Intelligent Personal Assistant for Managing Depression in Homebound Older Adults
Phase: NA
Conditions: Aging, Physical Dependence
Sponsor: Northwestern University

 
 
 
 
 
 
 
 
Title: Intelligent Personal Assistant for Managing Depression in Homebound Older Adults 
NCT Number: NCT04900272 
Document Date: October 22, 2021 
 

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PROTOCOL TITLE:  Intelligent Personal Assistant for Managing Depression in Homebound 
Older Adults
PRINCIPAL INVESTIGATOR:
Katherine O’Brien, MD
General Internal Medicine and Geriatrics
312-695-4525 
katherine.obrien@northwestern.edu
VERSION DATE: October 22, 2021
 
STUDY SUMMARY:
Investigational Agent(s) 
(Drugs or Devices)
N/A
IND / IDE / HDE # N/A
Indicate
Special Population(s)
Children 
 Children who are wards of the state 
 Adults Unable to Consent  
 Cognitively Impaired Adults 
 Neonates of Uncertain Viability 
 Pregnant Women 
 Prisoners (or other detained/paroled individuals) 
 Students/Employees 
Sample Size
50 stakeholders & 40 older adults 
Funding Source
Northwestern Older Americans Independence Center 
Pilot/Exploratory Studies Core
Indicate the type of consent 
to be obtained
Written 
Verbal/Waiver of Documentation of Informed Consent
Waiver of HIPAA Authorization 
Waiver/Alteration of Consent Process  
Site
 Lead Site ( For A Multiple Site Research Study)
 Data Coordinating Center (DCC)
Research Related 
Radiation Exposure
Yes 
 No 
DSMB / DMC / IDMC
Yes 
No
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OBJECTIVES:
The objective of this pilot study is to design a companion booklet and pilot test it with a voice-
controlled intelligent personal assistant (VIPA), Google Home or Amazon Alexa, to provide 
patients with skills and tools to help manage their social isolation. The companion booklet is a 
document that will be created using feedback obtained from a panel of geriatric experts, 
highlighting features of the VIPA that may be most beneficial to socially-isolated older adults. It 
will be submitted to the IRB for approval once finalized. The specific aims of this project are to:
Aim 1: Design a companion booklet to be used in conjunction with a VIPA (Google Home/Amazon 
Alexa) for improving social isolation and communication among homebound older adults, 
defined as someone who is unable to leave the home without assistance of a device or 
another person, due to a physical or cognitive condition.
Aim 2: Assess the feasibility and implementation of the VIPA (Google Home/Amazon Alexa) and 
the companion booklet and its impact on clinical and functional outcomes for older adults 
with social isolation.
BACKGROUND:
Loneliness and social isolation are both common in older adults in the US. In a prospective survey 
of a US population based cohort, 17.6% of adults over 65 years of age endorsed feeling lonely 
“much of the time” (Donovan et al.). And, according to Landerio and colleagues, up to 50% of 
those aged over 60 are at risk of social isolation.
Social distancing, which may necessitate increased isolation, is an essential public health strategy 
during a pandemic such as COVID-19, especially for those at increased risk of morbidity and 
mortality (Centers for Disease Control). Older adults are one such group facing an increased risk 
from COVID-19; in the United States, between 31-70% of adults aged 65 and older with confirmed 
COVID-19 infection have required hospitalization and 8/10 reported deaths due to COVID-19 
have been in adults older than 65 years of age (Centers for Disease Control). According to 
Armitage and Nellums however, self-isolation will have a disproportionate impact on elderly 
individuals, who may not have close friends and family, and whose social contact can be 
dependent on activities taking place outside the home (ex: at places of worship).
In a population-based Swiss cohort, independent of age, socially isolated individuals had 
increased risk of poor health, including poor self-rated health and presence of musculoskeletal 
disorders, moderate-severe depression, and multiple other comorbidities (Hammig). The same 
cohort also demonstrated an increased risk of unhealthy behaviors, such as physical inactivity, 
poor diet, and psychotropic drug use in socially isolated individuals (Hammig). In a population-
based cohort in the US, loneliness was associated with a 20% increased rate of cognitive decline 
in adults over 65 years, independent of socio-demographic factors, social network, poor health, 
and baseline depression (Donovan et al.).
The impact of COVID-19 necessitated social distancing and consequent loneliness on the health 
of older adults is an acute public health concern. First, COVID-19 related changes in the health 
system may impair the physical and mental health of older adults--especially those who are frail, 
very old, or with multiple comorbidities--due to changes in diet, exercise, social stimulation, and 
accessibility of functional supports (Steinman et. al.). Furthermore, based on lessons learned from 
previous pandemics such as SARS and MERS, social distancing and the loneliness and/or social 
isolation that could accompany it may have a negative impact on mental health (Venkatesh and 
Edirappuli). Factors such as maintaining a healthy lifestyle and hobbies, virtual social interactions, 
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and mindfulness may help to mitigate these effects (Venkatesh and Edirappuli). Thus, strategies 
ought to be implemented to mitigate the risk of increased morbidity and of infection from COVID-
19 due to the effects of isolation on the mental and physical health of the elderly (Armitage and 
Nellums) (Landerio et al).
Chen and Schulz found that information and communication technology strategies show promise 
in reducing social isolation in the elderly, but recognize that more information is needed regarding 
the efficacy of different interventions for different individuals (Chen and Schulz). Online 
technologies can be used to help provide a stronger sense of belonging and support for elderly 
individuals (Armitage and Nellums). 
Older adults have often been on the fringe of benefitting from technology. However, VIPAs (e.g. 
Google Home, Amazon Echo) may be useful to homebound older adults with social isolation, 
connecting them to caregivers and primary care; providing functional, cognitive, and social 
stimulation.
STUDY ENDPOINTS:
For Aim 1, the study endpoint will be the finalized VIPA companion booklet for use in the pilot.
For Aim 2, the study endpoint will be the completion of the 16 week pilot program. 
STUDY INTERVENTION(S) / INVESTIGATIONAL AGENT(S):
The VIPA accompanying instructional booklet focused on social-isolation in older adults that will 
be designed for this project will assist older adults with socialization, goal setting, monitoring, 
feedback and reminders.
PROCEDURES INVOLVED:
In Aim 1, a panel of geriatric experts and patients (n=15-50) will be recruited to help identify which 
applications available on the VIPA (Google Home/Amazon Alexa) may be the most useful for 
homebound older adults who may be socially isolated. Stakeholders will include geriatricians 
(attending physicians), nurses, social workers, patients, and caregivers of older adults. 
Stakeholders (geriatric experts) will independently use the Google Home or Amazon Alexa 
Assistant as a trial themselves for 2-4 weeks, and then select those VIPA features that they think 
may be the most relevant and useful for older adults to help minimize social isolation. 
Or, in the case of older adults and caregivers, they will be given the device, and either the study 
PI or Research Study Coordinator (RSC) will visit the participant’s home, or assist the patient 
virtually, to set up the Google Home or Amazon Alexa device. Participants will then provide 
feedback about the device after 2-4 weeks of use. This feedback will be collected over the phone 
with the Research Study Coordinator or online. Once responses are collected, the feedback will 
be implemented into an updated iteration of the companion booklet, which will be used for Aim 2. 
Based on the collective feedback from the geriatric expert and patient panel, we will design a 
finalized companion booklet to go along with the VIPA, highlighting the list of applications that 
may benefit older adults with social isolation. Once the VIPA companion booklet is updated, the 
stakeholders will review the booklet and provide feedback via a second online survey (or via 
telephone if unable to complete online) before it is finalized and is ready to be used in Aim 2 in 
the pilot study. The goal is a VIPA companion booklet along with the VIPA that will assist older 
adults with socialization, goal setting, monitoring, feedback and reminders. 
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For Aim 2, we will recruit a total of 20-40 older adult homebound patients who are likely to be 
socially isolated to use the VIPA and accompanying instructional booklet focused on social-
isolation. Either the study PI or Research Study Coordinator (RSC) will visit the participant’s 
home, or assist the patient virtually, once consented, to set up the Google Home or Amazon Alexa 
device for them and review the companion VIPA booklet with them. For Aim 2, participants will be 
asked to use the VIPA and accompanying second iteration of the instructional booklet focused on 
social-isolation. These participants will be surveyed over the phone, online, or in-person for 16 
weeks (baseline, 4 weeks, 8 weeks, and 16 weeks) with outcomes measured at each time point. 
These outcomes include: VIPA use and acceptability (Acceptability, Feasibility, and 
Appropriateness Scale); Social Isolation (PROMIS-Short Form 8a); Anxiety (GAD-7); Self Efficacy 
for Managing Social Interactions (PROMIS-Short Form 4a); Ability to Participate in Social Roles 
and Activities (PROMIS-Short Form 4a); Companionship (PROMIS-Short Form 4a); Geriatric 
Depression Scale (GDS – Short Form)functional status (PROMIS-Physical function); Cognitive 
Function (Brief MOCA); and Quality of Life/Well-being (Neuro-QOL Positive Affect & Well-Being). 
Demographics will be collected at baseline, and technology use data (adapted from Teacher 
Technology Integration Survey (TTIS)) will be collected at baseline and 16 weeks. We will also 
continue to collect feedback to iteratively optimize the technology, protocol, and implementation.
DATA AND SPECIMEN BANKING
Upon completion of all study activities, a final de-identified dataset will be created. This dataset 
will be stored indefinitely on the GIM server for secondary analyses. Only authorized personnel 
will have access to the dataset.
SHARING RESULTS WITH PARTICIPANTS
Study results will not be shared with participants or anyone else. 
STUDY TIMELINES
Aim 1 will be conducted during months 1-7 and Aim 2 will be conducted during months 8-24. 
INCLUSION AND EXCLUSION CRITERIA
No subjects will be excluded on the basis of race or ethnicity. 
In Aim 1, stakeholders will be eligible if they are:
1.
Adults aged 21 or older;
2.
English-speaking; and
3.
Currently provide at least 2 hours of weekly clinical support (e.g. emotional, social, 
physical, task-related) to an older adult (>65 yrs.) who may be socially isolated
Or 
1.
Adults aged 65 years or older;  
2.
Patients of the Northwestern Medicine Geriatrics Program;
3.
English-speaking;
4.
Able to verbally consent
In Aim 2, participants will be eligible if they are:
1.
Adults aged 65 years or older;  
2.
Homebound patients;
3.
Able to access the internet;
4.
English-speaking; and
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5.
Able to verbally consent 
VULNERABLE POPULATIONS – N/A
PARTICIPANT POPULATION(S)
Accrual 
Number:
Category/Group:
(Adults/Children 
Special/Vulnerable 
Populations)
Consented:
Maximum Number to be 
Consented or 
Reviewed/Collected/Screene
d
Enrolled:
Number to Complete 
the Study or Needed 
to Address the 
Research Question
Stakeholders (Aim 1)
50
50
Local
Older Adults (Aim 2)
40
40
Stakeholders (Aim 1)
50
50
Study-wide
Older Adults (Aim 2)
40
40
Total:
90
90
RECRUITMENT METHODS
Aim 1: Recruitment of Stakeholders
The PI will send out an email invitation to relevant listservs including healthcare providers and 
caregivers who care for older adult patients to recruit stakeholders. Older adults will be identified 
by clinicians.
After receiving the email invitation, interested individuals will click on the online REDCAP survey 
link to complete the online screener to determine their study eligibility, or they will be contacted 
via telephone to complete the screener to determine their study eligibility. Eligible participants will 
then be able to access the consent form online to provide consent, or they will provide verbal 
consent via telephone. Once a participant consents to be in the study, they will receive an email 
from the research study team within two weeks which includes a link to a brief online survey for 
them to complete once they complete their 2-4 week trial period of the VIPA. Those who cannot 
access the online survey will receive a phone call from the study team, and they will complete the 
survey over the phone. The survey will include some demographic questions and will include 
questions for them regarding their experience/use of the Google Home/Amazon Alexa device 
which will help inform the design of the companion VIPA booklet.  
An online or verbal consent will be obtained prior to the telephone survey. 
Aim 2: Recruitment of Patients
This study will be presented to providers in the Northwestern Medicine Geriatrics Program and 
other Chicago-based clinics, and they will be asked to pass along study information flyers to 
potential patient/caregiver subjects. In addition, clinic staff can provide the research study 
coordinator (RSC) with the names and phone numbers of potential participants via encrypted 
email. Potential participants may also be approached in-person at senior events or by posting 
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flyers at senior facilities. Potential subjects who are interested in learning more about the study 
will then contact the research staff by phone, or the research coordinator will contact potential 
participants. Potential participants will learn more about the study and, if interested, be screened 
for eligibility. To supplement the patient pool for recruitment, potential participants will also be 
identified through reports generated by the Enterprise Data Warehouse (EDW). This list of patient 
names, medical record numbers, phone numbers, address, and date of birth will be compiled in 
a report that can be securely accessed and reviewed by study staff. The PI or trained research 
study coordinators (RSCs) will review the charts of identified patients to confirm eligibility that 
cannot be ascertained via the EDW. Among the remaining eligible patients, research staff will 
send the patient’s clinician an Epic message with a list of their patients to review and remove any 
patients that should not be contacted within 3 days. The study staff will then contact identified 
patients and if they are interested in participating or learning more about the study, the RC will 
obtain verbal permission to ask the patient a brief series of questions to verify eligibility.  If patients 
are eligible, the PI or RSC will engage patients in the verbal informed consent process, or patients 
will be able to access the consent form online to provide consent when appropriate. The first 
phone survey, the baseline survey, will then be conducted over the phone or in-person by the PI 
or RSC with the patient, or online for those who are comfortable.
COMPENSATION FOR PARTICIPATION IN RESEARCH ACTIVITIES
Aim 1: For their participation as a stakeholder, each geriatrics expert panelist or patient will be 
provided a Google Home or Amazon Alexa (VIPA) which has a value of approximately $40, or a 
$20 gift card if they already have a device. Stakeholders will use this Google Home or Amazon 
Alexa device as part of their study engagement, and they will be able to keep the VIPA after study 
completion.
Aim 2: For their use of the Google Home or Amazon Alexa device and companion booklet as well 
as completion of study interviews, each older adult patient will be provided a Google Home or 
Amazon Alexa (VIPA) which has a value of approximately $40. This VIPA will be used throughout 
the study and they will be able to keep the VIPA after study completion. Patients will also receive 
a $20 gift card after completion of the study. Patients will receive the gift card compensation by 
mail. 
WITHDRAWAL OF PARTICIPANTS
Participants can choose to withdraw from the study at any time. If a participant chooses to 
withdraw from the research, any data collected up until the point of withdrawal will still be utilized 
as it will not include identifying information.
RISKS TO PARTICIPANTS
The risks of harm from being in this study are minimal. The most significant risk is that both 
stakeholders and patients will be using a VIPA which may result in a loss of confidentiality if 
someone else were to access the information gathered by the Google Home or Amazon Alexa 
device. However, the research team will not have access to the any of the information that may 
be gathered/stored on the VIPAs. Patients in Aim 2 may additionally experience distress or 
psychological discomfort while completing the phone surveys, especially when answering 
questions related to social isolation.
POTENTIAL BENEFITS TO PARTICIPANTS
We cannot promise any benefits to stakeholders or patients taking part in this research. However, 
possible benefits for stakeholders (Aim 1) include that as a result of participating in this study, 
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they may gain a better understanding of how to incorporate the use of VIPAs with patients/older 
adults that may be socially isolated.  
For patients (Aim 2), benefits may include learning helpful strategies using a VIPA to manage 
self-isolation and being able to access tools that might help them develop better socialization and 
communication habits while being homebound. 
DATA MANAGEMENT AND CONFIDENTIALITY
Data collected includes consent forms (online and verbal) and data collected during the study 
surveys.
Data Access. The Data Custodian is the Principal Investigator, Dr. Katherine O’Brien. Only 
authorized personnel listed on the IRB will have access to the data.  Any information that could 
allow identification of individual participants, including the master list, will be kept strictly 
confidential. 
Local Data Storage. Data will be stored in REDCap, a secure, web-based application, and on the 
Northwestern secure server for the length of the study. The PI or research coordinator will 
download the de-identified data only from REDCap monthly and save it to the dedicated project 
folder on the FSM department servers which are located in a HIPAA compliant data center. These 
data files do not contain any identifiable information, and are identified by project staff by an 
assigned study ID. Upon completion of all study activities, a final de-identified dataset will be 
created and all identifiable information will be deleted. This dataset will be stored indefinitely on 
the GIM server for secondary analyses. Only authorized personnel will have access to the 
dataset. All identifiable information will be deleted upon completion of the study 
PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF PARTICIPANTS
This study involves no greater than minimal risk. Due to this, we will not be convening a DSMB 
for this study.  
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS
In all research documentation, participants will be identified by a unique identification number 
(“Study ID”), not by name, and any other identifying information (e.g. personal and/or contact 
information) will be kept separate from the other data; all information will be kept in secure, 
password protected files. Further, subjects will be told that unless required by law, only the study 
investigators, members of the project staff, and representatives of Northwestern University will 
have the authority to review any study records. In such case, they too will be required to maintain 
confidentiality.
COMPENSATION FOR RESEARCH-RELATED INJURY – N/A
ECONOMIC BURDEN TO PARTICIPANTS – N/A
CONSENT PROCESS
Aim 1: Informed consent (online or verbal via telephone) will be collected for participants who are 
screened as eligible to participate in the study as stakeholders. The consent document is written 
in language that the potential participant can understand. A copy of the consent form will be 
accessed online or via telephone and can be downloaded and/or printed for their records, or can 
be mailed to the participant at their request.
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Aim 2: Informed consent will be obtained by the PI or trained RSC verbally over the phone, or 
online when appropriate, for any participants that are screened as eligible to participate in the 
study. All interviewers will follow the SOP: Informed Consent Process for Research (HRP-090). 
Informed consent will be viewed as a process, i.e., at several times during review of the IRB 
approved consent document, the participant will be asked to explain in his/her own words his/her 
understanding of the consent. This will enable the research personnel to enter into a dialogue 
with the participant and ensure that the participant understands that he/she is free to withdraw at 
any time without penalty. Information will be provided to the participants in terms that they can 
fully understand. There will be no exertion of any overt or covert coercion. The consent document 
is written in language that the potential participant can understand, and they will be encouraged 
to ask questions prior to giving consent. A copy of the verbal or online consent form will be mailed 
or emailed to study participants in Aim 2 of the study, depending on their preferred modality of 
receiving the copy of the consent form. 
Waiver of HIPAA Authorization are requested to identify subjects (patients) prior to 
enrollment into the study.
NON-ENGLISH SPEAKING PARTICIPANTS
Non-English speaking subjects will not be included in this research study.
WAIVER OR ALTERATION OF CONSENT PROCESS
The following groups will not be included in this research study. 
-
Participants who are not yet adults (infants, children, teenagers)
-
Cognitively Impaired Adults
-
Adults Unable to Consent
Aim 1: Process to Document Consent Online
Since the recruitment, screening, enrollment, and completion of the surveys will take place online 
or by telephone for stakeholders, we are requesting a waiver of written documentation of consent. 
We are not obtaining HIPAA Authorization to access PHI from participants. Eligible participants 
will consent online or complete a verbal consent by telephone before they are able to proceed 
with the first survey. The Waiver of Written Documentation of Consent does not adversely affect 
the rights and welfare of participants given that various protections will be in place to keep data 
de-identified, to not use the data for any other purposes outside of the scope of this study, and 
involves no more than minimal risk to participants. A copy of the consent form will be accessible 
to participants online and can be downloaded and/or printed for their records, or can be mailed to 
the participant at their request.
Aim 2: Process to Document Consent Online or Verbally
A verbal consent, or a waiver of documentation of consent, is deemed appropriate because the 
nature of the study involves minimal risk. We will not be obtaining HIPAA Authorization to access 
protected health information (PHI) from the medical records of participants. The Waiver of Written 
Documentation of Consent does not adversely affect the rights and welfare of participants given 
that various protections will be in place to keep data de-identified, to not use the data for any other 
purposes outside of the scope of this study, and involves no more than minimal risk to participants. 
Eligible participants will consent online or complete a verbal consent by telephone before they are 
able to proceed with the first survey. For those who are able to engage online, eligible participants 
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will receive an email invitation to the online REDCAP survey link to complete the online screener 
and, if eligible, the online consent form. For those over the phone, once the study team has read 
the verbal consent over the phone and answered any questions the patient may have, the patient 
will be asked if they would like to participate in the study. If a patient agrees to participate after 
the consent is read, the PI/RSC will record the patient’s name on the consent form and the PI/RSC 
will sign their own name on the form. These consent forms will be locked in a file cabinet only 
accessible to necessary research staff. Participants will be given the option to receive a copy of 
the consent form for reference if they request it either by mail or email.
Waiver of HIPAA Authorization are requested to identify subjects (patients) prior to enrollment 
into the study.  
PROTECTED HEALTH INFORMATION (PHI AND HIPAA)
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). In order 
to preserve participants’ confidentiality rights, research subjects will be assigned code numbers 
that will be used to identify all the information collected. Using these codes, none of the collection 
forms will contain the names of the participants. All electronic data will be stored on a password-
protected computer. A Microsoft Access master study tracking database will contain information 
linking participants to their study id numbers. This database will be encrypted and kept on a secure 
server and only accessible by study personnel. 
Survey data will be stored in REDCap. Individual study identification numbers will be assigned to 
each participant and only this number will appear on the survey. Subjects will be told that unless 
required by law, only the study investigators, members of the project staff, the funding agency 
and representatives of Institutional Review Boards will have the authority to review any study 
records. In such cases, these parties too will be required to maintain confidentiality. The final data 
set will be stripped of identifiers. Data will be shared via presentations at national and international 
meetings and in peer reviewed publications. Furthermore, all results will be shared with the 
funding institute.
QUALIFICATIONS TO CONDUCT RESEARCH AND RESOURCES AVAILABLE
This project is being led by Dr. Katherine O’Brien, with Drs. Bradley, Lindquist, Mohr, and Kwasny 
as mentors. Dr. Lindquist has been a colleague and mentor to Dr. O’Brien since she joined the 
Northwestern faculty in 2018. Both Dr. Kwasny and Dr. Mohr have a longstanding collaborative 
relationship with regard to research involving healthcare design and technology use, and Dr. 
O’Brien will leverage this existing partnership. Northwestern University will be the lead 
administrative site and data collection and coordinating site. Staff at Northwestern will work under 
the primary direction of Dr. O’Brien to recruit and retain patients and collect data. 
Dr. O’Brien, as the study PI, will personally train and supervise the research coordinator in the 
day-to-day execution of the study details. Although Dr. O’Brien will have executive decision-
making over all final research decisions, the research coordinator will be the first point of contact 
“on the ground,” with close access to and constant communication with Dr. O’Brien. Any IRB 
revisions or updates will be submitted by the research coordinator, in addition to any other 
administrative tasks (e.g. tracking of participant incentives, arranging for meeting space). 
Team Meetings: The entire co-investigator team (O’Brien, Bradley, Lindquist, Mohr, Kwasny) 
and the research coordinator will meet every other week during the two years of the grant. Dr. 
O’Brien and the research coordinator will be responsible for presenting interim outcome data, 
including the number of patients screened/enrolled/refused and any anticipated or unanticipated 
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obstacles encountered. Dr. O’Brien will then lead a discussion on any proposed solutions to 
problems with study design, execution, or analysis.
MULTI-SITE RESEARCH – N/A
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