A Study to Evaluate the Feasibility and Acceptability of a Diabetes Survival Skills + (DSS+) Training Intervention for Incarcerated Persons Transitioning to the Community (TTC)
Phase: NA
Conditions: Diabetes
Sponsor: University of Connecticut

Title: A Study to Evaluate the Feasibility and Acceptability of a Diabetes Survival Skills + 
DSS+) Training Intervention for Incarcerated Persons Transitioning to the Community (TTC) 
Approved February 24, 2022 No expiration
No NCT Number available for this protocol 

Ofﬁce of the Vice President for Research 
Research Compliance Services 
438 WHITNEY ROAD EXTENSION, UNIT 1246 
STORRS, CT 06269-1246 
PHONE 860.486.8802 
FAX 860.486.1044 
compliance.uconn.edu 
An Equal Opportunity Employer 
DATE: 
February 24, 2022 
TO: 
Louise Reagan, Ph.D., ANP-BC, APRN 
Nursing Instruction and Research 
FROM: 
RCS IRB Office/dsb. 
FWA# 00007125 
RE: 
Protocol #: H17-006, “A Study to Evaluate the Feasibility and Acceptability of a 
Diabetes Survival Skills + (DSS+) Training Intervention for Incarcerated Persons 
Transitioning to the Community (TTC)” 
Please refer to the Protocol # in all future correspondence with the IRB. 
Re-approval Period: From: February 24, 2022  To:  No Expiration Date 
The Institutional Review Board (IRB) re-approved this protocol on January 22, 2021. The 
research presents no more than minimal risk to human subjects and qualifies for expedited 
approval under category #8(c): Continuing review of research previously approved by the 
convened IRB as follows: where the remaining research activities are limited to data analysis. 
Since this study expired on January 21, 2022, the IRB acknowledges that:  a) no participants 
have been enrolled since the expiration date; b) no participants will be enrolled until the study 
has been re-approved; and c) no research has been conducted since the expiration date. 
All investigators of the University of Connecticut are responsible for complying with the 
“Responsibilities of Research Investigators” attached to this letter.  
Modifications:  If you wish to change any aspect of this study, such as the procedures, the consent 
forms, the investigators, or funding source, please submit the changes in writing to the IRB using 
the Amendment Review Form (IRB-3).  All modifications must be reviewed and approved by the 
IRB prior to initiation. 
Audit:  All protocols approved by the IRB may be audited by the Post Approval Monitor. 
Please keep this letter with your copy of the approved protocol. 
Attachments: 
1. Validated IRB-2
2.
“Responsibilities of Research Investigators”

IRB-1 Protocol Application, Version 6/2014  
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(IRB-1) Protocol Application for the Involvement of Human Participants in Research 
Institutional Review Board, Research Compliance Services 
SECTION I: General Information 
Nature of Study: 
(Place an “X” in 
the column.  
Check only one.) 
X 
Faculty Research 
Graduate Research 
Dissertation 
Undergraduate Research 
Masters Thesis 
Staff Research 
Study Title:  A Study to Evaluate the Feasibility and Acceptability of a Diabetes Survival Skills + 
(DSS+) Intervention for Incarcerated Persons Transitioning to the Community (TTC): 
Study Objective (2-3 sentence summary of study):  _ A study is proposed to determine the 
feasibility and acceptability of a Diabetes Survival Skills intervention training with and without a 
support group for incarcerated persons transitioning to the community. Feasibility will include limited 
efficacy testing to examine the effect of the DSS+ intervention on diabetes knowledge, self-efficacy, 
outcome expectancies, and diabetes related distress.  
PI, Student Investigator, Correspondent Information: 
Principal Investigator 
(PI) 
Student 
Investigator (only 
for Student 
Initiated Research) 
Correspondent (primary 
point of contact for 
correspondence, if 
applicable) 
Name (First, Last, 
Degree): 
Louise Reagan PhD 
Louise Reagan 
Department: 
Nursing 
Nursing 
Mailing Address: 
231 Glenbrook Road 
Storrs, CT 
231 Glenbrook Road 
Storrs, CT 
Preferred Phone #: 860-874-5644
860-874-5644
Emergency Phone 
# (Required Full 
Board, More than 
Min. Risk only): 
860-874-5644
Preferred E-Mail 
Address: 
Louise.reagan@uconn.edu 
Louise.reagan@uconn.edu 
Very Important:  Complete and attach the Appendix A form to list all UConn key personnel engaged 
in research and other non-UConn investigators.  
Internal office use only: 
Full Board __ Expedited __ 
Protocol #

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Section II:  Collaborating Institutions/Facilities and Other IRB Reviews 
 
Will the research be conducted only at Storrs and/or the five regional campuses, School of Law, or 
School of Social Work with no involvement of a collaborating institution?   ___  Yes 
X  No  (If 
yes, skip to Section III) 
 
Collaborating Institutions with a Collaborative Agreement with UConn-Storrs 
UConn has formal agreements with the University of Connecticut Health Center (UCHC), Hartford 
Hospital (HH) and the Connecticut Children’s Medical Center (CCMC) that authorize one IRB to take 
the lead with some research protocols.  This decision is made by the IRBs involved, but the PI may 
request which IRB he/she prefers to be the IRB of record.  See the IRB website for additional 
information.  If you are collaborating with one of the institutions listed below, place an X in the 
appropriate cell to indicate which institution, based on the preponderance of expected enrollment, you 
are requesting serve as the IRB of record or that independent IRB approval will be sought from each 
applicable site.  If you request that UConn-Storrs be the IRB of record, place an X in the appropriate 
cell. 
 
Institution Name 
% to be 
enrolled/consented 
Requested IRB of 
Record 
Independent IRB 
Review 
UConn Health Center 
 
 
 
Hartford Hospital 
 
 
 
Connecticut Children’s 
Medical Center 
 
 
 
UConn – Storrs 
 
 
 
Provide additional comments as needed:   
 
If the PI, Student Researcher or other Key Personnel has an affiliation/appointment with an Institution 
listed above, please explain:   
______________________________________________________________ 
 
 
Other Collaborating Institutions/Facilities 
If you are collaborating with other sites, provide the name of each institution/facility (e.g. other 
university, K-12 school, nursing home, tribal affiliation, etc.) and describe the type of involvement of 
each institution (e.g. recruitment, enrollment/consenting, study procedures, follow-up, data analysis).  
Indicate if IRB approval/site permission is attached (indicate yes, no, or pending).  You will need to 
obtain IRB approval from every collaborating institution that has an IRB before you can initiate 
research there. 
Note:  tabbing out of the bottom right cell will insert another row if needed. 
 
Name of Institution 
Describe Involvement 
IRB Approval/Site 
Permission Attached? 
CT Department of Corrections 
The proposed research will be 
conducted at two male 
Connecticut State correctional 
facilities- Osborne and Cybulski 
Correctional Institutions. 
Connecticut Department of 
Corrections Research Advisory 
Council (RAC), (pending IRB 
approval)  
 
 
 
Provide additional comments as needed:  Received administration approval from Colleen Gallagher, 
Director, Quality Assurance, Health& Addiction Services at State of Connecticut - 10/2016.  

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If the PI, Student Researcher or other Key Personnel has an affiliation/appointment with an Institution 
listed above, please explain:   
______________________________________________________________ 
 
International Research 
Will any aspect of the study take place outside of the United States?   ___  Yes   X No 
(If yes, complete table below) 
 
NOTE:  You may need to obtain IRB approval in the country where the research is taking place and/or 
a Federal-wide Assurance with the Office of Human Research Protections (OHRP). Please see the 
IRB website for additional information. 
 
List Location(s) 
Name of 
Collaborating 
Institution/Facility 
Describe 
Involvement 
IRB/Ethics Approval 
and/or Site 
Permission 
Attached? 
 
 
 
 
 
 
 
 
 
 
 
 
Provide additional comments as needed:  
 
 
If the PI, Student Researcher or other Key Personnel has an affiliation/appointment with an Institution 
listed above, please explain:   
______________________________________________________________ 
 
 
 
SECTION III: Funding 
 
It is the responsibility of the Principal Investigator to notify the IRB via an Amendment (IRB-3) or at 
Re-Approval, on an IRB-2 form if the funding source changes in any way. 
 
Funding Source: 
(Place an “X” in 
the column next 
to the funding 
source.) 
 
Departmental Funds 
 
Human Rights Institute 
X 
External (including subawards) 
 
Research Incentive Account 
X 
Faculty Grants (Large/Small) 
 
Faculty Start-Up Funds 
 
Graduate School DDF or EE 
Award 
 
Investigator Out-of-Pocket 
 
Office of Undergraduate 
Research Award 
 
Unfunded 
For Internal, UConn Funded Studies: 
If the research is supported either in whole or in part by internal funds (Internal Program Support, 
Office of Undergraduate Research, Research Incentive Accounts, etc) one COMPLETE copy of each 
grant application (if applicable) must be included with this application. 
 
 
 
Name of Internal/UConn Funding Source: Scholarship Facilitation Fund, OVPR 

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Principal Investigator: 
Louise Reagan, PhD 
Grant Title (if applicable and if different 
from protocol title): 
Diabetes Survival Skills + (DSS+) Intervention for 
Incarcerated Persons Transitioning to the 
Community (TTC)_: A Pilot Study 
KFS Account Number (if known and only 
applicable for Faculty Large and Small 
Grants funded by Internal Program 
 
Proposal Number (if applicable, e.g. 
 
Grant Status (i.e., pending/awarded): 
Awarded $2,000 2/10/2017 
Provide any additional comments as needed:  
 
Note:  If there is more than one funding source, copy the table format and add the additional funding 
source. 
 
 
For Externally Funded Studies: 
If the research is supported either in whole or in part by external funds (federal, state or private), one 
COMPLETE copy of each grant application or contract must be included with this application. 
 
For each funding source, please identify the following: 
NOTE: If the PI on the grant/contract is not the PI on this IRB protocol, submit an e-mail with this 
application in which the PI who is receiving the grant acknowledges use of this protocol under the 
grant. 
 
Name of Funding Source I (if UConn is 
the recipient of a subaward, list the 
institution providing the funding then list 
the primary source of funds): 
American Nurses Foundation 
Principal Investigator of /Grant: 
Louise Reagan PhD 
Contract/Grant Title: 
(if different from protocol title) 
Feasibility of a Diabetes Survival Skills 
Intervention for Incarcerated Persons 
Transitioning to the Community 
KFS Account Number: 
 
OSP Proposal Number: 
 
Grant/Contract Status: 
(i.e., pending/awarded) 
$5,000 Pending receipt of IRB approval 9/1/2017 
 
Will funds from this contract/grant be awarded to an individual or institution (via a PSA or subcontract) 
that will be engaged in human participant research?  ___  Yes   X  No 
If yes, indicate the name of the institution:  ___University of Connecticut ____________________ 
Provide any additional comments as needed: 
 
Name of Funding Source II(if UConn is 
the recipient of a subaward, list the 
institution providing the funding then list 
the primary source of funds): 
 
Principal Investigator of Contract/Grant: 
 

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Contract/Grant Title: 
(if different from protocol title) 
 
KFS Account Number: 
 
OSP Proposal Number: 
 
Grant/Contract Status: 
(i e
pending/awarded)
 
 
Will funds from this contract/grant be awarded to an individual or institution (via a PSA or subcontract) 
that will be engaged in human participant research?  ___  Yes   X  No 
If yes, indicate the name of the institution:  ______________________________________ 
Provide any additional comments as needed: 
 
 
Note:  If there are more than two funding sources, copy the table format and add the additional 
funding source. 
 
 
 
SECTION IV: Conflict of Interest (only required for externally funded research) 
 
At the time of proposal submission to the Office for Sponsored Programs (OSP), all investigators and 
key personnel are required to submit a Significant Financial Interest Review Form to OSP.  For more 
information, please go to the Conflict of Interest Committee website, 
http://www.compliance.uconn.edu/conflict.cfm. 
 
Is any investigator listed on this protocol required to submit the follow-up form, 
“supplemental” Significant Financial Interest Review Form?      ___  Yes  X  No 
 
If yes, please identify each individual: 
______________________________________________________ 
 
 
SECTION V: Human Participants 
 
Place your responses BELOW, not within, the box containing each item’s description. 
 
How many participants will be enrolled? 
If you are enrolling more than one population describe the total enrollment for each.  Note: 
Participants are generally considered to be ‘enrolled’ when they sign the consent form or have gone 
through an oral consent process.  Therefore, be sure to account for attrition in your enrollment 
number. 
There are over 18,000 incarcerated and transitioning to community men, women and adolescents 
living under the Connecticut Department of Corrections system.  It is estimated that the number of 
inmates with Type 1 or 2 diabetes exceeds 400. For the PIs dissertation research (H12-303), she 
recruited, consented, enrolled and interviewed 124 incarcerated persons in approximately four 
months. There was a large pool of incarcerated person with diabetes who requested participation in 
the prior study. The PI anticipate this same response but the sample size will be limited by the 
eligibility criteria of being within 6-9 months of release from prison.   
 

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For the proposed feasibility  study, ninety-six  participants (12 per group) will be enrolled to participate 
in Diabetes survival skills (DSS) education sessions in facilities designated as a treatment (Cybulski 
Correctional) and control group (Osborn Correctional). Forty-eight  participants in the treatment facility 
will have the option to participate in a support group 6 weeks after the completion of the DSS 
sessions. The DSS plus a support group is referred to as DSS+. Participants who enroll in the study are 
not required to join the support group. 
To allow for a control group in this feasibility study, the PI will recruit 96 participants from two male 
facilities. Forty-eight persons will be enrolled from the treatment facility (Cybulski correctional 
institution) and forty-eight  from the designated control facility (Osborne Correctional). Persons 
housed in these prisons have received or are completing an assigned sentence, may be directly 
released from the facilities to the community or half-way houses. One facility houses slightly less 
inmates but both have similar ethnic, and racial distributions. Nurses in the two facilities are 
contracted to provide nursing care to the inmate population and function under the same policies and 
proceduresAlthough there is no evidence to support the exact number of persons for Group patient 
education, the Center for Medicare and Medicaid has recommended 2-20 participants with an 
average of 10 participants (Health Care Finance Administration, 2000).  Attrition rates for diabetes 
self-management education (DSME) programs vary as do the number of sessions for various group 
DSME models. Attrition rate for individual and group DSME has been reported from 0-50% (Newman, 
Steed, & Mulligan, 2004). In consideration of attrition, twelve participants will be enrolled in each of 
the four sessions.   
 
To further reduce attrition rates, the PI will send appointment reminders to participate in a sealed 
envelope via the Connecticut Department of Corrections (CTDOC) mail system. This process will be 
accomplished in cooperation with the CDOC liaison.   
 
1. Health Care Finance Administration, rules and regulations. Fed Regist 65:83129–83154, 2000 
2. Newman, S., Steed, L., & Mulligan, K. (2004). Self-management interventions for chronic illness. 
The Lancet, 364(9444), 1523-1537. 
If applicable, how many potential participants will be screened?  
When screening procedures are conducted as part of the consent process, participants that fail to 
screen will be counted as being enrolled in the study. 
 
Interested participants will be screened for eligibility by the PI until the sample is achieved. 
It is estimated that the PI will screen 100-150 potential participants to achieve a sample of 96.  
Prior to scheduling a meeting with the potential participant, the PI will request that the DOC designee 
(Jennifer Benjamin RN, MSN, DNP, Correctional Health Services Program Director), review the sick 
slip requests of persons interested in participating to confirm that the inmate can be released form 
their units. Some inmates (potential participants) who have a higher DOC assigned security 
classification are not allowed to participate in groups. If interested potential participants do not meet 
the security classification, the PI will follow the DOC procedure for notifying participants who do not 
meet the DOC classification criteria. Confirming security classification is a routine procedure in the 
prison performed prior to all inmate activities and does not confer additional risk to the potential 
participants. 
After this procedure, The PI will proceed with contacting the inmate, scheduling an appointment to 
determine eligibility using the screening script (Attachment 4), obtain informed consent and begin 
study procedures.    
 
Individuals will be eligible to participate if they have Type 1 or 2 diabetes, are of male gender, any 
race, or ethnicity and: 1) are age 18 and older, 2) are able to speak, and understand English, 3) are 

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incarcerated and within 6-9months of being released from prison, and 4) have a CTDOC classification 
designation that allows them to participate in group sessions. 
 
 
 
 
Participant Population(s): 
Describe the participant population(s) including gender, ethnicity, age range, income, level of 
education, and language spoken. 
Of studies examining the health status of incarcerated persons in CT (Lewis, 2005; McGuire, 
Rosenheck & Kasprow, 2003), the average age of inmates is young, approximately 34 years, 
although there is a growing elderly population; the majority of inmates are male (91%), unmarried 
(86%) and of minority race (45% African-American, 27% white, 26% Hispanic, 2% other).  
The PIs prior research with 124 participants from the same population and setting found similar 
results to that of that Lewis (2005) and McGuire et al. (2003) with the exceptions of age and race of 
the participants. The participants in the PI’s study (Reagan, Walsh, & Shelton, 2016)(H12-303) were 
older and included a greater number of white participants. (see table I) Females were recruited for the 
prior study but with low enrollment likely due to the ratio of males to females incarcerated in the 
Connecticut Correctional system. The PI is conducting this pilot study research in two male facilities 
so females will not be recruited for the pilot. The PI intends to seek a distribution similar to what is 
reported here but recognizes that this may not be feasible. 
 
 
 
 
 
 
Table 1Sociodemographic and Clinical Characteristics of Incarcerated Persons with Diabetes (N 
= 124) 
Characteristic 
N 
% 
M 
SD 
Gender 
 
 
 
 
Male 
116 
93.5 
 
 
Female 
8 
6.5 
 
 
Age 
 
 
47.32 
9.46 
Race 
 
 
 
 
White, Non-
Hispanic 
Hispanic    
42 
 
29 
33.9 
 
23.4 
 
 
Black 
53 
42.7 
 
 
Marital Status 
 
 
 
 
Single/Divorced/ 
Separated 
101 
81.5 
 
 
Married/Partner 
23 
18.5 
 
 
Education 
 
 
 
 
< High School 
GED 
34 
27.4 
 
 
 
McGuire, J., Rosenheck, R. A. And Kasprow, W.J. ( 2003). Health status, service use and Costs 
among veterans receiving outreach services in jail or community settings. Psychiatric Services, 4, 
201-207. 

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Reagan, L. , Walsh, S.J., Shelton, D. (2016). Relationships of illness representation, diabetes 
knowledge, and self-care behaviour to glycemic control in incarcerated persons with diabetes, 
International Journal of Prisoner Health, Vol. 12 Iss: 3, pp.157 - 172 Int J Prison Health. 
12;12(3):157-72. doi: 10.1108/IJPH-04-2015-0010. 
Recruitment: 
Describe the recruitment process including who will recruit, when and where recruitment will take 
place and how participants will be identified and recruited (e.g., direct recruitment by study team in 
person, on the phone, by mail/email/internet, random sampling, referrals from other participants, 
snowball sampling and/or healthcare providers). Attach copies of all advertisement/recruitment 
materials for IRB review including phone scripts, web postings, newspaper advertisements.  If 
recruiting at off-campus sites, written permission and/or local IRB approval may be required. 
The PI will recruit all study participants. The PI will recruit participants similar to the method used for 
her dissertation research(H12-303). The recruitment process for the prior study was effective and has 
been used for other research projects in the prison. For the PIs dissertation research, she recruited, 
consented, enrolled and interviewed 124 incarcerated persons in approximately four months. There 
was a large pool of incarcerated person with Type 1 and 2 diabetes who requested participation in the 
prior study.  
 
1. Indirect Recruitment:  Recruitment flyer 
The inmate patient will be informed by way of a recruitment flyer(Attachment1) of the procedure for 
communicating to the researcher his interest of learning more about and/or participating in the study. 
Therefore, Inmate patients will self-identify if they wish to hear more about or participate in this study.   
The recruitment flyer pending CDOC approval will be posted to request inmate patient participation 
with this study.  The flyer will be posted in English and Spanish at a fifth grade reading level.  
Although exact numbers are not known, CDOC administration believes that there are inmates who 
speak and understand English but may read Spanish more easily than English. At the request of 
CDOC, fliers will be available in English and Spanish.  
 
Possible areas for posting the flyer include inmate housing units, inside and outside the medical exam 
rooms used for the Diabetic or Chronic care clinic, near the location of the medication line and where 
diabetic inmate patients check their finger stick blood glucose levels. Areas for posting will be 
determined with input from CDOC Research Advisory Council (RAC), CDOC administration and 
research liaison. As stated on the recruitment flyer, the inmate who is interested in participating in the 
study will be asked to:  
1.  Write in on a “sick slip” request his/her name and the words “Diabetes Study”  
2.  Place the sick slip in the request box.   
 
This “usual “procedure for requesting a sick visit or visit with the nurse or provider is similar in each 
facility. Upon IRB approval, the PI will work with the CDOC designated research liaison to refine this 
recruitment strategy. Usually, sick slips are sorted and prioritized by the CMHC nurse.  The nurse who 
is triaging the sick slip requests will place those slips indicating a request for information about the 
“diabetes study” in the PI’s mailbox. This mailbox will be located in the facilities medical record 
department or in some other designated location as determined by CDOC.   
The PI will pick-up the “Diabetes study” sick slip requests from medical records at least twice weekly 
and arrange to meet each of the inmates who completed this request. In the PI’s prior experience with 
interviewing inmates (H12-303), the correctional officer (CO) stationed at the facilities medical clinic 
arranged for the inmates to come to the medical clinic for meetings with the student. This procedure 
worked well, was arranged by CDOC administration and likely will be used for this research study. 

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Similar to a previous experience with interviewing inmates, a private yet secure exam or office space 
will be used to complete recruitment, screen and obtain informed consent. 
 
2. Direct Recruitment: In Person  
It is more than likely that some inmates are unable to read. In order to provide information about this 
study and thereby not exclude inmates who cannot read the flyer, the PI will arrange with the CDOC 
to be available in the waiting area of the medical clinics during some sessions of the diabetes chronic 
care clinic.  The PI will meet with inmates interested in hearing more about or participating in the study 
in a private area to speak. The PI would read the information on the recruitment flier to the interested 
inmate.   If interested in participating in the study, the PI would either 1. Record the inmates name and 
arrange to meet at a later time or 2. Proceed with screening.  
 
Additional plans to enhance the above described recruitment strategies are described here.  
1.  Prior to the study, the PI will provide a letter (Attachment 2) that includes a short description of the 
study to the CMHC Director of Nursing.  If agreeable, the Director of Nursing will send via email the 
letter with the description of the study to the CMHC nurses.  The PI will be available to come to the 
nursing supervisor meeting to describe the study. The PI will ask the nurses to direct patient inmates 
who inquire about this diabetes study to complete a “sick slip request” as outlined in recruitment 
strategy number 1.  
 
 
Special Population(s): 
Identify any special participant population(s) that you will be specifically targeting for the study.  
 
Check all that 
apply: (Place an 
“X” in the column 
next to the name 
of the special 
population.)  
 
Minors 
X Economically/Educationally 
Disadvantaged  
X Prisoners 
 
Members of the Armed Forces 
 
Pregnant Women/Neonates 
 
Non-English Speaking 
 
Decisionally Impaired 
 
Individuals Living with AIDS/HIV 
 
UConn Students 
 
Other (Please identify): 
 
UConn Employees 
 
 
 
UConn Students or Employees: 
Are you recruiting students who are in a class you teach or for which you have responsibility? ___  
Yes  X  No 
Are you recruiting employees who report to you?     ___  Yes  X No 
 
If ‘Yes,” explain why this population is necessary to the study and indicate precautions taken by the 
researchers to minimize potential undue influence or coercion: 
_________________________________________________________________________________
________ 
_________________________________________________________________________________
________ 
 
 
 
SECTION VI: Drugs/Devices, Genetic Testing, Radiation and Biological Samples 
 
Drug/Device Use 
Does the study involve the use of any of the following (check all that apply)?  

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• 
An FDA approved drug or medical device 
 
___  Yes  X  No 
• 
An investigative/unapproved drug, supplement or medical device ___  Yes  X No 
• 
A non-medical device ___  Yes  X  No 
• 
A proprietary product  ___  Yes  X  No 
• 
A biological agent 
___  Yes   X No 
 
If yes, please complete the Drug/Device Supplemental Form (IRB-1A) and attach it to this 
application. 
 
Biological Samples 
Does the study involve the use of biological samples?  
(Either banked or prospectively obtained) 
 
 
___  Yes   X  No 
If ‘Yes,’ you will need to obtain approval from the Biosafety Officer before the study can be initiated. 
Please attach a copy of the approval letter if approval has already been granted from the BSO. 
 
Genetic Testing 
Does the study involve the genetic testing of biological samples? ___  Yes  X  No 
If yes, please complete the Genetic Testing Supplemental Form (IRB-1B) and attach it to this 
application. 
 
Radiation or Radioisotopes  
Does the study involve the use of radiation or radioisotopes? 
___  Yes   X No 
If yes, you will need to obtain approval from the Radiation Safety Officer before the study can be 
initiated. Please attach of copy of approval letter if approval has already been granted from the RSO. 
 
 
 
 
 
 
 
 
SECTION VII: Research Plan 
 
Purpose 
State the reason for the study, the research hypothesis, and the goals of the proposed study as 
related to the research question(s).  
Decades of research involving community dwelling and ethnically diverse persons with 
diabetes support the effectiveness of various tailored and culturally relevant group/individual models 
of DSME/S for improving diabetes knowledge 1,2,3 self-care behavior(SCB)2 and metabolic control 2,4 
and stimulating participation in proactive risk reduction.5 Many inmates, are typically not included in 
this. It is unknown whether the evidence based DSME strategies used in the general community such 
as with discharge from the hospital to home are feasible, acceptable and effective for best supporting 
the transition of incarcerated persons in their continued DSM into the community.  For example, one 
study reported prisoners, at seven days’ post prison release, had higher rates of hospitalization for 
short-term diabetes complications and lower extremity amputations compared to matched controls.3 
Interviews with recently released prisoners revealed significant stress post-release related to not 
knowing how and when to take insulin.6 In another study, respondents reported lack of knowledge 
regarding what foods to eat, how to control their blood sugar, take medications, or access health care. 

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7 Diabetes Survival Skills such as taking medication, administering insulin, managing diet, blood 
glucose monitoring, sick day and hypo- and hyperglycemia management are considered basic skills 
needed for survival by all patients with diabetes. At a minimum, incarcerated persons transitioning to 
the community have a critical need for DSS.. The purpose of this study is to examine the feasibility 
and acceptability and preliminary efficacy testing of a 6-session  Diabetes Survival Skills(DSS) 
intervention to incarcerated persons with diabetes witin 6-9 months of transitioning to the community. 
In one facility, the Diabetes Survival Skills sessions will be followed by a support group(DSS+) and 
feasibility of the support group will be examined.   
Research questions: The general research questions for this feasibility study were developed based 
upon Orsmond and Cohn8 proposed questions to guide a feasibility study.  
1. How appropriate are the data collection procedures and outcome measures for the intended 
population and purpose of the study? 
2. Are study procedures and intervention suitable for and acceptable to participants? 
3. Does the research team have the resources and ability to manage the study and intervention? 
4. Does the intervention show promise of being successful with the intended population? 
1. 
The primary aim is to evaluate feasibility of the experimental protocol.  
Hypotheses: H1) Recruitment: 96 eligible persons will consent to participate in the study within 2 
months after the onset of recruitment H2) Attendance/Attrition: 90% of enrolled participants will attend 
and complete the 6-session DSS Training. H3) Engagement: 75% of enrolled participants’ will 
document responses to work-book questions, record blood glucose and if applicable associated diet 
or activity information. H4) Intervention implementation: The intervention will be delivered according to 
the DSS timeline (Figure1) and session outline. H5) Skill proficiency: Participants will return 
demonstrate how to use the blood glucose meter, insulin pen (as indicated), and blood glucose log, 
and other skills specific to DSS session 1-6. 
2. The secondary aim of this study is to determine participants’ acceptability of the program 
and program and study materials including the perspective in participating in the intervention 
using focus groups. 
3.The tertiary aim is to explore the preliminary efficacy and  the short-term effect of the DSS 
intervention on diabetes knowledge (Spoken Knowledge in Low Literacy for Diabetes) Appendix, self-
efficacy (Self-care of Diabetes Inventory Confidence Subscale), and distress (Problem Areas in 
Diabetes Scale) at baseline, immediate post-program and 6 weeks  post-DSS program, or 
immediately before release if release from prison is less than 6 weeks  post-DSS program.  
  
4.  Evaluate the feasibility of a post-session support group (one facility) by documenting potential   
problems with scheduling, participation, and engagement.   
 
The overall goal of this study is to use the results to inform a pilot study of the effect of a DSS 
(Diabetes Survival Skills) on clinical (e.g. glycemic control and Cardiovascular measures), 
psychosocial (e.g. Diabetes Related Stress, Quality of Life), and behavioral (e.g. self-care and 
adherence) post-release outcomes and to explore the feasibility of adding a support group to the DSS 
intervention (DSS+).   
Reference 
1. American Diabetes Association (2016). Standards of medical care in diabetes-2016 abridged for 
primary care providers. Clinical Diabetes. 33, 97–111. doi: 10.2337/dc12-s011 

IRB-1 Protocol Application, Version 6/2014  
 
Page 12 of 37 
 
2. Brunisholz, K. D., Briot, P., Hamilton, S., Joy, E. A., Lomax, M., Barton, N., . . . Cannon, W. 
(2014). Diabetes self-management education improves quality of care and clinical outcomes 
determined by a diabetes bundle measure. Journal of multidisciplinary healthcare, 7, 533.  
3. Chrvala, C. A., Sherr, D., & Lipman, R. D. (2015). Diabetes self-management education for adults 
with type 2 diabetes mellitus: A systematic review of the effect on glycemic control. Patient 
education and counseling.  
4. Powers, M. A., Bardsley, J., Cypress, M., Duker, P., Funnell, M. M., Fischl, A. H., . . . Vivian, E. 
(2015). Diabetes Self-management Education and Support in Type 2 Diabetes A Joint Position 
Statement of the American Diabetes Association, the American Association of Diabetes Educators, 
and the Academy of Nutrition and Dietetics. The Diabetes Educator, 41(4), 417-430.  
5. Fan, L., & Sidani, S. (2009). Effectiveness of Diabetes Self-management Education Intervention 
Elements: A Meta-analysis. Canadian Journal of Diabetes, 33(1), 18-26. doi: 
http://dx.doi.org/10.1016/S1499-2671(09)31005-9 
6. Thomas, E. H., Wang, E. A., Curry, L. A., & Chen, P. G. (2016). Patients’ experiences managing 
cardiovascular disease and risk factors in prison. Health & justice, 4(1), 1.  
7. Salem, B. E., Nyamathi, A., Idemundia, F., Slaughter, R., & Ames, M. (2013). At a Crossroads: 
Reentry Challenges and Healthcare Needs among Homeless Female Ex-Offenders. Journal of 
Forensic Nursing, 9(1), 14–22 
8. Orsmond, G. I., & Cohn, E. S. (2015). The Distinctive Features of a Feasibility Study Objectives 
and Guiding Questions. OTJR: occupation, participation and health, 35(3), 169-177. 
 
Introduction 
Provide a clear and succinct summary description of the background information that led to the plan 
for this project. Provide references as appropriate and, when applicable, previous work in animal 
and/or human studies.  Provide previous UConn protocol number, if applicable. 
 
Although there are conflicting reports of diabetes prevalence in prison ranging from 5-11%1,2, diabetes 
disproportionately affects African American and 
Latino persons who represent over half of 
incarcerated population3,4 (Figure 1). Typically, 
inmates come to prison from socially 
disadvantaged communities and return to the 
same communities 5. And the release rate of 
prisoners into the community is increasing 6,7 
Stabilizing mental and physical illnesses such as 
diabetes and engaging inmates in self-care prior to 
re-entry will not only improve the health and well-
being of the inmate but also has the potential to 
improve overall health and decrease health disparities 
in that community.   
Community based persons with diabetes perform 95% of their care, and make numerous and 
often complex decisions to self-manage diabetes.8,9 Engaging persons with diabetes in DSM is critical 
to improving diabetes and health outcomes10,11and as a result DSME and ongoing support (DSMT/S) 
has become the cornerstone of diabetes care 9.  Decades of research involving community dwelling 
Figure 1 

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and ethnically diverse persons with diabetes supports the effectiveness of various tailored and 
culturally relevant group/individual models of DSMT for improving diabetes knowledge12,13,14, self-
efficacy and empowerment15, self-care behavior(SCB)13 and metabolic control11,12 and stimulating 
participation in proactive risk reduction16.  Yet, research of this nature involving vulnerable 
incarcerated persons with diabetes planning to transition to the community is essentially non-
existent17.  
Additionally, Incarceration is a disruptive life event known to be associated with multiple 
stressors and threats to self-care 17 Many inmates have chronic stress from pre-incarceration issues 
such as substance abuse, 19,20 untreated or serious chronic health conditions 2, prior physical abuse, 
intimate partner violence, and/or repeated incarceration 7 Psychological, emotional, and related 
behavioral factors are important for self-managing diabetes, mental health and addiction disorders. 
Research shows that most inmates who recidivate don't have the proper coping mechanisms that will 
allow them to deal with life outside of prison21.  Cognitive dysfunction, often present in this population, 
can adversely affect memory and executive function 22, and impair diabetes self-management (DSM) 
abilities.   
The American Association of Diabetes Educators has identified transitions such as transferring 
to a new provider, moving from inpatient to outpatient, moving into a correctional facility or having a 
change in insurance status as critical times to providing DSME.  Areas of focus for a transition may 
include identifying needed adaptions in DSM, providing support for independent skills and self-
efficacy, establishing follow-up plans with providers and family or other support systems and assisting 
with facing challenges affecting the usual level of self-management.9   
Moving from the correctional facility to the community is also a time of transition. Incarcerated 
persons with diabetes transitioning to the community will need to navigate the health care system to 
obtain needed appointments and medications, and cope with other competing demands of findings 
housing and employment. Enhancing self-care skills and making plans for reentry is critical for 
incarcerated person with diabetes because they have been deskilled (e.g. limited selection in food 
selection and meal time, not allowed to administer insulin or measure glucose independently and on 
their schedule) as a result of prison. Or they may have been newly diagnosed with diabetes in prison 
and likely have not been independently performing key SCBs specifically Diabetes Survival Skills 
such as taking medication, administering insulin, managing diet, blood glucose monitoring, sick day 
and hypo- and hyperglycemia management.  
Interviews with recently released incarcerated persons revealed significant stress post-release 
related to skill deficits such as not knowing how and when to take insulin23.  Even with access to 
primary care post-release, hypertension blood pressure and diabetes A1C targets of formerly 
incarcerated persons were not maintained at six months’ post-release24. The combined effects of 
comorbidity, life history and the prison environment can potentially affect an incarcerated persons 
perceived control, motivation, and self-efficacy for diabetes self-care and thus the ability to plan and 
engage in self-care especially during transition phases.   
In preliminary research with incarcerated persons with diabetes in the Connecticut Department 
of Corrections(CDOC), the PI found significant diabetes knowledge deficits related to 
hypo/hyperglycemia, key SCBs, allowed within the prison, were not being performed, and lower 
personal control beliefs about their ability to affect diabetes outcomes were associated with lower A1C 
or worse metabolic control. 17 Thirty-five percent of the sample (n=124) were diagnosed with diabetes 
while in prison and likely had no experience with self-managing diabetes in the community.  

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Furthermore, A1C levels (a measure of metabolic control) were above the American Diabetes 
Association’s recommended target of 7% for most participants.10,17 Findings from the PI’s post-
program evaluation of the CDOC’s pilot of a two-year prison adapted eight session Group Medical 
Appointment (GMA) (combined group DSME/S and medical care)25 suggested that some inmates had 
health beliefs or perceptions not congruent with good DSM and limited diabetes knowledge 26.  
The findings, the combined with the knowledge that approximately 95% of inmates are 
released back into the community27 highlight the critical need and moral imperative for developing 
evidence based DSMT/S that address the health needs of vulnerable incarcerated persons and 
engage them in DSM particularly diabetes survival skills prior to their reintegration into society. The 
DSS Intervention is based on the National Standards of Diabetes Education, the PI’s prior research 
and preliminary work with incarcerated person with diabetes, and is grounded in the Information-
Motivation-Behavioral Skills 28,29model of DSM. 
Theoretical Framework  
The proposed study is guided by the Information-Motivation-Behavioral skills (IMB) model 28, 29 
of health behavior change.  The IMB model posits that a person needs accurate information about the 
health behavior, personal and social motivation to act on the information, and the behavioral skills to 
correctly perform the behavior 28 The IMB model has been used widely to inform health behavior 
change interventions for improving adherence to treatment among persons with HIV and more 
recently to enhance diabetes knowledge, motivation and behavioral skills for Latinos with diabetes. In 
a study with Latinos with diabetes, Osborn et al. 29 found that diabetes knowledge (knowledge), 
fatalistic attitudes (personal motivation), and social support (social motivation) were significant direct 
predictors of diabetes self-care and through behavior were related to glycemic control.    
The proximal outcomes of interest for the current study include diabetes knowledge 
(information), outcome expectances (personal motivation), self-efficacy (behavior skills), peer support 
(evaluated in one facility only) (social motivation) and diabetes related distress which may or may be 
mediated by peer support and self-efficacy 30. Given the small sample size, efficacy testing is limited. 
The goal is to continue the DSS or DSS+ intervention training and follow releasees out into the 
community to examine distal outcomes of the IMB model including adherence, and glycemic control.  
Table II. IMB based DSS   Intervention components  
Construct 
Operationalized   
How Provided  
Information  
Diabetes Knowledge 
• 
Interaction with APRN/PI expert in 
providing DSME. Focus on Diabetes 
Survival Skills. 
• 
Selected Low Literacy Patient 
Education Pamphlets from the 
Partnership to Improve Diabetes 
Education (PRIDE)study 31 
(Attachment 3) 
Motivation  
Support Group (for two groups) 
 
Outcome Expectancies 
• 
APRN/PI to facilitate using 
motivational interviewing techniques. 
• 
 Discussion of benefits of self-care 
Behavioral skills  Self-efficacy 
• 
Workbook Questions based on 
Diabetes Survival Skills found in the 

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Diabetes Education Prompt Pack 32 
(AADE,2016).  
• 
Return Demonstration/Simulation: 
Performing Finger sticks for Blood 
Glucose Monitoring, Insulin 
Administration, Documentation in Log 
Book, Food Selection, Hypoglycemia 
management.   
Possible 
Mediator  
Diabetes Related Distress 
• 
Review results of PAID survey at 
beginning of study to obtain an 
estimate of the level of distress among 
participants. Add stress and diabetes 
to DSS program if needed.  
• 
End every session with the three 
cycles of the 4-7-8 relaxation breath  
 
1. Lorber, D. L., Chavez, R. S., Dorman, J., Fisher, L. K., Guerken, S., Haas, L., & Wakeen, B.  (2013). 
Diabetes management in correctional institutions. Diabetes Care, 36 (SUPPL.1),  
S86-S92. 
doi:10.2337/dc13-S086. 
2. Wilper, A. P., Woolhandler, S., Boyd, J. W., Lasser, K. E., McCormick, D., Bor, D. H., & Himmelstein, D. 
U. (2009). The health and health care of US prisoners: Results of a  nationwide survey. American Journal 
of Public Health, 99(4), 666-672.  
doi:10.2105/AJPH.2008.144279 
3. Wang, E., & Green, J. (2010). Incarceration as a key variable in racial disparities of asthma prevalence. 
BMC Public Health, 10(1), 290. 
4. Dumont, D. M., Allen, S. A., Brockmann, B.W., Alexander, N. E., & Rich, J. D. (2013). Incarceration, 
community health, and racial disparities. Journal of Health Care for the Poor and Underserved, 24(1), 78-88. 
doi:10.1353/hpu.2013.0000.  
5. National Research Council (2014). The growth of incarceration in the united states: exploring causes and 
consequences. Committee on causes and consequences of high rates of incarceration, Western, T. B. & 
Redburn, S., eds. Committee on law and justice, Division of Behavioral and Social Sciences and Education. 
Washington DC:The National Academies Press.  
6. Cuellar, A. E. & Cheema, J. (2012). As roughly 700,000 prisoners are released annually, about half will gain 
health coverage and care under federal laws. Health Affairs, 31(5), 931-938.  
doi:10.1377/hlthaff.2011.0501. 
7. West, H., Sabol, W., & Greenman, S. (2010). Prisoners in 2009. Bureau of Justice Statistics, NCJ 231675. 
8. Pearson, M. L., Mattke, S., Shaw, R., Ridgely, M. S., & Wiseman, J. S. H. (2007). Patient Self-Management 
Support Programs: An Evaluation. Chrvala, C. A., Sherr, D., & Lipman, R. D. (2015). Diabetes self-
management education for adults with type 2 diabetes mellitus: A systematic review of the effect on 
glycemic control. Patient education and counseling. 
9. Powers, M. A., Bardsley, J., Cypress, M., Duker, P., Funnell, M. M., Fischl, A. H., . . . Vivian, E. (2015). 
Diabetes Self-management Education and Support in Type 2 Diabetes A Joint Position Statement of the 
American Diabetes Association, the American Association of Diabetes Educators, and the Academy of 
Nutrition and Dietetics. The Diabetes Educator, 41(4), 417-430.  
10. American Diabetes Association (2016). Standards of medical care in diabetes-2016 abridged for primary 
care providers. Clinical Diabetes. 33, 97–111. doi: 10.2337/dc12-s011 

IRB-1 Protocol Application, Version 6/2014  
 
Page 16 of 37 
 
11. Brunisholz, K. D., Briot, P., Hamilton, S., Joy, E. A., Lomax, M., Barton, N., . . . Cannon, W. (2014). 
Diabetes self-management education improves quality of care and clinical outcomes determined by a 
diabetes bundle measure. Journal of multidisciplinary healthcare, 7, 533.  
12. Chrvala, C. A., Sherr, D., & Lipman, R. D. (2015). Diabetes self-management education for adults with type 
2 diabetes mellitus: A systematic review of the effect on glycemic control. Patient education and counseling.  
13. Fan, L., & Sidani, S. (2009). Effectiveness of Diabetes Self-management Education Intervention Elements: 
A Meta-analysis. Canadian Journal of Diabetes, 33(1), 18-26. doi: http://dx.doi.org/10.1016/S1499-
2671(09)31005-9 
14. Newlin Lew, K., Nowlin, S., Chyun, D., & Melkus, G. (2014). State of the science: Diabetes self-
management interventions led by nurse principal investigators. Western Journal Nursing Research, 36(9), 
1111-1157.  
15. Tang TS, Funnell MM, Oh M. Lasting effects of a 2-year diabetesself-management support intervention: 
outcomes at 1-year follow-up.Prev Chronic Dis. 2012;9:E109. 
16. Kent, D., D'Eramo Melkus, G., Stuart, PM, McKoy, JM, Urbanski P, Boren SA, Coke L, Winters JE, 
Horsley NL, Sherr D, & Lipman R (2013). Reducing the risks of diabetes complications through diabetes 
self-management education and support.Popul Health Manag. 2013 Apr;16(2):74-81. doi: 
10.1089/pop.2012.0020. Epub 2013 Feb 13 
17. Reagan, L. , Walsh, S.J., Shelton, D. (2016) "Relationships of illness representation, diabetes knowledge, 
and self-care behaviour to glycemic control in incarcerated persons with diabetes", International Journal of 
Prisoner Health, Vol. 12 Iss: 3, pp.157 - 172  Int J Prison Health. 12;12(3):157-72. doi: 10.1108/IJPH-04-
2015-0010. 
18. Haney, C. (2001). From Prison To Home: The Effect Of Incarceration And Reentry On Children, Families, 
And Communities. The Psychological Impact of Incarceration: Implications for Post-Prison Adjustment. 
University of California, December, 2001, Santa Cruz, California.  
19. Binswanger,I.A., Nowels, K., Corsi, K., Glanz, J., Long, J., Booth, R., & Steiner, J.F. (2012).  Return to drug 
use and overdose after release from prison: a qualitative study of risk and protective factors. Addiction 
Science & Clinical Practice, 7, 3. doi:10.1186/1940-0640-7 
20. Calcaterra, S., Beaty, B., Mueller, S., Min, S., & Binswanger, I. (2014). The association between social 
stressors and drug use/hazardous drinking among former prison inmates. Journal of Substance Abuse, 47, 
41-49. 
21. Cavanagh, J. F., Frank, M. J., & Allen, J. J. (2011). Social stress reactivity alters reward and punishment 
learning. Social cognitive and affective neuroscience, 6, 3: 311-320.  
22. Thomas, E. H., Wang, E. A., Curry, L. A., & Chen, P. G. (2016). Patients’ experiences managing 
cardiovascular disease and risk factors in prison. Health & justice, 4(1), 1.  
23. Thomas, E. H., Wang, E. A., Curry, L. A., & Chen, P. G. (2016). Patients’ experiences managing 
cardiovascular disease and risk factors in prison. Health & justice, 4(1), 1.  
24. Fox, A. D., Anderson, M. R., Bartlett, G., Valverde, J., Starrels, J. L., & Cunningham, C. O. (2014). Health 
outcomes and retention in care following release from prison for patients of an urban post-incarceration 
transitions clinic. Journal of health care for the poor and underserved, 25(3), 1139. 
25. Gallagher, C., LaFrance, B., & Neff, L., (March 2011). Group Medical Appointments Chronic Disease Care 
A Pilot Project. Paper at 4th Academic and Health Policy Conference on Correctional Health. Boston, MA. 
March 10-11, 2011. 
26. Reagan, L. (2011, October). Inmates health beliefs about diabetes: Implications for diabetes education in the 
correctional setting. Proceedings of Custody and caring:  12th Biennial International Conference on the 
Nurse’s Role in the Criminal Justice System (p. 42).  Saskatoon, SK. 
27. Wang, E. A., & Wildeman, C. (2011). Studying health disparities by including incarcerated and formerly 
incarcerated individuals. Jama, 305(16), 1708-1709. 

IRB-1 Protocol Application, Version 6/2014  
 
Page 17 of 37 
 
28. Fisher, J.D., Fisher, W.A., Amico, K. R., & Harman, J.J. (2006). An information-motivation-behavioral 
skills model of adherence to antiretroviral therapy. Health Psychology, 25(4), 462-473.  
29. Osborn, C. Y., & Egede, L. E. (2010). Validation of an information-motivation-behavioral skills model of 
diabetes self-care (IMB-DSC). Patient Education and Counseling, 79(1), 49–54. 
30. de Vries, L., van der Heijden, A. A., van't Riet, E., Baan, C. A., Kostense, P. J., Rijken, M., ... & 
Nijpels, G. (2014). Peer support to decrease diabetes-related distress in patients with type 2 
diabetes mellitus: design of a randomised controlled trial. BMC endocrine disorders, 14(1), 1. 
31. Wolff, K., Chambers, L., Bumol, S., White, R. O., Gregory, B. P., Davis, D., & Rothman, R. L. (2016). The 
PRIDE (Partnership to Improve Diabetes Education) Toolkit Development and Evaluation of Novel   
       Literacy and Culturally Sensitive Diabetes Education Materials. The Diabetes Educator, 42(1), 23-33 
32.  AADE. (2016). Diabetes Education Prompt Deck. Educator Guide.  
 
Design, Procedures, Materials and Methods 
Describe the study design, including the sequence and timing of all study procedures.  Indicate 
expected start and completion dates.  Include screening procedures, if any.  The IRB strongly 
suggests that investigators incorporate flexibility into the study design to accommodate anticipated 
events (i.e. explain how missed study appointments can be made up by participants).  If the research 
involves study of existing samples/records, describe how authorization to access samples/records will 
be obtained.  If the study involves use of deception explain the reason why this is necessary.  If 
applicable, describe the use of audiotape and/or videotape and provide justification for use. If this 
study offers treatment for the participants’ condition, complete the Treatment Study Supplemental 
Form (IRB-1C) and attach it to this application for review.  If the study includes measures, survey 
instruments and questionnaires, identify each and, if available, provide references for the 
measures.  Describe what they intend to measure (relate to purpose/hypothesis) and their 
psychometric properties (e.g., reliability and validity).  Identify any that were specifically created for the 
study.   
Design: The proposed  study will examine the feasibility, acceptability and preliminary efficacy 
measures of a quasi-experimental non-equivalent control group 6-week intervention study with repeated 
measures at baseline, 6 weeks, and 12 weeks.  Acceptability of the DSS intervention will be examined 
using  a qualitative descriptive design with focus group interviewing.  
 
Prior to data collection, IRB approval from the University of Connecticut and the CDOC Research 
Advisory Council (RAC) will be obtained.  Procedures for the recruitment of inmates with diabetes will 
be determined in collaboration with the Connecticut Department of Corrections administration (CDOC). 
Recruitment procedures as described in the prior section have been previously used and approved by 
the CDOC RAC.  The final RAC approval has been obtained (see Connecticut department of 
Corrections letter of approval). .  The RAC has reviewed this proposal and granted  approval.  After 
UCONN IRB and RAC approval, meetings with the Wardens will be arranged, email communication will 
be sent to Correctional Managed Healthcare (CMHC) nursing director (Attachment 2), recruitment flyers 
will be posted in the participating prisons, and the researcher will negotiate dates and times to be 
available during several Chronic Care Clinic sessions for in person recruitment as described in the 
recruitment procedures.  
 
The “sick slips” from inmates requesting to hear more about the study will be collected from my assigned 
mailbox in medical records or another designated location and subsequently reviewed. Prior to 
scheduling a meeting with the potential participant, the PI will request that the DOC liaison or other 
designee review the list of potential participants to confirm that the participants meet the secure 

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classification to participate in groups.  If interested potential participants do not meet the security 
classification, the PI will follow the DOC procedure for notifying participants who do not meet the DOC 
classification criteria.  
All other interested potential participants will be contacted to meet with the PI. Similar to the system 
used for the PIs previous research, the researcher will work collaboratively with DOC liaison and the 
Correctional Officer (CO) routinely stationed in the medical clinic or infirmary of each prison site to 
schedule meetings with potential participants. The CO will call the cell block and ask that the inmate 
participant come to the medical clinic or another designated private room to meet with the PI. 
 
The PI will negotiate dates and times to meet with interested inmates at a CDOC assigned private 
location- likely an exam or office space in the medical clinic.  The door of the exam room will remain 
slightly ajar to provide privacy for inmate participant.  The PI will sit in front of the inmate participant with 
her back to the slightly open door, this procedure was advised by the CDOC and used during prior 
interactions with inmate patients.  The PI will be assigned a CDOC research liaison who will provide 
specifics of office or exam room location within the medical clinic.  A corrections officer is stationed at 
some of the medical clinics or at a minimum makes rounds within the unit on a regular basis. Inmates 
will be screened using the screening script (Attachment 4) and if eligible, informed consent (Attachment 
5) will be obtained. The inmate participant will be asked to read the Informed consent along with the 
researcher or if unable to read listen to the informed consent. Consent forms will be available in both 
English and Spanish if requested. Since patients will be able to speak and understand English, no 
interpreter is needed to assist with informed consent. They will be encouraged to ask questions and 
sign the form if they agree to participate.   
 
If the inmate provides a negative response to any one question on the screening exam, he will be 
thanked for his time and transferred to the care of the CO for transport/disposition back to the living 
quarters. 
 
After the potential participant consents to participate and signs the informed consent, the participant will 
be asked to complete the demographic survey (Attachment 7), the Health Literacy screening 
(Attachment 8) and the Montreal Cognitive Assessment, a measure of cognitive function (Attachment 
9). If the participant is not able to recall his medications and if the participant has consented to allowing 
the PI to access the medical or pharmacy record, the PI will arrange to obtain a list of the participant’s 
actual medications from the medical or pharmacy record. A HIPAA release form will be  signed if needed 
after completion of demographic survey. Obtaining informed consent and baseline demographic and 
cognitive measures will be considered visit 1 for participants from the treatment and control facilities. 
For the first two sessions (Group 1 First 48 participants) (Figure 1)The PI will screen potential 
participants until 48 participants are consented, and enrolled. Twenty-four participants in the 
designated Treatment facility (Cybulski Correctional Institution)divided into 2 groups of 12 will 
participate in the same DSS intervention on two separate occasions. Participants (n=24) in the Control 
facility (Osborn Correctional Institution) will receive the intervention upon completion of week twelve 
measurements.  Figure 1 outlines the schedule for the informed consent, DSS intervention sessions, 
quantitative assessments and focus groups. As noted in the legend for figure 1. the Control group will 
receive the intervention after week 12 if they choose to do so.  
 

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The PI will begin screening, recruitment and informed consent procedures for Group 2 (the second set 
of 48 participants) when Group 1 (first 48 participants) completes Visit 4 (approximate start time) 
(Figure 1).  Group 2 (n=24) in the control facility and n=24 in the treatment facility) will begin the DSS 
sessions and measurement schedule following the same procedures used for Group 1 and as 
described in Figure 1 Visits 2- 10.   The support group is optional for those in the treatment facility 
because this aspect of the study is being evaluated after the DSS education sessions and three 
measurement intervals have been completed.    

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Visit 1 
Week 1 
1.5 hours 
Visit 2  
Week 4 
1.5 hours 
 
Measure 1 
Visit 3 
Week 5 
1 hour 
Visit 4 
Week 6 
1 hour 
Visit 5 
Week 7 
1 hour 
Week 6 
Week 8 
1 hour 
Visit 7  
Week 9 
1.5 hours  
 
Measure 2 
Visit 8 
Week 11 
2 Hours 
  
Visit 9 
Week 15  
1 hour 
 
Measure 3 
Visit 10+ 
1 hour/week 
Optional 
Treat- 
ment 
Facility 
 
 Group 1 
N=24  
Group 2 
(N=24) 
 
(n=12 per 
DSS 
session) 
 
 
 
Informed 
consent 
 
STOFHLA 
MoCA 
Demographics 
 
 
Baseline 
Surveys 
SKILLD1 
SCODI2 
OEQ3 
PAID4 
  
Session 1 
Topic  
Diabetes 
Intro and 
Preparing 
for 
Discharge  
 
 
 
 
 
 
 
Session 2 
Topic 
Medicine 
taking 
 
 
 
 
 
 
 
Session 3 
Topic  
Monitoring 
 
 
 
 
 
 
 
Session 4 
Topic 
Hypo- 
glycemia 
 
 
 
 
 
 
 
Session 5 
Topic 
Basic Meal 
planning 
Surveys 
SKILLD 
SCODI 
OEQ 
PAID 
 
 
Session 6 
Topic 
Sick day 
manage 
post-
release 
follow-up 
Focus 
Group
(2) 
 
Surveys 
SKILLD 
SCODI 
OEQ 
PAID 
 
Support Group 
 
Control 
Facility
8 
 
 
Group 1 
(N=24) 
Group 2 
(N=24) 
 
Visit 1 
Week 1 
1.5. hours 
 
Informed 
consent 
 
STOFHLA5 
MoCA6 
Demographic7 
 
 
Visit 2  
Week 4 
1 hour  
 
Measure 1 
Surveys 
SKILLD 
SCODI 
OEQ 
PAID 
 
 
 
 
 
 
 
 
Visit 3 
Week 9 
1 hour  
 
Measure 2 
Surveys 
SKILLD 
SCODI 
OEQ 
PAID 
 
 
Visit 4  
Week 15 
60 min 
 
Measure 3 
Surveys 
SKILLD 
SCODI 
OEQ 
PAID 
 
Visit 5-10 
Week 15-20 
Optional 
 
DSS Sessions 1-6 
 
1 Spoken Knowledge Low Literacy in Diabetes; 2 Self-care of Diabetes Inventory Confidence subscale; 3. Diabetes Outcome 
Expectancies Questionnaire; 4. Problem Areas in Diabetes, 5. Short Test of Functional Health Literacy Adults, 6 Montreal Cognitive 
assessment, 7 Demographics 8 Control group to receive the intervention after week 12.

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The exact timing of the support group in the treatment facility will be negotiated with the CDOC but will 
not start prior to the completion of 12-week data collection time point for group 1 and 2). 
Intervention  
The DSS sessions will be held in a room in the medical area away from other inmate activities. There 
will be a correctional officer (CO)present outside of the room at all times and the door of the 
conference room will be slightly ajar according to the DOC’s safety related procedures.  The first 
session of the six sessions will be 90 minutes’ duration to allow for completion of the 4 instruments- 
the SKILLD (Attachment 10), SCODI (Attachment 11), and the PAID (Attachment 12,), OEQ 
(Attachment 13 note); The PI will read the instruments aloud to the group and collect the surveys 
before starting the session.  
 
At the beginning of each group session, confidentiality guidelines and group expectations will be 
addressed and clearly stated by the student investigator at every group session. Group members will 
be told of the importance of maintaining confidentiality and that “what is shared in the group remains 
in the group” and any information shared in groups should not be discussed outside the group. This 
will be discussed with every group at the beginning of each session.  Confidentiality guidelines will 
also be posted on a flip-board chart so it is visible for everyone to see and remember at every group 
session. Reminders not to discuss group topics outside the group will be reiterated at the end of the 
group session. These procedures will be maintained; however, confidentiality cannot be guaranteed 
The PI will also remind the participants at the beginning of each session that she will be taking notes 
related to diabetes related questions or concerns. 
Additionally, at the beginning of each group session members will be told what will happen if the 
student investigator is informed of self-harm intent and the obligation to refer the member to seek help 
from their healthcare provider. Since inclusion criteria selects only inmates who are preparing for 
release from prison this risk of self-harm is minimal but still needs to be identified and addressed. 
The only limit to privacy is related to the lack of anonymity to the PI. However, as healthcare 
professionals the PI will be obligated to adhere to HIPAA guidelines and confidentiality guidelines of 
the group. The PI will adhere to the standard of confidentiality of group process and group sharing.  
For session content, please refer to the intervention protocol (Attachment 15) 
During the last thirty minutes of the 90 minutes scheduled for the last session, they will complete the 4 
surveys. The PI will read all surveys aloud and collect the surveys after completion. All participants 
will be invited to participate in the audio recorded focus groups scheduled 2 weeks’ post DSS 
sessions to evaluate acceptability of the DSS intervention. At the 6 week  post DSS follow-up  to 
complete questionnaires, the participants will receive a certificate of participation and be thanked for 
their time. 
Focus Group Interviews 
The FGIs will be scheduled approximately two weeks from the date of the sixth and final DSS session 
(Table III) They will be provided with the date negotiated with the CDOC prior to the last session and a 
reminder notice will be sent to all participants who reaffirm their consent to participate in the focus 
group.  
The FGIs will consist of 8-10 participants, last approximately 90 minutes and be led by the PI. The PI 
will conduct at least one FGI in each facility for 8-10 participants. If more than 10 participants request 
participation, the PI will conduct additional FGIs. An interview guide (Attachment 14) will be used to 

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elicit information about the participant’s acceptability of the DSS program. The focus will groups will 
be audio recorded and a CITI trained, approved CDOC nursing student will observe and take notes 
during all four of the focus group sessions. 
The PI will review confidentiality guidelines and group expectations will be addressed and clearly 
stated at the beginning of the FGI. Group members will be told of the importance of maintaining 
confidentiality and that “what is shared in the group remains in the group” and any information shared 
in groups should not be discussed outside the group. This will be discussed with every group at the 
beginning of each session.  Confidentiality guidelines will also be posted on a flip-board chart so it is 
visible for everyone to see and remember at every group session. Reminders not to discuss group 
topics outside the group will be reiterated at the end of the group session. These procedures will be 
maintained; however, confidentiality cannot be guaranteed. Participants can request that the audio 
recorder be turned off if they wish to make a statement when not being recoded. The PI will ask the 
participants if the PI may contact them to clarify any areas of the FGI. At the end of the FGI, the 
participants will be thanked for their time and escorted back to their cell. The focus groups will begin 
approximately two weeks from the date of the sixth and final DSS session (Table III Visit 8/week 11) 
for Group 1 and 2. 
Table III. Focus Groups (8-10 participants per group) Intervention 
 
Treatment Facility  (2 hours) 
Two Focus Group Sessions 
each for Group 1 and 2    
Control Facility (2 hours) 
Two Focus Group Sessions 
each for Group 1 and 2   
 
Support Group 
For those participants in the DSS+ intervention in the treatment facility, they will have the option of 
participating in a weekly Diabetes support group to start after the 12-week data collection time point. 
The PI as facilitator of the support group adopts the support group facilitator strategies of connecting, 
exchanging information (e.g. correcting misinformation), managing group dynamics (coordinating flow 
and tone of support group discussion, facilitating peer to peer mentoring), and problem solving (e.g. 
skill reinforcement and practice) (Costello, 2013). There will not be any specific topics will be planned. 
The participants will interact with each other about matters relative to diabetes and preparing for 
release. The PI will observe and take notes during the support group. The support sessions will be 60 
minutes’ duration and will occur weekly or biweekly if interest is lacking e.g. no participation. The 
exact timing of the support will be negotiated with the CDOC but will not start prior to the 3 month 
post-DSS session data collection). 
Costello, J. F. (2013). Roles and Strategies of Diabetes Support Group Facilitators An Exploratory 
Study. The Diabetes Educator, 0145721713476347. 
 
Data Analysis:  
Measures: 
1. Demographic survey (Attachment 7).  Sociodemographic variables include age, gender, ethnicity, 
health status (type of diabetes, duration of illness and/or age at diagnosis), medications including 
dose, type, frequency, and administration method (keep on person[KOP], or direct observation 
medication line), medical problems, mental illness and prior alcohol/substance abuse, and years in 
prison.   
Commented [LAR1]: Table revised  

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2. Functional Health literacy will be measured by the S-TOFHLA (Attachment 8).1 The S-TOFHLA 
has been widely used with reported Cronbach’s alpha at 0.97.27 It has been widely used with diverse 
populations.   
3. Cognitive function will be measured by the Montreal Cognitive Assessment (MoCA)2(Attachment 
9) is designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different 
cognitive domains: attention and concentration, executive functions, memory, language, 
visuoconstructional skills, conceptual thinking, calculations, and orientation and takes approximately 
10 minutes to administer. The total possible score is 30 points; a score of 26 or above is considered 
normal. Internal consistency of the MoCA ranges from 0.72 – 0.83. Cronbach’s alpha in geriatric, 
mixed clinical population and stroke and vascular dementia populations.  
4. Feasibility measures Aim1: Feasibility will be will be evaluated with recruitment and enrollment 
tracking forms, attendance sheets, field notes, adherence to intervention manual, participant 
workbook entries, glucose meter procedure manual, and blood glucose logs to obtain data needed to 
support hypotheses. Reliability of all instruments will be evaluated.  
5. Acceptability measure Aim 2: Data will be obtained using an IRB approved FGI guide e.g.  probes 
such as perspective about the overall quality of the program? Or how well did the program prepare 
you for transitioning to the community?Preliminary Efficacy measure: Dependent Variables:  
1.Diabetes knowledge diabetes knowledge. Spoken Knowledge in Low Literacy for Diabetes scale 
(SKILLD) (Rothman et al., 2005)3(Attachment 10) is a 10-item scale that measures diabetes 
knowledge and takes less than 10 minutes to administer. Each item is scored as correct (0) or 
incorrect (1).  Total scores range from 0-100 % with higher scores indicating greater diabetes 
knowledge. Coefficients of internal reliability for the SKILLD have been reported at 0.72 (Kuder 
Richardson Coefficient of reliability) (Rothman et al., 2005) and 0.54 (Cronbach’s alpha) (Jeppesen, 
Hull, Raines, & Miser, 2012).4 Both Rothman et al.’s (2005) and Jeppesen et al.’s 4 (2012) studies 
supported construct validity and moderate criterion validity with the SKILLD. Additionally, as was done 
for the current study, individual items can be analyzed as the percentage of participants’ who 
responded correctly. The SKILLD instrument when used to evaluate knowledge in a population of 
incarcerated person with diabetes had Cronbach’s alpha of 0.65 5 (H12-303).  Both health literacy 
(p>0.05) and perceived knowledge about diabetes (p<0.05) were associated with diabetes knowledge 
and that the direction of the association was positive.  
2. Self-efficacy will be measured with the 11 item Self-care of Diabetes Inventory (SCODI) 
Confidence Subscale6 (Attachment 11). The SCODI measures the degree of confidence the person 
has about his or her ability to perform specific self-care task and to persist in forming an action despite 
barriers. The SCODI is scored on a standardized scale of 0-100 with higher scores indicating higher 
confidence. The SCODI has a global reliability index for multi-dimensional scales of 0.89 and alpha 
reliability of 0.80. The length of time to administer is not documented in the literature.   
3. Diabetes Related Emotional Distress will be measured with the PAID (Problem Areas in 
Diabetes) scale (Attachment 12). The PAID consists of 20 items with each item scored 0 to 4 ("Not a 
problem" to "Serious Problem"). The sum of the 20 items is multiplied by 1.25 to yield a final score 0-
100 with higher scores indicating greater distress. Internal consistency has been reported at 0.90 and 
has been consistently high ,,7,8.   
4. Outcome Expectancies Questionnaire (OEQ) (Attachment 13), a 20 item instrument, will 
measure Outcome expectancies or a “person’s perceptions of the consequences of performing 
diabetes self-care behavior”. 9 Perceptions of the consequences of an outcome have been associate 
linked to motivation to perform a behavior.  A high score on the OEQ indicates suggest strong beliefs 
that the performance of specific diabetes behaviors will lead to a specific outcome. 10 The OEQ 
Cronbach’s alpha has been reported at 0.80.  

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1. Baker DW, Williams MV, Parker RM, Gazmararian JA, Nurss J. Development of a brief test to 
measure functional health literacy. Patient Education and Counseling. 1999;38:33–42 
2. Nasreddine, Z. S., Phillips, N. A., Bédirian, V., Charbonneau, S., Whitehead, V., Collin, I., ... & 
Chertkow, H. (2005). The Montreal Cognitive Assessment, MoCA: a brief screening tool for 
mild cognitive impairment. Journal of the American Geriatrics Society, 53(4), 695-699. 
3. Rothman, R. , Malone, R., Bryant,B., Wolfe, C., Padgett, P.,DeWalt, D., Weinberger, 
M.Pignone,M.(2005). The Spoken Knowledge in Low Literacy in Diabetes Scale. The Diabetes 
Educator, 31(2), 215-224. 
4. Jeppesen, K.,  Hull, B., Raines, M.,  and Miser, F. (2012). A Validation Study of the Spoken 
Knowledge in Low Literacy in Diabetes Scale (SKILLD).  Journal of General Internal Medicine, 
27 (2), 207-212. 
5. Reagan, L. , Walsh, S.J., Shelton, D. (2016) "Relationships of illness representation, diabetes 
knowledge, and self-care behaviour to glycemic control in incarcerated persons with diabetes", 
International Journal of Prisoner Health, Vol. 12 Iss: 3, pp.157 - 172  Int J Prison Health. 
12;12(3):157-72. doi: 10.1108/IJPH-04-2015-0010 
6. In review, pending reference from author. 
7. Polonsky WH, Anderson BJ, Lohrer PA, Welch G, Jacobson AM, Aponte JE, Schwartz CE 
(1995). Assessment of diabetes-related distress. Diabetes Care 1995;18:754-60. 
8. Welch GW, Jacobson AM, Polonsky WH (1997). The Problem Areas in Diabetes Scale: An 
evaluation of its clinical utility. Diabetes Care 20:760-766, 1997. 
9. Glasgow, R. E., Toobert, D. J., Riddle, M., Donnelly, J., Mitchell, D. L., & Calder, D. (1989). 
Diabetes-specific social learning variables and self-care behaviors among persons with type II 
diabetes. Health Psychology, 8(3), 285. 
10. Chlebowy, D. O., & Garvin, B. J. (2006). Social support, self-efficacy, and outcome 
expectations impact on self-care behaviors and glycemic control in Caucasian and African 
American adults with type 2 diabetes. The Diabetes Educator, 32(5), 777-786 
 
Justification of Sample Size:  For qualitative and pilot studies, describe how the proposed sample size 
is appropriate for achieving the anticipated results.  For quantitative studies, provide a power analysis 
that includes effect size, power and level of significance with references for how the sample size was 
determined.  Explain the rate of attrition, with references as appropriate.  Data Analysis:  For all 
studies, provide a description of the statistical or qualitative methods used to analyze the data.   
 
Quantitative: 
Demographic data, sociocultural and cognitive function will be analyzed with univariate statistics. 
Justification of Sample size: h.    

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Previous research 24 has demonstrated that, in diabetes behavioral interventions targeting the 
variable “diabetes knowledge,” an effect size of 0.47-0.68 is achievable at p < .05. Therefore, with a 
moderate effect size (d=0.50), p<0.05, power 0.80, 2 groups, and an estimated moderate correlation 
(0.50) between 3 repeated measures, the power analysis 25 indicated a need for 86 participants. 
 
Attrition for DSME programs is reported to range as high as 20- 50%. 2,3. This wide variation and 
high rate of attrition has been reported as being multifactorial e.g. group versus individual program, 
accessibility, timing, presence of depression, older age of participant.4,5 Attrition rates for group 
DSME has been lower than non-group education.5 There is no data on attrition rates for DSME or 
other similar programs in the prison.  Factors possibly influencing attrition in the prison that need to be 
considered include movement of incarcerated persons between facilities and other restrictions of 
movement e.g. lockdown. 6 During the PI’s previous research, communication with the facility and 
CDOC designee was critical to identify real or potential issues affecting data collection. The PI will 
employ the following strategies to reduce attrition:  
1. Confirm with the CDOC designee prior to participant enrollment that the potential participant is 
within 6-9 months of release to the community. 2. Schedule the DSS+ sessions during the evening 
and possibly on the weekend to avoid conflicts with the participants work or day schedule. This 
strategy recommended by the CDOC administration and employed during the PI’s prior research 
worked well when scheduling meetings with potential participants.  Attendance for Potential 
participants who signed up to meet with the PI on a specific date to hear more about the study and 
possibly participate in the study was high. Only 2 potential participants declined to come for the 
scheduled meeting due to attendance at a religious service.   3. The CDOC designee will send 
reminders to DSS session participants the day before the scheduled session.  
2.  

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For these reasons, the PI expects attrition to be low for this study 5-10% and supports the sample 
size of 96.  It is estimated that the PI will screen 100-150 potential participants to achieve a total 
sample of 96 to account for attrition as high as 10%.Furthermore, one of the purposes of this 
feasibility study is to evaluate attrition.  
1. Leon, A.C., Davis, L.L., & Kraemer, H.C. (2011). The role and interpretation of pilot studies in 
clinical research. Journal of Psychiatric Research, 45 (5), 626-629. 
2. , S. L., Lau, J., Smith, S. J., Schmid, C. H., & Engelgau, M. M. (2002). Self-Management education 
for adults with type 2 Diabetes A meta-analysis of the effect on glycemic control. Diabetes care, 25(7), 
1159-1171. 
3. Sarkisian, C. A., Brown, A. F., Norris, K. C., Wintz, R. L., & Managione, C. M. (2003). A systematic 
review of diabetes self-care interventions for older, African American, or Latino adults. The Diabetes 
Educator, 29(3), 467-479. 
4. Adams, K. F., Sperl-Hillen, J. M., Davis, H., Spain, C. V., Hanson, A. M., Fernandes, O. D., ... & 
Beaton, S. (2013). Factors influencing patient completion of diabetes self-management education. 
Diabetes Spectrum, 26(1), 40-45. 
5. Gucciardi, E., DeMelo, M., Offenheim, A., Grace, S. L., & Stewart, D. E. (2007). Patient factors 
associated with attrition from a self‐management education programme. Journal of evaluation in 
clinical practice, 13(6), 913-919. 
6. Reagan, L., & Shelton, D. (2016). Methodological factors conducting research with incarcerated 
persons with diabetes. Applied Nursing Research, 29, 163-167. 
Statistical strategy: 
Data will be analyzed using SPSS. Descriptive methods will be used to generate summary statistics of 
demographic and study variables to answer questions 5 about feasibility. We will use the information 
obtained under Aim 1-3 to further refine the intervention. 
Aim 1 Feasibility: Counts, percentiles, measures of central tendency, and correlations will be 
examined to provide information to address each hypothesis in Aim 1. Additionally, quantitative 
content analysis using apriori themes from Diabetes Education Prompt Deck 34 from the PIs 
experience conducting research with incarcerated persons will be used to further assess participant 
engagement(H3) and intervention implementation(H5). 
Aim 2 Acceptability, Qualitative data from each FGI transcript (unit of analysis) will be analyzed with 
Krippendorff 43method of qualitative content analysis. An iterative process of coding and categorizing 
the data will be used to identify themes within and across transcripts. Two researchers will read each 
transcript, several times to come to consensus on themes. 
Aim 3 Preliminary efficacy of the effect of the DSS training on the IMB outcome variables will be 
evaluated with repeated-measures ANOVA and for the assumptions of repeated measures ANOVA. 
Qualitative  
The Focus Group Interview (FGI) will be guided by the interview guide (Appendix). Focus Groups 
Interview (FGIs) will be audiotaped with verbatim transcriptions, entered into a password secured 
Word file and imported into ATLAS/TI software for data management. Qualitative data from each 
transcript will be analyzed with Krippendorff method of qualitative content analysis. An iterative 
process of coding and categorizing the data will be used to identify themes within and across 
transcripts. Two researchers will review each transcript, read each transcript several times to come to 
consensus on themes.  
 

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Justification of Sample size: The rule of thumb is to conduct 4 focus groups and then determine if 
saturation is reached 7 Consensus is lacking in the literature on the total number of participants 
needed to achieve data saturation but five to eight participants but not more than 10 is usually 
adequate for most noncommercial topics when using focus group interviewing techniques. 7 The PI 
will enroll 10 participants per group to account for no-shows.   
7. Kreuger, K.A. & Casey, M.A. (2009). Focus Groups a Practical Guide for Applied Research. 4th 
ed.Washington DC.  
 
Inclusion/Exclusion Criteria 
List major inclusion and exclusion criteria.  Any proposed exclusion criterion based on gender (women 
of childbearing potential), age, or race must include justification for the exclusion.  Describe the 
conditions under which participants may be removed from the study, i.e., noncompliance with study 
rules, study termination, etc. 
 
1. Inclusion Criteria: 
All persons with Type 1 or 2 diabetes of male gender, any race or ethnicity who are incarcerated in 
selected Connecticut prisons as negotiated with CDOC (Osborn Correctional Institution, Somers, CT, 
and Cybulski Correctional Institution, Somers, CT) will be eligible to participate if he:  
• 
Has Type 1 or 2 diabetes 
• 
Is within 6-9 months of release from prison 
• 
Is able to speak and understand English  
• 
Is age 18 or over.  
• 
Agrees to voluntarily participate  
• 
Has capacity to provide written consent.   
 
2. Exclusion criteria  
• 
inmate patients who do not have diabetes  
• 
Inmates who do not speak and understand English.  
• 
Inmates who are in segregation or otherwise ineligible due to safety and security policies. 
 
3. Justification for exclusion: There is no one on the study team fluent in Spanish. This study has 
limitedfunding.   
 
4. Conditions under which inmates may be removed from the study: Those who are unable to provide 
consent and/or are in administrative segregation, the hospital, or demonstrate any illegal behavior or 
are removed by their primary clinician or the CT DOC for safety reasons.  The subject of disclosure of 
any illegal activity will be outlined in the consent sheet noting that the facilitators are mandated to 
report if a participant is disclosing that they are thinking of hurting themselves, others or breaking the 
law. All participants are informed of this verbally at time of consent.  The PI’s past experience with 
inmate populations has provided her with the experience that inmate participants are well aware of 
these facts. 
 
 
Risks and Inconveniences 
Describe the potential risks to participants (and secondary participants, if applicable) and steps taken 
to minimize risks.   Assess the likelihood of the risk occurring and, if it were to occur, the seriousness 
to the participant.  Types of risks to consider include: physical, psychological, social, legal, 
employment, and financial.   Also describe any anticipated inconveniences the participants may 
experience (time, abstention from food, etc.).  

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Physical Risks: 
Procedures to Protect 
Against / Minimize Risks 
Likelihood of 
Occurrence 
Seriousness too Subject if 
Risk Occurs 
Participant who uses 
insulin or anti-
hyperglycemic 
medications e.g. 
insulin may 
experience 
symptomatic 
hypoglycemia if 
consent, didactic or 
focus group sessions, 
disrupts meal or snack 
schedule.  
The Researcher will: 
1. coordinate with the
CTDOC to schedule all
sessions (consent
meeting, didactic DSS
and focus group) at a time
to not interfere with meal
and insulin administration.
2. confirm with the
potential or actual
participant who presents
for a consent meeting or
didactic or focus group
session that timing of
meals and
medication/insulin
administration were not
being interpreted by the 3.
monitor participant for
signs and symptoms of
hypo/hyperglycemia
during all sessions and
seek help from nursing
staff if needed.
Minimal 
Moderate 
There is a potential for 
violence to break out 
during the focus or 
support group.  
The researcher will:1. 
Coordinate with CTDOC 
administration during all 
phase of the research but 
specifically for formation 
of the DSS education 
sessions, support and 
focus groups.  
Ongoing communication 
will occur between the 
CDOC staff designated to 
approve inmates for 
participation in support 
groups.  
Minimal 
Serious 
Psychological 
Risks: 
Procedures to Protect 
Against / Minimize Risks 
Likelihood of 
Occurrence 
Seriousness to Subject if 
Risk Occurs 

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Participants may 
feel Inconvenienced 
with the time it 
takes to participant 
in didactic, support 
and focus 
group sessions.   
Efforts will be made to 
align procedures with 
inmate’s treatment as 
usual (TAU) schedules, 
and appointments are 
made with inmates when 
our activities infringe upon 
their free time so that they 
have the option of 
participating at a time that 
is convenient for them. 
Moderate 
Minimal  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Participants in the 
DSS treatment or 
Control group may be 
transferred to another 
correctional facility or 
released from prison 
before the end of the 
DSS program. As a 
result of these 
unplanned events, 
the participant may 
feel disappointed 
about not being able 
to complete the 
program.  
The DOC will 
communicate with the PI 
about impending transfers 
or early release dates. For 
transfers, the DOC will 
ask the participant if he 
would prefer to delay 
transfer until the end of 
the DSS. If not, the PI will 
meet with the participant 
prior to or after transfer to 
provide all of the 
education materials and 
answer any questions. If 
the participant is to be 
released from prison 
earlier than anticipated, 
the PI will meet with 
participant prior to 
discharge to provide all of 
the education materials 
associated with the 6-DSS 
sessions and answer their 
DSS related questions.  
Moderate 
Minimal 
Although incarcerated 
persons are used to 
being on waitlists for 
CDOC programming 
or other usual care 
services, potential or 
enrolled participants 
in the control group 
may be frustrated 
with waiting12 weeks 
for the DSS 
intervention.   
Potential participants who 
will be assigned to the 
control group may decline 
participation in the study if 
they do not want to wait 
for participation. Enrolled 
participants may withdraw 
from the study at any time 
and will be told this during 
informed consent.  
Minimal  
Minimal 

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Economical Risks:  
Procedures to Protect 
Against / Minimize 
Risks 
Likelihood 
of  
Occurrence 
Seriousness to Subject if  
Risk Occurs 
None 
 
NA 
NA 
NA 
 
 
 
 
Social Risks:  
Procedures to Protect 
Against / Minimize 
Risks 
Likelihood of  
Occurrence 
Seriousness to Subject if  
Risk Occurs 
Inmates may feel 
uncomfortable if 
others in the facility 
know they are 
participating in a 
research study. 
 
All measures will be taken 
to ensure a participant’s 
privacy and no 
information will be 
disclosed to any third 
parties without the 
participant’s permission. 
All research personnel 
are certified in meeting 
HIPAA requirements. 
Minimal 
Minimal to Moderate 
 
 
 
 
 
 
 
 
  
The focus group  
session will be audio-
recorded in order to 
accurately capture 
what is said. 
Although the 
researchers will take 
every 
precaution to 
maintain 
confidentiality of the 
data, the nature of 
focus and support 
groups prevents the 
researchers from 
guaranteeing 
confidentiality. 
Participants: 
1.  may request that the 
recording be paused at 
any time.  
2. can choose how much 
or how little you want to 
speak during the group. 
3. may request to leave 
the focus group at which 
time, a CO will be notified, 
and upon approval by the 
CO, the participant will 
return to his cell.  
3. will be asked not to use 
any names during 
the focus and support 
group discussion. 
4. will be asked to 
verbally commit to 
maintaining  
Moderate 
Moderate 

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Legal Risks:  
Procedures to Protect 
Against / Minimize 
Risks 
Likelihood of  
Occurrence 
Seriousness to Subject if  
Risk Occurs 
Request of research 
records by court 
subpoena 
 
The PI is not collecting 
any information related to 
participants’’ criminogenic 
activity or nature of their 
conviction or criminal 
offense. 
Minimal 
Minimal 
 
 
 
Benefits 
Describe anticipated benefits to the individual participants.  If individual participants may not benefit 
directly, state so here.  Describe anticipated benefits to society (i.e., added knowledge to the field of 
study) or a specific class of individuals (i.e., athletes or autistic children).   Do not include 
compensation or earned course credits in this section. 
 
Individual participant benefits: Benefits of participation in this study greatly outweigh the risks 
involved to participants.  As a result of participating in the DSS+ program, incarcerated person 
with diabetes could gain knowledge, be more confident in their ability to self-manage and be 
better prepared to self-manage diabetes upon release to the community.  
As an indirect benefit of participation: Inmates who participate in this study could potentially 
stimulate improvements to existing diabetes programming and as a result feel good about their 
participation.  
Anticipated benefits to society: Findings from this research will inform Diabetes Group 
education for incarcerated persons TTC. Evidence produced from this research will begin to 
reduce the disparity for the availability of evidence base care between persons with diabetes 
living in prison and those living in the general population.   
Risk/Benefit Analysis 
Describe the ratio of risks to benefits.  Risks to research participants should be justified by the 
anticipated benefits to the participants or society.  Provide your assessment of anticipated risks to 
participants and steps taken to minimize these risks, balanced against anticipated benefits to the 
individual or to society. 
We expect that there is low risk vs high benefit to the participant. Again, benefits of 
participation in this study greatly outweigh the risks involved to participants.  Risks as 
addressed above have been assessed as a minimal to moderate level with the exception of the 
court requested subpoena of study transcripts. The researcher will follow the above stated 
procedure (refer to table under risk/inconvenience) to minimize all risk. All measures will be 
taken to ensure a participant’s privacy and no information will be disclosed to any third parties 
without the participant’s permission. All research personnel are certified in meeting HIPAA 
requirements. 
 
Economic Considerations  
Describe any costs to the participants or amount and method of compensation that will be given to 
them.  Describe how you arrived at the amount and the plan for compensation; if it will be prorated, 

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please provide the breakdown. Experimental or extra course credit should be considered an economic 
consideration and included in this section.  Indicate when participants will receive compensation.   
 
. All participants will be provided with a glucose meter free of charge (approximate value $30.00) 
when they leave the prison. 
Data Safety Monitoring 
This is a prospective plan set up by the study investigators to assure that adverse events occurring 
during studies are identified, evaluated, and communicated to the IRB in a timely manner.  Although 
the investigators initially propose a Data Safety Monitoring Plan (DSMP), the IRB must approve the 
plan and may require revision of the plan.  A DSMP is required for all human studies at the University 
of Connecticut except for studies determined to be exempt from continuing IRB review.  For studies 
that present more than minimal risk to participants, the IRB will review and determine on a case-by-
case basis whether a data safety monitoring board is most appropriate.  Please refer to the IRB’s 
policy regarding data safety monitoring before completing this section - 
http://irb.uconn.edu/irb_sop/IRBSOP_submission.html#data_safety_monit.   
 
Issues that should be addressed in the DSMP include the following: 
1) frequency of the monitoring 
2) who will conduct the monitoring (Under UConn policy a student cannot be the sole person 
responsible for monitoring the data and safety of the protocol procedures.) 
3) what data will be monitored 
4) how the data will be evaluated for problems? 
5) what actions will be taken upon the occurrence of specific events or end points 
6) who will communicate to the IRB and how communication will occur 
 
Sample response to issues listed above for minimal risk/slight increase over minimal risk – “Survey 
results will be monitored by the PI in conjunction with the student investigator once every two weeks 
(items 1, 2 and 3).  Survey responses will be reviewed to monitor for clarity (i.e., the same question is 
skipped by 5 or more participants).  In that case, the question will be revised and an amendment will 
be submitted to the IRB (items 4, 5 and 6).” 
 
The PI, Louise Reagan PhD, will oversee the study procedures for data acquisition and validation.  
Survey results will be monitored by Louise Reagan once a month until completion of the study.  
Survey responses and audio transcripts will be reviewed to monitor for clarity.  If a problem is noted 
with data clarity, the question will be revised and an amendment will be submitted to the IRB.   
Data safety is assured through: 1) a common core of conjoint training and routinely scheduled fidelity 
monitoring; 2) continuous team (agency & faculty) feedback through weekly and monthly meetings 
with telephone and email communication as needed; and 3) final data editing and entry at UCONN 
School of Nursing; Any paper forms are retained in a locked file in at UConn Center for Nursing 
Scholarship locked file with access provided only to those who are involved in the project.  Computer 
files are password protected on faculty computers.  Access provided only to those working on the 
project.  Any variation from protocol will be corrected within two days and reported to the IRB within 
the same week. 
 
Privacy/Confidentiality 
Explain how the privacy interests of participants will be maintained during the study (note that privacy 
pertains to the individual not to the data).  Describe procedures for protecting confidentiality of data 
collected during the study and stored after study closure.  Describe how data will be coded.  Describe 
plans for storage and security of electronic data (plan must comply with the University’s Policy on the 

IRB-1 Protocol Application, Version 6/2014  
 
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Security Requirements for Protecting University Data at Rest).  If identifiable, sensitive information 
(illegal drug us 
e, criminal activity, etc.) will be collected, state whether a Certificate of Confidentiality will be obtained.  
Be sure to state whether any limits to confidentiality exist and identify any external agencies (study 
sponsor, FDA, etc.) that will have access to the data.  If participants will be screened, describe the 
plans for storage or destruction of identifiable data for those that failed the screening.   
 
Only the principal investigator (Louise Reagan) and UCONN IRB and CTDOC RAC approved 
members of the research team will have access to the information obtained on all the 
questionnaires.   
The following procedures will be used to protect the confidentiality of the participants’ data.  
The researchers will keep all study records locked in a secure location.   Research records will 
be labeled with a code.  The code will be derived from a number (1-125). A master key that 
links names and codes will be maintained in a separate and secure location at the UCONN 
school of Nursing.  The master key will be destroyed after 3 years.  All electronic files (e.g., 
database, spreadsheet, etc.) containing identifiable information will be password protected.  
Any computer hosting such files will also have password protection to prevent access by 
unauthorized users.  Only the members of the research staff will have access to the 
passwords.  Data that will be shared with others will be coded as described above to help 
protect the participant’s identity.  Data will be disseminated in as de-identified data in all 
publications and presentations. Records will be maintained for three years per the IRB policy. 
Limits to protecting the participants’ confidentiality exist if an inmate discloses child abuse and 
neglect, or harm to self or others.  If an insurer, medical care provider, or another person 
obtains 
The participant’s written consent to receive research information, then the researchers will not 
withhold the requested information. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SECTION VIII: Informed Consent 
 
As PI, you are responsible for taking reasonable steps to assure that the participants in this 
study are fully informed about and understand the study.   Even if you are not targeting 
participants from “Special Populations” as listed on page 4, such populations may be included 
in recruitment efforts.  Please keep this in mind as you design the Consent Process and 
provide the information requested in this section. 
 
Consent Setting 

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Describe the consent process including who will obtain consent, where and when will it be obtained, 
and how much time participants will have to make a decision.  Describe how the privacy of the 
participants will be maintained throughout the consent process.  State whether an assessment of 
consent materials will be conducted to assure that participants understand the information (may be 
warranted in studies with complicated study procedures, those that require extensive time 
commitments or those that expose participants to greater than minimal risk). 
The PI will obtain informed consent from all participants. For those participants who speak and 
understand English but prefer to read Spanish (determined by self-report), the PI will provide a copy 
of the consent form in Spanish and have the potential participant read the consent while the 
researcher reads the English version of the informed consent out loud to the participant.  The 
informed consent process will be conducted in a room designated by the CDOC administration. Once 
IRB approval is obtained, the PI will meet with the CDOC Research Advisory Council (RAC). At this 
time a CDOC research liaison who will assist with these details will be assigned to the PI. Considering 
that the PI will be interviewing inmates in two facilities, a location for the interview will be dependent 
on both the safety and security requirements of the facility and the privacy of the inmate participant.  
Modification of consent procedure for group 1(n=48) 
Capacity to Consent 
Describe how the capacity to consent will be assessed for participants with limited decision-making 
capacity, language barriers or hearing difficulty. If a participant is incapable of providing consent, you 
will need to obtain consent from the participant’s legal guardian (please see the IRB website for 
additional information). 
Low reading capabilities are expected.  The inmate will be provided a copy of the English or 
Spanish version of the consent form as it is read to them. Inmates will have the opportunity to 
ask questions.  They will be told that they have time to make their decision.  They will be asked 
to verbally report back their understanding of the consent form (Teach Back method).  The PI 
has 16+years’ experience as a Primary Care Provider and working on a Mobile Medical Van 
communicating with patients who have Limited English proficiency and low literacy and health 
literacy. Using Teach back technique (Schillinger et al., 2003) while watching facial expression 
will be employed to assess capacity to consent. Their ability to articulate a primary 
understanding regarding the consent will be accepted as their ability to provide consent.  They 
are allowed the opportunity to withdraw at any time without penalty. 
 
 
Parent/Guardian Permission and Assent  
If enrolling children, state how many parents/guardians will provide permission, whether the child’s assent will be obtained 
and if assent will be written or oral.  Provide a copy of the script to be used if oral assent will be obtained. 
 
NA 
 
 
 
Documentation of Consent 
Specify the forms that will be used for each participant population, i.e., adult consent form, surrogate consent form, child 
assent form (written form or oral script) or an information sheet. Copies of all forms should be attached to this application in 
the same format that they will be given to participants (templates and instructions are available on the IRB website).  
 
Adult Consent Form 
 
Waiver or Alteration of Consent 
The IRB may waive or alter the elements of consent in some minimal risks studies. If you plan to request either a waiver of 
consent (i.e., participants will not be asked to give consent), an alteration of consent ( e.g., deception) or a waiver of 

IRB-1 Protocol Application, Version 6/2014  
 
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signed consent (i.e., participants will give consent after reading an information sheet),  please answer the following 
questions using specific information from the study: 
 
 
Waiver (i.e. participants will not be asked to give consent) or alteration of consent (e.g. use of deception in 
research): 
 
• 
Why is the study considered to be minimal risk?   
NA 
 
• 
How will the waiver affect the participants’ rights and welfare?  The IRB must find that participants’ 
rights are not adversely affected.  For example, participants may choose not to answer any 
questions they do not want to answer and they may stop their participation in the research at any 
time. 
NA 
 
• 
Why would the research be impracticable without the waiver?  For studies that involve deception, 
explain how the research could not be done if participants know the full purpose of the study. 
 
NA 
• 
How will important information be returned to the participants, if appropriate?  For studies that 
involve deception, indicate that participants will be debriefed and that the researchers will be 
available in case participants have questions. 
NA 
 
 
Waiver of signed consent (i.e. participants give consent only after reading an information sheet): 
 
• 
Why is the study considered to be minimal risk?  
Prior to scheduling a meeting with the potential participant, the PI will request that the DOC 
designee (Jennifer Benjamin RN, MSN, DNP, Correctional Health Services Program Director), 
review the sick slip requests of persons interested in participating to confirm that the inmate can 
be released form their units. Some inmates (potential participants) who have a higher DOC 
assigned security classification are not allowed to participate in groups. If interested potential 
participants do not meet the security classification, the PI will follow the DOC procedure for 
notifying participants who do not meet the DOC classification criteria. Confirming security 
classification is a routine procedure in the prison performed prior to all inmate activities and does 
not confer additional risk to the potential participants. 
After this procedure, The PI will proceed with contacting the inmate, scheduling an appointment 
to meet, follow the procedures described in the screening for eligibility (Attachment 4), obtain 
informed consent and begin study procedures. No study procedures will occur until after 
participant signs the consent.   
  
• 
Does a breach of confidentiality constitute the principal risk to participants?  Relate this to the risks 
associated with a breach of confidentiality and indicate how risks will be minimized because of the 
waiver of signed consent. 
The PI will collect no personally identifiable information during the screening for eligibility 
process. As stated above, it is standard procedure to review the CT DOC security classification 
prior to all inmate group activities.  
 
• 
Would the signed consent form be the only record linking the participant to the research?  Relate 
this to the procedures to protect privacy/confidentiality. 
 

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  NoYes.   Research records will be labeled with a code.  The code will be derived from a 
number (1-125). A master key that links names and codes will be maintained in a separate and 
secure location at the UCONN school of Nursing.   
• 
Does the research include any activities that would require signed consent in a non-research 
setting?  For example, in non-research settings, normally there is no requirement for written consent 
for completion of questionnaires.   
NO 
 
 
HIPAA Authorization 
On the Storrs campus, the following sites are covered entities under the Health Insurance Portability and Accountability Act: 
 
1. Nayden Rehabilitation Clinic (outpatient physical therapy) 
2. Speech and Hearing Clinic 
3. Emergency Medical Services (EMS, Ambulance)  
 
If research participants are recruited through these entities, it may be necessary to obtain a Waiver of Authorization to allow 
you to access records for recruitment and an Authorization to use and disclose Protected Health Information (PHI).  Contact 
the Office of Research Compliance at 860-486-8802 for additional information.  Note:  Student Health Services is not 
covered by HIPAA; however, FERPA regulations apply. 
 
 
Principal Investigator Certification 
I understand the University of Connecticut’s policies concerning research involving human participants and I 
agree: 
 
1. To comply with all IRB policies, decisions, conditions, and requirements; 
2. That this study has been designed, to the best of my knowledge, to protect human participants engaged 
in research in accordance with the standards set by the University of Connecticut, the United States 
Department of Health and Human Services, the Food and Drug Administration, and any other 
sponsoring agency; 
3. To obtain prior approval from the IRB before amending the research protocol or the approved 
consent/assent form; 
4. To report to the IRB in accordance with IRB policy, any adverse event(s) and/or unanticipated 
problem(s) involving risks to participants; 
5. To submit the Re-Approval/Completion Form as needed; 
6. That my participation and the participation of any co-investigators does/do not violate the University of 
Connecticut policy on Individual Conflicts of Interest in Research; 
7. That each individual listed as study personnel in this application has a) completed the required human 
subjects training, and b) are knowledgeable of the study procedures described in the protocol;  
8. That each individual listed as study personnel in this application possesses the necessary training and 
experience for conducting research activities in the role described for them in this research study. 
 
 
 
Furthermore, by signing below, I also attest that I have appropriate facilities and resources for conducting the 
study. 
 
 
 
Original Signature of Principal Investigator 
Date 
 
 
 

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Original Signature of Student Investigator 
(Only for Student-Initiated Research) 
Date 
 
 
 
Original Signature of Medical Monitor 
(Required for all studies that will be monitored by a 
Physician) 
Date 
 
 
 
 
 
 
 
 
 
 
Department Head Certification 
 
This is to certify that I have read the protocol and believe that there is value in asking and answering these 
research questions using the approach described in this application.  To the best of my knowledge, the 
researcher(s) have the time, facilities, and expertise to conduct this study.   
 
 
 
Original Signature of Department Head 
(Required for ALL studies, unless grant 
application/contract is attached; see Section III) 
Date 
 

Version 1 DSS Treatment Group with support group
Consent Form for Participation in a Research Study
Principal Investigator: Louise Reagan, PhD  
Study Title: A Study to Evaluate the Feasibility and Acceptability of a Diabetes 
Survival Skills + (DSS+) Intervention for Incarcerated Persons Transitioning to 
the Community (TTC):
Introduction
I am faculty member in the School of Nursing at the University of Connecticut.  
You are asked to help us determine if a diabetes education program and support 
group called Diabetes Survival Skills+ (DSS+) is acceptable to incarcerated person 
preparing for release from prison.  The diabetes survival skills education is a six 
session program designed to provide you with the basic survival skills such as 
understanding the basic facts about diabetes, and taking diabetes medications or 
insulin, testing and keeping track of your blood sugar, recognizing and treating low 
blood sugar or hypoglycemia, and how to eat healthy and make an appointment 
with a doctor or nurse practitioner who will help you care for diabetes upon release 
from prison. We are also interested in learning if this diabetes education program 
has an effect on what you know and believe about diabetes, your confidence level in 
taking care of your diabetes, and your stress associated with diabetes.  After the 6 
diabetes education sessions, you can participate in a weekly or bi-weekly diabetes 
support group until the time of your release from prison. 
A grant from the University of Connecticut’s Office of the Vice President for 
Research (OVPR)will provide some funding for this study. The funding will be 
used to pay for a nursing student to assist me with the study, education materials, 
and a statistician to help with analyzing the information obtained from 
questionnaires completed by the participants.
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Version 1 DSS Treatment Group with support group
You are being asked to participate because you have diabetes and you will be 
released from prison within the next 6-9 months.

You do not have to be in the study.

If you say yes, you can quit at any time.

Please take as much time as you need to make your decision.

Your medical care will not change in any way if you say no.
Why is this study being done?
We want to learn more about what type of education program helps incarcerated 
persons to be prepared for managing diabetes when no longer incarcerated. 
We will use this information to plan diabetes education for incarcerated persons with 
diabetes leaving prison to help prepare them to care for diabetes while living in the 
community. 
What will I be asked to do? 
If you agree to be in the study, we will meet at least 9 times or more if you decide 
to participate in the support group. 
Visit 1: we will meet for 90 minutes or less at the correctional facility where 
you live. After you agree to be in the study and sign this document, you will 
be asked to complete 3 forms. I will read questions aloud asking you:   

your age, highest grade completed in school, gender, date of release from
prison, how long you were in prison, type of diabetes, medical history and
medications, whether you have use or have used alcohol or drugs, and if or
when you have participated in a diabetes education class.

to read information about health  and answer a few questions about what
you read.

to draw objects, and recall name of objects that are shown to you.

You do not have to answer any questions that you do not want to answer.
There are no right or wrong answers to these questions.

If you cannot name all of your medications and medical conditions, I will
ask you to sign a permission slip (HIPAA release) allowing me to look at
your medical and pharmacy record to obtain a list of your medications and
medical conditions (illnesses). You can refuse this request. Because we
need an accurate list of your medications and medical conditions, you will
not be able to participate in the study if you prefer that we not look at your
UCONN IRB PROTOCOL H17-006 APPROVED 4/6/18

Version 1 DSS Treatment Group with support group
medical record.  

After you have completed all 3 forms, the Officer will escort you to your
living area. Once we are ready to start the group diabetes education
program within the next month, I will send you a reminder stating the date
of the first Diabetes Education session.
Visit 2: Within the next month, we will meet for 90 minutes in a room at the 
correctional facility with 10-12 other incarcerated persons with diabetes who 
are also participating in the study. You will be asked to complete 4   
questionnaires. I will read the surveys aloud to you and the other participants. 
You will be asked questions about: 

what you know about diabetes.

how confident you feel about caring for your diabetes.

your beliefs and feelings about diabetes

the level of concern or stress you feel about diabetes and diabetes self-care
tasks.
After you complete the surveys that will take approximately 30 minutes, you 
will participate in a diabetes education class for 1 hour. You will learn about 
different topics and practice skills at each class to prepare you for managing 
your diabetes self-care activities in the community. 
During the 1-hour education sessions, there will be opportunities for you to 
talk with the other participants, a student nurse, and with me, the diabetes 
educator. You will be given educational pamphlets with information about the 
topic of the week and a workbook page that includes questions about taking 
care of your diabetes. I will ask you to complete the workbook page and 
return it to me at the next scheduled class. You do not have to answer any 
questions that you do not want to answer.
Visit 3-6: The next 4 educational sessions will be 1 hour and will include 
education and discussion only. We will review the workbook pages and 
practice skills such as glucose monitoring, medication taking, and healthy 
eating during each session. The CO will call you to each of the meetings and 
escort you back to your living quarters at the end of each session.
Visit 7: This session will proceed exactly as session 2. We will meet for 90 
minutes to participate in the final education session and complete 4 
surveys/questionnaires.  At this session, I will again ask you to participate in 
UCONN IRB PROTOCOL H17-006 APPROVED 4/6/18

Version 1 DSS Treatment Group with support group
weekly one-hour support groups with other interested participants. These 
sessions will start at a date and time decided by the Connecticut Department 
of Corrections (CT DOC). 
Visit 8: Two weeks after the completion of the last education session, you 
will be contacted to participate in a 1.5-2-hour focus group meeting with the 
PI, a student member of the research team and 8-10 study participants. During 
this meeting, I will ask you questions about how satisfied you were with the 
program, what you liked or did not like about the program, and other 
questions that will help me to hear your thoughts and opinion about the 
Diabetes Survival Skills program. 
Visit 9: We will meet for 45-60 minutes to complete the same 4 
questionnaires that you completed during visit 2. 
Visit 10+: If you agree, you and other participants of the study will meet to 
discuss diabetes related issues of interest to you. Participation in these groups 
is voluntary and may be stopped at any time or you can miss a session and 
join the next session a week later.  The PI will help with the flow and 
coordination of the support group but there will be no formal discussion or 
specific topic planned.
Here is a diagram showing a rough estimate of the schedule of study visits. 
Visit 1
   Visit 2 
   Visit 3-6
Visit 7 
 Visit 8   
 Visit 9  
 Visit 10+
Today
1.5 hours
Week 4
1.5 hour
Week 5-
8
1 hour
Week 9   
1.5 hours
Week 11
2 hours
Focus 
Group
Week 15
1 hour
Weeks  16+
1hour /week
optional
Consent
Complete 
3 forms
Complete 
4 forms
Class 1
Classes 
2-5
Complete 
4 forms
Class 6
Complete 
4 forms 
Support 
Group
We will only meet once for the Focus group (Visit 8) unless I need to ask you 
more about something you said during the first interview. In this case, one (1) 
follow-up interview may be needed to clarify something that you said.  With your 
permission I will contact you by mail to request this interview.
During the focus group, the student assistant will take notes and a pocket sized 
audio(tape) recorder will be used to audiotape the Focus group interview. 
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Version 1 DSS Treatment Group with support group

The recording is to make sure that I record exactly what you and the other
participants said during the interview.

Only approved members of the research team listen to the audiotape to
type (transcribe) what you said.

There will be no identifying information on the recording or the typed
report.

If you choose not to be audiotaped, you will not be able to participate in
the focus group with the other participants.

If you agree to being audiotaped but feel uncomfortable at any time during
the interview, I can turn off the recorder at your request.  Or if you don't
wish to continue, you can stop the interview at any time.
After the interview is over, you and the other participants will be thanked for your 
time and escorted back to your living quarters. At this time, you may continue 
participation in the weekly or bi-weekly diabetes support group. Depending on 
attendance at the support group, the group may meet weekly or bi-weekly. These 
sessions will start at a date and time decided by the CT DOC.  You will be 
notified of the schedule at least one day before the support group meeting. 
In the event you are released from incarceration prior to completing the DSS 
study and educational program, you have the option to give the CTDOC 
permission to release your contact information to the PI.  This information will be 
used by the PI to contact you and make arrangements to provide you the handouts 
and workbook pages from the diabetes classes you will miss, and the glucose 
meter you should receive for participating in the program. We will answer any of 
your diabetes related questions. 
In addition, when we meet or talk on the phone, if you agree, you will complete 
surveys you were unable to complete because of your release.  If you agree to 
complete the surveys, a member of the research team will contact once or twice 
(about 6 weeks and 12 weeks after you completed the program) to compete the 
surveys. You will have the option to complete the surveys on the phone with the 
PI or member of the research team or arrange to meet the PI at a local library to 
complete the surveys. The decision to participate in the surveys will not affect 
your ability to receive the educational handouts, the glucometer, and your 
certificate of completion. 
If you agree to be contacted after you are released from prison, you will meet or 
speak with a member of the research team at most an additional 1-3 visits to 
receive your glucose meter and education handouts, and complete 4 surveys. 
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Version 1 DSS Treatment Group with support group
What other options are there?
There are no other options. 
What are the risks or inconveniences of the study?
The risks involved with taking part in this study are low. Being in the study is 
strictly voluntary. There is a chance that your confidentiality can be 
compromised; however, we are taking safety measures to lower this risk.
One possible inconvenience is the time commitment to the study. You will meet 
with the PI on 9 occasions during the course of study or more should you decide 
to participate in the support group or meet with a member of the researcher team 
after you have been released from prison. The meetings will last about 1-2 hours. 
But you can take a break, if you do not want to answer a question or you feel 
uncomfortable or become tired. You are free to skip a question or stop the 
meeting for any reason. 
What are the benefits of the study?
There will be no direct benefit to you from your participation. Your help in this 
study may help us to develop and plan diabetes education for incarcerated 
persons preparing for release into the community. 
Will I receive payment for participation?  Are there costs to participate?
You do not pay.  You will not receive any compensation or payment for being in 
in this study. You will be able to take the glucose meter used in class home with 
you when you are released from prison.
How will my personal information be protected?
Only the principal investigator (Louise Reagan), and approved members of the 
research team will have access to the information obtained during the study.  If a 
person is used to type what is on the audiotape, he will have access to the 
information on the recording and be an approved member of the research team. 
There will no information on the recording that personally identifies you. 
At the conclusion of this study, the researchers may publish their findings and 
UCONN IRB PROTOCOL H17-006 APPROVED 4/6/18

Version 1 DSS Treatment Group with support group
present findings in a professional magazine or at a conference. The Information 
will be presented in summary format and you will not be identified in any 
publications or presentations. 
All research team members are current in Human Subjects certifications.  All 
consent forms, surveys, and study data are retained on a secure computer which 
will be in a locked office at UConn School of Nursing accessible only to team 
members.  A password coded file will be created using unique identifiers linking 
components of the data.  Once the data are analyzed, the list linking the subject 
identifiers and names will be destroyed.  Investigators must maintain research 
records for three years beyond the completion/termination of the study.
(Audio)Tapes will not identify study participants and will be transcribed into 
WORD file. Audiotapes will be secured in a locked file cabinet at the University 
of Connecticut school of nursing. Following transcription, the audiotapes will be 
erased. All transcribed data will be saved to a password protected University of 
Connecticut research computer.
Questionnaire data will be entered into an EXCEL or computer spreadsheet with 
no personally identifiable information. All research data files will be password 
encrypted/protected with access through password protected University of 
Connecticut computers. All paper forms will be retained in a secured locked file 
at the University of Connecticut.
You should also know that the UConn Institutional Review Board (IRB) and the 
Office of Research Compliance may inspect study records. These reviews will only 
focus on the researchers and not on your responses or involvement.  The IRB is a 
group of people who review research studies to protect the rights and welfare of 
research participants.
Your records will be maintained in accordance with state and federal laws.  We 
will do our best to protect the confidentiality of the information we gather from 
you but we cannot guarantee I 00% confidentiality.
In the event of being released from incarceration prior to completing the DSS 
educational program, you have the option to give the CTDOC permission to 
release contact information to the PI. This contact information will be maintained 
in a password protected file on the principle investigator’s office computer at the 
University of Connecticut along with other identified research documents. 
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Version 1 DSS Treatment Group with support group
Can I stop being in the study and what are my rights?
You do not have to be in this study if you do not want to. If you agree to be in the 
study, but later change your mind, you may drop out at any time. No one will treat 
you differently. You will not be penalized.  Your participation will have no effect on 
your parole or your release from prison.
There are no penalties or consequences of any kind if you decide that you do not 
want to participate. You do not have to answer any question that you do not want 
to answer.
You may be removed from the study if you are placed in administrative 
segregation, the hospital, or demonstrate any illegal behavior or your primary 
clinician or administration at the CT DOC thinks you should be removed for 
safety reasons.  
Whom do I contact if I have questions about the study?
Take as long as you like before you make a decision. We will be happy to answer 
any question you have about this study. If you have further questions about this 
study or if you have a research-related problem, you may contact the principal 
investigator, (Dr. Louise Reagan at louise.reagan@uconn.edu or 860-486-0593, 
or by mail: University of Connecticut, School of Nursing, 231 Glenbrook Rd., 
Storrs, CT 06269-4026. If you have any questions concerning your rights as a 
research participant, you may contact the University of Connecticut Institutional 
Review Board (IRB) at irb@uconn.edu.
Documentation of Consent:
By signing the document, you are saying:

You agree to be in the study.

We talked with you about the information in this document and answered all
your questions.

you are giving the CTDOC permission to release (give) your contact
information to the PI for the reasons stated in this document for the purpose
of contacting you after you have been released from prison.
You know that: 
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Version 1 DSS Treatment Group with support group

You can skip questions you do not want to answer.

You can stop answering our questions at any time and nothing will happen
to you.
You can call the office in charge of research at 860-486-8802if you have any 
questions about the study or about your rights. I have read this form and decided 
that I will participate in the project described above.  Its general purposes, the 
particulars of involvement and possible risks and inconveniences have been 
explained to my satisfaction.  I understand that I can withdraw at any time.  My 
signature also indicates that I have received a copy of this consent form.
Participant Signature:
Print Name:
Date:
Signature of Person 
Obtaining Consent
Print Name:
Date:
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Version 2 DSS Control group without support group
Consent Form for Participation in a Research Study
Principal Investigator: Louise Reagan, PhD  
Study Title: A Study to Evaluate the Feasibility and Acceptability of a Diabetes 
Survival Skills + (DSS+) Intervention for Incarcerated Persons Transitioning to 
the Community (TTC)
Introduction
I am faculty member in the School of Nursing at the University of Connecticut.  
You are asked to help us determine if a diabetes education program called Diabetes 
Survival Skills+ (DSS+) is acceptable to incarcerated person preparing for release 
from prison.  The diabetes survival skills education is a six session program 
designed to provide you with the basic survival skills such as understanding the 
basic facts about diabetes, and taking diabetes medications or insulin, testing and 
keeping track of your blood sugar, recognizing and treating low blood sugar or 
hypoglycemia, and how to eat healthy and make an appointment with a doctor or 
nurse practitioner who will help you care for diabetes upon release from prison. We 
are also interested in learning if this diabetes education program has an effect on 
what you know and believe about diabetes, your confidence level in taking care of 
your diabetes, and your stress associated with diabetes.  
A grant from the University of Connecticut’s Office of the Vice President for 
Research (OVPR)will provide some funding for this study. The funding will be 
used to pay for a nursing student to assist me with the study, education materials, 
and a statistician to help with analyzing the information obtained from 
questionnaires completed by the participants.
You are being asked to participate because you have diabetes and you will be 
released from prison within the next 6-9 months.

You do not have to be in the study.

If you say yes, you can quit at any time.

Please take as much time as you need to make your decision.
UCONN IRB PROTOCOL H17-006 APPROVED 4/6/18

Version 2 DSS Control group without support group

Your medical care will not change in any way if you say no.
Why is this study being done?
We want to learn more about what type of education program helps incarcerated 
persons to be prepared for managing diabetes when no longer incarcerated. 
We will use this information to plan diabetes education for incarcerated persons with 
diabetes leaving prison to help prepare them to care for diabetes while living in the 
community. 
What will I be asked to do? 
If you agree to be in the study, we will meet 4 times including today over a period 
of 14 weeks. After 14 weeks, you may participate in a diabetes education program 
with 10-12 additional incarcerated persons for 1 hour once weekly for 6 weeks. 
Visit 1: we will meet for 90 minutes or less at the correctional facility where 
you live. After you agree to be in the study and sign this document, you will 
be asked to complete 3 forms. I will read questions aloud asking you:   

your age, highest grade completed in school, gender, date of release from
prison, how long you were in prison, type of diabetes, medical history and
medications, whether you have use or have used alcohol or drugs, and if or
when you have participated in a diabetes education class.

to read information about health  and answer a few questions about what
you read.

to draw objects, and recall name of objects that are shown to you.

You do not have to answer any questions that you do not want to answer.
There are no right or wrong answers to these questions.

If you cannot name all of your medications and medical conditions, I will
ask you to sign a permission slip (HIPAA release) allowing me to look at
your medical and pharmacy record to obtain a list of your medications and
medical conditions (illnesses) and obtain your contact information from
the CDOC should you be released prior to completion of the studyYou can
refuse this request. Because we need an accurate list of your medications
and medical conditions, you will not be able to participate in the study if
you prefer that we not look at your medical record.

After you have completed all 3 forms, the Officer will escort you to your
living area.
UCONN IRB PROTOCOL H17-006 APPROVED 4/6/18

Version 2 DSS Control group without support group
Visit 2: Within the month following visit 1, we will meet for 60 minutes in 
a room at the correctional facility with 10-12 other incarcerated persons 
with diabetes who are also participating in the study. You will be asked to 
complete 4 questionnaires. I will read the surveys aloud to you and the 
other participants. You will be asked questions about: 

what you know about diabetes.

how confident you feel about caring for your diabetes.

your beliefs about diabetes

the level of concern or stress you feel about diabetes and diabetes self-care 
tasks.
After you complete the surveys,  the Officer will escort you to your living 
area. . 
Visit 3: Six weeks after visit 2 (week 9), We will meet for 60 minutes to 
complete the same 4 questionnaires that you completed during visit 2. After 
you complete the surveys,  the Officer will escort you to your living area. 
Visit 4: Six weeks after visit 3 (week 19), We will meet for 60 minutes to 
complete the same 4 questionnaires that you completed during visit 2 and 3. 
After you complete the surveys,  the Officer will escort you to your living 
area. You will receive a Certificate of Participation for completing the study. 
After completing visits 1-4, You will have the option to participate in a 1 hour 
6-session once weekly diabetes education program to prepare you for 
reentering the community. The diabetes education class will start 1 week after 
the completion of visit 4. 
If you choose to participate in the class, You will learn about different topics 
and practice skills at each class to prepare you for managing your diabetes 
self-care activities in the community. 
During the 1-hour education sessions, there will be opportunities for you to 
talk with the other participants, a student nurse, and with me, the diabetes 
educator. You will be given educational pamphlets with information about the 
topic of the week and a workbook page that includes questions about taking 
care of your diabetes. I will ask you to complete the workbook page and 
return it to me at the next scheduled class. You do not have to answer any 
questions that you do not want to answer.We will review the workbook pages 
and practice skills such as glucose monitoring, medication taking, and healthy 
eating during each session. The CO will call you to each of the meetings and 
UCONN IRB PROTOCOL H17-006 APPROVED 4/6/18

Version 2 DSS Control group without support group
escort you back to your living quarters at the end of each session. 
If you are going to be released from prison or transferred to another facility 
before you complete the diabetes classes, we will arrange to meet with you 
provide you the handouts and workbook pages from the diabetes classes you 
will miss. And, we will answer any of your diabetes related questions. 
In the event you are released from incarceration prior to completing the DSS 
study educational program, you have the option to sign a HIPPA release 
giving the CTDOC permission to release your contact information to the PI.  
This information will be used by the PI to contact you and arrange to provide 
you with the educational materials, and the glucometer you should receive for 
participating in the program and if you agree to complete surveys you were 
unable to complete because of your release.  If you agree to complete the 
surveys, a member of the research team will contact once or twice (about 6 
weeks and 12 weeks after you completed the program) to compete the 
surveys. You will have the option to complete the surveys on the phone with 
the PI or member of the research team or arrange to meet the PI at a local 
library to complete the surveys. The decision to participate in the surveys will 
not affect your ability to receive the educational materials, the glucometer, 
and your certificate of completion. 
If you agree to be contacted after you are released from prison, you will meet 
or speak with a member of the research team at most an additional 1-3 visits 
to receive your glucose meter and education handouts, and complete 4 
surveys. 
Here is a diagram showing a rough estimate of the schedule of study visits. 
Visit 1
Visit 2 
Visit 3
Visit 4 
Visit 5-10 
(optional)
Today
1.5 hours
Week 4
1 hour
Week 9   
1 hour
Week 15
1 hour
Week 15-20
1 hour /week
Consent
Complete 3 
forms
Complete 
4 forms
Complete 4 
forms
Complete 4 
forms 
Diabetes Classes
 What other options are there?
There are no other options. 
UCONN IRB PROTOCOL H17-006 APPROVED 4/6/18

Version 2 DSS Control group without support group
What are the risks or inconveniences of the study?
The risks involved with taking part in this study are low. Being in the study is 
strictly voluntary. There is a chance that your confidentiality can be 
compromised; however, we are taking safety measures to lower this risk.
One possible inconvenience is the time commitment to the study. You will meet 
with the PI 4  times during the course of study. The meetings will last about 1-2 
hours. But you can take a break if you do not want to answer a question or you 
feel uncomfortable or become tired. You are free to skip a question or stop the 
meeting for any reason.
Additionally, you will be asked to wait 12 weeks before participating in the 
diabetes education class. You may not want to wait to participate in the diabetes 
education classes. You may decline participation or stop participation at any time. 
What are the benefits of the study?
There will be no direct benefit to you from your participation. Your help in this 
study may help us to develop and plan diabetes education for incarcerated 
persons preparing for release into the community. 
Will I receive payment for participation?  Are there costs to participate?
You do not pay.  You will not receive any compensation or payment for being in 
in this study. You will be able to take the glucose meter used in class home with 
you when you are released from prison. 
How will my personal information be protected?
Only the principal investigator (Louise Reagan), and approved members of the 
research team will have access to the information obtained during the study. 
At the conclusion of this study, the researchers may publish their findings and 
present findings in a professional magazine or at a conference. The Information 
will be presented in summary format and you will not be identified in any 
publications or presentations. 
All research team members are current in Human Subjects certifications.  All 
consent forms, surveys, and study data are retained on a secure computer which 
UCONN IRB PROTOCOL H17-006 APPROVED 4/6/18

Version 2 DSS Control group without support group
will be in a locked office at UConn School of Nursing accessible only to team 
members.  A password coded file will be created using unique identifiers linking 
components of the data.  Once the data are analyzed, the list linking the subject 
identifiers and names will be destroyed.  Investigators must maintain research 
records for three years beyond the completion/termination of the study.
Questionnaire data will be entered into an EXCEL or computer spreadsheet with 
no personally identifiable information. All research data files will be password 
encrypted/protected with access through password protected University of 
Connecticut computers. All paper forms will be retained in a secured locked file 
at the University of Connecticut.
You should also know that the UConn Institutional Review Board (IRB) and the 
Office of Research Compliance may inspect study records. These reviews will only 
focus on the researchers and not on your responses or involvement.  The IRB is a 
group of people who review research studies to protect the rights and welfare of 
research participants.
Your records will be maintained in accordance with state and federal laws.  We 
will do our best to protect the confidentiality of the information we gather from 
you but we cannot guarantee I 00% confidentiality."
Can I stop being in the study and what are my rights?
You do not have to be in this study if you do not want to. If you agree to be in the 
study, but later change your mind, you may drop out at any time. No one will treat 
you differently. You will not be penalized.  Your participation will have no effect on 
your parole or your release from prison.
There are no penalties or consequences of any kind if you decide that you do not 
want to participate. You do not have to answer any question that you do not want 
to answer.
You may be removed from the study if you are placed in administrative 
segregation, the hospital, or demonstrate any illegal behavior or your primary 
clinician or administration at the CT DOC thinks you should be removed for 
safety reasons.  
UCONN IRB PROTOCOL H17-006 APPROVED 4/6/18

Version 2 DSS Control group without support group
Whom do I contact if I have questions about the study?
Take as long as you like before you make a decision. We will be happy to answer 
any question you have about this study. If you have further questions about this 
study or if you have a research-related problem, you may contact the principal 
investigator, (Dr. Louise Reagan at louise.reagan@uconn.edu or 860-486-0593, 
or by mail: University of Connecticut, School of Nursing, 231 Glenbrook Rd., 
Storrs, CT 06269-4026. If you have any questions concerning your rights as a 
research participant, you may contact the University of Connecticut Institutional 
Review Board (IRB) at irb@uconn.edu.
Documentation of Consent:
By signing the document, you are saying:

You agree to be in the study.

We talked with you about the information in this document and answered all
your questions.
You know that: 

You can skip questions you do not want to answer.

You can stop answering our questions at any time and nothing will happen
to you.
You can call the office in charge of research at 860-486-8802if you have any 
questions about the study or about your rights. I have read this form and decided 
that I will participate in the project described above.  Its general purposes, the 
particulars of involvement and possible risks and inconveniences have been 
explained to my satisfaction.  I understand that I can withdraw at any time.  My 
signature also indicates that I have received a copy of this consent form.
Participant Signature:
Print Name:
Date:
UCONN IRB PROTOCOL H17-006 APPROVED 4/6/18

Version 2 DSS Control group without support group
Signature of Person
Print Name:
Date:
Obtaining Consent
UCONN IRB PROTOCOL H17-006 APPROVED 4/6/18

Version 2 DSS Control group without support group
Consent Form for Participation in a Research Study
Principal Investigator: Louise Reagan, PhD  
Study Title: A Study to Evaluate the Feasibility and Acceptability of a Diabetes 
Survival Skills + (DSS+) Intervention for Incarcerated Persons Transitioning to 
the Community (TTC)
Introduction
I am faculty member in the School of Nursing at the University of Connecticut.  
You are asked to help us determine if a diabetes education program called Diabetes 
Survival Skills+ (DSS+) is acceptable to incarcerated person preparing for release 
from prison.  The diabetes survival skills education is a six session program 
designed to provide you with the basic survival skills such as understanding the 
basic facts about diabetes, and taking diabetes medications or insulin, testing and 
keeping track of your blood sugar, recognizing and treating low blood sugar or 
hypoglycemia, and how to eat healthy and make an appointment with a doctor or 
nurse practitioner who will help you care for diabetes upon release from prison. We 
are also interested in learning if this diabetes education program has an effect on 
what you know and believe about diabetes, your confidence level in taking care of 
your diabetes, and your stress associated with diabetes.  
A grant from the University of Connecticut’s Office of the Vice President for 
Research (OVPR)will provide some funding for this study. The funding will be 
used to pay for a nursing student to assist me with the study, education materials, 
and a statistician to help with analyzing the information obtained from 
questionnaires completed by the participants.
You are being asked to participate because you have diabetes and you will be 
released from prison within the next 6-9 months.

You do not have to be in the study.

If you say yes, you can quit at any time.

Please take as much time as you need to make your decision.
UCONN IRB PROTOCOL H17-006 APPROVED 4/6/18

Version 2 DSS Control group without support group

Your medical care will not change in any way if you say no.
Why is this study being done?
We want to learn more about what type of education program helps incarcerated 
persons to be prepared for managing diabetes when no longer incarcerated. 
We will use this information to plan diabetes education for incarcerated persons with 
diabetes leaving prison to help prepare them to care for diabetes while living in the 
community. 
What will I be asked to do? 
If you agree to be in the study, we will meet 4 times including today over a period 
of 14 weeks. After 14 weeks, you may participate in a diabetes education program 
with 10-12 additional incarcerated persons for 1 hour once weekly for 6 weeks. 
Visit 1: we will meet for 90 minutes or less at the correctional facility where 
you live. After you agree to be in the study and sign this document, you will 
be asked to complete 3 forms. I will read questions aloud asking you:   

your age, highest grade completed in school, gender, date of release from
prison, how long you were in prison, type of diabetes, medical history and
medications, whether you have use or have used alcohol or drugs, and if or
when you have participated in a diabetes education class.

to read information about health  and answer a few questions about what
you read.

to draw objects, and recall name of objects that are shown to you.

You do not have to answer any questions that you do not want to answer.
There are no right or wrong answers to these questions.

If you cannot name all of your medications and medical conditions, I will
ask you to sign a permission slip (HIPAA release) allowing me to look at
your medical and pharmacy record to obtain a list of your medications and
medical conditions (illnesses) and obtain your contact information from
the CDOC should you be released prior to completion of the studyYou can
refuse this request. Because we need an accurate list of your medications
and medical conditions, you will not be able to participate in the study if
you prefer that we not look at your medical record.

After you have completed all 3 forms, the Officer will escort you to your
living area.
UCONN IRB PROTOCOL H17-006 APPROVED 4/6/18

Version 2 DSS Control group without support group
Visit 2: Within the month following visit 1, we will meet for 60 minutes in 
a room at the correctional facility with 10-12 other incarcerated persons 
with diabetes who are also participating in the study. You will be asked to 
complete 4 questionnaires. I will read the surveys aloud to you and the 
other participants. You will be asked questions about: 

what you know about diabetes.

how confident you feel about caring for your diabetes.

your beliefs about diabetes

the level of concern or stress you feel about diabetes and diabetes self-care 
tasks.
After you complete the surveys,  the Officer will escort you to your living 
area. . 
Visit 3: Six weeks after visit 2 (week 9), We will meet for 60 minutes to 
complete the same 4 questionnaires that you completed during visit 2. After 
you complete the surveys,  the Officer will escort you to your living area. 
Visit 4: Six weeks after visit 3 (week 19), We will meet for 60 minutes to 
complete the same 4 questionnaires that you completed during visit 2 and 3. 
After you complete the surveys,  the Officer will escort you to your living 
area. You will receive a Certificate of Participation for completing the study. 
After completing visits 1-4, You will have the option to participate in a 1 hour 
6-session once weekly diabetes education program to prepare you for 
reentering the community. The diabetes education class will start 1 week after 
the completion of visit 4. 
If you choose to participate in the class, You will learn about different topics 
and practice skills at each class to prepare you for managing your diabetes 
self-care activities in the community. 
During the 1-hour education sessions, there will be opportunities for you to 
talk with the other participants, a student nurse, and with me, the diabetes 
educator. You will be given educational pamphlets with information about the 
topic of the week and a workbook page that includes questions about taking 
care of your diabetes. I will ask you to complete the workbook page and 
return it to me at the next scheduled class. You do not have to answer any 
questions that you do not want to answer.We will review the workbook pages 
and practice skills such as glucose monitoring, medication taking, and healthy 
eating during each session. The CO will call you to each of the meetings and 
UCONN IRB PROTOCOL H17-006 APPROVED 4/6/18

Version 2 DSS Control group without support group
escort you back to your living quarters at the end of each session. 
If you are going to be released from prison or transferred to another facility 
before you complete the diabetes classes, we will arrange to meet with you 
provide you the handouts and workbook pages from the diabetes classes you 
will miss. And, we will answer any of your diabetes related questions. 
In the event you are released from incarceration prior to completing the DSS 
study educational program, you have the option to sign a HIPPA release 
giving the CTDOC permission to release your contact information to the PI.  
If you anticipate release before completion of the diabetes classes, you may 
also choose to provide the study team with contact information before your 
release. This information will be used by the PI to contact you and arrange to 
provide you with the educational materials, and the glucometer you should 
receive for participating in the program and if you agree to complete surveys 
you were unable to complete because of your release.  If you agree to 
complete the surveys, a member of the research team will contact once or 
twice (about 6 weeks and 12 weeks after you completed the program) to 
compete the surveys. You will have the option to complete the surveys on the 
phone with the PI or member of the research team or arrange to meet the PI at 
a local library to complete the surveys. The decision to participate in the 
surveys will not affect your ability to receive the educational materials, the 
glucometer, and your certificate of completion. 
If you agree to be contacted after you are released from prison, you will meet 
or speak with a member of the research team at most an additional 1-3 visits 
to receive your glucose meter and education handouts, and complete 4 
surveys. 
Here is a diagram showing a rough estimate of the schedule of study visits. 
Visit 1
Visit 2 
Visit 3
Visit 4 
Visit 5-10 
(optional)
Today
1.5 hours
Week 4
1 hour
Week 9   
1 hour
Week 15
1 hour
Week 15-20
1 hour /week
Consent
Complete 3 
forms
Complete 
4 forms
Complete 4 
forms
Complete 4 
forms 
Diabetes Classes
 What other options are there?
UCONN IRB PROTOCOL H17-006 APPROVED 4/6/18

Version 2 DSS Control group without support group
There are no other options. 
What are the risks or inconveniences of the study?
The risks involved with taking part in this study are low. Being in the study is 
strictly voluntary. There is a chance that your confidentiality can be 
compromised; however, we are taking safety measures to lower this risk.
One possible inconvenience is the time commitment to the study. You will meet 
with the PI 4  times during the course of study. The meetings will last about 1-2 
hours. But you can take a break if you do not want to answer a question or you 
feel uncomfortable or become tired. You are free to skip a question or stop the 
meeting for any reason.
Additionally, you will be asked to wait 12 weeks before participating in the 
diabetes education class. You may not want to wait to participate in the diabetes 
education classes. You may decline participation or stop participation at any time. 
What are the benefits of the study?
There will be no direct benefit to you from your participation. Your help in this 
study may help us to develop and plan diabetes education for incarcerated 
persons preparing for release into the community. 
Will I receive payment for participation?  Are there costs to participate?
You do not pay.  You will not receive any compensation or payment for being in 
in this study. You will be able to take the glucose meter used in class home with 
you when you are released from prison. 
How will my personal information be protected?
Only the principal investigator (Louise Reagan), and approved members of the 
research team will have access to the information obtained during the study. 
At the conclusion of this study, the researchers may publish their findings and 
present findings in a professional magazine or at a conference. The Information 
will be presented in summary format and you will not be identified in any 
publications or presentations. 
UCONN IRB PROTOCOL H17-006 APPROVED 4/6/18

Version 2 DSS Control group without support group
All research team members are current in Human Subjects certifications.  All 
consent forms, surveys, and study data are retained on a secure computer which 
will be in a locked office at UConn School of Nursing accessible only to team 
members.  A password coded file will be created using unique identifiers linking 
components of the data.  Once the data are analyzed, the list linking the subject 
identifiers and names will be destroyed.  Investigators must maintain research 
records for three years beyond the completion/termination of the study.
Questionnaire data will be entered into an EXCEL or computer spreadsheet with 
no personally identifiable information. All research data files will be password 
encrypted/protected with access through password protected University of 
Connecticut computers. All paper forms will be retained in a secured locked file 
at the University of Connecticut.
You should also know that the UConn Institutional Review Board (IRB) and the 
Office of Research Compliance may inspect study records. These reviews will only 
focus on the researchers and not on your responses or involvement.  The IRB is a 
group of people who review research studies to protect the rights and welfare of 
research participants.
Your records will be maintained in accordance with state and federal laws.  We 
will do our best to protect the confidentiality of the information we gather from 
you but we cannot guarantee I 00% confidentiality."
Can I stop being in the study and what are my rights?
You do not have to be in this study if you do not want to. If you agree to be in the 
study, but later change your mind, you may drop out at any time. No one will treat 
you differently. You will not be penalized.  Your participation will have no effect on 
your parole or your release from prison.
There are no penalties or consequences of any kind if you decide that you do not 
want to participate. You do not have to answer any question that you do not want 
to answer.
You may be removed from the study if you are placed in administrative 
segregation, the hospital, or demonstrate any illegal behavior or your primary 
clinician or administration at the CT DOC thinks you should be removed for 
UCONN IRB PROTOCOL H17-006 APPROVED 4/6/18

Version 2 DSS Control group without support group
safety reasons.  
Whom do I contact if I have questions about the study?
Take as long as you like before you make a decision. We will be happy to answer 
any question you have about this study. If you have further questions about this 
study or if you have a research-related problem, you may contact the principal 
investigator, (Dr. Louise Reagan at louise.reagan@uconn.edu or 860-486-0593, 
or by mail: University of Connecticut, School of Nursing, 231 Glenbrook Rd., 
Storrs, CT 06269-4026. If you have any questions concerning your rights as a 
research participant, you may contact the University of Connecticut Institutional 
Review Board (IRB) at irb@uconn.edu.
Documentation of Consent:
By signing the document, you are saying:

You agree to be in the study.

We talked with you about the information in this document and answered all
your questions.
You know that: 

You can skip questions you do not want to answer.

You can stop answering our questions at any time and nothing will happen
to you.
You can call the office in charge of research at 860-486-8802if you have any 
questions about the study or about your rights. I have read this form and decided 
that I will participate in the project described above.  Its general purposes, the 
particulars of involvement and possible risks and inconveniences have been 
explained to my satisfaction.  I understand that I can withdraw at any time.  My 
signature also indicates that I have received a copy of this consent form.
UCONN IRB PROTOCOL H17-006 APPROVED 4/6/18

Version 2 DSS Control group without support group
Participant Signature:
Print Name:
Date:
Signature of Person
Print Name:
Date:
Obtaining Consent
UCONN IRB PROTOCOL H17-006 APPROVED 4/6/18