Seed-alter Dyad Social Support Intervention for Rural Dwelling Older Adults With T2DM
Phase: NA
Conditions: Type 2 Diabetes
Sponsor: Brittany L Smalls

Document Coversheet 
 
 Study Title: Seed-alter Dyad Social Support Intervention for Rural Dwelling Older Adults With 
T2DM 
Institution/Site:  
University of Kentucky 
Document (Approval/Update) Date: 
6/12/2024 
NCT Number: 
NCT04568486 
IRB Number 
45777 
Coversheet created: 
11/6/2024 
 
 

PROTOCOL TYPE (VERSION 4)
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comment(s)
 
IMPORTANT NOTE: You will not be able to change your selections for "Which IRB" and "Protocol Process Type" after
saving this section. If you select the wrong IRB or Protocol Process Type, you may need to create a new application. 
For guidance, see:
Which IRB?
Which Protocol Process Type?  
"Getting Started"
Please contact the Office of Research Integrity (ORI) at 859-257-9428, IRBsubmission@uky.edu, or request a consult to resolve any
questions prior to saving your selections.
 
Which IRB
Medical
NonMedical
Protocol Process Type
Exemption
Expedited
Full
(Must be risk level 1)
 
 
The revised Common Rule expanded exemption certification category 4 for certain secondary research with
identifiable information or biospecimens. The regulations no longer require the information or biospecimens to be
existing.  For more information see the Exemption Categories Tool.
 
Section 1 Page 1 of 1
IRB Approval
6/12/2024
IRB # 45777
IRB2

EXPEDITED CERTIFICATION
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To Be Completed Only If Protocol is to Receive Expedited Review
Applicability
A. Research activities that (1) present no more than *minimal risk to human subjects, and (2) involve only procedures listed in one or
more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR
46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on
this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the
specific circumstances of the proposed research involve no more than minimal risk to human subjects.
B. The categories in this list apply regardless of the age of subjects, except as noted.
C. The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably
place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation,
or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and
breach of confidentiality are no greater than minimal.
D. The expedited review procedure may not be used for classified research involving human subjects.
E. IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of
the type of review—expedited or convened—utilized by the IRB.
*“Minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in
and of themselves from those ordinarily encountered in daily life or during the performance of routine physical or psychological
examination or tests. 45 CFR 46.102(i)
Check the appropriate categories that apply to your research project:
 Study was originally approved by the full IRB at a convened meeting.
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 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 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.**
* Study must meet one of the IDE Exempt categories listed on the Device Form Attachment. 
** An approved Device used in research according to its approved labeling is considered Exempt from IDE requirements. 
NOTE: Select Category 1 for compassionate use medical device applications or individual patient expanded access
investigational drug applications for which FDA has waived the requirement for full review.
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 subjects, 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 subjects, the collection procedure, the
amount of blood to be collected, and the frequency with which it will be collected. For these subjects, 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.
NOTE: Intravenous (IV), Port, Central, or any other lines are NOT eligible under this category even if the research involves
“minimal risk”.
*In Kentucky, “child/children” refers to all individuals less than 18 years of age unless the individual(s) is/are legally
emancipated. (See Informed Consent SOP for discussion of “Emancipated Individuals” under Kentucky state law.)
Individuals less than 18 years of age who are not emancipated meet the federal definition for “child” (e.g., DHHS, FDA, and
U.S. Department of Education). Children are defined in the HHS regulations as “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.” If conducting research outside the state of Kentucky, you are responsible for complying with
applicable state law.
3) Prospective collection of biological specimens for research purposes by noninvasive means. Examples:
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45777

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 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 noninvasive 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 subject or an invasion of the subject’s 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 echocardiography;
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 or will be collected solely for non-
research purposes (such as medical treatment or diagnosis) as well as research involving existing information or specimens that
were previously collected for research purposes, provided they were not collected for the currently proposed research. (Note:
Some research in this category may qualify for Exempt review. This listing refers only to research that is not exempt.) 
(Note: If submission includes materials previously collected for either non-research or research purposes in a protocol for which
IRB approval expired, you may check Category 5. However, a separate category must also be selected for prospective collection
of data/specimens obtained solely for research purposes)
6) Collection of data from voice, video, digital, or image recordings made for research purposes.
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 subjects. This listing refers
only to research that is not exempt.)
Section 2 Page 2 of 2
45777

MODIFICATION REQUEST SECTION
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*** If this modification changes the scope of your activities to include COVID-19 related research, please insert “COVID19” at
the start of your Project and Short Titles.***
Select One:
This modification does not increase risk to study participants.
This modification may or will increase risk to study participants.
Is this modification request due to an Unanticipated Problem/Adverse Event, or Protocol Violation?
Yes
No
In your professional opinion, does this modification involve information that might relate to a subject’s willingness to continue to
take part in the research?
Yes
No
If yes, state how the information will be communicated to subjects (i.e., re-consent, send letter, etc.):
For each proposed modification, include a justification.
Example: Jane Doe, MD, is being added as co-investigator because she has expertise with the subjects on this protocol.
She has completed human subject protections training, and is authorized to obtain consent.
Change in study personnel.
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PROJECT INFORMATION
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Title of Project: (Use the exact title listed in the grant/contract application, if applicable). 
If your research investigates any aspect of COVID-19, please include "COVID19" at the beginning of your Project Title and Short Title 
Social Network Analysis and Social Support Intervention
for Older Rural Dwelling Adults with T2DM
Short Title Description 
Please use a few key words to easily identify your study - this text will be displayed in the Dashboard listing for your study.
STUDY 2: Rural Dwelling Older
Adults with T2DM
Anticipated Ending Date of Research Project: 
Maximum number of human subjects (or records/specimens to be reviewed) 
262
After approval, will the study be open to enrollment of new subjects or new data/specimen collection? 
Yes
No
Are you requesting that the UK IRB serve as the lead IRB for a multi-site study, OR that the UK IRB defer review to another IRB? [Click
here for "IRB Reliance" help]
Yes
No
If "Yes," before completing your IRB application, fill out the Reliance Request Form and submit it to irbreliance@uky.edu.
3/31/2024
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PI CONTACT INFORMATION
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Principal Investigator (PI) role for E-IRB access
The PI is the individual holding primary responsibility on the research project with the following permissions on the E-IRB application:
1. Read; 
2. write/edit;
3. receive communications; and 
4. submit to the IRB (IR, CR, MR, Other Review*).
If research is being submitted to or supported by an extramural funding agency such as NIH, a private foundation or a
pharmaceutical/manufacturing company, the PI listed on the grant application or the drug protocol must be listed as PI here. 
Please fill in any blank fields with the appropriate contact information (gray shaded fields are not editable). Required fields left blank will
be highlighted in pink after you click "Save".
To change home and work addresses, go to myUK and update using the Employee Self Service (ESS) portal. If name has changed,
the individual with the name change will need to submit a 'Name Change Form' to the Human Resources Benefits Office for entering
into SAP. The new name will need to be associated with the individual's Link Blue ID in SAP before the change is reflected in E-IRB.
Contact the HR Benefits Office for additional information.
The Principal Investigator's (PI) contact information is filled in automatically based on who logged in to create the application.
If you are not the Principal Investigator, do NOT add yourself as study personnel.
To change the PI contact information on an application in Researcher edit status:
click "Change Principal Investigator";
search for the PI's name using the search feature;
click "Select" by the name of the Principal Investigator, then "Save Contact Information".
You will automatically be added as study personnel with editing permissions to continue editing the application.
Change  Principal Investigator:
First Name: Brittany
Room# &
Bldg: 2195 Harrodsburg Rd
Suite 125
Last Name: Smalls
Speed
Sort#: 
40504
Middle Name L
Department:
Dept Code: 7H460
 
PI’s
Employee/Student
ID#:
12224507
Rank: 
Assistant Professor
 
PI's Telephone #:
859-323-4619
Degree: PhD, MHSA,
MSHPsych
PI's e-mail
address: Brittany.Smalls@uky.edu
PI's FAX
Number:
PI is R.N. 
Yes
No
HSP Trained: Yes
HSP Trained
Date: 1/1/2023
RCR Trained: Yes
Do you, the PI, have a significant financial interest related to your responsibilities at the University of Kentucky (that requires
disclosure per the UK administrative regulation 7:2)?
Yes
No
Family and Community Medici… 
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Section 5 Page 2 of 2
45777

RISK LEVEL
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Indicate which of the categories listed below accurately describes this protocol
(Risk Level 1) Not greater than minimal risk
(Risk Level 2) Greater than minimal risk, but presenting the prospect of direct benefit to individual subjects
(Risk Level 3) Greater than minimal risk, no prospect of direct benefit to individual subjects, but likely to yield generalizable
knowledge about the subject's disorder or condition.
(Risk Level 4) Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious
problem affecting the health or welfare of subjects.
*“Minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of
themselves from those ordinarily encountered in daily life or during the performance of routine physical or psychological
examination or tests.
***For Expedited and Exempt Applications, the research activities must be Risk Level 1 (no more than minimal risk to
human subjects).***
Refer to UK's guidance document on assessing the research risk for additional information.
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45777

SUBJECT DEMOGRAPHICS
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Age level of human subjects: (i.e., 6 mths.; 2yrs., etc..) 18 to 99
Study Population:
Describe the characteristics of the subject population, including age range, gender, ethnic background and health status. Identify the criteria for inclusion and
exclusion. 
Provide the following information:
A description of the subject selection criteria and rationale for selection in terms of the scientific objectives and proposed study design;
A compelling rationale for proposed exclusion of any sex/gender or racial/ethnic group;
Justification for the inclusion of vulnerable groups such as children, prisoners, adults with impaired consent capacity, or others who may be vulnerable to
coercion or undue influence.
Please consider these resources: 
NIH Diversity Policy 
FDA Diversity Guidance 
"Seeds", Older adult population: Type 2 diabetes patients in Kentucky, recruited from the Barren River Area Development District (BRADD), Community Action
Southern, and Barnstable Brown Diabetes Center. Study eligibility includes: (1) confirmed diagnosis of T2DM via electronic medical record; (2) age =55 years;
(3) able to provide consent; and (4) have had at least one clinic visit in the past year. These individuals will participate in the semi-structured interviews of Aim 2
to evaluate and understand current social support.
"Alters", Community Health Workers population: As a result of social network analysis of individual older adults (seeds) in Aim 1, a member of the social
network (alter) will be identified to participate in the intervention as a seed-alter dyad (N=262) social support intervention. Alter eligibility includes: =18 years of
age, able to provide informed consent, has at least weekly contact with the seed.
Attachments
Indicate the targeted/planned enrollment of the following members of minority groups and their subpopulations. Possible demographic
sources: Census Regional Analyst Edition, Kentucky Race/Ethnic Table, Kentucky Population Data. 
(Please note: The IRB will expect this information to be reported at Continuation Review time for Pre-2019 FDA-regulated
Expedited review and Full review applications):
Participant Demographics
Cisgender Man 
Cisgender Woman 
TGNB/TGE 
Unknown/Not Reported
American
Indian/Alaskan
Native:
Asian:
Black/African
American:
Latinx:
Native
Hawaiian/Pacific
Islander:
White:
American
Arab/Middle
Eastern/North
African:
Indigenous
People Around
the World:
More than One
Race:
Unknown or Not
Reported:
 
If unknown, please explain why:
Indicate the categories of subjects and controls to be included in the study. You may be required to complete additional forms depending on
the subject categories which apply to your research. If the study does not involve direct intervention or direct interaction with subjects, (e.g.,
record-review research, outcomes registries), do not check populations which the research does not specifically target. For example: a large
record review of a diverse population may incidentally include a prisoner or an international citizen, but you should not check those categories
if the focus of the study has nothing to do with that status.
1
1
0
1
1
2
0
0
0
0
125
131
0
0
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Check All That Apply (at least one item must be selected)
Children (individuals under age
18)
Wards of the State (Children)
Emancipated Minors
Students
College of Medicine Students
UK Medical Center Residents or
House Officers
Impaired Consent Capacity
Adults
Pregnant Women/Neonates/Fetal
Material
Prisoners
Non-English Speaking (translated
long or short form)
International Citizens
Normal Volunteers
Military Personnel and/or DoD
Civilian Employees
Patients
Appalachian Population
ADDITIONAL INFORMATION:
Please visit the IRB Survival Handbook for
more information on:
Children/Emancipated Minors
Students as Subjects
Prisoners
Impaired Consent Capacity Adults
Economically or Educationally
Disadvantaged Persons
Other Resources:
UKMC Residents or House Officers
[see requirement of GME]
Non-English Speaking [see also the
E-IRB Research Description section
on this same topic]
International Citizens [DoD SOP may
apply]
Military Personnel and/or DoD Civilian
Employees
Section 7 Page 2 of 3
45777

Traumatic brain injury or acquired brain
injury
Severe depressive disorders or Bipolar
disorders
Schizophrenia or other mental disorders
that
involve serious cognitive disturbances
Stroke
Developmental disabilities
Degenerative dementias
CNS cancers and other cancers with
possible CNS involvement
Late stage Parkinson’s Disease
Late stage persistent substance
dependence
Ischemic heart disease
HIV/AIDS
COPD
Renal insufficiency
Diabetes
Autoimmune or inflammatory disorders
Chronic non-malignant pain disorders
Drug effects
Other acute medical crises
Assessment of the potential recruitment of subjects with impaired consent capacity (or likelihood):
Check this box if your study does NOT involve direct intervention or direct interaction with subjects (e.g., record-review research, secondary
data analysis). If there is no direct intervention/interaction you will not need to answer the impaired consent capacity questions.
Does this study focus on adult subjects with any conditions that present a high likelihood of impaired consent capacity or fluctuations in
consent capacity? (see examples below)
Yes
No
If Yes and you are not filing for exemption certification, go to "Form T", complete the form, and attach it using the button below.
Examples of such conditions include:
Attachments
Attach Type
File Name
ImpairedConsent Form_T_1Ai STUDY 2 Rural Dwelling Older Adults with T2DM.doc
Section 7 Page 3 of 3
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INFORMED CONSENT/ASSENT PROCESS/WAIVER
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For creating your informed consent attachment(s), please download the most up-to-date version listed in "All Templates" under the
APPLICATION LINKS menu on the left, and edit to match your research project.
Additional Resources:
Informed Consent/Assent Website
Waiver of Consent vs. Waiver of Signatures
Sample Repository/Registry/Bank Consent Template
Consent/Assent Tips:
If you have multiple consent documents, be sure to upload each individually (not all in a combined file).
If another site is serving as the IRB for the project, attach the form as a “Reliance Consent Form” so the document will not receive
a UK IRB approval stamp; the reviewing IRB will need to stamp the consent forms.
Changes to consent documents (e.g., informed consent form, assent form, cover letter, etc...) should be reflected in a 'tracked
changes' version and uploaded separately with the Document Type "Highlighted Changes".
It is very important that only the documents you wish to have approved by the IRB are attached; DELETE OUTDATED FILES --
previously approved versions will still be available in Protocol History.
Attachments that are assigned a Document Type to which an IRB approval stamp applies will be considered the version(s) to be
used for enrolling subjects once IRB approval has been issued. 
Document Types that do NOT get an IRB approval stamp are:
"Highlighted Changes",
"Phone Script", and
"Reliance Consent Form",
"Sponsor's Sample Consent Form".
How to Get the Section Check Mark
1. You must:
a) provide a response in the text box below describing how investigators will obtain consent/assent, and 
b) check the box for at least one of the consent items and/or check mark one of the waivers
2. If applicable attach each corresponding document(s) as a read-only PDF.
3. If you no longer need a consent document approved (e.g., closed to enrollment), or, the consent document submitted does not
need a stamp for enrolling subjects (e.g., umbrella study, or sub-study), only select "Stamped Consent Doc(s) Not Needed".
4. After making your selection(s) be sure to scroll to the bottom of this section and SAVE your work!
Check All That Apply
Informed Consent Form (and/or Parental Permission Form and/or translated short form)
Assent Form
Cover Letter (for survey/questionnaire research)
Phone Script
Informed Consent/HIPAA Combined Form
Debriefing and/or Permission to Use Data Form
Reliance Consent Form
Sponsor's sample consent form for Dept. of Health and Human Services (DHHS)-approved protocol
Stamped Consent Doc(s) Not Needed
Attachments
Attach Type
File Name
Informed Consent/HIPAA Combined Form 2.23.23_SeedConsent_Clean.pdf
Informed Consent/Parental Permission
2.22.23_AlterConsent_Clean.pdf
Informed Consent Process:
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Using active voice, describe how investigators will obtain consent/assent. Include:
the circumstances under which consent will be sought and obtained
the timing of the consent process (including any waiting period between providing information and obtaining consent)
who will seek consent
how you will minimize the possibility of coercion or undue influence
the method used for documenting consent
if applicable, who is authorized to provide permission or consent on behalf of the subject
if applicable, specific instruments or techniques to assess and confirm potential subjects’ understanding of the information
Note: all individuals authorized to obtain informed consent should be designated as such in the E-IRB "Study Personnel" section of
this application.
Special considerations may include:
Obtaining consent/assent for special populations such as children, prisoners, or people with impaired decisional capacity
Research Involving Emancipated Individuals 
If you plan to enroll some or all prospective subjects as emancipated, consult with UK legal counsel prior to submitting this
application to the IRB. Include research legal counsel’s recommendations in the "Additional Information" section as a separate
document.
Research Involving Non-English Speaking Subjects 
For information on inclusion of non-English speaking subjects, or subjects from a foreign culture, see IRB Application Instructions
for Recruiting Non-English Speaking Participants or Participants from a Foreign Culture.
Research Repositories 
If the purpose of this submission is to establish a research repository describe the informed consent process. For guidance
regarding consent issues, process approaches, and sample language see the Sample Repository/Registry/Bank Consent
Template.
All study personnel will be CITI/HSP certified and able to obtain consent. Both the seed and alter must give his/her own consent
before participating in the intervention. Individuals will be consented prior to the start of the intervention, and will be able to participate
immediately after giving consent. Consent will be documented using either REDcap electronic consent, or a physical consent form.
Study personnel will read the informed consent to participants if they are unable to read, and will check for comprehension by asking
knowledge check questions such as "Do you understand what you will be asked to do?" "After learning about the study, do you still
want to participate?"
Should any subjects (Seeds, Alters) have complaints, they will be encouraged to contact the Principal Investigator, Brittany Smalls,
PhD at 859-323-4619 or brittany.smalls@uky.edu. They can also send a letter to Dr. Smalls at 740 South Limestone, J530 Kentucky
Clinic, Lexington KY 40536. They will also be provided the contact information for the University of Kentucky's ORI.
Request for Waiver of Informed Consent Process
If you are requesting IRB approval to waive the requirement for the informed consent process, or to alter some or all of the
elements of informed consent, complete, Section 1 and Section 2 below.
Note: The IRB does not approve waiver or alteration of the consent process for greater than minimal risk research, except
for planned emergency/acute care research as provided under FDA regulations. Contact ORI for regulations that apply to
single emergency use waiver or acute care research waiver (859-257-9428).
SECTION 1.
Check the appropriate item:
I am requesting a waiver of the requirement for the informed consent process.
I am requesting an alteration of the informed consent process.
If you checked the box for this item, describe which elements of consent will be altered and/or omitted, and justify the
alteration.
SECTION 2.
Explain how each condition applies to your research.
a) The research involves no more than minimal risk to the subject.
b) The rights and welfare of subjects will not be adversely affected.
c) The research could not practicably be carried out without the requested waiver or alteration.
d) Whenever possible, the subjects or legally authorized representatives will be provided with additional pertinent information
after they have participated in the study.
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Request for Waiver of Signatures
If you are requesting IRB approval to waive the requirement for signatures on informed consent forms, your research
activities must fit into one of three regulatory options:
1. The only record linking the participant and the research would be the consent document, and the principal risk would be
potential harm resulting from a breach of confidentiality (e.g., a study that involves participants who use illegal drugs).
2. The research presents no more than minimal risk to the participant and involves no procedures for which written consent
is normally required outside of the research context (e.g., a cover letter on a survey, or a phone script).
3. The participant (or legally authorized representative) is a member of a distinct cultural group or community in which
signing forms is not the norm, the research presents no more than minimal risk to the subject, and there is an appropriate
alternative mechanism for documenting that informed consent was obtained.
Select the option below that best fits your study. 
If the IRB approves a waiver of signatures, participants must still be provided oral or written information about the study.
To ensure you include required elements in your consent document, use the Cover Letter Template as a guide. There is
an English and a Spanish version.
 
Option 1
Describe how your study meets these criteria:
a) The only record linking the participant and the research would be the consent document:
b) The principal risk would be potential harm resulting from a breach of confidentiality (i.e., a study that involves subjects
who use illegal drugs).
Under this option, each participant (or legally authorized representative) must be asked whether (s)he wants to sign a
consent document; if the participant agrees to sign a consent document, only an IRB approved version should be
used.
Option 2
Describe how your study meets these criteria:
a) The research presents no more than minimal risk to the participant:
b) Involves no procedures for which written consent is normally required outside of the research context (i.e. a cover
letter on a survey, or a phone script):
Option 3
Describe how your study meets these criteria:
a) The subject (or legally authorized representative) is a member of a distinct cultural group or community in which
signing forms is not the norm.
b) The research presents no more than minimal risk to the subject.
c) There is an appropriate alternative mechanism for documenting that informed consent was obtained.
Section 8 Page 3 of 3
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STUDY PERSONNEL
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Do you have study personnel who will be assisting with the research?
After selecting 'Yes' or 'No' you must click the 'Save Study Personnel Information' button. 
Yes
No
Manage Study Personnel
Identify other study personnel assisting in research project:
The individual listed as PI in the 'PI Contact Information' section should NOT be added to this section.
If the research is required for a University of Kentucky academic program, the faculty advisor is also considered study personnel and should be listed below. ***Residents and
students who are PI’s are encouraged to designate the faculty advisor or at least one other individual as a contact with an editor role (DP).***
Role: DP = Editor (individual can view, navigate, and edit the application for any review phase (IR, CR/FR, MR) or 'Other Review", and submit Other Reviews on behalf of the PI.)
Role: SP = Reader (individual can view and navigate through the currently approved application only.)
To add an individual via the below feature:
Search for personnel;
Click "select" by the listing for the person you want to add;
For each person, specify responsibility in the project, whether authorized to obtain informed consent, AND denote who should receive E-IRB notifications (contact status).
NOTE: Study personnel must complete human subject protection (HSP) and Responsible Conduct of Research (RCR) training before implementing any research
procedures. For information about training requirements for study personnel, visit UK’s HSP FAQ page, the RCR Getting Started page, or contact ORI at 859-257-9428.
If you have documentation of current HSP training other than that acquired through UK CITI, you may submit it to ORI (HSPTrainingSupport@uky.edu) for credit.
Study personnel assisting in research project: 
Last Name
First Name
Responsibility In
Project
Role
A
C
Contact
Degree
StatusFlag
(HSP)
(HSP)Date
(RCR)
Removed?
Last
Updated
SFI
Active
Akwari
Kindness
Project
Assistance/Support
SP
N
N
 
P
Y
08/30/2023
Y
N
01/24/2024
N
Y
Borgatti
Stephen
Data
Analysis/Processing
SP
N
N
 
P
N
04/01/2021
Y
N
06/14/2019
N
Y
Douthitt
Key
Recruitment
SP
Y
N
 
P
Y
11/01/2023
Y
N
06/25/2020
N
Y
Feltner
Frances
Faculty Advisor
SP
Y
N
 
P
Y
07/13/2023
Y
N
07/09/2018
N
Y
Grissom
Zachary
Project
Assistance/Support
SP
N
N
 
S
Y
08/06/2022
Y
N
03/20/2023
N
Y
Jackson
Ellis
Data Collection
SP
N
N
 
N
Y
03/03/3000
 
N
06/27/2023
N
Y
Khanal
Suraksha
Data
Analysis/Processing
SP
N
N
 
P
Y
04/10/2023
Y
N
04/15/2024
N
Y
Kopelen
Victoria
Project
Assistance/Support
SP
N
N
 
S
Y
12/03/2023
Y
N
01/24/2024
N
Y
Kruse-Diehr
Aaron
Data
Analysis/Processing
SP
N
N
 
P
Y
02/21/2022
Y
N
02/10/2024
N
Y
Leshi
Oluwatosin
Project
Assistance/Support
SP
N
N
PhD
N
Y
03/03/3000
 
N
01/18/2023
N
Y
Moser
Debra
Faculty Advisor
SP
Y
N
 
P
Y
04/05/2023
Y
N
07/09/2018
N
Y
Schaefer
Jill
Study Coordinator
DP
Y
Y
 
P
Y
04/05/2023
Y
N
01/24/2024
N
Y
Schoenberg
Nancy
Co-Investigator
SP
Y
N
 
P
Y
03/04/2024
Y
N
07/09/2018
N
Y
Adu
Akosua
Project
Assistance/Support
DP
Y
Y
 
P
Y
08/22/2023
Y
Y
01/27/2020
N
Y
Bacha
Nicole
Study Coordinator
DP
Y
N
 
P
N
05/10/2021
 
Y
05/13/2022
N
N
Bateman
Emma
Project
Assistance/Support
SP
N
N
Bachelors
in
Science
Biology
S
N
01/03/2021
Y
Y
02/07/2024
N
Y
Coffey
Nicholas
Project
Assistance/Support
SP
Y
N
 
P
Y
07/11/2022
Y
Y
01/13/2022
N
N
Combs
Ellen
Project
Assistance/Support
SP
Y
N
 
P
N
05/29/2021
 
Y
01/13/2022
N
N
Cowley
Amy
Study Coordinator
DP
Y
Y
 
P
Y
07/31/2023
Y
Y
01/27/2020
N
Y
Gonzabato
Nelson
Data
Analysis/Processing
SP
N
N
 
P
Y
08/25/2023
Y
Y
02/10/2024
N
N
Haney
Kimberly
Study Coordinator
DP
Y
Y
 
P
Y
04/25/2024
Y
Y
01/13/2022
N
Y
Martin
Nicole
Project
Assistance/Support
SP
Y
N
 
S
N
03/30/2021
 
Y
01/13/2022
N
N
Mays
Alisha
Project
Assistance/Support
SP
Y
N
 
P
Y
01/13/2023
N
Y
01/27/2020
N
Y
Nathoo
Tayla
Project
Assistance/Support
SP
Y
N
 
P
N
10/06/2020
N
Y
01/13/2022
N
Y
Pearce
Kevin
Faculty Advisor
SP
N
N
 
P
Y
09/19/2022
Y
Y
06/14/2019
N
Y
Section 9 Page 1 of 2
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Last Name
First Name
Responsibility In
Project
Role
A
C
Contact
Degree
StatusFlag
(HSP)
(HSP)Date
(RCR)
Removed?
Last
Updated
SFI
Active
Smith
India
Project
Assistance/Support
SP
Y
N
 
P
Y
04/08/2024
 
Y
04/27/2020
N
N
Taylor
Zoe
Study Coordinator
DP
Y
N
MSPH
P
Y
05/12/2022
Y
Y
06/10/2024
N
Y
Vundi
Nikita
Project
Assistance/Support
SP
Y
N
 
P
N
11/25/2019
 
Y
01/27/2020
N
N
Section 9 Page 2 of 2
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RESEARCH DESCRIPTION
0 unresolved
comment(s)
You may attach a sponsor’s protocol pages in the “Additional Information” section and refer to them where necessary in
the Research Description. However, each prompt that applies to your study should contain at least a summary paragraph.
Pro Tips:
Save your work often to avoid losing data.
Use one of the attachment buttons in this section or under the Additional Information section to include supplemental
information with your application. During the document upload process, you will be able to provide a brief description
of the attachment.
Background
Include a brief review of existing literature in the area of your research. You should identify gaps in knowledge that should be addressed
and explain how your research will address those gaps or contribute to existing knowledge in this area. For interventional research,
search PubMed and ClinicalTrials.gov for duplicative ongoing and completed trials with same condition and intervention(s).
Social support is well documented as having a significant, independent relationship with T2DM self-care. In rural environments social
networks and social support may play a different role than in urban environments. In older rural-dwelling adults diagnosed with chronic
disease have worse social function and emotional well-being than older adults living in urban areas. The proposed research will
provide insight into the impact of social support within community- and individual-level social networks. Historically, social support has
been defined by relational characteristics such as marital status and perceived social support. Yet, these characteristics do not
adequately explain how relationships influence social support, health behaviors, and health outcomes. Social network analysis (SNA) is
characterized as the examination and interpretation of relational connections. This approach can be used to map social networks and
understand relationships between individuals as it pertains to social support. The preliminary data used for this K01 application was
collected from the BRFSS where data is self-reported and its accuracy cannot be confirmed, and a dataset where social support was
not the primary objective of the study and there was a small sample size all older adults. Yet, there remains a body of literature that
substantiates the influence of social support on T2DM self-care and the disproportionate burden of T2DM in older adults. The
proposed research will provide a comprehensive overview of the role of social support and how to leverage this support in a rural
community.
Objectives
List your research objectives. Please include a summary of intended research objectives in the box below.
Describe and evaluate the impact of social support on self-care and clinical outcomes in rural-dwelling older adults with T2DM through
semi-structured interviews (Aim 2). Test the feasibility and preliminary effectiveness of a 6-week intervention administered by the
research coordinator targeting rural-dwelling older adults with T2DM (seed) and an individual within their social support network (alter)
(Aim 3).
Study Design
Describe and explain the study design (e.g., observational, secondary analysis, single/double blind, parallel, crossover, deception, etc.).
Clinical Research: Indicate whether subjects will be randomized and whether subjects will receive any placebo.
Community-Based Participatory Research: If you are conducting community-based participatory research (CBPR), describe
strategies for involvement of community members in the design and implementation of the study, and dissemination of results from
the study.
Qualitative research: Indicate ranges where flexibility is needed, if a fixed interview transcript is not available, describe interview
topics including the most sensitive potential questions.
Research Repositories: If the purpose of this submission is to establish a Research Repository (bank, registry) and the material
you plan to collect is already available from a commercial supplier, clinical lab, or established IRB approved research repository,
provide scientific justification for establishing an additional repository collecting duplicate material. Describe the repository design
and operating procedures. For relevant information to include, see the UK Research Biospecimen Bank Guidance or the UK
Research Registry Guidance.
The study consists of two aims: For Aim 2, A mixed-methods approach will be used to map social networks of older adults and assess
their perceived social support from members of their social network and determine its influence on self-care and clinical outcomes. In
addition, through Aim 3, social networks will also be assessed to identify an individual within each older adult’s network who can best
facilitate optimal self-care. This person will form a dyad with the older adult to participate in a multilevel intervention which includes:
gauging the feasibility of using community health workers identified via social network analysis, to conduct self-care sessions in rural
communities and feasibility of seed-alter dyads to provide social support that improves self-care in older adults.
Attachments
Subject Recruitment Methods & Advertising
Section 10 Page 1 of 8
45777

Describe how the study team will identify and recruit subjects. Please consider the following items and provide additional information as
needed so that the IRB can follow each step of the recruitment process.
How will the study team identify potential participants?
Who will first contact the potential subjects, and how?
Will you use advertisements? If so, how will you distribute those?
How and where will the research team meet with potential participants?
If applicable, describe proposed outreach programs for recruiting women, minorities, or disparate populations.
How you will minimize undue influence in recruitment?
Attach copies of all recruiting and advertising materials (emails, verbal scripts, flyers, posts, messages, etc.).
For additional information on recruiting and advertising:
IRB Application Instructions - Advertisements
PI Guide to Identification and Recruitment of Human Subjects for Research
Seeds: Older adults will be primarily recruited from the University of Kentucky (UK) Center of Excellence in Rural Health clinic.
Additional recruitment locations will include UK’s Community and Family Medicine, Internal Medicine, Endocrinology, and Geriatric
outpatient clinics as well as with community organizations associated with the Barren River Area Development District (BRADD). Dr.
Key Douthitt, MD will identify eligible participants based on age (=55 years) and diagnosis of diabetes and send out recruitment letters
to these participants providing an overview of the study and contact information. Additionally, our providers Dr. Ginny Gottschalk and Dr.
Kelly Burgess have agreed to allow mailers to be sent to their eligible patients. Recruitment flyers will also be posted at all clinics
involved in recruitment efforts and study information will be available via UK Center for Clinical and Translational Science website that is
designed to assist investigators recruit eligible study participants. 
Alters: As a result of social network analysis of individual older adults (seeds) in Aim 1, a member of the social network (alter) will be
identified to participate in as a seed-alter dyad (N=262) social support intervention. Contact information for alters will be provided by
the seed during Aim 1. Eligible alters will be mailed a recruitment letter from the principal investigator that provides an overview of the
study and contact information. The seed and alter must be consented to participate in the intervention.
Seed: Recruitment letters signed by a primary care physician will be sent to eligible participants providing an overview of the study and
contact information. Recruitment flyers will also be posted at the Center of Excellence in Rural Health and study information will be
available via UK Center for Clinical and Translational Science website that is designed to assist investigators recruit eligible study
participants. 
Alter: Eligible alters will be mailed a recruitment letter from the principal investigator that provides an overview of the study and contact
information.
Attachments
Attach Type
File Name
Advertising
University of Kentucky Research-3.pdf
Advertising
Social Network Analysis and Social Support Intervention.pdf
Advertising
University of Kentucky Research-2.pdf
Advertising
SNA_CMRecruitment.pdf
Advertising
SNA.EmailRecruitment.pdf
Advertising
SNA.GENFlyer.pdf
Advertising
Flyer (1).pdf
Advertising
Flyer_Highlighted.pdf
Advertising
Social Networks UPDATED Provider Letter_Gottschalk.pdf
Advertising
Recruitment Letter_UPDATED.BURGESS-1.pdf
Advertising
Recruitment Letter_UPDATED.highlighted.BURGESS-1.pdf
Advertising
Social Networks UPDATED.highlighted.Provider Letter_Gottschalk.pdf
Section 10 Page 2 of 8
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Research Procedures
Describe how the research will be conducted.
What experience will study participants have?
What will study participants be expected to do?
How long will the study last?
Outline the schedule and timing of study procedures.
Provide visit-by-visit listing of all procedures that will take place.
Identify all procedures that will be carried out with each group of participants.
Describe deception and debrief procedures if deception is involved.
Differentiate between procedures that involve standard/routine clinical care and those that will be performed specifically for this
research project. List medications that are explicitly forbidden or permitted during study participation.
The PI will train research staff to administer the education sessions and the research staff will also be provided with a script to ensure
fidelity. The research coordinator will provide 6, 1.5 hour self-care sessions using the Diabetes Reversal Outcomes Programs
(DROP). Seed-alter dyads will participate in 6 weekly sessions will include modules the following modules: (1) Getting Started-
Diabetes and Insulin Resistance, (2) Carbohydrates and Fats, (3) Physical Activity, (4) Proteins and Metabolism Hormones, (5)
Oxidative Stress and Inflammation, (6) Epigenetic's, Weight Loss, and Reversal Strategy Wrap Up. The seed will complete the same
validated questionnaires from Aim 2 and their clinical outcomes will be abstracted from their electronic medical records for each study
visit and the member of the alter will complete validate surveys on social support and T2DM knowledge. Geriatric syndrome
information and resources will be provided to seed-alter dyads based on identified risks as a result of validated questionnaires
focused on geriatric syndromes.
Attachments
Attach Type
File Name
ResearchProcedures
Agenda- DEEPTraining.pdf
ResearchProcedures
79045_ResearchProcedures_581712 (1).pdf
Data Collection & Research Materials
In this section, please provide the following:
Describe all sources or methods for obtaining research materials about or from living individuals (such as specimens, records,
surveys, interviews, participant observation, etc.), and explain why this information is needed to conduct the study.
For each source or method described, please list or attach all data to be collected (such as genetic information, interview scripts,
survey tools, data collection forms for existing data, etc.).
If you will conduct a record or chart review, list the beginning and end dates of the records you will view.
Data collection will be semi-structured interviews that will be audio-recorded, de-identified and transcribed verbatim. A semi-structured
interview guide will be adapted from a previously published intervention assessing social networks and health behavior as well as
informed by preliminary data and expert opinion of my team of mentors and advisors. Interviews will include two broad general
questions asking “who” to map the social network of older rural-dwelling adults diagnosed with T2DM and “how” members of the social
network provide social support; using open-ended questions to elicit maximal information with minimal bias. Interview questions will
explore the follow domains (although additional domains may be identified during interview development): size and structure of social
network; resources available through social network; and beliefs of those in social network regarding T2DM knowledge and self-care.
A three question survey will be discharged post intervention to further assess community members perception of community leaders
and the tentative role they could play in diabetes education.
For Aim 3, consent will be collected one of two ways. Using a phone script to initiate the informed consent process, potential
participants have the option to complete consent using (1) a physical consent form (2) an electronic consent form using REDCap.
After consent has been obtained, a research assistant (RA) will collect demographics, T2DM and geriatric risk assessment data, and
baseline clinical outcomes (weight, height, pulse, systolic blood pressure, diastolic blood pressure, LDL, and Hemoglobin A1C levels)
will be abstracted from electronic medical records of all seeds. The RA will administer the education sessions, which will ideally occur
weekly. Once participants have completed the six education sessions, a summer SPARKS student will mail out an optional survey
assessing social needs, as well as a self addressed return envelope should the participant choose to complete the survey. At the 6-
and 12-month study visits the RA will obtain clinical outcomes and T2DM and geriatric assessments from all seeds. Alters will
complete assessments on T2DM knowledge and social support at baseline, 6 and 12 months. These time points have been chosen
because this provides enough time for participants to implement behavior changes that can result in meaningful changes in geriatric-
and T2DM- specific assessments. Additionally, relevant clinical measures, specifically blood pressure, HbA1c, and lipid panel are
clinically relevant for 6 months. Dyads will be given a booster session provided by RA at 6 months. These modules have been chosen
because they reinforce understanding of what T2DM looks like on an individual level, practical ways to manage T2DM, and how to
support those with T2DM. All self-care sessions and study visits will be held at designated community organizations—churches, senior
centers, schools, and community centers. In the event that any of these assessments reflect a risk for a geriatric syndrome, the seed-
alter dyad will be asked to contact the seed’s primary care provider (PCP), the PCP will be notified via research note the seed’s
electronic medical record, and Dr. Stiles will follow up with all PCPs that are notified. At the 6-month study visit older adults will be
asked to participate in a semi-structured interview as a follow up to the interview provided in Aim 2. The purpose of this interview to it
Section 10 Page 3 of 8
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examine if the participants social network, social support, and information provided via social networks changed over time and if there
is a relationship with their self-care adherence since baseline.
Attachments
Attach Type
File Name
DataCollection
E.J_Social Needs Questionnaire.docx
DataCollection
Study 2 Aim 3 PATIENT Assessment Tool.pdf
DataCollection
Evaluation survey questions.pdf
DataCollection
Evaluation survey questions_Clean.docx
DataCollection
Study 2 Aim 3 PATIENT Assessment Tool_Clean.pdf
DataCollection
75339_DataCollection_237366.pdf
DataCollection
75339_DataCollection_237366.pdf
DataCollection
Study 2 Aim 2_Community Networks Interview Guide_10 28 20.pdf
DataCollection
Charlson Comorbidity.pdf
DataCollection
Study 2 Aim 3 PATIENT Assessment Tool.pdf
DataCollection
Study 2 Aim 3 ALTER Assessment Tool.pdf
DataCollection
Orsmond and Cohn Feasibility interview packet.pdf
DataCollection
Study 2 Aim 3 PATIENT Assessment Tool.pdf
DataCollection
Study 2 Post-Intervention Questions.pdf
DataCollection
Study 2 Aim 3 PATIENT Assessment Tool.pdf
Resources
Describe the availability of the resources and adequacy of the facilities that you will use to perform the research. Such resources may
include:
Staffing and personnel, in terms of availability, number, expertise, and experience;
Computer or other technological resources, mobile or otherwise, required or created during the conduct of the research;
Psychological, social, or medical services, including equipment needed to protect subjects, medical monitoring, ancillary care, or
counseling or social support services that may be required because of research participation;
Resources for communication with subjects, such as language translation/interpretation services.
All self-care sessions and study visits will be held at designated community organizations-- churches, senior centers, schools and
community centers.
Potential Risks & Benefits
Risks
Describe any potential risks – including physical, psychological, social, legal, ability to re-identify subjects, or other risks. Assess
the seriousness and likelihood of each risk.
Which risks may affect a subject’s willingness to participate in the study?
Describe likely adverse effects of drugs, biologics, devices or procedures participants may encounter while in the study.
Qualitative research - describe ethical issues that could arise while conducting research in the field and strategies you may use to
handle those situations.
Describe any steps to mitigate these risks.
Benefits
Describe potential direct benefits to study participants – including diagnostic or therapeutic, physical, psychological or emotional,
learning benefits. This cannot include incentives or payments.
State if there are no direct benefits.
Describe potential benefits to society and/or general knowledge to be gained.
Describe why potential benefits are reasonable in relation to potential risks. If applicable, justify why risks to vulnerable subjects are
reasonable to potential benefits.
Potential Risk to participants are minimal as data collection involves: (1) confirmation of type 2 diabetes diagnosis using billing data
and electronic medical records, (2) semi-structured interviews, (3) completion of questionnaires, and (4) electronic chart review
(seeds) and collection of data in the form of validated questionnaires for both seeds and alters. Risks include potential loss of
confidentiality. Efforts to reduce loss of confidentiality are outlined in the Confidentiality section.
No direct benefits are expected for the seeds and alters who participate in the semi-structured interviews. There is the potential benefit
that may be experienced as the result of the intervention such as feelings of increased social support, improved clinical outcomes
associated with T2DM diagnosis, and self-management education gained by both seeds and alters. Furthermore, recognition by study
staff of significant stress or emotional strain in a seed or alter during an interview may prompt referral to a primary care physician or
other health care provider who may provide clinical care to these subjects. The risks posed to the subjects in this study are minimal
and are outweighed by the knowledge to be gained. Taken together, findings from this work will directly inform community-based
research; help clinicians, policy-makers and members of social networks facilitate adherence to T2DM self-care in rural dwelling older
Section 10 Page 4 of 8
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adults; and reveal targets to improve care for rural dwelling older adults living with complex chronic disease.
Available Alternative Opportunities/Treatments
Describe alternative treatments or opportunities that might be available to those who choose not to participate in the study, and which
offer the subject equal or greater advantages. If applicable, this should include a discussion of the current standard of care treatment(s).
Should subjects choose not to participate in the study, there is no alternative treatment offered. Subjects will be encouraged to seek
standard treatment of care from their provider.
Back to Top
Records, Privacy, and Confidentiality
Specify where the data and/or specimens will be stored and how the researcher will ensure the privacy and confidentiality of both.
Specify who will have access to the data/specimens and why they need access.
Describe how data will be managed after the study is complete:
If data/specimens will be maintained, specify whether identifiers will be removed from the maintained information/material.
If identifiers will not be removed, provide justification for retaining them and describe how you will protect confidentiality.
If the data/specimens will be destroyed, verify that this will not violate retention policies and will adhere to applicable facility
requirements.
If this study will use de-identified data from another source, describe what measures will be taken to ensure that subject identifiers are
not given to the investigator.
If applicable, describe procedures for sharing data/specimens with collaborators not affiliated with UK.
For additional considerations: 
Return of Research Results or Incidental Research Findings 
HIPAA policies 
FERPA policies 
Procedures for Transfer agreements 
Information regarding multi-site studies 
NIH Genomic Data Sharing (GDS) Policy 
Digital Data
Sources of research material include Electronic Health Records and medical billing information.
Information to be recorded includes: age, sex, race/ethnicity, marital status. Identity verification: prior to consent, all participants will be
asked to complete a verification survey through RedCap detailing their name, birthday, best contact number, and best email address. If
potential participants complete the verification survey but do not end up enrolling in the study, their verification survey data will be
promptly removed from the studies RedCap. Health status: comorbidities (quantified using Charlson Comorbidity Index). Social
support: The Medical Outcomes Study (MOS) Social Support Survey uses a 5-point Likert scale response to their perceived social
support with a corresponding value to assess perceived social support. Primary outcome variables. Clinical outcomes: Hemoglobin
A1c. Secondary outcome variables. Self-care: The Diabetes Self-Management Questionnaire is a 16-item questionnaire to assess
self-care activities activity associated with glycemic control and has an internal consistency of 0.84. Medication adherence: Brooks
Medication Adherence Scale is a 6-item scale with a reliability coefficient >0.69 and is sensitive to changes in adherence due to
intervention. Quality of life—EuroQol-5D (EQ-5D) is validated measure of 5 dimensions of health-related quality of life including
mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Seed characteristics: age, gender, race/ethnicity, education, employment status. Alter characteristics: age, gender, race/ethnicity,
education, relationship to the participant. Social support: The Medical Outcomes Study (MOS) Social Support Survey uses a 5-point
Likert scale response to their perceived social support with a corresponding value to assess perceived social support. Health status:
comorbidities will be quantified using Charlson Comorbidity Index. Geriatric syndrome risk assessments: Cognitive impairment:
Montreal Cognitive Assessment-Basic (MoCA-B) was developed to screen for mild cognitive impairment in elderly adults with low
education and varying literacy and has a reliability coefficient of 0.91. Nutritional status: Mini-Nutritional Assessment (MNA) was
designed and validated to provide a nutritional status in older adults patients in outpatient clinics, in hospitals, and nursing homes. The
MNA measures adequate nutritional status, protein-calorie malnutrition, and risk of malnutrition. Frailty: Fried Frailty Index measures five
domains of frailty based the definition provided by Fried et al. (2001): exhaustion, unintentional weight loss, low activity, slow walk, and
grip strength in the elderly. Physical function: Lawton’s Instrumental Activities for Daily Living Scale which evaluates the ability to
independently use the toilet, feed, dress, groom, bath and perform physical ambulation. Fall risk: Get Up and Go Test89 requires rising
from the chair and walking a short distance and walking back to the chair. The observer is asked to score the performance from 1
(normal—no evidence of fall risk) to 5 (severely abnormal—participant appeared at risk for fall during the assessment). Depression:
Geriatric Depression Scale is sensitive to those suffering from mild cognitive impairment and physical illness. Quality of life: EuroQol-
5D (EQ-5D) is validated measure of 5 dimensions of health-related quality of life including mobility, self-care, usual activities,
pain/discomfort, and anxiety/depression. The EQ-5D also includes a Visual Analogue Scale by which respondents can report their
perceived health status ranging from 0 (the worst possible health) to 100 (the best possible health).
Data collected from validated questionnaires and clinical outcomes (abstracted from the electronic medical records) will be stored in
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RedCap. All original data collection forms will only include assigned participant study IDs that were assigned at enrollment and stored
in a locked cabinet, in a locked office in the UK Center for Health Services Research. Study participants who are older adults (seeds)
will be asked to complete validated geriatric syndrome risk assessments at baseline, 6 and 12 months. During those assessments if it
is determined that a seed is at-risk for a geriatric syndrome, a letter will be sent to their primary care provider alerting them of our
finding. In that event, we will also recommend the seed to contact their primary care provider for further assessment. Additionally, a
board-certified geriatrician (Dr. Stiles) included as an advisor on this grant, will follow-up with primary care providers who have been
contacted as a result of our study findings to ensure that study participants receive appropriate standard of care for any identified
geriatric syndromes. Additionally, to maintain fidelity among CHWs a structured manual will be created to carefully track fidelity to the
protocol. The principal investigator along with the advisor in community health worker training (Dr. Feltner) will conduct random audits of
CHW activities by visiting with them or calling participants to check on interaction and advice given.
This study will collect qualitative and quantitative data with minimal risk of requiring medical attention to the research participant. The
semi-structured interviews will not inquire about personal health information of research participants. Research participants’ audio files
will be saved on an encrypted device and the information provided will be de-identified and transcribed by a member of the research
team. All audio files will also be saved on the UK Center for Health Services Research password protected server. We do not
anticipate that semi-structured interviews will be distressing, however in order to minimize risks to seeds and alters, the research
assistant will be carefully trained by both Drs. Smalls and Schoenberg in interview techniques. In the unlikely event that a participant
becomes overwhelmed or prefers not to continue the interview for any reason, the research assistant will be instructed to end the
interview. 
All staff involved in this proposal will have completed requisite training in the protection of human subjects as delineated by the
Institutional Review Board of the University of Kentucky (UK). All study documentation will be stored in a locked area, accessible only
to the PI, RA and other designated study staff. All interviews will be audio-recorded with the permission of the participant. The audio
files will be transcribed using a trained transcriptionist within UK’s Center for Health Services Research. Additionally, all desktop,
laptop, and handheld devices are encrypted according to UK policies. Participants will be assigned a numerical code for identification
in the files. Names and other identifiers will be kept in separate encrypted files accessible only to the investigators.
UK IRB policies state that IRB-related research records must be retained for a minimum of 6 years after study closure. Do
you confirm that you will retain all IRB-related records for a minimum of 6 years after study closure?
Yes
No
Payment
Describe the incentives (monetary or other) being offered to subjects for their participation. If monetary compensation is offered,
indicate the amount and describe the terms and schedule of payment. Please review this guidance for more information on payments to
subjects, including restrictions and expectations.
Initial interview with Seeds and Alters: Participants will receive $20 for completing the interview and validated surveys.
Both the seed and alter will receive $15 for each study visit completed at baseline, 6 and 12 months.
Costs to Subjects
Include a list of services and/or tests that will not be paid for by the sponsor and/or the study (e.g., MRI, HIV). Keep in mind that a
subject will not know what is “standard” – and thus not covered by the sponsor/study – unless you tell them.
There are no cost to subjects other than the time required to attend the sessions.
Data and Safety Monitoring
The IRB requires review and approval of data and safety monitoring plans for greater than minimal risk research or NIH-funded/FDA-
regulated clinical investigations.
If you are conducting greater than minimal risk research, or your clinical investigation is NIH-funded, describe your Data and Safety
Monitoring Plan (DSMP). Click here for additional guidance on developing a Data and Safety Monitoring Plan.
If this is a non-sponsored investigator-initiated protocol considered greater than minimal risk research, and if you are planning on
using a Data and Safety Monitoring Board (DSMB) as part of your DSMP, click here for additional guidance for information to
include with your IRB application.
n/a, risk level 1
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Future Use and Sharing of Material (e.g., Data/Specimens/Information)
If the material collected for this study will be used by members of the research team or shared with other researchers for future studies,
please address the following:
Section 10 Page 6 of 8
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list the biological specimens and/or information that will be kept
briefly describe the types, categories and/or purposes of the future research
describe any risks of the additional use
describe privacy/confidentiality protections that will be put into place
describe the period of time specimens/information may be used
describe procedures for sharing specimens/information with secondary researchers
describe the process for, and limitations to, withdrawal of specimens/data
No biological specimens will be obtained. All data will be de-identified and stored on a password-protected computer in the
Department of Family and Community Medicine, suite 125 at Turfland Clinic (2195 Harrodsburg Road, Lexington, KY 40504). All audio
recordings of interviews with potential CHWs will be stored on an encrypted and password-protected recording device, and de-
identified during transcription by the research team. Data will be kept for 6 years after study closure and deleted per UK Policy A13-
050 and A05-055. Per NIH requirements, all data will be made available upon request.
Are you recruiting or expect to enroll Non-English Speaking Subjects or Subjects from a Foreign Culture? (does not include short
form use for incidentally encountered non-English subjects)
Yes
No
Non-English Speaking Subjects or Subjects from a Foreign Culture
Recruitment and Consent:
Describe how information about the study will be communicated to potential subjects appropriate for their culture, and if necessary,
how new information about the research may be relayed to subjects during the study. 
When recruiting Non-English-speaking subjects, provide a consent document in the subject’s primary language. After saving this
section, attach both the English and translated consent documents in the “Informed Consent" section. 
Cultural and Language Consultants:
The PI is required to identify someone who is willing to serve as the cultural consultant to the IRB.
This person should be familiar with the culture of the subject population and/or be able to verify that translated documents are
the equivalent of the English version of documents submitted.
The consultant should not be involved with the study or have any interest in its IRB approval.
Please include the name, address, telephone number, and email of the person who agrees to be the cultural consultant for
your study.
ORI staff will facilitate the review process with your consultant. Please do not ask them to review your protocol separately.
For more details, see the IRB Application Instructions on Research Involving Non-English Speaking Subjects or Subjects from a
Foreign Culture. 
Local Requirements:
If you will conduct research at an international location, identify and describe:
relevant local regulations
data privacy regulations
applicable laws
ethics review requirements for human subject protection
Please provide links or sources where possible. If the project has been or will be reviewed by a local ethics review board, attach a
copy in the “Additional Information/Materials” section. You may also consult the current edition of the International Compilation of
Human Research Standards
Section 10 Page 7 of 8
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Does your study involve HIV/AIDS research and/or screening for other reportable diseases (e.g., Hepatitis C, etc…)?
Yes
No
HIV/AIDS Research
If you have questions about what constitutes a reportable disease and/or condition in the state of Kentucky, see ORI’s summary
sheet: “Reporting Requirements for Diseases and Conditions in Kentucky" [PDF].
HIV/AIDS Research: There are additional IRB requirements for designing and implementing the research and for obtaining
informed consent. Describe additional safeguards to minimize risk to subjects in the space provided below.
For additional information, visit the online IRB Survival Handbook to download a copy of the "Medical IRB's requirements for
Protection of Human Subjects in Research Involving HIV Testing" [D65.0000] [PDF], and visit the Office for Human Research
Protections web site for statements on AIDS research, or contact the Office of Research Integrity at 859-257-9428.
PI-Sponsored FDA-Regulated Research
Is this an investigator-initiated study that:
1) involves testing a Nonsignificant Risk (NSR) Device, or
2) is being conducted under an investigator-held Investigational New Drug (IND) or Investigational Device Exemption (IDE)?
Yes
No
PI-Sponsored FDA-Regulated Research
If the answer above is yes, then the investigator assumes the regulatory responsibilities of both the investigator and sponsor. The
Office of Research Integrity provides a summary list of sponsor IND regulatory requirements for drug trials [PDF], IDE regulatory
requirements for SR device trials [PDF], and abbreviated regulatory requirements for NSR device trials [PDF]. For detailed
descriptions see FDA Responsibilities for Device Study Sponsors or FDA Responsibilities for IND Drug Study Sponsor-
Investigators.
Describe the experience/knowledge/training (if any) of the investigator serving as a sponsor (e.g., previously held an
IND/IDE); and
Indicate if any sponsor obligations have been transferred to a commercial sponsor, contract research organization (CRO),
contract monitor, or other entity (provide details or attach FDA 1571).
IRB policy requires mandatory training for all investigators who are also FDA-regulated sponsors (see Sponsor-Investigator
FAQs). A sponsor-investigator must complete the applicable Office of Research Integrity web based training, (drug or device)
before final IRB approval is granted.
Has the sponsor-investigator completed the mandatory PI-sponsor training prior to this submission?
Yes
No
If the sponsor-investigator has completed equivalent sponsor-investigator training, submit documentation of the content for the
IRB’s consideration. 
Attachments
Section 10 Page 8 of 8
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HIPAA
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Is HIPAA applicable?
Yes
No
(Visit ORI's Health Insurance Portability and Accountability Act (HIPAA) web page to determine if your research falls under the HIPAA
Privacy Regulation.)
If yes, check below all that apply and attach the applicable document(s): 
HIPAA De-identification Certification Form
HIPAA Waiver of Authorization
Attachments
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STUDY DRUG INFORMATION
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The term drug may include:
FDA approved drugs,
unapproved use of approved drugs,
investigational drugs or biologics,
other compounds or products intended to affect structure or function of the body, and/or
complementary and alternative medicine products such as dietary supplements, substances generally recognized as safe (GRAS)
when used to diagnose, cure mitigate, treat or prevent disease, or clinical studies of e-cigarettes examining a potential therapeutic
purpose.
Does this protocol involve a drug including an FDA approved drug; unapproved use of an FDA approved drug; and/or an
investigational drug?
Yes
No
If yes, complete the questions below. Additional study drug guidance.
LIST EACH DRUG INVOLVED IN STUDY IN THE SPACE BELOW
Drug Name:
Note: Inpatient studies are required by Hospital Policy to utilize Investigational Drug Service (IDS) pharmacies (Oncology or
Non-Oncology). Use of IDS is highly recommended, but optional for outpatient studies. Outpatient studies not using IDS
services are subject to periodic inspection by the IDS for compliance with drug accountability good clinical practices. 
Indicate where study drug(s) will be housed and managed:
Investigational Drug Service (IDS) UK Hospital
Other Location:
Is the study being conducted under a valid Investigational New Drug (IND) application?
Yes
No
If Yes, list IND #(s) and complete the following:
IND Submitted/Held by:
Sponsor:
Held By:
Investigator:
Held By:
Other:
Held By:
Checkmark if the study is being conducted under FDA’s Expanded Access Program (e.g., Treatment IND)
or if this is an Individual Patient Expanded Access IND (FDA Form 3926).
FDA's Expanded Access Program Information for Individual Patient Expanded Access INDs, and attach the
following:
FDA Form 3926;
FDA expanded access approval or correspondence;
Confirmation of agreement from manufacturer or entity authorized to provide access to the product.
For guidance and reporting requirements at the conclusion of treatment see the Expanded Access SOP.
Complete and attach the required Study Drug Form picking "Study Drug Form" for the document type. Any
Section 12 Page 1 of 2
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applicable drug documentation (e.g., Investigator Brochure; approved labeling; publication; FDA correspondence,
etc.) should be attached using "Other Drug Documentation" for the document type.
Attachments
Section 12 Page 2 of 2
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STUDY DEVICE INFORMATION
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A DEVICE may be a:
component, part, accessory;
assay, reagent, or in-vitro diagnostic device;
software, digital health, or mobile medical app;
other instrument if intended to affect the structure or function of the body, diagnose, cure, mitigate, treat or prevent disease; or
a homemade device developed by an investigator or other non-commercial entity and not approved for marketing by FDA.
For additional information, helpful resources, and definitions, see ORI's Use of Any Device Being Tested in Research web page.
Does this protocol involve testing (collecting safety or efficacy data) of a medical device including an FDA approved device,
unapproved use of an approved device, humanitarian use device, and/or an investigational device?
Yes
No
[Note: If a marketed device(s) is only being used to elicit or measure a physiologic response or clinical outcome, AND, NO data will
be collected on or about the device itself, you may answer “no” above, save and exit this section, (Examples: a chemo drug study
uses an MRI to measure tumor growth but does NOT assess how effective the MRI is at making the measurement; an exercise study
uses a heart monitor to measure athletic performance but no safety or efficacy information will be collected about the device itself, nor
will the data collected be used for comparative purposes against any other similar device).]
If you answered yes above, please complete the following questions.
LIST EACH DEVICE BEING TESTED IN STUDY IN THE SPACE BELOW
Device Name:
Is the study being conducted under a valid Investigational Device Exemption (IDE),
Humanitarian Device Exemption (HDE) or Compassionate Use?
Yes
No
If Yes, complete the following: 
IDE or HDE #(s)
IDE/HDE Submitted/Held by:
Sponsor:
Held By:
Investigator:
Held By:
Other:
Held By:
 Check if this is a Treatment IDE or Compassionate Use under the Food and Drug Administration (FDA)
Expanded Access program.
For Individual or Small Group Expanded Access, see FDA's Early Expanded Access Program Information,
and attach the following:
FDA expanded access approval or sponsor’s authorization;
An independent assessment from an uninvolved physician, if available;
Confirmation of agreement from manufacturer or entity authorized to provide access to the product.
For guidance and reporting requirements at the conclusion of treatment see the Medical Device SOP.
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Does the intended use of any research device being tested (not clinically observed) in this study meet the regulatory definition of
Significant Risk (SR) device?
Yes. Device(s) being tested in this study presents a potential for serious risk to the health, safety, or welfare of a subject and
(1) is intended as an implant; or (2) is used in supporting or sustaining human life; or (3) is of substantial importance in
diagnosing, curing, mitigating or treating disease, or otherwise prevents impairment of human health; or (4) otherwise presents
a potential for serious risk to the health, safety, or welfare of a subject.
No. All devices being tested in this study do not present a potential for serious risk to the health, safety, or welfare of
subjects/participants.
Complete and attach the required Study Device Form, picking the "Study Device Form" for the document type. Any
applicable device documentation (e.g., Manufacturer information; patient information packet; approved labeling; FDA
correspondence, etc.) should be attached using "Other Device Documentation" for the document type.
Attachments
Section 13 Page 2 of 2
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RESEARCH SITES
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To complete this section, ensure the responses are accurate then click "SAVE".
A) Check all the applicable sites listed below at which the research will be conducted. If none apply, you do not need to check any
boxes.
UK Sites
UK Classroom(s)/Lab(s)
UK Clinics in Lexington
UK Clinics outside of Lexington
UK Healthcare Good Samaritan Hospital
UK Hospital
Schools/Education Institutions
Fayette Co. School Systems *
Other State/Regional School Systems
Institutions of Higher Education (other than UK)
*Fayette Co. School systems, as well as other non-UK
sites, have additional requirements that must be
addressed. See ORI's IRB Application Instructions -
Off-site Research web page for details.
Other Medical Facilities
Bluegrass Regional Mental Health Retardation Board
Cardinal Hill Hospital
Eastern State Hospital
Norton Healthcare
Nursing Homes
Shriner’s Children’s Hospital
Veterans Affairs Medical Center
Other Hospitals and Med. Centers
Correctional Facilities
Home Health Agencies
International Sites
Research activities conducted at performance sites that are not owned or operated by the University of Kentucky (UK) or
at sites that do not fall under the UK IRB’s authority, are subject to special procedures for coordination of research
review. Additional information is required (see IRB Application Instructions - Off-Site Research web page), including:
A letter of support and local context is required from non-UK sites. See Letters of Support and Local Context on the
IRB Application Instructions - Off-Site Research web page for more information.
Supportive documentation, including letters of support, can be attached below.
NOTE: If the non-UK sites or non-UK personnel are engaged in the research, there are additional federal and
university requirements which need to be completed for their participation. For instance, the other site(s) may need
to complete their own IRB review, or a cooperative review arrangement may need to be established with non-UK
sites.
Section 14 Page 1 of 2
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Questions about the participation of non-UK sites/personnel should be discussed with the ORI staff at (859) 257-
9428.
List all other non-UK owned/operated locations where the research will be conducted:
Community centers, senior citizen centers,
and churches.
Describe the role of any non-UK site(s) or non-UK personnel who will be participating in your research.
When able, Dr. Leshi will observe study
activities to include both baseline data
collection and education sessions. Dr. Leshi
is officially UK personnel. Ellis Jackson's
role includes data collection and analysis
using a social needs survey that will be sent
to participants by mail.
Attachments
Attach Type
File Name
-Individual Investigator Agreement UKY IRB 45777_IIA Leshi.pdf
B) Is this a multi-site study for which you are the lead investigator or UK is the lead site?
Yes
No
If YES, describe the plan for the management of reporting unanticipated problems, noncompliance, and submission of protocol
modifications and interim results from the non-UK sites:
C) If your research involves collaboration with any sites and/or personnel outside the University of Kentucky, then it is considered
multisite research and IRB reliance issues will need to be addressed. This may include national multi-center trials as well local studies
involving sites/personnel external to UK. If you would like to request that the University of Kentucky IRB (UK IRB) serve as the lead
IRB for your study, or if you would like the UK IRB to defer review to another IRB, please contact the IRBReliance@uky.edu.
Section 14 Page 2 of 2
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RESEARCH ATTRIBUTES
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Indicate the items below that apply to your research. Depending on the items applicable to your research, you may be required to
complete additional forms or meet additional requirements. Contact the ORI (859-257-9428) if you have questions about additional
requirements.
Not applicable
Check All That Apply
Academic Degree/Required Research
Alcohol/Drug/Substance Abuse Research
Biological Specimen Bank Creation (for sharing)
Cancer Research
CCTS-Center for Clinical & Translational Science
Certificate of Confidentiality
Clinical Research
Clinical Trial - Phase 1
Clinical Trial
Collection of Biological Specimens for internal banking and use
(not sharing)
Community-Based Participatory Research
Deception
Educational/Student Records (e.g., GPA, test scores)
Emergency Use (Single Patient)
Gene Transfer
Genetic Research
GWAS (Genome-Wide Association Study) or NIH Genomic Data
Sharing (GDS)
Human Cells, Tissues, and Cellular and Tissue Based Products
Individual Expanded Access or Compassionate Use
International Research
Planned Emergency Research Involving Exception from
Informed Consent
Recombinant DNA
Registry or data repository creation
Stem Cell Research
Suicide Ideation or Behavior Research
Survey Research
Transplants
Use, storage and disposal of radioactive material and radiation
producing devices
Vaccine Trials
For additional requirements and information:
Cancer Research (MCC PRMC)
Certificate of Confidentiality (look up
"Confidentiality/Privacy...")
CCTS (Center for Clinical and Translational
Science)
Clinical Research (look up "What is the definition
of....)
Clinical Trial
Collection of Biological Specimens for Banking
(look up "Specimen/Tissue Collection...")
Collection of Biological Specimens (look up
"Specimen/Tissue Collection...")
Community-Based Participatory Research (look
up "Community-Engaged...")
Data & Safety Monitoring Board (DSMB)
*For Medical IRB: Service Request Form for
CCTS DSMB
Data & Safety Monitoring Plan
Deception*
*For deception research, also go to the E-IRB
Application Informed Consent section,
checkmark and complete "Request for Waiver
of Informed Consent Process"
Emergency Use (Single Patient) [attach
Emergency Use Checklist] (PDF)
Genetic Research (look up "Specimen/Tissue
Collection...")
Gene Transfer
HIV/AIDS Research (look up "Reportable
Diseases/Conditions")
Screening for Reportable Diseases [E2.0000]
(PDF)
International Research (look up "International &
Non-English Speaking")
NIH Genomic Data Sharing (GDS) Policy (PDF)
Planned Emergency Research Involving Waiver
of Informed Consent*
*For Planned Emergency Research Involving
Waiver of Informed Consent, also go to the E-
IRB Application Informed Consent section,
checkmark and complete "Request for Waiver
of Informed Consent Process"
Use, storage and disposal of radioactive material
and radiation producing devices
Section 15 Page 1 of 2
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Section 15 Page 2 of 2
45777

FUNDING/SUPPORT
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If the research is being submitted to, supported by, or conducted in cooperation with an external or internal agency or funding program, indicate below
all the categories that apply. 
Not applicable
Check All That Apply
Grant application pending
(HHS) Dept. of Health & Human Services
(NIH) National Institutes of Health
(CDC) Centers for Disease Control & Prevention
(HRSA) Health Resources and Services
Administration
(SAMHSA) Substance Abuse and Mental Health
Services Administration
(DoJ) Department of Justice or Bureau of Prisons
(DoE) Department of Energy
(EPA) Environmental Protection Agency
Federal Agencies Other Than Those Listed Here
Industry (Other than Pharmaceutical Companies)
Internal Grant Program w/ proposal
Internal Grant Program w/o proposal
National Science Foundation
Other Institutions of Higher Education
Pharmaceutical Company
Private Foundation/Association
U.S. Department of Education
State
Click applicable listing(s) for additional requirements and information:
(HHS) Dept. of Health & Human Services
(NIH) National Institutes of Health
(CDC) Centers for Disease Control & Prevention
(HRSA) Health Resources & Services Administration
(SAMHSA) Substance Abuse & Mental Health Services Administration
Industry (Other than Pharmaceutical Companies) [IRB Fee Info]
National Science Foundation
(DoEd) U.S. Department of Education
(DoJ) Department of Justice or Bureau of Prisons 
(DoE) Department of Energy Summary and Department of Energy Identifiable
Information Compliance Checklist
(EPA) Environmental Protection Agency
Other:
Specify the funding source and/or cooperating organization(s) (e.g., National Cancer Institute, Ford Foundation, Eli Lilly & Company, South
Western Oncology Group, Bureau of Prisons, etc.):
 NIDDK
Add Related Grants
If applicable, please search for and select the OSPA Account number or Electronic Internal Approval Form (eIAF) # (notif #)
associated with this IRB application using the "Add Related Grants" button. 
If required by your funding agency, upload your grant using the "Grant/Contract Attachments" button.
Add Related Grants
Grant/Contract Attachments
The research involves use of Department of Defense (DoD) funding, military personnel, DoD facilities, or other DoD resources. (See DoD SOP
and DoD Summary for details)
Yes
No
Using the “attachments” button (below), attach applicable materials addressing the specific processes described in the DoD SOP.
DOD SOP Attachments
Section 16 Page 1 of 2
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Additional Certification: (If your project is federally funded, your funding agency may request an Assurance/ Certification/Declaration of Exemption
form.) Check the following if needed:
Protection of Human Subjects Assurance/Certification/Declaration of Exemption (Formerly Optional Form – 310)
Assurance/Certification Attachments
Section 16 Page 2 of 2
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OTHER REVIEW COMMITTEES
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If you check any of the below committees, additional materials may be required with your application submission.
Does your research fall under the purview of any of the other review committees listed below? [If yes, check all that apply and attach
applicable materials using the attachment button at the bottom of your screen.]
Yes
No
Institutional Biosafety Committee
Radiation Safety Committee
Radioactive Drug Research Committee
Markey Cancer Center (MCC) Protocol Review
and Monitoring Committee (PRMC)
Graduate Medical Education Committee (GME)
Office of Medical Education (OME)
Additional Information
Institutional Biosafety Committee (IBC) - Attach required IBC
materials
Radiation Safety Committee (RSC) - For applicability, see
instructions and attach form
Radioactive Drug Research Committee (RDRC)
Markey Cancer Center (MCC) Protocol Review and Monitoring
Committee (PRMC)** - Attach MCC PRMC materials, if any, per
instructions.
Office of Medical Education (OME)
Graduate Medical Education Committee (GME)
Attachments 
** If your study involves cancer research, be sure to select "Cancer Research" in the "Research Attributes"
section. ORI will send your research protocol to the Markey Cancer Center (MCC) Protocol Review and Monitoring
Committee (PRMC). The MCC PRMC is responsible for determining whether the study meets the National Cancer Institute
(NCI) definition of a clinical trial and for issuing documentation to you (the investigator) which confirms either that PRMC
approval has been obtained or that PRMC review is not required. Your IRB application will be processed and reviewed
independently from the PRMC review.
Section 17 Page 1 of 1
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ADDITIONAL INFORMATION/MATERIALS
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Do you want specific information inserted into your approval letter?
Yes
No
Approval Letter Details:
If you wish to have specific language included in your approval letter (e.g., serial #, internal tracking identifier, etc…), type that
language in the box below exactly as it should appear in the letter. The text you enter will automatically appear at the top of all
approval letters, identical to how you typed it, until you update it. Don't include instructions or questions to ORI staff as those will
appear in your approval letter. If these details need to be changed for any reason, you are responsible for updating the
content of this field.
Additional Materials:
If you have other materials you would like to include for the IRB's consideration, check all that apply and attach the corresponding
documents using the Attachments button below.
Detailed protocol
Dept. of Health & Human Services (DHHS) approved protocol (such as NIH sponsored Cooperative Group Clinical Trial)
Other Documents
Protocol/Other Attachments
Attach Type File Name
Other
UKY IRB 45777_IIA Leshi.pdf
Other
Verification survey .docx
Other
20230203-09_PFFS_Smalls_UKentuckyCollegeMed.pdf
Other
UKY IRB 4577_IIA_Jackson.pdf
Other
Ellis.Certificate.pdf
NOTE: Instructions for Dept. of Health & Human Services (DHHS)-approved protocol]
If you have password protected documents, that feature should be disabled prior to uploading to ensure access for IRB review.
To view the materials currently attached to your application, click “All Attachments” on the left menu bar.
Section 18 Page 1 of 1
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SIGNATURES (ASSURANCES)
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Introduction
All IRB applications require additional assurances by a Department Chairperson or equivalent (DA), and when applicable, a Faculty
Advisor or equivalent (FA). This signifies the acceptance of certain responsibilities and that the science is meritorious and deserving of
conduct in humans. The person assigned as DA should not also be listed in the Study Personnel section, and the individual assigned
as FA should be listed in the Study Personnel section.
For a list of responsibilities reflected by signing the Assurance Statement, refer to "What does the Department Chairperson’s
Assurance Statement on the IRB application mean?"
For a detailed illustration of how to complete this section, please review the short online video tutorial "Signatures
(Assurance) Section - How to Complete." Otherwise, follow the steps below.
Required Signatures:
First
Name
Last
Name
Role
Department
Date
Signed
 
Roberto
Cardarelli
Department
Authorization
Family and
Community
Medicine
03/02/2020
10:56 AM
View/Sign
Brittany
Smalls
Principal
Investigator
Family and
Community
Medicine
07/11/2018
11:42 AM
View/Sign
Department Authorization
 This is to certify that I have reviewed this research protocol and that I attest to the scientific validity and importance of
this study; to the qualifications of the investigator(s) to conduct the project and their time available for the project; that
facilities, equipment, and personnel are adequate to conduct the research; and that continued guidance will be provided
as appropriate. When the principal investigator assumes a sponsor function, the investigator has been notified of the
additional regulatory requirements of the sponsor and by signing the principal investigator Assurance Statement, confirms
he/she can comply with them.
*If the Principal Investigator is also the Chairperson of the department, the Vice Chairperson or equivalent should complete
the "Department Authorization".
**IF APPLICABLE FOR RELIANCE: I attest that the principal investigator has been notified of the regulatory requirements of
both the Reviewing and Relying IRBs, according to the information provided in the E-IRB application. The attached Reliance
Assurance Statement, signed by the principal investigator, confirms that he/she can comply with both sets of IRB
requirements.
Principal Investigator’s Assurance Statement
I understand the University of Kentucky's policies concerning research involving human subjects and I agree:
1. To comply with all IRB policies, decisions, conditions, and requirements;
2. To accept responsibility for the scientific and ethical conduct of this research study;
3. To obtain prior approval from the Institutional Review Board before amending or altering the research protocol or
implementing changes in the approved consent/assent form;
4. To report to the IRB in accord with IRB/IBC policy, any adverse event(s) and/or unanticipated problem(s) involving risks to
subjects;
5. To complete, on request by the IRB for Full and Expedited studies, the Continuation/Final Review Forms;
6. To notify the Office of Sponsored Projects Administration (OSPA) and/or the IRB (when applicable) of the development of
any financial interest not already disclosed;
7. Each individual listed as study personnel in this application has received the mandatory human research protections
Section 19 Page 1 of 2
45777

education (e.g., CITI);
8. Each individual listed as study personnel in this application possesses the necessary experience for conducting research
activities in the role described for this research study.
9. To recognize and accept additional regulatory responsibilities if serving as both a sponsor and investigator for FDA
regulated research.
Furthermore, by checking this box, I also attest that:
I have appropriate facilities and resources for conducting the study;
I am aware of and take full responsibility for the accuracy of all materials submitted to the IRB for review;
If applying for an exemption, I also certify that the only involvement of human subjects in this research study will be in the
categories specified in the Protocol Type: Exemption Categories section.
If applying for an Abbreviated Application (AA) to rely on an external IRB, I understand that certain items above (1, 3, 4, 7-8)
may not apply, or may be altered due to external institutional/IRB policies. I document my agreement with the Principal
Investigator Reliance Assurance Statement by digitally signing this application.
*You will be able to "sign" your assurance after you have sent your application for signatures (use Submission section). Please notify the
personnel required for signing your IRB application after sending for signatures. Once all signatures have been recorded, you will need
to return to this section to submit your application to ORI. 
Section 19 Page 2 of 2
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SUBMISSION INFORMATION
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Each Section/Subsection in the menu on the left must have a checkmark beside it (except this Submission section) indicating the
Section/Subsection has been completed. Otherwise your submission for IRB review and approval cannot be sent to the Office of
Research Integrity/IRB.
If applicable, remember to update the Approval Letter Details text box under the Additional Information section
If your materials require review at a convened IRB meeting which you will be asked to attend, it will be scheduled on the next available
agenda and you will receive a message to notify you of the date.
If you are making a change to an attachment, you need to delete the attachment, upload a highlighted version that contains the changes
(use Document Type of "Highlighted Changes"), and a version that contains the changes without any highlights (use the appropriate
Document Type for the item(s)). Do not delete approved attachments that are still in use.
Your protocol has been submitted.
Section 20 Page 1 of 1
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Document Type
File Loaded
Document Description
File
Size
Modified
By
Mod Date
ApprovalLetter
ApprovalLetter.pdf
 
0.081
jchine2
6/12/2024
10:40:41
AM
Stamped Consent
Form
2.22.23_AlterConsent_Clean.pdf
 
0.145
jchine2
6/12/2024
10:40:41
AM
Stamped Consent
Form
2.23.23_SeedConsent_Clean.pdf
 
0.192
jchine2
6/12/2024
10:40:40
AM
Advertising
Social Networks
UPDATED.highlighted.Provider
Letter_Gottschalk.pdf
Highlighted version
0.143
jlsc246
7/27/2023
8:21:03 AM
Advertising
Recruitment
Letter_UPDATED.highlighted.BURGESS-
1.pdf
Highlighted version
0.206
jlsc246
7/27/2023
8:20:38 AM
Advertising
Recruitment Letter_UPDATED.BURGESS-
1.pdf
Updated provider
Letter_Burgess
0.198
jlsc246
7/26/2023
3:19:12 PM
Advertising
Social Networks UPDATED Provider
Letter_Gottschalk.pdf
Updated provider
Letter_Gottschalk
0.135
jlsc246
7/26/2023
3:16:09 PM
DataCollection
E.J_Social Needs Questionnaire.docx
Social Needs Survey
0.019
jlsc246
6/29/2023
1:41:03 PM
AddInfoProduct
Ellis.Certificate.pdf
Ellis.Jackson.Certificate of
Completion
0.162
jlsc246
6/26/2023
2:49:11 PM
AddInfoProduct
UKY IRB 4577_IIA_Jackson.pdf
Ellis Jackson IIA
0.223
jlsc246
6/26/2023
2:47:00 PM
Advertising
Flyer_Highlighted.pdf
Updated recruitment flyer with
changes highlighted.
0.570
jlsc246
5/17/2023
3:43:28 PM
Advertising
Flyer (1).pdf
Updated recruitment flyer
0.566
jlsc246
5/17/2023
3:43:01 PM
Informed
ConsentHIPAA
Combined Form
2.23.23_SeedConsent_Clean.pdf
Seed Consent Clean
0.183
zmta225
2/23/2023
3:55:41 PM
Informed
ConsentParental
Permission
2.22.23_AlterConsent_Clean.pdf
Alter Consent Clean
0.137
zmta225
2/22/2023
12:38:45
PM
DataCollection
Study 2 Aim 3 PATIENT Assessment
Tool_Clean.pdf
Seed data collection tool clean
1.878
zmta225
2/22/2023
12:30:33
PM
DataCollection
Evaluation survey questions_Clean.docx
Seed 2 post-intervention
questions updated non
highlighted
0.015
zmta225
2/22/2023
12:29:05
PM
AddInfoProduct
20230203-
09_PFFS_Smalls_UKentuckyCollegeMed.pdf
Permission to use recently
updated frailty scale
0.630
zmta225
2/15/2023
10:32:29
AM
DataCollection
Evaluation survey questions.pdf
Study 2 Post-Intervention
Questions Updated
0.032
zmta225
2/15/2023
10:31:04
AM
DataCollection
Study 2 Aim 3 PATIENT Assessment Tool.pdf Seed Data Collection Tool
2.775
zmta225
2/15/2023
10:29:19
AM
-Individual Investigator
Agreement
UKY IRB 45777_IIA Leshi.pdf
Individual Investigator
Agreement for Dr. Oluwatosin
Leshi
0.296
zmta225
1/30/2023
8:15:24 AM
AddInfoProduct
UKY IRB 45777_IIA Leshi.pdf
Documentation needed for
addition of Dr. Leshi to IRB
protocol.
0.296
zmta225
1/27/2023
3:11:39 PM
Advertising
Social Network Analysis and Social Support
Intervention.pdf
Case Worker Flyer for
Recruitment
0.109
zmta225
11/3/2022
12:10:51
PM
Advertising
University of Kentucky Research-3.pdf
Flyer and Email Recruitment
0.583
zmta225
11/3/2022
12:10:31
Download all
Section 21 Page 1 of 2
45777

PM
AddInfoProduct
Verification survey .docx
This document will serve as a
template for the RedCap
verification survey.
0.013
zmta225
10/26/2022
8:57:08 AM
Advertising
SNA.GENFlyer.pdf
 
0.568
zmta225
8/8/2022
11:07:39
AM
Advertising
SNA.EmailRecruitment.pdf
 
0.394
zmta225
8/8/2022
11:06:14
AM
Advertising
SNA_CMRecruitment.pdf
 
0.109
zmta225
8/8/2022
11:06:03
AM
Advertising
University of Kentucky Research-2.pdf
 
0.567
zmta225
7/28/2022
10:31:16
AM
DataCollection
75339_DataCollection_237366.pdf
 
0.157
zmta225
7/18/2022
2:03:08 PM
DataCollection
75339_DataCollection_237366.pdf
 
0.157
zmta225
7/18/2022
1:00:19 PM
ResearchProcedures
79045_ResearchProcedures_581712 (1).pdf  
10.005 zmta225
7/14/2022
11:31:22
AM
DataCollection
Study 2 Aim 3 PATIENT Assessment Tool.pdf  
0.707
zmta225
7/13/2022
12:19:32
PM
DataCollection
Study 2 Post-Intervention Questions.pdf
 
0.029
zmta225
7/12/2022
2:36:10 PM
DataCollection
Study 2 Aim 3 PATIENT Assessment Tool.pdf  
1.704
zmta225
7/12/2022
2:36:00 PM
DataCollection
Study 2 Aim 2_Community Networks Interview
Guide_10 28 20.pdf
Study 2 Aim 2 Interview Guide
0.164
klha226
10/28/2020
10:09:59
AM
DataCollection
Orsmond and Cohn Feasibility interview
packet.pdf
Feasibility follow-up interview
packet
0.086
acmi238
8/14/2018
2:53:08 PM
DataCollection
Study 2 Aim 3 ALTER Assessment Tool.pdf
Atler data collection packet
0.092
acmi238
8/14/2018
2:52:00 PM
DataCollection
Study 2 Aim 3 PATIENT Assessment Tool.pdf Patient data collection packet
0.660
acmi238
8/14/2018
2:51:24 PM
DataCollection
Charlson Comorbidity.pdf
Charlson Comorbidity Index
0.157
acmi238
7/17/2018
11:11:14
AM
ResearchProcedures
Agenda- DEEPTraining.pdf
DEEP Training Modules Agenda 0.591
acmi238
7/17/2018
11:09:28
AM
ImpairedConsent
Form_T_1Ai STUDY 2 Rural Dwelling Older
Adults with T2DM.doc
Form T Study 2
0.085
acmi238
7/9/2018
9:16:20 AM
Section 21 Page 2 of 2
45777

Protocol Changes
Protocol Number: 45777
Study Personnel Changes:
Status
PPIdentity ProtocolID PersonID RoleInProtocol IsContact LastName FirstName Email
DeptCode RoomBuilding SpeedSort PhoneNum DeptDesc AuthorizedConsent ResponsibilityInProject Degree Rank StatusFlag IsRemoved ModBy
ModDate SFI IsPIRN MiddleName
Deleted 874804
97093
12645778 DP
N
Taylor
Zoe
Zoe.Taylor@uky.edu  
 
 
 
 
Y
Study Coordinator
MSPH
 
P
Y
blsm233
6/10/2024
11:18:47
AM
N
 
 
No Changes
There are no recorded changes tracked for this protocol.
Section 22 Page 1 of 1
45777

 
No comments
Section 23 Page 1 of 1
45777

Statistical Analysis Plan 45777 
Study Overview: Data was collected at three-time points baseline, 6 months, and 12 months to 
assess the effect of intervention on primary and secondary outcome variables.  
Descriptive statistics, change in mean score and correlation analysis was done. Sample 
characteristics were calculated for overall sample. Continuous variables were reported as mean 
and standard deviation while categorical variables were reported as frequency and percent for each 
time points. Pearson correlation analysis was done to assess the strength of relationship across 
difference time points between primary and secondary outcomes variables. Linear mixed effect 
model was done to analyze the change in primary outcome variable and secondary outcome 
variables mean score over time. Missing values were excluded from the analysis. Statistical 
Analysis was done in SAS v 9.4. A p-values of <0.05 was statistically signiﬁcant.