A Mobile Informatics Solution to Aid in Memory
Phase: NA
Conditions: Alzheimer Disease, Dementia
Sponsor: University of Minnesota

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 1 of 49 
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. 
Title: A Mobile Informatics Solution to Aid in Memory; NCT04700540 
Protocol 
This protocol version (V19) was IRB approved on 9/29/2023. 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 2 of 49 
Template Revised On: 11/1/2021      
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 
prior to IRB 
approval;  
 
☐ 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  

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 3 of 49 
Template Revised On: 11/1/2021      
☐ Yes 
✔ No 
Include the use of 
recombinant or synthetic 
nucleic acids, toxins, or 
infectious agents? 
STOP – Complete the Medical Template 
Protocol (HRP-590) 
These 
groups 
each have 
their own 
application 
process.  
☐ 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. 
 
 
PROTOCOL COVER PAGE 
Protocol Title 
A Mobile Informatics Solution to Aid in Memory 
Name: Jude Mikal 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 4 of 49 
Template Revised On: 11/1/2021      
Principal 
Investigator/Faculty 
Advisor 
Department: School of Public Health, Health Policy & Management 
Telephone Number: 385-212-4185 
Email Address: jpmikal@umn.edu 
Student Investigator 
Name: N/A 
Current Academic Status (Student, Fellow, Resident): 
  
Department: 
Telephone Number: 
Institutional Email Address: 
Scientific Assessment 
I believe Scientific Assessment is not required. 
Version 
Number/Date: 
Version 19, date: 8/31/2023 
 
 
 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 5 of 49 
Template Revised On: 11/1/2021      
REVISION HISTORY 
 
Revision # 
Version Date 
Summary of Changes 
Consent Change? 
2 
2 
Phase 1 updates: Focus groups 
instead of interviews 
Yes: phase 1 
consent at focus 
group session 
instead of at time of 
screening and 
enrollment.  
3 
2/26/2020 
Change in cognitive assessment tool 
and added details about phase 1 
focus groups. Added context of care 
survey for care partners to complete.  
Change in cognitive 
assessment tool 
4 
3/2/2020 
1. Clarification provided on using 
Mini-Cog and UBACC in consent 
process.  
2. Clarification on Baseline and 3 
month survey  
Clarification 
provided on using 
Mini-Cog and 
UBACC 
5 
5/6/2020 
Focus Groups will now be conducted 
via Zoom meetings. If needed, dyadic 
interviews will also be conducted with 
participants in place of focus groups. 
Questions were added to phase I 
about changes in technology use due 
to the COVID-19 pandemic. 
Yes: consent in 
phase 1 will now be 
conducted via 
Zoom, so consent 
will occur verbally 
with the caregiver 
and PWMC.  
6 
5/24/2020 
No focus groups will be conducted, 
instead only dyadic interviews will be 
conducted. The SR Checklist survey 
will be administered verbally during 
the interview instead of after the 
interview via mail or web. 
No 
7 
12/22/2020 
Updating protocol and materials with 
new Primary Investigator (switched 
from Dr. Joseph Gaugler to Dr. Jude 
Mikal). Changes reflect that Dr. 
Gaugler was responsible for Phase 1 
of the study while Dr. Mikal is 
responsible for Phase 2 of the study.   
No 
8 
3/28/2022 
Updated to new protocol template 
version available from the UMN IRB. 
No changes were made to content of 
the protocol, unless it was not 
specified by the previous protocol. 
No 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 6 of 49 
Template Revised On: 11/1/2021      
9 
5/25/2022 
Phase 1 specific content is colored 
green for ease of review (content was 
not changed since phase 1 has 
concluded).  
Specific changes made to Phase 2 
content: Updated staff changes, 
added brief pilot testing to ensure the 
study is not launched for multiple 
dyads before the technology has been 
debugged, added details about survey 
administration, added details about 
administering the UBACC before the 
follow-up surveys to ensure ongoing 
PWMC consent/assent, updated 
scales/information collected in the 
surveys, updated eligibility criteria so 
that the PWMC must live in the 
community, The TICS-40 will be 
administered to assess level of 
dementia severity and screen out 
participants who have severe 
dementia or no cognitive impairment, 
and added recruitment opportunities. 
 
Yes: updated 
consent forms for 
CP and PWMC and 
a PWMC assent 
form; created CP 
and PWMC consent 
scripts for reviewing 
consent form over 
the phone; added 
details about 
administering the 
UBACC to PWMC 
prior to each survey 
to ensure ongoing 
consent or assent.  
10 
7/1/2022 
The survey has been broken into Care 
Person and PWMC surveys, and more 
specifically baseline and follow-up 
surveys have been created for each 
participant type to better assess the 
SR based on results from Phase 1. 
Additionally, the semi-structured 
interview, UBACC and 
email/telephone script have been 
revised for Phase 2. An infographic 
has been created to share phase 1 
results with phase 1 participants. A 
screener form including the TICS-40 
questions has been developed along 
with additional recruitment materials 
(emails, fliers, newspaper, and 
Facebook ads). Cover letters for email 
and mail communication have been 
created for Phase 2 as well as 
telephone scripts, for communicating 
with participants throughout the 
study duration. Details have been 
Yes, the UBACC has 
been edited so that 
desired participant 
answers are 
updated for Phase 
2. Additionally, 
consent processes 
are detailed further 
in the protocol.  

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 7 of 49 
Template Revised On: 11/1/2021      
added about the RA’s blinding to 
randomization and survey data 
collection procedures. 
11 
9/2/2022 
1) Updated the protocol’s secure 
storage information (section 18) 
because the storage system intended 
for use has changed. 2) Also updated 
the protocol to reflect incentive 
payments of $50 for 20 semi 
structured interviews. Previously, only 
the survey payments were listed. 3) 
Updated incentive payments to be 
paid via Visa Debit Cards instead of 
Greenphire ClinCards. 4) Uploaded 
updated consent forms and consent 
scripts to include semi structured 
interview payment and Visa card 
instead of Clincard. 5) Uploaded 
updated cover letter templates to 
reflect semi structured interview and 
visa card payment were fitting.  6) 
Added Emily Merkel, research 
assistant, and Yun Leng Wong, 
research assistant, to the study. 
Yes: updated 
consent forms and 
scripts to include 
$50 participant 
payment if chosen 
for a semi 
structured 
interview and 
changed Clincard to 
Visa card. Process 
of consenting 
remains the same.  
12 
11/10/2022 
1) Updated the recruitment section of 
protocol (12) to include snowball 
recruitment and recruitment via 
professional network who works with 
target population. 2) Updated 
protocol to reflect reminder 
procedures for survey follow-up.  
No. 
13 
12/13/2022 
1)Specified the type of follow up 
surveys (Regular follow up, 
Bereavement or Long Term Care 
Transition), that would be 
administered to caregivers depending 
on their response to the disposition 
(section 5.2 note).  
2)Specified the possibility of potential 
participants screening themselves out 
informally before completing a 
screener, due to the natural 
progression of conversation.  
No. 
14 
1/25/2023 
Edited inclusion criteria to remove 
criteria that they must remain in the 
No.  

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 8 of 49 
Template Revised On: 11/1/2021      
same area for next 6 months. Decided 
this is not required for the technology 
to work appropriately and may help 
with recruitment.   
15 
2/14/2023 
1. Changed participant payment to 
Amazon gift card to allow for 
appropriately prorated amounts for 
those who do not complete all 
surveys, and to minimize fees that 
participants will face (as seen with 
Visa cards). Added further details 
about prorated amounts.  
2. Updated Data Baking to allow for 
data sharing, which aligns with the 
grant and approved consent forms. 
This discrepancy was noticed in 
review of data sharing requirements.  
 
16 
3/30/2023 
The protocol has been updated to 
include national recruitment websites 
and registries fitting to the 
population. 
no 
17 
4/12/2023 
Updated protocol to include an 
informed consent and rights summary 
to be read to the dyad before the 
semistructured interview. 
no 
19 
9/1/2023 
Updated the protocol to allow semi 
structured interviews following the 3-
month follow up time point. 
Interviews will be conducted at 3 
month or at 6 month with selected 
intervention participants to allow us 
to reach the goal of 20 interviews and 
have a more robust response due to 
the limitations imposed by study 
funding and timeline. All other 
procedures will remain the same.  
Also per the IRB's request, the care 
partner and pwmc full consent forms 
were updated to include NIH 
"Certificate of Confidentiality" text. 
Yes: added 
certificate of 
confidentiality text. 
 
 
 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 9 of 49 
Template Revised On: 11/1/2021      
 
Table of Contents 
1.0 
Objectives ...................................................................................................................................... 11 
2.0 
Background .................................................................................................................................... 11 
3.0 
Study Endpoints/Events/Outcomes .......................................................................................... 12 
4.0 
Study Intervention(s)/Interaction(s) ......................................................................................... 13 
5.0 
Procedures Involved ..................................................................................................................... 14 
6.0 
Data Banking ................................................................................................................................. 23 
7.0 
Sharing of Results with Participants ......................................................................................... 23 
8.0 
Study Duration .............................................................................................................................. 23 
9.0 
Study Population .......................................................................................................................... 24 
10.0 
Vulnerable Populations ............................................................................................................... 24 
11.0 
Number of Participants ............................................................................................................... 28 
12.0 
Recruitment Methods .................................................................................................................. 28 
13.0 
Withdrawal of Participants ........................................................................................................ 30 
14.0 
Risks to Participants ..................................................................................................................... 31 
15.0 
Incomplete Disclosure or Deception .......................................................................................... 32 
16.0 
Potential Benefits to Participants .............................................................................................. 32 
17.0 
Statistical Considerations ............................................................................................................ 32 
18.0 
Health Information and Privacy Compliance ........................................................................... 35 
19.0 
Confidentiality ............................................................................................................................... 38 
20.0 
Provisions to Monitor the Data to Ensure the Safety of Participants ................................. 39 
21.0 
Compensation for Research-Related Injury ............................................................................. 42 
22.0 
Consent Process ............................................................................................................................ 42 
23.0 
Setting ............................................................................................................................................ 45 
24.0 
Multi-Site Research ...................................................................................................................... 45 
25.0 
Coordinating Center Research.................................................................................................... 45 
26.0 
Resources Available ..................................................................................................................... 46 
27.0 
References ..................................................................................................................................... 46 
 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 10 of 49 
Template Revised On: 11/1/2021      
ABBREVIATIONS/DEFINITIONS 
 
Abbreviation 
Full Text 
AD 
Alzheimer’s Disease 
ADRD 
Alzheimer’s Disease and Related Dementias 
AME 
Advanced Medical Electronics 
PWMC 
Person with Memory Concerns 
RA 
Research Assistant 
RCT 
Randomized Controlled Trial 
SR 
Smartwatch Reminder 
MCI 
Mild Cognitive Impairment 
UBACC 
University of California, San Diego Brief Assessment of Capacity to 
Consent 
TICS 
Telephone Interview for Cognitive Status 
LTFU 
Lost to follow up 
 
 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 11 of 49 
Template Revised On: 11/1/2021      
1.0 
Objectives 
1.1 
Purpose:  
 
We propose to develop an informatics system to assist people with memory impairment. 
Early stages of Alzheimer's and Alzheimer's related dementia often causes memory 
concerns. Persons with Memory Concern often cannot match names with faces or cannot 
recognize faces with a sure feeling of familiarity. Persons with Memory Concern (PWMC) 
may have difficulty remembering the names of family members and friends or may 
address them with a wrong name. They recognize the faces they see daily, such as a 
spouse or caregiver, but they may confuse visiting friends and grandchildren. The inability 
to remember names or relationships contributes to isolation and deeply affects their 
social lives. The proposed solution is a Smartwatch Reminder (SR) system to conspicuously 
provide this information to the PWMC when needed. This system will automatically 
transmit pictures and relevant information to a smartwatch worn by the PWMC when 
family or friends visit. The system will be evaluated on the target persons with memory 
concern population to measure engagement and improvements in social interactions and 
well-being. 
 
Phase I Aims: 
Aim1: The phase I will develop a prototype SR system with limited features. It will work on 
one model of smartphone and smartwatch. The prototype system can be used to get 
feedback from potential users. 
Aim 2: Examine the feasibility of the SR system for PWMC. 
The result of Phase I will include user feedback that demonstrates the acceptability and 
perceived utility of the system. 
Phase II Aims: 
Aim 3: Phase II will develop smartphone and smartwatch apps designed to work with the 
popular products of 2022. The project will provide a smartwatch and tablet for dyads in 
the treatment group. Family, friends, etc. of the treatment group participants will be able 
to download a smartphone app from an online store. Instructional material will be created 
to show the suggested information that can be entered into the app. 
Aim 4: Evaluate whether the Smartwatch Reminders exerts positive benefits for PWMCs’ 
social engagement and well-being via an embedded experimental mixed methods design 
that combines the collection and analysis of qualitative data within a traditional 
randomized controlled trial (RCT) design. 
 
2.0 
Background 
2.1 Significance of Research Question/Purpose:  Millions of Americans have dementia, 
the loss of mental functions, e.g., thinking, memory, and reasoning, which interferes with 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 12 of 49 
Template Revised On: 11/1/2021      
their daily functioning. While some cases of dementia are caused by medical conditions 
that can be treated, most cannot be reversed. Hence, the focus switches from treatment 
to palliative care, i.e., developing a plan to make life easier and more comfortable for 
individuals with dementia and their caregivers. The proposed project will develop an 
important tool to improve the well-being for persons with dementia. There are three 
types of strategies that have been utilized to assist people with memory problems: 
repetitive drill and practice, internal strategies for remembering, and external aids to cue 
or assist people with remembering(1). Only the third strategy, using an external tool, has 
been demonstrated to improve social interactions for patients with AD(1-4). 
2.2 Preliminary Data: AME Corp. working with Dr. Joseph Gaugler at the University of 
Minnesota has recently completed a study of the use of a smartwatch to display the 
names of people in the vicinity that were identified by face recognition. AME called this 
system a Social Support Assistant (SSA). The SSA consisted of a smartwatch and a body 
worn device with a camera. The bodyworn device had a database of face images of the 
friends and family of the PWMC. Face recognition software in the bodyworn device 
matched the faces of people who approached the PWMC to the database. Each time a 
new face match occurred the picture and name would appear on the smartwatch. Other 
information could also appear to identify the relationship that person has with the PWMC. 
A phone app was developed that automated the creation of the face image database for 
the device worn by the PWMC’s. This app allowed a new person to take selfies of their 
face at different angles to optimize the face recognition success. Another person could 
also use the app to take the pictures if the new person being enrolled could not do it 
themselves. The testing successfully showed that PWMC liked using reminders about 
friends and family. 
2.3 Existing Literature: A recent review of intelligent assistive technology describes the 
products that have been or are under development for persons with dementia(5). It is 
significant that none of these devices has been tested in a clinical study with dementia 
subjects(5). There are also no electronic devices proposed to assist PWMC with the 
recognition of other persons. While little has been developed or tested for PWMC, 
electronic devices that store information and prompt users to attend to the information 
with alarm and messaging features have been tested with patients with memory 
impairments due to other neurological conditions with promising results(2). For all 
devices being developed for PWMC, it is important to consider their familiarity with the 
type of device prior to their disease due to their limited ability to learn new 
information(2). Aids that are simple to use and utilize familiar interfaces are most likely to 
be successful(2). 
 
3.0 
Study Endpoints/Events/Outcomes 
3.1 
Primary Endpoint/Event/Outcome:  
Phase I: Twenty care partners will complete a system review checklist and context of care 
items in a dyadic interview setting. The intervention will be considered successful if at 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 13 of 49 
Template Revised On: 11/1/2021      
least 75% of participants score an average of 4 (out of 5) points or higher on the checklist, 
indicating that SR met their needs (i.e., indicated agree or strongly agree that the SR was 
useful, acceptable, and feasible overall). This threshold has been used as a benchmark for 
success in prior research evaluating technological interventions for PWMC and their care 
partners(6-8). If the criteria for success are not met, the technology will be refined based 
on feedback and suggestions from PWMC and care partners, before conducting additional 
testing with the improved prototypes. Ample qualitative feedback will be available via the 
dyadic interviews to guide such refinement. 
Phase II: Baseline and 6 month data will be used in a 2x2 repeated measures analysis of 
covariance to examine whether use of the SR results in statistically significant changes in 
PWMC negative health transitions and , social interaction, pleasant events, social stress, 
loneliness, relationship closeness, and community engagement and care partner well-
being, such as social support, depression and burden (9). The primary independent 
variable in the proposed investigation consists of an indicator variable for random 
assignment into the SR treatment condition or the attention control group. Additional 
analyses will determine if covariates (context of care, mobile device proficiency, and 
dementia severity indicators) significantly vary across the SR treatment and attention 
control groups at baseline and over 6-months. If statistically significant variations between 
the SR treatment and control groups are found, baseline and/or change scores for these 
covariates will be included in all repeated measures analyses of covariance tests to 
provide additional statistical control. 
3.2  
Secondary Endpoint(s)/Event(s)/Outcome(s): We will apply a parallel convergent 
mixed methods design. Quantitative and qualitative data will be collected and analyzed 
separately, and then paired side-by-side for comparison(10, 11). Quantitative analyses are 
expected to provide breadth in presenting group-level trends, while qualitative analyses 
will provide insight into variation within these trends, and allow study participants to 
identify meaningful SR components for themselves. After independent quantitative and 
qualitative analyses, the results will be paired side by side for comparison. Researchers 
will identify and iteratively discuss areas of convergence and divergence to validate the 
results(10-13). 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 toward additional questions and analysis(12, 13). This comparative, 
mixed method analysis approach may suggest how and why PWMCs experience the 
greatest benefit while using the SR. 
 
4.0 
Study Intervention(s)/Interaction(s) 
4.1  
Description: Researchers will interact with study participants during Phase I and 
Phase II (Table 1). In Phase I, researchers will enroll 20 PWMC and their care partners to 
participate in a dyadic interview session. The dyadic interviews will occur via the HIPAA-
compliant video conferencing platform, Zoom. The interviews will begin with questions 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 14 of 49 
Template Revised On: 11/1/2021      
about the participants’ technology use prior to and during the COVID-19 pandemic then 
participants will watch a brief instructional video followed by a question and answer 
session on the smartwatch technology, a verbally administered survey, and end with a 
semi-structured discussion about the SR. In Phase II, researchers will enroll 100 PWMC 
and their care partners to participate in initial, 3-month, and 6-month surveys. Half of the 
dyads will be randomly assigned to receive the smartwatch technology for a 6-month 
period and the other half will be randomly assigned to the usual care control group. 20 
PWMC and their care partners who receive the smartwatch technology will be asked to 
participate in a semi-structured interview in the month following their 3 or 6-month 
survey. 
 
Table 1. Phase I and II Schedule for AME Developers and UMN-Affiliate Researchers 
 
Months 
1-6 
Months 
7-12 
Months 
13-24 
Months 
25-36 
Project Management: Weekly Web Conference and Annual 
In-Person Meetings 
● 
● 
● 
● 
● Recruit and train RA  
● Build Smartwatch Reminder 
● Data management and entry protocols 
● 
○ 
○ 
○ 
Phase I (Months 1-12) 
 
 
 
 
● Enroll 20 PWMC and their care partners 
● 
○ 
 
 
● Complete dyadic interviews      
● 
○ 
 
 
● Analyze Phase I qual/quan data 
● Refine Smartwatch Reminder content and protocol 
for Phase II 
○ 
● 
 
 
Phase II (Months 12-36) 
 
 
 
 
● Enroll 100 PWMC and their care partners 
 
 
● 
○ 
● Complete initial, 3-month, 6-month, and embedded 
qual data collection   
 
 
● 
● 
● Analyze qual/quan data  
 
 
○ 
● 
● Disseminate Phase II findings 
 
 
○ 
● 
NOTE: RA = research assistant; PWMC = persons with memory concerns; qual = qualitative; 
quan = quantitative; ● = primary focus; ○ = secondary focus 
 
5.0 
Procedures Involved 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 15 of 49 
Template Revised On: 11/1/2021      
5.1  
Study Design: The proposed study will enable us to investigate the utility of the 
Smartwatch Reminder for individuals with varying degrees of memory concern. We will 
evaluate the immediate utility of the Smartwatch for persons with memory concern, and 
determine the extent to which participants practice using the system in the three months 
after it is introduced.  By including participants with mild-to-moderate cognitive 
impairment we will also ascertain the feasibility of starting to use the Smartwatch system 
at a time when participants may immediately benefit from the cues and information 
provided by the system. Through interview questions, we will probe PWMC and their care 
partners to understand if using the Smartwatch in the early stages of cognitive decline is a 
valuable experience and if they would consider using the Smartwatch as the PWMC 
experiences cognitive decline. 
AME has assembled an interdisciplinary team with the necessary skills to achieve the 
objectives of the project and effectively carry out the study design (Figure 1). Mr. Havey at 
AME is an experienced Primary Investigator with decades of project management and 
electronics engineering experience. AME’s Dan Hedin has worked on multiple smartphone 
and smartwatch projects and has published papers on them. Greg Seifert and Paul Gibson 
at AME are the Technical Managers on the study. AME has also partnered with Matt 
Knutson, Louis Barrett and Kevin Kramer as engineers.   
Figure 1. Structure of Industry and Academic Study Collaborators 
 
The Principal Investigator in Phase I, Dr. Gaugler, PhD, at the University of Minnesota has 
an established track-record of conducting research on PWMC and their care partners. He 
has built on his well-established research foci to apply novel technologies that assist 
family and professional caregivers of persons with dementia. The Principal Investigator in 
Phase II, Dr. Jude Mikal, at the University of Minnesota has acted as a consultant to faculty 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 16 of 49 
Template Revised On: 11/1/2021      
and investigative teams in the areas of project development, research design, and grant 
development. In addition, he is an expert in qualitative research methods, transition-
related stress, computer-mediated communication and computer-mediated social 
support. Collaborating Co-Investigators on this project include Dr. Mitchell (PhD and 
Assistant Professor of Psychology at Emmanuel College), Dr. Finlay (PhD and Postdoctoral 
Research Fellow in the University of Michigan Institute for Social Research), and Dr. 
Jutkowitz (PhD and Assistant Professor in the Brown School of Public Health and 
researcher at the Center of Innovation in Long-Term Services and Supports at the 
Providence VA Medical Center). The Co-Is have collaborated extensively with Dr. Gaugler 
and each other on multiple evaluations of interventions and services for PWMC, including 
innovative technological interventions in dementia care projects. This includes evaluating 
a remote activity monitoring program that installed sensors in the home of a PWMC. Each 
investigator also has independent expertise in qualitative, quantitative, and mixed-
methods research and participation in multiple randomized trials. Dr. Mitchell is a 
psychologist with expertise in social support and adult development, and a focus on mixed 
methods. Dr. Finlay is a health geographer and environmental gerontologist whose 
methodological expertise include global positioning systems tracking, in-person and 
virtual geospatial audits, interviews, surveys, and cognitive and physical testing. Dr. 
Jutkowitz is a health services researcher focused on understanding the cost and value of 
care provided to individuals with PWMC. His prior work includes conducting a cost-
effectiveness study alongside a randomized trial evaluating a dementia caregiver support 
program and evaluating the effect of cognitive decline on time spent providing informal 
caregiver. Our team of collaborators is well-positioned to conduct an evaluation of the 
Smartwatch Reminder (SR). 
 
5.2  
Study Procedures:   
Phase I Feasibility Pilot Study 
Overview. The objective of Phase I is to make an initial, limited assessment of the value of 
the Smartwatch Reminder (SR) for PWMC and their care partners. 
Phase I Sample Size. The academic team will purposively sample 20 dyads (PWMC and 
their care partners) of varying kin relationships (adult child vs. spouse), gender, and 
race/ethnicity to participate in Phase I feasibility testing.  
Phase I Procedure. A parallel-convergent mixed methods design (QUAN+QUAL) will be 
used to generate qualitative and quantitative data on the feasibility and utility of the SR 
system.  
1. Initial Contact: During initial contacts with potential participants, the RA will explain the 
study procedures and invite care partners to participate in the study. Care partners will 
have the opportunity to ask questions about the study procedures. 
2. Enrollment: If the care partner agrees to participate, the RA will screen the participant 
and schedule the dyad for a      dyadic interview session (see Section 9, “Study 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 17 of 49 
Template Revised On: 11/1/2021      
Population”). An email will be sent to the participants containing an instructional 
pamphlet to read over before the interview. 
3. Consent: The RA will first ensure that the dyad is able to use the video conferencing 
platform and troubleshoot any issues that may have occurred. The RA will then obtain 
informed consent from the care provider and PWMC (see Section 21, “Consent Process”).        
4. Dyadic Interview Sessions: The RA will digitally record each session. Audio recordings will 
be transcribed by a professional transcriptionist. The interview      will begin with the 
context of care questions (see Appendix). Participants will then be asked questions on 
technology use prior to and during the COVID-19 pandemic. The RA will then play a video 
on how to use the SR system to the PWMC and their care partner. Next, participants will 
ask the RA questions they have about how the technology works (e.g., navigating the 
smartphone app; entering new profiles, photos, and information; using the smartwatch to 
identify the caregiver and other persons nearby).  
 
Immediately after the SR tutorial, participants will be asked to complete a brief survey 
including the SR checklist to evaluate their perceptions of the technology. Questions will 
be asked verbally during the interview session. The SR checklist includes Likert items 
designed to measure both the PWMC and care partners’ perceptions of the performance 
of SR in terms of ease of use, clarity, and quality of information provided.  
 
The RA will then ask the participants semi-structured questions      to elicit open-ended 
data on the feasibility and utility of SR (see Appendix). The interview questions include 
prompts about technology more generally to elicit feedback about opportunities and 
barriers for technology to assist care partners and PWMC in navigating everyday life. This 
will provide a more comprehensive perspective regarding the feasibility and use of the SR 
system.  Participants      will provide in-depth information on the reasons why PWMC and 
care partners felt the SR will or will not be  easy to use, and will point out barriers or 
facilitators to use that will be critical to address when refining SR prior to Phase II.  
 
Phase I Data Collection.       
18-item system review checklist. This will be completed verbally by      care partners and 
PWMCs during the dyadic interviews. The checklist includes Likert items designed to 
measure both the PWMC and care partners’ perceptions of the performance of SR in 
terms of ease of use, clarity, and quality of information provided.  
Context of care.  Questions will be completed verbally during the dyadic interviews. Care 
partners and PWMCs can  complete the context of care variables. It includes items on 
geographic location, time since diagnosis, type of dementia diagnosis, Medicaid status, 
living arrangement of the PWMC, and demographics of the PWMC and the care partner. 
 
Semi-structured questions. The RA will conduct dyadic interviews with Phase I 
participants to elicit open-ended data on the feasibility and utility of SR. Questions will 
also elicit feedback on how participants’ technology use has changed due to the COVID-19 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 18 of 49 
Template Revised On: 11/1/2021      
pandemic. The semi-structured questions will provide in-depth information on the 
reasons why PWMC and care partners felt the SR was or was not easy to use, and will 
point out barriers or facilitators to use that will be critical to address when refining SR 
prior to Phase II (33). 
 
Phase II. Evaluate the Smartwatch Reminder Efficacy 
Overview of Phase II. The primary goal of the SR is to facilitate social interaction for 
PWMC by providing facial recognition of family, friends, and other key people. In this 
Phase II study, the SR will be evaluated to determine whether it provides positive benefits 
for PWMC’s social interactions and well-being.  
Phase II Sample Size. 100 dyads (PWMCs and their care partners) will be enrolled. Half of 
the PWMCs will be randomly assigned to the intervention group (i.e., use of SR) and half 
to the attention control group. The intervention group will receive the SR.  
Procedure. An embedded experimental mixed methods design 
([QUAN+qual]→[QUAN+qual])(12) will be utilized to combine the collection and analysis 
of qualitative data within a traditional randomized controlled trial design(12). This will 
assist the project team in examining the process of the SR’s implementation during the 
evaluation to determine whether or not and why the SR worked for PWMCs and their care 
partners(12, 34, 35). 
Pilot Testing. Prior to initiating full recruitment, we will pilot test the Smartwatch System 
technology among 1-2 dyads. This will ensure that any possible bugs in the Smartwatch 
System are worked out before many more dyads are enrolled and given the technology. If 
no or very minimal problems are found, the 1-2 dyads would remain in the study and be 
included in the total of 100 dyads recruited. If many problems are found, the 1-2 dyads 
would remain in the study, but their data would not be used, so 100 more dyads would 
still need to be recruited.  
1. Initial Contact: During initial contacts with potential participants, the RA (or, if needed, 
Drs. Mitchell, Mikal and Jutkowitz or the research coordinators) will explain the study 
procedures and invite care partners to participate in the study. Care partners will have the 
opportunity to ask questions about the study procedures. 
2. Enrollment: If the care partner agrees to participate, the RA will schedule a brief 
screening and enrollment procedure using the inclusion criteria (see Section 9, “Study 
Population”). The RA will obtain informed consent/assent from the care partner and 
PWMC (see Section 21, “Consent Process”). 
3. Baseline survey: Following enrollment, a baseline survey will be administered to both the 
CP and PWMC (either online in Qualtrics or via mail, if preferred) within 2 weeks of 
enrollment (see Appendix). The RA will administer this prior to exposure to the 
intervention/attention control. 
4. Randomization: Following completion of the baseline survey, PWMC and their care 
partners will be randomly assigned to the SR treatment condition that receives full access 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 19 of 49 
Template Revised On: 11/1/2021      
to the SR along with the training procedures 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 Dr. Mikal. For those in the SR 
treatment group, the research coordinator will schedule a time to introduce the SR to the 
PWMC and the care partner via Zoom or telephone.  
To ensure blinding is maintained, the RA will not have access to the password-protected 
database containing participants’ group assignment, and will not review survey data 
completion (which would un-blind the RA since all of the treatment participant follow-up 
surveys will contain the system review and all control participant follow-up surveys will 
not). Additionally, opaque, sealed envelopes will be created for the research coordinator 
to reveal which group each participant was randomized into. The outside of each 
envelope will be labeled with a dyad’s ID and the inside will contain their group 
assignment, which will ensure integrity of the randomization order since no one will be 
able to change the order once the envelopes are created. 
5. 3-month survey or contact call: A survey will be administered (either online in Qualtrics 
or via mail, if preferred) by the RA to all participating care partners and PWMC 3 months 
following enrollment. A brief disposition survey will be administered before the 3- and 6-
month follow-up surveys to determine if the PWMC has moved or passed away. A system 
review of the SR will be assessed via a checklist and open-ended questions (see Appendix) 
and will be sent only to dyads in the intervention group in their follow-up survey (the RA 
will remain blinded because they will email participants personalized links to the survey 
which do not indicate whether the participant is receiving the SR system review or not in 
their follow-up survey). The attention control group will receive a 3-month contact call 
from the research coordinator. Based on our prior experience, PWMC and care partners in 
an attention control group will often seek information and psychosocial support during 
these calls. We will provide free information resources (e.g., brochures or websites of the 
Alzheimer’s Association). See section 10.2 about re-assessing each PWMC’s capacity to 
consent at each time point.  
6. 6-month survey or contact call: A survey will be administered (either online in Qualtrics 
or via mail, if preferred) by the RA to all participating care partners and PWMC 6 months 
following enrollment. A brief disposition survey will be administered before the 3- and 6-
month follow-up surveys to determine if the PWMC has moved or passed away. 
Additionally, a system review of the SR will be administered by the RA to participating 
care partners and PWMC in the intervention group 6 months following enrollment (while 
remaining blinded). The attention control group will receive a 6-month contact call from 
the research coordinator.  
7. Data tracking for 6 months: Detailed data on frequency and duration of use by PWMC 
and their care partners will be tracked directly by the SR, allowing for an analysis of exact 
utilization and practicality (i.e., how long and often PWMC and their care partners actually 
use the technology). This data will be shared with us securely via Box by AME. 
8. Semi-structured interview: 20 semi-structured interviews will take place up to one month 
after completion of the final 6-month follow-up survey with intervention group 
participants only. Due to a change in study funding and timeline, as of 9/1/23, to meet the 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 20 of 49 
Template Revised On: 11/1/2021      
20 semi-structured interviews, some semi-structured interviews will now take place 
following the 3-month follow up survey with intervention participants. Dyads will 
complete only one interview at 3 or 6 months, not at each time point.  
Note: Baseline and follow-up surveys and interviews will be in a format that is convenient 
to care partners and PWMCs: through online or mail formats, whichever is desired by the 
individual. Each baseline survey is anticipated to take no more than 45 minutes to 
complete with follow-up surveys expected to take approximately 20-30 minutes to 
complete. If the PWMC has passed away or moved into a long-term care facility as 
determined by the brief disposition survey at 3- or 6-months, the PWMC would not be 
administered any additional surveys and the care partner would receive shortened follow-
up surveys if they agree to continue, depending on the person with memory concern’s 
scenario (bereavement or transition to a long term care/assisted living facility).  
The RA will complete disposition calls or emails ±7 days prior to a scheduled follow-up 
survey. The RA will contact care partners within 1 week of a missed survey to resend, and 
update participants’ contact information as needed throughout the project. RA will follow 
up with CG and PWMC via email reminders at 1, 2 and 3 weeks past the date a survey was 
sent if it is still incomplete. Additionally, at 3 weeks RA/RC will try to contact dyad via 
phone. If no response, participants will be considered lost to follow up (LTFU) for that 
time point. 
Note: If LTFU occurs at baseline, the dyad will be withdrawn from study as they were not 
randomized. 
An annual project newsletter will be sent to all participants to provide updates on study 
progress as well as provide seasonal caregiving tips. Finally, in order to provide additional 
rapport and incentive to participate in the attention control group, all PWMC and care 
partner dyads in the proposed project will be provided with up to a $100 participation 
incentive following completion of their 6-month survey (see more information in Payment 
section 12.5). Those in the treatment group who are selected for and complete a semi-
structured interview will receive an additional $50 participation incentive. 
Phase II Data Collection.  
The RA will administer the baseline and follow-up surveys at 3- and 6-months, and will be 
blinded to randomization. Completion of these follow-ups may occur outside of the 
timeframe for initial contact based on participant scheduling needs.  
Baseline, 3-Month and 6-Month Survey. The RA will administer all surveys (see 
Appendix). The surveys are designed to collect information from both PWMC and care 
partners. The selected measures have strong psychometric properties, sensitivity to 
change, and clinical relevance in the evaluation of health technology such as SR. Our past 
experience in distributing surveys of similar length indicate that they take PWMC and 
their care partners approximately 20-45 minutes to complete. Mean and sum scores will 
be calculated for all scales. 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 21 of 49 
Template Revised On: 11/1/2021      
● Context of care (baseline only). Care partners will complete context of care variables 
include geographic location, time since diagnosis, type of dementia diagnosis, Medicaid 
status, living arrangement of the PWMC, and demographics of the PWMC and the care 
partner. 
● Dementia severity. Care partners will complete validated measures of dementia severity 
including the PWMC’s dependence on assistance with 6 activity of daily living tasks and 
dependence on assistance with 6 instrumental activity of daily living tasks(16-18, 50-52). 
An 8-item scale will assess the intensity of PWMCs’ memory losses, communication 
deficits, and recognition failures at each time point (memory impairment)(19, 20). From 
the Dementia Severity Rating Scale, we are using one item about the PWMC’s recognition 
of others (53). Additionally, during screening, the PWMC will complete the Telephone 
Interview for Cognitive Status (TICS-40) developed from the Aging, Demographics, and 
Memory Study), which will assess their level of dementia severity at the beginning of the 
study (50). 
● Social interaction. Questionnaires will be administered to care partners to determine the 
frequency and quality of PWMCs’ interaction in six different areas: in-person visits; 
telephone/video calls; traditional mail correspondence, text messaging, or email;, and 
social media. Per the recommendations of prior research on informal long-term care, a 
prior week estimate will be completed that includes frequency and duration of each 
activity(22). A 7-day time-window was chosen as it is less prone to recall error. In addition 
to frequency data, satisfaction with the quality of interaction will be assessed on a simple 
5-point scale, similar to prior reliable measures utilized in Alzheimer’s disease and related 
dementias care partner intervention studies(23). 
● Pleasant Events/Social Engagement. Care partners will complete the Pleasant Events 
Schedule-AD (PES-AD) Short Version (24, 25) for PWMCs. The PES-AD Short Version 
includes 20 items of events and activities for PWMCs. As originally constructed, the items 
of the PES-AD were within the capacity of individuals suffering from the earlier/milder 
stages of dementia, and thus were appropriate for inclusion in this Phase II project(24, 
25). Items are rated according to their frequency during the past month and how much 
the PWMC enjoys the activity. An overall summary score assessing frequency of 
engagement in enjoyable activities is generated by multiplying each frequency and 
enjoyment item with each other and summing the resulting responses. The PES-AD has 
demonstrated excellent reliability and validity(24, 25). 
● Global Health. The PWMCs’ overall health and quality of life are being measured using the 
PROMIS Scale v1.2 – Global Health (26). This assesses various aspects of health and life, 
such as ratings of mood, satisfaction with social activities/relationships, average pain, etc. 
through a series of 10 questions asked of the PWMC.  
● Mobile Device Proficiency and social media use. The Mobile Device Proficiency 
Questionnaire (MDPQ-16; short form) is a 16-item scale used to measure how proficient 
the CP and PWMC are using various new technologies, such as tablets and their different 
features (27). The CPs’ social media usage is also being measured using 3 questions 
developed by the research team.   

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 22 of 49 
Template Revised On: 11/1/2021      
● Social Support/Loneliness. Socioemotional support will be measured on a five-item scale 
to assess the affective assistance provided to the care partners by relatives or friends at 
each time point(19, 20). The Lubben Social Network Scale-6 (LSNS-6) is a six-item scale 
that assesses social isolation among the CP and PWMC (55). Loneliness will be measured 
with the 3-item Short Scale for Measuring Loneliness in Large Surveys(28). 
● Care partner well-being. The 11-item Eriksonian Psychosocial Stage Inventory - Identity 
scale(29) will be administered to assess changes in identity coherence. The 10-item Center 
for Epidemiological Studies-Depression scale will be used to measure care partner 
depressive symptoms(30, 31). 
● Relationship closeness. A 6-item measure of Relationship Closeness (32) will be used to 
evaluate the quality of the relationship between the PWMC and their care partner. This 6-
item measure is part of the Stress Process Model for Residential Care (SPM-RC), 
developed by Whitlatch and colleagues and based on the Stress Process Model (SPM) for 
dementia caregiving. The measure assesses caregiver agreement with statements about 
their relationship with their relative using a 4-point Likert scale (1=strongly disagree, 
4=strongly agree). Higher scores indicate a closer relationship (range 6-24).  
● Community engagement. A 15-item survey developed specifically for the project will 
evaluate the PWMC’s typical social interactions and destinations accessed outside of the 
home. The survey evaluates average frequency of leaving the home; socializing in-person 
with family and friends; and destinations accessed including senior centers, gyms and 
recreational facilities, educational classes, libraries, faith services, club meetings, coffee 
shops/cafes, and parks. Following the 15-item survey, an open-ended question to be 
applied post-baseline asks in which situations the SR system was and was not useful, and 
why. 
● Caregiving Burden. A short version of the Burden Scale for Family Caregivers (BSFC-s) is a 
valid measure of subjective burden among family caregivers and is measured using 10-
items on a 4-point scale (54). 
 
Phase II will also feature 20 semi-structured interviews with purposively sampled dyads 
who are randomly assigned to receive SR. These interviews will take place up to one 
month after completion of the final 6-month follow-up survey. As of 8/31/2023 due to 
funding and timeline changes, interviews may also take place up to one month after 
completion of the 3-month follow-up survey. Dyads will only complete an interview at one 
time point (not both). It was determined that interviews at 3 months will be as rich in data 
as the 6 month surveys.  A sequential mixed methods sampling approach will be 
utilized(36) where the results of the first methodological strand will inform the selection 
of participants in this second methodological strand. Specifically, the academic 
collaborators (led by Dr. Mikal) will purposively select 10 dyads who report average 
system review checklist scores between 4 and 5 (i.e., SR met their needs) and 10 dyads 
who indicate average system review checklist scores of 3 and below (i.e., neutral and 
below regarding SR meeting their needs). A stratified purposive sampling approach will be 
applied: the academic collaborators will identify family care partners of different kin 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 23 of 49 
Template Revised On: 11/1/2021      
relationship (care partner is spouse vs. adult child), PWMC with varying dementia severity 
(middle versus late stage dementia symptomatology), caregiver gender, and racial or 
ethnic background of caregivers to participate. 
The open-ended responses of the semi-structured interviews will provide in-depth 
information on the reasons why dyads felt SR did or did not enhance their interactions 
with each other and their friends and family. The research assistant will schedule and 
conduct the semi-structured interviews and will digitally record each one with permission. 
If permission to record the interview is not granted, relevant field notes will be taken 
during and immediately following the interview. Audio recordings will be transcribed by a 
professional transcriptionist into a Microsoft Word file which will then be uploaded to 
NVivo (37) for subsequent analysis. This mixed methods design will allow the research 
team to link the efficacy results of the study to the thematic categories developed from 
the semi-structured interviews. 
 
5.3  
Follow-Up: N/A: The study team will not conduct long-term follow up with study 
participants.  
5.4  
Individually Identifiable Health Information: N/A: The research team will not 
access any medical records or other sources of private information about participants, 
apart from the information provided directly by participants in surveys, interviews, or 
direct communication with research team members.  
 
6.0 
Data Banking 
 
 
6.1 
Storage and Access:  Any datasets generated and/or analyzed and published or placed in a 
data repository will be de-identified.  
6.2 
Data: See 6.1.  
6.3 
Release/Sharing: 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 [unless permitted by law or regulatory oversight]. 
 
7.0 
Sharing of Results with Participants 
7.1 
A report of the study findings will be provided to participants via an infographic. 
The report will only include aggregated findings and de-identified participant quotes (no 
other individual-level data). 
8.0 
Study Duration 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 24 of 49 
Template Revised On: 11/1/2021      
8.1  
Phase I: Each individual participant will take part in Phase I of the study one time 
for a dyadic interview. We anticipate taking 6 months to enroll all 20 participants.  We 
expect all study procedures and data analysis to take 12 months total.  
Phase II: Each participant will take part in the study for a total of about 6 months (data 
collection at enrollment, 3, and 6 months).  We anticipate taking 12 months to enroll all 
100 dyads.  All study procedures and data analysis are anticipated to be completed within 
24 months. 
9.0 
Study Population 
9.1  
Inclusion Criteria: Inclusion criteria for PWMC are as follows: 1) English speaking; 
2) a physician diagnosis of early-stage Alzheimer’s disease or mild-to-moderate cognitive 
impairment; 3) live in the community (including at home with or without the care partner, 
in a retirement community, etc.); 4) no history of serious mental illness (i.e., any major 
psychiatric disorder) and 5) must have some level of cellular connection in their place of 
residence (if known). 
Care partners of PWMC must: 1) speak English; 2) be 21 years of age and over; 3) self-
identify as someone who provides assistance to the PWMC because of their memory loss 
(these individuals are called ‘‘care partners,’’ as these individuals may or may not provide 
the intensive hands-on care typical of ‘‘caregivers’’); and 5) indicate a willingness to use 
the smartwatch system as well as to being randomized to a control group. 
9.2  
Exclusion Criteria: Those who do not meet the criteria above will be excluded. 
Additionally, PWMC with severe or no dementia are not eligible.  
9.3 Screening: Potential participants will complete a brief screening survey prior to enrollment, 
including items assessing each of the inclusion criteria listed above.  Those who are considered 
eligible based on their responses will be invited to participate in the study. It is possible that 
potential participant informally screen as ineligible before completing a screener due to the 
natural progression of conversation via telephone or email. In these instances we would not 
continue to formally screener with those who we know are already ineligible. 
In Phase II, PWMC will be administered the TICS-40 (Telephone Interview for Cognitive Status- 
developed for the Aging, Demographics, and Memory Study) via Zoom or the telephone during 
screening (50). The TICS-40 is a brief, 17-item screening tool, with scores ranging from 0 to 40, 
that is used to screen for different levels of cognitive impairment. According to a crosswalk 
between the Mini-Mental State Exam and the TICS-40, cutoff TICS-40 scores for mild dementia 
are 17-24, for moderate dementia are 6-16, and severe dementia are 0-5 (51, 52). Individuals 
with scores indicating presence of mild or moderate dementia (scores from 6 to 24) will be 
eligible to participate in the research. Individuals without the presence of dementia or with 
severe dementia will not be eligible.   
 
10 Vulnerable Populations 
10.1 
Vulnerable Populations:  

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 25 of 49 
Template Revised On: 11/1/2021      
 
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 
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 
Excluded 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 26 of 49 
Template Revised On: 11/1/2021      
research during a stressful situation 
such as emergency room setting, 
childbirth (labor), etc. 
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:  
The smartwatch technology being tested in this study is designed to be used by 
persons with mild-to-moderate dementia severity.  Testing the feasibility and utility of 
the technology for persons with mild or moderate cognitive impairment is therefore 
an important research objective.  It is anticipated that the technology will be most 
useful to individuals whose memory has deteriorated enough to benefit from the cues 
and reminders provided by the smartwatch.  Therefore, moderate cognitive 
impairment may represent the least degree of impairment compatible with the aims 
of the study.  By including participants with mild-to-moderate cognitive impairment, 
we will learn whether the technology is feasible for various stages of cognitive 
impairment, whether the technology provides improvements in social interactions, 
and whether there are modifications that might improve the utility of the technology 
for PWMC. 
 
Due to the natural progression of AD/ADRD and the length of the study, PWMC will be 
reassessed for their capacity to consent and re-assent or re-consent to participate in 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 27 of 49 
Template Revised On: 11/1/2021      
the research at 3- and 6-month time points. We will use the UCSD Brief Assessment of 
Capacity to Consent to determine whether participants are capable of providing 
consent for themselves. Those who are not able to provide consent will be asked to 
re-assent to participate, in which case, assent will be documented by asked the 
participant to verbally sign an assent form (attached). Those who are able to provide 
consent will be asked to re-consent to participate using the brief follow-up consent 
form (attached).  
 
Since the study involves no invasive procedures, there will be no physical risks to study 
participants. Thus, no research-related injuries need to be disclosed as none are 
expected. The consideration of need is potentially stressful, and thus there are 
possible psychological risks for the PWMC and care partners. However, the research 
team has considerable experience providing psychosocial support to Alzheimer’s 
disease and related dementia caregivers on various research protocols, so serious 
psychological risks are unlikely to occur based on this experience. The potential social 
or legal risks for the participants relate only to possible violations of confidentiality.  
Participants with impaired capacity to consent will be closely monitored when first 
introduced to the smartwatch technology and taught how to use it; given that this 
technology is non-invasive, additional monitoring in Phase II will take place at the 3- 
and 6-month survey interviews.  Participants with memory concerns will be withdrawn 
from the study if they appear unduly distressed.  
We will use the UCSD Brief Assessment of Capacity to Consent to determine whether 
participants are capable of providing consent for themselves.  Those who are not able 
to provide consent personally will be asked to assent to participate.  In that case, 
assent will be documented by asking the participant to verbally sign an assent form 
(attached).  All potential participants will be informed of the research objectives and 
procedures to the greatest extent that is compatible with their understanding.  
Though not specifically targeted for inclusion, participants from some of the above 
groups (indicated in the table) may be allowed to participate, as indicated in the table. 
Participants will be reminded that all study procedures are voluntary and will not 
impact the care they receive from any institution. We do not anticipate any individuals 
from the above noted groups to have increased risk from participating in the proposed 
research, such as an increased risk of coercion, etc. Thus, our standard protocol 
practices (i.e. data security, confidentiality procedures, etc.) provide reasonable 
protections to these vulnerable participants.  
The research does involve cognitively impaired adults, or adults with fluctuating, 
diminished, or lacking capacity to consent, this the (CHECKLIST: Cognitively Impaired 
Adults (HRP-417)) below has been reviewed.  
10.2.1 This population must be included in the research study because they are 
part of the target population. By including this population in the research, 
we will learn whether or not the Smartwatch Reminder technology is 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 28 of 49 
Template Revised On: 11/1/2021      
helpful to PWMC and in what ways it may be helpful to them, as well as 
their care partners.  
10.2.2 Persons with Memory Concerns are being included in the study if they have 
the capacity to consent or not, because we need to know if individuals with 
lesser and higher degrees of cognitive impairment benefit from the SR or 
not. Individuals with severe cognitive impairment, such as late-stage 
dementia are not included in our study because we do not expect the SR to 
provide any benefit to this group. 
10.2.3 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 their family caregiver. Additionally, the person with 
memory loss either consents or assents to the research before each survey 
based on their 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 or because they 
would be ineligible (i.e. must live in the community therefore prisoners would be 
ineligible).  
 
11 Number of Participants 
11.1 
Number of Participants to be Consented:   
Phase I: 20 dyads, or 40 participants 
Phase II: 100 dyads, or 200 participants 
 
12 Recruitment Methods 
12.1 Recruitment Process: Participants will be recruited in various in-person and online 
ways using the approved text and images.  In person recruitment opportunities may 
include advertisements at memory clubs and programs for PWMC, through the Care 
Options Network, and at the annual Caring for People with Memory Loss 
Conference. Additionally, virtual recruitment via advertisement in the University of 
Minnesota Caregiver Registry and via newsletters shared by colleagues and 
professionals in this area of work are engaged with the target population.  The 
research coordinators, Dr. Mikal, Dr. Mitchell, Dr. Finlay, or Dr. Jutkowitz will initiate 
email, telephone, or mail contact with family members on the Registry and who 
respond to an advertisement, or those who complete a permission to contact form 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 29 of 49 
Template Revised On: 11/1/2021      
(sent out via emails, shared at the conference, via newsletters, etc.; attached). In 
addition, Dr. Mikal, Dr. Mitchell, Dr. Finlay, or Dr. Jutkowitz will ask professional care 
providers on the Registry to identify potential family members for recruitment 
purposes, including family members of diverse ethnic or racial origin and geographic 
location (given that many provide care to under-represented older persons). 
Snowball recruitment among potential/enrolled participants may also be used. In 
this case, following the initial screening conversation, potential participants may be 
asked if they know of anyone else who might be fitting for the study. If so, UMN 
staff will share an approved flyer for the [potential] participant to then share. If 
needed, participants will be recruited via ads on facebook and newspapers, on the 
National Institutes of Health-supported website called researchmatch.org, and other 
national research recruiting sites and registries fitting for this population (such as 
Banner Health and FTD Disorders Registry LLC). Using this method, only those who 
are interested are contacted.  
Registration forms for educational presentations (by study staff or other agencies) 
may include an opportunity for individuals interested to provide their permission for 
the research team to contact them to share additional information about the study. 
[Thus, by nature of this, UMN staff or other agency staff involved in planning, 
hosting, or post-webinar certificates will have access to the names/contact 
information of those indicating interest in receiving more information about the 
study]. Presentation “polls” may offer an additional opportunity for presentation 
attendees to provide permission for contact. Presentation slides may also be used 
during these community presentations to increase outreach. Hard copy permission 
forms may also be presented at in-person presentations. 
Note: General promotional materials/text (emails/newsletters/flyers/etc) are shared 
in the context of general promotional recruitment efforts. However, study staff do 
not pursue individualized study-related contact with potential participants until 
contact is made by an interested individual or a permission form/request for 
information is obtained. 
12.2 Source of Participants:  Participants will be community members who respond to a 
recruitment source listed in 12.1. Dr. Gaugler and his evaluation team developed 
and actively maintain the Caregiver Registry based on their community outreach and 
education efforts on Alzheimer’s disease and related dementias. All individuals in 
the Registry have provided permission for Dr. Gaugler and his team to contact them 
to participate in research. The registry includes 675 family members of PWMCs and 
316 professionals as of August 2018, and calls for new registry participants occur 
annually from March to June. 
12.3 Identification of Potential Participants: Individuals will self-identify as potential 
participants. Dr. Gaugler has developed and maintains the University of Minnesota 
Caregiver Registry based on his various community outreach and education efforts 
on Alzheimer’s disease and related dementias (#1007S85812). All individuals in the 
Registry have provided permission for Dr. Gaugler and his research staff to contact 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 30 of 49 
Template Revised On: 11/1/2021      
them to participate in research. Dr. Gaugler has conducted several prior and ongoing 
evaluations of early-stage dementia support programs throughout the 
Minneapolis/St. Paul area and works with several memory clubs and programs for 
PWMC. . Dr. Gaugler also directs the Center for Healthy Aging and Innovation which 
hosts events among our target population, which may also be used for recruitment. 
Finally, Dr. Gaugler is a member of the Care Options Network, and will post an 
invitation to participate to Network members. No medical records will be used to 
identify potential participants.  
12.3.1 For information contained in private/protected records, explain how the 
researcher has legitimate access to these records: N/A 
12.3.2 Dr. Mikal, Dr. Mitchell, Dr. Finlay, Dr. Jutkowitz, the research coordinators, 
or the research assistant will make initial contact with potential 
participants who respond to advertisements or complete a permission to 
contact form. 
12.3.3 No medical records will be used to identify potential participants. 
12.4 
Recruitment Materials: Flyers, emails, ads, and phone calls will be used for 
recruitment.  A copy of the flyer and email/phone script are included in the IRB 
application. 
 
12.5 
Payment: In order to provide additional rapport and incentive to participate, all 
care partner and PWMC dyads in the proposed project will be provided with up to a 
$100 participation incentive. Those who are selected and complete a semi structured 
interview will be provided an additional $50 participation incentive. Compensation will 
be mailed after completion of  participation (following the dyadic interview for Phase 
I, and after the 6 month assessment for Phase II). For phase II, dyads will receive a 
prorated amount based on the number of surveys completed ($33.00 for one, $66.00 
for two, or $100.00 for all three) The dyads will be compensated using Amazon gift 
cards. 
13 Withdrawal of Participants 
13.1 
Withdrawal Circumstances:  If instances of elder abuse or mistreatment are 
identified or reported to the research team, the Minnesota Adult Abuse Reporting 
Center will be contacted (1-844-880-1574) and the participant will be withdrawn from 
the study without their consent. 
 
Withdrawal Procedures: In instances where care partners or PWMCs wish to withdraw 
from the study, we will determine the reason for study withdrawal, and whether or 
not the care partner or PWMC agrees to still complete regular, brief surveys (either 
online or over the phone) to collect data on outcome variables.  Data prior to 
withdrawal will be used in subsequent analyses unless the dyad does not wish for 
their data to be included at all.  

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 31 of 49 
Template Revised On: 11/1/2021      
13.2 
Termination Procedures: Following completion of the Phase II study period, 
participants will be asked to return the SR technology to the research team.  We will 
thank them for participating and distribute compensation.  After all participants have 
completed their study period, we will clean and analyze the data, and generate 
reports of the findings.  Data will be securely stored for 5 years or until all 
dissemination efforts have been completed.    
14 Risks to Participants 
14.1  Foreseeable Risks: Since the study involves no invasive procedures, there will be 
no physical risks to study participants. The consideration of need is potentially stressful, and thus 
there are possible psychological risks for the PWMC and care partner. Since research team has 
considerable experience providing psychosocial support to Alzheimer’s disease and related 
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. 
Complete privacy cannot be guaranteed while using Zoom video conferencing, as some tools 
keep participant data, and we cannot guarantee others are not keeping a log of the discussion. 
Additional steps will be taken by password protecting these dyadic interviews. 
The experience of the University of Minnesota research team will minimize the possibility of 
psychological risks. The unlikelihood of such problems is evident from the absence of any 
clinically significant problems during the past fifteen years that Dr. Gaugler has operated various 
protocols related to dementia caregiving research. Additionally, as another safeguard, 
participants will receive a list of ADRD and caregiving resources (approved) at each time point 
with their baseline and follow-up surveys, during a time where sensitive questions may prompt 
emotional responses related to current and future situations. RA will be trained to interview in 
ways that are non-threatening, friendly, and respectful. 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 care partners or 
PWMCs 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. 
In the event a care partner or PWMC does become upset during the interview process, the RA 
will contact the PI who will be available for consultation. If a participant is in crisis because of 
their care situation or some other reason, research staff will be instructed to consult with the PI. 
With the participant’s 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 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 Ombudsman will be notified to protect the rights of persons with dementia and their 
families. 
There is a possibility that data collected by AME from the technology, such as location, could be 
lost. This is very unlikely to occur, but participants will be made aware of this risk prior to 
consenting.  

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 32 of 49 
Template Revised On: 11/1/2021      
14.2 
Reproduction Risks: N/A 
14.3  Risks to Others: N/A 
15 Incomplete Disclosure or Deception 
15.2 Incomplete Disclosure or Deception:  
This study will not use incomplete disclosure or deception. 
16 Potential Benefits to Participants 
16.1  Potential Benefits: We anticipate that using the smartwatch technology will 
benefit participants by improving social interactions and well-being.    
17 Statistical Considerations 
17.1  Data Analysis Plan:  
Phase I Quantitative Analysis: As the aim of Phase I is to examine the feasibility, acceptability, 
and utility of Smartwatch Reminder, the quantitative analyses of Phase I will largely rely on 
descriptive statistics. Specifically, Phase I quantitative analyses will utilize frequency tables and 
means to examine sample characteristics and item-level responses to the 18-item system review 
checklist and context of care items (see appendix). Mean scores for each item, as well as an 
overall summary score for each participant, will be calculated.  
Phase I Qualitative Analysis: Analyses of qualitative treatment fidelity data will primarily focus on 
thematic content analysis of open-ended data to examine Smartwatch 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(38, 39). 
Grounded theory techniques described by Morse(38) and Strauss and Corbin(39) will guide the 
analyses of qualitative data in this evaluation. These approaches allow participants to construct 
meanings, perceptions, and behaviors from their own vantage points. Dr. Mitchell and Dr. Finlay 
will lead open-coding of all available qualitative data: the interview transcripts and RA field notes. 
All qualitative data will be thematically analyzed using Braun and Clarke’s (2006) six steps of 
thematic analysis: (1) familiarization; (2) generation of initial codes; (3) search for themes; (4) 
review themes; (5) define and name themes; and (6) write up of themes analyzed. Researchers 
will follow an iterative process to continually identify themes, linkages, and explanations. Regular 
debriefing and audit trails (clear pathways detailing how the data are collected and managed) will 
enhance transparency and credibility(40). All open-ended data collected will be first read by Dr. 
Mitchell and Dr. Finlay 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). These themes will provide 
insights as to the SR’s implementation and use (i.e., treatment fidelity/process evaluation 
embedded component) and mechanisms of benefit (i.e., semi-structured interview embedded 
component). During weekly meetings in the analysis phase of the proposed project, Dr. Mitchell 
and Dr. Finlay 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 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 33 of 49 
Template Revised On: 11/1/2021      
audit trail). In addition, patterns that link particular themes will be identified and discussed in 
successive meetings between Dr. Mitchell and Dr. Finlay to identify more complex processes of 
Smartwatch use or this technology’s pathways to benefit PWMC and their care partners. During 
monthly team meetings, the development of codes, categories, and themes will be reviewed with 
the other academic investigators (Drs. Gaugler and Jutkowitz) and the AME team 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. 
Phase II Quantitative Analysis: Data available at baseline and 6 months will allow for a 2x2 
repeated measures analysis of covariance to examine whether use of the SR results in statistically 
significant changes in PWMC negative health transitions and , social interaction, pleasant events, 
social stress, loneliness, , relationship closeness, and community engagement and care partner 
well-being, such as social support, depression and burden (9). The primary independent variable 
in the proposed investigation consists of an indicator variable for random assignment into the SR 
treatment condition or the attention control group. IBM SPSS Statistics 21(41) will be used to 
conduct these analyses, as it supports a range of univariate, bivariate, and multivariate statistical 
analysis procedures. The team has extensive experience conducting longitudinal analyses on their 
prior research on dementia(5, 6, 42-44). Our proposed analyses will provide in-depth tests of the 
study hypotheses. Outcomes will include statistical significance of within-subjects, or 6-month 
change, in those in the Smartwatch Reminder treatment or control groups on key outcome 
variables (see above). Additional analyses will determine if covariates (context of care, mobile 
device proficiency,  and dementia severity indicators) significantly vary across the SR treatment 
and attention control groups at baseline and over 6-months. If statistically significant variations 
between the SR treatment and control groups are found, baseline and/or change scores for these 
covariates will be included in all repeated measures analyses of covariance tests to provide 
additional statistical control. 
Variations in SR use and setting: Empirical treatment fidelity data and context of care measures 
that assess heterogeneity in the use of SR within the treatment condition (e.g., frequency and 
duration of SR use) will be included as a series of additional analyses. These analyses will explore 
the effects of variations in SR use on the outcomes hypothesized above for PWMCs and their care 
partners. 
Phase II Qualitative Analysis: The methods described in Phase I Qualitative Analysis will be 
applied to the open-ended system review checklist responses, as well as the interviews gathered 
at the end of Phase II. 
Phase II mixed methods analysis: Researchers will apply a parallel convergent mixed methods 
design. Quantitative and qualitative data will be collected and analyzed separately, and then 
paired side-by-side for comparison(10, 11). Quantitative analyses are expected to provide 
breadth in presenting group-level trends, while qualitative analyses will provide insight into 
variation within these trends, and allow study participants to identify meaningful SR components 
for themselves. After independent quantitative and qualitative analyses, the results will be paired 
side by side for comparison. Researchers will identify and iteratively discuss areas of convergence 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 34 of 49 
Template Revised On: 11/1/2021      
and divergence to validate the results(10-13). 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 toward additional questions and analysis(12, 13). This comparative, mixed 
method analysis approach may suggest how and why PWMCs experience the greatest benefit 
while using the SRS. 
17.2 
Power Analysis:  
 
Phase I: The purpose of Phase I is to evaluate feasibility and utility of the SR 
system, and to identify areas for potential improvement of the technology.  The 
sample size of 20 dyads is appropriate for these objectives.  
Phase II: A repeated measures analysis of covariance (ANCOVA) will be utilized to 
capitalize on the randomized design and the two sets of data that will be collected. 
The number of PWMC-care partner dyads to be enrolled to address study 
hypotheses was determined using power analysis procedures(45, 46). A sample 
size of 100 to identify a medium statistical effect (standardized regression 
coefficient = 0.15) at a suitable level of statistical power (0.80 is considered an 
excellent power value) is able to effectively incorporate up to 6 baseline covariates 
that vary significantly across the randomly assigned Smartwatch Reminder 
treatment and control conditions if they exist (as random assignment is often used 
to ensure statistically comparable treatment and control conditions, we feel this is 
a conservative estimate of baseline covariates)(46). Specifically, we relied on 
statistical power tables by the expert statistician Cohen(46) to conduct our 
assessment of power. As noted in Table 2 of Cohen (1992)(45), an alpha level of 
.05, a medium effect size of .15 (as opposed to using specific measures, Cohen 
operationalized a medium effect size of .15 as one that is observable, and a survey 
across the social sciences suggested that this proposed effect size was close to the 
average of observed effects), and a multiple regression model (similar to an 
ANCOVA) that includes up to 6 covariates requires a sample size of 97. For these 
reasons, an expected sample size of 100 PWMC and care partner dyads will be 
sufficient to conduct the Phase II efficacy evaluation. We anticipate having less 
than a 3% attrition rate which will ensure we maintain sufficient power. As noted 
in various recommendations for mixed methods sampling, 20 participants is 
considered an adequate sample size for semi-structured interview protocols to 
ensure the richness and depth of open-ended data collected(36, 47). 
17.3  Statistical Analysis:  
Statistical analyses used will include calculation of frequencies, bivariate correlations, 
t-tests, chi-square tests, and repeated measures ANCOVA as detailed above. 
17.3 
Data Integrity:  
 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 35 of 49 
Template Revised On: 11/1/2021      
Several steps will be taken to ensure data quality. The psychometric properties of the 
study measures are generally well-established; however, additional steps will be 
taken to ensure the reliability and validity of the study measures. For example, 
internal reliability will be established with Cronbach's alpha (α) estimates for each 
measure and subscale. In addition, construct validity will be comprehensively 
assessed with a confirmatory factor analysis. In this particular method, individual 
items of each measure are loaded onto their latent construct. Indices of fit in 
structural equation models (e.g., Root Mean Square Error of Approximation = .05, 
Goodness of Fit Index =.97, Non-Normative Fit Index = .93 and Comparative Fit Index 
= .97; ‘excellent’ fit is demonstrated in models where p > .05, RMSEA < .05, GFI >.92, 
NNFI >.95 and CFI > .95)(32) then act as tests of significance for the construct validity 
of each measure. These procedures will help to establish the psychometric qualities 
of each tool beyond their utilization in prior study. Each outcome variable will be 
examined to determine if skewness exists or outliers are present. Normal probability 
plots and histograms of each dependent variable will be analyzed; this step is 
necessary because individual outcome variables must have near-normal distributions 
in order to be included in subsequent models. If the outcome variables are not 
normally distributed, the original variables can be subjected to algebraic 
transformations or other standard transformation techniques to meet model 
assumptions(9). 
 
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. 
 
18.2 
Identify the source of Private Health Information you will be using for your 
research (Check all that apply)   

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 36 of 49 
Template Revised On: 11/1/2021      
☐ 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: N/A, not reviewing records 
18.4 
Approximate number of records required for review: 
N/A 
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.  
 
 
Participants will be communicated with via telephone, Zoom, mail, and 
email. As part of the consent form, participants will agree or not to use 
unencrypted email for communication throughout the study. If a participant 
requests the use of encrypted emails, we will do so. PHI will not be sent to 
participants via any form of communication.  
18.6 
Access to participants 
Only participants who have consented and agreed to participate in the research 
will be included. All information obtained from the participants will remain 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 37 of 49 
Template Revised On: 11/1/2021      
strictly confidential and will not be released except at the express written 
request of the study participant. 
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:  https://remote-access.ahc.umn.edu S:\Public_Health_Center-on-
Aging\Mikal\Smartwatch Memory Aid Troy Karkula 
 ✔ Store 
 
✔ Analyze 
✔ Share 
      In an AHC-IS supported desktop or laptop.  
Provide UMN device numbers of all devices:  
All data will be stored in an AHC-IE Data Shelter which is a virtual Windows server 
that provides researchers a secure environment in which to work with clinical data. 
All viewing and manipulation of the data will take place within the Data Shelter. All 
data is password protected and only personnel named on our IRB protocol will be 
given permission to login to the Shelter to view and analyze the requested data. 
Furthermore, per the policies of the AHC-IE, only authorized users who have 
completed HIPAA training will be granted access. The data will be maintained in the 
AHC-IE Data Shelter for 2-3 years after the conclusion of Phase II, which is the time 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 38 of 49 
Template Revised On: 11/1/2021      
anticipated it will take to disseminate any and all research papers or presentations 
from these data. 
 
       Store 
      Analyze 
      Share 
✔ Other.   
 Similarly, paper forms of the data will be located in a locked file cabinet in Dr. 
Mikal’s research office only accessible to him, and other approved research staff.  
Unless the data are being filed or accessed, these cabinets will remain locked. 
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 
☐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: Semi-structured interview recordings will be 
sent to ProductionTranscripts for transcription. Audio recordings and transcripts are 
shared between the UMN and ProductionTranscripts via ProductionTranscripts’ 
secure transfer website. De-identified transcripts may be analyzed in NVivo 
software, which is on the AHC Secure Server. On the AHC Secure Server, participant 
data may be analyzed using SPSS or R.  
18.9 Links to identifiable data: 2-3 years after phase II is completed, any identifiable data 
and the link will be destroyed.  
 
18.10 Sharing of Data with Research Team Members. Team members will have access to 
data on the server, Qualtrics, Box, and paper forms in Dr. Mikal’s office, as 
indicated above.  
 
18.11 
Storage of Documents: paper forms of the data will be located in a locked 
file cabinet in Dr. Mikal’s research office only accessible to him and other 
approved research staff.  Unless the data are being filed or accessed, these 
cabinets will remain locked. 
 
18.12 
Disposal of Documents: Identifiable data will be destroyed 2-3 years after 
the conclusion of phase II in order to disseminate findings.  

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 39 of 49 
Template Revised On: 11/1/2021      
19 Confidentiality 
19.1  
Data Security:  
A copy of the consent form or other research study information will not be placed in the 
participants’ medical, employment, or educational records.  
The research team will not access any medical records or other sources of private information 
about participants, apart from the information provided directly by participants in surveys, 
interviews, or direct communication with research team members.  
 
20 Provisions to Monitor the Data to Ensure the Safety of Participants 
20.1 Data Integrity Monitoring.  
As the proposed project will pose minimal risks to study participants the Principal 
Investigator (Dr. Gaugler in Phase I and Dr. Mikal in Phase II) and Co-Investigators, Dr. 
Mitchell, Dr. Finlay, and Dr. Jutkowitz, will serve as the primary monitoring entities of this 
study.  
 
In addition to ongoing review of protocol and human subjects research compliance during 
weekly project meetings with research staff, the research coordinators and the Co-Is (Dr. 
Mitchell, Dr. Finlay, and Dr. Jutkowitz) will generate quarterly reports (every 3 months) 
and will randomly audit 3 cases every 3 months to ensure that each case complies with 
Institutional Review Board (IRB) requirements, including use of IRB-approved forms 
(particularly the verbal consent form) and that each staff person on the proposed project 
adheres to the study protocol.  In both weekly meetings and quarterly audit reports, the 
Co-Is will actively work with project staff to minimize research-associated risk and protect 
confidentiality of participant data (see Protection of Human Research Subjects).  
 
The research coordinators and the Co-Is, Dr. Mitchell, Dr. Finlay, and Dr. Jutkowitz, (who 
have oversight for the data management and analysis of the project), will produce a 
quarterly audit report that will highlight the results of the audit analysis as well as study 
progress.  In addition, the report 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 PI will review the audit report 
to ensure ongoing quality control, and will work with the Co-Is if needed, to ascertain if 
audited cases deviate from the approved study protocol.  Audit reports are described in 
more detail below. 
 
As noted above, the proposed study involves no invasive procedures and there will be no 
physical risks to study participants. The consideration of need is potentially stressful, and 
thus there are possible psychological risks for PWMC and their care partners. However, 
potential participants with a history of serious mental illness (i.e., any major psychiatric 
disorder) will not be included in the study and since the research team has considerable 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 40 of 49 
Template Revised On: 11/1/2021      
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. 
Quarterly audit reports.  The research coordinators and the Co-Is, Dr. Mitchell, Dr. Finlay, and Dr. 
Jutkowitz (who also have oversight for the data management and analysis of the project), will 
produce a quarterly audit report that will highlight the results of the audit analysis as well as 
study progress.  In addition, the report 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 PI will review the audit report to ensure 
ongoing quality control, and will work with the Co-Is if needed, to ascertain if audited cases 
deviate from the approved study protocol.  In instances of adverse events occurring, related to 
the intervention (see below), the PI, the NIA project officer, and the University of Minnesota IRB 
will be notified immediately. 
The audit reports will include the following: Table of contents, Narrative/trial summary, Summary 
of main findings, Discussion of issues or problems, Report preparation procedures, Study 
description, Project organizational chart, personnel, Brief statement of purpose of trial, Projected 
timetable and schedule, Study administration, Recruitment and participant status, Table 1: 
Enrollment by year or month of study, Figure 1: Comparison of target to actual enrollment by 
month, Forms status (e.g., consent, completing of screener, baseline assessment battery, etc.). 
20.2 Data Safety Monitoring.  
Monitoring study safety.  In both weekly meetings and quarterly audit reports, the Co-Is 
will actively work with project staff to minimize research-associated risk and protect 
confidentiality of participant data (see Protection of Human Research Subjects).  Research 
staff will be trained to interview in ways that are non-threatening, friendly, and respectful.  
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 participants 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. 
 
In the event a participant does become upset during the interview process, research staff 
will contact the PI, who will be available for consultation.  If a participant is in crisis 
because of their care situation or some other reason, research staff will be instructed to 
consult with the PI.  With the participant’s 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 persons with dementia 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 Ombudsman will be notified to protect the rights of persons with dementia and their 
families.  
 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 41 of 49 
Template Revised On: 11/1/2021      
Reporting Adverse Events and Unanticipated Problems. In addition to ongoing monitoring of 
protocol and human subjects compliance and reporting and the production of bi-annual case 
audits to the PI, the Co-Is 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 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, the Co-Is 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.  The Co-Is will review study-related data on an ongoing 
basis and will alert the PI, University of Minnesota IRB, and the NIA program officer as well as NIA 
if these events occur.  Specifically, the Co-Is 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 
Smartwatch Reminder system.  All adverse event reports and any additional documentation will 
be further provided and collated in the quarterly audit reports for review by the PI, University of 
Minnesota IRB, and the NIA project officer. 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 42 of 49 
Template Revised On: 11/1/2021      
 
21 Compensation for Research-Related Injury 
21.1 
Compensation for Research-Related Injury:  
 
The research involves no greater than Minimal Risk to participants, and 
research-related injury is not anticipated.   
 
21.2 
Contract Language: N/A 
22 Consent Process 
 
22.1 
Consent Process (when consent will be obtained): 
 
In Phase I, care partners and PWMC will take part in a brief consent and enrollment procedure via 
Zoom, during the first hour of the dyadic interview. The research staff will read the verbal 
consent form verbatim over Zoom to the care partners, and give them the opportunity to ask 
questions prior to consenting to participate. Care partners will be asked to provide verbal consent 
to participate after the consent form is read to them verbatim. Completed consent forms will be 
emailed to care partners and PWMC for their records. In Phase II, care partners will be asked to 
provide verbal consent to participate. After volunteering to participate, the RA will schedule a 
brief screening, consent and enrollment procedure to take place either via Zoom or telephone.  
In Phase I and II, we will use the UCSD Brief Assessment of Capacity to Consent (UBACC) to 
determine whether PWMC participants are capable of providing consent for themselves. In phase 
I, we will also administer a cognitive screening test called the Mini-Cog to screen for presence of 
dementia. In Phase I, these will be administered via Zoom. The UCSD Brief Assessment of 
Capacity to Consent will be administered verbally, as usual in Phases I and II. In Phase II, 
individuals with a UBACC score of 14.5 or higher are considered able to have the capacity to 
consent and will be asked to consent to participation. While individuals with a UBACC score lower 
than 14.5 do not and will be asked to assent to participation. In Phase II, assent will be 
documented by asking the participant to verbally sign an assent form after it is read verbatim to 
them. Afterwards, the assent form will be emailed to the participant for their records. All 
potential participants will be informed of the research objectives and procedures to the greatest 
extent that is compatible with their understanding.  
All questions in the Mini-Cog are administered verbally except for one question that requires 
drawing of an analog clock face. To administer this question will ask the care partner to draw a 
circle on a standard sheet of paper so the PWMC can complete the assessment by drawing the 
clock face on the circle. The RA will show the care partner a piece of paper with a circle drawn on 
it for reference to ensure proper circle size. Those with a Mini-Cog score of 3 or higher and are 
able to provide consent personally will be asked to provide verbal consent for Phase I.  Those 
who are not able to provide consent personally or with a Mini-Cog score of 2 or below will be 
asked to assent to participate. In that case, assent will be documented by asking the participant 
to verbally sign an assent form after it is read verbatim in Phase I  (attached). In Phase I, the 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 43 of 49 
Template Revised On: 11/1/2021      
assent form will be emailed to the participant for their records.  All potential participants will be 
informed of the research objectives and procedures to the greatest extent that is compatible with 
their understanding. Participants with impaired capacity to consent will be closely monitored, 
and will be withdrawn from the study if they appear unduly distressed. We will re-administer the 
UBACC  during follow-up with Phase II participants who are PWMC to ensure ongoing consent or 
assent to participation. 
 
In Phase II, dyads will be encouraged to go through the consent process together at the same 
time, such as on Zoom. However, not all dyads will live together or have access to Zoom 
technology. Therefore, CP and PWMC will have the option of consenting over the phone. 
Additionally, CP will have the option of filling out their consent form online in Qualtrics once it 
has been summarized for them over the phone. Given the nature of administering the UBACC and 
the consent/assent process for PWMC, they can only provide consent/assent over the phone or 
Zoom.  
 
Due to the natural progression of AD/ADRD and the length of the study, PWMC will be reassessed 
for their capacity to consent and re-assent or re-consent to participate in the research at 3- and 
6-month time points. We will read a script to the CP over the telephone to communicate our 
follow-up procedures. We will then use the UCSD Brief Assessment of Capacity to Consent to 
determine whether PWMC are capable of providing consent for themselves. Those who are not 
able to provide consent will be asked to re-assent to participate, in which case, assent will be 
documented by asking the participant to verbally sign an assent form (attached). Those who are 
able to provide consent will be asked to re-consent to participate using the brief follow-up 
consent form (attached). Prior to beginning the semi-structured interview (within one month of 
the 3 or 6-month PWMC reassent/consent), a brief Informed Particpation statement will be read 
to the Care Partner and Person with Memory Concerns, then allowing each of them to ask 
questions or decide not to participate. If needed, the research coordinator or research assistant 
will resend the 3 or 6 month consent/re-assent form for full details. 
              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):  
Due to COVID-19 concerns for the vulnerable population being studied and to improve 
convenience for dyads, UMN staff will administer a verbal consent form to participants via 
Zoom or the telephone using a consent script. A verbal consent or assent form will be 
administered to PWMC, as determined by scores on the UCSD Brief Assessment of Capacity 
to Consent, via Zoom using a script.  As all scripts state, participants will be asked if they have 
any questions regarding the study prior to asking for their consent or assent to participate. 
The research staff will document the care partner and PWMC’s's verbal consent or assent by 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 44 of 49 
Template Revised On: 11/1/2021      
signing the form. This consent and assent forms will be completed by the research team or 
participants electronically via Qualtrics. 
The consent and assent forms/scripts were developed using IRB-templates. If a participant 
enrolls, a copy of the completed consent or assent form (signed by the research team if 
consenting online) will be emailed to the participant for their records.  
 The study does not involve newborn dried blood spots.  
 
22.4 Non-English Speaking Participants:   
N/A – All participants will be English-speaking 
22.5 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 years of 
age): 
N/A – All participants will be over the age of 18.  
22.6 Cognitively Impaired Adults, or adults with fluctuating or diminished capacity to 
consent: 
Care partners will be asked to provide verbal consent to participate. We will use the UCSD 
Brief Assessment of Capacity to Consent to determine whether PWMC participants are 
capable of providing consent for themselves.  Those who are not able to provide consent 
personally will be asked to assent to participate.  In that case, assent will be documented by 
asking the participant to verbally sign an assent form after it is read verbatim (attached).   All 
potential participants will be informed of the research objectives and procedures to the 
greatest extent that is compatible with their understanding. 
22.7 Adults Unable to Consent: 
22.7.1 Permission:  
The care partner enrolling in the study with the care recipient will be 
responsible for signing with the person with diminished capacity to 
consent. 
 
22.7.2 Assent:  
 
As noted above, we will use the UCSD Brief Assessment of Capacity to 
Consent to determine whether PWMC participants are capable of 
providing consent for themselves.  Those who are not able to provide 
consent personally will be asked to assent to participate.  In that case, 
assent will be documented by asking the participant to verbally sign 
an assent form after it is read verbatim (attached). 
22.7.3 Dissent:  

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 45 of 49 
Template Revised On: 11/1/2021      
The assent form will not be verbally signed by the person with 
diminished capacity to consent if they do not assent to participate in 
the research.  
23 Setting 
23.3 Research Sites:  
Participants will be recruited through the University of Minnesota Caregiver Registry. Dr. 
Gaugler and his evaluation team developed and actively maintain the Registry based on their 
community outreach and education efforts on Alzheimer’s disease and related dementias. All 
individuals in the Registry have provided permission for Dr. Gaugler and his team to contact 
them to participate in research. The registry includes 675 family members of PWMCs and 316 
professionals as of August 2018, and calls for new registry participants occur annually from 
March to June. The RA, Dr. Mikal, Dr. Mitchell, or Dr. Jutkowitz will initiate email, telephone, 
or mail contact with family members on the Registry. In addition, Dr. Mikal, Dr. Mitchell, or 
Dr. Jutkowitz will ask professional care providers on the Registry to identify potential family 
members for recruitment purposes, including family members of diverse ethnic or racial 
origin and geographic location (given that many provide care to under-represented older 
persons). In addition, Dr. Gaugler has conducted several prior and ongoing evaluations of 
early-stage dementia support programs throughout the Minneapolis/St. Paul area and works 
with several memory clubs and programs for PWMC. Dr. Gaugler will contact each of these 
programs, in addition to the early-stage services coordinator at the Minnesota-North Dakota 
Alzheimer’s Association Regional Office with whom he has collaborated to further identify 
PWMCs and their care partners for the proposed project. Dr. Gaugler also holds an annual 
Caring For Persons with Memory Loss Conference where participants will be recruited. Dr. 
Gaugler also directs the Center for Healthy Aging and Innovation which hosts events among 
our target population, which may also be used for recruitment. Participants may also be 
recruited via ads on Facebook or in newspapers. Finally, Dr. Gaugler is a member of the Care 
Options Network, and will post an invitation to participate to Network members. 
 
In Phase I, interaction with participants will take place in a HIPAA-compliant video 
conferencing platform, Zoom. In Phase II, interaction with participants will take place via 
telephone, email or Zoom communication. In other instances, if requested, interaction may 
take place in a private office room in Mayo Memorial Building (Dr. Mikal’s research office) . 
23.4 International Research:  
N/A – the research will only take place in Minnesota 
23.5 Community Based Participatory Research:  
N/A – the research will not involve community-based partners 
24 Multi-Site Research 
N/A 
25 Coordinating Center Research 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 46 of 49 
Template Revised On: 11/1/2021      
N/A  
26 Resources Available 
26.3 Resources Available:  
Advanced Medical Electronics (AME) has a 9,220 square foot office and engineering facility in 
Maple Grove, Minnesota. Design work will take place in this facility. A complete set of tools 
and resources are maintained in this facility for the design, testing, and manufacturing of 
electronic medical devices and their associated software packages. AME is well equipped 
with electronic test equipment including digital oscilloscopes, logic analyzers, frequency 
analyzers, signal sources, digital meters, and power supplies. AME maintains a prototype 
fabrication capability for electronics circuit assembly, metal-working, and plastic fabrication. 
Mechanical design tools include a full CAD seat of Pro-E. AME owns several embedded 
processor emulator systems to support the development of embedded code. AME maintains 
a suite of Silvaco, Inc. integrated circuit design CAD tools. More details for AME resources 
available to support the proposed research and development tasks are provided below in the 
equipment section. 
 
Dr. Gaugler is a Professor and Dr. Mikal is a Research Scientist at the University of 
Minnesota’s School of Public Health. The School of Public Health is among the top schools of 
public health in the nation. For the last four out of five years, the School has attracted more 
National Institutes of Health research funding than any other public university school of 
public health. The School has strong links to the community in our backyard and around the 
globe and has ranked in the top ten among public university schools of public health in total 
grants and contracts. The Division of Health Policy and Management’s educational programs 
feature five majors and dozens of opportunities for joint degrees and certificates. The 
Division has extensive research and educational management capabilities, including a full-
time administrator, several full-time student administrators, a financial management staff, 
computer services (including programmer/analysts), and an available publications staff. At 
present there are over 75 research projects underway totaling over $50 million dollars and 
employing over 90 research assistants. 
 
27 References 
 
1. 
Nolan BA, Mathews RM, Harrison M. Using external memory aids to increase room finding 
by older adults with dementia. Am J Alzheimers Dis Other Demen. 2001;16(4):251-4. PMID: 
11501349. 
2. 
Bourgeois MS, Hickey E. Dementia: From diagnosis to management-A functional 
approach: New York, NY: Taylor & Francis; 2011. 
3. 
Fried-Oken M, Rowland C, Baker G, Dixon M, Mills C, Schultz D, Oken B. The Effect of 
Voice Output on the AAC-Supported Conversations of Persons with Alzheimer's Disease. ACM 
Trans Access Comput. 2009;1(3):15. PMCID: PMC3141213. 
4. 
Bharucha AJ, Anand V, Forlizzi J, Dew MA, Reynolds CF 3rd, Stevens S, Wactlar H. 
Intelligent assistive technology applications to dementia care: current capabilities, limitations, and 
future challenges. Am J Geriatr Psychiatry. 2009;17(2):88-104. PMCID: PMC2768007. 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 47 of 49 
Template Revised On: 11/1/2021      
5. 
Gaugler JE, Zmora R, Mitchell LL, Finlay JM, Peterson CM, McCarron H, Jutkowitz E. Six-
Month Effectiveness of Remote Activity Monitoring for Persons Living With Dementia and Their 
Family Caregivers: An Experimental Mixed Methods Study. Gerontologist. 2019;59(1):78-89. 
PMID: 29982413; PMCID: PMC6326253. 
6. 
Mitchell LL, Peterson CM, Rud SR, Jutkowitz E, Sarkinen A, Trost S, Porta CM, Finlay JM, 
Gaugler JE. "It's Like a Cyber-Security Blanket": The Utility of Remote Activity Monitoring in 
Family Dementia Care. J Appl Gerontol. 2018:733464818760238. PMID: 29504488; PMCID: 
PMC6353693. 
7. 
Hamel AV, Sims TL, Klassen D, Havey T, Gaugler JE. Memory Matters: A Mixed-Methods 
Feasibility Study of a Mobile Aid to Stimulate Reminiscence in Individuals With Memory Loss. J 
Gerontol Nurs. 2016;42(7):15-24. PMCID: PMC5458778. 
8. 
Garlinghouse A, Rud S, Johnson K, Plocher T, Klassen D, Havey T, Gaugler JE. Creating 
objects with 3D printers to stimulate reminiscence in memory loss: A mixed-method feasibility 
study. Inform Health Soc Care. 2018;43(4):362-78. PMID: 28786714; PMCID: PMC6375677. 
9. 
Tabachnick BG, Fidell LS. Using multivariate statistics. 5th ed. Boston, MA: Allyn & 
Bacon/Pearson Education; 2007. 
10. 
Creswell JW. A Concise Introduction to Mixed Methods Research. Los Angeles, CA: 
SAGE Publications; 2014. 
11. 
Finlay JM, Kobayashi LC. Social isolation and loneliness in later life: A parallel convergent 
mixed-methods case study of older adults and their residential contexts in the Minneapolis 
metropolitan area, USA. Soc Sci Med. 2018;208:25-33. PMID: 29758475. 
12. 
Creswell JW, Clark VLP. Designing and conducting mixed methods research: Wiley Online 
Library; 2007. 
13. 
Morse J, Niehaus L. Mixed Method Design: Principles and Procedures. Walnut Creek, CA: 
Left Coast Press, Inc.; 2009. 
14. 
Backinger CL, Kingsley PA. Write it right: Recommendations for developing user 
instruction manuals for medical devices used in home health care. Washington, DC: Food and 
Drug Administration, 1993 HHS Publication FDA 93-4258. 
15. 
Tariq SH, Tumosa N, Chibnall JT, Perry MH 3rd, Morley JE. Comparison of the Saint 
Louis University mental status examination and the mini-mental state examination for detecting 
dementia and mild neurocognitive disorder--a pilot study. Am J Geriatr Psychiatry. 
2006;14(11):900-10. PMID: 17068312. 
16. 
Katz S, Ford AB, Moskowitz RW, Jackson BA, Jaffe MW. Studies of Illness in the Aged. 
The Index of Adl: A Standardized Measure of Biological and Psychosocial Function. JAMA. 
1963;185:914-9. PMID: 14044222. 
17. 
Graf C. The Lawton instrumental activities of daily living scale. Am J Nurs. 2008;108(4):52-
62; quiz -3. PMID: 18367931. 
18. 
Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental 
activities of daily living. Gerontologist. 1969;9(3):179-86. PMID: 5349366. 
19. 
Anashensel CS, Pearlin CI, Mullan JT, Zarit SH, Whitlatch CJ. Profiles in caregiving: The 
unexpected career. San Diego, CA: Academic Press; 1995. 
20. 
Pearlin LI, Mullan JT, Semple SJ, Skaff MM. Caregiving and the stress process: an 
overview of concepts and their measures. Gerontologist. 1990;30(5):583-94. PMID: 2276631. 
21. 
Teri L, Truax P, Logsdon R, Uomoto J, Zarit S, Vitaliano PP. Assessment of behavioral 
problems in dementia: the revised memory and behavior problems checklist. Psychol Aging. 
1992;7(4):622-31. PMID: 1466831. 
22. 
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):205-31. PMID: 12148687. 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 48 of 49 
Template Revised On: 11/1/2021      
23. 
Roth DL, Mittelman MS, Clay OJ, Madan A, Haley WE. Changes in social support as 
mediators of the impact of a psychosocial intervention for spouse caregivers of persons with 
Alzheimer's disease. Psychol Aging. 2005;20(4):634-44. PMID: 16420138. 
24. 
Logsdon RG, Teri L. The Pleasant Events Schedule-AD: psychometric properties and 
relationship to depression and cognition in Alzheimer's disease patients. Gerontologist. 
1997;37(1):40-5. PMID: 9046704. 
25. 
Teri L, Logsdon RG. Identifying pleasant activities for Alzheimer's disease patients: the 
pleasant events schedule-AD. Gerontologist. 1991;31(1):124-7. PMID: 2007468. 
26. 
Pellicciari, L., Chiarotto, A., Giusti, E., Crins, M. H. P., Roorda, L. D., & Terwee, C. B. 
(2021). Psychometric properties of the patient-reported outcomes measurement information 
system scale v1.2: global health (PROMIS-GH) in a Dutch general population. Health and Quality 
of Life Outcomes, 19(1), 226-226.  
27. 
Roque, N. A., & Boot, W. R. (2018). A new tool for assessing mobile device proficiency in 
older adults: the mobile device proficiency questionnaire. Journal of Applied Gerontology, 37(2), 
131-156. 28. Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring 
Loneliness in Large Surveys: Results From Two Population-Based Studies. Research on Aging. 
2004;26(6):655-672. doi:10.1177/0164027504268574 
   
29. 
Rosenthal DA, Gurney RM, Moore SM. From trust on intimacy: A new inventory for 
examining erikson's stages of psychosocial development. J Youth Adolesc. 1981;10(6):525-37. 
PMID: 24310543. 
30. 
Radloff LS. Scale: A Self-Report Depression Scale for Research in the General 
Population. J Clin Exp Neuropsychol. 1977;19:34-356. 
31. 
Weissman MM, Sholomskas D, Pottenger M, Prusoff BA, Locke BZ. Assessing depressive 
symptoms in five psychiatric populations: a validation study. Am J Epidemiol. 1977;106(3):203-14. 
PMID: 900119. 
32. 
Whitlatch CJ, Schur D, Noelker LS, Ejaz FK, Looman WJ. The stress process of family 
caregiving in institutional settings. Gerontologist. 2001;41:462-473. 
33. 
Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan 
CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 
2009;36(5):452-7. PMCID: PMC2859314. 
 
34. 
Creswell JW, Fetters MD, Plano Clark VL, Morales A. Mixed methods intervention trials. 
In: Andrew S, Halcomb EJ, editors. Mixed Methods Research for Nursing and the Health 
Sciences: Oxford: Wiley-Blackwell; 2009. p. 161-80. 
35. 
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. PMID: 14731152. 
36. 
Teddlie C, Yu F. Mixed methods sampling a typology with examples. J Mix Methods Res. 
2007;1(1):77-100. 
37. 
Richards L. NVivo Qualitative Data Analysis Software Version 11.0. 2016. 
38. 
Morse JM, Field PA. Qualitative research methods for health professionals. Sage; 1995. 
39. 
Straus A, Corbin J. Basics of qualitative research: Techniques and procedures for 
developing grounded theory. 2nd ed. 1998. 
 
40. 
Marshall C, Rossman GB. Designing qualitative research: SAGE Publications; 2014. 
41. 
IBM Corporation. IMB SPSS statistics for Windows. 2012. 
42. 
Finlay JM, Davila H, Whipple MO, McCreedy EM, Jutkowitz E, Jensen A, Kane RA. What 
we learned through asking about evidence: A model for interdisciplinary student engagement. 
Gerontol Geriatr Educ. 2018:1-15. PMID: 29364792; PMCID: PMC6057849. 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: A Mobile Informatics Solution to Aid in Memory 
VERSION DATE: 7/1/2022 
 
Page 49 of 49 
Template Revised On: 11/1/2021      
43. 
Jutkowitz E, Kane RL, Gaugler JE, MacLehose RF, Dowd B, Kuntz KM. Societal and 
Family Lifetime Cost of Dementia: Implications for Policy. J Am Geriatr Soc. 2017;65(10):2169-75. 
PMCID: PMC5657516. 
44. 
Jutkowitz E, MacLehose RF, Gaugler JE, Dowd B, Kuntz KM, Kane RL. Risk Factors 
Associated With Cognitive, Functional, and Behavioral Trajectories of Newly Diagnosed Dementia 
Patients. J Gerontol A Biol Sci Med Sci. 2017;72(2):251-8. PMCID: PMC5344797. 
45. 
Cohen J. A power primer. Psychol Bull. 1992;112(1):155-9. PMID: 19565683. 
46. 
Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Lawrence 
Erlbaum Associates, Publishers; 1988. 
47. 
Collins KM, Onwuegbuzie AJ, Jiao QG. A mixed methods investigation of mixed methods 
sampling designs in social and health science research. J Mix Methods Res. 2007;1(3):267-94. 
48. 
Gaugler JE. Final report: Contemporary journeys pilot evaluation. 2010. 
49. 
Gaugler JE. Final report: Discover your story. 2010. 
50.  
Langa K, M, Plassman B, L, Wallace R, B, Herzog A, R, Heeringa S, G, Ofstedal M, B, 
Burke J, R, Fisher G, G, Fultz N, H, Hurd M, D, Potter G, G, Rodgers W, L, Steffens D, C, Weir D, 
R, Willis R, J: The Aging, Demographics, and Memory Study: Study Design and Methods. 
Neuroepidemiology 2005;25:181-191. doi: 10.1159/000087448 
51.  
Fong TG, Fearing MA, Jones RN, et al. Telephone interview for cognitive status: Creating 
a crosswalk with the Mini-Mental State Examination. Alzheimers Dement. 2009;5(6):492-497. 
doi:10.1016/j.jalz.2009.02.007 
52.  
Perneczky R, Wagenpfeil S, Komossa K, Grimmer T, Diehl J, Kurz A. Mapping scores 
onto stages: mini-mental state examination and clinical dementia rating. Am J Geriatr Psychiatry. 
2006;14(2):139-144. doi:10.1097/01.JGP.0000192478.82189.a8 
53.       Clark CM, Ewbank DC. Performance of the Dementia Severity Rating Scale: A Caregiver 
Questionnaire for Rating Severity in Alzheimer Disease. Alzheimer Disease and Associated 
Disorders. 1996; 10 (1):31-39.  
54.       Graessel E, Berth H, Lichte T, Grau H. Subjective caregiver burden: validity of the 10-item 
short version of the Burden Scale for Family Caregivers BSFC-s. BMC Geriatr. 2014;14:23. 
Published 2014 Feb 20. doi:10.1186/1471-2318-14-23 
55.      Lubben, J., Blozik, E., Gillmann, G., IIiffe, S., von Renteln Kruse, W., Beck, J. C., & Stuck, 
A. E. (2006). Performance of an abbreviated version of the Lubben Social Network Scale among 
three European Community–dwelling older adult populations. Gerontologist, 46(4), 503–513.