Fall Detection and Prevention for Memory Care Through Real-time Artificial Intelligence Applied to Video: A Randomized Control Trial
Phase: NA
Conditions: Alzheimer's Disease and Related Dementia, Fall Injury
Sponsor: SafelyYou

 
 
 
Revision Date: 10/23/19 
 
 
 
 
 
 
Fall Detection and Prevention for Memory Care through Real-time Artificial 
Intelligence Applied to Video 
 
Protocol Number: SY-NIA-GX001 
 
 
Clinicaltrial.gov registration number: NCT03685240 
 
 
 
  
 
 
 
Primary Investigator: 
Glen Xiong, MD; CMO Safely You 
 
co-PI 
George Netscher, CEO SafelyYou 
 
 
 
Research Sites: 
SafelyYou Office – 450 Townsend St, San Francisco, CA 94107 
 
 
 
Purpose 
The purpose of the research is to study a new safety monitoring system developed by 
SafelyYou to help care for a loved one with dementia. The goal is to provide better support 
for unwitnessed falls.  
The SafelyYou Guardian system is based on AI-enabled cameras which detect fall related 
events and upload video only when these events are detected. The addition of a Human in 
the Loop (HIL) will alert the facility staff when an event is detected by the system. This would 
allow the facility to continue with its current safety precaution but add another level of 
support by using HIL’s to monitor for falls in real-time and 24/7. 
This process enables staff to know about falls without requiring residents wear a device and 
to see how falls occur for residents that cannot advocate for themselves while still protecting 

 
 
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resident privacy by only uploading video when safety critical events are detected. Seeing 
how the resident went to the ground (1) prevents the need for emergency room visits when 
residents intentionally moved to the ground without risk and (2) allows the care team to 
determine what caused an event like a fall and what changes can be made to reduce risk.  
 
                                            
                                                                                                                        
AIMS & HYPOTHESES FOR RANDOMIZED, WAITLIST-CONTROL STUDY. 
Aim #1. To assess whether SafelyYou Guardian + HIL will lower fall rates. Hypothesis 
1. Compared to standard-of-care (waitlist control group), SafelyYou Guardian will reduce fall 
rates in study participant over the study period of 6 months. 
 
Aim #2. To assess how use of the SafelyYou Guardian affects time spent on the 
ground after a fall.  Longer time to fall discovery is associated with higher human 
suffering and often leads to higher medical morbidity/mortality. Hypothesis 2: SafelyYou 
Guardian + HIL will reduce time to fall discovery (time from fall to staff notification) to 
under 5 minutes and reduce time spent on the ground to under 15 minutes. Since there 
is no way to measure control participants time spend on the ground, the aim will not 
have a comparison but will be descriptive.   
Aim #3. To assess whether SafelyYou Guardian will lead to improvement in hard 
clinical outcomes.  Hypothesis 3: SafelyYou Guardian participants will lower ED visits 
and hospitalizations when compared to control. This reduction in ED and hospitalization 
will correlate with reduced fall rates (aim #1) and reduced time spent on the ground 
(aim #2).  We will review the strength of the association with aim #1 and #2 outcomes.      
 
  
Design   
For Aim 1, we plan to recruit 460 study participants from 19 memory care facilities.  For the 
purpose of this study, facilities will include Skilled Nursing Facilities (SNFs), or equivalent. 
\Aim 1 will be a randomized controlled study using a waitlist control group.  The 
randomization will occur at the individual (resident) level within each facility to control for 
variations at each facility in terms of facility size, facility administration, and staff training. 
During the first 6 months, n=230 will receive the intervention (SafelyYou Guardian, i.e. real-
time alarms through a phone call from the HIL to the facility, front line staff intervention, and 
OT review), and n=230 will not receive the intervention. This design is the most rigorous way 
to test the intervention against the control: the randomization allows for control of 
confounding variables and has been previously used in the evaluation of medications, non-
pharmacological, and mobile electronic interventions (where use of placebo treatment and 
blinding is not feasible) [87-89]. Previous work used a baseline as control, allowing possible 
confounding variables. As we recognize that 50% of the interested participants will not 
receive the intervention, those residents will be offered the intervention for a 6-month 
extension period (in order to accomplish Aim 2). This is the best compromise between the 
need for a rigorous randomized controlled trial vs. ethical responsibility to maximize benefit 
to each study participant.   
  
For Aim #2, we will measure response times to each fall and the amount of time a resident 
spends on the ground after each fall. We intend to include all 460 participants’ data from Aim 
#1.  These will be participants who receive the initial intervention (n=230) and the additional 
participants who are on the waitlist control group who will receive the intervention in the 
second 6month period.  The design for Aim #2 is observational in nature.  The significance is 
that a large cohort of video data about the naturalistic progression of falls in residents with 
dementia has never been conducted to our knowledge. We will determine if the two time 
variables (time to fall discovery by staff and time spent on the ground after a fall, controlling 

 
 
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for baseline participant characteristics – i.e., demographics and medical conditions) and 
facility size, will predict need for ER visits or hospitalizations.  
For aim #3, we will ascertain the occurrence of fall in the intervention group by doing follow-
up case review of each detected fall.  For the control group, we perform biweekly check with 
facility staff and family regarding knowledge and documentation of any falls.  For falls in both 
the intervention and control group, we will additional collected data regarding occurrence of 
ED visit and hospitalization days.  We will also include occurrence (or absence) of any 
operations, intensive care unit stays, and other medical procedures.  We will also collect 
mortality data.    
Participant recruitment and retention   
In the Phase I project, recruitment was performed by hosting a family night with care staff 
from the facility. Recruitment rate among families attending family nights was 85%. Our 
retention over 10 months with the 11 partner facility was near 100% (no family / resident 
ever requested to remove the system). One resident did begin taking the sign off the door 
after enrolling in the study, and the system was removed with approval from the family since 
he may have been attempting to object to the study. We credit this high retention to the very 
little burden required.  
The recruitment of 460 residents will happen in batches (we expect to have access to our 
entire cohort 6 months from the start of the project).  Once the resident population is 
recruited, we will deploy the system and onboard the facility staff.  Onboarding will be 
gradual over 3 months. Through randomization, the population is split in half. One half, the 
control group, will not receive the intervention for the first 6 months, but will get the 
intervention for the next 6 months. The other half, the intervention group, will be in the study 
for the first 6 months only and then continue for the next 6 months. In total, 12 months will be 
needed per cohort.  Installing the system requires 1-5 days depending on the facility size to 
mount the SafelyYou Guardian in the electrical closet alongside the router and PoE switches 
required to connect and power the cameras. Installation will be provided by SafelyYou 
contractor.   
Subject Identification, Recruitment and Consent 
All consent procedures will be conducted by the research study personnel or the facility 
memory care representative who often has a personal relationship with residents and 
families. At this time, the informed consent document will be explained in detail and any 
questions will be answered. All participants will have a documented cognitive impairment 
and designated Legally Authorized Representatives. Because the designated Legally 
Authorized Representatives is required for the individual to live in a memory care facility, no 
participants will have capacity to consent independently. Legally Authorized Representatives 
will instead provide consent. If the individuals with dementia express any desire not to 
participate verbally or non-verbally to facility staff or Legally Authorized Representatives, 
they are instructed to alert research study personnel to remove the participate from the 
study.. If at any time, residents express verbal or nonverbal indication that they would like 
the camera removed, facility staff are instructed to place a cover over the camera and alert 
research study personnel at (415) 579 3630 or research@safely-you.com to remove the 
resident from the study. Camera covers are provided in advance with more available as 
needed.  
Subjects will not be compensated for participation in this study. 
Subjects will not be charged for any of the study activities. 
Inclusion criteria: residents included for this study are residents of memory care facilities who 
have agreed to participate in this clinical trial.  All pilots have been conducted based on 
study design approved by the UC Berkeley IRB and the California Department of Social 

 
 
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Services Community Care Licensing Division. We have not selectively recruited or excluded 
ethnic (or other) minorities.  
Exclusion criteria: (1) residents about to be transferred to a different facility where higher 
level of care is needed; (2) residents unable to consent and without Legally Authorized 
Representatives to provide consent, and (3) residents with Legally Authorized 
Representatives that choose not to take part. Compensation and measures to reduced 
dropouts:  
Drop out: We do expect some residents to move to another location or pass away and have 
included the expected dropout based on the Phase I project into the statistical calculations 
used below to determine the necessary participant number.  
  
Study procedures  
After informed consent, each participant will be randomized to either standard-of-care (wait 
list control) vs. intervention.  We will randomize participants within each facility as they are 
enrolled into the study.  This ensures that site differences such as size, staff training, and 
other confounding variables will be controlled for by having a balanced number of 
intervention/control participants per site. Family meetings and staff education sessions will 
be conducted at each site.  
If Legally Authorized Representatives wish to access recorded fall videos at any time, they 
can do so by contacting facility staff so they can walk through recorded video for the resident 
at the facility. These are sensitive videos, so we require Legally Authorized Representatives 
to visit the facility to view the videos with facility staff.   
 
Privacy and security safeguards. Privacy: A common concern with any video-based 
monitoring system is privacy. Through the series of pilots discussed previously and shown in 
Fig. 3, we have systematically validated the privacy/safety tradeoffs for residents, families, 
staff, owners, and operators of memory care facilities. Pilot 2 demonstrated at small scale 
(one facility, 10 residents) that the industry would be receptive to video-based fall detection 
and prevention. Pilots 3 and 4 confirmed the approach with 11 facilities and 87 residents 
while demonstrating significant positive outcomes including 37% reduction in use of EMS for 
falls and 38% reduction in total falls. We now have paid commitments for 480 beds and 
ongoing discussions regarding expansion within the networks from the Phase I facilities, 
validating the benefits outweigh potential privacy and legal concerns for a number of families 
and providers. The combined benefits of (1) reduced time on the ground due to real-time 
intervention of front line staff, (2) immediate assessment of severity when a resident is found 
on the ground without witness, and (3) reduced likelihood of future falls through intervention 
of OT make our commercial approach viable. The key point is that as dementia progresses, 
the need to keep a loved one safe often surpasses concerns regarding their privacy. The 
benefits provided by SafelyYou in terms of reduced falls and ED visits have surpassed the 
concerns for the majority in memory care facilities where 85%-90% opt-in for the system. For 
more information from families and care staff validating these numbers and sentiments, 
please see letters from Fanning, Obenauer, Bigelow, Kimokeo, and video:  
https://youtu.be/ThUsBVOAJ3A. This video was made with explicit permission from all 
residents/families for the purposes of promoting our work and supporting further recruitment. 
During pilots 2, 3 and 4, no live video was available and video was recorded whenever 
motion was detected. For new customers signing up for the system and for the Phase II 
clinical trial, no live video access is available and videos that do not contain a detected fall 
are not kept after 60 seconds as enabled by the highly accurate fall detection system 
developed in Phase I. We have never placed video cameras in bathrooms and will not for 
the Phase II clinical trial. In our 11 partner facilities, the Phase I showed that only 5-10% of 

 
 
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falls occur in the bathroom, and there is much good that can be done without needing the 
system in the bathroom. All study protocols have been approved by the UC Berkeley 
Committee for the Protection of Human Subjects. In all studies, privacy guidelines published 
by the California (CA) Department of Social Services (DSS) for video recording in private 
rooms  
(http://ccld.ca.gov/res/pdf/OfficeFunctions.pdf) have been followed including signs on all 
doors to inform visitors and staff of video recording, no audio recording to avoid accidentally 
recording someone in a room which did not consent to recording, and signed privacy waivers 
are required from legal representatives. Care staff were further instructed to take down 
cameras if residents ever appeared to object. In a recent presentation of the Phase I results 
to California DSS which included the Deputy Director of the Department, explicit approval 
was granted by DSS to expand our operations in California. One representative from DSS 
commented that this should be required for dementia care; another confirmed that we are 
the only company operating this type of technology in California currently (since this was the 
first approval of this type given by DSS). We thus take several steps to provide privacy 
safeguards and believe that SafelyYou meets a critical unmet need for ADRD care where 
safety concerns often surpass privacy concerns.   
Security: SafelyYou relies on HIPAA compliant, state-of-the-art cybersecurity software and 
software architectures that protect against attacks/failures. AWS Cloud Security and local 
data encryption in motion and at-rest are used to prevent video being available to 
unauthorized users. See data management plan for details.   
 
Recording: The recording process for the video proceeds as follows. A small, password-
protected computer is placed in the facility and connected to each camera. Video will be 
recorded and stored on this small computer in an encrypted format. Recordings will be sent 
directly to SafelyYou through an encrypted channel after an event is detected and available 
to the facility staff through a password protected website hosted on Amazon Web Services.  
Event Detection: As videos are recorded at the facility, the computer located in the facility 
will analyze the video streams and keep a buffer of 10 minutes of prior video from each 
camera. If a resident is detected on the ground or a resident is detected going from a laying 
position to a sitting position in bed, an alert will automatically be sent to the Magellan team, 
and the 10-minutes of buffer video will be uploaded. They will confirm a resident is on the 
ground by viewing a blurred version of the video as described above and reach out to the 
facility staff by phone or e-call system to inform them of the situation. The 10 minutes of 
video after a resident on the ground is confirmed will also be uploaded, enabling 20-minute 
window into how the fall occurred with minimal burden on the frontline care team. As long as 
an event such as a resident on the ground is detected, the system will continue to upload 
video in this way.  
Abuse Reporting: Abuse reporting will be conducted following the requirements of the 
Welfare and Institutions (WIC) code. If any potential evidence of abuse is discovered, facility 
management will be immediately alerted. Note that evidence of abuse may be missed by the 
SafelyYou system since only video of detected events is uploaded. The SafelyYou system is 
not meant to be a system for reporting abuse; it is meant to be a system for improving fall 
prevention practices in memory care. The research system is not intended to screen for 
abuse or theft suspicions. As discussed below, only video of detected events are available. It 
is thus very possible that incidents of abuse or theft are never uploaded for viewing by facility 
personnel.  
 
Confidentiality: Study data will be handled as confidentially as possible. If results of this 
study are published or presented, individual names and other personally identifiable 

 
 
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information will not be used unless you give explicit permission for this in the separate media 
release form. 
To minimize the risks to confidentiality, we will do the following: 
● 
During data collection, all data will be transmitted over a secure channel.  
● 
Research records, including video recordings and computer-based data, will be stored in 
an encrypted format, on a password-protected computer in a physically secure room. 
● 
Study data will be kept confidential, unless it is certain information that it must be 
reported for legal or ethical reasons, such as child abuse, elder abuse, intent to hurt self 
or others. We use the term elder abuse as defined by California Law in the Welfare and 
Institutions (WIC) code. 
The research data will be maintained for possible use in future research. We will retain this 
data for up to 5 years after the study is over at which point it will be deleted. It is retained for 
5 years to ensure sufficient time is given to study the content within the data and publish the 
results. It will not be used for any purpose beyond what is described here without explicit 
approval. Use of the study data will be restricted to SafelyYou research study personnel and 
their collaborators. For instance, if medically relevant information is observed such as 
significant patterns in fall behavior, we may ask primary care physician or medical 
collaborators from the UCSF Memory and Aging Center to provide additional clinical 
consultation.  The same measures described above will be taken to protect confidentiality of 
this study data. 
 
Data collection:  
Demographic and clinical data set: We collect demographic data including age, gender, 
race/ethnicity, primary clinical diagnoses for SNF stay with specific focus on dementia 
subtype, most recent orthopedic surgery (<3 months) or reason for hospitalization, chronic 
medical conditions (top 3), and baseline medications (number of medications).  Beyond the 
data collected from the video, data specific to the falls is collected either by direct extraction 
from the platform or from incident reports kept by facilities as (State regulations require 
facility track and file incident reports for all known falls). For the control population, the time 
of unwitnessed falls is unknown, but the number of falls and ER visits is collected from the 
existing facility incident reports. For the population equipped with SafelyYou Guardian, we 
will have direct access to the time of the fall, the time it took the HIL to verify the fall and call 
the facility, and the time on the ground. Note that for the residents with SafelyYou Guardian, 
we expect these values to be in increments of minutes. 
Clinical outcomes.  
For Aim #1, the primary outcomes are the number of falls detected by facilities using the 
adverse incident reporting system as per routine facility protocol. While use of video 
detected falls will be used in the intervention group to assist with prevention of future falls, 
we will not use this as the actual outcome measure: is not the standard-of-care, and the 
control group will not have video recorded outcomes. There is a bias for detecting falls using 
video since existing fall reporting systems do not capture falls which staff do not know about 
(e.g., when a resident is able to get back in bed after a fall). Staff-detected falls which 
automatically trigger adverse incident reporting is the “real-world” outcome measure and 
current stand-of-care.  Thus, outcomes will differ by facility (each facility has different 
adverse incident reporting operations and implementation, hence the randomization at each 
facility will adjust for such variables).  
Aim #2 will be a naturalistic observation of SafelyYou Guardian with HIL for 6 months. 
Specifically, for all the facilities, the use of the SafelyYou Guardian enables direct notification 
of falls to front-line staff in the facilities, by intervention of the HIL.  We can directly measure 
time on the ground for the residents as follows: (1) The time of the fall is recorded by 

 
 
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SafelyYou Guardian (which detected it); (2) The time of intervention of the front-line staff is 
logged by the staff after finding the residents on the ground. This means that for the 
population with treatment, we can directly measure the time of fall discovery (successful call 
leading to front line staff intervention), and time on  the ground (since time of the intervention 
is logged by the facility). This is because time on the ground for monitored residents can be 
measured precisely by video recording. Reduction of the time on the ground can be 
computed given the difference between the two.  
Aim #3 will include number of ER visits and number of hospitalizations.  We will obtain 
information about resident demographics, medical comorbidities, emergency room visits, 
and hospitalization data by asking the study participant legal representatives.  In addition, we 
will have participant / participant Durable Power of Attorney complete HIPAA consent forms 
for release of medical records when indicated if the details of data are not available.   
  
Data analysis: For aims 1, statistical analyses to address baseline comparison: Subjects’ 
baseline characteristics (demographics and medical conditions) will be compared between 
the intervention and control groups using 2-sample t-tests (or appropriate nonparametric 
tests if the assumption of normality appears to be violated) and chi-square tests for 
continuous and categorical variables.  Descriptive statistics will be used (means, 
frequencies, standard deviations, 95% confidence intervals) for all variables.  We will 
examine the Aim #1a outcomes using a Poisson mixed-effects model to account for the 
nesting of outcomes within centers. We will account for baseline measures of resident 
activation and health status and resident demographics to statistically adjust for baseline 
imbalances, reduce residual intra-cluster correlation and improve the precision of estimated 
effects. Power analyses were performed via a simulation study in R version 3.4. and the 
lme4 package.  We used 3 months of pilot data to guide and set assumptions for the data 
generating process. Based off initial data, we assumed centers ranged in size from 25-45 
participants, and that roughly 30% of participants at each site would consent to the trial. Of 
those who consent, 50% will be randomized to the intervention. We fit the pilot data to a 
Poisson mixed effects model to obtain an estimate of the average monthly fall rate (0.49) as 
well as the between cluster variation in log fall rate (σbtwn = 0.467). We generated 1000 
sample data sets assuming different effect sizes (40%, 30%, 25% reduction in falls) and 
calculated the power obtained to detect this improvement due to intervention, as a function 
of the number of centers.  
Following the sample size for a time-averaged response methodology laid out in Fitzmaurice 
et al., we adjusted the total number of centers needed by a factor related to the number of 
observed months, anticipated participants per center (30% of 35 participants per center with 
10% dropout) and the correlation between measurement months. The dropout rate was 
roughly at ~1% per month so a 10% dropout over 6 months is a conservative estimate.  We 
assumed an extremely conservative estimate of the correlation between time points 
(months) of 0.8 and 6 months of follow-up. Reproducible R code is available at 
https://github.com/Teresa1207/. We estimate that a total sample size of 460 (n=230/arm) out 
of 19 facilities will be needed for a power of 80% to detect a 30% reduction in falls in the 
intervention group vs. control.  Our approach of focusing on estimation and uncertainty and 
accepting the sample size collected for the main study, is congruent with experts’ 
recommendations stating that the purpose of economic evaluation is not hypothesis testing; 
given there is no hypothesis testing, there is no requirement for a separate sample size 
calculation. For Aim 2, we will use similar descriptive statistics as described in Aim 1. For 
Aim 3, We will use a multivariate regression model to examine predictors of the main 
outcome, ER visits and hospitalizations (binary variable), using time to fall discovery by staff 
and time spent on the ground as the main predictors while controlling for baseline participant 
characteristics and facility characteristics.     

 
 
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Risk/Benefit Assessment 
Minimal risk for study participants is expected as the system does not physically interact with 
study participants in any way and only provides supplementary support while all existing 
safety protocols in the facility remain in place.  
Risks and/or discomforts include loss of privacy by placing a camera in the private room. 
Although the system is designed to keep video only when a fall is detected, false alarms do 
occur which can cause video to be uploaded at any time. If subjects feel uncomfortable 
about privacy once the cameras are installed, they may withdraw from the study at any time.  
The research study personnel take several steps to protect the privacy of each participant. 
The recorded video does not have audio capability in order to protect private communication 
of residents and their visitors. Physical signs are posted visibly at the entrance to all private 
rooms containing cameras. The signs state that video recording is in progress to ensure all 
visitors and staff entering the room are aware of the camera. Cameras are placed in the 
private bedroom only, not in the private bathroom. Cameras record video only when an 
event is detected. Video (with no audio) will be reviewed by the research study personnel 
after collection. If more than one resident occupies a room, all roommates must provide 
informed consent for any to participate. All data is encrypted in transit and at rest.  
Installation of the wall-mounted cameras will require inserting screws into the wall in the 
corner of the room adjacent to the ceiling and installing cabling which may be visible. No 
other risk of property damage is expected. 
The ongoing safety procedures at the facility will remain in place. 
The SafelyYou system has demonstrated reduced fall risk and unnecessary emergency 
room visits for those using it in previous studies with under 100 residents enrolled and 
hundreds more that have used it as a commercial product. We believe the system will 
provide significant benefits through faster response times to safety-critical situations, help 
staff make informed decisions about the need for transfer to the emergency room following 
unwitnessed falls, and reduce the overall frequency of falls through improved root cause 
analysis to minimize the risk of repeat falls, but this is active research, and we do not know if 
any of these benefits will occur for certain.   
In the long-term, we hope that the information gained from the study will help produce a 
robust safety system to improve the quality and reduce the cost of dementia care.  
Alternatives to participation are to not enroll in the system and continue to receive standard 
dementia care are the participating facility.