aging. 2007;22(1):28-36. 
11. Logsdon RG. Dementia: Psychosocial interventions for family caregivers. Lancet. 
2008;372(9634):182-183. 
12. Zarit SH. Empirically supported treatment for family caregivers. In: Qualls SH, Zarit SH, eds. 
Aging families and caregiving. Hoboken, NJ: John Wiley & Sons, Inc.; 2009:131-154. 
13. Demiris G, Hensel BK, Skubic M, Rantz M. Senior residents' perceived need of and preferences 
for "smart home" sensor technologies. Int J Technol Assess Health Care. 2008;24(1):120-124. doi: 
10.1017/S0266462307080154. 
14. Kinney J, Cart K, Reddecliff L. Assessing the impact of an internet-bnased monitoring system 
on caergiver values. . 2012. 
15. Kinney JM, Kart CS, Murdoch LD, Conley C. Striving to provide safety assistance for families of 
elders: The SAFE house project. Dementia: The International Journal of Social Research and 
Practice. 2004;3(3):351-370. 
16. Kinney JM, Kart CS, Murdoch LD, Ziemba TF. Challenges in caregiving and creative solutions: 
Using technology to facilitate caring for a relative with dementia. Ageing International. 
2003;28(3):295-314. 
17. Rosenberg L, Kottorp A, Nygard L. Readiness for technolocy use with people with dementia: 
The perspective of significant others. Journal of Applied Gerontology. 2012;31(4):510-530. 
18. Barrett LL. Healthy@Home. . 2008. 
19. Demiris G, Hensel BK. Technologies for an aging society: A systematic review of "smart home" 
applications. Yearb Med Inform. 2008:33-40. 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 45 of 48 
Template Revised On: 11/1/2021      
20. Rantz MJ, Skubic M, Koopman RJ, et al. Automated technology to speed recognition of signs 
of illness in older adults. J Gerontol Nurs. 2012;38(4):18-23. doi: 10.3928/00989134-20120307-01; 
10.3928/00989134-20120307-01. 
21. Gaugler JE. Promoting family involvement in long-term care settings: A guide to programs that 
work. Baltimore, MD: Health Professions Press; 2005. 
22. Brodaty H, Donkin M. Family caregivers of people with dementia. Dialogues in Clinical 
Neuroscience. 2009;11(2):217-228.  
23. Landau R, Auslander GK, Werner S, Shoval N, Heinik J. Families' and professional caregivers' 
views of using advanced technology to track people with dementia. Qual Health Res. 
2010;20(3):409-419. doi: 10.1177/1049732309359171. 
24. Dang S, Remon N, Harris J, et al. Care coordination assisted by technology for multiethnic 
caregivers of persons with dementia: A pilot clinical demonstration project on caregiver burden 
and depression. J Telemed Telecare. 2008;14(8):443-447. doi: 10.1258/jtt.2008.080608. 
25. Rentz M, Hoene AV. Online coaching for caregivers: Using technology to provide support and 
information. Alzheimers Care Today. 2010;11:206-209. 
26. Finkel S, Czaja SJ, Schulz R, Martinovich Z, Harris C, Pezzuto D. E-care: A telecommunications 
technology intervention for family caregivers of dementia patients. Am J Geriatr Psychiatry. 
2007;15(5):443-448. doi: 10.1097/JGP.0b013e3180437d87. 
27. Czaja SJ, Rubert MP. Telecommunications technology as an aid to family caregivers of persons 
with dementia. Psychosom Med. 2002;64(3):469-476. 
28. Marziali E, Garcia LJ. Dementia caregivers' responses to 2 internet-based intervention 
programs. Am J Alzheimers Dis Other Demen. 2011;26(1):36-43. doi: 
10.1177/1533317510387586. 
29. Gallagher-Thompson D, Wang PC, Liu W, et al. Effectiveness of a psychoeducational skill 
training DVD program to reduce stress in chinese american dementia caregivers: Results of a 
preliminary study. Aging Ment Health. 2010;14(3):263-273. doi: 10.1080/13607860903420989. 
30. Benefield LE, Beck C. Reducing the distance in distance-caregiving by technology innovation. 
Clin Interv Aging. 2007;2(2):267-272. 
31. Bank AL, Arguelles S, Rubert M, Eisdorfer C, Czaja SJ. The value of telephone support groups 
among ethnically diverse caregivers of persons with dementia. Gerontologist. 2006;46(1):134-
138. 
32. Wiet SG. Future of caring for an aging population: Trends, technology, and caregiving. Stud 
Health Technol Inform. 2005;118:220-230. 
33. Magnusson L, Hanson E, Nolan M. Assisting carers using the ACTION model for working with 
family carers. Br J Nurs. 2002;11(11):759-763. 
34. Powell J, Chiu T, Eysenbach G. A systematic review of networked technologies supporting 
carers of people with dementia. J Telemed Telecare. 2008;14(3):154-156. doi: 
10.1258/jtt.2008.003018. 
35. Topo P. Technology studies to meet the needs of people with dementia and their caregivers. 
Journal of Applied Gerontology. 2009;28(1):5-37. doi: 10.1177/0733464808324019. 
36. Olsson A, Engström M, Skovdahl K, Lampic C. My, your and our needs for safety and security: 
Relatives? reflections on using information and communication technology in dementia care. 
Scand J Caring Sci. 2012;26(1):104-112. doi: 10.1111/j.1471-6712.2011.00916.x. 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 46 of 48 
Template Revised On: 11/1/2021      
37. Gaugler JE, Kane RL, Kane RA, Newcomer R. The longitudinal effects of early behavior 
problems in the dementia caregiving career. Psychol Aging. 2005;20(1):100-116. 
38. Schulz R. Chronic stress exposure in the elderly: The health effects of caregiving. . 2003. 
39. Kane RL. The chronic disease crisis<br />. . 2008. 
40. Wagner EH, Austin BT, Von Korff M. Organizing care for patients with chronic illness. Milbank 
Q. 1996;74(4):511-544. 
41. Henly SJ, Wyman JF, Gaugler JE. Health trajectory research: A call to action for nursing 
science. Nurs Res. 2011;60(3 Suppl):S79-82. doi: 10.1097/NNR.0b013e31821cc240. 
42. Henly SJ. Lost in time: The person in nursing research. Nurs Res. 2007;56(3):147. 
43. Blechman E. Personal health records for older adults with chronic conditions and their 
informal caregivers. In: Qualls SH, Zarit SH, eds. Aging families and caregiving. Hoboken, NJ: John 
Wiley & Sons, Inc.; 2009:287-310. 
44. Archer N, Fevrier-Thomas U, Lokker C, McKibbon KA, Straus SE. Personal health records: A 
scoping review. J Am Med Inform Assoc. 2011;18(4):515-522. doi: 10.1136/amiajnl-2011-000105. 
45. Tobacman JK, Kissinger P, Wells M, et al. Implementation of personal health records by case 
managers in a VAMC general medicine clinic. Patient Educ Couns. 2004;54(1):27-33. doi: 
10.1016/S0738-3991(03)00184-8. 
46. Leveille SG, Huang A, Tsai SB, Allen M, Weingart SN, Iezzoni LI. Health coaching via an internet 
portal for primary care patients with chronic conditions: A randomized controlled trial. Med Care. 
2009;47(1):41-47. doi: 10.1097/MLR.0b013e3181844dd0. 
47. Bourgeois FT, Simons WW, Olson K, Brownstein JS, Mandl KD. Evaluation of influenza 
prevention in the workplace using a personally controlled health record: Randomized controlled 
trial. J Med Internet Res. 2008;10(1):e5. doi: 10.2196/jmir.984. 
48. Finkelstein J, Knight A, Marinopoulos S, et al. Enabling patient-centered care through health 
information technology. . 2012;Evidence Reports/Technology Assessments, No. 206. 
49. Mittelman MS, Haley WE, Clay OJ, Roth DL. Improving caregiver well-being delays nursing 
home placement of patients with alzheimer's disease. Neurology. 2006;67(9):1592-1599. 
50. Mittelman, M.S., Roth, D.L., Haley, W.E. & Zarit,S.H. Effects of a caregiver intervention on 
negative caregiver appraisals of behavior problems in patients with alzheimer's disease: Results 
of a randomized trial. Journals of Gerontology, Psychological Sciences. 2004;59B:P27-P34. 
51. Mittelman, M. S., Epstein, C., & Pierzchala,A. Counseling the alzheimer's caregiver: A resource 
for health care professionals. Chicago: AMA Press; 2003. 
52. Pearlin LI, Mullan JT, Semple SJ, Skaff MM. Caregiving and the stress process: An overview of 
concepts and their measures. Gerontologist. 1990;30:583-594. 
53. Aneshensel CS, Pearlin LI, Mullan JT, Zarit SH, Whitlatch CJ.  profiles in caregiving: The 
unexpected career. San Diego: Academic Press; 1995. 
54. Whitlatch CJ, Schur D, Noelker LS, Ejaz FK, Looman WJ. The stress process of family caregiving 
in institutional settings. Gerontologist. 2001;41:462-473. 
55. Hilgeman MM, Durkin DW, Sun F, et al. Testing a theoretical model of the stress process in 
alzheimer's caregivers with race as a moderator. Gerontologist. 2009;49(2):248-261. doi: 
10.1093/geront/gnp015. 
56. Jimison H, Gorman P, Woods S, et al. Barriers and drivers of health information technology 
use for the elderly, chronically ill, and underserved. 2008;09-E004. 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 47 of 48 
Template Revised On: 11/1/2021      
57. Creswell JW, Plano Clark VL. Designing and conducting mixed methods research. 2nd ed. 
Thousand Oaks, CA: SAGE Publications, Inc.; 2010. 
58. Tashakkori A, Teddlie C, eds. Mixed methods in social & behavioral research. 2nd ed. 
Thousand Oaks, CA: SAGE Publications, Inc.; 2010. 
59. Hanson WE, Creswell JW, Plano Clark VL, Petska KS, Creswell JD. Mixed methods research 
designs in counseling psychology. J Couns Psychol. 2005;52(2):224-235. 
60. Creswell JW, Fetters MD, Plano Clark VL, Morales A. Mixed methods intervention trials. In: 
Andrew S, Halcomb E, eds. Mixed methods research for nursing and the health sciences. 
Chichester, UK: Wiley-Blackwell; 2009:159-180. 
61. Victor CR, Ross F, Axford J. Capturing lay perspectives in a randomized control trial of a health 
promotion intervention for people with osteoarthritis of the knee. J Eval Clin Pract. 
2004;10(1):63-70. 
62. Evans A, Harraf F, Donaldson N, Kalra L. Randomized controlled study of stroke unit care 
versus stroke team care in different stroke subtypes. Stroke. 2002;33(2):449-455.  
63. Evans L, Hardy L. Injury rehabilitation: A goal-setting intervention study. Res Q Exerc Sport. 
2002;73(3):310-319. 
64. The University of Minnesota Graduate School. Mixed methods. 
http://www.grad.umn.edu/projects-priorities/idinitiatives/groups/mixedmethods/index.html. 
Updated 2012. Accessed May 15th, 2013. 
65. Healthsense I. Reports and white papers. 
http://www.healthsense.com/index.php/company/reference-materials. Accessed May 1st, 2012. 
66. Wolfe W. Families of frail seniors call sensors a godsend. Minneapolis StarTribune. 2012. 
Available from: http://www.startribune.com/lifestyle/health/147523215.html. 
67. Viswanathan M, Ammerman A, Eng E, et al. Community-based participatory research: 
Assessing the evidence. Evid Rep Technol Assess (Summ). 2004;(99)(99):1-8. 
68. Raudenbush SW, Spybrook J, Liu X, Congdon R. Optimal design for longitudinal and multilevel 
research: Documentation for the "optimal design" software. . Chicago, IL.: Scientific Software 
International; 2004. 
69. Cohen J. Statistical power analysis for the behavioral sciences. San Diego, CA: Academic Press; 
1988. 
70. Teddlie C, Yu F. Mixed methods sampling: A typology with examples. Journal of Mixed 
Methods Research. 2007;1(1):77-100. 
71. Collins KMT, Onwuegbuzie AJ, Jiao QG. A mixed methods investigation of mixed methods 
sampling designs in social and health science research. Journal of Mixed Methods Research. 
2007;1(3):267-294. 
72. Bryk, T., & Raudenbush,S. Hierarchical linear models: Applications and data analysis methods. 
Newbury Park, CA: Sage Publications; 1992. 
73. Rogosa DR. Myths and methods: Myths about longitudinal research plus supplemental 
questions. In: Gottman JM, ed. The analysis of change. Mahwah, New Jersey: Lawrence Erlbaum 
Associates; 1996:3-66. 
74. Raudenbush SW, Bryk AS.  hierarchical linear models: Application and data analysis methods. 
2nd ed. Sage Publications; 2002. 

SOCIAL PROTOCOL (HRP-580) 
 
VERSION DATE: 9/11/23 
PROTOCOL TITLE: A Proactive Health Monitoring Intervention for Dementia Caregivers: The 
eNeighbor  
 
       
 
Page 48 of 48 
Template Revised On: 11/1/2021      
75. Singer JD, Willett JB. Applied longitudinal data analysis: Modeling change and event 
occurrence.. New York, New York: Oxford University Press; 2003. 
76. IBM Corporation. IBM SPSS statistics for windows. . 2012. 
77. Hébert R, Bravo G, Préville M. Reliability, validity and reference values of the zarit burden 
interview for assessing informal caregivers of community-dwelling older persons with dementia. 
Can J Aging. 2000;19:494-507. 
78. Watson LC, Pignone MP. Screening accuracy for late-life depression in primary care: A 
systematic review. J Fam Pract. 2003;52(12):956-964. 
79. Strauss A, Corbin J. Basics of qualitative research: Techniques and procedures for developing 
grounded theory. Thousand Oaks, CA: SAGE Publications, Inc.; 1998. 
80. Morse JM, Niehaus L. Mixed method design: Principle and procedures (developing qualitative 
inquiry). Walnut Creek, CA: Left Coast Press; 2009. 
81. Morse JM, Field PA. Qualitative research methods for health professionals. Thousand Oaks, 
CA: SAGE Publications; 1995.