Web-Based Problem Solving Self-Management Program for African Americans With Type 2 Diabetes
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Sponsor: University of Kansas Medical Center

 
 
Protocol and Statistical Analysis Plan 
 
Study Title: A Web-based Problem-Solving Program for African American Patients with Type 
2 Diabetes 
 
PI: Michelle L. Redmond, PhD 
 
April 23, 2021 
 
Clincialtrials.gov #NCT03855449 

 
KUMC – HRPP- 02/01/2016 
 
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University of Kansas Medical Center  
RESEARCH PROTOCOL INVOLVING HUMAN SUBJECTS  
TEMPLATE WITH GUIDANCE 
Version date: 4 
Principal Investigator: Michelle L. Redmond, PhD  
Study Title: A Web-based Problem-Solving Program for African American Patients with Type 2 
Diabetes 
Co- Investigator(s): Nicole Nollen, PhD, Paigton Mayes, PhD, Robert Badgett, MD 
 
 
I. 
Purpose, Background and Rationale 
A. Aim and Hypotheses  
Significant disparities by race/ethnicity exist in the prevalence of type 2 diabetes and its health 
outcomes. In the US, diabetes affects 13.2% of African Americans, compared to 7.6% of Whites. 
Behavioral factors, such as poor diet, low physical activity, general lack of good self-management 
skills and self-care knowledge are associated with poor glucose control among African Americans 
African Americans are 77% more likely to develop diabetes and its associated health complications 
compared to non-Hispanic Whites. Thus, this higher disease burden and lower adherence to self-
management among African Americans calls for innovative approaches to self-management training 
Problem solving is a reliable tool for the behavior change necessary to improve self-management, and 
the American Association of Diabetes Educators identifies it as one of 7 core diabetes self-
management behaviors. One approach to helping African Americans develop the skills to solving 
problems is Problem Solving Skills Training (PSST). This therapeutic skill-training technique is 
delivered face-to-face to help patients identify their problems, learn skills to solve them, and 
implement solutions for particular challenges or obstacles in their disease self-management. Hill-
Briggs and colleagues adapted PSST into a curriculum titled Decision-Making Education for Choices 
in Diabetes Every Day (DECIDE), which has successfully helped African American populations 
improve self-management behaviors, adherence, problem-solving and CVD clinical outcomes 
(HbA1c, Blood pressure, LDL, HDL). The specific aim is to: 
 
1. Test eDECIDE in a pilot 18-week RCT, measuring change in HbA1c (primary outcome) and the 
following secondary outcomes: blood pressure, cholesterol, problem-solving skills, diabetes and 
cardiovascular disease knowledge, nutrition, and diabetes self-care behaviors. 
 
Primary Hypothesis: Participants randomized to eDECIDE (intervention group) will have 
comparable improvement in HbA1c compared to those randomized to traditional DECIDE 
(control group) at the end of 18-weeks. 
 
Secondary Hypothesis: Participants randomized to eDECIDE (intervention group) will have 
comparable improvement in problem-solving skills, diabetes self-management knowledge and 
behaviors, and clinical measures compared to traditional DECIDE (control group) at the end 
of 18-weeks. 
 
 
 
 

 
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B. Background and Significance 
1. Study Significance: This web-based approach will allow for future studies (using mHealth mobile 
applications) that can examine best practices for which type of problem-solving skills training is most 
effective to improve diabetes health outcomes for individuals. Results will inform the development of 
interventions aimed at reducing complications from uncontrolled diabetes as well as interventions 
aimed at promoting problem-solving and self-management. Identifying how to make problem-solving 
interventions more accessible would strengthen current investigations into improving health outcomes 
among underserved populations. It is believed that the minimal risk involved in the proposed study is 
reasonable considering that it could lead to more effective ways to manage diabetes among vulnerable. 
Since participation in traditional diabetes self-management programs is low, delivering tailored 
problem-solving skills training could increase self-efficacy and adherence among African Americans, 
thus improving glycemic control and further reducing health complications. 
 
We propose to design and test a web-based application of the DECIDE curriculum for African 
Americans with uncontrolled diabetes. According to a Pew Internet study, 62% of African Americans 
have home access to the Internet, 27 and a previous web-based intervention indicated 80% of urban 
African Americans living with diabetes were using computers.28 This application is not only a feasible 
approach to skills training, but innovative and cost-effective, allowing more flexibility, control, and 
self-directed access to training than face-to-face group sessions do. This new modality to deliver 
problem-solving interventions has the potential to reach much more of the African American 
population by providing easier access to diabetes self-management education.   
 
Literature Review:  Novel interventions are needed to promote diabetes self-management among 
African Americans to improve glycemic control and reduce the risk for diabetes-related adverse 
events. Type 2 diabetes is a major public health concern that disproportionally affects African 
Americans, with more than 4.9 million adults 20 years or older living with the disease. African 
Americans experience worse health outcomes from diabetes complications compared to non-Hispanic 
whites. Uncontrolled, it can lead to both macrovascular (e.g., coronary artery disease [CAD], stroke, 
lower-extremity amputations) and microvascular complications (blindness, renal or nervous system 
damage). A healthy diet, regular physical activity, medication/insulin adherence, and monitoring blood 
glucose are all important self-management behaviors for proper glycemic control. Previous studies 
have examined the relationship between diabetes self-management and race/ethnicity, with significant 
differences between African Americans and non-Hispanic whites. Kieffer and colleagues found 
African Americans struggle the most with self-management behaviors centered on dietary factors 
(food preparation, cost, preferences, and family support) and physical activity barriers (lack of 
childcare, social support, and safety). African Americans with uncontrolled diabetes require some 
level of behavior change to increase knowledge of and adherence to self-management behaviors, 
ultimately lessening the impact of associated poor health outcomes. Problem-solving skills training is 
beneficial in increasing success with maintaining certain self-management behaviors, while improving 
health outcomes. In diabetes self-management, problem-solving refers to applying the process of 
recognizing and identifying problems, generating solutions, and making decisions to surmount specific 
barriers to completing self-management tasks. For example, patients may struggle with following a 
prescribed diet, but problem-solving skills can help them identify which barriers impede them the 
most, whether selecting the right foods when eating out or finding solutions to preparing healthy meals 
for an entire family, so interventions are needed to help patients reach optimal problem-solving skill.   
 

 
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C. Rationale 
1. The long-term goal is to understand how problem-solving skills training, delivered by novel 
technology, can improve self-management in African American patients with uncontrolled diabetes. 
The objective of this application, which is our first step in pursuit of that goal, is to translate the 
evidence-based DECIDE curriculum into a user-centered web-based program (eDECIDE). In previous 
study phases we have conducted a task analysis and usability testing. Now, we are focusing on the 
pilot RCT. Our current aim is to test the eDECIDE application in a pilot, 18-week randomized 
controlled trial with participants randomized to either eDECIDE (intervention group) or traditional 
DECIDE (control group). 
2. Problem-solving skills training interventions have typically used group methods, one-on-one sessions, 
and DVDs. Currently, no studies have been conducted on the delivery and potential efficacy of 
problem-solving skills training for diabetes self-management behavior in a web-based format. 
Delivering a problem-solving intervention through a web-based component is an innovative way to 
reach the desired underserved population that is the focus of this application. This approach will 
empower the population with greater resources and tools to improve self-management and health 
outcomes. In addition, the web-based format allows participants to receive tailored real-time feedback 
on potential problem-solving issues that emerge (e.g., dietary and other self-care issues), on self-
management knowledge and skills in a more self-directed manner, allowing for future studies of 
mobile applications to examine best practices for the type of problem-solving skills training most 
effective to improve diabetes health outcomes. 
3. The proposed study will be the first to use a website (eDECIDE) to deliver problem-solving skills 
training for African Americans with Type 2 diabetes. This is significant because it has the potential to 
extend the reach of DECIDE with its proven efficacy in community settings. 
 
II. 
Research Plan and Design 
 
A. Study Objectives: The goal of this research is to conduct a 18-week randomized controlled trial pilot of 
eDECIDE that tests the feasibility of adapting DECIDE into eDECIDE, in an effort to lower HbA1c levels 
among African Americans, by promoting the use of problem-solving skills.  
B. Study Type and Design: This study is a randomized controlled trial pilot that will occur over an 18-week 
period. Participants will be recruited from local community health clinics and screened for A1C over 7.0% 
and clinical health measures (based on medical chart review), readability, Internet access, and cognitive 
impairment. Participants will be randomized into either the traditional DECIDE group (control) or the 
eDECIDE group (intervention). Traditional DECIDE consists of the regular 18-week in-person group 
sessions led by the candidate, as facilitator. The eDECIDE group sessions will consist of the newly 
translated online method. To assess problem-solving, diabetes self-care behaviors, diabetes and CVD 
knowledge, and dietary habits, participants will be administered the validated instruments listed in Table 5 
at baseline, post-intervention, then at 3-month follow-up. Once participants are screened and randomized, 
they will be enrolled in the web-based program or the traditionally based program and complete a total of 
18 weekly sessions. For eDECIDE, participants will have access to the weekly curriculum through a 
password-protected, interactive website. Participants in the intervention group will be asked to input their 
HbA1c number on the eDECIDE website. They will also be asked to create a unique username and 
password to login and use the eDECIDE website.  All stored data will be secure and encrypted. Website is 
in development. Participants will be prompted to complete their workbook pages and answer any problems 
about barriers for the week. After prompting, participants will have the opportunity to submit their 

 
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completed workbook homework to their personal health coach (PI: Michelle Redmond). Homework and 
sessions will be delivered through an eLearning system accessible through the eDECIDE website. 
Participants retrieve feedback via the website when logging back into their account. The personal health 
coach will not deliver problem-solving content. All content is scripted on the website and eLearning 
portal. Each week for 18 weeks, participants are asked to log on at least once for a total of 1 hour to 
complete the bi-weekly problem-solving training for that week. The training would include completing 
workbook pages and submitting responses to the coach. Participants in both groups will receive $75 in gift 
cards ($15 at first session, $20 at completion of the 18 weeks, then $20 at 3-month follow-up 
 
C. Sample size, statistical methods, and power calculation 
The primary outcome of interest is HbA1c measurement in the traditional DECIDE (control) group and 
eDECIDE (intervention) group. A .5% change in HbA1c has been considered clinically meaningful. The 
standard deviation in both arms is assumed to be 1.3%.61 Based on 2 sample t-test, assuming type I error 
rate of 5%, and attrition rate of 20%, with 35 participants in each group, the study is powered at 80% to 
detect a change in HbA1c level of at least 1% between the 2 groups. Hill-Briggs’ intervention was 
successful in detecting HbA1c change of at least 1% in a previous study. We will recruit 100 participants 
allowing for attrition to reach our goal of 70 for the pilot RCT. Block randomization with block size of 10 
will be employed. Within each block 5 participants will be assigned at random to control and 5 to 
intervention group using computer derived labels. 
 
For baseline characteristics of data, descriptive statistics will be reported as mean and standard deviation 
for continuous variables, and as count and percentage for categorical variables. Depending on the 
distribution of the continuous variables Wilcoxon rank sum test or t-test will be used to test for difference 
in continuous variables across the control and intervention group. Chi-Square test of independence will be 
used to assess the association between categorical variables and the two groups. The analysis will be based 
on “Intention-to-treat” principle. A 2-sided p-value of 0.05 will be used to assess statistical significance. 
Missing Data: If the proportion of missing data is small (5%), complete case analysis will be carried out. If 
the proportion is higher, then multiple imputations will be used to impute missing values. 
 
The post-intervention HbA1c levels in the intervention group will be compared to the control group using 
linear regression model after adjusting for baseline HbA1c levels. Additionally, average percentage change 
in HbA1c level across the 2 groups will be computed and compared using 2 sample t-test or Wilcoxon 
rank sum test (depending on the distribution of data). 
 
The secondary outcomes of interest are additional clinical measures (blood pressure, LDL, HDL), dietary 
habits, diabetes self-management behaviors, Diabetes and CVD knowledge, and problem-solving skills for 
health-related problems as assessed by instruments listed in Table 5. 
 
1. Blinding Procedures: This study will not involve blinding (masking).  Participants and research staff 
will be aware of random group assignment.  
 
2. Subject Enrollment: The primary outcome of interest is HbA1c measurement in the traditional 
DECIDE (control) group and eDECIDE (intervention) group.  A .5% change in HbA1c has been 
considered clinically meaningful. The standard deviation in both arms is assumed to be 1.3%.61  Based 
on 2 sample t-test, assuming type I error rate of 5%, and attrition rate of 20%, with 35 participants in 

 
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each group, the study is powered at 80% to detect a change in HbA1c level of at least 1% between the 
2 groups.24-25 Hill-Briggs’ intervention was successful in detecting HbA1c change of at least 1% in a 
previous study.24-25  We will recruit 100 participants allowing for attrition to reach our goal of 70 for 
the pilot RCT.  Block randomization with block size of 10 will be employed. Within each block 5 
participants will be assigned at random to control and 5 to intervention group using computer derived 
labels. 
 
D. Subject Criteria (See Vulnerable Populations appendix, if applicable): While uncontrolled diabetes 
affects more than one racial/ethnic group, our study will focus on African American adults because the 
burden of disease and consequent health complications is greatest among this population, particularly in 
the state of Kansas. Here, African Americans have the highest diabetes prevalence (15.7%) compared to 
8.7% for non-Hispanic whites. In Sedgwick County (the county in which KUSM-W is located), African 
Americans make up 9% of the population, but have the highest prevalence of diagnosed diabetes within 
the county at 15%, with Non-Hispanic whites at 8.1%.54 This study will take place in our local community 
where improvements and innovations in access to diabetes self-management services are greatly needed. 
Examining multiple racial/ethnic groups is beyond the scope of the current application. Our intent is to 
determine the efficacy of eDECIDE with a focus on our most at-risk group (i.e., African Americans).  
Future studies will allow the resources and time to expand the study population beyond African 
Americans. 
 
1. Inclusion criteria: Potential participants will be initially screened based on clinic (KU Internal 
Medicine Clinic) databases. They will be included if they have an HbA1c of > 7%, absence of 
significant comorbidities that limit adherence to self-management protocol, or expected to limit 
lifespan to < 3 years (chest pain, amputation, cancer diagnosis) based on medical chart audit review, 
are deemed suitable by clinicians, are African American, and are at least 21 years and older. The 
candidate will contact those who meet inclusion criteria to further undergo a telephone eligibility 
screen. The screen will ascertain eligibility based on no current participation in a self-management 
program and daily access to the Internet (in a home or private location).  
2. Exclusion criteria: During the baseline visit, potential participants will then be screened for exclusion 
criteria: visual and cognitive impairment, 51-52 inability to give informed consent, and unable to 
complete baseline assessment (clinical measures, study questionnaires, venipuncture). 
 
3. Withdrawal/Termination criteria: Subject’s participation will be terminated if requested by the subject.  
Subject’s will need to continue to meet eligibility requirements to remain in the study (i.e. Internet 
access, etc.) to remain in the study.  
4. A study subject can’t participant in another study that is related to diabetes self-management as this 
may compromise out study outcomes. 
 
E.  Specific methods and techniques used throughout the study       
 
1. Laboratory tests: Our study will collect and possibly perform blood draws (approximately 2 
tablespoons)- to measure HbA1c and Cholesterol level. This blood draw would be collected at 
baseline, post-intervention (18 weeks) and again at 3-month follow-up. The laboratory test would be 
conducted either by the participating clinic or a contracted laboratory for participants to visit.  
 
 
 
Behavioral questionnaires: Health-problem-solving survey, Diabetes self-care survey,  

 
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patient-provider communication survey 
 
2. Study Procedures: Participants will be randomized into either the traditional DECIDE group (control) 
or the eDECIDE group (intervention). Traditional DECIDE consists of the regular 9 in-person group 
sessions delivered bi-weekly. The eDECIDE group sessions will consist of the newly translated online 
method. To assess problem-solving, diabetes self-care behaviors, diabetes and CVD knowledge, and 
dietary habits, participants will be administered the validated instruments at baseline, post-
intervention, then at 3-month follow-up. Once participants are screened and randomized, they will be 
enrolled in the web-based program or the traditionally based program and complete a total of 18 
weekly sessions. For eDECIDE, participants will have access to the weekly curriculum through a 
password-protected, interactive website. Participants will be prompted to complete their workbook 
pages and answer any problems about barriers for the week. After prompting, participants will have 
the opportunity to submit their completed workbook homework to their personal health coach (who 
will be hired for the RCT and work closely with Dr. Redmond for review and feedback through a 
Dropbox embedded within the web page. Participants retrieve feedback via the website when logging 
back into their account. The personal health coach will not deliver problem-solving content. All 
content is scripted on the website. Each week for 18-weeks, participants are asked to log on at least 
once for a total of 1 hour to complete the weekly problem-solving training for that week. The training 
would include completing workbook pages and submitting responses to the coach. Participants in both 
groups will receive $50 in gift cards ($10 at first session, $20 at completion of the 9 weeks, then $20 at 
3-month follow-up. Surveys will be administered that are suited to measure diabetes self-care 
behaviors, dietary patterns, diabetes and CVD knowledge, and barriers to problem-solving for specific 
health behaviors. Diabetes Self-management behaviors will be measured by SDSCA. Dietary habits 
will be measured by STCFFS. Problem-solving ability for related health problems will be measured by 
HPSS. 
3. The initial HbA1c reading to check study eligibility would be a routine test performed at the clinic 
(chart audit).   It is also possible if a study participant had a recent HbA1c reading the study could use 
this as well.  
4. Any laboratory test will be either conducted through a contracted laboratory (CTSU- Wichita 
Campus).  Study personnel will not collect any body components. Study personnel will only receive a 
written lab report.  
 
5. Timeline:  
Recruitment  Enrollment-
Starts 
Baseline Visit 
eDECIDE Sessions  
18- weeks 
(Intervention) 
Traditional DECIDE 
Sessions  
18-weeks  
(Control) 
Post-
Intervention 
Visit 
(After 18weeks) 
3-Month Follow-
up- post 
intervention 
Visit 
June-August  
September 
Behavioral 
Questionnaires-
Virtual  
Delivered over 18 
weeks (9 sessions) 
online self-directed   
Delivered over 18 
weeks (9 sessions) self-
directed-paper   
Behavioral 
Questionnaires-
Virtual 
Behavioral 
Questionnaires-
Virtual  
 
Conduct 
prescreen 
First 
Laboratory 
Blood Draw 
Will receive weekly 
email/text reminders  
Will receive weekly 
email/text reminders 
2nd Laboratory 
Blood Draw 
Last Laboratory 
Blood Draw 
 
Medical 
Chart Audit 
(HbA1c) 
 
 
 
 
 
 

 
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F. Risk/benefit assessment:   
1. Physical risk There are no known physical risks of subjects participating in a web-based study. 
2. Psychological risk There are no known psychological risks of subjects participating in a web-based 
study. If an adverse event should occur, the subject will have the opportunity to withdraw from the 
study. Dr. Nicole Nollen (Primary Mentor) will be available for consultation should an adverse event 
happen. Throughout the study, research personnel will monitor for issues related to safety of subjects 
as well as privacy of data. Should an adverse event occur, research personnel will document it. The 
following information will be monitored throughout the study: number of subjects screened and 
enrolled drop-outs, and serious and non-serious adverse events. This data, with the exception of 
serious adverse events, will be reported every 12-months. Because no serious adverse events are 
anticipated in this study, any such events will be immediately reported to the KUSM-W Human 
Subjects Committee. If the severity of an adverse event requires emergency medical attention, 
appropriate KUSM-W providers/staff will be contacted to provide medical attention. 
 
3. Social risk There are no known risks of subjects participating in a web-based study. Previous studies 
have successfully conducted web-based interventions and maintained confidentiality of subjects.59-60 
To minimize potential issues with confidentiality subjects will receive a secure password protected 
login for the duration of the 18-week web-based portion of this study.  All communication via the 
Internet will take place across a secure server.  Medical chart data will be collected in person by the PI 
from a designated medical staff person at the participating clinic.   
 
A potential risk of participating in the study is a breach of confidentiality and loss of privacy. To 
further address privacy, as well as to ensure confidentiality, the investigators will ensure the following 
measures are taken. All data obtained in the study will be kept confidential. The only parties having 
access to the data in the proposed study will be the Principal Investigator (Dr. Redmond), Mentor (Dr. 
Nicole Nollen) and appropriate research staff, and the KUSM-W Human Subjects Committee.    
 
Hardcopies of completed subject questionnaires will be locked in a secure file cabinet in the PI’s 
office. Responses to the surveys and the clinical/treatment/surveillance information obtained from the 
EHR will be maintained on the KUSM-W REDCap database. Only the necessary members of the 
research team will have access to the REDCap database.  After a member of the research team initially 
enters the data, an additional member will review the data and identify errors. A log will be kept of all 
data collection and analysis steps completed for each subject. For the task analysis and usability 
testing, a research log will be kept by the research technician regarding steps completed and any errors 
detected.  
Participants in the intervention group are asked to input their HbA1c number on the eDECIDE 
website. They will also be asked to create a unique username and password to login and use the 
eDECIDE website.  All stored data will be secure and encrypted. Website is in development.  
 
4. Economic risk There are no known economic risks of subjects participating in a web-based study. 
 
5. Potential benefit of participating in the study  
a. Delivering a problem-solving intervention through a web-based component is an innovative 
way to reach the desired underserved population which is the focus of this application. This 
approach will allow for greater resources and tools at the disposal of subjects involved in the 
study, thus improving their self-management and health outcomes related to their disease.  
 

 
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b. In addition, the web-based format allows subjects to receive tailored real-time feedback on 
potential problem-solving issues that emerge (i.e. dietary and physical activity issues, other 
self-care issues), on diabetes self-management knowledge.  
 
c. This approach (web-based) will allow for future studies (using mHealth mobile applications) 
that can examine best practices for which type of problem-solving skills training is most 
effective to improve diabetes health outcomes for particular individuals. Results will inform 
the development of interventions aimed at reducing complications from uncontrolled diabetes 
as well as interventions aimed at promoting problem-solving and self-management. 
Identifying how to make problem-solving interventions more accessible would strengthen 
current investigations into improving health outcomes among underserved populations. It is 
believed that the minimal risk involved in the proposed study is reasonable considering that it 
could lead to more effective ways to manage diabetes among vulnerable. Since participation in 
traditional diabetes self-management programs is low, delivering tailored problem-solving 
skills training could increase self-efficacy and adherence among African Americans, thus 
improving glycemic control and further reducing health complications. 
G. Location where study will be performed: This study will take place at the University of Kansas School 
of Medicine-Wichita.   
H. Collaboration (with another institution, if applicable):  No collaboration with other institutions.  
I. Single IRB Review for a Multi-site study (if applicable):  N/A only singe site IRB needed. 
 
1. For which sites will KUMC serve as the IRB of record? All 
2. Indicate which study activities will occur at each site. If all study procedures will be identical across 
study sites, state this.  KUMC Only Site 
3. Describe how you will assess the capacity of each site to perform the research (e.g., expertise, staffing, 
space, equipment, etc.)  If applicable, include site evaluation tools in your IRB submission.  KUMC is 
the only site 
4. Describe how the lead investigators will ensure that all participating sites use the IRB-approved 
version of the protocol, consent, recruitment materials and other study documents. KUMC Only site  
5. Describe how the lead investigators will communicate with and disseminate new information to other 
sites (e.g., training meetings, regularly-scheduled conference calls, notifications, etc.)     KUMC 
Only site    
6. Describe how the lead investigator will assess protocol compliance, unanticipated problems and 
adverse events at other sites. KUMC Only site 
7. Name the member of the KUMC study team who will be the point of contact to coordinate oversight 
and communication with the sites.  KUMC Only site 
 
 
J. Community-Based Participatory Research (if applicable) 
1. Participants and the nature of their involvement: Target community is African Americans in Sedgwick 
County, KS.  In the prior study (phase II) of this research we got input from community members on 
the build and design prototype of the eDECIDE website.  Therefore, this work is being created with 
the user perspective included.  We have also added an aim to the current study to get feedback on the 
eDECIDE intervention, overall.  

 
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2. Cultural issues:  We do not anticipate there being problems with cultural or community attitudes 
towards this research.  We will recruitment with a community perspective in mind.  Our recruitment 
materials are culturally specific for race, age, and gender. All reading materials and curriculum 
material was created for a 5th grade reading level to be accessible to all. The eventual website will also 
use this same rule of 5th grade reading level. 
 
3. Origin of the research question: From the researcher.  The community has participated in previous 
studies and members of the community participated in a qualitative study indicating an interest in the 
study topic. 
 
4. Risks and Benefits:  The risk to the community is minimal the benefit will be the availability of novel 
technology to help manage type 2 diabetes. 
 
5. Study Description and Process:  Previously, participants recruited by the same means as the current 
study, conducted usability testing with the researchers to ensure that the program platform and design 
was feasible, usable, and that participants who used it were satisfied with the overall intervention. 
 
6. Return of results: Community and study participants will be able to access any study results through 
community presentations, peer reviewed journal articles and more.  
 
7. Sustainability: No current plan. No partnership currently exist.  
 
K. Personnel who will conduct the study, including: 
1. Indicate, by title, who will be present during study procedure(s): Dr. Michelle Redmond, Study PI 
2. Primary responsibility for the following activities, for example:  
a. Determining eligibility: Research Assistant/ Principle Investigator  
b. Obtaining informed consent: Research Assistant/ Principle Investigator  
c. Providing on-going information to the study sponsor and the IRB:     Research Assistant/ 
Principle Investigator    
d. Maintaining participant's research records: Research Assistant/ Principle Investigator 
e. Completing physical examination:    Research Assistant/ Principle Investigator     
f. Taking vital signs, height, weight: N/A 
g. Drawing / collecting laboratory specimens: N/A- contracting out to a 3rd party 
h. Performing / conducting tests, procedures, interventions, questionnaires:    Research 
Assistant/ Principle Investigator     
i. Completing study data forms:     Research Assistant/ Principle Investigator    
j. Managing study database: Research Assistant/ Principle Investigator 
 
L. Assessment of Subject Safety and Development of a Data and Safety Monitoring Plan 
 

 
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1. Elements of the plan include: 
a. Persons/groups who will review the data (study team; independent safety monitor, data 
monitoring committee or formal DSMB) Study team  
b. Data/events that will be reviewed Timeline for data collection points, REDCap data entry 
process and logon’s to eDECIDE website  
c. Frequency of review:  Will review daily/weekly and as needed to maintain study schedule  
d. Types of analyses to be performed: Will run basic statistics or log entry to see how often 
participants log on to website. Will monitor computer security to ensure participant’s 
confidentiality remains in take per HIPPA guidelines.  
e. Safety-related triggers that would cause the PI to stop or alter the study Any breach in 
confidentiality based on the website  
2. Describe how adverse events and unanticipated problems will be ascertained and handled.  
Explain exactly which type of problems will be considered serious and reported to the IRB. The 
reporting timeframe should also be detailed. Because we are conducting a virtual/online 
intervention one concern is a data breach.  We are working with our web designers and OIS to ensure 
all data transmitted will be through an encrypted secure mechanism through KUMC. This is also why 
the website and eLearning site will be hosted on the KUMC server to ensure data safety and security 
of participants. We do not anticipate major physical adverse events which could be tied to the 
activities of this study.  Participants are only being asked to share information about obstacles or 
issues that impede their managing their diabetes. We will not ask participants to engage in any 
physical activity or weight loss.  Another anticipated event might be blood draws.  As stated early we 
will utilize a laboratory (likely CTSU-Wichita Campus) to arrange for participants to receive their 
blood draw or the KU Internal Medicine Resident Clinic.  
3. If a participant should encounter an adverse event. Participation will cease. The case will be reviewed 
by the study team and notify the IRB. 
 
 
III. 
Subject Participation 
 
A. Recruitment: 
1. Recruitment will take place in a community setting (clinics, distribution of filers) 
2. Filers will be disbursed traditionally and though social media (Facebook, Twitter, etc.) 
3. See attached letter 
4. Planned distribution will be to clinic providers and if applicable in terms of community presentations a letter will 
be sent out to request a recruiting meeting  
B. Screening Interview/questionnaire: Participants will call or email if interested in participating in the study. They 
will answer the screening questions and based on responses will be able to move to the next study phase.  Consent to 
participate in the screening process will consists of a question: “Do you consent to the prescreen questionnaire?” 
C. Informed consent process and timing of obtaining of consent 
1 
Study personnel,  
2 
Consent call- calling participant to go over the consent, answer questions, obtain consent. Due to current COVID 
protocol, we will obtain an e-consent through REDCap.  Study personnel will call potential participants, go over 
the prescreen and then complete the consent.  
D. Alternatives to Participation: There are no alternatives  
E. Costs to Subjects: No cost to subjects 

 
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F. How new information will be conveyed to the study subject and how it will be documented: Written format by a 
letter if new information needs to be shared. 
G. Payment, including a prorated plan for payment: Participants receive a gift card for incentive. 
H. Payment for a research-related injury: There will be no payment for research related injury as participants are not 
being asked to engage in any type of physical activity or any activity which should result in injury.  
IV. 
Data Collection and Protection 
A. Data Management and Security:  
The group sessions will not ask for any protected information or unique identifiers.  All data collected will be 
evaluated and analyzed only as group data and no specific participants will be identified in presentation or 
publication of study results. All demographic data will be stored in REDCap on a secure KU serve (P-drive).  Only 
study personnel will have access to collected data. All data will be stored on the KU server (P-drive).  Items will 
be stored on a password protected laptop or computer.   
 
The only party having access to the dataset other than the PI and investigators is the HSC2.  The data will only be 
reviewed by non-investigators when required by law or by the governing IRBs.  Following completion of the 
study, research data will be archived on password-protected computers restricted to research personnel. No direct 
identifiers will be included with this data. 
 
The University of Kansas School of Medicine-Wichita employs a "private" TCP/IP addressing scheme 
for on-campus workstations and file servers, ensuring that they cannot be seen from outside computers.  
The network is also protected by a next generation firewall system that includes intruder 
detection/prevention as well as malware and threat prevention.  University managed workstations are 
encrypted with hardware encryption and malware detection software.  Authentication to the network 
requires unique user ID's, and complex passwords that require changing every 180 days.  Sensitive 
information stored on network file shares is encrypted with file level encryption.   
  
1. 
Following completion of the study, research data will be archived on password-protected computers 
restricted to research personnel. Data will be kept for at least seven years, in accordance with the 
KUMC research record retention policy. No direct identifiers will be included with this data 
2. 
We will always use a study id to identify a participant other than the raw database which will be kept in a secure 
REDCap database. 
3. 
The Study team (PI, Research Assistant & Statistician) will have access to REDCap database with linked study 
IDs & participants full name.  
4. 
linked by study ID in REDCap Secure Database. 
5. 
REDCap Database, which is a secure password, protected program.  Only study team members with access will 
be able to view the REDCap database.  
6. 
study will test a website that will involve participants creating a username and password 
7. 
Data will not be sent outside of KUMC 
 
B. Sample / Specimen Collection: No samples will be collected at sites.  Any laboratory collections will be done 
through a contracted provider or review of medical chart audit.  
C. Tissue Banking Considerations: This is not relevant to this study. No tissue banking will take place.  
D. Procedures to protect subject confidentiality: This study will use a secure website, hosted on KUMC server. Any 
and all data that must be transmitted will be encrypted and secure. No personal health information will be stored on 

 
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the website other than the participants chosen username and password. Website is underdevelopment and will be 
built to met HIPPA qualifications.  
E. Quality Assurance / Monitoring 
1. 
Data will be kept in REDCap and maintained in this database to ensure data collection goals are meet and 
subjects are monitored  
2. 
No plans for 3rd party monitoring  
 
V. 
Data Analysis and Reporting Stop Here  
3. Statistical and Data Analysis:   
 
For baseline characteristics of data, descriptive statistics will be reported as mean and standard 
deviation for continuous variables; and as count and percentage for categorical variables. Depending 
on the distribution of the continuous variables Wilcoxon rank sum test or t-test will be used to test for 
difference in continuous variables across the control and intervention group. Chi-Square test of 
independence will be used to assess the association between categorical variables and the two groups. 
The analysis will be based on “Intention-to-treat” principle. A 2-sided p-value of 0.05 will be used to 
assess statistical significance. Missing Data: If the proportion of missing data is small (5%), complete 
case analysis will be carried out. If the proportion is higher, then multiple imputations will be used to 
impute missing values. 
 
A. The post-intervention HbA1c levels in the intervention group will be compared to the control group using 
linear regression model after adjusting for baseline HbA1c levels. Additionally, average percentage change 
in HbA1c level across the 2 groups will be computed and compared using 2 sample t-test or Wilcoxon 
rank sum test (depending on the distribution of data). 
B. Outcome: The post-intervention HbA1c levels in the intervention group will be compared to the control 
group using linear regression model after adjusting for baseline HbA1c levels. Additionally average 
percentage change in HbA1c level across the 2 groups will be computed and compared using 2 sample t-
test or Wilcoxon rank sum test (depending on the distribution of data). The secondary outcomes of interest 
are additional clinical measures (blood pressure, LDL, HDL), dietary habits, diabetes self-management 
behaviors, Diabetes and CVD knowledge, and problem-solving skills for health-related problems as 
assessed by instruments listed in Table 5. 
C. Study results to participants: We will make available any published study results. Our study team will also 
make available any community presentations to allow participants to learn about the final findings of the 
study and next steps. 
 
D. Publication Plan: We will publish study results to peer-reviewed journals: preliminary findings and a protocol paper.  
All identifying information will be removed before publication. 
 
VI. 
Bibliography / References / Literature Cited: see attachment 
 
APPENDIX I: VULNERABLE POPULATIONS 
 
I.     Groups below are not part of the active recruitment pool or target groups 
 

 
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II.     Cognitively or decisional impaired individuals: Those with cognitive or decisional impairment will not be eligible for 
the study.  
 
III.     Children: Children will not be eligible for the study. 
 
IV.     Pregnant women: Women who are currently pregnant or have gestational diabetes will not be eligible for this study. 
 
V.    Prisoners: Prisoners are not an eligible population for this study. 
 
VI.     Students and/or Employees: This is a community recruitment effort.  KUMC Students and Employees will not be 
recruited for this study.