Enhancing Sleep Quality for Nursing Home Residents With Dementia: Pragmatic Trial of an Evidence-Based Frontline Huddling Program
Phase: NA
Conditions: Alzheimer Disease, Dementia, Sleep Disorder, Sleep Disturbance
Sponsor: University of Alabama, Tuscaloosa

 
PROTOCOL
IRB Form
University of Alabama
Protocol # 19-09-2831
 Date Printed:
03/22/2022
Amendment
1
Personnel Information
3
Subject Population
6
Study Location
7
General Checklist
7
Funding
8
Expedited Review
8
Background , Purpose , Study Procedures
10
Radioisotopes or Radiation Machines
28
Drugs, Reagents, Chemicals, or Biologic Products
29
Devices
30
Subject Population(a-h)
30
Subject Population(i-l)
31
Subject Population(m)
31
Subject Population(n)
34
Subject Population(p)
41
Risks
44
Benefits/Alternatives, Procedures to Maintain Confidentiality
56
 Potential Conflict of Interest
59
Informed Consent
61

 
PROTOCOL
IRB Form
University of Alabama
Protocol # 19-09-2831
 Date Printed:
03/22/2022
Assent
65
HIPAA
66
Attachments
67
PI Obligations
71
Event History
71

Page 1 of 73
 
1
PROTOCOL
IRB Form
University of Alabama
Protocol # 19-09-2831
Snow
------------------------------------------------------------------------------
Protocol Title:
Enhancing Sleep Quality for Nursing Home Residents with Dementia:
Pragmatic Trial of an Evidence-Based Frontline Huddling Program
(Pilot Phase-R61) ["40 Winks Study"]
Protocol Status:
SUBMITTED TO IRB
Date Submitted:
03/22/2022
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
* * * Amendment * * *
Amendment
Complete this form and with it, submit any affected IRB materials needing revision. Please
provide the entire revised documents (not just revised pages). Protocol amendments must
receive IRB review and approval before they are implemented, unless an immediate change is
necessary to eliminate an apparent hazard to the participants.
1)
Number of accrued participants
11
2)
Status of Study (check one):
X Continuing to accrue study participants.
Closed to accrual. Date closed:
3)
Special populations (mark as applicable):
Children (<18 years of age)
Prisoner population targeted or study participant became a prisoner
4)
Summarize the proposed changes to the protocol in lay terms including the type of change AND what the
change involves.
1. Modifying our LAR Script to include teleform to our list of ways that Legally Authorized
Representatives can return completed consent forms.
2. Adding an option for regular group interviews of the NH leadership team to the NH
Staff section of the Informed Consent section in protocol
3. Modifying the NH staff informed consent information document to reflect the addition
of NH leadership team group interviews
4. Correcting the NH Staff section of the Informed Consent section to accurately reflect
that a waiver of written consent was obtained from IRB in 2019
(Please note: the Updates (current) box below indicates that changes were made to
several sections such as Background, but these were not actual changes to the protocol.
We have been using the method of ALL CAPS to indicate all protocol changes for
reviewer convenience. We have gone through the protocol and changed ALL CAPS from
the last amendment (12/22) to "sentence case" so that the ALL CAPS CHANGES in this
March amendment will stand out for the reviewer.)
5)
What is the stimulus for this/these proposed changes - check all that apply:
Unanticipated or adverse events have arisen
X Prospects' questions suggest ways to improve study explanation and consent form

Page 2 of 73
 
Participants' responses suggest that data collection instruments or procedures should
be changed.
Recruitment is going very slowly (Please provide numerical details about your
recruitment, enrollment, retention, or completion in #3 below.)
New information has arisen that suggests an additional population or category of
participant should be included or deleted.
New information has arisen that prospective or current participants should know.
Reduce participant burden
Changes in funding require adjustments in study
Requirement of sponsor
COI issue requires change in procedure or disclosure to participants
X OTHER:
As this pilot study has
progressed, we have
realized that additional
group interviews of the NH
Leadership Team will help
us better meet one of our
original study goals of
understanding the
implementation process.
5.a)
Provide justification/explanation for the proposed changes.
1. Modifying our LAR Script to include teleform to our list of ways that Legally Authorized
Representatives can return completed consent forms:  Some LARs have struggled with
submitting their consent electronically and yet have not wanted to receive a paper copy
in the mail -- we hope the addition of the teleform option will be helpful to these LARs
2. Adding an option for regular group interviews of the NH leadership team to the NH
Staff section of the Informed Consent section in protocol: The NH Leadership Team
meets regularly with the research staff for planning and review of intervention
implementation efforts. The addition of a regular group interview option to these
meetings will allow the research team to capture NH Leadership Team reflections on
facilitators and barriers to implementation in an ongoing way that will be more nuanced
as it will allow for real-time data capture.
3. Modifying the NH staff informed consent information document to reflect the addition
of NH leadership team group interviews: This change is necessary to enact #2 above.
4. Correcting the NH Staff section of the Informed Consent section to accurately reflect
that a waiver of written consent was obtained from IRB in 2019: In making changes #2
and #3 above we realized that this section of the protocol had been written in future
tense "we will ask the IRB to approve a waiver of written consent" that was confusing
because in fact the waiver of written consent had been submitted to the IRB and
approved back in 2019.
5.b)
What is the effect of the requested changes on participant burden?
X None
Increases
Decreases
6)
Will currently accrued participants need to be notified of changes?
N
If no, please justify why not.

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Changes only affect research operations going forward, they do not change the conditions
under which previously consented participants operate
If yes, please explain how AND  when notification or re-consenting will occur.
7)
Will the proposed change(s) affect the risk-benefit ratio for participants?
N
What is your specific appraisal of the new risk-benefit ratio?
Minimal Risk
Greater than Minimal Risk but has potential direct benefit
Provide Justification
Greater than minimal risk and no direct benefit but with potential to yield generalizable
knowledge about the participants' disorder or condition
Provide Justification
Proceed to appropriate section(s) of the electronic application and make your changes. Also
make necessary changes in the protocol, Consent Form(s), Assent Form(s), Recruitment
Statement, or other attachments, if applicable. Use track changes in uploaded documents
being revised. Please upload a clean copy of each revised document to be stamped upon IRB
approval.
Sponsored Studies: Remember to update the Sponsor's Protocol version number and date in
Funding section of the protocol.
NOTE: Protocol amendments must receive IRB review and approval before they are
implemented, unless an immediate change is necessary to eliminate an apparent hazard to
the participants.
Background , Purpose , Study Procedures
Benefits/Alternatives,Procedures to main
Informed Consent
Attachments
Subject Population(n)
---------------------------------------------------------------------------------------------
* * * Personnel Information * * *
Study Personnel Roles:
-Principal Investigator: accepts responsibility for study, can edit protocol, must submit to IRB
-Administrative Contact: additional study contact, can edit/prepare protocol, may or may not also be member of
research team
-Key Personnel (Research Team): University of Alabama member of research team, can view protocol (not edit)
-Non-Alabama Collaborator: member of research team from another institution or organization outside of
University of Alabama, has no access to system, must be provided with PDF of protocol.
-Department Chair: Official Department Chair, may or may not also be a member of research team, can view the
protocol (not edit). NOTE: a proxy may be listed if the Chair is the PI.
IMPORTANT NOTE: Human Participants Protection Training is mandatory for all research team personnel.
Principal Investigator  Mandatory
PI must be University of Alabama affiliate.
Name of Principal Investigator
(Faculty, Staff or Student)
Degree (MD/PhD/Other)
Title

Page 4 of 73
 
Snow, Andrea
PhD
Professor
Email
Phone
Fax
LSNOW@ua.edu
+1 205 348 7518
+1 205 348 7520
Department Name
 
 
Psychology
 
 
Please indicate your status
Faculty
 
Is the (Role) also a Department Chair?
N
Human Subjects Training Completed?
Y
If you have completed training that is not auto-populated below, upload a copy in the
Attachments section.
Research Team Member Duties Picklist
1.
X Recruitment
2.
X Obtains consent
3.
X Determine participant Eligibility for
Accrual
4a.
Participant Physical Examinations
4b.
Follow-up Visits including physical
assessments
5.
X Perform study procedures or
Specimen Collection
6a.
Administer and/or Dispense Study
Drugs, Biologics or Devices
6b.
Receive, Store, Manipulate or
Account for Study Drugs, Biologics
or Devices
7.
X Participant Randomization or Registry
8.
X Collection of Participant Data
9.
X Report Data (CRFs, e-CRFs,
Spreadsheets)
10.
X Data Analysis
11a. X Review Adverse Events
11b.
Treat and Classify Adverse Events
12.
Other (Please insert explanation below.)
 
 
No training data is available.
 
 
Administrative Contact
Name of
Administrative
Contact.
Degree
(MD/PhD/Other)
Title
Department Name
Cox, Brian
MS
Research Project
Coord PT
Ctr for Mental Health
& Aging-CMHA
 
Key Personnel (Research Team)

Page 5 of 73
 
Name of Key
Personnel (Research
Team)
Degree
(MD/PhD/Other)
Title
Department Name
Smith, Katelyn
MS
Research Assistant
Psychology
George, Regina
MS
Research Assistant
Psychology
Cassell, Jack
Research Assistant
Psychology
Blankenbeker,
Richard
Research Assistant
Psychology
Loup, Julia
MS
Research Assistant
Psychology
 
Non - Alabama Collaborator
Name of Non -
Alabama
Collaborator
Degree
(MD/PhD/Other)
Title
Department Name
Christine Hartmann
PhD
Associate Professor,
UMass Lowell
Other
Kathy Richards
PhD MSN BSN
Professor, University
of Texas School of
Nursing
Other
Liam Fry
MD
Professor, Dell
Medical School,
University of Texas
Other
Robert Morgan
PhD
Professor, University
of Texas School of
Public Health
Other
Megan McCullough
PhD
Research Assistant
Professor, UMass
Lowell
Other
Rosa Baier
PhD
Associate Director,
Brown Center for
Long-Term Care
Quality & Innovation
Other
Ellen McCreedy
PhD
Assistant Professor,
Brown University
Other
Barbara Frank
MPA
Co-Founder, B&F
Consulting
Other
Cathie Brady
MS
Co-founder, B&F
Consulting
Other
 
Department Chair  Mandatory
The official Department Chair should be listed here. If the Department Chair is the PI, a proxy
may be listed.
Name of Department Chair
Degree (MD/PhD/Other)
Title
Davis, Thompson
PhD
New Faculty-PA Not
Receive

Page 6 of 73
 
Email
Phone
Fax
tedavis10@ua.edu
205-348-5083
Department Name
 
 
Psychology
 
 
Human Subjects Training Completed?
N
If you have completed training that is not auto-populated below, upload a copy in the
Attachments section.
Is Chair a member of the study team?
N
Research Team Member Duties Picklist
1.
Recruitment
2.
Obtains consent
3.
Determine Participant Eligibility for
Accrual
4a.
Participant Physical Examinations
4b.
Follow-up Visits including physical
assessments
5.
Perform study procedures or
Specimen Collection
6a.
Administer and/or Dispense Study
Drugs, Biologics or Devices
6b.
Receive, Store, Manipulate or
Account for Study Drugs, Biologics
or Devices
7.
Participant Randomization or Registry
8.
Collection of Participant Data
9.
Report Data (CRFs, e-CRFs,
Spreadsheets)
10.
Data Analysis
11a.
Review Adverse Events
11b.
Treat and Classify Adverse Events
12.
Other (Please insert explanation below.)
 
 
No training data is available.
 
---------------------------------------------------------------------------------------------
* * * Subject Population * * *
Subject Population(s) Checklist
Select All That Apply:
X Adult Volunteers
X Cognitively Impaired Participants
X Employees
Fetuses
Minors (under 18)
Pregnant Women
Prisoners
Students (Note: If students will be compensated extra-credit or course credit for participation in the research,
they must be given a non-research alternative for obtaining the same amount of credit, which is of
comparable time and effort as is required by the research activity.)
Terminally Ill Participants
Wards of the State (Note: Please consider whether the research population may also be considered
"prisoners" or "cognitively impaired." If so, please mark the appropriate corresponding categories in the
Subject Population Checklist)
Non-English Speakers (Note: Please provide copies of all correspondence that will be used as a part of the
research in English as well as in the native language of participants. Please also attach a copy of the

Page 7 of 73
 
Translator's Declaration.)
Other (any population that is not specified above)
---------------------------------------------------------------------------------------------
* * * Study Location * * *
Study Location(s) Checklist
Indicate where the study will be conducted. Select all that apply:
X The University of Alabama
Another University or College
VA Center
Hospital
X Other
Community Nursing Homes
in the Vivage Corporation
(Colorado:
https://www.vivage.com),
Caraday Corporation
(https://caradayhealth.com/
), and White Oak
Management Corporation
(https://whiteoakmanor.com
/)
---------------------------------------------------------------------------------------------
* * * General Checklist * * *
General Checklist
Select All That Apply :
Study Eligible for Exempt Review
Non-human participants research
Collection of Specimens
Data collection via e-mail or the Internet
FDA Approved Device
FDA approved drugs, reagents, other chemicals administered to participants (even if they are not being
studied), or biologic products
Genetic Testing
HIV Testing
Human blood, cells, tissues, or body fluids
Investigational drugs, reagents, chemicals, or biologic products
Investigational Device
X Investigator Initiated Study
X Medical Records
X Photography, Video, or Voice-Recording Participants
X Questionnaires and/or tests
Radioisotopes/radiation-producing machines, even if standard of care
rDNA/Gene Transfer Therapy
Registry or Repository Creation
Specimens to be stored for future research projects (must be in consent form)
Study of existing data or specimens

Page 8 of 73
 
Other (clarify in text box to the right)
---------------------------------------------------------------------------------------------
* * * Funding * * *
Funding Checklist
NONE
 Funding - Grants/Contracts
Funding Type
Funded By
Government
National Institute of Health
NOTE: Applicable grant application, contract or subcontract, investigator's brochure, and
sponsor's protocol (for all industry sponsored clinical trials) must be attached. Click "Add" to
attach the documents.
---------------------------------------------------------------------------------------------
* * * Expedited Review * * *
To request an Expedited Review, check the appropriate category(ies) below. Provide justification for your request
for Expedited Review.
To qualify for expedited review, research activities must (1) present no more than minimal risk
to human subjects, and (2) involve only procedures listed in one or more of the categories
below.
Select one or more of the following paragraph(s):
1.
Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
a)
Research on drugs for which an investigational new drug application (21 CFR Part 31, 32) is not
required. (Note: Research on marketed drugs that significantly increases the risks or decreases the
acceptability of the risks associated with the use of the product is not eligible for expedited review.)
b)
Research on medical devices for which
i)
An investigational device exemption application (21 CFR Part 812) is not required; or
ii)
The medical device is cleared/approved for marketing and the medical device is being used in
accordance with its cleared/approved labeling.
2.
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
a)
From healthy, nonpregnant adults who weigh at least 110 pounds. For these participants, the
amounts drawn may not exceed 550 ml in an 8-week period and collection may not occur more
frequently than 2 times per week; or
b)
From other adults and children, considering the age, weight, and health of the participants, the
collection procedure, the amount of blood to be collected, and the frequency with which it will be
collected. For these participants, the amount drawn may not exceed the lesser of 50 ml or 3 ml per
kg in an 8-week period and collection may not occur more frequently than 2 times per week.
Children are "persons who have not attained the legal age for consent to
treatments or procedures involved in the research, under the applicable law of the
jurisdiction in which the research will be conducted."
3.
Prospective collection of biological specimens for research purposes by non-invasive means.
EXAMPLES: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous
teeth at time of exfoliation or if routine patient care indicates a need for extraction;
(c) permanent teeth if routine patient care indicates a need for extraction; (d)
excreta and external secretions (including sweat); (e) uncannulated saliva
collected either in an unstimulated fashion or stimulated by chewing gumbase or

Page 9 of 73
 
wax or by applying a dilute citric solution to the tongue; (f) placenta removed at
delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to
or during labor; (h) supra-and subgingival dental plaque and calculus, provided the
collection procedure is not more invasive than routine prophylactic scaling of the
teeth and the process is accomplished in accordance with accepted prophylactic
techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin
swab, or mouth washings; (j) sputum collected after saline mist nebulization.
4.
Collection of data through non-invasive procedures (not involving general anesthesia or sedation)
routinely employed in clinical practice, excluding procedures involving X-rays or microwaves. Where
medical devices are employed, they must be cleared/approved for marketing. (Studies intended to
evaluate the safety and effectiveness of the medical device are not generally eligible for expedited
review, including studies of cleared medical devices for new indications.)
EXAMPLES: (a) physical sensors that are applied either to the surface of the body
or at a distance and do not involve input of significant amounts of energy into the
participant or an invasion of the participants' privacy; (b) weighing or testing
sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography,
electroencephalography, thermography, detection of naturally occurring
radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler
blood flow, and echocardiology; (e) moderate exercise, muscular strength testing,
body composition assessment, and flexibility testing where appropriate given the
age, weight and health of the individual.
5.
Research involving materials (data, documents, records, or specimens) that have been collected, or will
be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some
research in this category may be exempt from the HHS regulations for the protection of human
participants. 45CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
6.
Collection of data from voice, video, digital, or image recordings made for research purposes. This
category should only be selected if the present research will involve analysis of data that has been
previously recorded.
7.
Research on individual or group characteristics or behavior (including, but not limited to, research on
perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and
social behavior) or research employing survey, interview, oral history, focus group, program evaluation,
human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category
may be exempt from the HHS regulations for the protection of human participants. 45 CFR 46.101(b)(2)
and (b)(3). This listing refers only to research that is not exempt.)
8.
 [FOR IRB use only]. Continuing review of research previously approved by a convened IRB only when
condition (a), (b), or (c) is met.
a)
Previously approved research where
(i)
The research is permanently closed to the enrollment of new participants;
(ii)
All participants have completed all research-related interventions; and
(iii) The research remains active only for the long term follow-up of
participants.
b)
Previously approved research where no participants have been enrolled and
no additional risks have been identified.
c)
Previously approved research where the remaining research activities are
limited to data analysis.
9.
[FOR IRB use only]. Continuing review or research not conducted under an
investigational new drug application or investigational drug exemption where expedited

Page 10 of 73
 
categories two (2) through eight (8) do not apply but the IRB has determined and
documented at a convened meeting that the research involves no greater than minimal
risk and no additional risks have been identified.
---------------------------------------------------------------------------------------------
* * * Background , Purpose , Study Procedures * * *
Study Title
Enhancing Sleep Quality for Nursing Home Residents with Dementia: Pragmatic Trial of an
Evidence-Based Frontline Huddling Program (Pilot Phase-R61) ["40 Winks Study"]
Complete Sections 1 - 15. Specify N/A as appropriate. Do not leave any required sections blank.
1)
Background
a)
Describe past experimental and/or clinical findings leading to the formulation of the study, if
applicable.
<PLEASE NOTE THAT ALL CAPS IS USED THROUGHOUT TO INDICATE
PROPOSED CHANGES IN 3/21/21 AMENDMENT. CHANGES THAT WERE IN
ALL CAPS IN PREVIOUS VERSIONS AND SUBSEQUENTLY APPROVED HAVE
BEEN MOVED TO sentence case.>
A layman’s case for the benefits of a good night’s sleep is easy to make: imagine
someone woke you last night every two hours. How do you feel? Now imagine that
routine continues every night for the next month. For many residents of nursing
homes (NHs), such awakening is standard practice.
NHs implement such routines to address various challenges (e.g, incontinence),
even though evidence from both objective and subjective measures identifies
disturbed sleep as a key contributor to many types of physical, emotional, and
cognitive decline.[1-4] Disturbed sleep places individuals at higher risk for frailty,
morbidity, and even mortality.[5-10] And individuals with Alzheimer’s disease or
related dementias (ADRD)—almost two-thirds of long-stay NH residents[11]—are
likely to be particularly affected by sleep disturbance.[12,13]
Ample evidence underscores the negative health effects of sleep disturbance
(lower total sleep time, increased sleep fragmentation, etc.) in older adults. Poor
sleep quality in this population is associated with increases in self-reported fatigue,
difficulties with activities of daily living (ADLs), depression, and risk of falling, and
with decreases in memory, mobility, morbidity, and even survival.[3,41-44] Yet
nursing home (NH) residents with Alzheimer's disease and related dementias
(ADRD) experience suboptimal sleeping conditions at best. They spend much of
their day without engaging in physical activity.[45,46] In addition, stimuli inherent in
most traditional NH environments, including frequent noise and light [47-49] as well
as, for example, efforts to reduce incontinence,[50] may also exacerbate sleep
disturbance. A 2018 systematic review of nonpharmacological sleep interventions
in NHs indicated promise for increased daytime light exposure, nighttime use of
melatonin, and acupressure.[51] But because sleep itself results from a complex
interplay of resident, staff-generated, and environmental factors,[52] sleep
regimens for residents may work best when individualized instead of applied
generically.[53,54] Yet healthcare workers, including those working in NHs, have
generally poor knowledge of the relationship between sleep disturbance and
clinical conditions, the availability of evidence-based interventions and assessment
tools, and the environment’s impact on sleep,[55] thus limiting their ability to
intervene.
NH residents with ADRD are more likely to receive antipsychotic or antidepressant
medications than other residents.[56] Yet antipsychotic or antidepressant use may
worsen nighttime sleep for residents with ADRD,[57] while withdrawal from

Page 11 of 73
 
antipsychotic medication may also, at least temporarily, worsen sleep.[58] Pain
may also affect sleep. The American Geriatrics Society and National Institute on
Aging 2016 conference on sleep called for more research into the relationship
between sleep disturbance and pain.[59] A critical review examining prospective
studies from 2005 to 2012 found significant support for—in what is a bidirectional
relationship between sleep and pain—sleep disturbance as the stronger
predictor.[60] The relationship between sleep quality and physical functioning (e.g.,
ADLs) is well-established. Poorer objective sleep is associated with poorer physical
functioning in older adults [3,6,44,61] and those with ADRD.[62]
Engagement in meaningful activity may play a critical role in improving resident
sleep. Providing individualized activities can reduce daytime sleeping and improved
circadian rhythm (Richards et al., 2005) as well as increased duration and
improved quality of sleep (Richards et al., 2011; Namazi et al., 1995; Naylor et al.,
2000). These findings are of particular importance as NHs face unique challenges
brought on by the covid-19 virus. Many aspects of NH residents’ environments
have changed to improve infection control; however, these changes have produced
unprecedented barriers to address the social and personal needs of residents
(Iaboni et al., 2020; Wu, 2020). While limited daylight exposure, social isolation,
and disruption of previous routines are known to increase sleep disturbances
(Lorenz et al., 2011), many of these practices have been put in place to limit
resident exposure. By increasing engagement in meaningful activities, this may
address the logical and practical concerns of the covid-19 response as well as
residents disturbed sleep.
Despite the common knowledge that sleep disturbance has negative impacts on
NH residents, and despite the availability of easy ways to measure (e.g.,
actigraphy) and intervene to increase sleep, little has been done to improve the
situation. In NHs, barriers to quality improvement (QI) such as staffing problems
and top-down approaches hamper efforts to enhance care quality.[14,15] Studies in
NHs also underscore the importance of open communication and relationship-
building to improve resident clinical outcomes.[14,16,17] A recent systematic
review highlighted key components for successful NH QI: changing staff behavior,
targeting specific care tasks, and using intervention theories.[18] One QI practice
that capitalizes on this evidence and therefore has potential to meaningfully impact
resident sleep is frontline staff huddling—brief, stand-up meetings to facilitate
efficient, collaborative information exchange. Frontline staff huddling promotes
communication across clinical roles[19-21] and improvements in clinical
outcomes.[22-24] In NHs, it can improve quality of care and help sustain
changes.[25] But use of frontline staff huddling in NHs remains limited.
Our research team standardized a NH frontline staff huddling program building on
the theory of relational coordination, which posits that high-quality communication
and relationships improve outcomes.[26] The program, known as LOCK (see
Figure 1), is derived from evidence supporting strengths-based learning,[27,28]
systematic observation[29] relationship-based teamwork,[30,31] and
efficiency.[32,33] In LOCK, staff (A) “Learn from bright spots” (focus on evidence of
positive change); (B) “Observe” (collect data through systematic observation); (C)
“Collaborate in huddles” (conduct frontline huddles); and (D) “Keep it bite-size”
(limit activities to 5-15 minutes for efficiency). The program’s methods have
improved clinical care in community NHs, even in those with a history of serious,
intransigent quality issues. [35,36] The program guides frontline staff on how to
address a particular resident outcome of concern, in the case of this pilot study,
sleep (LOCK sleep program).
The LOCK program was implemented to target NH staff-resident interactions in a

Page 12 of 73
 
successful
6-site pilot study in VA NHs. [34] Our LOCK program pilot targeting staff-resident
interactions enabled 6 Veterans Health Administration (VA) NHs to make
meaningful quantitative and qualitative improvements in communication frequency,
communication quality, staff QI mindset, and staff QI capabilities.[34]
In 2017, based on these results, VA rolled the LOCK program out to all its 134 VA
NHs. We achieved this roll-out with the support of B&F Consulting (national experts
in NH QI implementation, and consultants for this current pilot study). The initial
rollout was performed using a train-the-trainer approach, [37-39,81] with 4
participants from each NH attending a regional training led by B&F Consulting. The
program then expanded to focus on other clinical issues, e.g., pain, catheter use,
and pressure ulcers. Because all NHs in the VA system were exposed, a matching
analysis of exposed vs. control NHs was not possible. Semi-structured qualitative
interviews with staff at 12 VA NHs that excelled in the program revealed a wide
range of improvements including the following: increases in resident engagement,
staff morale, and staff engagement; reductions in falls and catheter-associated
urinary tract infections; and increases in use of appropriate infection control,
appropriate analgesic documentation, nonpharmacologic pain management, and
pressure ulcer prevention.
We next conducted a preliminary adaptation of the LOCK program methods to
address
resident sleep in a group of 8 VA NHs. Qualitative data based on field notes from
two 1.5-day site visits to each of the 8 NHs provide preliminary evidence of the
program’s acceptability, feasibility, and positive outcomes. Across all 8 NHs, we
found consistent uptake of sleep intervention efforts, including resident sleep
assessments (sleep behavior tracking/actigraph use/sunlight exposure tracking),
individualized reduction of night-time incontinence care practices, alterations of
medication administration schedules, reduction of night-time blue light and noise,
and alterations of daytime activity schedules and natural light exposure. Outcomes
include reduced pain, reduced psychotropic use, increased daytime activity, and
resident and family enthusiasm for sleep program participation.
In sum, this preliminary work (1) enabled us to standardize the LOCK program, (2)
resulted in qualitative data on best LOCK program implementation practices, and
(3) generated implementation materials, all of which we will use for this current pilot
study. During this pilot study, we will refine the LOCK program to focus on sleep
and meaningful activity in non-VA NHs.
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b)
Describe any animal experimentation and findings leading to the formulation of the study, if there is
no supporting human data.
N/A
2)
Purpose of the study
a)
Provide a brief lay summary of the project in <200 words. The lay summary should be readily
understandable to the general public.
This study will improve clinical outcomes for an important, growing, and vulnerable
population—nursing home (NH) residents with Alzheimer’s disease or related
dementias (ADRDs)—by implementing an evidence-based intervention (LOCK) to
improve these residents’ sleep and increase meaningful activity. It will also
significantly increase our understanding of how to implement and sustain nursing
home interventions.
b)
List your research objectives (specific aims & hypotheses of the study).
In community (non-VA) NHs [one from each of 3 NH corporations, still to be
recruited], our multi-disciplinary team proposes to (1) refine the LOCK sleep
program to improve sleep and increase meaningful activity for residents with ADRD
during this pilot (R61) phase, (2) which will prepare the team for the next phase of
this NIH-funded grant (the R33 phase, to be described in a follow-up IRB protocol
when this phase is completed, in approximately one year) to test the impact and
sustainability of this intervention for NH residents with ADRD in an incomplete
stepped-wedge randomized controlled trial.
(This study is funded by a National Institute of Aging pragmatic clinical trial RFA
and grant mechanism called R61/R33, in which the R61 is a pilot grant for one
year. The investigator team submits a report after the R61 phase indicating what
was learned during the pilot phase and showing evidence that the pilot milestones
are achieved. Then NIA funds the next four years of the randomized controlled trial

Page 17 of 73
 
with the R33 mechanism. The current proposal only describes the pilot study (R61
phase). A separate proposal will be submitted for the randomized controlled trial
(R33) when the R61 phase is close to completion. We will wait to submit the R33
proposal because National Institute of Aging wishes for modifications to the R33
design and intervention to be made based on the R61 data collection/intervention
experience and the R61 quantitative and qualitative data analyses.)
This current pilot study R61 phase (1 year; n = 3 NHs; 1 NH per corporation) has
the following specific aims:
1. Refine the LOCK sleep program train-the-trainer protocol by implementing and
pilot-testing in three NHs.
2. Test and refine the research methods to: effectively identify eligible NHs and
residents; obtain consent; collect primary data from residents and staff; explore
staff impressions of additional sleep measurement devices (Fitbits); transfer
primary and secondary data to our data center; and merge all data.
c)
Describe the study design (e.g., single/double blind, parallel, crossover, control, experimental,
observational, etc.)
N/A
Single blind
Double blind
Parallel
Crossover
Control group
Experimental group
Observational
X Other
This is a pilot study (R61 phase) to pilot the methods for an upcoming
randomized controlled trial (see study funding mechanism explanation in
previous section #2B above). The upcoming randomized controlled trial will be an
incomplete stepped-wedge, cluster randomized controlled trial (RCT) design in
which each nursing home (NH) serves as its own control. Our design can be
classified in the NIH Model for Behavioral Intervention Development as Stage III,
real world-based hybrid efficacy-effectiveness research.
This pilot study (R61 phase) pilots the methods for this design in 3 NHs. In this
pilot we will use a convenience sample of three nursing homes (NHs), one
recruited from each of three different NH corporations that are anticipated to
participate in the eventual randomized controlled trial.
Each nursing home will serve as its own control. Control data will be collected for
1 week, then the intervention will begin and intervention data will be collected for
6 weeks, then the sustainment phase will begin and sustainment data will be
collected for 8 weeks.
d)
Provide a timeline for individual participant recruitment and follow-up (analysis for the study is
required).
Each site will serve as its own control.
Control data will be collected for 1 week, then the intervention will begin and
intervention data will be collected for 6 weeks, then the sustainment phase will
begin and sustainment data will be collected for 8 weeks for a total of 15 weeks per
participant.

Page 18 of 73
 
The duration of the intervention period for any NH is 15 weeks, which includes
three 7-day sleep measurement periods (baseline measurement before week 1,
post-intervention measurement at week 8, and sustainment measurement at week
15).
e)
Will participant be randomized?
N
f)
If participants will be given placebo, please justify placebo use, and describe contents of the
placebo.
N/A
3)
Study Procedures
a)
Is this project a multicenter study (i.e., same project is conducted elsewhere by a different
investigator)?
N
Is University of Alabama acting as a coordinating center for other sites?
Will the University of Alabama site be participating in all parts/procedures/arms of the study?
If No, explain what University of Alabama will NOT participate in:
b)
Describe all the procedures, from screening through end-of-study, that the human participant must
undergo in the research project, including study visits, drug treatments, randomization and the
procedures that are part of standard of care. Specify which procedures are for research and which
are standard of care. If study involves only retrospective record review, describe that review process
here, including how records will be selected for review. Please note: The box below is for text only. If
you would like to add tables, charts, etc., Click "Add" to attach the documents.
Research Study Team: The study leadership team will be led by Dr. Snow (UA;
LOCK sleep program co-developer, clinical geropsychologist, NH field expert) and
will include Dr. Richards (Univ. TX School of Nursing; nurse, clinical NH and
dementia sleep expert), Dr. Fry (Univ. TX Medical School, geriatrician, clinical
geriatrics NH expert); Dr. Morgan (Univ TX School of Public Health, study
statistician, data center lead), Dr. Hartmann (UMass Lowell; LOCK sleep program
co-developer; social worker; implementation science expert), Dr. MCullough
(UMass Lowell, medical anthropologist, qualitative expert), Ms. Baier and Dr.
McCreedy (Brown University’s Long-Term Care Quality and Innovation Center; NH
implementation experts, NH recruitment experts), and B&F Consulting (national
experts in NH quality improvement implementation). The project team, comprising
Drs. Snow and Hartmann, Brian Cox, and research assistants, will meet weekly.
The following teams will each meet bi-weekly: NH staff training team (Snow, B&F
Consulting); Quantitative/Clinical Data Team (Hartmann, Richards, Morgan, Fry,
research staff). This following team will meet monthly: Qualitative/Implementation
Team (Hartmann, McCullough, Baier, McCreedy). The entire investigator team will
meet monthly.
Collaborating Sites and Roles:
The research will be performed by the research study team located at the
University of Alabama, University of Massachusetts-Lowell, Brown University,
University of Texas at Austin (School of Nursing and Dell Medical School), and the
University of Texas at Houston (School of Public Health). Only the University of
Alabama site will enroll human subjects and the University of Alabama IRB will
serve as the single IRB.  Dr. Snow at the University of Alabama will be responsible
for oversight of the entire project. Collaborating sites where human subjects
research will be performed are the NHs from the three corporations who are
participating. These nursing homes will be drawn from three separate NH
corporations.
NH Recruitment:
We have recruited three NH corporations for this study: Vivage, Caraday, and
White Oak.

Page 19 of 73
 
We will work closely with the 3 recruited corporations to identify 3 NHs (1 per
corporation) to participate in this pilot study. Stakeholder engagement will occur at
both the corporate and the NH levels. At the corporate level, each corporation will
assign a corporate coach who will attend all study staff training visits to their
corporation’s NH to learn how to prepare NHs for and support NHs in the
implementation of the LOCK sleep program (the corporate coach is an employee of
the nursing home corporation. Determination of if that coach enters the facility or
works only virtually with staff will rely on corporation policy re who is allowed to
enter facilities according to their covid-era infection control procedures). At the NH
level, each NH will create LOCK sleep program NH Leadership and NH
Implementation teams and will support frontline staff involvement in the LOCK
sleep program.
•NH Leadership Team: Each NH will establish a NH leadership team consisting at
least of the Director of Nursing, the NH administrator, the staff educator, and the QI
designee (additional members may be added if needed to assist with limited study
support activities as described below). The NH leadership team will be trained by
the study team in protection of human subjects and limited applicable study
procedures, i.e., (1) mailing introductory letters to resident LARs; (2) mailing of
actigraphs/Fitbits and global rating forms to research staff; and (3) helping
researchers arrange telephone calls with NH residents who may have capacity to
provide their own consent.
•NH Leadership Teams will engage in limited study support activities, as follows:
(1) Mailing an IRB-approved study introduction letter to the legally authorized
representative (LAR) of each NH resident with an ADRD diagnosis and providing
all NH staff with a study introduction letter.
(2) Collecting and mailing outcome data (e.g., actigraphs at completion of a 7-day
measurement period, completed staff ratings of resident sleep global change) to
the University of Alabama project office using UA-supplied self-addressed postage-
paid mailers from a tracked express mailing service (e.g., UPS).
(3) Assisting in telephone appointment arrangements and logistical support so that
study team members can conduct telephone-based informed consent for NH
residents who may have capacity to provide their own consent.
•NH leadership teams will not engage in research study tasks which will be
completed exclusively by research study team members with appropriate study
protection training:
(1) Conducting informed consent with staff, LARs, and residents.
(2) Conducting staff interviews: staff decisions whether or not to participate in
interviews will be kept confidential from NH leadership teams to protect staff from
potential coercion to participate in research.
Subject Populations and Anticipated Numbers:
(1) NH Residents. Primary outcomes are measured at the level of NH residents.
We anticipate enrolling 57 residents (approximately 19 per each of 3 NHs) in this
pilot study (R61 phase).
(2) NH Staff.
a. Training and Intervention Participation.
We will invite all NH staff to participate in the training and intervention. In the 3 NHs
in this pilot study (R61 phase) we anticipate enrolling 120 NAs, 45 LPNs, 5 RNs,
and 30 interdisciplinary treatment team/leadership team members. There are no
known risks to the nursing staff associated with the training, intervention, and
resident assessment activities requested of the NH staff. These are resident care
and quality improvement activities that are fully within their job descriptions.

Page 20 of 73
 
Consequently, consent for participation from the NH staff in these activities is not
considered necessary as these activities are not human subjects research. In our
past funded research involving NH staff, consent for these types of activities has
also not been considered necessary. The nursing staff should benefit greatly from
learning frontline huddling and sleep intervention skills. If successful, their
application of these interventions will result in stronger NH staff teamwork and
communication and healthier and less distressed NH residents and thus contribute
to a less stressful and dangerous work environment.
b. Interview Participation.
We anticipate inviting 20 NH staff per NH (10 frontline staff engaged in the
intervention, 10 LOCK sleep program leadership and intervention team members)
to participate in interviews. In the 3 NHs in this pilot study (R61 phase) we
anticipate enrolling 60 staff total. Because participation in qualitative interviews is
outside of the usual work activities of the NH staff, we will obtain informed consent
from NH staff before asking them to voluntarily participate in these activities. The
NH staff will be informed of the purpose of all procedures: there is no element of
deception. They will not be identified personally in any data collection used for
research purposes. There will be no adverse consequences for NH staff refusing to
take part in these activities.
NH Resident Inclusion and Exclusion Criteria: In the potential participant pool, we
will include all NH residents aged >=50 years with an ADRD diagnosis. We include
residents across the range of ADRD severity because this is consistent with the
LOCK sleep program, in which staff will focus on residents with ADRD who have
the greatest sleep problems without differentiating by ADRD severity. To identify
participants, NH staff will use frontline staff huddles. NH staff will be trained to use
the STOP-Bang screening tool to identify NH residents with high risk of obstructive
sleep apnea (OSA) [82-84] and will be trained on appropriate procedures for
referring any positively screened residents for medical evaluation. We will exclude
residents with a high risk of OSA who are not being treated for OSA because
actigraph measurements are inaccurate in that population.[85] Staff will also
exclude residents who have a persistent bilateral resting tremor or paralysis in both
arms (a subset of persons with Parkinson’s disease and related significant tremor-
causing diagnoses), due to actigraph measurement inaccuracies.[86]
NH Staff Inclusion and Exclusion Criteria:
Staff will not be excluded on the basis of race, ethnicity, gender, or age. As
described above, a subset of NH staff will be recruited for interview participation
based upon job type and intervention engagement (e.g., frontline staff versus
leadership/interdisciplinary team members).
OBTAINING NH Staff and Resident Consent:
NH Resident Consent:
We will ask the administration department at each NH to compile a list of all NH
residents with an ADRD or related dementia/cognitive impairment diagnosis. The
administration department will send a letter to each resident’s legally authorized
representative (LAR) informing them of the study and inviting the LAR to opt out if
they do not wish to be contacted by research staff. Opt-out procedures have been
demonstrated to yield higher response rates and lower rates of non-response bias
compared to opt-in procedures, and to be acceptable to participants, with no
difference in rates of reported distress or complaints compared to opt-in
procedures.[105-108] In our past federally funded research involving people with
dementia, opt-out consent has been approved by multiple IRBs and worked well.
Contact information of those LARs not opting out will be shared with University of
Alabama (UA) study staff. We are requesting of this IRB a waiver of consent and
HIPAA authorization for screening purposes regarding the sharing of these contact

Page 21 of 73
 
information. Research staff will contact all LARs who do not opt out, inviting the
LAR to consent to the NH resident’s participation. The consent process will be
described in more detail in the consent portion of this IRB proposal.
NH Staff Consent:
The NH leadership team or their designees will provide to all NH staff an IRB-
approved study introduction letter (including option to opt out within two weeks if
they do not wish to be contacted by study staff). Contact information of those NH
staff not opting out will be shared with UA study staff. We are requesting of this IRB
a waiver of consent and HIPAA authorization for screening purposes regarding the
sharing of these contact information.
Research study staff will contact NH staff (via email and/or phone) to invite them to
participate in mid-implementation and/or post-implementation interviews about their
experiences with the LOCK sleep program and Fitbits. The list of NH staff who
agree and decline interview participation will remain confidential to protect NH staff
from any possible coercion to participate. The consent process will be described in
more detail in the consent portion of this IRB proposal.
NOTE: The LOCK sleep program itself comprises clinical practices common in NH
QI efforts. These clinical practices that will be taught via the LOCK sleep program
training thus fall within the scope of staff positions and require no consent.
Sources of Research Data (see Table 1):
NH Resident Data will be collected for consented NH residents from Brief interview
of family/friends (see attachment), NH staff interview of the resident (see
attachment), NH staff ratings (clinical global assessments of change in overall
sleep quality and sleep-related conditions - see Appendix; NH staff sleep reports -
see attachment); through primary data collection (actigraph/Fitbit measurements;
these are wristwatch-sized devices worn on the wrist); through medical records
(age, diagnoses, medical history, and medications); and through NH secondary
data from the Minimum Data Set (MDS; all Medicare-reimbursed NHs are required
to collect MDS assessments on all residents; the MDS contains information on
resident medical conditions, functioning, cognition, psychotropic and pain/analgesic
medication use, activities of daily living decline, and sleep-, mood-, and activity-
related items). Table 1 summarizes the primary and secondary outcomes and data
sources.
NH Staff Data: staff interview data will be collected via audiorecorded qualitative
interview (see Appendix).
Data Collection Procedures:
NH Resident Primary Research Data Collection: will consist only of actigraph/fitbit
data.
We will measure total sleep time (TST) with data from Micro-Mini Motionlogger
Actigraphs (Ambulatory Monitoring Inc., Ardsley, NY).[87] We will define nighttime
as 10pm to 6am and will compute TST as the total number of minutes asleep
during a nighttime period. We will measure sleep for 7 days at each measurement
period (see Figure 2) to obtain reliable measurements and will use the average
TST across this period. We will also examine the following: wake after sleep onset
(total number of minutes awake during nighttime), how often the resident awoke
during the nighttime, sleep efficiency (the ratio of
minutes asleep to minutes awake over the period), and sleep fragmentation (an
index of restlessness computed as the percentage of one-minute epochs scored as
awake). Sensitivity of actigraph measurement for sleep is very good (actigraphy =
sleep when polysomnography = sleep was 0.97). [88]

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We will also explore measuring sleep time using Fitbits. Fitbits are known to be
inferior to actigraphs for sleep research measurement purposes because Fitbits
tend to overestimate total sleep time, among other limitations.[70,71]  But Fitbits
are considerably less expensive than actigraphs, offer an easy user interface, and
collect data on sleep plus multiple other dimensions, making them potentially useful
to NH staff for non-research purposes. Studies are lacking on NH staff impressions
of the perceived potential usefulness of Fitbits for informal measurement. We will
therefore explore staff impressions of Fitbits through semi-structured interviews
after the R61’s 22-week measurement period. If staff find Fitbit
information of added use and staff and residents consistently find it acceptable to
use 2 devices
at the same time (actigraph plus Fitbit), we will consider use Fitbits beyond this pilot
study into the randomized controlled trial (R33 phase).
Dr. Kathy Richards, PhD MSN (nurse co-investigator with extensive NIA and VA
principal investigator experience using objective sleep measurements including
actigraphs in studies with NH residents and people with dementia, who tolerated
the devices well without removing them.[109-111] NH staff will assist residents to
wear both an actigraph and a Fitbit side by side on a wrist for 7 days during each of
the 3 measurement periods (weeks 1, 8, AND 15). We will use Dr. Richards’
effective procedures for assuring that NH staff maintain charge and do not lose
actigraphs or Fitbits (e.g., Nighttime Agitation and Restless Legs Syndrome in
People with Alzheimer's disease, R01 AG051588-01A1, NIH-funded).
Due to covid-era infection prevention restrictions in nursing homes, research staff
will not enter nursing home. The study was already designed as a pragmatic trial
relying on nursing home staff rather than research staff activity for data collection
and intervention, so the modifications required are minor. All training will be
conducted virtually through zoom or similar teleconference platforms. Nursing
home staff will collect data and mail via tracked mailers. All actigraphs/fitbits will be
single-resident use (no resident sharing).
NH Staff Data About NH Residents: The NH Leadership and NH Implementation
teams will be trained by our research study team on the LOCK Sleep Program
methods (see Figure 1), including how to facilitate and implement front-line staff
huddles to discuss resident sleep issues. Once this training is complete, we will ask
NH huddle facilitators to use a huddle to establish a team consensus rating of each
enrolled NH resident’s overall sleep quality and up to 2 additional symptoms or
behaviors of concern potentially related to sleep quality (e.g., agitation, pain).
Ratings will be obtained using the using the Clinical Global Impression of Change
rating scale (CGIC; see Appendix); CGIC ratings evidence high reliability and
responsivity under a wide range of circumstances and are frequently used as
outcomes in clinical trials. [97-104] Each LOCK sleep program huddle facilitator will
lead their huddle team to complete clinical global impression of change ratings of
enrolled residents’ overall sleep quality at the end of each 7-night sleep
measurement period and at the end of each week of the 6-week sleep intervention
period. These rating forms will be part of the standard care practices being taught
to the NH staff -- such assessments are within the typical scope of staff
responsibilities.  The NH clinical team will file these assessments in the NH
residents' medical chart. The NH Leadership team will copy these rating forms and
share with the research team. NH staff will also record resident sleep reports in a
study binder kept at the nurse's station during the three assessment weeks (week
1, 8, & 15) [see attachment].
NH Staff Interviews: We will recruit and consent a sample of NH staff engaged in
huddles to participate in virtual interviews at mid- and post-implementation semi-

Page 23 of 73
 
structured interviews to explore staff perceptions of the LOCK sleep intervention’s
effectiveness, feasibility, facilitators, and challenges, as well as their impressions of
the interview process itself to inform for the upcoming randomized controlled trial
(R33 phase) (e.g., length, location, etc. for busy NH staff) and use of Actigraphs
and Fitbits (see Appendices for interview guides). These interviews will be
conducted by a research staff member trained to conduct qualitative interviews
remotely. For both interviews, we will recruit the LOCK sleep program leadership
and implementation team members, as well as a sample of frontline staff, with an
approximate sample size of 20 staff per NH.
Medical Record/Secondary Data About NH Residents: To assess inter-resident
variability in sleep, a research assistant will work with NH staff remotely to guide
the NH at the end of the 15-week measurement period to collect data from the
NH’s medical record on the following for the entire period: (a) changes in any
sedating medications and changes in dosages; (2) incidents of delirium; (3) any
urinary tract infections; (4) doses of any sedating medications, including as needed
ones. Also collected from medical records will be information to characterize the
NH residents (age, diagnoses, medical history, and medications). NH secondary
data will be collected also from the NH Minimum Data Set (MDS; all Medicare-
reimbursed NHs are required to collect MDS assessments on all residents; the
MDS contains information on resident medical conditions, functioning, cognition,
psychotropic and pain/analgesic medication use, activities of daily living decline,
and sleep-, mood-, and activity-related items).
Extracting, transferring, and merging data: Every week, the NH Leadership team
will use a researcher-provided tracked insured express mail service (e.g., UPS) to
send the research team at the University of Alabama all completed Clinical Global
Impressions of Change staff rating forms and any actigraphs and Fitbits for which
the assessment periods are complete. Research staff will mail back actigraphs and
Fitbits after download and maintenance. We considered electronic data
transmission options but opted for mail for the following reasons: (a) We will be
able to assure equipment maintenance and appropriate data downloads, reducing
missing data errors. (b) For busy NH staff, copying and packaging will take
significantly less time and technological skill than scanning, uploading, and
transmitting electronic data. Thus, after research staff upload the data at the
University of Alabama, they will transfer the data to the University of Texas Health
Science Center at Houston School of Public Health (UTHealth SPH) Data Center
via secure file transfer procedures established by the Data Center. The data
transfer and data security processes will be discussed in more detail in Section #10
(Procedures To Maintain Confidentiality).
Study Staff Training:
This study does involve the vulnerable population of nursing home residents with
dementia. This study also involves NH employees, who are vulnerable to the extent
that they may feel coerced to participate in research activities by their supervisors
given that the NH leaders and parent corporation are supportive of overall study
participation. To protect all vulnerable subjects, in addition to the NIH-required
computer-based trainings (on the protection of human research participants,
HIPAA, and Good Clinical Practice), the UA study staff will attend a 2-day training
session specific to the proposed project led by Dr. Snow. The PI will review the
overall goals of the study, study policies and procedures, data collection manuals,
adverse event identification and reporting, subject confidentiality, communication
techniques and principles for working with persons with dementia, and appropriate
procedures for working by telephone with LARs for consent, for working by
telephone with people with dementia for consent and for determining capacity to
consent. Procedures will be reviewed for protecting employees from possible

Page 24 of 73
 
coercion for participation from supervisors including maintaining confidentiality of
those employees who do and do not consent to research interviews. During these
training sessions, professionally produced videotapes of staff interactions with
persons with dementia will be shown and the PI and study staff will role play all
informed consent, capacity assessment, and data collection processes. Drs.
McCullough and Hartmann will provide training on appropriate procedures for NH
staff interviews. Dr. Morgan will provide training on appropriate procedures for data
safety and security.
Dr. Richards will work together to provide training on appropriate assessment
equipment (e.g., actigraph, fitbit) maintenance and data downloading. For example,
staff will be instructed that: (A) each actigraph should be used for only one resident.
All actigraphs will be shipped to NHs in subpackage of storage envelopes wth a
space for resident name so that they can be identifiably stored when resident is not
wearing. Multiple actigraphs will be shipped to each NH every week or two weeks
to assure that there is always enough new actigraphs available for use to prevent
any possibility of staff sharing across residents; (B) all portions of the bands and
backs of the actigraph/fitbits should be carefully and thoroughly disinfected with a
Sani-Cloth prime germicidal disposable wipe (or similar product that is appropriate
for healthcare equipment that comes into patient contact such as stethoscopes)
and left on the device for 1 minute as per product instructions to reach maximum
bactericidal/fungicidal/virucidal/tubercolocidal effectiveness. The watch front of the
actigraph/fitbits should be disinfected with a Sani-Cloth Easy Screen Cleaning
Wipe (or similar product that is a 70% isopropyl alcohol solution and is designed for
use on touch screens and other electronic devices that are degraded by more
intensive chemicals).
NH Leadership Team Training:
Study staff will provide a 2-hour virtual training on procedures to protect vulnerable
subjects, as follows: proper procedure for, and importance of only using IRB-
approved procedures and letters when sending study opt-out letters to LARs;
proper procedures for maintaining security and privacy of data packages mailed to
the University of Alabama project office; proper procedures for avoiding coercion or
appearance of coercion of research participation when working with NH staff (e.g.,
not asking staff about research interview participation); proper procedures for
assisting in telephone appointment arrangements and providing logistical support
when study team members conduct telephone-based NH resident consenting and
capacity to consent assessment; importance of only study team members
conducting actual consent procedures of anyone (LARs, NH residents, NH staff);
importance of only properly trained NH leadership team members participating in
study procedures.
Dr. Richards will work together to provide virtual training on the appropriate
application of actigraphs and Fitbits to promote comfort and prevent adverse
experiences, as well as appropriate assessment equipment maintenance and data
mailing. For example, the NH leadership team will be trained on the appropriate
actigraph/fitbit cleaning as described in the previous subsection (Staff Training).
They will also be taught that actigraphs/fitbits should only be applied to dry, clean
skin. The skin should be gently washed with the skin cleanser approved for facility
use for the nursing home resident (typically a non-soap cleanser such as cetaphil,
but this may differ depending upon the specific resident), gently rinsed with a clean
damp washcloth, and then carefully dried to avoid trapping moisture between the
actigraph/fitbit and skin. Similarly, when the actigraph/fitbit is removed in the
morning, the skin should be again cleansed and dried.
NH Staff Intervention Training and Intervention Implementation:

Page 25 of 73
 
NH Staff Training will follow train-the-trainer principles, an established, effective
mechanism for training NH staff.[37-39,81]  To prepare for the training, B&F
Consulting (Barbara Frank & Cathie Brady, research study team members, national
NH quality improvement implementation experts, authors of two books on their
method which highly influenced the development of the LOCK Sleep Program
[25,35]) will guide each NH in the establishment of LOCK sleep program teams: (a)
a NH Leadership team consisting of the Director of Nursing, the NH administrator,
the staff educator, and the QI designee and (b) an implementation team consisting,
at minimum, of the Minimum Data Set (MDS) coordinator, unit managers, and the
medical director. B&F Consulting will visit each NH 5 times over the course of the
R61 phase to train and support the NHs; Dr. Snow and other research staff will also
virtually attend several visits and will attend all phone calls with the sites. The
corporate coaches will attend all B&F consulting virtual visits to their corporation’s
NH to prepare for the subsequent randomized controlled trial (the R33 phase),
when the corporate coaches will assume leadership of the training with B&F
support. B&F Consulting’s will conduct visits to train leadership and staff and begin
the implementation, in and then conduct virtual visits to support implementation,
and then then finally a virtual visit to support sustainment.
The 3 NHs will implement the program starting at approximately the same time.
Based on prior
experience (both in VA and in B&F’s experience in non-VA NHs), we anticipate an
initial 8-week period in which each NH builds its frontline staff huddle practice
across all units (pre-implementation). After this, each NH will begin the LOCK sleep
intervention on all its units. For each resident, their involvement in the study will be
15 weeks -- 1 week of baseline assessment, 6 weeks of active intervention focus in
the staff huddles with a 1-week post-intervention measurement period, and 8-
weeks of sustainment with a final post-sustainment 1-week measurement period.
The leadership team will communicate broadly about the program, ensuring all staff
(including new hires) are introduced to and maintain implementation of the LOCK
sleep program and perform the periodic sleep measurements.
The training will include the following components. B&F Consulting will virtually
train the leadership and implementation teams to guide staff to use huddles to
identify residents with ADRD whose sleep is
disrupted, explore residents’ personal histories with help from family, and develop
action plans to
pilot test individualized, person-centered sleep improvement approaches. B&F
Consulting will also
guide the teams to teach staff to use observation and data collection to monitor the
impact of
their action plans and change the plans as appropriate. The training will also
instruct staff in
actigraph/fitbit use. It will include information on why good sleep is important for
residents with ADRD,
the etiology of poor sleep, evidence-based sleep improvement interventions (e.g.,
good sleep hygiene, minimizing noise and light and resident disturbance at night,
maximizing engaging activity during the day, good nutrition and hydration practices
to promote sleep). As an example of training in techniques to reduce night-time
interruption, nursing staff will be trained on procedures for checking on the resident
without disturbing them if asleep, such as the use of small flashlights pointed
toward the floor using use amber illumination (rather than turning on overhead
sleep disruptive blue lights) to allow the nursing staff to check the resident and
room without awakening a sleeping resident. This increases safety because
sleeping residents are residents who are not getting up.  Whereas waking a
resident to use the restroom can result in the resident not being able to easily go

Page 26 of 73
 
back to sleep, which then puts them at risk of getting up due to restlessness or
agitation after the nurse leaves.
The training will emphasize the importance of customized individualized care,
incremental approaches to treatment changes, and how to use huddles to integrate
such interventions into individualized treatment plans. For example, "decrease in
nighttime interruption" does not mean never checking on the resident during the
night. Staff will be trained on the importance of using small PDSA (plan-do-study-
act) cycles to assure that all care changes are pursued incrementally in an
individualized, customized manner.  This is not about one-size-fits-all care. There is
no blanket edict to not interrupt the patient for the entire night. Rather, the
instruction is for the team to consider and explore ways of promoting longer periods
of uninterrupted sleep, and to test these innovations in incremental trials over a
period of days or weeks.
NH Staff Trained Trainers Providing Training:
After B&F Consulting has trained the NH Leadership and implementation teams,
those teams will then be responsible for training others in the NH. As part of the
intervention training, NH staff will be trained by their NH Leadership or
implementation teams or their trained designees on proper use and placement and
cleaning of actigraphs and Fitbits, verbal and behavioral signs of distress that might
indicate actigraph/Fitbit-related discomfort/distress, and appropriate modification
techniques to try to relieve such distress. NH staff will be informed that the devices
should be removed in the unlikely event that distress behaviors are not relieved by
modification techniques. NH staff will be trained on importance of NH resident
autonomy, and will be engaged in a discussion of how to assess for and honor NH
resident assent or lack thereof with regard to the devices.
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to high performance : doing better together. Baltimore: Health Professions Press;
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: what you do matters. Baltimore: Health Professions Press; 2011.
37.Franzmann J, Haberstroh J, Pantel J. Train the trainer in dementia care. A
program to foster communication skills in nursing home staff caring for dementia
patients. Z Gerontol Geriatr. 2016;49(3):209-215.
38.Mayrhofer A, Goodman C, Smeeton N, Handley M, Amador S, Davies S. The
feasibility of a train-the-trainer approach to end of life care training in care homes:
an evaluation. BMC Palliat Care. 2016;15:11.
39.Sampson EL, Vickerstaff V, Lietz S, Orrell M. Improving the care of people with
dementia in general hospitals: evaluation of a whole-system train-the-trainer model.
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70.de Zambotti M, Goldstone A, Claudatos S, Colrain IM, Baker FC. A validation
study of Fitbit Charge 2 compared with polysomnography in adults. Chronobiology
international. 2018;35(4):465-476.
71.Kolla BP, Mansukhani S, Mansukhani MP. Consumer sleep tracking devices: a
review of mechanisms, validity and utility. Expert review of medical devices.
2016;13(5):497-506.
81.Colon-Emeric C, Toles M, Cary MP, Jr., et al. Sustaining complex interventions
in long-term care: a qualitative study of direct care staff and managers.
Implementation science : IS. 2016;11:94.
82.Chung F, Subramanyam R, Liao P, Sasaki E, Shapiro C, Sun Y. High STOP-
Bang score indicates a high probability of obstructive sleep apnoea. British journal
of anaesthesia. 2012;108(5):768-775.
83.Chung F, Yang Y, Brown R, Liao P. Alternative scoring models of STOP-bang

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Academy of Sleep Medicine. 2014;10(9):951-958.
84.Chung F, Yegneswaran B, Liao P, et al. STOP questionnaire: a tool to screen
patients for obstructive sleep apnea. Anesthesiology. 2008;108(5):812-821.
85.Smith MT, McCrae CS, Cheung J, et al. Use of Actigraphy for the Evaluation of
Sleep Disorders and Circadian Rhythm Sleep-Wake Disorders: An American
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86.Maglione JE, Liu L, Neikrug AB, et al. Actigraphy for the assessment of sleep
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87.Bellone GJ, Plano SA, Cardinali DP, Chada DP, Vigo DE, Golombek DA.
Comparative analysis of actigraphy performance in healthy young subjects. Sleep
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88.Marino M, Li Y, Rueschman MN, et al. Measuring sleep: accuracy, sensitivity,
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109.Richards K, Shue VM, Beck CK, Lambert CW, Bliwise DL. Restless legs
syndrome risk factors, behaviors, and diagnoses in persons with early to moderate
dementia and sleep disturbance. Behavioral sleep medicine. 2010;8(1):48-61.
110.Richards KC, Lambert C, Beck CK, et al. Strength training, walking, and social
activity improve sleep in nursing home and assisted living residents: randomized
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111.Rose KM, Beck C, Tsai PF, et al. Sleep disturbances and nocturnal agitation
behaviors in older adults with dementia. Sleep. 2011;34(6):779-786.
c)
Provide stopping rules for the study, If the proposed study is a clinical trial where a drug, vaccine,
device or other treatment is compared to a placebo group or comparison treatment group, what are
the guidelines or endpoints by which early decisions regarding efficacy or lack of efficacy can be
made? For example, it may be reasonable to stop enrollment on a study when efficacy has already
been clearly demonstrated, to avoid unnecessary enrollments of additional participants.
Alternatively, it may be reasonable to stop enrollment when it is clear that efficacy will never be
demonstrated, given the statistical power of the study as designed. Describe the guidelines that are
in place to assist in making these determinations, if relevant to the proposed study.
We will exclude residents with a high risk of OSA who are not being treated for
OSA because actigraph measurements are inaccurate in that population.85 Staff
will also exclude residents who have a persistent bilateral resting tremor or
paralysis in both arms (a subset of persons with Parkinson’s disease and related
significant tremor-causing diagnoses), due to actigraph measurement inaccuracies.
d)
Describe how data analysis will be performed (statistical tests, methods of evaluating data) and
indicate the smallest group/unit for which separate reporting will occur. For studies involving a
questionnaire, if data and reliability information are available, please describe or provide references.
(Page numbers from a sponsor's protocol/grant may be referenced in this section).
Data analysis for this pilot study (R61 phase) will inform revisions to our upcoming
randomized controlled trial (R33 phase). We will conduct a preliminary assessment
of our outcome measures, particularly our primary outcomes from the actigraphy
TST measurements and fitbit sleep time measurements, and secondary outcomes
from the MDS and our supplementary sleep data (see Table 1). We will examine
ranges, indicators of variability (change over time), and rates of missing data. We
will also examine indicators by demographic characteristics (e.g., age, gender) and
level of dementia severity (mild, moderate, severe). To test the sensitivity of our
secondary outcomes and supplementary sleep data to individual differences in TST
and change in TST, we will preliminarily examine the relationships of these with
average TST and variability in TST.
For the qualitative interviews, all interviews will be audio recorded and transcribed
and Dr. McCullough will guide the experienced qualitative team in using a rapid
appraisal template analysis,[112,113] a rigorous technique for thematically
organizing and analyzing data. The analysis will identify, in particular, areas for
modifications to the LOCK sleep program training. Interviews will also inform our
decision of whether or not to include Fitbits as part of the subsequent randomized
controlled trial (R33 phase), based on staff members’ impressions of the value of
Fitbits and their impressions of the feasibility of using both devices. We will also
modify interview guides (see Appendix) for the next phase, as necessary.
[Selected References]
112.King N. Using templates in the thematic analysis of text. In: Essential Guide to
Qualitative Methods in Organizational Research. London: SAGE Publications Ltd;
2004.
113.Beebe J. Basic Concepts and Techniques of Rapid Appraisal. Human
Organization. 1995;54(1):42-51.
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* * * Radioisotopes or Radiation Machines * * *

Page 29 of 73
 
4)
Radioisotopes or Radiation Machines
Please note: For projects requiring radiation procedures, please contact the UA Environmental
Health and Safety Office at 348-6010
a)
If applicable, summarize in lay language the radiographic diagnostic and therapeutic procedures associated
with this protocol. (X-ray, fluoroscopy, CT, radioactive materials, nuclear medicine, PET-CT, radiation
oncology, accelerator, Cyber Knife procedures, etc.).
b)
Are the radiation procedures being performed a normal part of the clinical management for the medical
condition that is under study (Standard of Care), or are the procedures being performed because the
research participant is participating in this project (extra CT scans, more fluoroscopy time, additional
Nuclear Medicine Studies, etc.) (Not Standard of Care)? If some procedures are Standard of Care and
some are Not Standard of Care, check both boxes.
NOT STANDARD OF CARE
STANDARD OF CARE
If it is not standard of
care,complete the rest of
this section. Provide the
University of Alabama
RSC approval
information below.
If it is only standard of
care, skip the rest of this
section.
c)
Are research-related radiation procedures limited to X-rays only?
Yes (Complete X-ray table).
No (Skip X-ray table).
d)
Total Radiation Exposure (in mRems) from x-ray procedures:
To calculate radiation exposure from x-rays only, University of Alabama allows use of the
Duke University Radiation Safety Committee dose estimate calculator. University of
Alabama does not allow use of this website to calculate any other type of radiation
exposure.
To determine the dose estimate, click on the appropriate links, below (you will be taken to
the Duke University Radiation Safety Committee website). Enter the x-ray procedures
into the appropriate fields of the website and click "create statement". Enter the dose
estimate from the statement in the table above.
For studies involving adults, please click here.
For pediatric studies, please click here..
e)
Please list all radiation procedures (including x-ray) that are research-related (not standard of care). Include
the anatomical location and specify the number of times that each procedure will be conducted throughout
the entire study.
NOTE: The IRB will determine if this study requires radiation safety review by the Radiation
Safety Officer or the Radiation Safety Committee.
For more information on how to submit for radiation safety review, contact the Radiation
Safety Officer.
---------------------------------------------------------------------------------------------
* * * Drugs, Reagents, Chemicals, or Biologic Products * * *
5.
Drugs, Reagents, Chemicals, or Biologic Products
Pilot
Phase I
Phase II
Phase III
Phase IV
Not Phased
a)
Please list in the space below all investigational drugs, reagents or chemicals to be
administered to participants during this study.

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b)
Please list in the space below all FDA approved drugs, reagents, chemicals to be
administered to participants during this study.
Please read the IND Statement 1 and  IND Statement 2.
---------------------------------------------------------------------------------------------
* * * Devices * * *
6.
Devices
a)
Please list in the space below all investigational devices to be used on participants during this study.
b)
Please list in the space below all FDA approved devices to be used on participants during this study.
---------------------------------------------------------------------------------------------
* * * Subject Population(a-h) * * *
7.
Subject Population - In the space below, please detail the participants that you are requesting to recruit
(include description of each group requested)
a)
Expected age range of participants. (For example - 19 yrs to 90 yrs).
In the potential participant pool, we will include all NH residents aged >=50 years with an
ADRD diagnosis.
b)
i) Number to be directly solicited for this research.
N/A
all res. at 3 NHs
ii) Number to be consented (including withdrawals or screen
failures)
N/A
70
iii)Number expected to complete the study.
57
c)
If this is multi-center study, number of participants to complete
the study study-wide
N/A
57
d)
If study involves review of medical or other records, number of
records to be reviewed.
N/A
70
e)
If women, minorities, or minors are excluded, a clear compelling rationale must be provided unless not
applicable. Examples for not including minors: disease does not occur in children; drug or device would
interfere with normal growth and development; etc.
1. Inclusion of Women and Minorities
Participants will be selected according the inclusion/exclusion criteria described in the
methods section. We aim to recruit a sample that will be representative of the national
nursing home (NH) population. Based upon the 2015 Centers for Medicaid and Medicare
Nursing Home Compendium,122 we will aim to enroll approximately 67% women and
33% men. The national figures for 2015 were: 79% White not Hispanic, 13.8% Black not
Hispanic, 4.9% Hispanic, 1.6% Asian, .4% American Indian/Alaskan Native, .1% Native
Hawaiian Pacific Islander, and .3% more than one race.
We will make every effort to include a representative sample of minorities. Men and
members of minority groups will be actively recruited during this protocol.
We will use unbiased statistical analyses and proper methods of inference to estimate
and compare intervention effects by sex/gender, race, and/or ethnicity. We will conduct
exploratory analyses to detect any differences in intervention effect among these groups,
because prior studies do not strongly indicate nor negate the existence of such effects.
2. Inclusion of Children
Children will not be included in this study. Children are unlikely to live or work in NHs and
unlikely to have dementia.
f)
Describe how potential participants will be identified for recruitment (e.g., chart review, referral from
individual's treating physician, those individuals answering an ad). How will potential participants learn
about the research, and how will they be recruited (e.g., flyer, e-mail, web posting, telephone, etc.)? State
where recruitment materials will be located. Click "Add" to upload recruitment materials document.
Important to remember: Study Activities cannot begin until IRB approval is granted.

Page 31 of 73
 
In the potential participant pool, we will include all NH residents aged >=50 years with
an ADRD diagnosis. We include residents across the range of ADRD severity because
this is consistent with the LOCK sleep program, in which staff will focus on residents
with ADRD who have the greatest sleep problems without differentiating by ADRD
severity. To identify participants, NH staff will use frontline staff huddles.
Research staff will recruit and consent a sample of NH staff at mid- and post-
implementation for (mid-) and (post-) PHONE interviews about their experiences with
the LOCK sleep program and Fitbits. NOTE: The LOCK sleep program itself comprises
clinical practices common in NH QI efforts. These practices thus fall within the scope of
staff positions and require no consent.
---------------------------------------------------------------------------------------------
* * * Subject Population(i-l) * * *
7.
Subject Population (continued)
i)
Inclusion and Exclusion Criteria.
Identify inclusion criteria.
In the potential participant pool, we will include all NH residents aged >=50 years with
an ADRD diagnosis. We include residents across the range of ADRD severity because
this is consistent with the LOCK sleep program, in which staff will focus on residents
with ADRD who have the greatest sleep problems without differentiating by ADRD
severity. To identify participants, NH staff will use frontline staff huddles. NH staff will be
trained to use the STOP-Bang screening tool to identify NH residents with high risk of
obstructive sleep apnea (OSA) 82-84 and will be trained on appropriate procedures for
referring any positively screened residents for medical evaluation
Identify exclusion criteria.
We will exclude residents with a high risk of OSA who are not being treated for OSA
because actigraph measurements are inaccurate in that population.85 Staff will also
exclude residents who have a persistent bilateral resting tremor or paralysis in both
arms (a subset of persons with Parkinson’s disease and related significant tremor-
causing diagnoses), due to actigraph measurement inaccuracies.
j)
Compensation. Explain the amount and schedule of compensation, if any, that will be paid for participation
in the study. Include provisions for prorating payment.
N/A
k)
Describe who will cover study related costs. Explain any costs that will be charged to the participant.Include
provisions for prorating payment.
All study related costs will be covered by the NIA grant funding.
l)
Estimate the probable duration of the entire study including data analysis and publication. This estimate
should include the total time each participant is to be involved and the duration the data about the
participant is to be collected. If the study is Investigator-initiated, a timeline for individual participant
recruitment, follow-up, total time for participant accrual, and data analysis for the study is required.
The entire pilot study will last 1 year.  Each NH resident participant will be involved in a
15 week data collection period.
---------------------------------------------------------------------------------------------
* * * Subject Population(m) * * *
Research Involving Children
NOTE: Investigators, please include this information with the e-Protocol application if your research involves
children. In Alabama a child is an individual less than 18 years of age unless the child is legally emancipated. If
your research involves children with more than one vulnerability (e.g., children who are pregnant, incarcerated, or
cognitively impaired) attach the supplementary information for that vulnerable population as well.
Minimal risk means that the probability and magnitude of the harm or discomfort anticipated in

Page 32 of 73
 
the research are not greater in and of themselves than those ordinarily encountered in daily
life of a healthy child or during the performance of routine physical or psychological exams or
tests.
Section 1.
Select and complete the category that applies to your research.
Category 1 (45 CFR 46.404; 21 CFR 50.51) My research does not involve greater than
minimal risk.
a)
My research falls under this category because:
b)
Describe what provisions will be made for soliciting the assent of the children, and the
permission of both parents, or the legal guardian.  (Permission from both parents must be
obtained unless one parent/guardian is deceased, unknown, incompetent, or not
reasonably available, or when only one parent/guardian has legal responsibility for the
care and custody of the child). Justify reason(s) if seeking permission from only one
parent.
Category 2 (45 CFR 46.405; 21 CFR 50.52) My research involves greater than minimal risk
but presents the prospect of direct benefit to the individual participants.
a)
My research falls under this category because:
b)
Justify the risk(s) by explaining the anticipated benefit to the participants:
c)
Explain how the relation of the anticipated benefit to the risk is at least as favorable to the
participants as that presented by available alternative approaches:
d)
Describe what provisions will be made for soliciting the assent of the children, and the
permission of at least one parent/guardian.  (Permission from both parents must be
obtained unless one parent/guardian is deceased, unknown, incompetent, or not
reasonably available, or when only one parent/guardian has legal responsibility for the
care and custody of the child). Justify reason(s) if seeking permission from only one
parent.
Category 3 (45 CFR 46.406; 21 CFR 50.53) My research involves greater than minimal
risk, and no prospect of direct benefit to individual participant, but likely to yield
generalizable knowledge about the participant's disorder or condition.
a)
My research falls under this category because:
b)
Describe how the risks for participating in your research represent a minor increase over
minimal risk (i.e., the children being recruited have a disorder or condition that would
place them in a group other than an average healthy child; therefore, the research
qualifies as a minor increment over minimal risk.  This risk is slightly more than what the
average healthy child would experience, but is reasonable for these participants because
it is not more than they would experience or expect given their condition.).
c)
Describe how the research intervention(s)/procedure(s) present experiences to
participants that are reasonably commensurate to those inherent in their actual or
expected medical, dental, psychological, social, or educational situations:

Page 33 of 73
 
d)
Explain why the intervention or procedure is likely to yield generalizable knowledge about
the participants' disorder or condition, which is of vital importance for the understanding
or amelioration of the participants' disorder or condition:
e)
Describe what provisions will be made for soliciting the assent of the children, and the
permission of both parents/guardians.  (Permission from both parents must be obtained
unless one parent/guardian is deceased, unknown, incompetent, or not reasonably
available, or when only one parent/guardian has legal responsibility for the care and
custody of the child). Justify reason(s) for seeking permission from only one parent.
Category 4 (45 CFR 46.407; 21 CFR 50.54) My research does not fall under Category 1, 2,
or 3 listed above.  However, the research presents a reasonable opportunity to understand,
prevent, or alleviate a serious problem affecting the health or welfare of children.
(NOTE:  If your research is funded by, or funding has been sought from the Department
of Health and Human Services (DHHS), Department of Education, or is FDA regulated, a
report must be sent for review to the DHHS Secretary, Secretary of the US Department
of Education, or Commissioner of FDA. If this category is applicable, the Office of
Research Compliance will prepare and submit a report of IRB review to the appropriate
federal official(s)).
a)
My research falls under this category because:
b)
Describe what provisions will be made for soliciting the assent of the children, and the
permission of both parents/guardians. (Permission from both parents must be obtained
unless one parent/guardian is deceased, unknown, incompetent, or not reasonably
available, or when only one parent/guardian has legal responsibility for the care and
custody of the child). Justify reason(s) if seeking permission from only one parent.
Section 2.
In order to effectively assess and evaluate the risk of your proposed research to children, the
IRB requires the following information.  Respond to all items.
a)
Provide justification for the participation of children as research participants in your study.
b)
Has this research been conducted in adults?
If yes, is there any indication that the proposed research would benefit, or at least not be
harmful to children?
c)
Indicate how many children you propose to enroll in the study and justify this number
(whenever possible, involve the fewest number of children necessary to obtain
statistically significant data which will contribute to a meaningful analysis relative to the
purpose of the study).
d)
Describe how assent of a child will be obtained and documented (if applicable).  If not
applicable, explain why.
I am requesting waiver of the requirement for assent.

Page 34 of 73
 
Justify:
OR
I have attached an assent form/assent script for IRB review.
e)
Explain what methods will be used for evaluating dissent (i.e., description of behaviors
that would indicate child does not want to participate (such as moving away, certain facial
expressions, head movements, etc...).
f)
Describe how parental permission will be obtained. [Note: If you propose to waive the
requirement for parental permission (i.e., getting parental permission may be against the
best interest of the child, i.e., a study of abused or neglected children), describe what
measures will be taken to protect the rights and welfare of the children.]
I am requesting waiver of the requirement for parental permission.
Justify:
OR
I have attached a parental permission form for IRB review.
g)
Describe measures that will be taken to ensure that a parent is present when the child
participates in any research interventions or procedures. [Note:  If the nature of the
research is such that it is not appropriate to have a parent present (i.e., research into
sensitive personal issues, physical examinations of teenagers, etc...) please explain why.]
h)
Describe the expertise of the research staff/study personnel for dealing with children at
the ages included and whether they are knowledgeable and sensitive to the physical and
psychological needs of the children and their families.  Describe the appropriateness of
facility in which the research will be conducted in relation to environment and/or
equipment accommodating to children.
i)
If applicable, provide any additional information that may support your request to involve
children in this research.
---------------------------------------------------------------------------------------------
* * * Subject Population(n) * * *
Research with cognitively impaired persons
NOTE:  Investigators, please include this form with IRB application if your research involves cognitively impaired
(decisionally impaired or decisionally challenged) persons.  If your research involves people with more than one
vulnerability, please complete the supplementary form for that population as well.
The IRB may ask you to designate an impartial observer to monitor the consent process or it may send its own
representative to do so.
Section 1.
Note:Check the box next to the category that in your best judgment applies to your research,
and provide the information requested in the space provided.
Note: Minimal risk means that the probability and magnitude of the harm or discomfort
anticipated in the research are not greater in and of themselves than those ordinarily
encountered in daily life or during the performance of routine physical or psychological exams

Page 35 of 73
 
or tests.  (i.e., daily life of health persons)
X Category 1 My research does not involve greater than minimal risk.
Explain.  If appropriate, describe what  provisions are in place for allowing a Legally
Authorized Representative (LAR) or other person with the participant's best interests at
heart to assist the participant in navigating the research process:
As described in Section 2 sub-section #2 below, LARs will always be contacted and
taken through a proxy consent process before NH residents with ADRD diagnoses are
contacted.
Category 2 My research presents greater than minimal risk and prospect of direct benefit to the participants.
Explain.  If appropriate, describe what provisions are in place for allowing a Legally
Authorized Representative (LAR) or other person with the participant's best interests at
heart to assist the participant in navigating the research process.
Category 3 My research presents greater than minimal risk and no prospect of direct benefit to the
participants, but likely to yield generalizable knowledge about the participant's disorder or condition, because:
Explain.  If appropriate, describe what provisions are in place for allowing a Legally
Authorized Representative (LAR) or other person with the participant's best interests at
heart to assist the participant in navigating the research process.
Category 4 My research does not fall under Category 1, 2, or 3, listed above.
If you check this category, the IRB determines additional safeguards on a case-by-case basis.
Section 2.
1.
Explain why individuals with impaired decision-making capacity are suitable for this
research. If the objective(s) of the study allow for inclusion of competent participants,
provide compelling justification for inclusion of incompetent participants.
This study does involve the vulnerable population of nursing home residents with
dementia. Sleep problems and related issues in NH residents with dementia is a well-
documented problem. This study implements an intervention to improve the sleep
experience for these residents and increase engagement in meaningful actvities. To
evaluate the effects of the sleep program for people with dementia, people with dementia
must be enrolled. If the LOCK sleep program is found to be effective in enhancing clinical
care and outcomes, the approach can be shared with other NHs and incorporated into
general NH practice. The risks in this study for NH residents are minimal, and the
knowledge gained may result in improved quality of sleep, and ultimately improved
quality of life for NH residents with dementia.
2.
Describe who will determine individuals' competency to consent and the criteria to be
used in determining competency (e.g., use of standardized measurements, consults with
another qualified professional, etc...).
All consents as described below will be conducted by an IRB-approved study staff
member who has been trained by Dr. Snow (principal investigator). The study staff
member will be responsible for explaining the study, answering questions, and obtaining
informed consent.
Cognitively Impaired NH Resident Consent – Step 1. Legally Authorized Representative
Consent
NH leadership team [see Section #3B-Study Procedures] or their designees will identify
all NH residents with an ADRD diagnosis and mail to their legally authorized
representatives (LARs) an IRB-approved study introduction letter (including option to opt
out within one month if they do not wish to be contacted by study staff). Opt-out
procedures have been demonstrated to yield higher response rates and lower rates of

Page 36 of 73
 
non-response bias compared to opt-in procedures, and to be acceptable to participants,
with no difference in rates of reported distress or complaints compared to opt-in
procedures.[105-108] In our past federally funded research involving people with
dementia, opt-out consent has been approved by multiple IRBs and worked well. Contact
information of those LARs not opting out will be shared with University of Alabama (UA)
study staff. We will request of the IRB a waiver of consent and HIPAA authorization for
screening purposes regarding the sharing of these contact information.
Study staff will mail an IRB-approved study information packet via a tracked, express
mailing service to all LARs who do not opt out. These materials will include a cover letter,
an IRB-approved informed consent form (ICF), and an express mail return envelope so
the LAR can send the signed ICF to the UA study office. LARs will be encouraged to
contact study staff via phone or email for an appointment to discuss the study and go
through the consent form together before signing the ICFs. Study staff will contact the
LARs via phone and/or email within one week of sending the packet and will re-contact
the LAR up to 6 times within the next month as needed to establish contact (if contact
has not been established within one month, and NH staff are not able to determine that
the LAR’s contact information has changed, then the lack of contact will be considered a
soft refusal and no other contact will be attempted).
During a phone appointment, study staff will review all important elements of the ICF with
the LAR, including the following: description of the study, information on how to contact
the investigators and the NH administrator and director of nursing, a statement that there
is no prejudice for refusal to participate, a statement that the subject may withdraw from
the study at any time without prejudice, and statement regarding risk and benefit of
participation. The LAR will be encouraged to ask questions. The LAR will be encouraged
to call the PI if they have any remaining questions before signing the consent form.
Cognitively Impaired NH Resident Consent – Step 2. Screening for Capacity for NH
Resident Consent/NH Resident Assent
Some NH residents with mild ADRD may have the capacity to provide their own consent.
For residents with likely mild ADRD and a LAR who can be contacted, a conservative
two-step process will be used to address the ethical balance of the beneficence of
assuring that residents who do not have the capacity to consent are protected by LAR
oversight with the promotion of autonomy for residents who do have capacity to consent.
Once LAR consent is received for a resident, the NH leadership team will be asked to
identify that resident’s most recent MDS Brief Interview for Mental Status score[120]
(BIMS; see Appendix for measure), a cognitive screening measure with good reliability
and validity. For residents with BIMS scores in the mild range (above 10), the NH
leadership team will be asked to arrange and support a telephone appointment between
that resident and a study staff person (if the resident turns out to NOT have the cognitive
ability to participate in the following telephone-based procedure, then they would also
NOT have the cognitive capacity to provide informed consent, which requires higher level
cognitive abilities).
In the telephone appointment, the study staff member will provide information about the
study and will screen for capacity to consent by assessing the following. Does the
resident respond appropriately to a social greeting? Is the resident oriented to place?
Does the resident understand who the study team member is after the team member
explains their identity? During the course of this introductory conversation, was the
resident able to respond fluently and socially appropriately? If so, the team member will
go through the consent form with them. Residents will then be asked a series of
questions to assure their understanding. These questions are as follows:
Describe in your own words what this study is about?
Describe what I am asking you to do to participate in this study?
Are you required to do this interview with me?

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What will happen if you don’t talk to me?
What happens if you decide you don’t want to participate once we get started?
What will I do with the information you give me?
The NH leadership team member will support this telephone conversation by assuring
that the resident has a quiet environment to have the telephone conversation and that
the resident has in front of them a printed large-font version of the ICF written in first
person with the signature area flagged. If the resident is able to respond appropriately to
all the capacity screening questions, and they do wish to participate, then the resident
will be instructed to sign the ICF. The study staff person will contact the NH leadership
team member and ask them to make a copy of the ICF for the resident to keep, place a
copy in the medical chart, and express mail the original to the UA study office using a
provided pre-paid envelope. If the resident is able to respond appropriately to all the
capacity screening questions and does not wish to participate then they will not be
enrolled in the study, regardless of the LAR’s consent. In this case, the study team
member will let the NH leadership team and the LAR know that the resident has declined
participation.
Under all circumstances, the NH resident’s autonomy will be respected. For NH residents
without capacity to consent, their assent to participate will be obtained whenever
possible, and their decision to withdraw at any time (whether expressed verbally or by
resistance to participation) will be honored (see also staff training in Section #3B-Study
Procedures).
For residents with likely mild ADRD (BIMS score above 10) but no lar, the nursing home
leadership team and study staff will go directly to the resident to invite their participation
and screen their capacity to consent using the same process described above.
All above procedures apply to securing consent for the research study team to have
access to NH resident personally identifiable data.
NOTE: the LOCK sleep program does not include any activities that are outside of
standard NH practice, therefore NH staff will be free to enroll any NH residents that they
believe will benefit into the LOCK sleep program regardless of resident consent status;
however the NH leadership team will only be allowed to share with the research study
team data for residents who are consented for the study.
3.
It should be recognized that decision-making capacity may fluctuate, requiring ongoing
assessment during the course of the research. Is it reasonable to expect that during
the course of the research, subjects may lose their capacity to consent or their ability
to withdraw?
Y
a)
Describe what provisions are in place for periodic re-consent. Include the rationale
and procedure,  the proposed interval,  any changes in behavior that might signal
the need to re-consent whether or not the proposed interval has elapsed, and any
consultative resources that are available for these decisions.  Describe the process
for re-consent or re-assent, or reassessment of willingness to continue participation.
Re-consenting provisions will not be included because the course of the study is a
relatively short 22 weeks (5.5 months), an amount of time in which it is unlikely,
although possible, that cognitive capacity will significantly change. Further, the
main focus of the intervention is with staff behavior. Staff will be implementing
interventions that are considered good standard clinical practice, such as providing
meaningful activities during the day to help reduce resident daytime napping and
reducing noise and resident interruptions at night to promote uninterrupted sleep.
Therefore, is is unlikely, although possible, that resident willingness to continue
participation will change over this relatively short amount of time.

Page 38 of 73
 
The most likely cause of resident unwillingness to continue participation would be
over the wearing of the actigraph and/or fitbit. NH staff will be trained by their NH
leadership teams or their trained designees (who will have been trained by Dr.
Snow or her study team designees) on proper use and placement of actigraphs
and Fitbits, verbal and behavioral signs of
distress that might indicate actigraph/Fitbit-related discomfort/distress [e.g., verbal
indicators such as words (e.g., "take it off!"), distress sounds (e.g., crying, moaning,
groaning), physical movements (e.g., picking at the device, shaking the arm)], and
appropriate modification techniques to try to relieve such distress. NH staff will be
informed that the devices should be removed in the unlikely event that distress
behaviors are not relieved by modification techniques. NH staff will be trained on
importance of NH resident autonomy, and will be engaged in a discussion of how to
assess for and honor NH
resident assent or lack thereof with regard to the devices.
b)
Describe what provisions are in place to protect the participants' rights in the event
they lose their capacity to consent or their capacity to withdraw during the course of
the research. (e.g., power of attorney, consent a caregiver as well as the patient,
etc.).
Most residents will not have the capacity to consent. As described above,
behavioral indicators of withdraw of assent will be honored and NH staff will be
carefully trained to recognize these indicators. In addition, LARs will have the study
team's contact information and a copy of their consent form which clearly indicates
how they can reach the study team and withdrawn consent at any time. These
procedures will be reviewed with LARs as part of the consent process.
c)
Describe what provisions are in place for use of additional waiting periods to allow
potential participants time to consult with family members about whether or not to
participate.
Most residents will not have the capacity to consent, and LARs will be consenting.
LARs will always be contacted about potential participation before the NH resident
is contacted. As described above, if it becomes apparent that the NH resident is
able to consent for themselves, their decision will be honored even if it is discrepant
from that of the LAR (i.e., if LAR says yes but resident decides no).
4.
Explain how you will identify who is authorized to give legally valid consent on behalf of
any individual(s) determined to be incapable of consenting on their own behalf.
We will be guided by the medical chart documentation of who is identified as the legally
authorized representative (LAR), combined with guidance from the nursing home staff
who know the NH resident and family the best regarding who is the appropriate LAR.
5.
Explain the criteria you will use for determining when assent is required for participants
who are not competent.
We will always look for assent for participants who are not competent to consent. The
behavioral indicators of lack of assent for the actigraph/fitbit are described above.
There are no study self-report data collected from residents. All resident data involved in
this study are data that the NH collects as part of their standard clinical practices (e.g.,
Minimum Data Set (MDS) data that is mandated data collected as per
Medicare/Medicaid reimbursement rules). All other resident involvement is concordant
with clinical best practice.  The main focus of the intervention is with staff behavior. Staff
will be implementing interventions that are considered good standard clinical practice,
such as providing meaningful activities during the day to help reduce resident daytime
napping and reducing noise and resident interruptions at night to promote uninterrupted
sleep.
6.
Explain what methods will be used for evaluating dissent (e.g., description of behaviors

Page 39 of 73
 
that would indicate individual does not want to participate (such as moving away, certain
facial expressions, head movements, etc...).
Verbal and behavioral signs of distress that might indicate actigraph/Fitbit-related
discomfort/distress include: verbal indicators such as words (e.g., "take it off!"), distress
sounds (e.g., crying, moaning, groaning), and physical movements (e.g., picking at the
device, shaking the arm)].
7.
The research protocol should include someone who can be reasonably assumed to have
the participant's best interest in mind and can assist the participant in navigating the
consent and research process. A person holding durable power of attorney or other legal
designee, spouse, close relative who is involved in ongoing care of participant, other
person with a personal or blood relationship who is involved in ongoing care of
participant, or other close relatives or friends may assume this role.  Describe how
individuals will be identified to serve in this capacity.  If this request is not appropriate for
this study, justify why it should be waived.
As described in #4 above, we will be guided by the medical chart documentation of who
is identified as the legally authorized representative (LAR), combined with guidance from
the nursing home staff who know the NH resident and family the best. LARs will always
be contacted about potential participation before the NH resident is contacted.
8.
If applicable, describe when and how the individual's health care provider will be
consulted prior to participation in the research.  NOTE:  If the Principal Investigator (PI) is
also the individual's health care provider, address how the PI will separate the roles of
clinician and researcher.
The medical director of the nursing home will be consulted before NH residents are
enrolled in the study. By law, NH residents may use any physician they would like and
therefore the medical director may not be their personal physician, but would still have
medical oversight over their well-being and would be able to offer recommendations if for
any reason a particular resident had contraindications for participation.  Similarly, the
director of nursing and the entire NH clinical interdisciplinary team will be consulted
before NH residents are enrolled in the study, providing adequate opportunity for any
clinical team member to indicate if participation of a particular resident would be
contraindicated.
9.
Will the research interfere with current therapy or medications?
N
If yes, describe what the changes may entail (i.e., if the subjparticipantl be removed from
routine drugs/treatments, wash out periods, etc.) and the potential risks.
10. Does your research involve institutionalized individuals?
Y
a)
Justify the use of institutionalized individuals and explain why non-institutionalized
individuals can not be substituted.
This is a study of how to improve nursing home treatment. Because the factors that
affect nursing home treatment are systemic, investigation of interventions to
improve nursing home treatment can only occur within the system of the nursing
home itself.
Section 3.
Complete this section if your research involves individuals from the Department of Veterans
Affairs (VA).
1.
Address procedures you will use to ensure the participant's representative is informed
regarding his/her role and obligation to protect the incompetent participant or person with
impaired decision-making capacity.
N/A

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2.
Address procedures you will use to ensure the participant's representative has been told
of his/her obligation to try to determine what the prospective participant would do if
competent, or if the prospective participant's wishes cannot be determined, what the
participant's representative thinks is in the incompetent person's best interests:
N/A
3.
The VA has specific requirements and procedures for determining and documenting in
the person's medical record that an individual is incompetent or decisionally-impaired.
There are additional requirements if the lack of decision-making capacity is based on
diagnoses of mental illness.  These requirements are outlined in the Veterans Health
Administration (VHA) Handbook 1200.5, Section II.   Have you reviewed these
requirements and included them in your procedures?
N
4.
Justify that the research involves no significant risks, or if the research presents
probability of harm, justify that there is at least a greater probability of direct benefit to the
participant:
N/A
Note:[Veterans Health Administration Handbook 1200.5, July 15, 2003, Section 11 - Research
Involving Human participants with Surrogate Consent, and Appendix D Vulnerable
Populations, Section 6(c)]
Section 4.
For research involving cognitively impaired persons outside the state of Alabama, also
complete this section.
a)
Provide information regarding the state definition of legally authorized representative,
child, decisionally-impaired, or guardian, as applicable to the research and to the federal
definitions.  [If the research is to be conducted in more than one state outside of
Alabama, provide this information for each state.]
Three states are involved – Colorado, South Carolina, and Texas. The definitions of
Legally Authorized Representative and decisionally-impaired person for these states are
consistent with those used in Alabama as described in the definitions section below (i.e.,
Alabama law does not specify who may make such decisions. UA legal counsel
recommends the following in this order of preference: A legally appointed guardian, a
health care proxy or person authorized to make medical decisions in conjunction with a
durable power of attorney, a spouse, an adult child, next of kin, or a person or agency
acting in loco parentis).
References:
Colorado: https://casetext.com/statute/colorado-revised-statutes/title-15-probate-trusts-
and-fiduciaries/declarations-future-medical-treatment/article-185-proxy-and-surrogate-
decision-makers-for-medical-treatment-and-for-health-care-benefit-decisions
South Carolina: https://www.palmettohealthfoundation.org/document-
library/research/policies-pgrs
Texas:
https://www.uthscsa.edu/sites/default/files/Services/forms/irbconsentpolicyattachment1.p
df
Definitions:
Assent - is defined as a child's or decisionally-challenged individual's affirmative agreement to
participate in research. Mere failure to object should not, absent affirmative agreement, be
construed as assent.
Competence "Technically, a legal term, used to denote capacity to act on one's own behalf;
the ability to understand information presented, to appreciate the consequences of acting (or
not acting) on that information, and to make a choice." [OHRP Institutional Review Board
Guidebook, Chapter VI, Section D]

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Permission is defined as the agreement of parent(s) or guardian to the participation of their
child or ward in research or clinical investigation. Permission includes the element of consent
set forth in federal regulations and outlined in the informed consent template included in the
IRB expedited and full review applications.
In Alabama child/children refers to all individuals less than 18 years of age unless the
individual(s) is/are legally emancipated. (See Guidance:  Alabama Law on Children, Minors,
Consent, and Other Research-Related Topics.  Individuals less than 18 years of age who are
not emancipated meet the federal definition for "child" (e.g., Department of Health and Human
Services (DHHS), Food and Drug Administration (FDA), and U.S. Department of Education).
Legally authorized representative (LAR) is an individual who has the authority to make
research participation decisions on behalf of another. Alabama law does not specify who may
make such decisions. UA legal counsel recommends the following in this order of preference:
A legally appointed guardian, a health care proxy or person authorized to make medical
decisions in conjunction with a durable power of attorney, a spouse, an adult child, next of kin,
or a person or agency acting in loco parentis.
NOTE:  Consent from a legally authorized representative involves all the ethical and
regulatory concerns that apply to consent from the prospective participant.
---------------------------------------------------------------------------------------------
* * * Subject Population(p) * * *
Research Involving Prisoners
NOTE:  Investigators, please include this information with the e-Protocol application if your research involves
prisoners. This includes studies of known prisoners and studies recruiting participants at risk of becoming
involuntary prisoners, such as participants with histories of substance abuse. Remember that persons
involuntarily committed to mental health facilities (Taylor Hardin Secure Mental Health Facility, Mary Starke
Harper, etc.) by the courts are also prisoners.
If participants unexpectedly become prisoners, go directly to SECTION FOUR of this form.
If your research involves prisoners with more than one vulnerability (i.e., prisoners who are also children or
pregnant, are involuntarily committed to mental health facilities), attach the supplementary form for that
vulnerable population as well.
Regardless of the category of your research, be sure that your application makes clear why the research must be
done on prisoners.
Indicate the category that best represents your research by checking the applicable box below, and explain in the
space provided for that category why your research meets the criteria.
Note: For research involving prisoners, the definition of minimal risk refers to the probability
and magnitude of physical or psychological harm that is normally encountered in the daily
lives, or in the routine medical, dental or psychological examination of healthy persons.
Category 1  (45 CFR 46.306(a)(2)(i))
My research involves the study of possible causes, effects, processes of incarceration,
and of criminal behavior. (Processes of incarceration can be interpreted broadly to
include substance abuse research, half-way houses, counseling techniques, criminal
behavior, etc.)
Justify how the research presents no more than minimal risk and no more than inconvenience to the
participants:
Category 2  (45 CFR 46.306(a)(2)(ii))
My research involves the study of prisons as institutional structures, or of prisoners as
incarcerated persons. (This category is usually used fairly narrowly as when looking at
prisoner diet and conditions of prison life.)
Justify how the research presents no more than minimal risk and no more than inconvenience to the
participants
Category 3  (45 CFR 46.306(a)(2)(iii))

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My research involves the study of conditions particularly affecting prisoners as a class.
(This category is less frequently used than the previous ones and refers to such
research as vaccine trials, research on hepatitis, and social and psychological problems
such as alcoholism, drug addiction, and sexual assaults.  Minimal risk studies should not
go under this category.) For DHHS-funded research, OHRP has consulted with
appropriate experts including experts in penology, medicine, and ethics, and published
notice, in the Federal Register, of its intent to approve such research.
Note: Contact the Office of Research Compliance at (205) (348-8461 for more
information
Explain what condition(s) will be studied and provide rationale for each:
Category 4  (45 CFR 46.306(a)(2)(iv))
My research involves the study of practices, both innovative and accepted, which have
the intent and reasonable probability of improving the health or well-being of the
participant. (Note:  It is rare for research involving placebo or control groups to fall in this
category because of the difficulty in justifying improvement of the health or well-being of
the participant being given placebo or in a control group.)  For DHHS-funded research
which requires the assignment of prisoners in a manner consistent with protocols
approved by the IRB to control groups which may not benefit from the research, the
study may proceed only after OHRP has consulted with appropriate experts, including
experts in penology, medicine, and ethics, and published notice, in the Federal Register,
of its intent to approve such research.
Note:  Contact the Office of Research Compliance at (205) 348-8461 for more
information.
Explain the research practices that will be used in this study and how they are intended to improve the
health and well-being of the participants:
Section 2.  [45 CFR 46.305]
Note: When an IRB is reviewing a protocol in which a prisoner will be a participant, the IRB
must find and document justification that six additional conditions are met. Describe in the
space provided how each condition applies to your research.
1.
Advantages acquired through participation in the research, when compared to the
prisoners' current situation, are not so great that they impair their ability to weigh risks.
Describe the possible advantages that can be expected for prisoner participants:
2.
Risks are the same as those that would be accepted by non-prisoners.
Describe the possible risks that can be expected for prisoner participants and justify that they are the
same as for non-prisoners:
3.
Procedures for selection are fair to all prisoners and are immune from intervention by
prison authorities in prisons; control participants must be randomly selected.
a)
Describe how prisoners will be selected for participation:
b)
Describe what measures will be taken to prevent intervention by prison authorities in the selection
process:
4.
Parole boards cannot take into consideration a prisoner's participation in research.
Informed consent must state participation will not affect length of sentence or parole.

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5.
For studies that require follow-up, provisions are made including consideration for the
length of individual sentences; informed consent must reflect provisions for follow-up.
Describe what provisions have been made for follow-up and how this information will be relayed to the
prisoner participants:
6.
Information about the study is presented in a language understandable to prisoners.
Describe what efforts have been made to present information about the study in a
language   that is understandable to the prisoner population. This may mean a non-
English language or an appropriate reading level in whatever language the prisoner
uses.:
Section 3. Only complete if applicable:  Epidemiologic Research Involving Prisoners and Funded by the
Department of Health and Human Services (DHHS)
Note: Effective June 20, 2003, DHHS adopted policy that allows waiver of the requirement for
documenting applicability of a 45 CFR 306(a)(2) category (as found in Section 1 of this form)
for certain epidemiologic research involving prisoners.  This waiver applies to DHHS
conducted or supported epidemiologic research on prisoners that presents no more than
minimal risk and no more than inconvenience to the prisoner-participants.
Check the box below if your research meets the listed criteria, then provide justification in the
space provided.
1.
My research is funded by HHS and I request a waiver for meeting the category
conditions under Section 1 of this form.
2.
My research involves epidemiologic research intended to describe the
prevalence/incidence of a disease by identifying all cases, or to study potential risk
factor associations for a disease; and
3.
Prisoners are not the sole focus of my research.
Justify how the research presents no more than minimal risk and no more than inconvenience to the participants:
Section 4.   Complete if applicable:
Prisoners are not the targeted population
Note: Although prisoners may not be the target population for your research, a participant
could become a prisoner during the course of the study (particularly if studying a subject
population at high-risk of incarceration).
Note: If you did not receive IRB approval for involvement of prisoners, and a participant
becomes a prisoner during the study, all research interactions and interventions with, and
obtaining identifiable private information about, the now-incarcerated participant must cease
until IRB approval has been issued for their continuation in the research.  If you need IRB
approval for a prisoner participant to continue participation in your research, select and
complete the applicable category from Section 1, complete section 2 and this section, then
submit for IRB review.
In special circumstances in which the Principal Investigator asserts that it is in the best interest
of the participant to remain in the research study while incarcerated, the IRB Chairperson may
determine that the participant may continue to participate in the research prior to satisfying the
requirements of Subpart C.  However, subsequent IRB review and approval of this completed
form, documenting that the requirements of Subpart C are met, is required.
Prisoners are not a target population for my research, but a participant became a prisoner
during the study and I am seeking IRB approval so the participant can continue

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during the study and I am seeking IRB approval so the participant can continue
participation in the research.
Explain the importance of continuing to intervene, interact, or collect identifiable private information during
the participant's incarceration:
Note: Prisoner: An individual involuntarily confined in a penal institution, including persons: (1)
sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or
sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of
alcoholism,) under statutes or commitment procedures providing such alternatives to criminal
prosecution or incarceration in a penal institution [45 CFR 46.303(c)]. Note:  Persons on
Probation and parole are usually NOT considered to be prisoners.
If you will receive or are seeking Department of Health and Human Services (HHS) funding for
this study, a certification letter must be submitted to the Office for Human Research
Protections (OHRP). The research cannot be initiated until OHRP issues approval. The Office
of Research Compliance (ORC) will prepare and submit the certification report to OHRP.
Contact the Director for the Office of Research Compliance at 205-348-8461 8641 for more
information.
---------------------------------------------------------------------------------------------
* * * Risks * * *
8.
Risks
There is no research that can be considered totally risk free (e.g., a potential risk of breach of
confidentiality). Therefore, when describing the risk, the lowest level of risk is "no more than
minimal risk".
a)
For the following categories include a scientific estimate of the frequency, severity, and reversibility of
potential risks. Wherever possible, include statistical incidence of complications and the mortality rate of
proposed procedures. Where there has been insufficient time to accumulate significant data on risk,a
statement to this effect should be included. (In describing these risks in the consent form to the participant,
it is helpful to use comparisons which are meaningful to persons unfamiliar with medical terminology).
Address any risks related to (input N/A if not applicable):
1.
Use of investigational drugs. Please include the clinical adverse events (AEs) associated
with each of the drugs with an indication of frequency, severity and reversibility. This
information can often be found in the Investigator(s) brochure. NOTE: Include any likely
adverse effects associated with placebos or washout periods that participants may
experience while in the study.
N/A
2.
Use of investigational devices. Please include the clinical adverse events (AEs)
associated with each of the devices with an indication of frequency, severity and
reversibility. This information can often be found in the Investigator(s) brochure. NOTE:
Include any likely adverse effects associated with procedures that participants may
experience while in the study.
No investigational devices will be used.
3.
Use of FDA approved drugs, reagents, chemicals, or biologic products. Please include
the clinical adverse events (AEs) associated with each of the drugs with an indication of
frequency, severity and reversibility. This information can often be found in the package
insert provided by the manufacturer. NOTE: Include any likely adverse effects associated
with placebos or washout periods that participants may experience while in the study.
N/A
4.
Use of FDA approved devices. Please include the clinical adverse events (AEs)
associated with each of the devices with an indication of frequency, severity and
reversibility. This information can often be found in the Investigator(s) brochure. NOTE:
Include any likely adverse effects associated with procedures that participants may

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experience while in the study.
N/A
5.
Describe any risks related to performing study procedures. Please include all
investigational, non-investigational, and non-invasive procedures (e.g., surgery, blood
draws, treadmill tests).
No more than minimal risk.
Regarding psychological risks to NH residents, the LOCK sleep program including
frontline huddling provides a sequence of steps for the process of assessing and
responding to sleep problems. During the intervention period NH residents enrolled in the
LOCK sleep program will receive actigraph and Fitbit assessment, and although our
teams’ experience with use of these devices in hundreds of people with dementia
indicates that they are widely tolerated as comfortable, there is a small risk a resident
may find the devices to be uncomfortable or otherwise distressing. As part of their
intervention training, staff will be instructed on behavioral signs of distress. If a participant
exhibits significant behavioral distress due to assessment, staff will be instructed on
modifications and alternatives. If the distress does not subside, staff will be instructed to
discontinue the assessment.
6.
Describe any risks related to the use of radioisotopes/radiation-producing machines (e.g.,
X-rays, CT scans, fluoroscopy).
N/A
7.
For clinical studies (of a drug, vaccine, device or treatment), describe any alternative
procedure(s) or course(s) of treatment. List important risks and benefits of these
alternatives in order to compare to study procedure(s) or course(s) of treatment. This
information MUST be included here. Any standard treatment that is being withheld must
be disclosed and the information must be included in the consent form.
The intervention described will be implemented NH-wide. The study is a pilot (R61) for
the methods for a subsequent randomized controlled trial (R33 -- an incomplete stepped-
wedge cluster randomized controlled trial design in which each NH serves as its own
control). There will therefore be no alternative treatments. NH residents and their legally
authorized representatives will have the right to refuse participation in any portion of their
care just as they would with usual NH care, including use of actigraphs and Fitbits. NH
staff will have the right to refuse any interviews.
8a. Describe any other physical, psychological, social or legal risks the participant may
experience.
No more than minimal risk.
The risks for participants in this trial are minimal. There are no anticipated physical or
economic risks associated with this study. There are no psychological risks beyond what
was described in Risks sub-item #5 above.
For both NH residents and staff, an unlikely legal or social risk associated with
participating in this study would be invasion of privacy in the remote chance that there is
a loss or lack of protection of data containing personally identifiable information. These
are research risks, not therapeutic risks. The study team will use careful procedures to
guard the security and confidentiality of all data.
For both NH residents and staff, a potential risk is that a person may not want to
participate in the study and may feel coerced to do so. Therefore, to minimize this type of
risk, all informed consent contact with potential participants will come through the study
staff only, and all NH staff participation discussions and decisions will be kept
confidential.

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8b. Data Safety Monitoring
Is there a Data Monitoring Committee (DMC) or Board (DSMB)?
Y
If yes, describe its role, if it is independent of the sponsor or research team, the make-up
of the Board and their qualifications, and how often the Board will meet.
1 Frequency of Data and Safety Monitoring
The Principal Investigator (PI) will be responsible for ensuring participants’ safety on a
daily basis. The Data and Safety Monitoring Board will meet at least once a year by
teleconference (and more often as needed). The DSMB will act in an advisory capacity
to the NIA Director by monitoring participant safety; evaluating the progress of the
study; and reviewing procedures for maintaining the confidentiality of data and the
quality of data collection, management, and analyses.
2 Content of Data and Safety Monitoring Report
The content of the data and safety monitoring report will include: protocol synopsis,
study status, summary of past DSMB meetings, recruitment and participant status, data
quality status, and safety information. Blinded reports will be produced for open
sessions and unblinded reports for closed sessions. The DSMB will be guided by the
NIA DSMB Report Template.
3 DSMB Membership and Affiliation
All members of the DSMB will have extensive experience in the conduct and analysis of
clinical trials and/or clinical expertise in the study population. The committee will be
named in conjunction with the NIA Program Officer. The board will comprise a physician
with geriatrics or nursing home (NH) expertise, a nurse scientist with expertise in
geriatrics or NHs, a behavioral clinician with expertise in geriatrics or NHs, a
biostatistician, and an additional clinician scientist with sleep expertise. They will be
completely independent of the study investigators and staff and have no scientific,
financial, or other conflict of interest with the study.
DSMB membership will be reviewed and approved by the NIA. Should there be any
questions regarding the independence of the DSMB, it will be addressed and corrected
if necessary at that time.
4 Conflict of Interest for DSMB
Each DSMB member will sign a Conflict of Interest Statement which includes current
affiliations, if any, with pharmaceutical and biotechnology companies (e.g., stockholder,
consultant), and any other relationship that could be perceived as a conflict of interest
related to the study and / or associated with commercial interests pertinent to study
objectives.
5 Protection of Confidentiality
Data will be presented in a blinded manner during the open sessions of the DSMB. At
DSMB meetings, data and discussion are confidential. Participant identities will not be
known to the DSMB members.
6 DSMB Responsibilities and Procedures
The DSMB will be responsible for reviewing the research protocol and informed consent
documents, and developing plans for data safety and monitoring. They will evaluate the
progress of the trial, including periodic assessments of data quality and timeliness,
recruitment, accrual and retention, participant risk versus benefit, performance of the
trial sites, and other factors that can affect study outcome; consider factors external to
the study when relevant information becomes available, such as scientific or therapeutic
developments that may have an impact on the safety of the participants or the ethics of
the trial; review study performance and make recommendations; and assist in the
resolution of problems reported by the Principal Investigator (PI). The DSMB will report
on the safety and progress of the trial to the NIA Program Officer and make

Page 47 of 73
 
recommendations to the Program Officer and the PI concerning continuation,
termination, or other modifications of the trial based on the observed beneficial or
adverse effects. They will ensure the confidentiality of the results by monitoring all study
data and analysis.
The DSMB will meet at least once a year, or more frequently as determined by the
board at the first meeting. Emergency meetings also may be called at any time by the
DSMB Chairperson or by NIA. A majority of members must be present for called
meetings in order to constitute a quorum. The NIA Program Officer or designee will be
invited to attend all meetings.
DSMB meetings will consist of open and closed sessions. Open session discussion will
focus on the conduct and progress of the study, including participant accrual, protocol
compliance, and problems encountered. The closed sessions will be attended by the
DSMB members and the study statistician. Meetings shall be closed to the public
because discussions may address confidential participant data. During the closed
sessions, data will be presented and discussed. An executive, open session may follow
a closed session at request of PI or DSMB; at that time, the Board will inform the NIA
Program Officer and PI of their recommendation to continue or to terminate the study as
was decided by the formal DSMB vote in closed session. The PI and key members of
the study team will generally attend the open and executive sessions of the meetings.
At their first meeting, the DSMB will discuss the protocol and establish guidelines for
study monitoring. The DSMB Chairperson, in consultation with the PI and the NIA
Program Officer as needed, will prepare the agenda. Unless otherwise designated by
the DSMB, the DSMB Chair will serve as the contact person for unanticipated problem
and serious adverse event reporting. Procedures for notifying the Chair of the DSMB
and the NIA Program Official of any such events will also be discussed. The format and
content of the reports for both the open and closed sessions will be finalized and
approved, although additional changes and requests can be addressed throughout the
study. At the first meeting, the Board will decide if an interim analysis will take place
(e.g. after n participants have been accrued or completed the trial). Interim analyses of
efficacy data will only be performed if planned and approved in advance, and when
criteria for possible stopping are clearly defined. Well-defined stopping rules will be
established during the first DSMB meeting to guide expected causes of termination.
The PI and Dr. Morgan (study statistician) will be responsible for coordinating activities
of the DSMB including the following: 1) Arranging DSMB meetings and
communications. 2) Identifying and reviewing open session materials to be presented to
the DSMB. DSMB meeting materials to be reviewed by the DSMB members will be
prepared by Dr. Morgan and sent to members at least 7 days before the meeting.
Interim data reports will consist of two parts: Part 1 –Open Session Reports (for
example, accrual, participant baseline characteristics, adverse events, serious adverse
events); and Part 2 - Closed Session Reports.
The Chair of the DSMB will be responsible for the following: 1) developing the meeting
agenda; 2) requesting information for the meetings from the PI and the study
statistician; 3) overseeing the meetings; 4) verifying that the reports and
recommendations prepared are an accurate and complete record of the DSMB’s
deliberations; 5) serving as contact person for unanticipated problem and serious
adverse event reporting.
The DSMB members will 1) familiarize themselves with the research protocol and
consent forms, 2) review interim reports of adverse events, 3) review interim analyses of
outcome data as it relates to safety, 4) review interim reports of trial participant accrual,
and 5) make recommendations to the investigators concerning continuation,

Page 48 of 73
 
termination, or modification of the trial.
Between meetings of the DSMB and throughout the course of the trial, information
regarding issues deemed critical to the trial or to the safety of research participants will
be provided to the Chair of the DSMB and the Program Officer by the PI.
A formal report containing the recommendations for continuation or modifications of the
study will be prepared by the DSMB Chairperson. This draft report will be sent to the
DSMB members within 7 days after the meeting. Once approved by the DSMB
members, and no later than 2 weeks after the DSMB meeting, the DSMB Chair will
forward the formal DSMB recommendation to the NIA Program Officer and PI. It is the
responsibility of the PI to distribute the DSMB recommendation to all co-investigators
and to ensure that copies are submitted to all the IRBs associated with the study when
necessary.
If study termination is ever considered by the DSMB, the full vote of the DSMB will be
required. A recommendation to terminate the study will be made by a majority vote. The
DSMB Chair will provide the tiebreaking vote in the event of a 50-50 split vote. In the
event of a majority vote for continuation with at least one vote for study termination, a
written statement with accompanying reasons for the vote(s) to terminate should be
contained within the report issued by the DSMB. In the event of a recommendation to
modify the protocol or to terminate the study, the PI may disagree with the
recommendation of the DSMB. If the PI does not concur with the recommendation of
the DSMB, then the IRB, the institution official, and the funding agency must be notified
in writing of this disagreement and the reason for it. The PI may appeal the decision and
offer an alternative to termination or study modification for consideration by the DSMB.
If an impasse is reached, the appeal will be forwarded to the Chair of the Institutional
IRB who will review the case under advisement from the PI and the Chair of the DSMB
and will recommend a course of action. This course of action will be recorded by the
DSMB and the NIA Program Officer.
If no, please justify why not.
Is there a Data Safety Monitoring Plan (DSMP)?
Y
If yes, describe the data and safety monitoring plan developed to ensure the safety of
participants and the validity and integrity of research data. Monitoring should be
commensurate with risks and with the size and complexity of the trials. As such, state
that SAEs will be reviewed by a qualified MD in real time and indicate how often
aggregate data will be reviewed for safety trends.
Data and Safety Monitoring Plan
1.0 Participant Safety
1.1 Potential Risks and Benefits for Participants
Potential Risks
The risks for participants in this trial are minimal. There are no anticipated physical or
economic risks associated with this study. Regarding psychological risks to NH
residents, the LOCK sleep program including frontline huddling provides a sequence of
steps for the process of assessing and responding to sleep problems. During the
intervention period NH residents enrolled in the LOCK sleep program will receive
actigraph and Fitbit assessment, and although our team's experience with use of these
devices in hundreds of people with dementia indicates that they are widely tolerated as
comfortable, there is a small risk a resident may find the devices to be uncomfortable or
otherwise distressing. As part of their intervention training, staff will be instructed on

Page 49 of 73
 
behavioral signs of distress. If a participant exhibits significant behavioral distress due to
assessment, staff will be instructed on modifications and alternatives. If the distress
does not subside, staff will be instructed to discontinue the assessment (staff training
also discussed in 1.3.b. Protection Against Risks).
For both NH residents and staff, an unlikely legal or social risk associated with
participating in this study would be invasion of privacy in the remote chance that there is
a loss or lack of protection of data containing personally identifiable information. These
are research risks, not therapeutic risks. The study team will use careful procedures to
guard the security and confidentiality of all data (see 1.3.b. Protection Against Risks).
For both NH residents and staff, a potential risk is that a person may not want to
participate in the study and may feel coerced to do so. Therefore, to minimize this type
of risk, all informed consent contact with potential participants will come through the
study staff only, and all NH staff participation discussions and decisions will be kept
confidential (see 1.3.b. Protection Against Risks).
Potential Benefits
The intervention may benefit NH residents by leading to better and earlier detection and
treatment of sleep problems and from increased attention to their conditions. The
intervention may benefit NH staff by improving communication and teamwork, thereby
improving the work experience.
1.2 Adverse Event/Serious Adverse Event/Unanticipated Problem Collection and
Reporting
Definitions
We will follow OHRP and UA IRB guidance and policies regarding definitions, collection,
and reporting of Adverse Events (AEs), Serious Adverse Events (SAEs), and
Unanticipated Problems (UPs). We expect that there will potentially be four categories
of events/problems as follows: 1) Anticipated AEs unrelated to the intervention, 2)
Anticipated AEs related to the intervention, 3) Unanticipated AEs and unanticipated
problems unrelated to the intervention, and 4) Unanticipated AEs and unanticipated
problems related to the intervention.
Reporting
As per National Institute on Aging (NIA) policy, all deaths will be reported within 24
hours of the study staff’s knowledge of death to the NIA Program Officer and the DSMB
Chair. Unanticipated SAEs related to the intervention will be reported within 48 hours of
the study staff’s knowledge of death to the NIA Program Officer and the DSMB Chair. A
summary of all other SAEs will be reported quarterly to the NIA Program Officer and the
DSMB Chair.
Study staff will continue to follow up with the participant and their treating clinical team
until any clinical events have resolved. If there is a SAE that is thought by a treating
clinician, co-investigator nurse scientist Dr. Richards, study consultant geriatrician Dr.
Fry, or Dr. Snow to be possibly or probably related to the intervention, the PI will
immediately notify the DSMB and NIA Program Officer. The PI or designee will also
immediately communicate with the NH leadership team and corporate coach at the NH
for immediate investigation by the relevant treating team. Any insights about any
possible iatrogenic effects of any components of the intervention will be immediately
shared with all active NH intervention sites.
Grading Scale and Study Relatedness Criteria
Anticipated AEs unrelated to the intervention:  NH residents enrolled in the trial will have
dementia and likely will have other pre-existing significant health issues that require NH

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placement. It is anticipated that some participants will experience health events (new
conditions or worsening of previous conditions), hospitalization, or death during the trial
that will be due to the dementia and/or other pre-existing significant health issues and
unrelated to the intervention. As per NIA policy, all deaths will be reported to the NIA
and IRB within 24 hours, regardless of relation to intervention.
Anticipated AEs related to the intervention:  Intervention-related AEs for NH residents
might include: a) actigraph/fitbit-related skin reactions such as redness, itching, or other
skin conditions or discomfort; b) distress or discomfort associated with actigraph/fitbit-
related wear or NH staff attention; c) distress or discomfort associated with other LOCK
sleep intervention NH staff attention or requests. Intervention-related AEs for NH staff
might include:  distress related to interview questions. Such events may be reportable
depending upon the seriousness of the event and increase of risk to participant. The
NH’s treating clinical team’s opinion of the seriousness of the event will be solicited and
the PI, co-investigator nurse scientist Dr. Richards and study co-investigator geriatrician
Dr. Fry will be consulted to determine seriousness and reportability of the event.
Unanticipated AEs and unanticipated problems related to the intervention: As with
intervention-related AEs, unanticipated AEs and unanticipated problems will be
evaluated for seriousness with input from the NH’s treating clinical team (if applicable),
the PI and clinical study team members Drs. Richards and Fry (if applicable) or data-
related study team members including data coordinating center leader and study
statistician Dr. Morgan (if applicable).
1.3 Protection Against Study Risks
a. Informed Consent and Assent
Study staff will obtain all necessary IRB authorizations for protocols and materials
described below. All consents will be conducted by an IRB-approved study staff
member who has been trained by Dr. Snow. The study staff member will be responsible
for explaining the study, answering questions, and obtaining informed consent.
NH Resident Consent – Step 1. Legally Authorized Representative Consent
NH leadership team or their designees will identify all NH residents with an ADRD
diagnosis and mail to their legally authorized representatives (LARs) an IRB-approved
study introduction letter (including option to opt out within one month if they do not wish
to be contacted by study staff). Opt-out procedures have been demonstrated to yield
higher response rates and lower rates of non-response bias compared to opt-in
procedures, and to be acceptable to participants, with no difference in rates of reported
distress or complaints compared to opt-in procedures.105-108 In our past federally
funded research involving people with dementia, opt-out consent has been approved by
multiple IRBs and worked well. Contact information of those LARs not opting out will be
shared with University of Alabama (UA) study staff. We will request of the IRB a waiver
of consent and HIPAA authorization for screening purposes regarding the sharing of
these contact information.
Study staff will mail an IRB-approved study information packet via a tracked, express
mailing service to all LARs who do not opt out. These materials will include a cover
letter, an IRB-approved informed consent form (ICF), and an express mail return
envelope so the LAR can send the signed ICF to the UA study office. LARs will be
encouraged to contact study staff via phone or email for an appointment to discuss the
study and go through the consent form together before signing the ICFs. Study staff will
contact the LARs via phone and/or email within one week of sending the packet and will
re-contact the LAR up to 6 times within the next month as needed to establish contact (if
contact has not been established within one month, and NH staff are not able to
determine that the LAR’s contact information has changed, then the lack of contact will

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be considered a soft refusal and no other contact will be attempted).
During a phone appointment, study staff will review all important elements of the ICF
with the LAR, including the following: description of the study, information on how to
contact the investigators and the NH administrator and director of nursing, a statement
that there is no prejudice for refusal to participate, a statement that the subject may
withdraw from the study at any time without prejudice, and statement regarding risk and
benefit of participation. The LAR will be encouraged to ask questions. The LAR will be
encouraged to call the PI if they have any remaining questions before signing the
consent form.
NH Resident Consent – Step 2. Screening for Capacity for NH Resident Consent/NH
Resident Assent
Some NH residents with mild ADRD may have the capacity to provide their own
consent. FOR RESIDENTS WITH LIKELY MILD ADRD AND AN LAR WHO CAN BE
CONTACTED, a CONSERVATIVE two-step process will be used to address the ethical
balance of the beneficence of assuring that residents who do not have the capacity to
consent are protected by LAR oversight with the promotion of autonomy for residents
who do have capacity to consent. Once LAR consent is received for a resident, the NH
leadership team will be asked to identify that resident’s most recent MDS Brief Interview
for Mental Status (BIMS) [reference #120] , a cognitive screening measure with good
reliability and validity. For residents with BIMS scores in the mild range (above 10), the
NH leadership team will be asked to arrange and support a telephone appointment
between that resident and a study staff person (if the resident turns out to not have the
cognitive ability to participate in the following telephone-based procedure, then they
would also not have the cognitive capacity to provide informed consent, which requires
higher level cognitive abilities).
In the telephone appointment, the study staff member will provide information about the
study and will screen for capacity to consent by assessing the following. Does the
resident respond appropriately to a social greeting? Is the resident oriented to place?
Does the resident understand who the study team member is after the team member
explains their identity? During the course of this introductory conversation, was the
resident able to respond fluently and socially appropriately? If so, the team member will
go through the consent form with them. Residents will then be asked a series of
questions to assure their understanding. These questions are as follows:
Describe in your own words what this study is about?
Describe what I am asking you to do to participate in this study?
Are you required to do this interview with me?
What will happen if you don’t talk to me?
What happens if you decide you don’t want to participate once we get started?
What will I do with the information you give me?
The NH leadership team member will support this telephone conversation by assuring
that the resident has a quiet environment to have the telephone conversation and that
the resident has in front of them a printed large-font version of the ICF with the
signature area flagged. If the resident is able to respond appropriately to all the capacity
screening questions, and they do wish to participate, then the resident will be instructed
to sign the ICF. The study staff person will contact the NH leadership team member and
ask them to make a copy of the ICF for the resident to keep, place a copy in the medical
chart, and express mail the original to the UA study office using a provided pre-paid
envelope. If the resident is able to respond appropriately to all the capacity screening
questions and does not wish to participate then they will not be enrolled in the study,
regardless of the LAR’s consent. In this case, the study team member will let the NH
leadership team and the LAR know that the resident has declined participation.

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Under all circumstances, the NH resident’s autonomy will be respected. For NH
residents without capacity to consent, their assent to participate will be obtained
whenever possible, and their decision to withdraw at any time (whether expressed
verbally or by resistance to participation) will be honored (see also staff training in 1.3.b.
Protection Against Risks).
FOR RESIDENTS WITH LIKELY MILD ADRD (BIMS SCORE ABOVE 10) BUT NO
LAR, THE NURSING HOME LEADERSHIP TEAM AND STUDY STAFF WILL GO
DIRECTLY TO THE RESIDENT TO INVITE THEIR PARTICIPATION AND SCREEN
THEIR CAPACITY TO CONSENT USING THE SAME PROCESS DESCRIBED
ABOVE.
All above procedures apply to securing consent for the study team to have access to
NH resident personally identifiable data. We note that because the LOCK sleep
program does not include any activities that are outside of standard NH practice, NH
staff will be free to enroll any NH residents that they believe will benefit into the LOCK
sleep program regardless of resident consent status; but the NH leadership team will
only share with researchers data from residents who are consented for the study.
NH Staff Consent
The NH leadership team or their designees will provide to all NH staff an IRB-approved
study introduction letter (including option to opt out within two weeks if they do not wish
to be contacted by study staff). Contact information of those NH staff not opting out will
be shared with UA study staff. We will request of the IRB a waiver of consent for
screening purposes regarding the sharing of these contact information.
UA Study staff will contact NH staff (via email and/or phone, see next paragraph) to
invite them to participate in mid-implementation phone interviews. Study staff will also
contact NH staff to invite them to participate in post-implementation interviews (phone).
The list of NH staff who agree and decline interview participation will remain confidential
to protect NH staff from any possible coercion to participate (see 1.3.b. Protection
Against Risks).
For mid-implementation interviews, study team members will, on the PI’s behalf, send
out e-mails to all NH staff who do not opt out. The first e-mail will contain text from Dr.
Snow soliciting voluntary participation in the telephone interviews. E-mail reminders will
be sent, one in each of the four weeks after the initial e-mail, with follow up phone calls
to the participant’s work phone to remind them about the email. All emails will include
information on how to opt out of the study. We will continue recruitment until we have
recruited the desired sample size or until one month has passed. To facilitate staff
involvement, we will secure permission from the director of each NH that staff may take
part in the study during their normal hours of work. For post-implementation interviews,
study team members will follow these same procedures. In addition, a study team
member will virtually visit each NH in person at the end of the intervention period to
work with NH staff to collect information from the enrolled NH residents’ medical record
and also to recruit for and conduct any needed remaining post-implementation phone
interviews. The study staff person will virtually attend change of shift meetings, huddles,
and other staff meetings to invite interview participation and will also invite staff to
contact research staff for virtual one-on-one discussions if staff member has questions
about volunteering to participate. We have successfully used similar procedures in our
previous federally funded studies involving NH staff.
In all recruitment activities, it will be made clear that participation is strictly voluntary and
no adverse consequences to the person’s job status or any other adverse
consequences will occur if the person declines to participate in these activities and that
their final decision to participate or not will be kept confidential from all NH and

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corporate staff.
Mid-implementation interviews will take place via telephone or teleconference platform.
Post-implementation interviews will take place via telephone or teleconference platform.
We will apply for a waiver of documentation of informed consent for the 1-hour, audio-
recorded mid-implementation and post-implementation interviews, allowing us to obtain
verbal consent. We will provide a consent information sheet to potential participants in
the stead of an informed consent document that requires signature. We will record each
subject giving permission to be recorded on the audio recording.
The study staff member will review with the NH staff member all relevant elements of
consent on the consent information sheet, including the following: description of the
study activities, time requirement, information on how to contact the investigators, a
statement that there is no prejudice for refusal to participate, a statement that the
subject may withdraw from the study at any time without prejudice, a statement
encouraging the reader to ask questions, and a statement regarding risk and benefit of
participation. All informed consent guidelines of the IRB will be followed. If at any time
during the interview the staff member indicates a desire to stop participating, the
participant will be withdrawn from the interview portion of the study. Confidentiality of all
interview data will be protected by using participant code numbers on the data collection
forms.
b. Protection Against Risks
Study staff training
To protect all vulnerable subjects, in addition to the NIH-required computer-based
trainings (on the protection of human research participants, HIPAA, and Good Clinical
Practice), the UA study staff will attend a 2-day training session specific to the proposed
project led by Dr. Snow. The PI will review the overall goals of the study, study policies
and procedures, data collection manuals, adverse event identification and reporting,
subject confidentiality, communication techniques and principles for working with
persons with dementia, and appropriate procedures for working by telephone with LARs
for consent, for working by telephone with people with dementia for consent and for
determining capacity to consent. Procedures will be reviewed for protecting employees
from possible coercion for participation from supervisors including maintaining
confidentiality of those employees who do and do not consent to research interviews.
During these training sessions, professionally produced videotapes of staff interactions
with persons with dementia will be shown and the PI and study staff will role play all
informed consent, capacity assessment, and data collection processes. Dr. Richards
will provide training on appropriate assessment equipment maintenance and data
downloading. Drs. McCullough and Hartmann will provide training on appropriate
procedures for NH staff interviews.
NH leadership team training: The NH leadership team will complete NIH-required
computer-based trainings (on the protection of human research participants, HIPAA,
and Good Clinical Principles). Study staff will also provide a 2-hour training on
procedures to protect vulnerable subjects, as follows: proper procedure for, and
importance of only using IRB-approved procedures and letters when sending study opt-
out letters to LARs; proper procedures for maintaining security and privacy of data
packages mailed to the University of Alabama project office; proper procedures for
avoiding coercion or appearance of coercion of research participation when working
with NH staff (e.g., not asking staff about research interview participation); proper
procedures for assisting in telephone appointment arrangements and providing logistical
support when study team members conduct telephone-based NH resident consenting
and capacity to consent assessment; importance of only study team members
conducting actual consent procedures of anyone (LARs, NH residents, NH staff);

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importance of only properly trained NH leadership team members participating in study
procedures. Dr. Richards (via zoom teleconference) will work together to provide
training on the appropriate application of actigraphs and Fitbits to promote comfort and
prevent adverse experiences, as well as appropriate assessment equipment
maintenance and data mailing.
NH staff training: As part of the intervention training, NH staff will be trained by their NH
leadership teams or their trained designees on proper use and placement of actigraphs
and Fitbits, verbal and behavioral signs of distress that might indicate actigraph/Fitbit-
related discomfort/distress, and appropriate modification techniques to try to relieve
such distress. NH staff will be informed that the devices should be removed in the
unlikely event that distress behaviors are not relieved by modification techniques. NH
staff will be trained on importance of NH resident autonomy, and will be engaged in a
discussion of how to assess for and honor NH resident assent or lack thereof with
regard to the devices.
Personally Identifiable Information: Access, Management, and Protection
The study staff will have access to individually identifiable data about participants. The
NH leadership team will have access to individually identifiable data about participants
(see also Protection of Human Subjects, section 1.a, sub-sections Subject Populations
and Collaborating Sites and Roles). To protect against the risk of accidental access to
or inappropriate divulging of identifiable data, the flow of individually identifiable data
and steps to assure its appropriate access, management, and protection, are outlined
below.
1. NH Residents
a. Study staff will successfully obtain all necessary IRB authorizations for protocols and
materials described below
b. NH leadership team or their designees will identify all NH residents with an ADRD
diagnosis and the NH leadership team will mail to those residents’ legally authorized
representatives (LARs) an IRB-approved study introduction letter (including option to
opt out within one month if they do not wish to be contacted by study staff). Contact
information of those LARs not opting out will be shared with University of Alabama (UA)
study staff.
c. UA study staff will contact LARs and attempt to gain informed consent for NH resident
participation. Study staff will weekly provide an updated list of consented residents with
study identification numbers to the NH leadership team along with copies of all
completed informed consent forms so that a copy can be filed in the resident’s medical
records and a copy can be stored along with the complete list and other IRB approvals
and relevant study information in an essential documents binder (electronic or physical)
at the NH. These processes will assure that NH staff will be able to easily verify that
study staff only have access to personally identifiable data of residents are involved in
the study.
d. NH staff will work together in frontline huddles to complete screening of all eligible
residents, identify residents with sleep problems to enroll in the LOCK sleep program,
and collect assessment data for enrolled residents.
e. Every week, the NH leadership team will use researcher-provided tracked express
mail service envelopes to send the UA study staff the following: 1) all completed staff
rating forms, identified by NH resident subject number; and 2) any actigraphs and Fitbits
for which the assessment periods are complete, identified by subject number. Research
staff will mail back actigraphs and Fitbits after data download, deletion of data from the
devices, and maintenance.

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f. UA study staff will conduct a virtual visit to each NH during the post-intervention
period to work with NH staff to extract information from the medical records of
consented NH residents.
g. UA study staff will upload all data at UA and then transfer to the University of Texas
School of Public Health (UTHealth SPH) Data Center via secure file transfer procedures
as established by Dr. Morgan and the Data Center.
h. MDS data will be obtained by Dr. Morgan and the UTHealth SPH Data Center
through data use agreement for use of personally identifiable information from CMS.
MDS data for consented NH residents will be linked and merged with the other data
described above.
i. When data are reported in publication and presentation they will only be reported in
aggregate form, and neither NH nor participant will be identifiable.
2. NH Staff for interviews
a. Study staff will successfully obtain all necessary IRB authorizations for protocols and
materials described below.
b. NH leadership team will provide to all NH staff an IRB-approved study introduction
letter (including option to opt out within one month if they do not wish to be contacted by
study staff). Contact information of those NH staff not opting out will be shared with UA
study staff.
c. UA Study staff will contact NH staff to invite them to participate in mid-implementation
virtual interviews. Study staff will also contact NH staff to invite them to participate in
post-implementation interviews. The list of NH staff who agree and decline interview
participation will remain confidential to protect NH staff from any possible coercion to
participate (see 1.3.b. Protection Against Risks).
d. UA study staff will conduct virtual interviews with consented NH staff. Interviews will
be audio recorded. Recordings will be uploaded at UA, identified only by subject
number, and shared with a university-approved transcription service via secure file
transfer procedures as established by Dr. Morgan and the UTHealth SPH Data Center.
Transcribed files, identified only by subject number, will be returned via the same
secure file transfer procedures to UA for tracked storage and analysis and to Drs.
McCullough and Hartmann at Boston University for analysis.
e. When data are reported in publication and presentation they will only be reported in
aggregate form, and neither NH nor participant will be identifiable.
3. Data Management and Protection. Dr. Morgan and the UTHealth SPH Data Center
will create protocols for overseeing the security and protection of all data collected for
this study.  Personally identifiable information will be only be stored in the secure and
securely backed up UA data server and UTHealth SPH Data Center in password
protected files. Other collaborating sites (Boston University, Brown University, and
University of Texas at Austin) will only work with data identified by subject number.
2.0 Interim Analysis
At the first meeting, the Data Safety and Monitoring Board (DSMB) will decide if an
interim analysis will take place (e.g. after n participants have been accrued or
completed the trial). Interim analyses of efficacy data will only be performed if planned
and approved in advance, and when criteria for possible stopping are clearly defined.

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It is not anticipated that interim analyses will be undertaken given the minimal potential
risks to participants in this trial.
3.0 Data and Safety Monitoring
The DSMB procedures are described above in the Risks Sub-section #8b.
If no, please justify why not.
---------------------------------------------------------------------------------------------
* * * Benefits/Alternatives, Procedures to Maintain Confidentiality * * *
9.
Benefits/Alternatives
a)
Benefits. Describe the potential benefit(s) to be gained by the participants and how the results of the study
may benefit future participants and/or society in general. Indicate if there is no direct benefit to the
participants.
The intervention may benefit NH residents by leading to better and earlier detection and
treatment of sleep problems and from increased attention to their conditions. The
intervention may benefit NH staff by improving communication and teamwork, thereby
improving the work experience.
Sleep problems and related issues in NH residents with dementia is a well-documented
problem. This study implements an intervention to improve the sleep experience for
these residents and increase access to meaningful activities. If the LOCK sleep program
is found to be effective in enhancing clinical care and outcomes, the approach can be
shared with other NHs and incorporated into general NH practice. The risks in this study
for NH residents are minimal, and the knowledge gained may result in improved quality
of sleep, and ultimately improved quality of life for NH residents with dementia. Similarly
the risks for NH staff are minimal, and the knowledge to be gained may result in a more
effective and enjoyable workplace experience. Thus, the potential benefits exceed risks.
b)
Alternatives. Describe any alternative treatments and procedures available to the participants should they
choose not to participate in the study. If no such alternatives exist, please state that the alternative is
nonparticipation. For some studies, such as record reviews, a description of alternatives would not be
applicable.
The intervention described will be implemented NH-wide. The study uses an incomplete
stepped-wedge cluster randomized controlled trial design in which each NH serves as its
own control. There will therefore be no alternative treatments. NH residents and their
legally authorized representatives will have the right to refuse participation in any portion
of their care just as they would with usual NH care, including use of actigraphs and
Fitbits. NH staff will have the right to refuse any interviews.
10.
Procedures to Maintain Confidentiality
Federal regulations require that study data and consent documents be kept for a minimum of
three (3) years, and HIPAA documents be kept for a minimum of six (6) years after the
completion of the study by the PI. For longitudinal or sponsored projects, the PI may be
required to keep the data and documents for a longer time period.
Data Security
Please indicate how information will be secured. All information must be stored using at least
two of the following safeguards and must be kept in accordance with the University of
Alabama Information Security Policies. (If you are using both electronic data and hard copy
data, you will need two safeguards for each type).
a)
Electronic Data: (mark all that apply - at least 2 - or indicate not applicable)
Not applicable
X Password access

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X Coded, with a master list kept as a hardcopy or on a secure network (confidential)
Data collected anonymously
Secure network (e.g., firewall)
Data are de-identified by PI or research team
Other
Please specify:
b)
Hardcopy Data: (mark all that apply - at least 2 - or indicate not applicable))
Not applicable
Locked suite
X Locked office
X Locked file cabinet
X Coded, with a master list secured and kept separately (confidential)
Data collected anonymously
24 hour personnel supervision
Data are de-identified by PI or research team
Other
Please specify:
c)
Describe measures employed to protect the identity of the participants, their responses,
and any data that you obtain from private records (e.g., identifiers will be stripped so data
cannot be linked to participants, or code numbers will be used, etc.). If data will be coded,
specify the procedures for coding the data so that confidentiality of individual participants
is protected. If you will keep a master list linking study codes to participant identifiers,
explain why this is necessary, how and where you will secure the master list, and how
long it will be kept.
Sources of Materials
NH resident data will be collected for consented NH residents from NH staff ratings
(global assessments of change in overall sleep quality and sleep-related conditions;
Sleep reports from NH staff), NH staff sleep interview of resident, family/friend sleep
interview about resident, and actigraph/Fitbit measurements (wristwatch-sized devices
worn on the wrist); medical records (age, diagnoses, medical history, and medications);
and MDS assessments (Brief Interview for Mental Status score, psychotropic medication
use, pain and analgesic medication use, activities of daily living decline, sleep-related
items). NH staff interview data will be collected via audiorecorded qualitative interview.
See Table 1 in Attachments for a listing of all study outcomes and data sources.
Personally Identifiable Information: Access, Management, and Protection
The study staff will have access to individually identifiable data about participants. The
NH leadership team will have access to individually identifiable data about participants.
The flow of individually identifiable data and steps to assure its appropriate access,
management, and protection, are outlined below.
1. NH Residents
a. Study staff will successfully obtain all necessary IRB authorizations for protocols and
materials described below
b. NH leadership team or their designees will identify all NH residents with an ADRD
diagnosis and the NH leadership team will mail to those residents’ legally authorized
representatives (LARs) an IRB-approved study introduction letter (including option to opt

Page 58 of 73
 
representatives (LARs) an IRB-approved study introduction letter (including option to opt
out within one month if they do not wish to be contacted by study staff). Contact
information of those LARs not opting out will be shared with University of Alabama (UA)
study staff.
c. UA study staff will contact LARs and attempt to gain informed consent for NH resident
participation (see 2.a. Informed Consent and Assent). Study staff will weekly provide an
updated list of consented residents with study identification numbers to the NH
leadership team along with copies of all completed informed consent forms so that a
copy can be filed in the resident’s medical records and a copy can be stored along with
the complete list and other IRB approvals and relevant study information in an essential
documents binder (electronic or physical) at the NH. These processes will assure that
NH staff will be able to easily verify that study staff only have access to personally
identifiable data of residents are involved in the study.
d. NH staff will work together in frontline huddles to complete screening of all eligible
residents, identify residents with sleep problems to enroll in the LOCK sleep program,
and collect assessment data for enrolled residents.
e. Every week, the NH leadership team will use researcher-provided tracked express
mail service envelopes to send the UA study staff the following: 1) all completed staff
rating forms, identified by NH resident subject number; and 2) any actigraphs and Fitbits
for which the assessment periods are complete, identified by subject number. Research
staff will mail back actigraphs and Fitbits after data download, deletion of data from the
devices, and maintenance.
f. UA study staff will conduct a virtual visit to each NH once during the post-intervention
period to work with NH staff to extract information from the medical records of consented
NH residents (this process and the information to be extracted will be clearly described in
IRB-approved protocols and consent forms).
g. UA study staff will upload all data at UA and then transfer to the University of Texas
School of Public Health (UTHealth SPH) Data Center via secure file transfer procedures
as established by Dr. Morgan and the Data Center.
h. MDS data will be obtained by Dr. Morgan and the UTHealth SPH Data Center through
data use agreement for use of personally identifiable information from CMS.  MDS data
for consented NH residents will be linked and merged with the other data described
above.
i. When data are reported in publication and presentation they will only be reported in
aggregate form, and neither NH nor participant will be identifiable.
2. NH Staff for interviews
a. Study staff will successfully obtain all necessary IRB authorizations for protocols and
materials described below.
b. NH leadership team will provide to all NH staff an IRB-approved study introduction
letter (including option to opt out within one month if they do not wish to be contacted by
study staff). Contact information of those NH staff not opting out will be shared with UA
study staff.
c. UA Study staff will contact NH staff to invite them to participate in mid-implementation
virtual interviews. Study staff will also contact NH staff to invite them to participate in
post-implementation virtual interviews. The list of NH staff who agree and decline
interview participation will remain confidential to protect NH staff from any possible

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coercion to participate.
d. UA study staff will conduct interviews with consented NH staff. Interviews will be audio
recorded. Recordings will be uploaded at UA, identified only by subject number, and
shared with a university-approved transcription service via secure file transfer
procedures as established by Dr. Morgan and the UTHealth SPH Data Center.
Transcribed files, identified only by subject number, will be returned via the same secure
file transfer procedures to UA for tracked storage and analysis and to Dr. Hartmann at
UMass Lowell for analysis.
e. When data are reported in publication and presentation they will only be reported in
aggregate form, and neither NH nor participant will be identifiable.
3. Data Management and Protection. Dr. Morgan and the UTHealth SPH Data Center will
create protocols for overseeing the security and protection of all data collected for this
study.  Personally identifiable information will be only be stored in the secure and
securely backed up UA data server and UTHealth SPH Data Center in password
protected files. Other collaborating sites (UMass Lowell, Brown University, and University
of Texas at Austin) will only work with data identified by subject number.
d)
If data or specimens are being shared outside of the research team, indicate who will
receive the material and specifically what they will receive (data or specimens).
N/A. Data will be shared across different sites that are all part of the research team -- this
is described above.
e)
If samples or data will be provided from an outside source, indicate whether you will have
access to identifiers, and, if so, how identifiable information is protected. Please provide a
letter from the appropriate persons indicating that data will be provided in a de-identified
manner.
Data will be collected from NH medical records and from NH Minimum Data Set (MDS)
records. We will have access to identifiers, and are submitting the appropriate HIPPAA
authorizations. We will protect data by separating identifiers from the data itself using
subject IDs and a master coding checklist kept locked in a separate location.
f)
If data will be collected via e-mail or the internet, how will anonymity or confidentiality be
protected? Describe how data will be protected during electronic transmission and how
data will be recorded (i.e., will internet protocol (IP) address and/or e-mail addresses be
removed from data?).
g)
If you will be audio/video recording or photographing participants, provide a rationale for
recording/photographing. Describe confidentiality procedures, including the final
disposition of the recordings/photos (destruction, archiving, etc.) and a reasonable
timeline by which this disposition will occur.
---------------------------------------------------------------------------------------------
* * *  Potential Conflict of Interest * * *
11)
Potential Conflict of Interest
Federal regulations and UA policy require all investigators to disclose their significant financial
interests to allow a review of potential conflicts of interest. If a potential conflict of interest is
identified, a formal plan must be developed and implemented to manage, reduce, or eliminate
the conflict.
Examples of significant financial interests include receipt of income, honoraria, and stock or
stock options from a public or private entity sponsoring the research. They may also include a
consulting arrangement or membership on an advisory board of the entity.  Significant

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consulting arrangement or membership on an advisory board of the entity.  Significant
financial interests are reported on the UA Statement of Financial Interest.
All members of the research team who are involved in the design, conduct, or reporting of
research (i.e., senior/key personnel) should have a current Statement of Financial Interest and
conflict of interest training on file prior to submitting the IRB protocol.  Please refer to the
Office for Research Compliance website for additional information regarding the financial
conflict of interest requirements, as well as links to the disclosure form and training at
(http://osp.ua.edu/site/RC_CoI.html).
The Statement of Financial Interest must be submitted annually and within 30 days of
discovering or acquiring a new or increased financial interest. Conflict of interest training must
be completed once every four years.
If such a relationship as described above exists between a member of the research team and
the sponsor of the research, the investigator is also required to disclose this relationship and
identify the entity involved on the informed consent form. For questions regarding Conflict of
Interest consult the   Conflict of Interest in Research Policy.
Check one of the following:
1)
X No Financial Interest or Financial interest less than or equal to $5K
2)
Financial Interest exceeding $5K but not exceeding $25K, and/or more than 5 percent
equity interest in aggregate
3)
Financial Interest exceeding $25K
Check all those that apply:
Consulting
Speaking Fees or Honoraria
Gifts
Patent
Copyright
Licensing agreement or royalty income
Equity interests, (including stock, stock options, warrants, partnership or equitable
ownership interests), or serving on a scientific advisory board or board of directors
Other fees/compensation
Describe financial interests(s) and indicate specific amounts for each subcategory
checked. Be sure to describe how these financial interests relate to the protocol being
submitted.
Note to Investigator(s) Reporting a Potential Conflict of Interest
Investigator(s) must have:
1)
Current, up-to-date Conflict of Interest Disclosure Form on file with the University of
Alabama Conflict of Interest Committee (COIC) that describes any financial relationship
indicated above.
.
This information must be disclosed on the University of Alabama confidential Conflict of
Interest Disclosure Form for review by the COIC before accruing research participants in
this study. If your current Disclosure Form does not contain this information, you are
required to submit an updated Disclosure Form to the COIC.
2)
Financial disclosure statement incorporated into the consent document. Please see
Model Consent for suggested language.
3)
You may not begin your study until your disclosure form has been reviewed and any
required management plan has been approved by the COIC.
Does any member of the study team, members' spouses, or members' dependent children have any
N

Page 61 of 73
 
significant financial interests related to the work to be conducted as part of the above-referenced project?
 
Name of Personnel with Financial Conflict of Interest
Other research staff that may have a conflict. Please specify below.
Any member of the study team who answers in the affirmative must be listed in the box below.
A staff person will contact any researcher listed above to obtain additional information
regarding the specific financial interest(s).
I certify that all members of the study team have answered the financial interests question and only those
individuals listed in the box above have disclosed any financial interest related to this study.
Y
---------------------------------------------------------------------------------------------
* * * Informed Consent * * *
12
Informed Consent
Federal regulations require that informed consent be obtained from individuals prior to their participation in
research unless the IRB grants a waiver of consent. Answer the questions, below, then click Add to provide the
necessary consent documents and information regarding participant consent. Multiple consents/waivers may be
added, but they must be uploaded one at a time.
NOTE: You may refer to the University of Alabama IRB Guidance for Obtaining Informed
Consent for considerations regarding the consent/assent process.
State N/A if not applicable.
1)
How is consent being obtained? When and where will the discussion take place?
Informed Consent and Assent
Study staff will obtain all necessary IRB authorizations for protocols and materials
described below. All consents will be conducted by an IRB-approved study staff member
who has been trained by Dr. Snow. The study staff member will be responsible for
explaining the study, answering questions, and obtaining informed consent.
NH Resident Consent:
Step 1. Legally Authorized Representative Consent
NH leadership team or their designees will identify all NH residents with an ADRD
diagnosis and mail to their legally authorized representatives (LARs) an IRB-approved
study introduction letter (including option to opt out within one month if they do not wish
to be contacted by study staff). Opt-out procedures have been demonstrated to yield
higher response rates and lower rates of non-response bias compared to opt-in
procedures, and to be acceptable to participants, with no difference in rates of reported
distress or complaints compared to opt-in procedures.105-108 In our past federally
funded research involving people with dementia, opt-out consent has been approved by
multiple IRBs and worked well. Contact information of those LARs not opting out will be
shared with University of Alabama (UA) study staff. We will request of the IRB a waiver
of consent and HIPAA authorization for screening purposes regarding the sharing of
these contact information.
Study staff will mail an IRB-approved study information packet via a tracked, express
mailing service to all LARs who do not opt out. These materials will include a cover letter,
an IRB-approved informed consent form (ICF), and an express mail return envelope so
the LAR can send the signed ICF to the UA study office. LARs will be encouraged to
contact study staff via phone or email for an appointment to discuss the study and go
through the consent form together before signing the ICFs. Study staff will contact the
LARs via phone and/or email within one week of sending the packet and will re-contact
the LAR up to 8 times within the next month as needed to establish contact (if contact
has not been established within one month, and NH staff are not able to determine that
the LAR’s contact information has changed, then the lack of contact will be considered a

Page 62 of 73
 
soft refusal and no other contact will be attempted).
During a phone appointment, study staff will review all important elements of the ICF with
the LAR, including the following: description of the study, information on how to contact
the investigators and the NH administrator and director of nursing, a statement that there
is no prejudice for refusal to participate, a statement that the subject may withdraw from
the study at any time without prejudice, and statement regarding risk and benefit of
participation. The LAR will be encouraged to ask questions. The LAR will be encouraged
to call the PI if they have any remaining questions before signing the consent form.
NH Resident Consent:
Step 2. Screening for Capacity for NH Resident Consent/NH Resident Assent
Some NH residents with mild ADRD and available LARs may have the capacity to
provide their own consent. A conservative two-step process will be used to address the
ethical balance of the beneficence of assuring that residents who do not have the
capacity to consent are protected by LAR oversight with the promotion of autonomy for
residents who do have capacity to consent. Once LAR consent is received for a resident,
the NH leadership team will be asked to identify that resident’s most recent MDS Brief
Interview for Mental Status [120] (BIMS; see Appendix for copy of measure) score, a
cognitive screening measure with good reliability and validity. For residents with BIMS
scores in the mild range (above 10), the NH leadership team will be asked to arrange
and support a telephone appointment between that resident and a study staff person (if
the resident turns out to not have the cognitive ability to participate in the following
telephone-based procedure, then they would also not have the cognitive capacity to
provide informed consent, which requires higher level cognitive abilities).
In the telephone appointment, the study staff member will provide information about the
study and will screen for capacity to consent by assessing the following. Does the
resident respond appropriately to a social greeting? Is the resident oriented to place?
Does the resident understand who the study team member is after the team member
explains their identity? During the course of this introductory conversation, was the
resident able to respond fluently and socially appropriately? If so, the team member will
go through the consent form with them. Residents will then be asked a series of
questions to assure their understanding. These questions are as follows:
- Describe in your own words what this study is about?
- Describe what I am asking you to do to participate in this study?
- Are you required to do this interview with me?
- What will happen if you don’t talk to me?
- What happens if you decide you don’t want to participate once we get started?
- What will I do with the information you give me?
The NH leadership team member will support this telephone conversation by assuring
that the resident has a quiet environment to have the telephone conversation and that
the resident has in front of them a printed large-font version of the ICF with the signature
area flagged. If the resident is able to respond appropriately to all the capacity screening
questions, and they do wish to participate, then the resident will be instructed to sign the
ICF. The study staff person will contact the NH leadership team member and ask them to
make a copy of the ICF for the resident to keep, place a copy in the medical chart, and
express mail the original to the UA study office using a provided pre-paid envelope. If the
resident is able to respond appropriately to all the capacity screening questions and does
not wish to participate then they will not be enrolled in the study, regardless of the LAR’s
consent. In this case, the study team member will let the NH leadership team and the
LAR know that the resident has declined participation.
Under all circumstances, the NH resident’s autonomy will be respected. For NH residents
without capacity to consent, their assent to participate will be obtained whenever
possible, and their decision to withdraw at any time (whether expressed verbally or by

Page 63 of 73
 
resistance to participation) will be honored (see also staff training in 2.c Vulnerable
Subjects).
For residents with likely mild ADRD (BIMS score above 10) but no lar, the nursing home
leadership team and study staff will go directly to the resident to invite their participation
and screen their capacity to consent using the same process described above.
All above procedures apply to securing consent for the study team to have access to NH
resident personally identifiable data. We note that because the LOCK sleep program
does not include any activities that are outside of standard NH practice, NH staff will be
free to enroll any NH residents that they believe will benefit into the LOCK sleep program
regardless of resident consent status; but the NH leadership team will only share with
researchers data from residents who are consented for the study.
NH Staff Consent:
The NH leadership team or their designees will provide to all NH staff an IRB-approved
study introduction letter (including option to opt out within two weeks if they do not wish
to be contacted by study staff). Contact information of those NH staff not opting out will
be shared with UA study staff. We HAVE RECEIVED FROM THE IRB (IN 2019) a waiver
of consent for screening purposes regarding the sharing of these contact information.
UA Study staff will contact NH staff (via email and/or phone, see next paragraph) to invite
them to participate in mid-implementation interviews (VIA PHONE OR VIRTUALLY).
Study staff will also contact NH staff to invite them to participate in post-implementation
virtual interviews. The list of NH staff who agree and decline interview participation will
remain confidential to protect NH staff from any possible coercion to participate.
For mid-implementation interviews, study team members will, on the PI’s behalf, send
out e-mails to all NH staff who do not opt out. The first e-mail will contain text from Dr.
Snow soliciting voluntary participation in the PHONE OR VIRTUAL interviews. E-mail
reminders will be sent, one in each of the four weeks after the initial e-mail, with follow up
phone calls to the participant’s work phone to remind them about the email. All emails
will include information on how to opt out of the study. We will continue recruitment until
we have recruited the desired sample size or until one month has passed. To facilitate
staff involvement, we will secure permission from the director of each NH that staff may
take part in the study during their normal hours of work. For post-implementation
interviews, study team members will follow these same procedures. In addition, a study
team member will virtually visit each NH at the end of the intervention period to work with
NH staff to collect information from the enrolled NH residents’ medical record and also to
recruit for any needed remaining post-implementation virtual interviews. The study staff
person will virtually attend change of shift meetings, huddles, and other staff meetings to
invite interview participation and will also invite staff virtual contact for one-on-one to
discuss interviews and to ask if the staff member would like to volunteer to participate.
We have successfully used these procedures in our previous federally funded studies
involving NH staff.
In all recruitment activities, it will be made clear that participation is strictly voluntary and
no adverse consequences to the person’s job status or any other adverse consequences
will occur if the person declines to participate in these activities and that their final
decision to participate or not will be kept confidential from all NH and corporate staff.
Mid-implementation interviews will take place virtually. Post-implementation interviews
will take place virtually.
NH LEADERSHIP TEAM MEMBERS WILL ALSO BE INVITED TO PARTICIPATE IN
IMPLEMENTATION INTERVIEWS, AND WILL ALSO BE INVITED TO PARTICIPATE IN

Page 64 of 73
 
GROUP INTERVIEWS. BECAUSE WE ARE ALREADY IN DIRECT EMAIL CONTACT
WITH NH LEADERSHIP TEAM MEMBERS TO WORK WITH THEM FOR THE
REGULAR LEADERSHIP TEAM MEETINGS REGARDING THEIR ROLES IN
INTERVENTION IMPLEMENTATION, WE WILL ALREADY HAVE THEIR EMAIL
INFORMATION AND WILL REACH OUT DIRECTLY VIA EMAIL TO THEM TO INVITE
THEM TO BOTH THE IMPLEMENTATION INTERVIEWS AND THE GROUP
INTERVIEWS. WE WILL USE THE SAME METHODS DESCRIBED ABOVE TO
ASSURE PARTICIPANTS RIGHTS FOR THE NH LEADERSHIP TEAM MEMBERS
DURING THEIR INVITATIONS:
A) ALL EMAILS WILL INCLUDE INFORMATION ON HOW TO OPT OUT OF THE
STUDY. IN ALL RECRUITMENT ACTIVITIES, IT WILL BE MADE CLEAR THAT
PARTICIPATION IS STRICTLY VOLUNTARY AND NO ADVERSE CONSEQUENCES
TO THE PERSON’S JOB STATUS OR ANY OTHER ADVERSE CONSEQUENCES
WILL OCCUR IF THE PERSON DECLINES TO PARTICIPATE IN THESE ACTIVITIES
AND THAT THEIR FINAL DECISION TO PARTICIPATE OR NOT WILL BE KEPT
CONFIDENTIAL FROM ALL OTHER NH AND CORPORATE STAFF.
FOR GROUP INTERVIEWS OF NH LEADERSHIP TEAM MEMBERS, ALL
LEADERSHIP TEAM MEMBERS WILL BE INVITED TO PARTICIPATE IN PERIODIC
(APPROXIMATELY BI-WEEKLY) SHORT INTERVIEWS AT THE END OF THE
REGULAR LEADERSHIP TEAM MEETINGS. TEAM MEMBERS WILL BE INVITED TO
"THINK ALOUD" REGARDING THEIR EXPERIENCES WITH THE PROCESS OF
INTERVENTION IMPLEMENTATION TO DATE AND TO SHARE REFLECTIONS ON
FACILITATORS AND BARRIERS TO IMPLEMENTATION TO DATE.
We HAVE RECEIVED FROM THE IRB (IN 2019) a waiver of documentation of informed
consent for the interviews, allowing us to obtain verbal consent. We will provide a
consent information sheet to potential participants in the stead of an informed consent
document that requires signature. We will record each subject giving permission to be
recorded on the audio recording.
The study staff member will review with the NH staff member all relevant elements of
consent on the consent information sheet, including the following: description of the
study activities, time requirement, information on how to contact the investigators, a
statement that there is no prejudice for refusal to participate, a statement that the subject
may withdraw from the study at any time without prejudice, a statement encouraging the
reader to ask questions, and a statement regarding risk and benefit of participation. All
informed consent guidelines of the IRB will be followed. If at any time during the interview
the staff member indicates a desire to stop participating, the participant will be withdrawn
from the interview portion of the study. Confidentiality of all interview data will be
protected by using participant code numbers on the data collection forms.
SELECTED REFERENCES
120.Chodosh J, Edelen MO, Buchanan JL, et al. Nursing home assessment of cognitive
impairment: development and testing of a brief instrument of mental status (BIMS). J Am
Geriatr Soc. 2008;56(11):2069-2075.
2)
Explain how risks, benefits, and alternatives will be discussed.
Risks will be described first. Efforts to mitigate risk (e.g., data security procedures to
ensure confidentiality of data, procedures to keep employee participation information
confidential, staff training to ensure that cognitively impaired individuals' autonomy and
potential withdrawal of assent are honored).
Benefits will then be described in an appropriately tentative manner, as follows. Sleep
problems and related issues in NH residents with dementia is a well-documented
problem. This study implements an intervention which may improve the sleep experience
for these residents. If the LOCK sleep program is found to be effective in enhancing

Page 65 of 73
 
for these residents. If the LOCK sleep program is found to be effective in enhancing
clinical care and outcomes, the approach could be shared with other NHs and
incorporated into general NH practice. The risks in this study for NH residents are
considered minimal, but risk cannot be eliminated. The knowledge gained may result in
improved quality of sleep, and ultimately improved quality of life for NH residents with
dementia, but benefits cannot be guaranteed. Similarly the risks for NH staff are minimal,
but risk cannot be eliminated, and the knowledge to be gained may result in a more
effective and enjoyable workplace experience, but these benefits cannot be guaranteed.
Regarding alternatives to participation, the LOCK sleep program intervention described
will be implemented NH-wide. The study uses an incomplete stepped-wedge cluster
randomized controlled trial design in which each NH serves as its own control. There will
therefore be no alternative treatments. NH residents and their legally authorized
representatives will have the right to refuse participation in any portion of their care just
as they would with usual NH care, including use of actigraphs and Fitbits. NH staff will
have the right to refuse any interviews.
Informed Consent
Title
Consent Type
Attached Date
Waiver of written consent for
NH staff
Waiver of Written Consent
10/16/2019
NH Staff Consent 40Winks
Oct2020 Approved_NO
CHANGES
Consent
12/21/2021
LAR Consent - Track
Changes
Consent
12/21/2021
LAR Consent - Clean
Consent
12/21/2021
Resident Self-Consent if have
capacity_TRACK CHANGES
STARTING FROM LAR
CONSENT
Consent
12/21/2021
Resident Self-Consent if have
capacity_CLEAN
Consent
12/21/2021
NH Staff Consent 40Winks
TRACK CHANGES TO
Oct2020 Approved _
ver03.21.22
Consent
03/22/2022
NH Staff Consent 40Winks
CLEAN CHANGES
ACCEPTED TO Oct2020
Approved _ ver03.21.22
Consent
03/22/2022
---------------------------------------------------------------------------------------------
* * * Assent * * *
13
Assent
Complete this section if your study includes minors. An assent document should be used if participants are 6 to
18 years of age. The Assent Form Template provides guidelines for writing assent documents.
1)
Will minors be asked to give assent? If not, please justify.
Note: For studies that require a discussion about reproductive risks, note that the conversation

Page 66 of 73
 
with the minor should take place separately from the parents. Also, if a minor will reach
adulthood (18 in Missouri) during the course of the study, they will need to be asked to
consent as an adult at that time to continue in the study.
---------------------------------------------------------------------------------------------
* * * HIPAA * * *
14
HIPAA
Studies that receive or create protected health information (PHI) are subject to HIPAA
regulations. PHI is health information with one or more personal identifiers. For more
information see: http://www.ua.edu/research/index.html If you are working with UMC, then a
separate IRB approval is required. This must be obtained prior to IRB submission and
attached.
1)
Will health information be accessed, received or collected?
No health information. HIPAA does not apply.
X Yes (continue to question 2).
2)
Which personal identifiers will be accessed, received or collected?
No identifiers. I certify that no identifiers from the list below will be received or
collected and linked to health information. HIPAA does not apply (skip remainder of
page).
X Names
Social Security numbers
X Telephone numbers
Linkable code or any other unique identifying number (note this does not mean the
unique code assigned by the Investigator(s) to code the research data)
All geographic subdivisions smaller than a State, including street address, city,
county, precinct, zip code, and their equivalent geocodes, except for the initial three
digits of a zip code, if, according to the current publicly available data from the Bureau
of the Census: (1) The geographic unit formed by combining all zip codes with the
same three initial digits contains more than 20,000 people; and (2) The initial three
digits of a zip code for all such geographic units containing 20,000 or fewer people is
changed to 000
X All elements of dates (except year) for dates directly related to an individual, including
birth date, admission date, discharge date, date of death; and all ages over 89 and all
elements of dates (including year) indicative of such age, except that such ages and
elements may be aggregated into a single category of age 90 or older
Fax numbers
X Electronic mail addresses
Medical record numbers
Health plan beneficiary numbers
Account numbers
Certificate/license numbers
Vehicle identifiers and serial numbers, including license plate numbers
Device identifiers and serial numbers
Web Universal Resource Locations (URLs)
Internet Protocol (IP) address numbers
Biometric identifiers, including finger and voice prints
Full face photographic images and any comparable images
If you are receiving or collecting health information and at least one personal identifier, HIPAA applies to your
study. Please continue to complete the sections, below.

Page 67 of 73
 
3)
Sources of Protected Health Information:
X Hospital/medical records for in or out patients
X Physician/clinic records
Laboratory, pathology and/or radiology results
Biological samples
X Interviews or questionnaires/health histories
Mental health records
Data previously collected for research purposes
Billing records
X Other  Please describe:
Our secondary outcomes come from the MDS 3.0. Every Medicare-certified NH is
required to complete
an MDS assessment for every resident at admission, quarterly, and at discharge, in
addition to
whenever the resident's status changes.
4)
If data will be shared outside the research team and the study involves PHI indicate how the research team
will share the information. Contact the University of Alabama Privacy Officer for guidance on the proper
procedures for sharing of protected health information. http://hipaa.ua.edu/
X Not applicable (continue to question 5).
Only linkable code that can link data to the identity of the participant. A code access
agreement or business associate agreement may be needed when data are shared
with other non-University of Alabama entities. If necessary, the agreement can be
added and uploaded in item #5, below.
Limited identifiers: Zip codes, dates of birth, or other dates only. The study qualifies
as a Limited Data Set. A data use agreement may be needed when data are shared
with other non-AlaUniversity of Alabamatities. If necessary, the agreement can be
added and uploaded in item #5, below.
With unlimited identifiers. The consent document and HIPAA Authorization form must
describe how the information will be disclosed.
5)
A HIPAA Authorization Form or Waiver of HIPAA Authorization is required for this study. Use the table
below to add HIPAA Documents for your study. If you are accessing medical records, or other health
records that include PHI, you must complete a waiver of HIPAA authorization.
HIPAA Documents
HIPAA Documents
Title
Attached Date
HIPAA Authorization
HiPAA Authorization
10/16/2019
Waiver of Authorization
Waiver HiPAA Authorization
for Screening
HIPAA Authorization
HIPAA TRACK CHANGES
12.20.21
12/21/2021
HIPAA Authorization
HIPAA CLEAN COPY
12.20.21
12/21/2021
---------------------------------------------------------------------------------------------
* * * Attachments * * *
15)
Attachments
In this section, please upload additional documents associated with your protocol. Failure to attach files
associated with the protocol may result in the protocol being returned to you.
Possible documents for this protocol could include:

Page 68 of 73
 
Bibliography
Cooperating Institution's IRB Approval
Data Collection Sheet
Debriefing Script
Device Information/Documentation
Grant Proposal/Sub-Contract
Human Participants Training Certificate/Proof of Training
IND Application Letter
Information Sheet/Brochure
Interview/Focus Group Questions
Investigator's Brochure
Letter of Agreement/Cooperation
Package Insert
Patient Diary Form
Phone Script
Questionnaire/Survey
Recruitment Material (e.g., flyers, ads, e-mail text)
Recruitment Statement (if there is no waiver of written consent)
Scientific/PPC Review
Sponsor's Protocol
Sponsor's Protocol Amendment
Study Design Chart/Table
Waiver Request
Other files associated with the protocol (most standard formats accepted: pdf, jpg, tif, mp3,
wmv, etc.)
To update or revise any attachments, please delete the existing attachment and upload the revised document to
replace it.
Document Type
Document Name
Attached Date
Submitted Date
Questionnaire/Survey IRB protocol
appendices
measures
10/15/2019
10/16/2019
Human Subjects
Training
Certificate/Proof of
Training
11. Snow - CITI
10/15/2019
10/16/2019
Human Subjects
Training
Certificate/Proof of
Training
5. Hartmann -CITI
10/15/2019
10/16/2019
Human Subjects
Training
Certificate/Proof of
Training
10. Richards - CITI
10/15/2019
10/16/2019
Human Subjects
Training
Certificate/Proof of
Training
4. Fry - CITI
10/15/2019
10/16/2019

Page 69 of 73
 
Human Subjects
Training
Certificate/Proof of
Training
8. Morgan - CITI
10/15/2019
10/16/2019
Other
Figure 1 LOCK
Elements
10/15/2019
10/16/2019
Other
Table 1 Outcome
measurements and
sources
10/15/2019
10/16/2019
Grant Proposal/Sub-
Contract
Research
Plan_Bibliography_NI
A 1R61AG065619-01
10/15/2019
10/16/2019
Grant Proposal/Sub-
Contract
NIH_Notice of
Award_1R61AG0656
19-01
10/15/2019
10/16/2019
Other
All Investigator
Biosketches_Bundled
10/15/2019
10/16/2019
Human Subjects
Training
Certificate/Proof of
Training
1. Baier - CITI
10/15/2019
10/16/2019
Human Subjects
Training
Certificate/Proof of
Training
2. Brady - CITI
10/15/2019
10/16/2019
Human Subjects
Training
Certificate/Proof of
Training
3. Frank - CITI
10/15/2019
10/16/2019
Human Subjects
Training
Certificate/Proof of
Training
6. McCreedy - CITI
10/15/2019
10/16/2019
Human Subjects
Training
Certificate/Proof of
Training
7. McCullough - CITI
10/15/2019
10/16/2019
Other
Snow 19-024-ME 11-
18-19 Notification
11/18/2019
11/18/2019
Other
B&F Consulting LOS
Excerpt
11/26/2019
11/26/2019
Other
Biosketch
CathieBrady_201902
19
11/26/2019
11/26/2019
Other
Biosketch
BarbaraFrank_20190
218
11/26/2019
11/26/2019
Other
19-024-ME_response
cover letter_11.26.19
11/26/2019
11/26/2019
Other
Snow 19-024-ME
Approval
12/12/2019
12/12/2019

Page 70 of 73
 
Other
Snow 19-024-ME-R1
Approval
11/09/2020
11/09/2020
Other
Brookshire_LOS
04/05/2021
04/05/2021
Other
Snow 19-024-ME-
R1-A Approval
04/16/2021
04/16/2021
Human Subjects
Training
Certificate/Proof of
Training
George Medical
Research
09/17/2021
09/17/2021
Human Subjects
Training
Certificate/Proof of
Training
J Cassell CITI -
5.9.24
09/17/2021
09/17/2021
Human Subjects
Training
Certificate/Proof of
Training
J Loup - CITI -
8.28.2024
09/17/2021
09/17/2021
Other
40Winks Caraday
Letter of Support
060221
09/17/2021
09/17/2021
Other
40 Winks Letter of
Support_White Oak
09/17/2021
09/17/2021
Other
40Winks Vivage LOS
Final april 2021
09/17/2021
09/17/2021
Other
NIA to Snow_DSMB
Meeting
Summary_2021_05_
17
09/17/2021
09/17/2021
Other
NIA to Snow_Intro
DSMB Meeting
Summary
Final_2020_11_11
09/17/2021
09/17/2021
Other
NIATOS~3
09/17/2021
09/17/2021
Other
40 Winks IRB
Approval and
Consent Forms
exp11.04.21
09/17/2021
09/17/2021
Other
Snow 19-024-ME-R2
Approval
10/15/2021
10/15/2021
Data Collection
Sheet
Sleep Interview
Resident ver12.2021
12/21/2021
12/21/2021
Data Collection
Sheet
Sleep Report Family
ver12.20.21
12/21/2021
12/21/2021
Data Collection
Sheet
Sleep Report Staff
ver12.20.21
12/21/2021
12/21/2021
Recruitment Material
(e.g., flyers, ads, e-
mail text)
LAR Letter from
Nursing home
ver12.20.21
12/21/2021
12/21/2021

Page 71 of 73
 
Recruitment Material
(e.g., flyers, ads, e-
mail text)
LAR Phone Script
ver12.20.21
12/21/2021
12/21/2021
Recruitment Material
(e.g., flyers, ads, e-
mail text)
LAR Packet from
Research Team
ver12.20.21
12/21/2021
12/21/2021
Other
IRB COVER LETTER
Amendment
ver12.15.21
12/21/2021
12/21/2021
IRB Approval
Snow 19-024-ME-
R2-A Revision
Approval
01/18/2022
03/22/2022
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ver03.21.22
03/22/2022
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* * * PI Obligations * * *
PI Obligations
By clicking the box below, you indicate that you accept responsibility for and will follow the
ethical guidelines.
1)
Have you completed the annual Statement of Financial Interest (i.e., disclosure)?
Y
NOTE: An annual disclosure must be completed by all faculty, staff, and students who are
identified as senior/key personnel receiving federal funding for research.  The disclosure can
be completed online at https://www.formstack.com/forms/index.php?1338617-e6Kw9EILFS.
2)
Have your financial interests changed significantly since you completed the annual
disclosure form?
N
According to the UA policy on conflict of interest, it is the PI's responsibility to inform co-
investigators, staff, or students involved in the design, conduct, or reporting of federally
sponsored research of their requirement to complete the Statement of Financial Interest.
X I accept this responsibility.
By submitting this form, the PRINCIPAL INVESTIGATOR certifies that he/she has read the
UA policy on conflict of interest and has a current Statement of Financial Interest on file.  In
addition, the PI certifies that, to the best of his/her knowledge, no person working on this
project at UA has a conflict of interest or, if a conflict of interest does exist, an appropriate
management plan is in place.
X The Principal Investigator has read and agrees to abide by the above obligations.
The Department Chair has read and agrees to abide by the above obligations.
The Faculty Sponsor / Mentor has read and agrees to abide by the above obligations.
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* * * Event History * * *
Event History

Page 72 of 73
 
Date
Status
View Attachments
Letters
09/22/2019
NEW FORM
CREATED
10/16/2019
NEW FORM
SUBMITTED
Y
10/31/2019
NEW FORM PANEL
ASSIGNED
11/01/2019
NEW FORM
REVIEWER(S)
ASSIGNED
12/12/2019
NEW FORM PANEL
REASSIGNED
12/12/2019
NEW FORM
REVIEWER(S)
ASSIGNED
12/12/2019
NEW FORM
APPROVED
Y
Y
10/27/2020
AMENDMENT 1
FORM CREATED
10/28/2020
AMENDMENT 1
FORM DELETED
10/28/2020
CONTINUING
REVIEW 1 FORM
CREATED
10/28/2020
CONTINUING
REVIEW 1 FORM
SUBMITTED
Y
11/02/2020
CONTINUING
REVIEW 1 FORM
PANEL
REASSIGNED
11/02/2020
CONTINUING
REVIEW 1 FORM
REVIEWER(S)
ASSIGNED
11/09/2020
CONTINUING
REVIEW 1 FORM
PANEL
REASSIGNED
11/09/2020
CONTINUING
REVIEW 1 FORM
REVIEWER(S)
ASSIGNED
11/09/2020
CONTINUING
REVIEW 1 FORM
APPROVED
Y
Y
01/21/2021
AMENDMENT 2
FORM CREATED
04/05/2021
AMENDMENT 2
FORM SUBMITTED
Y

Page 73 of 73
 
04/15/2021
AMENDMENT 2
FORM
REVIEWER(S)
ASSIGNED
04/16/2021
AMENDMENT 2
FORM APPROVED
Y
Y
09/09/2021
CONTINUING
REVIEW 2 FORM
CREATED
09/17/2021
CONTINUING
REVIEW 2 FORM
SUBMITTED
Y
10/07/2021
CONTINUING
REVIEW 2 FORM
PANEL
REASSIGNED
10/07/2021
CONTINUING
REVIEW 2 FORM
REVIEWER(S)
ASSIGNED
10/15/2021
CONTINUING
REVIEW 2 FORM
APPROVED
Y
Y
11/28/2021
AMENDMENT 3
FORM CREATED
12/21/2021
AMENDMENT 3
FORM SUBMITTED
Y
01/06/2022
AMENDMENT 3
FORM
REVIEWER(S)
ASSIGNED
01/18/2022
AMENDMENT 3
FORM PANEL
REASSIGNED
01/18/2022
AMENDMENT 3
FORM
REVIEWER(S)
ASSIGNED
01/18/2022
AMENDMENT 3
FORM APPROVED
Y
Y
02/15/2022
AMENDMENT 4
FORM CREATED
03/22/2022
AMENDMENT 4
FORM SUBMITTED
Y