Technology Intervention to Support Caregiving for Alzheimer's Disease (I-CARE)
Phase: NA
Conditions: Dementia, Alzheimer Type
Sponsor: Indiana University

Technology IntervenƟon to Support Caregiving for Alzheimer's Disease (I-CARE) 
 
NCT03119259 
 
 
 
 
 
 
 
 
 
 
 
 
 
June 23, 2020 
 

AbbreviaƟons  
ABC: Aging brain care 
ADRD: Alzheimer’s disease and related demenƟas 
BCN: Brain CareNotes 
BPSD: Behavioral and Psychological Symptoms of DemenƟa 
HIPAA: Health Insurance Portability and Accountability Act 
IRB: InsƟtuƟonal Review Board 
IU: Indiana University 
HABC Monitor: Healthy Aging Brain Care Monitor 
RA: Research assistant 
RC: Research coordinator 
REDCap: Research Electronic Data Capture 
SUS: System Usability Scale 
 
 

Background  
Caring for someone with Alzheimer’s disease and related demenƟas (ADRD) is associated with 
higher rates of psychological morbidity and burden, social isolaƟon, ﬁnancial hardship, and 
deterioraƟon of physical health [1]. Much care is administered by informal caregivers, who are 
family or friends who provide regular care outside of a formal professional role to those people 
who unable to funcƟon independently [2]. In 2019, 16.3 million informal caregivers provided 
18.6 billion hours of unpaid care to the 5.8 million Americans living with ADRD [3]. This care has 
been valued at a naƟonwide contribuƟon of $244 billion [3]. Informal caregivers of paƟents with 
ADRD manage a complex spectrum of paƟents’ behavioral and psychological symptoms related 
to demenƟa (BPSD); BPSD are major contribuƟng factors to caregivers’ burden and adverse 
health outcomes [2, 4]. Excessive caregiver burden leads to higher unplanned hospitalizaƟon 
rates and poorer quality of life [5, 6]. The NaƟonal Alzheimer’s Project Act recognizes the need 
for intervenƟons that “enable family caregivers to conƟnue to provide care while maintaining 
their own health and well-being.” [7] A variety of intervenƟons have been shown to be eﬀecƟve 
in reducing both BPSD symptoms and caregiver burden [8–10]. However, with the threefold 
increase of the number of Americans living with ADRD projected for 2050, an eﬀecƟve 
intervenƟon would also need to be easily scalable if it were to meaningfully address these 
problems [11].  
Mobile health and telehealth technologies oﬀer a means of addressing these issues [12]. 
Internet-based technologies have been shown to be an eﬀecƟve means of intervenƟon for older 
adults in general [13]. Although a recent systemaƟc review suggests potenƟal beneﬁts of mobile 
applicaƟons for persons with cogniƟve impairment, telehealth applicaƟons, which connect 
paƟents and informal caregivers to healthcare professionals, were rarely studied in these 
populaƟons, especially among persons with ADRD and their informal caregivers [14]. However, 
factors such as age, educaƟon, and cogniƟve impairment can make uƟlizing this approach less 
eﬀecƟve, thus highlighƟng the need for eﬀecƟve design and careful tesƟng for usability, 
acceptability, and actual use [15–17].  
Methods  
Study design  
This is a randomized controlled pilot trial of 60 ADRD paƟent-caregiver dyads to test the 
feasibility and esƟmate the potenƟal eﬀect on caregiver burden and BPSD of the mobile 
telehealth technology Brain CareNotes (BCN). ParƟcipants will be recruited from two health 
systems and randomly assigned to either the BCN intervenƟon arm or usual care comparator. 
Study parƟcipaƟon will last for 6 months.  
The primary goal of this trial is to test the feasibility outcomes of: (a) recruitment rate, (b) 
data compleƟon, (c) BCN usability, (d) BCN acceptance, and (e) BCN use, assessed either on an 
ongoing basis or at 3- and 6- month post-intervenƟon. Secondarily, the trial will esƟmate the 
intervenƟon’s eﬀect on outcomes of caregiver burden and paƟent BPSD at 3 and 6 months, 
assessed by the Neuropsychiatric Inventory.  

The target sample was chosen to mirror a dyad-per research-staﬀ enrollment rate over the 
course of the trial comparable to what would be needed for a larger trial powered to detect 
intervenƟon eﬀects on caregiver and paƟent outcomes. This sample size of 60 dyads was judged 
to produce adequately precise conﬁdence intervals around esƟmates of the feasibility outcomes 
[18]. With this sample size, there is also 80% power to detect a large eﬀect size on caregiver and 
paƟent outcomes of 0.75 standard deviaƟons between the two groups.  
 
Seƫng and parƟcipants  
This study has a planned enrollment of 60 paƟent caregiver dyads. There will be a recruitment 
of 30 dyads in the intervenƟon arm and 30 dyads in the usual care comparator. Dyads will be 
recruited from two health systems in Indiana, USA: (1) geriatric clinics specializing in paƟents 
with cogniƟve impairment at Eskenazi Health, a safety net public healthcare system serving 
Indianapolis, Indiana; and (2) primary care clinics at Indiana University (IU) Health, a nonproﬁt 
academic healthcare system. All dyads contain both a paƟent with a diagnosis of ADRD and an 
informal caregiver who manages their care. PaƟents with ADRD and their caregivers are key 
intervenƟon targets because they are at high risk of BPSD- and BPSD-related adverse eﬀects on 
caregivers, respecƟvely. BPSD in this populaƟon are a top contributor to hospitalizaƟon, nursing 
home placement, and new disease or disability.  
 
DescripƟon of intervenƟon  
The primary intervenƟon of this study is the delivery of the BCN mobile telehealth applicaƟon 
(app), a mobile app for informal caregivers of paƟents with ADRD. BCN delivers 24/7 
psychoeducaƟon and caregiver support. In addiƟon, there are caregiver-reported assessment of 
paƟent BPSD and tools for self-management and caregiver-clinician communicaƟon. BCN 
provides 24/7 access to informaƟon on caregiving delivered through “bite-sized” CareNotes, 
which convert evidence-based best pracƟces into simple, single sentences oﬀering pracƟcal 
advice. For example, advice for everyday care during mealƟme is to “Oﬀer regular drinks to 
avoid dehydraƟon.” Personal, relatable stories are used to anchor informaƟon modules and 
show how caregiving challenges are universal across cultures. These stories were prepared by 
demenƟa care professionals based on past experiences with actual paƟents. BCN provides 
paƟent and caregiver self-assessment tools in the form of the Healthy Aging Brain Care (HABC) 
Monitor, a clinically validated test of caregiver percepƟons of cogniƟve, funcƟonal, and 
behavioral symptoms and caregiver distress [19]. This assessment is delivered through the 
mobile app and securely communicates the results to pracƟcing clinicians. The results of 
completed assessments are available in real Ɵme to clinicians, who presently receive daily alerts 
indicaƟng new completed assessments and are expected to review and document all new 
assessments. The results of these assessments are used to personalize the CareNote advice 
cards given to the caregiver. In this regard, the recommended CareNote advice cards presented 
to a user are algorithmically selected based on individual item scores on the assessment. 
Caregivers are also given the ability to browse, save, edit, and arrange recommended advice 

cards. Lastly, the app oﬀers a secure messaging system that connects caregivers and clinicians. 
The messaging is available 24/7 to both parƟes, although clinicians are expected to use the 
messaging during work hours. In the present delivery of the intervenƟon, community health 
workers with training in coaching caregivers of persons with demenƟa on behavioral symptom 
management receive a daily morning email informing them whether new messages have been 
received, with the expectaƟon they will check for and respond to messages throughout the day. 
Regardless of who iniƟates the messaging, the responsible clinician communicates with 
caregiver users through the BCN secure messaging system. When a user completes a BPSD self-
assessment via the BCN app, this is treated as an assessment comparable to phone or in-person 
assessment by a clinician and can therefore be used in place of those. However, the use of BCN 
does not replace other services or visits for purposes other than BPSD assessment.  
Caregivers in dyads randomized to BCN will receive a HIPAA compliant BCN applicaƟon link 
to download the mobile app to their personal mobile device if the device meets minimum 
technical requirements. If the caregiver does not have a mobile device meeƟng minimum 
requirements, a smartphone device with unlimited network data plan from AT&T and the BCN 
app installed will be provided by research staﬀ for the duraƟon of the study.  
A research assistant (RA) will orient parƟcipants to the device, provide training on the BCN 
soŌware, and troubleshoot technical issues in person or remotely. ParƟcipants will receive 
technical support by phone or electronically by members of the study team, during work hours. 
They will also be provided paper and in-app help manuals. Hardware, soŌware, and 
connecƟvity checkups will be provided by study research personnel as needed. 
DescripƟon of usual care comparator  
All paƟents and informal caregivers in both the intervenƟon and usual care arms will receive 
usual primary care provided by Eskenazi Health or IU Health. AddiƟonally, usual care for 
paƟents with ADRD at Eskenazi Health includes care in the Aging Brain Care (ABC) clinical 
program, delivered by an interdisciplinary team including experƟse in geriatric medicine, social 
work, and nursing, led by a care coordinator according to an individualized care plan.  
Inclusion/exclusion criteria  
ParƟcipant eligibility criteria are the paƟent has received a diagnosis of possible or probable 
Alzheimer’s disease or related demenƟa from a physician at Eskenazi Health or IU Health, the 
caregiver is at least 18 years of age and does not have a visual impairment signiﬁcant enough to 
interfere with their ability to use BCN, both paƟent and caregiver are community-dwelling in 
central Indiana, and both paƟent and caregiver are willing to parƟcipate according to the study 
protocol. Exclusion criteria are the paƟent or their informal caregiver does not have the ability 
to communicate in English. 
Recruitment and retenƟon  
ParƟcipants will be recruited from two large healthcare delivery systems in Indiana. Dyads will 
be screened using the inclusion/exclusion criteria listed above by a RC or RA, using each 

system’s respecƟve electronic health records system. Eligible dyads will be called by RAs and RCs 
to see if they are interested in study parƟcipaƟon. To minimize the burden of study 
parƟcipaƟon, subjects will receive the opƟon of remote data collecƟon by phone and data 
collecƟon at a locaƟon convenient to the parƟcipants, the default for the later being the 
paƟent’s home. Research staﬀ will be in regular contact with parƟcipants to maintain 
engagement.  
Due to variaƟon between usual care in the two healthcare systems, study site will be 
recorded as an indicator to include as a covariate in analyses.  
A challenge to the success of the proposed study is achieving adequate enrollment and 
retenƟon. Enrolling older adults including persons with ADRD is uniquely challenging and 
retenƟon is complicated by an approximate 8% annual atriƟon due to death alone. This study 
will also require enrolling two individuals per dyad, who must consent to a 6-month study 
period and three assessments.  
Ethics and informed consent  
This trial was approved by the Indiana University InsƟtuƟonal Review Board (IRB# 1606267154) 
and is registered on ClinicalTrials.gov (NCT03119259). Both health systems approved the studies 
through their internal approval system. The two health systems do not have independent IRBs 
and instead have an arrangement with the university IRB for their studies. Informed consent will 
be obtained from the paƟent or legally authorized representaƟve and separately from the 
caregiver by a trained RA or RC. Individuals will receive verbal and writen informaƟon about 
consent and HIPAA authorizaƟon, including answers to all their quesƟons and a copy of the 
documents. Each individual or their surrogate must provide verbal or writen documented 
consent and HIPAA authorizaƟon to parƟcipate. Consent by proxy will be used for a paƟent if 
any of the following three condiƟons is met:  
1.  The paƟent has an MMSE score = 17  
2.  The paƟent is unable to answer any of the following 4 quesƟons correctly:  
a.  What do you understand is wrong with your brain health right now?  
b.  Can you please explain in your own words the choices I have presented to you?  
c.  If you decide to parƟcipate in this study, what good things might happen and what 
harm might occur? 
d.  Can you please explain how you decided to parƟcipate (or not parƟcipate) in this 
study?  
3.  The paƟent’s provider states that the paƟent does not have the capacity to consent to 
parƟcipaƟon in the study based upon the provider’s knowledge of the paƟent. 
 
When consent by proxy is used, research personnel will also seek the assent of the paƟent.  
 
Risks of trial parƟcipaƟon are expected to be minimal and rare. ParƟcipants or their 
surrogates can choose to withdraw from the study at any Ɵme, for any reason. All research 

personnel are IRB-approved and appropriately trained on conﬁdenƟality and enrollment 
procedures. Eligible and enrolled parƟcipants’ data will be collected, shared, and maintained in 
accordance with the IU IRB and HIPAA guidelines. Only IRB-approved study team members will 
have access to the collected data. In addiƟon, all consented parƟcipants will be assigned a 
unique study idenƟﬁer upon enrollment. The data will be stored in a secure Research Electronic 
Data Capture (REDCap) database on a password-protected IU server. REDCap was speciﬁcally 
developed around HIPAA security guidelines. 
 
RandomizaƟon  
This randomized controlled pilot trial uƟlizes a randomizaƟon block to sort subjects into the BCN 
intervenƟon or usual care comparator group in a 1:1 manner. The randomizaƟon blocks were 
created by the PI, approved by an independent biostaƟsƟcs faculty member, and loaded in 
REDCap by the team biostaƟsƟcian. Masking/blinding to randomizaƟon was not implemented.  
 
Assessments and outcomes  
Assessments will be performed at baseline pre-randomizaƟon and at 3- and 6-month follow-ups 
post-randomizaƟon.  The caregiver is contacted by phone to schedule each appointment. The 
feasibility outcomes assessed are (a) recruitment rate, (b) data compleƟon, (c) BCN usability, (d) 
BCN acceptance, and (e) BCN use. The outcomes measured to esƟmate potenƟal eﬀect sizes of 
the intervenƟon are caregiver burden and paƟent BPSD. Assessments will be performed by 
appointment on the phone or in person. ParƟcipants will receive $25 per assessment and up to 
$75 in total for the enƟre project.  
Recruitment rate and data compleƟon will be collected via Ɵmestamped research records in 
REDCap on an ongoing basis throughout the duraƟon of the trial. Recruitment rate will be 
collected conƟnually via Ɵmestamped research records in REDCap and computed at the end of 
the accrual period by calculaƟng # approached, # agreeing, # consenƟng, and # consenƟng/# 
approached. We will also calculate the monthly rate. Data compleƟon will be collected 
conƟnually in the REDCap study database and computed aŌer the ﬁnal assessment by 
calculaƟng # of complete assessments per consenƟng parƟcipant/total possible assessments. 
We will separately compute missing data and atriƟon for all causes vs. death in the intervenƟon 
vs. control groups. A data manager will assist in feasibility data capture and reporƟng.  
BCN usability will be assessed in the BCN intervenƟon group at 3 and 6 months by the 
Simpliﬁed System Usability Scale (SUS) [20], a 10-item quesƟonnaire administered to caregivers. 
The Simpliﬁed SUS contains statements about usability (e.g., “Learning to use Brain CareNotes 
was quick for me”) answered on a 5-point response scale (strongly disagree to strongly agree) 
and is modiﬁed from the original validated SUS [21]. BCN acceptance will be assessed in the 
BCN intervenƟon group at 3 and 6 months as the mean score on the Behavioral IntenƟon 
QuesƟonnaire administered to caregivers. It is a 4-item quesƟonnaire and uses a 7-point 
response scale from 0 (not at all) to 6 (a great deal) [22, 23]. Behavioral intenƟon is the 
accepted measure of technology acceptance. BCN use will be collected conƟnually from 
captured server acƟvity for log-in, survey iniƟaƟon, survey compleƟon, use of CareNotes advice 

cards, and messages sent and received. We will compute daily, weekly, and monthly use rates 
for each use type and for any use at 3 and 6 months.  
The Neuropsychiatric Inventory (NPI) will be administered to caregivers, measuring 
caregiver-reported paƟent behavior and obstacles to caregiving [24]. Informal caregiver burden 
will be assessed by calculaƟng the NPI Caregiver Distress Score (possible range from 0 to 60) 
from the NPI assessed at baseline, 3 months, and 6 months. PaƟent BPSD will be assessed by 
calculaƟng the NPI total score (possible range from 0 to 144) from the NPI at baseline, 3 
months, and 6 months.  
 
AddiƟonal data collecƟon  
Demographic data for both the caregiver and paƟent will be collected aŌer enrollment, 
including age, gender, race, ethnicity, educaƟon level, employment status, annual household 
income, living situaƟon, and insurance status. The total hours over the previous 2 weeks the 
caregiver spent with the paƟent and the duraƟon of Ɵme the caregiver has been caring for the 
paƟent will be recorded. Medical data for the paƟent will also be collected. Health literacy will 
be assessed by the Single-Item Literacy Screener (SILS) [25].  
 
Analyses  
The completeness and distribuƟons of all variables will be checked. We will check the shape of 
conƟnuous distribuƟons to detect strong deviaƟon from normality and will apply normalizing 
transformaƟons as needed for highly non-normally distributed variables (e.g., NPI). Internal 
consistencies of scale scores will be assessed with Cronbach’s coeﬃcient alpha. Two-sample t 
tests and chi-squared tests will be used to compare demographic and clinical characterisƟcs of 
the parƟcipants between the two groups at baseline. The primary aim is to evaluate the 
feasibility of BCN as an intervenƟon. The following variables will be determined to test this: 
(a) A recruitment rate per month 
(b) CompleƟon on primary outcome measures 
(c) Mean score on the 10-item SUS [21] 
(d) BCN acceptance on the Behavioral IntenƟon 3-item scale [17] 
(e) % weekly BCN use 
Analyses for (a) and (b) will be descripƟve in nature, and no staƟsƟcal tests will calculated. 
For (c), we will calculate the mean and standard deviaƟon for the composite SUS to calculate 
the 90% conﬁdence interval. For (d) and (e), we will calculate the proporƟon of paƟents with 
BCN acceptance and weekly BCN use and then calculate 90% conﬁdence intervals.  
A secondary aim is to esƟmate the eﬀect of the BCN intervenƟon on caregiver burden. A 
linear mixed model will be used to compare the two groups on the mean total NPI-Caregiver 
Distress Scores at 3 and 6 months, using an analysis-of-covariance (ANCOVA) style of model in 
which the baseline measure of the outcome variable is included as a ﬁxed eﬀect. Time (3 and 6 
months), intervenƟon (BCN vs. usual care), and the interacƟon between Ɵme and intervenƟon 

will be included in the model to test for group diﬀerences at each Ɵme point. If NPI is highly 
posiƟvely skewed, as we have observed in prior research, we will perform a transformaƟon on 
NPI, such as log (NPI+1), to saƟsfy model assumpƟons. All analyses will be intenƟon to treat 
(ITT), and addiƟonal sensiƟvity analyses will assess the eﬀect of impuƟng missing outcomes 
using several mulƟple imputaƟon techniques (both missing at random and not missing at 
random).  
Another secondary aim is to esƟmate the eﬀect of the BCN intervenƟon on BPSD. Analyses 
will be performed as described above for caregiver burden, except the outcome will be the NPI 
total score.  
Data and safety monitoring plan and board  
The Principal InvesƟgators and an independent Safety Oﬃcer will be responsible for data and 
safety monitoring, with support from the team’s data manager and biostaƟsƟcian. Research 
staﬀ will prepare for them a formal report communicaƟng the study’s enrollment progress, data 
collecƟon, and parƟcipant safety. InvesƟgators will meet at least every 2 weeks with the study 
team to review ongoing study progress and parƟcipant safety and will review and discuss every 
reportable event within 48 h. The frequency for reviewing data in this study diﬀers according to 
the type of data:   
Reviewed at Each Occurrence 
• Self-reported adverse events 
• Serious adverse event meeƟng prompt reporƟng 
Reviewed Quarterly 
• Summary of serious adverse events 
• Protocol violaƟons/noncompliance 
• Subject accrual/randomizaƟon 
• Withdrawal rates 
• Subject complaints 
• Compliance to intervenƟons 
Reviewed Annually 
• Summary of adverse events 
• Out of range data 
• Reassessment of risk-to-beneﬁt 
 
All data for each parƟcipant will be compiled in a single REDCap database. REDCap oﬀers 
secure access, regular backup, data validaƟon, and structured data collecƟon via mobile devices 
for all interviewer-administered assessments. Medical and care process data will be collected 

from electronic medical records and entered into the REDCap database. Data on device use will 
be obtained via server queries and uploaded to REDCap. Recruitment process data will be 
directly input into REDCap by research staﬀ. A staﬀ biostaƟsƟcian or data manager will perform 
the merging of all data streams using unique idenƟﬁers assigned to the study parƟcipants. They 
will regularly review data for data entry errors and other irregulariƟes.  
Special consideraƟons  
A challenge for this study is ensuring that those randomized to receive BCN have adequate 
ongoing access to BCN technology. We have addressed this challenge by applying iteraƟve user-
centered design and tesƟng of BCN, paying consideraƟon to the needs and abiliƟes of middle-
aged and older adult caregivers. The user-centered design and tesƟng process included a study 
of processes and unmet needs of the current clinical program [26], followed by the app 
designers convening individual and group meeƟng of caregivers and clinicians to discuss needs 
and design ideas. ThereaŌer, we collected iniƟal feedback from caregivers on screen mockups 
and features, followed by a brief ﬁeld test of the applicaƟon with 11 caregivers who used BCN 
on an Android device. In the post-test usability interview, we assessed caregivers’ perceived 
usefulness, usability, desirability, and credibility of the app and adjusted the app to address 
problems. When possible, the BCN app is installed directly on the caregiver’s smartphone. 
Those dyads that need a smartphone are provided a smartphone with an unlimited data plan 
for the duraƟon of the study. We will document the proporƟon that requires such addiƟonal 
assistance, as this may ulƟmately aﬀect the realworld implementaƟon of an intervenƟon like 
BCN. Assistance with soŌware installaƟon and subsequent technical support needs are provided 
for all study parƟcipants. We have also budgeted for network and development support to 
monitor and remediate (e.g., with patches) any emergent technical malfuncƟons, operaƟng 
system changes, or security vulnerabiliƟes during the study. These steps are important to 
reducing the risks of systemaƟcally excluding more vulnerable parƟcipants and creaƟng or 
increasing inequaliƟes in technology studies [27]. 
Discussion 
Reducing caregiver burden and minimizing BPSD are important for improving wellbeing and 
reducing other health risks of ADRD caregiving. Mobile and telehealth technology applicaƟons 
are promising intervenƟons to improve these outcomes in a scalable manner [14]. However, 
before a technology is deployed to a large sample or in clinical pracƟce, it must be evaluated for 
usability, acceptance, and potenƟal eﬃcacy. This is especially needed to avoid the potenƟal for 
harm or waste of eﬀort when the technology is intended for older and cogniƟvely impaired 
individuals, those who provide them informal care, or other vulnerable groups. The present 
randomized controlled pilot study aims to collect the necessary evidence to determine the 
viability of the BCN telehealth system.  
If found to be feasible and potenƟally eﬃcacious, BCN and other mobile technologies have 
the potenƟal to be scalable. An app such as BCN could be shared with a broad pool of study 
parƟcipants or members of the public through exisƟng public app marketplaces and can be 

downloaded on personal devices or accessed via a website. Although the cost of an intervenƟon 
such as BCN would have to be further assessed, once it is built, major anƟcipated technology 
costs include soŌware and security maintenance. AddiƟonal costs may be related to Ɵme spent 
by a community health worker reviewing data entered by caregivers into the app and 
parƟcipaƟng in secure messaging. A telehealth system also allows collaboraƟve, interdisciplinary 
care from individuals as diverse as geriatricians, care coordinators, nurses, social workers, 
community health workers, informal caregivers, and community members. The breadth of 
involvement and the low barriers to access permit contribuƟons to care from larger 
“workforces,” for example, community health workers, volunteers, or a network of informal 
caregivers. This is an important advance given anƟcipated increases in the demand for ADRD 
care and the limited number and cost of geriatricians and memory care specialty services. 
Another, more prospecƟve potenƟal for a telehealth system is to deliver care or health coaching 
through or assisted by arƟﬁcial intelligence.  
Overall, if successful, this pilot study can serve as a test case for a new way of delivering 
beter care to paƟents with ADRD and their caregivers. 
 
 

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