Word Retrieval in the Wild: An Ecological Momentary Assessment Pilot Study in People With Post-Stroke Aphasia
Phase: NA
Conditions: Aphasia, Acquired
Sponsor: Northeastern University

Word Retrieval in the Wild: An Ecological Momentary Assessment Pilot Study in People with Post-
Stroke Aphasia 
Version 1.000
Protocol  
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Word Retrieval in the Wild: An Ecological Momentary 
Assessment Pilot Study in People with Post-Stroke 
Aphasia 
This title should include, where possible, information on the participants, condition being evaluated, and 
intervention(s) studied. 
Unique Protocol Identification Number:  
National Clinical Trial (NCT) Identified Number: 05338216 
Principal Investigator: Erin Meier 
Sponsor: Tufts Clinical and Translational Science Institute (CTSI) 
"Sponsor" indicates an institution, foundation, or individual who takes responsibility for and initiates a 
clinical investigation; often times this is the university with which the Principal Investigator is affiliated. 
Grant Title: Tufts CTSI NIH Clinical and Translational Science Pilot Stuy Award 
Grant Number: UL1 TR002544 
Funded by: NCATS 
Version Number: v.1.000 
15 March 2022 
All versions should have a version number and a date. Use an international date format (e.g.,YYYY-MM-
DD [2017-12-21] or write out the month (e.g., 21 December 2017). 
For the initial submission of a protocol to the IRB, indicate "Not applicable; this is the first version of the 
protocol." in the table below. For any subsequent amendment being submitted to the IRB, add details of 
the specific changes that are being implemented in the amendment. Please note that Section 10.4 is a 
high-level summary of all formal protocol versions/amendments. 
 
 
Participants may voluntarily withdraw from the study at any time. If a participant withdraws, the study 
team will obtain the reason(s) for withdraw. If the study term observes several time periods of missed 
trials, they will address the issue with a participant during the weekly check-in. As feasibility is the 
cornerstone of this trial, the study team will not discontinue participants for reasons related to protocol 
adherence. As the exception, if a participant's medical status changes during the study, the study team  
 
 
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Word Retrieval in the Wild: An Ecological Momentary Assessment Pilot Study in People with Post-
Stroke Aphasia 
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Stroke Aphasia 
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STATEMENT OF COMPLIANCE 
Provide a statement that the trial will be conducted in compliance with the protocol, International 
Council on Harmonisation Good Clinical Practice (ICH GCP) and applicable state, local and federal 
regulatory requirements. Each engaged institution must have a current Federal-Wide Assurance (FWA) 
issued by the Office for Human Research Protections (OHRP) and must provide this protocol and the 
associated informed consent documents and recruitment materials for review and approval by an 
appropriate Institutional Review Board (IRB) or Ethics Committee (EC) registered with OHRP. Any 
amendments to the protocol or consent materials must also be approved before implementation. Select 
one of the two statements below. If the study is an intramural NIH study, use the second statement 
below: 
1. The trial will be carried out in accordance with International Council on Harmonisation Good 
Clinical Practice (ICH GCP) and the following: 
o 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812). 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of NIH-funded clinical trials have 
completed Human Subjects Protection and ICH GCP Training. 
OR 
2. The trial will be conducted in accordance with International Council on Harmonisation Good 
Clinical Practice (ICH GCP), applicable United States (US) Code of Federal Regulations (CFR), and 
the [specify NIH Institute or Center (IC) [ Terms and Conditions of Award. The Principal 
Investigator will assure that no deviation from, or changes to the protocol will take place 
without prior agreement from the funding agency and documented approval from the 
Institutional Review Board (IRB), and the Investigational New Drug (IND) or Investigational 
Device Exemption (IDE) sponsor, if applicable, except where necessary to eliminate an 
immediate hazard(s) to the trial participants. All personnel involved in the conduct of this study 
have completed Human Subjects Protection and ICH GCP Training. 
For either option above, the following paragraph would be included: 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the IRB for review and approval. Approval of both the protocol and the consent 
form(s) must be obtained before any participant is consented. Any amendment to the protocol 
will require review and approval by the IRB before the changes are implemented to the study. 
All changes to the consent form(s) will be IRB approved; a determination will be made regarding 
whether a new consent needs to be obtained from participants who provided consent, using a 
previously approved consent form. 
INVESTIGATOR'S SIGNATURE 
Principal Investigator or Clinical Site Investigator: 

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Signed: 
Erin L. Meier 
Date: 
3/18/2022 
Name*:  
Erin Meier 
Title*:  
Assistant Professor of Communication Sciences and Disorders 
 
 
Investigator Contact Information: 
Affiliation*:  Northeastern University 
Address:  
360 Huntington Avenue, FR228C; Boston, MA 02115 
Telephone:  617-373-7438 
Email:  
e.meier@northeastern.edu 
 
For multi-site studies, the protocol should be signed by the clinical site investigator who is responsible  
for the day to day study implementation at his/her specific clinical site:  
Signed: 
  
Date: 
  
Name:  
  
Title:  
  
Affiliation:    
 
 

Word Retrieval in the Wild: An Ecological Momentary Assessment Pilot Study in People with Post-
Stroke Aphasia 
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1 PROTOCOL SUMMARY 
1.1 SYNOPSIS 
Title: 
Word Retrieval in the Wild: An Ecological Momentary 
Assessment Pilot Study in People with Post-Stroke Aphasia 
Grant Number: 
UL1 TR002544 
Study Description: 
People with post-stroke aphasia (PWA) suffer from anomia, a condition 
where they know what they want to 
say but cannot retrieve the words. For PWA, word retrieval changes 
moment-to-moment, leading to diminished 
motivation to participate in conversations and disengagement from 
social interactions. In the real world, anomia 
variability and severity are compounded by contextual factors of 
communication exchanges (noise, dual-tasking). 
Ecological momentary assessment (EMA) involves in-situ measurement 
of a behavior over time during everyday 
life. EMA has promise for capturing real-world anomia, yet EMA 
methods have not been tested in PWA. 
To target in-situ anomia, PWA will complete 36 picture-naming 
trials/day for three weeks, 
delivered either as a single trial 36 times per day (1-item EMA 
condition) or in four sets of nine trials/set per day (9-item EMA 
condition). Prior to completing community/home-based EMAs, 
participants will undergo standardized testing and smart device 
training. During the EMA period, participants will complete a brief 
survey about their EMA experiences at the end of each week. Following 
completion of the EMA protocol, participants will complete one final 
assessment and exit interview session. 
Objectives*: 
Primary Objective: To evaluate the feasibility of ecological 
momentary assessment (EMA) of naming 
abilities in people with post-stroke aphasia 
Secondary 
Objectives: 
Determine relationships between feasibility 
metrics and personal factors 
 
Endpoints*: 
Primary Endpoint: Compliance and completion over a 3-week 
EMA protocol 
Secondary 
Endpoints: 
Perceived burden of completing EMAs 
during the 3-week protocol 
Study Population: 
Individuals with post-stroke aphasia 
Phase* or Stage: 
Chronic stroke (at least 6 months after stroke onset) 

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Description of 
Sites/Facilities Enrolling 
Participants: 
Participants will be recruited through The Aphasia Network 
(TAN) Lab at Northeastern University. 
Description of Study 
Intervention/Experimental 
Manipulation: 
Following consent and prior to completing community/home-based 
EMAs, participants will undergo standardized testing and smart device 
training. PWA will be pseudorandomly assigned to either the 1-item or 
9-item EMA condition, counterbalanced for aphasia severity. Next, 
PWA will complete the three-week community/home-based EMA 
protocol. Each day, PWA will be scheduled to attempt naming aloud 36 
pictures that appear on the smartwatch, either delivered either as a 
single trial 36 times per day (1-item EMA condition) or in four sets of 
nine trials/set per day (9-item EMA condition).  During the EMA period, 
participants will complete a brief survey about their EMA experiences 
at the end of each week. Following completion of the EMA protocol, 
participants will complete one final assessment and exit interview 
session. 
Study Duration*: 
1 year 
Participant Duration: 
5-6 weeks 
 
 
1.2 SCHEMA 
Figure 1. Study Design 
 
  
  
  
  
 
 
1.3 SCHEDULE OF ACTIVITIES 
Study Phase 
Activities 

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Pre-EMA Testing 
Testing: (1) Quick Aphasia Battery (QAB) to measure overall 
aphasia severity, (2) the Pattern Comparison Processing 
Speed Test and Flanker Inhibitory Control and Attention Test 
from the NIH Cognition Toolbox to measure non-linguistic 
visual attention and executive functions, respectively, (3) 
brief, standardized picture description and story elicitation 
tasks to index anomia in discourse, and (4) an overt object 
naming test to index word retrieval via a standard SLP 
assessment format (i.e., single administration in a quiet 1:1 
interaction). The naming test will include normed real 
photos17 of the 260 items from the Snodgrass and 
Vanderwart stimuli set. PWA will also participate in an intake 
interview and complete a questionnaire about their comfort 
with technology, adapted for aphasia (simple language, short 
phrases). 
  
Smart device training including: (1) Smartwatch Orientation: 
PWA will be oriented to the smartwatch (interface, charging, 
etc.) through simple verbal and written instructions and 
visual demonstrations. (2) EMA Task Training: PWA will be 
instructed on the specific EMA naming task, including 
instructions on how to tap on the screen and the optimal 
approach for providing verbal responses (i.e., mouth close to 
the watch). Then, PWA will complete an 18-item traditional 
EMA-style naming task probe (i.e., several trials back-to-back 
on the smartwatch) in a quiet room in The Aphasia Network 
(TAN) Lab at Northeastern University. During this probe, SLP 
graduate student research assistants (RAs) will provide 
cueing and feedback so that PWA successfully learn how to 
operate the smartwatch and respond to prompts. (3) EMA 
Protocol Simulation: PWA will complete a “real-world” EMA 
task probe in a distracting environment (i.e., coffee shop or 
university bookstore on Northeastern’s campus). For this 
final activity, over a 45-minute period, 18 smartwatch 
prompts will be given, either randomly interspersed with one 
naming trial per prompt (for PWA in the 1-item condition) or 
split into two sets of 9 trials per prompt (for PWA in the 9-
item EMA condition). This final activity will mirror the three-
week EMA protocol. 
EMA Protocol 
For three weeks, PWA will name aloud pictures that 
appear on the smartwatch as they go about their daily 
activities. At the end of each week, PWA will complete 
a virtual check-in with the study team at which time they 
will also complete a brief (16-item) Qualtrics survey 
about their EMA experiences that week. 

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Post-EMA Protocol Testing 
and Exit Interview 
In a final session, PWA will complete the overt object 
naming test in standard SLP format once more. Finally, 
they will participate in an exit interview about the study. 
 
 

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2 INTRODUCTION 
2.1 STUDY RATIONALE 
Ecological momentary assessment (EMA) holds promise for providing objective insight into the everyday 
experiences of patients with a variety of clinical conditions. To date, there is little EMA research that 
includes stroke survivors with aphasia. Thus, the primary rationale for this study is to evaluate and 
demonstrate the feasibility of a novel smartwatch-delivered, audio-based EMA of naming protocol in 
individuals with chronic aphasia. This project is an important first step towards testing the clinical utility 
of EMA for better understanding everyday communication difficulties and other challenges that PWA 
face in daily life. 
 
 
2.2 BACKGROUND 
Impaired word retrieval—also known as anomia—is one of the most debilitating symptoms stroke 
survivors with aphasia, a communication disorder characterized by impaired language, face in their daily 
lives. Like “tip-of- the-tongue” states experienced by neurotypical individuals, anomic moments in 
people with aphasia (PWA) occur when an individual knows what they want to say but cannot retrieve 
the word. Unlike “tip-of-the-tongue,” anomia in PWA pervades communication exchanges and is 
characterized by inconsistent ability to retrieve a given word across attempts. The severity and 
unpredictability of anomia lead many PWA to disengage from conversation and social situations, which 
can severely impact their participation and quality of life. In daily life, anomia can be further 
compounded by real-world communication contexts such as attempting to communicate in distracting 
settings (e.g., with background noise and/or other people in the vicinity) or when completing other 
tasks. In clinical practice, speech-language pathologists (SLPs) typically assess anomia by administering a 
standardized test once to a patient in a quiet room. This approach captures neither the variability typical 
of post-stroke anomia nor the realities of real-world communication. In contrast, ecological momentary 
assessment (EMA) is a method often used in health research to measure physical, mental, or cognitive 
states in a person’s daily life over several days, weeks or even months. Traditional EMA involves a device 
prompting a participant to answer a set of questions a few times a day, whereas micro-interaction-
based EMA (μEMA) uses single-question, “at-a-glance” prompts that are interspersed over time rather 
than grouped into sets. Our pilot studies demonstrate that μEMA has higher response rates and lower 
perceived burden than traditional EMA in neurotypical individuals despite its higher interruption rate. 
Thus, we propose that EMA—particularly μEMA—is a viable approach to capture real-world anomia in 
PWAs’ daily lives. Yet, despite the increasing use of technology-based assessments and therapy 
platforms for PWA, neither EMA nor μEMA methods have been utilized in aphasia. 
 
 

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2.3 RISK/BENEFIT ASSESSMENT 
2.3.1 KNOWN POTENTIAL RISKS 
There are no known risks of ecological momentary assessment (EMA). 
2.3.2 KNOWN POTENTIAL BENEFITS 
There are no direct benefits as EMA is an assessment, not treatment method. Some participants may 
find completing the protocol engaging. 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS 
The risks do not outweigh any potential benefits. 
 
 

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3 OBJECTIVES AND ENDPOINTS 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
PUTATIVE 
MECHANISMS OF 
ACTION 
Primary 
Assess EMA compliance 
in PWA 
  
  
  
  
Assess EMA completion 
in PWA 
Compliance will be 
calculated by dividing 
the number of 
answered prompts by 
the number of 
scheduled prompts 
  
Completion will be 
calculated by dividing 
the number of 
answered prompts by 
the number of 
delivered prompts 
This metric is often used in 
describing feasibility of 
EMA protocols. 
  
  
  
Compliance reflects 
protocol adherence 
excluding trials missed due 
to the watch being 
off/uncharged or a 
problem with the trial 
flow. 
 N/A - not an intervention 
Secondary 
Assess speech 
intelligibility of 
EMAs 
Recorded responses 
will be tagged as 
fully intelligible (1) 
or partially or 
completely 
unintelligible (0) 
Speech EMA requires 
intelligible responses to 
be clinically useful 
N/A - not an intervention 
Assess perceived 
burden from EMAs in 
PWA 
Perceived burden 
will be calculated by 
averaging Likert 
ratings from the 
Qualtrics survey 
questions regarding 
perceived burden  
 Gathering information 
about participants 
experiences with a novel 
protocol is important for 
establishing its clinical 
utility 
N/A - not an intervention 
Tertiary/Exploratory 
 Determine 
relationships between 
EMA feasibility metrics 
and personal factors 
 N/A 
 No explicit endpoint are 
applicable for this 
objective 
 N/A - not an intervention 

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4 STUDY DESIGN 
4.1 OVERALL DESIGN 
Figure 1. Study Design 
 
 
 
4.2 SCIENTIFIC RATIONALE FOR STUDY DESIGN 
The study design will allow the research team to address the primary objectives of assessing protocol 
feasibility in multiple ways (compliance, completion, and perceived burden) as well as the secondary 
objective of exploring personal factors (age, cognitive abilities) that relate to feasibility metrics. 
 
 
4.3 JUSTIFICATION FOR INTERVENTION 
N/A - This study does not involve an intervention. 
 
 
4.4 END-OF-STUDY DEFINITION 
The end-of-study will be at the end of the funding period (i.e., 1 year). This study is a small-scale, 
observational feasibility trial in which no impact on clinical outcomes is expected. 
 
 

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5 STUDY POPULATION 
5.1 INCLUSION CRITERIA 
Inclusion criteria include: (1) current/pre-stroke English proficiency, (2) normal/corrected-to-normal 
vision and hearing, (3) medical stability, (4) history of left hemisphere stroke at least six months prior to 
enrollment, and (5) presence of aphasia as determined by consideration of scores on language 
assessments (e.g., Quick Aphasia Battery, discourse tasks) and the study team’s clinical judgment. 
 
 
5.2 EXCLUSION CRITERIA 
The exclusion criterion will be a history of neurological disease affecting the brain besides stroke. 
 
 
5.3 LIFESTYLE CONSIDERATIONS 
PWA with severe aphasia who do not have a care partner to assist with study logistics (e.g., charging 
smartwatches, scheduling appointments) may have more difficulty participating, but they will not be 
precluded from participating. PWA who have severe hemiplegia or hemiparesis may also have more 
difficulty participating, but accommodations (e.g., use of stretch wristbands to ease donning the watch) 
will be employed. 
 
 
5.4 SCREEN FAILURES 
Participants who do not test as aphasic on standardized testing or who do not endorse language 
challenges consistent with aphasia will be ineligible to participate. 
 
 
5.5 STRATEGIES FOR RECRUITMENT AND RETENTION 
Dr. Meier has a strong foothold in the Boston aphasia research community due to her time at Boston 
University as a PhD student and has several existing and developing collaborations at area institutions 
that will offer ample opportunities for recruitment for this study. Although the final sample for this pilot 
study is small, a multipronged approach will be implemented to ensure recruitment goals are met. 

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Specifically, recruitment at the following sites and via the following methods will be launched in parallel 
at the beginning of the project and will continue until the project’s end and/or until recruitment goals 
are achieved: 
  
Northeastern University Speech, Language, and Hearing Center (SLHC): The Northeastern University 
SLHC provides clinical SLP and audiology services to individuals across the lifespan with communication 
disorders. Led by Professor Elizabeth Martin, the Aphasia Workshop is a new program offered through 
the SLHC in which PWA complete a one-time assessment of speech and language skills. Each academic 
semester, up to five PWA participate in this program. Prof. Martin has agreed to share study flyers with 
new participants each semester and to email previous Aphasia Workshop attendees. Prof. Martin is also 
the coordinator of adult SLP practicum placements for graduate students in the Communication 
Sciences and Disorders Department at Northeastern and has contacts with several SLPs working in the 
greater Boston area. Prof. Martin has agreed to email area SLPs with information about TAN Lab and the 
proposed study. 
  
Boston University (BU) Aphasia Research Laboratory: Directed by Dr. Swathi Kiran, the BU Aphasia 
Research Lab maintains a database of nearly 300 PWA. Dr. Kiran has agreed to share study flyers with 
the many PWA currently active in her research lab and allow TAN Lab study team members to speak 
directly to interested PWA following their sessions at the BU Aphasia Research Lab. The BU Aphasia Lab 
manager will also follow up with PWA who agreed to be contacted for future research opportunities and 
will provide interested PWA the contact information for TAN Lab. 
  
Other Recruitment Methods: We will recruit stroke survivors via flyers placed at local hospitals, senior 
centers, and clinics that serve individuals with neurogenic disorders. We will also develop and 
implement a pipeline for recruiting stroke survivors through Tufts Medical Center that will be initiated 
following a meeting with the Tufts Recruitment and Retention Team. Finally, we will present at the 
Boston University Aphasia Community Group in April 2022 (established via personal communication 
between Dr. Meier and Dr. Elizabeth Hoover, the clinical director of the BU Aphasia Resource Center). 
The Aphasia Community Group is held one Saturday per month and regularly welcomes up to 100 PWA 
and their family/friends. 
  
When possible, TAN Lab study team members will take advantage of “the clinical moment” that occurs 
with face-to-face interactions with patients at community engagement events and via one-on-one 
clinical research encounters. The goal of these interactions will not solely be to inform potential 
participants of the present study but to engage PWA in the research process, convey the larger goals of 
TAN Lab, and describe our work towards maximizing outcomes for PWA. Dr. Meier and TAN Lab SLP 
graduate student RAs will utilize their clinical aphasia expertise and collaborate with the Tufts CTSI 
Recruitment and Retention Team to develop effective externally facing materials for engaging potential 
participants. Written recruitment materials and in-person communications will incorporate aphasia-
friendly language (simple language, short phrases) and multimodal auditory-visual strategies to aid 
comprehension for PWA with severe language deficits. Working with the Tufts CTSI Recruitment and 

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Retention Team, we will also develop and implement strategies to ensure recruitment of participants of 
color. One strategy will be to maximize engagement with Hispanic/Latinx and Asian PWA involved in an 
active clinical trial conducted by the BU Aphasia Research Lab on bilingual aphasia recovery. Given our 
multipronged approach, the large pool of potential participants, and expected high interest in the study, 
we anticipate having a waitlist of potential participants. Thus, a second approach will be to prioritize 
participation of PWA of color on the waitlist to ensure their necessary inclusion in this study. All efforts 
will be made to maximize retention of enrolled participants. We will do so by: (1) careful screening of 
potential participants in which we explain in detail the procedures (e.g., protocols, time commitment) 
and provide time and opportunity for addressing the questions/concerns of participants and/or care 
providers, (2) providing flexible scheduling options and assistance with arranging transportation as 
needed, and (3) weekly contacts in weeks 2-4 during the EMA/μEMA protocols with PWA and/or their 
care providers. 
 
 

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6 STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
6.1 STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION  
6.1.1 STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
  
Participants will be pseudo-randomly assigned to either the 1-item EMA condition (n = 10) or 9-item 
EMA condition (n = 10). For every prompt, the smartwatch will vibrate to alert the participant to a 
prompt to complete either a single picture naming trial (in the 1-item condition) or a set of picture 
naming trials (in the 9-item EMA condition). Participants in both conditions will be scheduled to 
complete 36 overt picture naming trials per day for three weeks. The only difference between 
conditions will be the trial delivery schedule: PWA in the 1-item condition will complete a single naming 
trial at a time, 36 times per day whereas PWA in the 9-item EMA condition will receive four prompts per 
day to complete a set of nine picture naming trials per prompt. The twofold rationale for comparing 1-
item and 9-item EMA conditions is that we will be able to ensure the results reflect the viability of either 
delivery schedule specifically and not just the novelty of smartwatch use, and this approach will provide 
preliminary data regarding which method works best for which PWA. 
6.1.2 ADMINISTRATION AND/OR DOSING 
In each condition, the smartwatch will vibrate to alert PWA to a single naming trial (1-item condition) or 
naming trial set (9-item EMA condition). After the vibration alert, PWA will see a screen that says “Ready 
to name a picture?” (1-item condition) or “Ready to name some pictures?” (9-item EMA condition). If 
the participant taps YES, a picture will appear, and the device will begin recording audio. PWA will have 
up to five seconds to provide an oral response, after which a “Thanks!” screen will appear. The five-
second response window was selected based on research showing that PWA correctly name pictures 
within 3.5 seconds, on average, with longer response latencies for incorrect responses. If a participant 
fails to respond to a vibration prompt or pushes the NO button to the “Ready?” screen, they will be re-
prompted five minutes later via one more vibration alert. During the three-week EMA protocol, each 
participant will attempt to name 108 unique objects derived from the 260-item Snodgrass and 
Vanderwart photoset. The subset of pictures presented to each participant will be based on their 
naming evaluation (during week 1, session 1). When possible, half of the pictures will be items the PWA 
named correctly during the evaluation, and the other half will be incorrectly named pictures. This 
approach will allow us to gauge naming variability over time of items PWA are able versus unable to 
name during traditional SLP assessment, providing an important window into anomia. To mitigate 
practice effects, the individual pictures (1-item condition) or picture sets (9-item EMA condition) will be 
presented randomly without replacement until all 108 pictures have been presented, and then the 
picture cycle will restart. In both conditions, 36 naming trials will be scheduled per day, resulting in a 
total of 756 scheduled trials for each participant across the experiment. In the 1-item EMA condition, 
single-naming trial prompts will appear at random intervals from 10am to 8pm. In the 9-item EMA 
condition, PWA will receive four prompts per day to complete a set of nine picture naming trials per 
prompt; one prompt will be scheduled in every 2.5-hour block between 10am and 8pm. 

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6.2 FIDELITY 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
N/A - There is no intervention as part of this trial. Data used to calculate compliance, completion, and 
perceived burden will be automatically digitally recorded. Speech intelligibility ratings will be completed 
for all samples by one rater, and 20% of samples will be assessed by a second rater. 
 
 
6.3 MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING  
PWA will be pseudo-randomly assigned to either the 1-item or 9-item EMA condition. This quasi-
randomization will be done to ensure the conditions are balanced for overall aphasia severity. No 
blinding will be performed. 
 
 
6.4 STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
N/A - This study does not involve intervention. 
 
 
6.5 CONCOMITANT THERAPY 
  
6.5.1 RESCUE THERAPY 
Participants are allowed to continue any therapy (including speech-language therapy) that they are 
receiving at the time of the study. Because this trial involves no intervention, concomitant therapy will 
not impact the trial results. The study team will not dispense rescue therapy. 
 
 

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7 STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1 DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION  
If the study term observes several time periods of missed trials, they will address the issue with a 
participant during the weekly check-in. As feasibility is the cornerstone of this trial, the study team will 
not discontinue participants for reasons related to protocol adherence. 
 
 
7.2 PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY  
Participants are free to withdraw from participation in the study at any time upon request. If a 
participant withdraws, the study team will obtain the reason(s) for withdraw. An investigator may 
discontinue a participant from the study for the following reasons: (1) Lost-to-follow up; unable to 
contact subject (see Section 7.3, Lost to Follow-Up), and (2) any event or medical condition or situation 
occurs such that continued collection of study data would not be in the best interest of the participant 
or might require an additional EMA period that would confound the interpretation of the study. 
 
 
7.3 LOST TO FOLLOW-UP 
A participant will be considered lost to follow-up if they fail to return for three scheduled check-ins or 
sessions and study staff are unable to contact the participant after at least 3 attempts. The following 
actions will be taken if a participant fails to return to the lab for a required study visit: 
• 
The site will attempt to contact the participant, reschedule the missed visit or check-in, counsel the 
participant on the importance of maintaining the assigned visit schedule, and ascertain if the participant 
wishes to and/or should continue in the study 
• 
Before a participant is deemed lost to follow-up, the investigator or designee will make every effort to 
regain contact with the participant (where possible, 3 telephone calls and/or emails). These contact 
attempts will be documented in the participant’s study file. 
• 
Should the participant continue to be unreachable, they will be considered to have withdrawn from the 
study with a primary reason of lost to follow-up. 
 
 

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8 STUDY ASSESSMENTS AND PROCEDURES 
8.1 ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
Endpoint Assessments: Feasibility will be classified in three ways: (1) PWAs’ adherence to the 
smartwatch μEMA or EMA protocol via compliance and completion, (2) PWAs’ perceived burden of 
completing the EMA protocol, and (3) speech intelligibility of recorded naming attempts. Currently, 
PWAs’ capacity for adhering to a smartwatch EMA protocol via button press responses or verbal 
responses is unknown. As such, compliance will be based on the number of YES button responses to the 
“Ready?” screen whereas completion will be based on naming attempts. Specifically, similar to Intille et 
al. (2016), compliance will be determined by the number of YES responses over scheduled trials, 
including trials missed due to the watch being off/uncharged. Completion will be calculated as trials with 
captured audio (reflecting attempted naming) over delivered trials, excluding trials missed to the watch 
being off/uncharged. Perceived burden will be measured via responses to the weekly surveys during 
weeks 2-4. Finally, speech intelligibility will be measured by a categorical rating of responses captured in 
each audio clip (i.e., completely intelligible, partially intelligible, or completely unintelligible). 
  
Other Non-Safety Assessments: Before the EMA period, PWA will be administered the following testing 
battery. The Quick Aphasia Battery (QAB) will be used as our eligibility assessment and to measure 
overall aphasia severity. The Pattern Comparison Processing Speed Test and Flanker Inhibitory Control 
and Attention Test from the NIH Cognition Toolbox will be used to measure non-linguistic visual 
attention and executive functions, respectively. We will use brief, standardized picture description and 
story elicitation tasks from the AphasiaBank protocol to index anomia in discourse. Participants will 
complete an overt object naming test twice before EMA and once after EMA so that the research team 
can evaluate word retrieval via the standard SLP assessment format (i.e., single administration in a quiet 
1:1 interaction). This picture naming probe will include normed real photos of the 260 items from the 
Snodgrass and Vanderwart stimuli set. Before EMA, PWA will also participate in an intake interview and 
complete a questionnaire about their comfort with technology, adapted for aphasia (simple language, 
short phrases). 
 
 
8.2 SAFETY ASSESSMENTS 
No safety assessment were administered. 
 
 

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8.3 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
8.3.1 DEFINITION OF ADVERSE EVENTS 
An adverse event is defined as any untoward medical occurrence associated with the use of the EMA 
system. 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
A serious adverse event is defined as any untoward medical occurrence in a clinical trial participant that 
meets at least one of the following criteria: death, life-threatening injury, results in hospitalization 
and/or permanent injury. 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
Please see below. 
8.3.3.1 SEVERITY OF EVENT 
  
For adverse events (AEs) not included in the protocol defined grading system, the following guidelines 
will be used to describe severity. 
(1) Mild: Events require minimal or no treatment and do not interfere with the participants' daily 
activities. 
(2) Moderate: Events result in a low level of inconvenience or concern with the EMA measures. 
Moderate events may cause some interference with functioning. 
(3) Severe: Events interrupt a participant's usual daily activity and may require treatment. Severe events 
are potentially life-threatening or incapacitating. 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
  
All adverse events (AEs) will have their relationship to study procedures, including EMAs, assessed by an 
appropriately-trained lab member based on temporal relationship and their judgment. The degree of 
certainty about causality will be graded using the categories below. 
- Related: The AE is known to occur with the study procedures, there is a reasonable possibility that the 
study procedures caused the AE, or there is a temporal relationship between the study procedures and 
the event. Reasonable possibility means that there is evidence to suggest a causal relationship between 
the study procedures and the AE. 
-Not Related: There is not a reasonable possibility that the study procedures caused the event, there is 
no temporal relationship between the study procedures and event onset, or an alternate etiology has 
been established. 
8.3.3.3 EXPECTEDNESS 
  
A trained lab member with appropriate expertise in will be responsible for determining whether an 
adverse event (AE) is expected or unexpected. An AE will be considered unexpected if the nature, 

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severity, or frequency of the event is not consistent with the risk information previously described for 
the study procedures. 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
  
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during study visits and interviews of a study participant. All AEs, not otherwise 
precluded per the protocol, will be captured on the appropriate case report form (CRF). Information to 
be collected includes event description, time of onset, study team member's assessment of severity, 
relationship to study procedures (assessed only by those with the training and authority to make a 
diagnosis), and time of resolution/stabilization of the event. All AEs occurring while on study will be 
documented appropriately regardless of relationship. All AEs will be followed to adequate resolution. 
  
Any medical or psychiatric condition that is present at the time that the participant is screened will be 
considered as baseline and not reported as an AE. However, if the study participant's condition 
deteriorates at any time during the study, it will be recorded as an AE. Changes in the severity of an AE 
will be documented to allow an assessment of the duration of the event at each level of severity to be 
performed. Documentation of onset and duration of each episode will be maintained for AEs 
characterized as intermittent. 
  
PI Meier will record events with start dates occurring any time after informed consent is obtained until 7 
(for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.At each study visit, 
the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed 
for outcome information until resolution or stabilization. 
8.3.5 ADVERSE EVENT REPORTING 
  
In consultation with the PI, a trained member of the study team will be responsible for conducting an 
evaluation of a serious adverse event and will report the results of such evaluation to the Tufts CTSI 
program director, NCATS, and the reviewing Institutional Review Board (IRB) as soon as possible, but in 
no event later than 7 working days after the investigator first learns of the event.  
8.3.6 SERIOUS ADVERSE EVENT REPORTING 
PI Meier will record events with start dates occurring any time after informed consent is obtained until 7 
(for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.At each study visit, 
the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed 
for outcome information until resolution or stabilization. 
8.3.7 REPORTING EVENTS TO PARTICIPANTS 
  
Participants will be informed of any significant adverse events (AEs) or serious adverse events (SAEs) 
that may impact their safety or participation in the study. If an AE occurs, study staff will assess the 

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severity, provide appropriate medical guidance, and, if necessary, refer the participant for further 
medical care. Serious adverse events will be reported to the study’s principal investigator, institutional 
review board (IRB), and relevant regulatory authorities in accordance with established guidelines. 
Participants will be notified of any changes to study procedures or risks based on reported events. 
Contact information for reporting concerns or symptoms is provided in the informed consent document. 
8.3.8 EVENTS OF SPECIAL INTEREST 
N/A 
8.3.9 REPORTING OF PREGNANCY 
N/A 
 
 
8.4 UNANTICIPATED PROBLEMS 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
  
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human 
Research Protections (OHRP). OHRP considers unanticipated problems involving risks to participants or 
others to include, in general, any incident, experience, or outcome that meets all of the following 
criteria: 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-approved 
research protocol and informed consent document; and (b) the characteristics of the participant 
population being studied; 
• 
Related or possibly related to participation in the research ("possibly related" means there is a reasonable 
possibility that the incident, experience, or outcome may have been caused by the procedures involved in 
the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
8.4.2 UNANTICIPATED PROBLEMS REPORTING 
  
The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB) and to the principal investigators (PIs). The UP report will include the following information: 
• 
Protocol identifying information: protocol title and number, PI's name, and the IRB project number 
• 
A detailed description of the event, incident, experience, or outcome 

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• 
An explanation of the basis for determining that the event, incident, experience, or outcome represents 
an UP 
• 
A description of any changes to the protocol or other corrective actions that have been taken or are 
proposed in response to the UP. 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline: UPs 
that are serious adverse events (SAEs) will be reported to the IRB and to the DCC/study sponsor/funding 
agency within [insert timeline in accordance with policy] of the investigator becoming aware of the 
event. Any other UP will be reported to the IRB and to the study sponsor within 10 days of the 
investigator becoming aware of the problem. All UPs will be reported to appropriate institutional 
officials (as required by an institution's written reporting procedures), the supporting agency head (or 
designee), and the Office for Human Research Protections (OHRP) within 30 days of the IRB's receipt of 
the report of the problem from the investigator. 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
If participant notification is required, the research team will develop a clear, participant-friendly 
communication that provides a description of the issue, outlines any potential risks, and explains how it 
may impact participants. The communication will avoid unnecessary alarm while ensuring transparency. 
Additionally, participants will be informed of any changes to study procedures or additional precautions 
being implemented to ensure their safety. The notification will also include contact information for 
participants to reach the study team if they have questions or concerns. Before distribution, the IRB will 
review and approve the communication to ensure clarity, accuracy, and compliance with ethical 
guidelines. Participants will be informed through the most appropriate method based on the urgency 
and nature of the issue. Urgent matters affecting participant safety will be communicated via phone 
calls to ensure immediate awareness and response. Non-urgent updates, including general study-related 
changes, will be conveyed through email or mailed letters. In cases where participants are scheduled for 
in-person study visits, the research team may provide information and discuss concerns during these 
visits. Regardless of the method used, all communications will be documented in study records to 
ensure accountability and compliance with study protocols. 
 
 

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9 STATISTICAL CONSIDERATIONS 
9.1 STATISTICAL HYPOTHESES 
• 
Primary Efficacy Endpoint(s): Compliance and completion will be significantly higher for participants who 
complete the 1-item EMA condition versus participants who complete the 9-item EMA condition.  
• 
Secondary Efficacy Endpoint(s): Speech intelligibility will be over 80% across trials. Perceived burden will 
not significantly differ between participants who complete the 1-item versus 9-item EMA conditions. 
  
 
 
9.2 SAMPLE SIZE DETERMINATION 
For the Aim #1 logistic mixed effects models, two groups of 10 PWA per group will achieve 80% power 
to detect an odds ratio of 1.20 in a design of 756 repeated measures with a AR(1) covariance structure 
and when the correlation between observations of the same subject is 0.600 and alpha is 0.05. If the 
proportion of completed trials for the EMA group is 0.500, a statistically significant result will occur if the 
μEMA group proportion is 0.545 or greater. In Intille et al.4, the mean difference in proportions between 
the μEMA and EMA conditions was >0.20 for compliance and completion, which is much higher than the 
needed 0.045 difference. This suggests we will have ample power to detect significant differences 
between the two conditions. 
 
 
9.3 POPULATIONS FOR ANALYSES 
Participants with post-stroke aphasia 
 
 
9.4 STATISTICAL ANALYSES 
9.4.1 GENERAL APPROACH 
Please see specific information below. 
9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
We will code each trial in the EMA time series to index compliance, completion, and speech 
intelligibility. Every scheduled trial (n = 756 total trials) will be coded as 0 for a nonresponse/ NO button 

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response or 1 for a YES button response, reflecting compliance. Every delivered trial with a naming 
attempt captured on audio (n trials will vary by person) will be coded as 0 for incomplete or 1 for 
complete, reflecting completion. For each of these measures, we will run a logistic mixed effects model 
with one of the feasibility measures (i.e., compliance, completion) as the dependent variable, condition 
(1-item vs. 9-item) as the independent variable, and random effects of participant and trial.  
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
Every audio clip (n trials will vary by person, depending on the number of naming attempts) will be 
coded as 0 for completely or partially unintelligible and 1 for completely intelligible, reflecting speech 
intelligibility. We will run a logistic mixed effects model with intelligibility as the dependent variable, 
condition (1-item vs. 9-item) as the independent variable, and random effects of participant and 
trial. For perceived burden, we will collect responses on three questions/survey for three weeks. Given 
the small amount of data, survey responses will be plotted to visualize trends in increasing/decreasing 
burden rather than compared statistically. We will statistically compared averaged burden ratings 
between participants in the 1-item vs. 9-item condition using t-tests or Wilcoxon rank sum tests 
(depending on the distribution of the data). 
9.4.4 SAFETY ANALYSES 
N/A 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
Descriptive statistics will include demographics (age, sex, race, ethnicity, and handedness) as well as 
baseline behavioral testing results, including overall aphasia severity (per the Quick Aphasia Battery), 
non-linguistic cognitive skills (per the NIH-Toolbox tasks), confrontation naming ability (per the Boston 
Naming Test and the Snodgrass & Vanderwart probe), and comfort with technology survey data. 
9.4.6 PLANNED INTERIM ANALYSES 
N/A 
9.4.7 SUB-GROUP ANALYSES 
No sub-group analyses based on demographics will be performed based on the small sample size for this 
feasibility study. Instead we will conduct exploratory analyses (see 9.4.9) regarding relationships 
between personal factors and EMA feasibility metrics. 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
  
Individual participant data will be listed by measure. 
9.4.9 EXPLORATORY ANALYSES 
We will conduct a series of partial correlations between patient-specific factors and feasibility measures 
(compliance, completion, speech intelligibility, and perceived burden), controlling for study condition. 
Patient-specific factors will include age, aphasia severity (derived from the QAB), non-linguistic cognitive 
skills (averaged performance on the two NIH Toolbox tasks), and a summary score derived from the 

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comfort with technology survey. Here, compliance will be the proportion of YES button responses 
divided by total scheduled trials (YESbutton/756) for each participant. Completion will be the proportion 
of naming attempts divided by total delivered trials (n naming attempts/n trials delivered). Speech 
intelligibility will be the proportion of completely intelligible responses divided by the total number of 
naming attempts (n completely intelligible trials/n naming attempts). Perceived burden will be 
calculated as the sum of all burden question Likert responses. Multiple comparison correction will be 
done at a false discovery rate of p < 0.05. 
 
 

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10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS  
10.1.1 INFORMED CONSENT PROCESS 
  
Please see below 
10.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
  
Consent forms describing in detail the study intervention, study procedures, and risks are given to the 
participant and written documentation of informed consent is required prior to starting 
intervention/administering study intervention. 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
Interested potential participants or family members/caregivers of PWA who contact The Aphasia 
Network (TAN) Lab will be contacted by PI Meier or a trained research assistant via phone or email, and 
an initial meeting will be scheduled in person at TAN Lab or in the comfort of the participant’s home. 
During the initial meeting, study personnel will provide details about the study, answer questions, and 
complete a brief demographic and medical history intake. If the potential participant is interested in 
enrolling in the study, lab personnel (PI Meier or a trained TAN Lab research assistant) will explain study 
procedures and answer participant and caregiver questions. During the informed consent process, 
potential participants will be shown the EMA equipment (either through photographs or the physical 
apparatus). Additional measures will be taken to obtain informed consent from individuals with 
impairment language comprehension due to stroke. Individuals with post-stroke aphasia may have 
difficulty understanding spoken and/or written language due to their aphasia. To ensure these 
participants understand study protocols, lab personnel (PI Meier or a TAN Lab research assistant trained 
to communicate with people with aphasia) will supplement the standard consent form text with simpler 
spoken and/or written language and provide pictures or videos (of e.g., the smart watch) as needed. 
Supplemental spoken and/or written language will include key words/phrases from the provided 
materials but reframed or highlighted to maximize the understanding of study procedures by 
participants with aphasia. At the end of this process for both the longitudinal study and focus group, 
potential participants with aphasia will be asked a series of simple questions regarding basic 
study/group procedures to check their comprehension. If a participant fails the comprehension check 
(i.e., answers any question incorrectly), information pertaining to the incorrectly answered item(s) will 
be reviewed and another comprehension check will be done. For individuals with aphasia who are not 
capable of providing consent, informed written consent will be obtained from a legally authorized 
representative (e.g., family member, caregiver). Verbal or nonverbal assent will be obtained and 
reaffirmed throughout the study procedures. If participants exhibit discomfort, fatigue, or verbal or 
nonverbal signs of distress, breaks will be provided, and study procedures will be terminated early if 

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necessary. Potential participants will be allowed as much time as they require to consider study 
protocols and decide whether they wish to participate in the study. Then, informed written consent will 
be obtained. 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party to study participants and funding agency. If the study is 
prematurely terminated or suspended, the Principal Investigator (PI) will promptly inform study 
participants, the IRB, and sponsor and will provide the reason(s) for the termination or suspension. 
Study participants will be contacted, as applicable, and be informed of changes to study visit schedule. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Insufficient compliance of study staff to the protocol (i.e., significant protocol violations) 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 
The study may resume once concerns about safety, protocol compliance, and data quality are 
addressed, and satisfy the funding agency, sponsor, and IRB. 
10.1.3 CONFIDENTIALITY AND PRIVACY 
  
  
Confidentiality will be maintained throughout all data collection and data management procedures. 
Each participant will be assigned a unique alphanumeric code that will be used on paper documents, 
electronic databases, other digital data, and in conversations between study team members. Hard 
copies of paper documents containing identifying information (e.g., case history forms) will be stored in 
a locked cabinet within The Aphasia Network (TAN) laboratory (PI Meier). EMA data that inherently 
contain some identifying information (e.g., naming attempts in audio files) will be stored on a password-
protected server. Only co-PIs Meier and Intille and approved, trained research assistants and co-
investigators will have access to participant data. Participants’ demographic (e.g., age, sex, education) 
and diagnostic information will be used only to describe group characteristics of study participants. 
Identifying information will be removed before compiling summary data. If during any study sessions 
that are conducted in a participant’s home, the researchers observe specific acts of abuse or harm, the 
study team will bring this to the attention of the Principal Investigator overseeing this research and the 
Northeastern University Institutional Review Board who may take appropriate next steps. 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA 
  

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Electronic data, including EMA data and audio samples, will be kept indefinitely for use in future studies 
in TAN Lab. 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
Principal Investigator  
Medical Monitor or Independent Safety 
Monitor 
Erin Meier 
  
Stephen Intille 
  
  
  
  
  
  
  
  
10.1.6 SAFETY OVERSIGHT 
  
A Data and Safety Monitoring Board (DSMB) is not warranted and therefore will not be used in this trial. 
10.1.7 CLINICAL MONITORING 
N/A 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
  
Quality control (QC) procedures will be implemented as follows: 
• 
Informed consent - Study staff will review both the documentation of the consenting process as well as a 
percentage of the completed consent documents. This review will evaluate compliance with GCP, 
accuracy, and completeness. Feedback will be provided to the study team to ensure proper consenting 
procedures are followed. 
• 
Source documents and the electronic data - Data will be initially captured on source documents (see 
Section 10.1.9, Data Handling and Record Keeping) and will ultimately be entered into the study database. 
To ensure accuracy site staff will compare a representative sample of source data against the database, 
targeting key data points in that review. 
• 
Protocol Deviations - The study team will review protocol deviations on an ongoing basis and will 
implement corrective actions when the quantity or nature of deviations are deemed to be at a level of 
concern. 
Should independent monitoring become necessary, the PI will provide direct access to all trial related 
sites, source data/documents, and reports for the purpose of monitoring and auditing by the 
sponsor/funding agency, and inspection by local and regulatory authorities. 

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10.1.9 DATA HANDLING AND RECORD KEEPING 
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES 
Data on the phones will be stored in the protected application space of the device and pushed to the 
study team’s server over the course of the EMA/μEMA protocol for each participant. During the study, 
data will be periodically uploaded to a secure research server, and periodically backed up from the 
server onto an external hard drive that is password protected. Only the researchers will have access to 
the data. Raw electronic data files will be stored on a secure, password-protected server. A REDCap 
(Research Electronic Data Capture) database will be maintained that will contain participant data, 
including identifying information. REDCap is a free, secure, web-based application hosted by Tufts 
Clinical and Translational Science (CTSI). CTSI has all the necessary physical and operational security in 
place to meet or exceed federal and state security and privacy regulations for data transmissions and 
storage using REDCap.  De-identified audio samples and behavioral and lexical access data may be 
shared for use in research studies at other sites. De-identified audio samples and behavioral and lexical 
access data may be used in teaching and academic presentations with participant approval (please see 
the consent forms). Videos, photographs, and identifying information about participants will not be 
shared with other research sites nor in academic presentations unless the participant provides separate 
explicit permission. Hard copies of forms containing identifying information and signed consent 
documents will be kept for 7 years and stored in a locked filing cabinet in TAN Lab. After that time, 
identifying documents will be destroyed (i.e., shredded). 
10.1.9.2 STUDY RECORDS RETENTION 
Once the study is complete, all final data will be removed from the phone to ensure maximum safety of 
data storage. The smart watch devices will be wiped clean of any information at the end of the study 
when the participants turn them back in to the researchers.  
10.1.10 PROTOCOL DEVIATIONS 
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol, 
International Council on Harmonisation Good Clinical Practice (ICH GCP). The noncompliance may be 
either on the part of the participant, the investigator, or the study site staff. As a result of deviations, 
corrective actions will be developed by the site and implemented promptly. Protocol deviations will be 
handled in accordance with the following GCP guidelines: 
• 
Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3 
• 
Section 5.1 Quality Assurance and Quality Control, subsection 5.1.1 
• 
Section 5.20 Noncompliance, subsections 5.20.1, and 5.20.2. 
It will be the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations within 30 working days of identification of the protocol deviation, or within 10 working days 
of the scheduled protocol-required activity. Protocol deviations must be sent to the reviewing IRB per 

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their policies. The site investigator is responsible for knowing and adhering to the reviewing IRB 
requirements. 
10.1.11 PUBLICATION AND DATA SHARING POLICY 
  
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 
such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-
reviewed journals. Data from this study may be requested from other researchers 5 years after the 
completion of the primary endpoint by contacting PI Meier. 
10.1.12 CONFLICT OF INTEREST POLICY 
Any actual conflict of interest of persons who have a role in the design, conduct, analysis, publication, or 
any aspect of this trial will be disclosed and managed. Furthermore, persons who have a perceived 
conflict of interest will be required to have such conflicts managed in a way that is appropriate to their 
participation in the design and conduct of this trial. The study leadership in conjunction with the NCATS 
has established policies and procedures for all study group members to disclose all conflicts of interest 
and will establish a mechanism for the management of all reported dualities of interest. 
 
 
10.2 ADDITIONAL CONSIDERATIONS 
N/A 
 
 
10.3 ABBREVIATIONS AND SPECIAL TERMS 
AE 
Adverse Event 
ANCOVA 
Analysis of Covariance 
CFR 
Code of Federal Regulations 
CLIA 
Clinical Laboratory Improvement Amendments 
CMP 
Clinical Monitoring Plan 
COC 
Certificate of Confidentiality 
CONSORT Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 

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DSMB 
Data Safety Monitoring Board 
DRE 
Disease-Related Event 
EC 
Ethics Committee 
EMA 
Ecological Momentary Assessment 
eCRF 
Electronic Case Report Forms 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act of 2007 
FFR 
Federal Financial Report 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
GWAS 
Genome-Wide Association Studies 
HIPAA 
Health Insurance Portability and Accountability Act 
IB 
Investigator's Brochure 
ICH 
International Council on Harmonisation 
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
ITT 
Intention-To-Treat 
LSMEANS 
Least-squares Means 
MedDRA 
Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
NCT 
National Clinical Trial 
NIH 
National Institutes of Health 
NIH IC 
NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 

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10.4 PROTOCOL AMENDMENT HISTORY 
Version 
Date 
Description of Change  
Brief Rationale 
N/A 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 

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11 REFERENCES