A Mobile Tai Chi Platform for Fall Prevention and Cognition in Older Adults
Phase: NA
Conditions: Aging, Fall
Sponsor: Spaulding Rehabilitation Hospital

 
 
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Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
 
Principal Investigator: 
Paolo Bonato, PhD 
 
Project Title: A Mobile Tai Chi Platform for Fall Prevention and Cognition in Older Adults  
 
Version Date: 
October 19th, 2022 
 
 
1. 
 Background and Significance 
 
Non-pharmacological early-intervention strategies to slow the growing epidemic of age-related 
cognitive decline and dementia, and their well-established impact on functional outcomes, must 
include the targeting of executive function (EF). EF encompasses several essential higher 
cognitive skills, including attentional control, planning, response inhibition and working 
memory.1 In addition to portending Alzheimer’s disease,2–5 executive dysfunction in older adults 
is associated with impaired gait and balance and higher fall risk,6–11 which significantly decrease 
functional independence and overall quality of life (QOL).12 
 
Exercise is considered a promising intervention for preservation and restoration of cognitive 
function in older adults, including EF,13–16 with  literature reviews suggesting that multimodal 
training that integrates physical and cognitive training may have advantages over unimodal  
interventions.17–19 Tai Chi (TC) is an increasingly popular multimodal mind-body exercise that 
incorporates physical, cognitive,  social, and meditative components within the same activity.20,21 
Recent meta-analyses show that TC is a promising intervention for EF and global cognitive 
function in older adults. In several studies, TC was found to be superior to conventional 
exercise.22–24 
 
The CDC and many other agencies endorse TC. Yet surprisingly, a comprehensive 2014 national 
survey found that only 1.2% of the entire adult population reported using TC for health, 
suggesting potential limitations in access to training programs.25 Limited access to community 
training programs is also indicated by the fact that a significant percentage of survey respondents 
reported learning TC from online or video courses.  
 
During phase I of the SBIR NIH grant, we developed algorithms based on information gathered 
from wearable sensors to estimate adherence, proficiency, and safety metrics. During the non-
clinical stages of phase II, we developed a complete beta-version of the Tele-TC platform. The 
Tele-TC system consists of a set of 5 wearable sensors and an app installed on a commercially 
available tablet.  
 

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As a preliminary step toward designing a future study to assess the clinical benefits of the Tele-
TC platform as a training system for elderly with mild cognitive impairments, we herein propose 
to assess:  
• If the system enables monitoring longitudinally of adherence, proficiency, and safety.  
• If the system is acceptable and user-friendly for its intended use in the home setting. 
• As an exploratory aim: if a 12-week training program using the Tele-TC platform leads to 
improvements in cognitive function, balance, physical activity, self-efficacy, health-
related quality of life, and gait.  
 
If this preliminary study leads to positive results, we will embark on a follow-up study to assess 
the potential clinical benefits of using the technology as part of a clinical intervention on 
cognition, balance, physical activity, gait, self-efficacy, and health-related quality of life. 
 
 
2. 
Specific Aims and Objectives  
 
The overall goal of the study is to test the delivery of a novel Tele-Tai Chi (TC) intervention in a 
single-arm feasibility study for community-dwelling TC-naïve older adults with mild cognitive 
impairment (N=20 total). We will assess feasibility and acceptability measures of the Tele-TC 
intervention and its specific components through both qualitative and quantitative feedback, as 
well as the systematic tracking of adherence data to inform future trials and potential clinical use 
of the Tele-TC system. We will also explore changes in clinically relevant outcome measures 
including cognitive function, physical activity, self-efficacy, quality of life, balance, gait, and 
evaluate changes in TC proficiency.   
 
 
Primary aims 
• Aim 1: To evaluate the feasibility, acceptability, and 
safety of a novel home-based Tele-TC intervention 
by tracking recruitment, retention, adherence, and 
adverse events.  
o Hypothesis 1: We will be able to recruit 20 
older adults with mild cognitive impairment 
and limit withdrawals to 20% or less.  
o Hypothesis 2: Participants will complete 
>60% of recommended Tele-TC sessions.  
o Hypothesis 3: Protocols for assessing safety 
can be developed and reliably administered, 
and preliminary evidence will support Tele-TC can be delivered safely.   
 
 
 
 
Figure 1: Study system.  

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Exploratory aims 
• Aim 2: To evaluate changes in the level of proficiency of TC during a 12-week simplified TC 
program using the Tele-TC platform at home. 
o Hypothesis 1: We will be able to collect reliable data on TC proficiency during Tele-
TC use by study participants. 
o Hypothesis 2: Proficiency scores will improve over 12 weeks of training using the 
Tele-TC program supporting protocol learnability.    
• Aim 3: To gather feedback from end-users on ease of use of the Tele-TC platform. We plan 
to collect feedback from elderly subjects to assess if the system is user-friendly enough 
to envision its use in a clinical setting. 
o Hypothesis 1: We will be able to collect reliable data on ease of use of the platform 
using qualitative and quantitative measures.  
• Aim 4: To explore changes in clinically relevant outcome measures including cognitive 
function, physical activity, self-efficacy, quality of life, balance, and gait.  
o Hypothesis 1: We will be able to collect reliable outcomes data at each testing 
visit.  
o Hypothesis 2: We will see clinically relevant changes in outcomes measures at 12 
weeks.  
 
3. 
General Description of Study Design 
 
As a preliminary test of our platform’s suitability as a home-based TC program for people with 
mild cognitive impairments, we will recruit a convenience sample of 20 community-dwelling TC-
naïve older adults with mild cognitive impairments into a single-arm longitudinal study of home-
based TC learning, combined with remote and in-person data collections. In-person data 
collection will take place at the Spaulding Rehabilitation Hospital Motion Analysis Laboratory.  
 
 
4. 
Subject Selection 
 
Inclusion criteria: 
Eligibility criteria are purposefully broad to maximize generalizability of the study results. To be 
eligible to participate in the study, individuals will have to meet the following criteria: 
• Men and women between 60 and 85 years old 
• TC naïve (never practiced TC) 
• With mild cognitive impairments (Montreal Cognitive Assessment (MoCA)-Blind score 
between 17 and 13). 
• Self-reported ability to walk continuously for 15 minutes without an assistive device 
• Working email address 
• Prior experience with and current access to a computer, smart phone or tablet device 
 
Exclusion criteria: 
Individuals will not be eligible to participate in the study if they exhibit any of the following: 

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• Chronic neuromuscular conditions (e.g. Parkinson’s disease, multiple sclerosis, stroke) 
• Acute medical conditions requiring hospitalization within the past 6 months or that 
could interfere with safely participating in the study 
• Active cancer 
• Significant musculoskeletal conditions requiring chronic use of pain medication 
• Significant cognitive impairment (Diagnosed with dementia (self-reported), or Montreal 
Cognitive Assessment (MoCA)-Blind score < 13) 
 
All subjects will be recruited by IRB approved study staff for this protocol. Recruitment strategies 
will include the use of the following sources:  
• Physicians and therapists may refer interested patients to the study (we will provide 
physicians and therapists with study flyers and brochures to inform clinicians of the study 
details). 
• Flyers posted in outpatient clinics, therapy gyms, and public spaces both inside and 
outside the hospital campus. 
• PowerPoint presentation to inform clinicians and prospective participants about the 
study. 
• Contacts at local senior and community centers. 
• Recruitment letters sent to patients within the Partners network who have previously 
expressed interest for participating in research studies. 
• Via contacts with patients who have consented to be directly contacted in the Partners 
Research Patient Data Registry (RPDR) or RSVP for Health. 
• Via contact to the patients listed for direct contact in the Partners Research Patient Data 
Registry (RPDR) and Patient Gateway (via research invitation letters), as appropriate. A 
manual medical record review will be performed on all potential participants identified 
in this manner to ensure they are appropriate candidates for participation.  
• Via targeted medical records review (i.e. current inpatients/outpatients within relevant 
departments at MGB institutions) using EPIC. Potential participants identified in this 
manner will be contacted through Patient Gateway (via research invitation letters) or 
mailed letters as appropriate. 
• Via the Partners Clinical Trials (Rally) website. 
• Via newsletters or community boards such as the Osher Center for Integrative Medicine 
newsletter. 
 
Recruitment will also occur through the Spaulding Research Registry, which is a database of 
persons who have had a stroke, traumatic brain injury, or spinal cord injury and wish to be 
considered for participation in research studies at Spaulding Rehabilitation Hospital - Boston and 
other affiliated Harvard institutions. Patient information kept in the registry includes name, 
contact information, diagnosis with date of onset, laterality and language involvement for stroke, 
level of injury for SCI, severity for TBI, date of birth and gender. In addition, a record of referrals 
to specific studies, with dates and enrollment status, will be maintained for each registry 
member. The information is patient reported and is maintained in an encrypted, Mass General 
Brigham approved database. When investigators with IRB approved protocols request assistance 

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in identifying potential subjects, the Registry will create a list of those in the database with the 
desired characteristics. The Investigator will provide a letter describing the study which the 
Registry will send to those on the list. Patients receiving these letters contact the Investigator 
directly to pursue potential participation in the study.  
 
Subjects who are interested and willing to participate in the study will undergo an initial screening 
over the phone or in-person to determine their eligibility. Subjects who underwent the phone 
screening and qualify will be sent study information and will be scheduled to visit the lab where 
they will undergo a final screening in-person to assess whether they meet all the inclusion and 
exclusion criteria. Testing will only be performed after obtaining signed consent from the subject. 
 
The study entails no cost to the subject. We will cover parking costs for all participants who park 
at the SRH garage while taking part in the study. Participants will be compensated for their time 
at study completion. 
 
 
5. 
Subject Enrollment 
 
The study procedures will be carried out remotely using a Zoom Enterprise Partners account or 
in person. Prior to the first visit, we will perform a phone screening to determine eligibility of 
prospective study volunteers. Individuals will be informed that identifiable information may be 
recorded during the phone screening. If a subject is deemed eligible, identifiable information (e.g. 
name, contact info) will be collected, and an informed consent form will be emailed to subjects 
for review.  Baseline testing at a future date will be scheduled.    
 
Eligible subjects will undergo the informed consent process in person, by phone or on Zoom 
Enterprise with a trained research assistant at the beginning of the baseline testing visit. Once 
consented, subjects will undergo baseline assessments (visit #1) in person using REDcap Survey. 
After baseline testing, subjects will participate in the Tele-TC intervention, with recommended 
training sessions at least three times a week, along with two or more supplementary one-on-one 
live sessions (lasting upwards to 45 minutes) with TC instructors. TC proficiency using wearable 
sensors will be assessed at visit #1 baseline, at two follow-up assessments (visit #2 and visit #3) 
at approximately 4 and 8 weeks, and at a final assessment (visit #4) at 12 weeks. A semi-
structured qualitative interview will also be performed at visit #1 and #4.   
 
6. 
STUDY PROCEDURES 
 
Below, we provide a detailed description of the study procedures.  
 
1. Screening and Informed Consent (Visit #1A) 
 
Prior to beginning the consent process, study staff will ensure subjects’ eligibility using a brief 
questionnaire. This, in addition to the phone screening done as part of the recruitment process 
prior to the first visit, will ensure the eligibility of prospective study volunteers. The phone 

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screening is not only undertaken to allow researchers to confirm the subjects’ eligibility, but it is 
also an opportunity for the volunteer to ask any additional questions they might have regarding 
the study. The phone screen includes administration of the Montreal Cognitive Assessment 
(MoCA)-Blind, an adapted version of the original MoCA, a validated, rapid screening instrument 
for mild cognitive impairment. Informed consent will be obtained by trained study staff in 
person. Study staff will explain all the study procedures, equipment, and the risks associated 
with them as outlined in the informed consent form (ICF). The devices will be provided to the 
subjects after consent. 
 
 
 
 
Subjects will be provided among others with two mobile devices and requisite chargers, a tablet 
travel stand, tripod, two GeneActiv watches, 5 wearable sensors, each of them with elastic 
bands and with chargers and wires. Of the two mobile devices, one will be used to interact with 
the developed TC app and the other will be used an extra mobile device and stand for virtual 
visits and video recording.  
 
 
  
Figure 2: Flow Chart of the study. 
Patient Enrollment
Phone Screening
End Study
Consent and Baseline Assessments
Eligible
Not Eligible
Visit 0
Visit 1
Lab Visit
Home-based Tai Chi Training
Assessment
Visit 2 (Week 4)
Home-based Tai Chi Training
Assessment
Visit 3 (Week 8)
Home-based Tai Chi Training
Post-Intervention Assessment
Visit 4 (Week 12)
Lab Visit
Virtual Visit
Virtual Visit

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2. Assessments (Visits #1B, #2, #3 and #4) 
 
At Visit #1B, subjects will be instructed in how to use the tablet-based Tele-TC program. The 
mobile devices and the sensors will be provided to each participant and will be preprogramed 
will all required software. It is worth emphasizing that, as part of the consent process, all subjects 
will be asked permission to be videorecorded during the assessments via Zoom Enterprise.  
 
Visits will be divided into two components: 1) clinical assessments and 2) instrumented 
monitoring of TC performance.  
 
The following clinical assessments will be performed during Visits #1B and #4. 
 
The following questionnaires will be provided to the subjects through REDcap Survey with an 
email link. It will take around 45 minutes to complete all of the questionnaires. 
• Activities Specific Balance Confidence (ABC): 16-item self-report measure in which 
patients rate their balance confidence for performing activities. 
• PROMIS® (Patient-Reported Outcomes Measurement Information System) 29 (PROMIS-
29) instrument: 29-item questionnaire assessing each of the following domains: anxiety, 
depression, fatigue, physical function, pain interference, pain intensity, sleep disturbance, 
and ability to participate in social roles and activities. The instrument contains four items 
from each primary domain plus a single pain intensity rating.  
• Physical Activity Scale for the Elderly (PASE): self-reported level of physical activity in 
individuals aged 65 years or older during the previous 7 days. 
• Exercise Self-efficacy Questionnaire (SEE): A 9-item questionnaire that focuses on the self-
efficacy expectations for exercise for older adults; specifically, the ability to continue to 
exercise despite barriers. 
 
Clinical assessments which take around 15 minutes will include tests such as: 
• Trail Making Test A/B: Executive function will be assessed using the Trail Making Test. 
Participants will be timed while sequentially connecting a series of numbered circles (part 
A), as well as connecting an alternating series of numbers and letters (part B). The 
adjusted trail making score (i.e., part B minus A, sec) is sensitive to changes in executive 
function and frontal lobe pathology in older adults. The trail making Test will be camera-
recorded. 
• Controlled Oral Word Association Test (COWAT): examines working memory span. 
COWAT requires the participant to produce as many words as possible that begin with a 
given letter of the alphabet (F,A,S). There is 1 minute allowed for each of the three letters. 
The score is the sum of all acceptable words produced in the three trials. COWAT has good 
reliability and validity. The test will be audio-recorded and transcribed to ensure accurate 
collection of subjects’ verbal responses. 
• Digit Span Test: widely used measure of short-term memory, i.e. the number of digits a 
person can absorb and recall in correct serial order. Two trials of eight number sequences 

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are read aloud. The number sequences start out easy, with just two numbers, and get 
progressively more difficult, the last being nine digits. Scores are based on the number of 
sequences correctly recalled (i.e., until the participant consecutively fails two trials of the 
same digit span length). BDS has good reliability and validity. 
• Grip Strength: we will measure the grip strength of both upper limbs using a hand grip 
dynamometer. We will repeat the measure three times.  
• Instrumented and camera-recorded monitoring of balance in each leg separately: Subjects 
will be asked to stand on one leg for 30 seconds.   
• Instrumented and camera-recorded Timed-Up-and-Go: Subjects will be asked to stand up 
from a chair, walk at their normal speed around a cone, turn around, and come back to 
sit in the chair. 
• Instrumented and camera-recorded Timed-Up-and-Go dual task: Subjects will be asked to 
complete the previous task while counting backwards by three.  
• Instrumented and camera-recorded Sit-to-Stand: Subjects will be asked to stand up from 
a chair while keeping their arms crossed across their chest during 30 seconds. 
•  Instrumented and camera-recorded monitoring of balance in both legs with feet 
shoulder-width apart and as close as possible without touching.  
• Instrumented and camera-recorded monitoring of gait: Subjects will be asked to walk back 
and forth for 2 minutes.  
• Instrumented and camera-recorded monitoring the miniBEST: It is a shortened version of 
the Balance Evaluation System Test (BESTest). It is a 14-item test scored on a 3-level 
ordinal scale. It aims to target and identify different balance control systems. 
 
Instrumented and camera-recorded monitoring of TC performance will be performed during 
Visits #1B, #2, #3 and #4:  
• Participants will be instrumented with 5 sensors (one on each limb and one on the trunk) 
and they will be following the instructions from the Tele-TC platform.  
 
Study staff will use Zoom to communicate with subjects during the visits done remotely. The 
performance of TC exercises will also be videorecorded and scored using the proficiency metric 
described in our preliminary studies section to provide a gold standard. We will try to use the 
sensors during the remote visits, but if it is not possible, we will document the reasons and 
continue the TC exercises only with video. 
 
Subjects will be asked to don one Smart GeneActiv watch by ActivInsights* on their wrist to 
monitor activity during approximately a week after visits #1B and a week before visit #4. 
 
We will ask the participants to send the GeneActiv back to the lab after wearing it. We will be 
sending another GeneActiv about two weeks before visit #4. 
 
 

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3. TC Training Sessions the Tele-TC Platform (12 weeks) 
 
Study volunteers will participate in a 12-week simplified TC program that we have used in 
multiple prior clinical studies. In this pilot study, the intervention will be delivered via our 
platform-based application. All participants will be provided with a tablet with the Tele-TC 
software installed. The structured intervention, designed for older adults, emphasizes essential 
TC movements that are easily comprehensible and can be performed repetitively in a flowing 
manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-
Ch'ing's Yang-style short form. Additionally, a complementary set of traditional TC warm-up 
exercises that focus on loosening the physical body, incorporating mindfulness and imagery into 
movement, promoting overall relaxation, and coordinating breathing awareness are included. 
Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability 
and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at 
least 3 days a week for 12 weeks. In addition to data on practice frequency, duration, protocol 
adherence and training proficiency being automatically collected through our platform, a weekly 
REDcap survey will be used to monitor adverse events. The TC program will also include 2 or more 
live instructional sessions via Zoom with a TC instructor.  
 
4. Remote Monitoring of Falls and Other Adverse Events 
 
We will monitor falls during the subject’s participation in the intervention study. Falls will be 
defined as any event in which the participant unintentionally comes to rest on the ground or 
other lower level, not as a result of a major intrinsic event or an overwhelmingly external hazard. 
Falls will be systematically monitored in two ways. As part of our safety and adverse events (AE) 
monitoring, participants will be asked to complete a weekly REDcap adverse events survey about 
their TC practice and activities of daily living. Study staff will follow-up by phone with participants 
as necessary. During study visits #1b-#4, study personnel will inquire about and record 
characteristics and details of falls and other adverse events.  
 
5. Feedback from the Subjects  
 
During the last visit (visit #4), we will conduct a semi-structured qualitative interview to gather 
feedback from the subjects regarding the feasibility and acceptability of the study overall, and 
more specifically the usability of the Tele-TC platform. We will ask them to provide us with 
feedback regarding general characteristics of the platform, possible improvements of the system, 
and whether they would consider using the system on a daily basis at home. The qualitative 
interview will be audio recorded. In addition, at the end of the study, we will use an adapted 
version of the System Usability Scale (SUS). 
 
 

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6. Return of devices 
 
The subjects will be asked to return the devices (mobile devices, sensors, tablet stands) during 
visit#4. The final payment for the study ($70) will be contingent on the return of the study 
equipment.  
 
7. Data variables analysis to be collected 
 
The primary outcomes of the study are the retention and the protocol adherence during the 
study, and the System Usability Scale collected post-intervention.  
The exploratory outcomes will include the following:  
- The ease of use of the Tele-Tai Chi platform measure with the qualitative interview 
collected post intervention.  
- The changes in outcomes collected at baseline and post-intervention: the Activities-
specific Balance Confidence (ABC) scores, PROMIS 29 scores, the Physical Activity Scale 
for the Elderly (PASE), the Trail Making Test A/B scores, Self-Efficacy Exercise (SEE) scores, 
the grip strength, the Controlled Oral Word Association Test (COWAT), the Digit Span 
Test, the Timed-Up-and-Go, the Timed-Up-and-Go dual task single leg stance, the Sit-to-
Stand performance, the balance on both legs with feet shoulder-width apart, the  balance 
on both legs with feet close to each other, the normalized-to-height stride length and 
stride time variability, the activity level, and the Mini-Balance Evaluation Systems Test 
(MiniBEST) collected only in individuals who are willing to be tested in the MAL.  
- The changes in The Tai Chi proficiency scores collected at baseline, 4 weeks, 8 weeks, 
and post-intervention. 
 
8. Remuneration 
 
Subjects will be compensated based on the procedures undertaken. Subjects will receive up to 
$240. The compensation amount will be as follows: 
• Virtual visits: $50 for each follow-up testing session (4-week, 8-week) for a total of $100 
• In-person visits: $70 for baseline and post-intervention testing session for a total of $140 
If during the study the study staff determines that the participant cannot safely complete the 
session, he/she will be asked to stop – but he/she will still receive $35 for their time and effort. 
 
Additionally, associated travel fees accrued by subjects to participate in the study (e.g. parking 
fees at SRH) will be covered by the Motion Analysis Laboratory. 
 
 
7. 
Risks and Discomforts 
 
TC is likely to be safe, as there have been no reports of serious adverse impacts in the TC 
literature. We experienced no serious adverse events in our pilot studies with COPD, heart 
failure, vestibulopathy, and osteopenic populations. However, there may be some potential 
expected risks to participants including the following:  

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1. TC and other motor tasks included in the clinical evaluations of balance and gait may 
cause some muscle soreness in highly deconditioned individuals. This soreness is likely to only 
last a short time. In addition, shortness of breath, dizziness, or falls are possible. However, these 
risks are unlikely and will be discussed in both the protocol and consent form.  
2. Possible discomforts associated with using the sensors are the same as those 
experienced when wearing other wearable devices such as bracelets, watches and heart monitor 
straps. Prolonged use of the sensors may cause sweating and skin irritation. 
 
There is a possibility that subjects could fall or trip during the experimental procedures, or that 
they may experience an allergic reaction or minor skin irritation to the band used to attach the 
sensors to the body. There is also a possibility that subjects may become fatigued or experience 
muscle soreness. 
 
The risk of falling during the TC exercises and balance tests will be minimized by excluding 
subjects with balance impairments and risk of falls based on medical history, self-reported 
previous falls, and some clinical tests to assess potential balance impairments in study 
participants, whose outcome will be used by a rehabilitation specialist to determine if the subject 
can safely perform the TC exercises. If a subject falls during remote visits or TC practice, they will 
be referred to their physician or to urgent care as needed.  
 
Fatigue and muscle soreness will be minimized by allowing subjects to rest at any point during 
the experimental procedures. 
 
Subjects will be encouraged to contact MAL staff with any questions or concerns they may have 
at any time during the study or after its completion. 
 
Overall, the potential risks to participants are modest and are likely to be viewed as reasonable 
in relation to the anticipated benefits to subjects and others. 
 
When - according to a rehabilitation specialist during in-person testing, or research staff during 
virtual testing - subjects are unable to safely perform the TC exercises that are part of the 
experimental procedures, the experiment will end. Subjects will be told why the experiment must 
stop and will be advised to seek medical care if appropriate. 
 
Subjects will be told that the study procedures may be associated with discomfort due to wearing 
the sensors and by fatigue/muscle soreness. In case subjects experience discomfort or excessive 
fatigue, they will be free to remove the sensors and end their participation in the study. 
 
Unintentional loss/disclosure of Protected Health Information may occur and is considered a 
minimal risk due to the security measures enforced at SRH. Confidential information will be kept 
in a locked filing cabinet, on REDcap, and on password-protected computers in the MAL. 
 
 

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8. 
Benefits 
 
Study participants are not expected to directly benefit from their participation, but it is possible 
that subjects will experience some positive impact on cognition, physical and mental health as a 
result of their performing TC exercises, as has been shown in prior TC studies. Information gained 
during the study is expected to contribute to the development of systems to facilitate the 
deployment of TC-based interventions. 
 
 
9. 
Statistical Analysis 
 
Descriptive statistics will be derived for all the above-described clinical assessment outcomes and 
correlations will be sought with the sensor-based estimates of the metrics of adherence, 
proficiency and safety derived using the previously developed algorithms. Exploratory statistical 
analyses will be performed to power future clinical studies aimed to test the relationship 
between the proposed metrics of adherence and proficiency and the clinical outcomes of the 
intervention. Whereas conclusive statistical analyses to explore such correlations are beyond the 
scope of the proposed project, the data collected in this pilot study are expected to provide 
justification for a future trial aimed to assess the efficacy of the Tele-TC Platform as a training 
system for older adults with mild cognitive impairments. 
 
10.   Monitoring and Quality Assurance 
 
Because this study’s procedures pose minimal risk to the subjects, bimonthly data and procedural 
reviews by the PI in consultation with study staff will be sufficient to identify and ameliorate any 
potential safety issues. Any safety concerns about the equipment or testing protocol will be 
brought to the immediate attention of Dr. Bonato. Study staff will conduct bimonthly audits to 
ensure compliance with regulatory requirements for study documentation. 
 
Approval of protocol, informed consent procedures, and recruitment will be obtained from the 
IRB during annual reviews. 
 
Adverse event reporting will be done according to Partners Human Research Policy. Remedial 
action to prevent reoccurrence of the event will be instituted prior to the resumption of study 
procedures. 
 
Study staff will conduct quarterly audits to ensure compliance with regulatory standards for study 
documentation. 
 
 
 

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11.   Privacy and Confidentiality 
 
☒ Study procedures will be conducted in a private setting 
☒ Only data and/or specimens necessary for the conduct of the study will be collected 
☒ Data collected (paper and/or electronic) will be maintained in a secure location with 
appropriate protections such as password protection, encryption, physical security 
measures (locked files/areas) 
☐ Specimens collected will be maintained in a secure location with appropriate 
protections (e.g. locked storage spaces, laboratory areas) 
☒ Data and specimens will only be shared with individuals who are members of the IRB-
approved research team or approved for sharing as described in this IRB protocol 
☒  Data and/or specimens requiring transportation from one location or electronic space to 
another will be transported only in a secure manner (e.g. encrypted files, password 
protection, using chain-of-custody procedures, etc.) 
☒   All electronic communication with participants will comply with Mass General Brigham 
secure communication policies 
☒ Identifiers will be coded or removed as soon as feasible and access to files linking 
identifiers with coded data or specimens will be limited to the minimal necessary 
members of the research team required to conduct the research 
☒ All staff are trained on and will follow the Mass General Brigham policies and 
procedures for maintaining appropriate confidentiality of research data and specimens 
☒ The PI will ensure that all staff implement and follow any Research Information Service 
Office (RISO) requirements for this research 
☐ Additional privacy and/or confidentiality protections 
 
 
The MAL will assign each new subject an alphanumeric identifier, which will henceforth be the 
sole means of identification connected to their data. All data will be collected under this identifier 
and will be kept isolated from any personal health information. All data will be stored on REDcap. 
Information shared with individuals outside of Partners will be labeled using an alphanumeric 
identifier and will be devoid of personal health information. 
 
Video recordings and photos will be stored securely in the MAL; only investigators listed on the 
study will have access to them. Patients will be given the choice to have video/photo material 
used for academic articles and presentations. 
 
This project is supported by the National Institutes of Health via an STTR award to BioSensics 
(primary site) and the involvement of researchers at SRH and BWH. De-identified data will be 
shared with BioSensics. 
 
 
 

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2. Hamel R, Köhler S, Sistermans N, et al. The trajectory of cognitive decline in the pre-dementia 
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1519. doi:10.1017/S0033291714002645  
3. Kirova A-M, Bays RB, Lagalwar S. Working memory and executive function decline across normal 
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