Aim-3: Alzheimer's Disease and Related Dementias Prevention Messaging to Increase Smoking Cessation Attempts in Older Adult Smokers
Phase: NA
Conditions: Smoking Cessation
Sponsor: University of Wisconsin, Madison

Aim-3: Alzheimer's Disease and Related Dementias Prevention Messaging 
to Increase Smoking Cessation Attempts in Older Adult Smokers   
Protocol and Statistical Analysis Plan 
Principal Investigator: 
Adrienne L. Johnson, PhD 
(she/her/hers) 
Assistant Professor 
Center for Tobacco Research and Intervention 
Department of Medicine 
University of Wisconsin School of Medicine and Public Health 
Study Sponsor: 
DHHS, PHS, NATIONAL INSTITUTES OF HEALTH 
Protocol Number: 
NCT05194917 
Version Number and Date: 
Version 7; 02/05/2025 
Contact Information: 
Adrienne L Johnson, PhD 
Telephone:   608-265-4797 
Email:   aljohnson43@ctri.wisc.edu   
IRB Approval: 
IRB Approval Number: 2023-0650 
Approval Date: 05/22/2023 

2023-0650
SF: nPBA: Basic Study Information
Date: Wednesday, February 5, 2025 3:15:00 PM
Print
Close
University of
Wisconsin-Madison
MR IRB Application
Study # : 2023-0650
Principal Investigator:
Adrienne Johnson
Basic Study Information
1. Formal Title
This is the title that will appear in correspondence.
* Provide the full, formal study title.
Motivating Change in Aging Smokers (MCAS 3)
 
2. Transferred Study
Answer Yes to this question only if:
a) the principal investigator (PI) for this application is coming to UW-Madison, UW
Health, or the Madison VA from another institution and,
b) they plan to open a study here that is already IRB-approved at their previous
institution.
* Is this study being transferred from another institution?
  Yes  No
3. Principal Investigator
* Identify the Principal Investigator.
Adrienne Johnson

2023-0650
SF: nPBA: Type of Research Application
Type of Research Application
1. Type of Research Application
* Select one of the following: Full review

2023-0650
SF: nPBA: PI Appointment
PI Appointment
1. Principal Investigator
PI: Adrienne Johnson 
2. Primary Appointment
* Choose the appointment under which you will be conducting this
research. Note, most UW-Madison employees with clinical appointments
at UW Health conduct ALL their research under their UW-Madison
appointment. Only choose option 2 (UW Hospital and Clinics) if the
scope of your UW-Madison appointment does NOT include research.
UW-Madison
3. UW-Madison Appointment
3.1. Appointment Details
* Identify the appointment under which the PI will conduct this
research.
 
Title
Type UDDS
Department Combined Name
Assistant Professor
FA
A534253
SMPH/MEDICINE/GEN INT MD
3.2. Appointment Not Found
Check if the appointment is not listed above. 
4. Investigator-Initiated Study
* Is this an investigator-initiated study?
  Yes  No

2023-0650
SF: nPBA: Study Team
Study Team
1. Points of Contact Selection
Points of contact can edit the application and will receive email notifications about this
submission.
Please do not use personal email addresses (e.g., Gmail, Hotmail, etc.). A campus
business email can be changed following the instructions here.
If the PI is serving as the only study point of contact, indicate that here.
Can’t find someone in the chooser? See this FAQ for help.
To register a NetID, click here.
* Identify the points of contact for this study (limit of four).
Name
Email
Sarah Jarvis
sjarvis3@wisc.edu
Adrienne Johnson
aljohnson43@ctri.wisc.edu
Mark Zehner
mark.zehner@ctri.wisc.edu
2. All Other Study Team Personnel
List ONLY UW-Madison, UW Health, or Madison VA personnel. External personnel will be
listed elsewhere in the application.
Please do not use personal email addresses (e.g., Gmail, Hotmail, etc.). A campus
business email can be changed following the instructions here.
Study team members listed below will have read-access only and will not be able to
edit the application. They also will not receive email notifications.
Can’t find someone in the chooser? See this FAQ for help.
To register a NetID, click here.
List all the other members of the study team (not including the PI or
points of contact).
Name
Email
Brooke Anderson
brooke.anderson@ctri.wisc.edu
Todd Hayes-Birchler
hayesbirchle@ctri.wisc.edu
Hannah Hayward
hahayward@ctri.wisc.edu
Chris Hollenback
ch3@ctri.wisc.edu
Kate Kobinsky
ks6@ctri.wisc.edu

Name
Email
Danielle McCarthy
demccarthy@ctri.wisc.edu
Adam Nunez
adam.nunez@wisc.edu
Thomas Piasecki
tpiasecki@wisc.edu
Megan Piper
mep@ctri.wisc.edu
Lisa Rogers
lmrogers@ctri.wisc.edu
Julia Sales Leite
jsleite@outlook.com
Jonah Stankovsky
jstankov@ctri.wisc.edu

2023-0650
SF: nPBA: Study Team Roles
Study Team Roles
1. Primary POC
If the PI is serving as the primary point of contact, indicate that here.
* Identify the primary point of contact for this study.
Adrienne Johnson
2. Human Subject Involvement
* Does this study involve recruiting, consenting, or interacting with
human subjects?
  Yes  No
2.1. Study Team Details
For each study team member below, click the  button and check the boxes to indicate
that study team member's roles for this study. Note: Some study team members may not
have any roles listed below.
Tell us which study team members will: recruit human subjects, obtain
informed consent from human subjects, interact with human subjects, or
perform cognitive assessments on human subjects.
Study Team Member
Recruit
Subjects
Obtain Informed
Consent
Interact with
Subjects
Brooke Anderson
 
 
 
Todd Hayes-Birchler
 
 
 
Hannah Hayward
 
 
 
Chris Hollenback
 
 
 
Sarah Jarvis
yes
yes
yes
Adrienne Johnson
yes
yes
yes
Kate Kobinsky
yes
yes
yes
Danielle McCarthy
 
 
 
Adam Nunez
 
 
 
Thomas Piasecki
 
 
 
Megan Piper
 
 
 
Lisa Rogers
 
 
 

Study Team Member
Recruit
Subjects
Obtain Informed
Consent
Interact with
Subjects
Julia Sales Leite
yes
yes
yes
Jonah Stankovsky
 
 
 
Mark Zehner
 
 
 

2023-0650
SF: nPBA: Funding
Funding
 
1. Funding Administered by UW Madison
Answer no to this question if this study will only be supported by VA funding; you will
have the opportunity to add VA funding later in the application.
* Do you have pending or approved funding administered through
Research and Sponsored Programs (RSP) or Business Services to
support this project?
  Yes  No
1.1. Funding Sources
For federal funds, pending sources may be listed if the grant has received a
highly meritorious score. For example, an impact score of <30 is an indication
of a highly meritorious NIH grant proposal. Receipt of a request for Just In
Time (JIT) documentation is another indication of a highly meritorious
proposal.
For non-federal funds, pending sources may be listed if you have
confirmation from the sponsor that funding will be awarded due to merit AND
the sponsor has a peer-review process.
For industry, do not select industry sponsors who are only providing
drug/device OR only limited support for the study.
* Use this chooser to select each funding source administered
through UW-Madison that will support this study or project.
 
Funding Source Details
View
PI Name
Johnson,Adrienne  
Proposal
ID
MSN242995  
Award ID
MSN242995  
Funding
Title
ADRD Prevention Messaging to Increase Smoking
Cessation Attempts in Older Adult Smokers  
Project
ID
No Value Entered  
Sponsor
(Source)
DHHS, PHS, NATIONAL INSTITUTES OF HEALTH  
Sponsor
Reference
Number
1K23AG067929-01A1  
Primary
Sponsor
No Value Entered  

 
Funding Source Details
Primary
Sponsor
Reference
Number
No Value Entered  
Federal
Yes  
Status
Active  
Start
Date
5/1/2021  
End Date
2/28/2026  
2. Other Funding
* Do you have pending or approved funding NOT listed on this page?
  Yes  No

2023-0650
SF: nPBA: Conflict of Interest
Conflict Of Interest
Please review the study team member Outside Activities Report (OAR) and
managed entities data below before answering the questions on this page.
The following study team members have not completed
their OAR for the year:
Brooke Anderson, Sarah Jarvis, Danielle McCarthy, Julia Sales
Leite, Jonah Stankovsky
NOTE: Per campus policy all study team members must submit
an OAR every year and keep it up to date.
No study team members have any managed entities at
this time.
1. Intellectual Property
* Do any study team members involved in the design or conduct of the
research (including their spouses and dependent children) own
intellectual property that will be used in the study or project?
  Yes  No
2. Other Entities
* Besides the sponsor(s) of this project or entities listed above, do any
study team members have a fiduciary or financial relationship with
entities that will be involved in this study or that may be significantly
affected by it?
  Yes  No
3. Incentives

* Do any of the study team receive any incentives for recruiting human
subjects or any other purpose directly related to the study or project?
  Yes  No

2023-0650
SF: nPBA: VA Status
VA Status
All studies that fall under Madison VA purview must be reviewed and
approved by the VA Research and Development (R&D) Committee in addition
to being reviewed by the Health Sciences IRB. For information about the VA
R&D Committee review process, please contact
VHAMADRDCoordinator@va.gov.
1. VA Status
* Does this study involve the Madison VA (Wm. S. Middleton VA
Hospital); e.g., funding from the VA, conducted under VA appointment,
use of VA facility, recruitment of veterans or use of their data or samples
at the Madison VA?
  Yes  No

2023-0650
SF: nPBA: PRMC CRU
Scientific Review: PRMC & CRU
1. Cancer Related
* Is the scientific question of the protocol cancer related?
  Yes  No 
2. Targeting Cancer Patients
* Are you specifically targeting cancer patients for enrollment in this
study?
  Yes  No 
3. Use of Cancer Data or Images
* Does this study involve the review and/or use of biological
specimens/data/images/records from cancer patients?
  Yes  No 
4. Use of CRU
If the answer to this question is Yes, you must upload a copy of the CRU application to
the Submit activity form.
* Will this study use the Clinical Research Unit (CRU)?
  Yes  No 

2023-0650
SF: nPBA: Protocol Feasibility via UROC
UROC Determination
Submission of research studies that meet certain criteria must be reviewed
by either Protocol Review and Monitoring Committee (PRMC) or UW
Health/SMPH Research Operations Committee (UROC) prior to review by the
IRB. The UROC Endorsement Letter, if review is required, must be uploaded
prior to submission of your protocol to the IRB. For more information about
UROC review, visit the UROC KB Page.
1. Criteria for UROC Review
* Select all the criteria below that apply to your study.
None of the above apply or the study was approved by the IRB prior to July 1, 2024.

2023-0650
SF: nPBA: ClinicalTrials.gov Information
ClinicalTrials.gov Information
This page is designed to aid in identifying ClinicalTrials.gov registration
requirements. Registration may be required by the FDA, NIH, or if you are
planning to publish in a journal that follows International Committee of
Medical Journal Editors (ICMJE) guidance. Please answer each question
carefully.
UW-Madison has a free service available to assist you in registering your
record with ClinicalTrials.gov. Contact
CT.gov_Help@clinicaltrials.wisc.edu for more information.
For information on registration and results reporting requirements see our
KnowledgeBase page or contact the Office of Research Compliance at
ClinicalTrials.gov_Support@research.wisc.edu.
1. Study Intervention(s)
Prospective assignment means enrolling study subjects and collecting data on them
in the future. It is a study not solely reliant on existing or retrospective data. It is not a
requirement to have multiple groups or arms for a study to be considered prospectively
assigned.
An intervention is any manipulation of the subject or subject's environment for the
purpose of modifying one or more health-related biomedical or behavioral processes
and/or endpoints. Any study that is not observational (where participants may receive
a drug, device, medical procedure, or behavioral intervention as part of their standard
clinical care) should be considered interventional. Examples include: drugs/small
molecules/compounds; biologics; devices; procedures (e.g., surgical techniques);
delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change
health-related behavior (e.g., diet, cognitive therapy, exercise, development of new
habits); treatment strategies; prevention strategies; and, diagnostic strategies.
A health-related biomedical or behavioral outcome is defined as the pre-specified
goal(s) or condition(s) that reflect the effect of one or more interventions on human
subjects’ biomedical status, behavioral status, or quality of life. Examples include:
positive or negative changes to physiological or biological parameters (e.g.,
improvement of lung capacity, gene expression); positive or negative changes to
psychological or neurodevelopmental parameters (e.g., mood management
intervention for smokers; reading comprehension and /or information retention);
positive or negative changes to disease processes; positive or negative changes to
health-related behaviors; and, positive or negative changes to quality of life.
* Are subjects prospectively assigned by the protocol to any
intervention(s) that are being evaluated for any health-related

biomedical or behavioral outcomes?
  Yes  No 
2. ClinicalTrials.gov Determinants
* Check the box(es) that apply to this study:
NIH funded, when registration is a required condition of the grant (consult your award
letter or with your NIH Program Officer if unsure)
3. FDA or NIH Requirement
* Based on your responses, registration with ClinicalTrials.gov may be
required by the FDA or NIH. Will UW-Madison (study team or service line
support staff) register the study with ClinicalTrials.gov?
  Yes  No 
 
 
 

2023-0650
SF: nPBA: External Collaborations 2
External Collaborations
1. Outside UW Activities
* Will any UW/UW Health or Madison VA personnel conduct any of the
following study activities at locations outside the UW/UW Health or
Madison VA: subject recruitment, obtaining informed consent, or
interacting or intervening with subjects?
  Yes  No   
2. Requesting UW Serve as IRB
Please note that you must consult with RELIANT before you submit a request for the
UW to serve as the reviewing IRB for external sites or individuals. A consultation may
be requested here.
* Are you requesting that UW Madison serve as the reviewing IRB for
any external sites or individuals?
  Yes  No 

2023-0650
SF: nPBA: Sharing Data Outside UW
Sharing Data Outside UW
1. Sharing Data Outside UW Madison
* Will subject data, images, or specimens be shared outside the UW
Madison?
  Yes  No 

2023-0650
SF: nPBA: Study Procedures and Special Populations
Study Procedures and Special Populations
1. Study Procedures Involved
Select "Review or use of information from health care records"
* If your study involves any of the following special procedures or
considerations, additional information may be needed. Select all that
apply. If none apply, check Not Applicable.
Creation of audio or video recordings or photographs
Interviews, focus groups, surveys, questionnaires, assessments (e.g., QOL, SCID, BDI,
etc.)
2. Special Populations
If you will collect data points identifying individuals as any of the following, select the
corresponding box(es).
* Is the research designed to include any of the following populations?
Select “Not Applicable” if the research will not include any of the
populations below. NOTE: If enrolling pregnant women, children, or
prisoners, and you can identify them as such, check the box.
Poor/uninsured, elderly/aged, or educationally disadvantaged

2023-0650
SF: nPBA: Research Design and Procedures
Research Design and Procedures
1. Overall Purpose
Describe the research questions or gap in knowledge the study proposes to address or
contribute to in language that someone who is educated but not an expert in the field
can understand.
* What is the overall purpose and aim of this project or study?
The purpose of this research is to evaluate messages that motivate older smokers
to make quit attempts using evidence based smoking treatments (EBSTs).
2. Pre-Existing Information/Background Knowledge
* What prior information or knowledge exists to support the conduct of
this project or study?
An estimated 5.8 million people have Alzheimer’s disease and related dementias
(ADRD) in the U.S., costing $290 billion per year. The incidence of ADRD is
expected to triple by 2050, costing an estimated $1.1 trillion per year. Due to the
rapid growth and tremendous impact of this disease, focus has shifted towards
targeting modifiable risk factors to prevent and slow the development of ADRD,
potentially preventing approximately 40% of ADRD cases. A candidate risk factor,
cigarette smoking, is the leading preventable cause of death and disability in the
U.S., resulting in 480,000 deaths and costing over $300 billion each year.
Epidemiological studies show that cigarette smoking is prospectively associated
with a 70% increased risk of Alzheimer’s disease (AD) dementia onset, accounting
for at least 13.9% of ADRD cases. Smoking directly increases the likelihood and
severity of at least five risk factors for ADRD onset (i.e., diabetes, hypertension,
stroke, heart disease, and high cholesterol). Smoking cessation can lower these risk
factors, even among an aging population.
Regardless of genetic risk, healthy lifestyle modifications such as smoking cessation
can cut the risk of ADRD in half. Due to the known relations between smoking,
other ADRD risk factors, and ADRD, the World Health Organization, Institute of
Medicine, and Alzheimer’s Association state that smoking cessation is among the
top priorities for reducing cognitive decline and preventing onset of dementia.
Fortunately, evidence-based smoking treatments (EBSTs) exist that can double or
triple cessation success. Older adult smokers are at especially high risk for ADRD.
Currently, there are 19 million smokers ages 45 and older. Given the predicted
doubling of older adults in the next 25 years, helping older smokers quit is a
vital public health priority. Unfortunately, older smokers are half as likely to attempt
to quit smoking compared to younger adults. Lower cessation efforts in older
smokers may be a function of both clinician inaction and dysfunctional
beliefs/motivational deficits of older smokers. Compared to younger adults, older
smokers are less likely to receive advice to quit or be offered EBSTs (e.g.,
pharmacotherapy, counseling) by healthcare professionals. Moreover, older
smokers’ doubts about the benefits of quitting later in life and the efficacy of
smoking cessation interventions may reduce older smokers’ motivation to quit13.
Importantly, older smokers who do attempt to quit are more likely to maintain
abstinence than younger smokers when using EBSTs. The chief obstacle to reducing
smoking among older adults does not appear to be treatment efficacy, but rather
failing to motivate this underserved population to make quit attempts using EBSTs.

According to the Health Belief Model, impactful motivational messages for older
smokers should focus on threats they perceive as important and personally relevant
and messages should be offered with a feasible, effective course of action to
address the health threat. Older adults’ greatest aging-related fear is cognitive
decline and developing dementia; it is both important and relevant. The link
between smoking and ADRD risk factors and the availability of EBSTs offers an
effective strategy to respond to this threat. Unfortunately, the indirect relation
between smoking and ADRD risk expressed via known ADRD risk factors has not
been clearly articulated to the general or medical community, and is not used as a
motivator for smoking cessation. Building novel interventions for translation will
facilitate more rapid dissemination and subsequent impact on public health. The
overarching objective of this proposal is to test a readily translatable Stage 1
motivational intervention for smoking cessation in older adults consisting of: (1) a
novel patient-informed motivational message promoting smoking cessation; and (2)
ready access to EBSTs for smoking cessation. This responds to two of NIA’s goals:
(1) develop effective interventions to maintain health, well-being, and function and
prevent age-related diseases/disabilities; and (2) disseminate information to the
public, medical, and scientific communities. This project will evaluate the
motivational impact of a message packages developed from a previous study (IRB#
2020-1429).
3. Study Procedures and Interventions
Provide an overview of the types of records that will be reviewed, what information
from these records will be collected, and the kinds of analyses that will be performed
on the study data. If data from multiple sources will be used describe this here (e.g.,
medical record information connected to imaging or billing information or data from
multiple institutions collated).
* Briefly describe the procedures and interventions that will be
performed for this project or study and all study arms involved. Do not
include information on recruitment or consent.
Participants will be randomized to one of four messaging interventions; 1) active
control (CDC TIPS from former smokers campaign), 2) active control (American
Lung Association campaign), 3) treatment condition including message package
focused on the link between smoking and dementia, 4) no intervention control. The
messaging intervention will be delivered via mail, which will include a QR code link
that will allow participants to view associated motivational video. Participants will
then complete the first of 2 telephone survey assessments (lasting ~30 minutes).
Participants will then receive three mailers over the next couple of months and will
schedule their follow-up call approximately 2.5 months later. At one to two weeks,
one month, and two months after this call they will be mailed the corresponding
message to their group (no intervention group will not be sent a message package).
Follow up telephone assessments will occur within approximately 1-2 weeks
following intervention exposure marked by date the intervention mailer was sent.
Up to 20 participants randomized to the intervention condition will complete an
additional brief qualitative interview following their second telephone survey
assessment (lasting ~20 minutes). The qualitative interview will focus on the
perceived impact of the message, preferred number of message exposures,
preferred modality of message receipt, and suggested improvement to message
content. Health Believe Model (HBM) constructs assessed include: perceived
severity, perceived benefits (i.e., efficacy of EBSTs; impact of quitting on ADRD
risk), perceived barriers (i.e., knowledge of how to access EBSTs in healthcare
setting), and self-efficacy (i.e., confidence in ability to quit in the next 30 days).

4.
Incidental or Adventitious Findings
* Will any study procedures produce incidental or adventitious findings
(e.g., imaging scans, laboratory blood tests, depression screening
questionnaires, etc.)?
  Yes  No 
5. Instruments/Technology Involved (Includes AI/ML
Algorithms)
This question is intended to identify projects involving the development or use of
medical devices. This does not apply to surveys, questionnaires, or statistical analysis
software.
* Are there instruments or technology of any kind, including software,
tests run on samples, and algorithms, used or developed in the study?
  Yes  No

2023-0650
SF: nPBA: Subject Identification Medical Records
Subject Identification: Medical Records
1. Medical Record Use
* Will medical records be used to identify subjects or records?
  Yes  No

2023-0650
SF: nPBA: Risks and Benefits
Risks and Benefits
1. Direct Benefits Intended
For this type of research there are generally no direct benefits to subjects. The
response to this question, "There are no direct benefits to subjects", would be
acceptable.
* Are any of the research activities intended to directly benefit
subjects?
  Yes  No
2. Potential Benefits to Society
Describe how the research might help future patients.
* Describe the importance of the knowledge reasonably to be gained
from this study and what benefit the research may provide to society.
The knowledge gained from this study will identify the most impactful motivational
message to promote smoking cessation and the use of evidence-based cessation
treatment in older adult smokers. This population of smokers are particularly at risk
for all of the known health effects of smoking, including dementia.
3. Direct Physical Intervention
A physical intervention refers to study procedures that may pose a risk (however
minimal) to a subject's body (e.g., blood draws, MRI scans, drug or device trials,
exercise, dietary restrictions/supplements). Examples of activities that are NOT
physical intervention include obtaining informed consent and administering surveys.
* Does this study involve direct physical intervention with subjects?
  Yes  No    
4. Potential Psychosocial Risks
For this type of research the risks to subjects are generally limited to the risk of breach
of confidentiality. The response to this question, "There is a risk of breach of
confidentiality", would be acceptable.
* Describe any potential psychosocial risks to subjects, such as
psychological stress or confidentiality risks (including risk to reputation,

economic risks, and legal risks).
There is a risk of a confidentiality breach.
Participants may become upset or experience discomfort.
 
5. Procedures to Minimize Risks
The response to this question should address how the risk of breach of confidentiality
will be minimized. For example, it could be described that the study team has several
measures in place to protect against a breach of confidentiality, such as limiting the
number of people who view identifiable information, coding study instruments, storing
study data in restricted areas and on computers that are password-protected, only
transmitting coded data outside the institution (if data will be shared), and using a
secure web-interface to transmit data off-site (if data will be shared).
* Describe the procedures in place to minimize risks from all
interventions performed for research purposes. This should include
activities in place to identify, monitor, mitigate, and eliminate risks to
the degree possible.
Data will be stored securely according to campus policy.
Participants will be informed of the approximate length of study activities during the
consent process and will be offered the opportunity to take breaks during the study
activities if needed.
Participants will be informed about all aspects of the study during consent and have
the option to skip or withdraw from any activities that make them upset or
uncomfortable.
 
 

2023-0650
SF: nPBA: Subject Population
Subject Population
1. Total Subjects
You must provide an integer. If you are enrolling a range of subjects (e.g., 50 to 100
subjects), enter the larger number.
* Provide the number of subjects that will be enrolled at sites for which
UW Madison is serving as the reviewing IRB.
220
 
2. Inclusion Criteria
* Describe the main inclusion criteria.
- Adults between the ages of 50-80
- Self-reported current smoker
- Do not hold a current diagnosis of dementia or Mild Cognitive Impairment (MCI)
- Can read/write in English
 
3. Exclusion Criteria
* Describe the main exclusion criteria.
History of Mild Cognitive Impairment (MCI) or dementia.
 
4. Targeted Populations
Populations could be racial/ethnic, sex, or gender (this also applies to gender identity,
or lack thereof).
* Will this study target or exclude specific populations?
  Yes  No
4.1. Targeted Population Justification

* Describe the population that will be targeted or excluded and
provide justification.
This study will target an elderly population (ages 50 to 80 years old). Given
the intervention being tested is intended for older adult smokers, it is
necessary that we recruit individuals from this age group. This population
of smokers are particularly at risk for all of the known health effects of
smoking, including dementia. Participants with self-reported history of MCI
or dementia will be excluded to ensure ability to provide consent.
 

2023-0650
SF: nPBA: Special Populations Justification
Special Populations Justification
1. Justification
If more than one special population is enrolled, separate justifications should be
provided for each unique population.
* What is the justification for the inclusion of these subjects?
Older adults/elderly are the main focus of this study and therefore required to be
included.
 
2. Safeguards
Include the measures that will be taken to minimize any potential coercion or undue
influence in recruitment and ongoing participation in the study.
* Describe the additional safeguards that have been included in this
study to protect the rights and welfare of these subjects.
We will only include participants with the cognitive capacity to consent as defined
by lack of MCI or dementia diagnosis.
 

2023-0650
SF: nPBA: Recruitment Methods
Recruitment Methods
1. Recruitment Plan
This description should address what methods will be used, when and how often they
will be used, and how many times potential subjects will be contacted.
* Describe the recruitment plan for this study.
Participants will be recruited nationally (within the United States) primarily via
social media advertisements. Should these efforts fail, we will use flyers, web
banners, and television advertisements. If television advertisements are used, we
will upload a TV ad script with a COP at that time. The English translation of the La
Communidad web banner ad is as follows: "Are you 50 to 80 years old and smoke?
Get paid up to $75 for sharing your opinions on smoking in English for a University
of Wisconsin research study via phone. You do NOT need to quit smoking. Click
here!" Those interested in participating in the study will complete the online
qualtrics screener or call the provided contact information to enroll in the study
directly with UW-CTRI staff. Upon contacting UW-CTRI we will confirm their location
via their provided address.
 
2. Recruitment Material Upload
Upload recruitment materials such as recruitment emails, letters, phone
scripts, brochures, or advertisements.

facebook ad_v3(0.04)

LaCommunidad-Ad_v1(0.01)
MCAS_TVadscript_v1_09_13_2023(0.01)

recruitment flyer_v3(0.04)
3. Approved Recruitment Database Usage
* Are you using an IRB approved recruitment database to disseminate
recruitment materials or to contact subjects?
  Yes  No

2023-0650
SF: nPBA: Subject Screening
Subject Screening
1. Preliminary Eligibility Screen
* Will subjects undergo a preliminary screen to determine basic
eligibility?
  Yes  No
1.1. Screening Materials
* Upload a copy of the screening questionnaire.
Phone Screen v4(0.05)
qualtrics screen_v4(0.04)
1.2. Data Retention
If you are retaining screen data, the previously uploaded questionnaire/script
should address this and include authorization language for maintaining PHI if
HIPAA applies.
* Will you be retaining screen data from subjects who do not
enroll in the study?
  Yes  No 
1.2.1. Retention Justification
Describe the purpose of retaining the screen data.
Phone screen data will be maintained separately from the
participant database once these data are not needed for study
operations.
 
1.2.2. Data Storage and Maintenance
Describe where the screen data will be maintained. If
these data will be retained in a recruitment database,
indicate whether the development of a recruitment

database is the purpose of this study OR provide the IRB
protocol number of the database.
All phone screen data for those who do not consent to participate
in the study will be maintained in HIPAA-de-identified form until
the end of the study and then destroyed.
 
2. Planned Study Procedures Before Obtaining Consent
Examples include fasting, discontinuing medications, etc.
* Will there be any procedures performed before informed consent is
obtained from subjects (apart from screening)?
  Yes  No

2023-0650
SF: nPBA: Renumeration and Costs
Remuneration and Costs
1. Payment
* Will subjects be compensated to participate in the study?
  Yes  No
1.1. Travel and Other Expenses
* Is payment limited to covering travel expenses and other
costs incurred by subjects as a result of study participation?
  Yes  No 
1.2. Payment Plan
Include the amount of payment(s), proration, multiple payment schedules,
etc. Payments to research participants must adhere to campus policy.
Questions about payment methods can be directed to Business Services.
* Describe the payment plan.
Participants will be paid $35 for their time and effort for the first phone
interview and $40 for the second interview (max. possible/person=$75).
Additionally, up to 20 participants will be invited to participate in a brief
qualitative interview following the second survey interview. Those who
participate in this optional additional interview will be paid $25 more for
their additional time and effort.
 
1.3. Child/Parent Payment
* Are any payments being offered to child subjects?
  Yes  No
1.4. Nonmonetary Compensation
* Will nonmonetary compensation be offered?
  Yes  No  

 
2. Costs
* Will subjects incur any costs as a result of study participation
(pharmacy preparation fees, payment for a device, billing of study
procedures to subjects insurance)?
  Yes  No  

2023-0650
SF: nPBA: Privacy and Confidentiality
Privacy and Confidentiality
1. Privacy Plan
Privacy is defined in terms of having control over the extent, timing, and circumstances
of sharing oneself (physically, behaviorally, or intellectually) with others. In the context
of research, this primarily pertains to methods used to obtain information about
subjects or the setting in which research takes place. 
* Explain how the subjects' privacy will be protected. (e.g., research
intervention is conducted in a private room).
All communications regarding research activities will be directly with the consented
participant and from a location where privacy can be maintained. Participant study
data will be collected by research personnel and will be stored on secure, password
protected servers. Data will be accessible only to assigned study staff for their
study function; computer workstations will be password-protected, and thus
secured from unauthorized use. A Certificate of Confidentiality will be issued for the
study.
2. Level of Identifiability
* Select how subjects are identified in the data. Check all that apply.
Directly: Direct Identifiers stored on data (e.g., name, initials, phone number, SSN, or
medical record number, stored on data)
2.1. Necessity of Data
* Explain the necessity of collecting or maintaining data
linked to subjects’ identities.
This will allow for study payments to be sent to participants and to
contact participants for follow up assessments. Data will be stored in a
password protected file on a secure departmental server.
 
2.2. Retaining Data
* How long will data linked to subjects’ identities be retained?
Subject identify will be linked to data until data collection is complete.

At that time, participants information will be deidentified.
 
3. Data Protection Plan
Records and data include informed consent documents, case report forms or study flow
sheets, survey instruments, database or spreadsheet, screening logs or telephone
eligibility sheets, web based information gathering tool, audio/video/photo recordings
of subjects, labeled specimens, data about subjects, subject identifiers, etc.
The study team should describe how data confidentiality will be protected. Some
measures that are often used and acceptable to the IRB are: using codes so that no
direct subject identifiers are recorded on data collection sheets; creating codes for data
that are not based on subject identifiers (i.e., avoiding codes that include subject
initials or are based on birth dates); and destroying the link to the code as soon as
possible.
* How will the study team protect research records, data, and/or
specimens against inappropriate use or disclosure, or malicious or
accidental loss, or destruction? Include how and where the data and/or
specimens will be stored.
Video and/or audio files will be recorded using a secure device and will be stored in
a restricted access folder on the department server. Audio files are for transcription
purposes only and will be permanently destroyed as soon as transcription is
complete. If names or identifiable information are revealed during the recordings,
this information will not recorded in the transcription. Electronic files will be stored
on a secure department server.
Servers at the UW-CTRI Madison office are physically secured in a locked room.
Data backups are created nightly and stored in a locked safe. Significant safeguards
have been implemented to protect data including virus and adware protection,
firewall, access controls and encryption when appropriate such as wireless and
remote access. All UW-CTRI staff members have completed HIPAA and human
subjects training and are aware of the sensitivity of study-related data. The UW-
SMPH has developed school-wide data security policies and procedures. UW-CTRI
data security policies and procedures conform to those of the UW-SMPH. No
publications or presentations resulting from this research program will contain any
identifying information about individual participants. Following cleaning and
verification of data at the conclusion of the study, all research data will be placed in
a de-identified data set at UW-CTRI.
4. Certificate of Confidentiality
If NIH, CDC, FDA, or other federal funding from an agency that automatically issues a
Certificate of Confidentiality as part of the terms of the award, answer “Yes”.
* Is there a Certificate of Confidentiality (CoC), or will one be obtained,
for this research?
  Yes  No 

4.1. CoC Details
* Select the answer that applies to your CoC.

I will rely on a CoC that is included as part of current NIH, CDC,
FDA, or other federal funding from an agency that
automatically issues a Certificate of Confidentiality as part of
the terms of the award.

I will apply for a CoC (there is no NIH, CDC, FDA, or other federal
funding from an agency that automatically issues a Certificate of
Confidentiality as part of the terms of the award).
I have obtained a CoC.
 

2023-0650
SF: nPBA: Retention of Data and/or Specimens
Retention of Data and or Specimens
1. Future Research Plans
* Will data and/or specimens collected for this study be banked for
future research outside the scope of the current project?
  Yes  No 

2023-0650
SF: nPBA: Consent General
Consent: General
1. Obtaining Consent/Assent
* Will you obtain consent or assent from some or all participants?
  Yes  No 
1.1. Signed Consent/Assent
* Will you obtain signed consent or assent from all
participants?
  Yes  No 
1.2. Altering Required Elements
* Are you proposing to alter required elements of consent or
assent (e.g. required information will not be disclosed, or the
research involves deception)?
  Yes  No 
1.3. No Consent/Assent
* Are there some participants from whom you will not obtain
consent or assent?
  Yes  No 
 

2023-0650
SF: nPBA: Waiver of Signed Consent
Waiver of Signed Consent
1. Waiver of Signed Consent Process
* Are you requesting a waiver of signed consent for all components of
the study?
  Yes  No
2. Criteria
* Under which of the following criteria does this research qualify for
waiver of signed consent? The research presents no more than minimal risk of
harm to subjects and involves no procedures for which written consent is normally
required outside of the research context.
3. Criteria Justification
* Provide a justification for the criterion selected above.
The research is a benign behavioral intervention that will be of minimal risk to the
participants. Data security measures minimize the risk of breach of confidentiality,
and the study activities do not normally require written consent outside the
research context.

2023-0650
SF: nPBA: Consent Details
Consent Overview
1. Consent Process
* Describe the consent process, including when and where it will occur
and how the consent process will be conducted (e.g., face to face, phone
or video discussion) and how consent information will be provided to
participants (e.g., in person, mailed/emailed).
Consenting will be done over the phone. After completing the Phone Screen, study
staff will use the Study Information Sheet (see uploaded Study Information Sheet)
to discuss study procedures and all elements of informed consent including:
• Study sponsor
• Invitation/Summary
• Study purpose
• Study participation, including assessments, schedule of study contacts, and
treatment overview
• Risks, Benefits, and Costs
• Payment for participation
• How to revoke authorization
• Confidentiality
• How to contact study staff
We will provide a text copy of the the information sheet to the participants by mail
after the initial call. Due to the screening and initial survey assessment occurring in
the same call it is not feasible to provide the information to the participants prior to
the first call. We will offer to email participants the information sheet if they
explicitly ask for it, otherwise it will be mailed to participants.
2. Special Populations Involved
* Will the study enroll participants with limited English proficiency, who
are illiterate/low-literacy, or have visual/hearing impairments?
  Yes  No
3. Qualification Affirmation
* Do you confirm that all study personnel responsible for obtaining
informed consent have the following qualifications: 1) are familiar with
the details of the study; 2) will ensure subjects are provided with
sufficient information to make an informed and voluntary decision about
study participation; 3) are familiar with UW-Madison policies regarding

informed consent?
  Yes  No 

2023-0650
SF: nPBA: Consent Upload
Consent and Authorization Upload
1. Consent/Assent Documentation
• E.g., information sheet, consent form, assent form, translated consent documents.
• Please use IRBs informed consent templates to develop consent processes and
documents for non-exempt studies.
• For educational and social-behavioral studies, you can use the Consent Form Wizard.
The Wizard does not include HIPAA authorization language.
* Upload all consent authorization, and/or assent documents.
consent process_v2(0.02)
Study information sheet_v4(0.06)

2023-0650
SF: nPBA: HIPAA General
HIPAA
1. Identifiable Information
* Will the research involve identifiable health information for any
reason?
  Yes  No 
1.1. UW Madison Health Care Component or Madison
VA
The HCC of the UW-Madison currently includes SMPH clinical departments;
School of Pharmacy (clinical units only); School of Nursing; University Health
Services (non-student records only); State Laboratory of Hygiene; and
Waisman Center (clinical units only). Ensure the PI or any study team
members are covered under HIPAA Privacy Rule regulations as part of their
appointment.
* Are you or any member of the study team conducting the
study under an appointment that is within the UW-Madison
Health Care Component (HCC) and/or Affiliated Covered Entity
(ACE) or the Madison VA?
  Yes  No 
1.2. HIPAA Authorization
* Will HIPAA authorization for access to the PHI be obtained for
all or some subjects, or for only some uses?
Yes, always: HIPAA authorization will be obtained from all subjects with
signed documentation.

Yes, sometimes or without signed documentation: HIPAA
authorization will not be obtained from some subjects/uses or
may be obtained without a signature.
No: HIPAA authorization will not be obtained from any subjects.
1.3. External PHI Access
* Will you access or obtain fully identifiable health information
from a health care provider that is not UW or UW Health or the
Madison VA, such as Meriter or ACHC, without first obtaining

patient permission or authorization?
  Yes  No 

2023-0650
SF: nPBA: HIPAA Partial Waiver and Authorization
Authorization and Waivers
When sharing fully identifiable health information outside of UW or UW
Health or obtaining it from a covered entity that is not UW or UW Health
(e.g. bringing PHI from Meriter to a UW workstation to contact for phone
screening or to recruit), you may need a partial waiver of authorization and
accounting for disclosures may be required. Please consult with the HIPAA
Privacy Officer and consult the Accounting for Disclosures Guidance found
here.
1. HIPAA Requirement Fulfillment
* Please select which option(s) will be applied to fulfill HIPAA
requirements.
Request Partial Waiver or Altered Authorization
2. Applicable HIPAA Identifiers
Select which of following identifiers will be associated with the health
information you propose to collect for study purposes. Check all that
apply to your study. If none of these identifiers will be collected for you
study, select 'None of the Above'.
Names
Geographic subdivisions smaller than a state
All elements of dates (except year) related to an individual including:
*Dates of admission, discharge, or service
*Dates of birth or death
Telephone numbers
Electronic mail addresses

2023-0650
SF: nPBA: HIPAA Request for Partial Waiver/Authorization
Request for Authorization/Waivers
When sharing fully identifiable health information outside of UW or UW
Health or obtaining it from a covered entity that is not UW or UW Health
(e.g. bringing PHI from Meriter to a UW workstation to contact for phone
screening or to recruit), you may need a partial waiver of authorization and
accounting for disclosures may be required. Please consult with the HIPAA
Privacy Officer and consult the Accounting for Disclosures Guidance found
here.
1. Altered Authorization
HIPAA authorization for research must be project-specific. Standard clinical consent
and authorization does not cover research use. If you will not obtain authorization in
writing or seek to significantly modify the standard HIPAA authorization language, an
altered authorization is necessary.
* Are you requesting an altered authorization?
  Yes  No
1.1. Altered Authorization - Details
Please describe how authorization will be altered.
Verbal authorization
2. Partial Waiver of Authorization
If you will not obtain authorization from any subjects, a full waiver is required.
* Are you requesting a partial waiver of authorization? 
  Yes  No
3. Type of PHI Records
* Identify the PHI to be used. Select all that apply.
Demographic information

4. Confirm Policy for Sharing PHI Externally
For help, see HIPAA – Privacy & Security Coordinators. Examples of directly identifiable
data is data that includes name, MRN, narrative text fields, or a rare condition that can
be traced back to an individual.
  If you disclose directly identifiable PHI outside the HIPAA covered entity
under which you are conducting the study, confirm you will contact the
UW Madison HIPAA Privacy Officer or the Madison VA Privacy Officer.
  Yes  No 
5. PHI Protection Plan
 
* Describe your plan to protect PHI form unauthorized use or
disclosure.
Paper files will be stored in a secure campus location and destroyed after data has
been entered electronically.
Electronic files will be stored on a secure department server.
Only approved personnel will have access to study data.
 
6. PHI Destruction Plan
 
* Describe your plan for destroying identifiers at the earliest possible
opportunity.
Identifiers will be destroyed at study closure.
 
7. Waiver/Alteration Justification
 
* Explain why the study cannot practicably be conducted without the
waiver of authorization or altered authorization.
Signed consent will not be obtained in the interest of limiting the number of study
documents with the participant’s name and participation in the study activities

indicates consent and authorization.
Only the minimum necessary PHI needed will be collected.
 
8. Limitations Confirmation
* Federal law prohibits the re-use or disclosure of PHI in connection
with this research to any person or entity other than those authorized to
receive it, except: (1) as required by law; (2) for authorized oversight of
the research; or (3) in connection with other research for which the
HIPAA Privacy Rule permits the PHI to be used or disclosed. Do you
agree to abide by these limitations in order to obtain a waiver of
authorization?
  Yes  No 

2023-0650
SF: nPBA: Recordings and Photographs
Audio/Video Recordings and Photographs
1. Recordings Collected
* Select which of the following will be collected for this study. Check all
that apply.

Audio recordings

Video recordings

Photographs
2. Identifiable Recordings
E.g., full face photo/video, audio recording of first and last name, or other individually
identifiable information.
* Will the subject be identifiable in the audio/video recording or
photograph?
  Yes  No   
3. Retain Recordings
* Will the audio/video recordings or photographs be retained beyond
the conclusion of this study?
  Yes  No   
4. External Transcription
* Will anyone outside the study team transcribe audio recordings?
  Yes  No 
4.1. Transcriber Details
* Indicate who will perform the transcription.
Transcription will be done by a professional transcription service.

 

2023-0650
SF: nPBA: Interviews, Focus Groups, Surveys, Questionnaires
Interviews, Focus Groups, Surveys,
Questionnaires
1. Tool Details
* Describe the interview tools, questionnaires, or surveys that will be
used. Click the add button to provide information about each tool to be
used.
View
   
Tool
Description
Optional Qualitative Interview  
Tool
Standardized
No  
File name
Outline of Qualitative Interviews_V1_2023.10.13.docx
Tool Manner
Telephone
Tool Manner
Other
No Value Entered  
Date
Modified
10/20/2023  
View
   
Tool
Description
Follow Up Survey  
Tool
Standardized
No  
File name
MCAS Aim 3 3 Month Follow Up
Questionnaire_V2_10_20_23_trackedchanges.docx
Tool Manner
Telephone
Tool Manner
Other
No Value Entered  
Date
Modified
10/20/2023  
View
   
Tool
Description
Baseline Survey  
Tool
Standardized
No  
File name
MCAS Aim 3 Baseline Questionnaire_V5
Tool Manner
Telephone

Tool Manner
Other
No Value Entered  
Date
Modified
9/13/2023  
2. Cognitive or Psychological Assessment
* Are any of the uploaded instruments used to assess cognitive or
psychological status or function?
  Yes  No

2023-0650
SF: nPBA: Interviews, Focus Groups, Surveys, Questionnaires Cont.
Interviews, Focus Groups, Surveys,
Questionnaires Cont.
1. Focus Group
* Will the study involve conducting focus groups?
  Yes  No
2. In-Home Visit
* Does the study involve in-home visits?
  Yes  No

2023-0650
SF: nPBA: Supplemental Information
Supplemental Information
1. Additional Documents
Provide any additional relevant documents (e.g., data sharing
agreements, letters of support, MOUs, site permission letters), if
applicable.

active control flyer 1(0.01)

active control flyer 2(0.01)

active control flyer 3(0.01)
active control videos(0.01)

fear flyer(0.01)

fear video(0.01)
MCAS Mailing 1 Cover Letter Active Control and Treatment
Condition (Groups 1, 2, 4)_v2(0.02)
MCAS Mailing 1 Cover Letter No Treatment Condition (Group
3)_v2(0.02)
MCAS Mailing 2 Cover Letter Active Control and Treatment
Condition (Groups 1, 2, 4)_v2(0.02)
MCAS Mailing 3 Cover Letter Active Control and Treatment
Condition (Groups 1, 2, 4)_v2(0.02)
MCAS Mailing for Follow-up Payment v1_11_8_23.docx(0.01)
MCAS Video Group 1 Email 1.docx(0.01)
MCAS Video Group 1 Email 2.docx(0.01)
MCAS Video Group 1 Email 3.docx(0.01)
MCAS Video Group 1 Email
3_V2_10_20_23_trackedchanges.docx(0.01)
MCAS Video Group 2 Email 1.docx(0.01)
MCAS Video Group 2 Email 2.docx(0.01)
MCAS Video Group 2 Email 3.docx(0.01)
MCAS Video Group 2 Email
3_V2_10_20_23_trackedchanges.docx(0.01)
MCAS Video Group 4 Email 1.docx(0.01)

MCAS Video Group 4 Email 2.docx(0.01)
MCAS Video Group 4 Email 3.docx(0.01)
MCAS Video Group 4 Email
3_V2_10_20_23_trackedchanges.docx(0.01)
1.1. Describe Documents
Describe what additional documents were added in 1.
We have added a cover letter to be included with the participants' final study
payment.
 

2023-0650
SF: nPBA: Final Page
Final Page
1. Assurance
The information presented in this application is accurate;
If the application is being submitted on behalf of the Principal
Investigator (PI) rather than by the PI, the information presented was
done so with the PI's agreement; and
The specific aims and description of research (including subject
population, subject interventions, collaborators, performance sites, and
general scope of work) in this IRB application are consistent with those
described in the sources of support listed as providing financial and/or
material resources to conduct this study.
* Do you certify the above statements?
  Yes  No
2. Complete and Submit Application Instructions
To complete and submit this application to the IRB office, please follow the steps
below:
Select 'Finish' or 'Exit' on this page to be directed to the application workspace.
In the application workspace, click the Submit activity to send the application to
the IRB office. NOTE: The Submit activity is only available to certain study team
members.
 

Statistical Analysis Plan  
 
Dr. Johnson will use SPSS to examine differences in changes in motivation (primary), number of 24 hour 
quit attempts (secondary), and use of evidence-based treatment (secondary) between groups. 
Specifically, she will examine differences in mean scores from baseline and follow up between the 
treatment group and three control groups. Given the pilot nature of this study, we will not be 
statistically powered to conduct regression analyses. Therefore, descriptive analyses will be the primary 
analytic method.