Order 638034: review of literature portion for paper
Running head: SELF-MANAGEMENT 1
Self-Management Clinics for Type 2 Diabetes
South University
College of Nursing
SELF-MANAGEMENT 2
Abstract
Objective: The aim of this study is to examine the effects of using a three-part self-management
class focusing on healthy diets, physical activity, and medication management for those with
type 2 diabetes.
Background: The type 2 diabetes diagnosis rates are rapidly increasing in the United States.
The use of self-management techniques may be one way to help manage diabetes. A variety of
studies have been performed concluding there are positive effects with the use of self-
management that included: blood glucose monitoring, community self-management program
involvement, diet modification, and overall lifestyle modifications.
Methods: A descriptive survey will be used to examine patient data of those involved in the self-
management classes prior to the first class. The survey will include the patient’s goals and
objectives, visits to clinic, and clinical data such as: Body Mass Index (BMI), blood pressure,
height, weight, medications prescribed, cholesterol levels, and hemoglobin A1c. The same
survey will then be administered to examine the patient goals at 1 month, 3 month, 6 month, and
1 year markings to evaluate changes in goals and objectives, visits to clinic, and clinical data.
Descriptive statistics will be used to describe the data.
SELF-MANAGEMENT 3
Self-Management Clinic for Type 2 Diabetes
Section I – Introduction
Introduction
Diabetes, along with obesity, has become an epidemic within the United States. Nearly
26 million people are affected with some form of diabetes; an estimated 90% have type 2
diabetes (T2D) (American Diabetes Association [ADA], 2013). With the fast growing number of
diabetics in the United States, it is increasingly necessary to develop self-management programs
and increase research to help manage the disease.
The use of self-management techniques may be one way to help manage diabetes.
Researchers have conducted a variety of studies to examine the use of self-management in Type
2 Diabetes. Techniques include: blood glucose monitoring, community self-management
program involvement, diet modification, and overall lifestyle modifications (Bartol, 2013; Jessee
& Rutledge, 2012; Lorig et al., 2009). A self-management clinic may help provide patients with
better education and reinforcement to help improve their lives due to chronic disease.
Refinement of self-management skills may help to improve overall health and lifestyles
of those with T2D. It is essential that a person with T2D receive immediate education and skills
needed to successfully manage their chronic disease. In order to improve self-management, it is
important to improve ways that people can gain more knowledge and accept more responsibility
for their disease. The goal of this study is to analyze the problems of T2D and how a self-
management program may help reduce the morbidity and mortality associated with the disease.
SELF-MANAGEMENT 4
Overview of the Problem
Type 2 Diabetes accounts for nearly 90% of the diagnosed cases of diabetes (World
Health Organization [WHO], 2013). In the United States alone, there is an estimated 18.8
million people diagnosed with diabetes and 7.0 million people undiagnosed cases (Centers for
Disease Control [CDC], 2011). In 2010 alone, an estimated 1.9 million adults age 20 and older
were diagnosed with one form of diabetes (CDC, 2011). Diabetes is the 7th leading cause of
death in the United States, partly due to the comorbidities that are associated with the disease.
Diabetes is growing at a rapid rate and the costs associated with the disease are
staggering. “The estimated cost of diagnosed diabetes in 2013 was $245 billion dollars,
including $176 billion in direct medical costs and $69 billion in reduced productivity” (ADA,
2013) The people with T2D are typically obese and have many comorbidities such as
hypertension, increased cholesterol, kidney disease, and heart disease (CDC, 2011). In order to
help improve the care of T2D patients, it is essential to provide education to help empower the
patient. By increasing knowledge, one may potentially improve the self-management skills and
behaviors of the individual.
Research findings show that patients with T2D engaging in a community or group based
self-management program have improved lifestyles and decreased exacerbations of the disease
by simply improving their self-management. Maintaining control of the disease is key to helping
prevent further complications. Self-management can help reduce health care costs, morbidity,
and mortality associated with diabetes. Proper care and management can be taught and is
something that the patient can have control over.
SELF-MANAGEMENT 5
Purpose of Study
The purpose of this study is to explore the effect of a three-part self-management
program that will focus on healthy diets, increasing physical activity, medication management,
goals, motivation, and barriers to improving healthy lifestyles.
Research Hypothesis
It is hypothesized that T2D patients enrolled in a self-management program will have
improved self-management, improved behaviors as measured by a pre and post class evaluation,
and improved clinical data outcomes (Hemoglobin A1c, blood pressure, lipid levels, and BMI).
Definition of Terms
Self-Management is defined as an activity that involves a patient taking proper control of
his/her disease by improving their health as measured by improved behaviors and clinical data
outcomes, diet, and activity; thus, requiring less office visits, improved health, fewer health
exacerbations, and fewer comorbidities. The operational definition will be any activity that helps
promote an increase in one’s overall improvement of self-care and less dependence on health
care professionals for management. Self-management will be measured by examining clinical
data outcomes, behavioral evaluations, and acknowledgement of how to properly manage the
disease.
Type 2 Diabetes is defined as a condition in which the body does not make enough
insulin or does not respond to the insulin that is made (ADA, 2013).
Indigent care clinic is defined as a medical facility where patients with low income and
no insurance can receive either free or reduced cost medical care and treatment (Kelch, 2005).
SELF-MANAGEMENT 6 Healthy diet is defined as following the national recommendations regarding the five
food groups as listed by the United States Department of Agriculture (2013). The operational
definition will be a diet that consists of fruits, vegetables, lean protein, and a decrease in
carbohydrates, fats, and sugars that will be measured by documentation of meals during the three
class sessions.
Physical activity is defined as any activity that requires a person to move around, use
muscles, and achieve a higher heart rate than a sedentary lifestyle, thus using more energy than
resting. (National Heart, Lung, and Blood Institute [NHLBI], 2013). The operational definition
will be any activity that involved active movement that will be measured by using a pedometer
and documentation of physical activity performed and will be compared to A1C and lipid levels,
blood pressure, and BMI’s.
Hemoglobin A1c is a test to measure the percentage of hemoglobin that is glycosylated
(Mayo Clinic, 2013). The operational definition will be a measure of glycosylated hemoglobin
in a particular blood sample to determine the level of diabetic control.
Lipid levels also known as cholesterol levels are blood derived numbers that identify
lipoproteins and triglycerides (Mayo Clinic, 2013). The operational definition will be the
lipoprotein levels identified in the blood to measure very low-lipoproteins (VLDL), low-density
lipoproteins (LDL), high-density lipoproteins (HDL), and triglycerides.
Blood pressure is defined as the force of the blood against the walls of the arteries
equating to two numbers: systolic and diastolic, with 120/80 being normal (NHLBI, 2013). The
operational definition will be blood pressure measurements at the beginning and end of the
intervention to measure for changes measured using a blood pressure cuff and
sphygmomanometer.
SELF-MANAGEMENT 7 Body Mass Index a measurement of a person’s overall body mass when calculating
weight and height that then falls into one of four categories: underweight, normal, overweight,
obese, morbidly obese (Centers for Disease Control and Prevention [CDC], 2013). The
operational definition of body mass index will be calculated number that is used to identify if a
person is underweight, normal, overweight, obese, or morbidly obese and will be calculated
using the CDC standard of height in meters squared divided by weight in kilograms.
Medication management is defined as knowing the drug taken, reason for it, when and
how to take the drug. The operational definition will be an activity that involves a patient taking
active control of their medication and knowledge regarding reason for medication and all aspects
of proper medication administration.
Goals are defined as the objectives that a patient would like to accomplish during their
time in the program. The operational definition will be the objectives that a patient would like to
do while in the program that will be documented using pre-made tools.
Assumptions
The researcher will make several assumptions for this study. The first assumption is that
all participants will be honest when answering the questionnaire at the beginning of the classes.
The second assumption is that all subjects will be active participants in the study by attending all
three classes, follow the directions, and continue with the follow-up questions during the one-
year time frame. The final assumption is that the participants learn best in groups.
Limitations
A limitation of the study is that it will be conducted on a convenience sample from the
local indigent care clinic in Savannah, Georgia, and, therefore, can only be generalized to the
study population and not to the entire T2D population. Another limitation of the study is that the
SELF-MANAGEMENT 8 sample size will be limited due to the number of people who use the indigent care clinic and have
T2D, and can be accommodated in the self-management classes, further limiting the
generalizability of the findings. A final limitation of the study is that it will be conducted by a
novice researcher, which may impact the final results accuracy.
Summary
The incidence of T2D diagnosis is growing rapidly. It is imperative to improve self-
management to improve patient health, but to also reduce health care costs related to increased
medication needs, increasing comorbidities, and increasing hospitalization rates due to the
effects of the disease. It is expected that the incidence of T2D will continue to rise, so it is
necessary to find ways to increase patient knowledge, power, and self-management of their
disease. The purpose of this study is to explore the effect of a three-part self-management
program that will focus on healthy diets, increasing physical activity, medication management,
goals, motivation, and barriers to improving healthy lifestyles. In the next section, the researcher
will present a literature review and theoretical framework regarding self-management with T2D.
Section II – Literature Review and Theoretical Framework
Literature Review
The purpose of this study is to explore the effect of a three-part self-management
program that will focus on healthy diets, increasing physical activity, medication management,
goals, motivation, and barriers to improving healthy lifestyles; thus, a comprehensive literature
search was conducted finding articles related to T2D and self-management. Hundreds of studies
have been performed to evaluate the effectiveness of self-management and self-management
programs on the overall success of T2D management. In the literature review, the researcher
focused on adult diabetic patients, and how a management program affects risk factors,
SELF-MANAGEMENT 9 management of disease, and improve changes in lifestyles resulting from an increase in physical
activity, having a healthy diet, and improved medication management.
Bartol (2013) examined the role of the nurse practitioner (NP) in a primary care setting
and the impact the NP has on patients with T2D by evaluating personal experience and clinical
studies. The goal of the project was to utilize NPs to help motivate, guide, and treat patients, all
while increasing the patient’s self-awareness to influence positive self-management skills
(Bartol, 2013). The study found that a NP can help influence lifestyle modifications such as
improvement in eating and exercise habits (Bartol, 2013). Patients working with a NP were
more likely to perform self-monitoring of blood glucose, increase motivation, and improve
commitment to the delicate management of their disease (Bartol, 2013).
Nurse practitioners play an important role when dealing with self-management, but it is
important that the practitioner be aware that barriers may exist for the patient with type 2
diabetes. Jesse and Rutledge (2012) conducted a study that involved 26 participants in two
groups, each of which containing 13 participants. According the researchers, while diabetic
education and self-management programs were extremely successful, there were barriers to care
in the presence of fuel, time, transportation, work, and family issues. Researchers reported, after
a pre and post test, that mean blood sugars improved by 50.37 mg/dl, A1C’s improved by 2.0%,
knowledge improved by 1.26 points, and self-efficacy improved by 0.49 points, which all were
significant for the study (Jesse & Rutledge, 2012). The researchers concluded that it was
important to continue to move forward with education and self-management improved clinical
outcomes like random blood glucose levels and hemoglobin A1Cs (Jessee & Rutledge, 2012).
Education for self-management of a disease is important, but reviewing therapeutic
treatments is also necessary for some patients. Tierney (2012) conducted a qualitative study
SELF-MANAGEMENT 10 through analysis of published guidelines for the management of type 2 diabetes, review articles,
primary manuscripts, and FDA prescribing information documents and found that NPs play a
vital role in the management of T2D when one medication was not sufficient for diabetic control.
Tierney (2012) concluded that a NP should create individual plans for his/her diabetic patients.
By including education about self-management to delay further progression of the disease, NPs
are meeting the requirements of their patients and helping to increase awareness and promoting
increased compliance and an increase in the overall positive outcomes (Tierney, 2012).
In another study, Whittemore and associates (2010) examined the effects using primary
care NPs to increase positive T2D outcomes and lifestyle modification program success among
58 participants in a mixed method clinical trial. The lifestyle modification program involved
multiple meetings and follow-up appointments at specific intervals to evaluate the success and
needs of the program (Whittemore et al., 2010). Overall, the program was successful, not only in
terms of diabetic control (p<0.05), but also in the increase of patient satisfaction (p=0.05).
Patient satisfaction is an important indicator for any improvement of lifestyle (Whittemore et al.,
2010). The patients need to feel like they are not wasting their time. Researchers concluded that
the program was helpful for patients who were prediabetics in terms of helping them to learn
about diabetic prevention programs and the ways to reduce risk factors related to the disease
(Whittemore et al., 2010).
In a 2012 qualitative study, Mathew and associates examined the needs, barriers,
challenges, and experiences of men and women who had T2D using self-management education
and skills. Mathew and associates (2012) found that there are important factors in self-
management education that need to be accounted for when dealing with different genders.
Gender differences present barriers and challenges; each gender needs to have a tailored
SELF-MANAGEMENT 11 approach to help improve outcomes (Mathew et al., 2012). The study involved 35 participants
from suburban diabetes education center. Despite the critical nature of self-management for the
improvement of diabetic outcomes, participants in the study still desired a primary care provider
to be involved for both emotional and practical management of the disease (Mathew et al., 2012).
Statistical evidence was not provided to aide in the support of the study.
By interacting with the community and forming community-based diabetes education
programs, Lorig and associates (2009) found an increase in diabetes management. Lorig and
fellow researchers (2009) found in their study involving 345 adults, long-term follow-ups and
peer-based diabetes management programs helped improve depression (p=0.005), primary care
provider communication (p=0.001), self-efficacy (p=0.001), hemoglobin A1C (p<0.01), and
healthy lifestyles (p<0.01). Through their study, researchers demonstrated that education is key
to the successful management of diabetes with evidence that represented strong statistical
significance (Lorig et al., 2009). Education programs and primary care provider follow-up
appointments can help to improve outcomes, communication, and self-management skills that
are necessary to reduce morbidity and mortality of the disease.
In another research study, by Sperl-Hillen and associates (2013) examined the use of self-
management education that was split into three categories: individual, group, and usual care.
Education focused on topics like hemoglobin A1c trends, self-efficacy, improved dietary
choices, physical activity, and medication compliance (Sperl-Hillen et al., 2013). The study
involved 623 adults with type 2 diabetes in a self-management education program. Quarterly
follow-up surveys were used along with a one-year follow-up survey to assess the changes of the
self-management education participants (Spel-Hillen et al., 2013). Researchers concluded that
SELF-MANAGEMENT 12 education was necessary and helped to improve blood glucose control in the short term (p=0.03)
(Sperl-Hillen et al., 2013).
A different type of approach for T2D self-management was reported in an article by Lui
and colleagues (2012). The study examined the use of a group visit model that would be
conducted monthly for 12 months in a sample of 205 type 2 diabetics ages 35 to 80. Each month
the group, which consisted of 20 to 25 participants, discussed group self-management education,
group interaction, planning, and one-on-one provider meetings to address questions and concerns
that lasted about two hours (Lui et al., 2012). The study was focused on rural areas of the
country, where patients may not have received the necessary self-management and diabetes
education required to help manage their disease properly (Lui et al., 2012). Researchers
concluded that self-management group visit models were successful due to patients having an
increased self-efficacy, improved physical activity, and a decrease in blood pressure (Lui et al.,
2012). The intervention group significantly increased both their physical activity (p=0.001) and
increased their diabetes self-efficacy (p=0.02) (Lui et al, 2012).
In another group visit program, Dontje and associates (2011) examine the outcomes
related to self-management of diabetes in a group of 51 patients. The study involved hemoglobin
A1c criteria to determine the collaboration needed with primary care providers to provide group
visits (Dontje, 2011). The group visits took place at an academic health center where diabetes
patients would meet over a 32-month period visit that totaled 197 visits. The visits were
normally 90 to120 minutes and provided information from a health care provider and group
component (Dontje, 2011). Researchers concluded that providing group visits to diabetic
patients, resulted in an improvement in self-management skills (influenza improvement 5.5%,
pneumonia improvement 41.2% and smoking use improvement 6.0%), diabetes management
SELF-MANAGEMENT 13 (Blood pressure improvement 35.5%, LDL improvement 5.8%, eye exams 22.0%, microalbumin
29.2%, A1C -5.7%), and overall satisfaction (4.7/5), showing strong clinical significance for the
study (Dontje, 2011).
Khunti and associates (2012) examined self-management programs and education for 824
newly diagnosed adult patients with T2D. Two groups of participants were created: one group
received a structured education program that lasted six hours led by two health care
professionals, and the other group received standard care without a structured education program
(Kunti et al., 2012). Participants in both groups were followed for three years and assessed for
quality of life, blood pressure, lipid levels, hemoglobin A1C, emotional impact, and beliefs of
illness (Khunti et al., 2012). Researchers concluded that one six-hour class did make a
significant difference (p=0.001) from the group who did not have a class in improvement of
lifestyle choices (Khunti et al., 2012). The study may show a helpful link between continuing
education versus one time education. Increasing education and self-management skills can likely
help a patient, but it is important to have patient follow-ups and education refreshers to keep the
patient on track with diabetes and prediabetes management.
A patient’s willingness to accept diabetes is important when developing a self-
management plan. A patient must be aware of his/her blood sugar and the importance of regular
testing. A study by Polonsky (2013) emphasized the importance of regular glucose testing but
focused on why people who are self-monitoring their diabetes have such a difficult time adhering
to a treatment plan. The study consisted of 886 participants who had type 2 diabetes. Patients in
the study found that frequent blood glucose testing was pointless, so they would avoid
performing the self-management task (Polonsky, 2013). The conclusion was that patients need
to focus on the big picture and be active participants in the self-management of their diabetes
SELF-MANAGEMENT 14 rather than focusing on day-to-day behavioral issues related to testing (Polonsky, 2013). Three
major obstacle factors were identified: avoidance (b=-0.23 & p<0.001), pointlessness (b=-0.15
& p<0.001), burden, which was not associated with self-monitoring. (Polonsky, 2013).
Steinbekk and researchers (2012) performed a systematic review and meta-analysis of
research based on type 2 diabetes group education for directing self-management. Diabetes self-
management education can occur in many forms and finding the best way to improve outcomes
was a major objective for the researchers. Only 21 studies were found that included the criteria
being researched (Steinbekk, 2012). From data collected, researchers concluded that type 2
diabetes self-management best occurred with group-based learning, which resulted in
improvements in clinical (hemoglobin A1C p>0.00001, fasting blood glucose p<0.00001)
lifestyle and diabetes knowledge (p=0.03), and psychological outcomes (p=0.01) (Steinbekk,
2012).
Lorig and associates (2013) conducted a research study using 114 participants to examine
the effectiveness of providing generic chronic disease self-management education to people with
type 2 diabetes. The study was focused on English speaking adults with type 2 diabetes who
would be apart of Stanford University’s Chronic Disease Self-Management Program (Lorig et
al., 2013). The participants were required to submit baseline laboratory data and answer
questionnaires. Half of the participants had A1C’s between 6% and 6.9%, and the other half had
A1C’s greater than 7.0%. Stanford University’s program is quickly becoming a gold standard
for self-management of chronic disease (Lorig, 2013). The participants of the study who had a
A1C greater than 7% were able to lower their AlC’s within 6 months (p=0.013). The
participants with A1C’s less than 7 were able to maintain their baseline hemoglobin A1C’s
)p=0.720). Both groups also improved their self-management behaviors by improving quality of
SELF-MANAGEMENT 15 sleep, medication adherence, days of exercise, physician visits, emergency room visits, fatigue,
and days kept from usual activities when compared to baseline assessment. (Lorig, 2013). The
study was a positive indicator that education focused at a broad topic such as chronic diseases
can make a positive impact on patients with type 2 diabetes (Lorig, 2013).
Magee and associates (2011) examined how a community-based diabetes self-
management program could affect outcomes in a group of 360 African Americans with diabetes.
The goal of the project was to decrease hemoglobin A1cs, emergency department visits, and
improve adherence to medication plans (Magee, 2011). The study consisted of two 2.5-hour
classes that primarily focused on cardiovascular disease risk factors and how to improve
communication with a primary care provider (Magee, 2011). Overall, there was a major
improvement regarding diabetes knowledge: particularly hemoglobin A1c (p<0.001), blood
pressure (p<0.057), and cholesterol (p<0.77). The study also found that participants were more
likely (p<0.001) to keep their hemoglobin A1c <7% compared to those who do not take place in
diabetes self-management classes (Magee, 2011).
Tang and associates (2011) examined the preparations needed for people with type 2
diabetes to educate their peers properly. The study examined diabetes self-management and
support for the disease using nine African American adults with diabetes. The participants of the
study were given three attempts at a diabetes competency exam regarding diabetes knowledge,
empowerment-based facilitation, listening ability, and self-efficacy (Tang, 2011). After a 12-
week study, researchers concluded that it is possible and positive to have a peer-based diabetes
self-management program. The results concluded that after the 12-week course, all participants
were able to pass a diabetes competency test in fewer than three attempts. Participants found the
peer-based group to be beneficial (scale mean= 4.5/5.0, SD=0.75, p=0.05) (Tang, 2011).
SELF-MANAGEMENT 16
The literature reviewed mainly supports evidence that strongly suggested that education
and self-management programs might be successful in improving the lives of patients with
diabetes. For diabetes management, a specific clinical guideline was created by the ADA
(American Diabetes Association [ADA], 2013). By using the ADA guideline and current
evidence based literature reviews, patients with T2D can have improved management with the
help of their primary care provider and experience increase in their own self-efficacy and
management of the disease. In the next section the researcher describes the theoretical
framework to guide the self-management program and provides direction for this research study
Theoretical Framework
Orem’s Self-Care Deficit Theory (2001) has been used frequently to help create programs
to increase self-awareness, health promotion, disease management, and influence future nursing
education (Berbiglia, 2011; Horan, 2004; Orem & Taylor, 2003; Wilson et al., 2008). The
theory was formulated to improve the view of a person as a whole and as a unique individual
with needs to be meet. The theory utilized nursing knowledge to restore and maintain a person’s
health. The theory also focuses on basic human needs that are required for life. As an essential
part of the theory, it was necessary for the nurse to think about how to promote health, while still
meeting the basic needs such as food, oxygenation, and shelter (Orem & Taylor, 2003).
The Self-Care Deficit Theory has four major concepts: self-care, self-care agency, self-
care requisites, and therapeutic self-care demand (Orem & Taylor, 2003). The self-care deficit
theory is to be used with the primary outcome of improving a patient’s possible outcomes by
increasing their health, knowledge, and ability. The health care provider can predict the
outcomes by assessing the self-care deficits present at the beginning of a program, and as care
SELF-MANAGEMENT 17 continues, the provider can reassess to see if the patient(s) are still needing the same, less, or
more support and education compared to the baseline assessment.
The self-care deficit theory involves the four metaparadigms of nursing: nursing, patient
(person), health, and environment. Nursing is the activity and service that assists a patient to
meet self-care needs. The theory is based upon nursing art, prudence, service, and agency. It is
also an activity that promotes health. Patient (person) is the one receiving the self-care education
and health promotion. Based on the fact that people are unique, have needs, and may not be able
to meet his/her own needs is one of the major themes of the theory. Health, in Orem’s theory, is
the one receiving the care is attempting to restore health and eliminate self-care deficits.
Environment is based on the development and physical conditions a person is having any given
time (Orem & Taylor, 2003).
The self-care deficit theory works well with the development of a self-management
program, because it will focus on nursing systems with a central idea that a health care provider
is involved with a patient to help them obtain an optimal level of function. It can be further
broken down into three categories of nursing care support and level of self-care deficit. Self-
deficit contains three categories: life processes, development, and health deviation. When a
health care provider is evaluating and formulating a plan, the patient is placed into one of three
categories according to their ability and level of eagerness to perform self-care tasks, including
self-management tasks. The categories are: wholly compensatory, partly compensatory, and
supportive-educative. Wholly compensatory occurs when the nurse providing all self-care
activities for the patient. Partly compensatory occurs when the nurse and patient work together
to complete self-care needs. The patient can do some of the care independently, but the nurse
can help provide the care that the patient is unable to perform. Supportive-educative occurs
SELF-MANAGEMENT 18 when the nurse provides education and support for the patient as they perform self-care. The
patient is mostly independent, but needs education and reinforcement to complete care (Orem &
Taylor, 2003).
The theory was not meant to be linear. It is a dynamic theory that takes into account that
people are unique and always changing. Just as people change, health status can also change
quickly. By being dynamic, the theory has the ability to be used in multiple situations that may
help promote health, improve education, and be used in multiple disciplines.
Orem’s (2001) self-care deficit theory will be used to guide the development of the self-
management program that will be implemented by this researcher. The model serves as an
important theory that will help health care providers and the patient’s in the self-care
management clinic to improve their knowledge, behavior, ability, and self-ability to improve the
their health status, especially when dealing with type 2 diabetes. The health care provider will be
able to assess the level of self-care management and deficits that the patient may have in the
program. The provider can then use the theory to help guide the program and individuals to
improve the areas that are deficits. The provider’s goal will be for the patients to move through
the self-care deficit model by identifying deficits and, by the end of the three self-management
classes, detect if there is a difference in their health and self-management responsibilities.
The Self-Care Deficit Theory by Dorothea Orem (2001) provides a structural foundation
to help the researcher identify how ready the participants of the study are for change. Using
tools and responses, the researcher will be able to use the theory to also understand how much
assistance a participant may need to make progress using the self-management classes. The next
section will include the methodology as to how the research will be designed in terms of
SELF-MANAGEMENT 19 research, sampling, data collection, instrumentation, procedures, data analysis and protection of
subject rights.
Section III – Methodology
The purpose of this study is to explore the effect of a three-part self-management
program that will focus on healthy diets, increasing physical activity, medication management,
goals, motivation, and barriers to improving healthy lifestyles. Improvement of self-
management skills may produce long-term benefits for both patients and the health care industry
(Bartol, 2012; Jessee & Rutledge, 2012; Khunti et al., 2012). The researcher has chosen a quasi-
experimental design to explore the effect of the use of self-management in the control of type 2
diabetes.
Research Design
A pre-experimental design is used to examine a group of participants and explore the
outcomes of a variable used for the group. An independent variable will be introduced to the
group that makes it a pre-experimental design (Melnyk &Fineout-Overholt, 2011). The
researcher has chosen a pre-experimental design because the purpose of the study is to explore
the effects of a self-management program on patients with type 2 diabetes. Through pre-
experimental design, the researcher will collect data from a convenience sample of patients with
type 2 diabetes at an indigent care clinic in Savannah, Georgia. The research variables used in
this study include a three-part self-management program, hemoglobin A1C, blood pressure,
BMI, goals, medication management, physical activity, lipid levels, healthy diets, and self-
assessment of self-management skills.
SELF-MANAGEMENT 20 Sampling Design
The sampling design is a nonprobability convenience sampling design. Data will be
collected from a group of adults seen in an indigent care clinic in Savannah, Georgia. The adults
will be recruited from a list of patients with type 2 diabetes. All patients who have type 2
diabetes will be invited to participate, or until a maximum of 25 people agree to participate in the
study. The inclusion criteria are adults ages 18 to 55, diagnosis of type 2 diabetes, ability to
speak and write English at a minimum 4th grade level, no previous attendance at a self-
management program, and use the indigent care clinic. The use of a nonprobability convenience
sampling design was chosen for multiple reasons to help aid the researcher in obtaining
participants. According to Tappen (2011), nonprobability convenience sampling uses people
that area available to the researcher, aids in obtaining participants when the number of subjects is
limited, helps decrease nonresponse, aids in accessibility, and helps when there are limitations on
resources. Due to the limitations on resources, available subjects, and availability, a
nonprobability convenience sampling design would work best.
Protection of Subject Rights
The protection of subject rights will begin by obtaining permission to conduct the study
from South University Institutional Review Board (IRB) and from management at the indigent
care clinic. The indigent care clinic is managed by a hospital system; thus, permission will also
be obtained from the IRB at that health system.
All potential participants will receive a consent form that will describe the purpose of the
study along with the risks and benefits from participating in the study. Each potential participant
will be informed that participation in the study is completely voluntary with a withdrawal option.
Participants of the study will be informed that only the researcher and the researcher’s professor
SELF-MANAGEMENT 21 will have access to any information regarding their identity and participation within the study.
All data will be confidential and anonymous.
The participants of the study will complete a demographic questionnaire, which will then
be coded to protect patient identity. Any and all questionnaire responses and clinical data will be
coded to protect identity as well. The participants will also be informed that while individual
data is collected only group data will be reported. The participants will also know that all results
will be made available to them, including the final results of the study. The consent forms will be
stored in a locked file, and a photocopy of the form will also be in all patient files at the clinic.
See Appendix A for a copy of the tool for participation rights.
Data Collection
The following sections will summarize the instrumentation and procedures necessary to
perform the study to identify the effects of three self-management classes for patients with type 2
diabetes. The section will describe the mechanics of the study and the essential tools necessary to
complete the study.
Instrumentation
The researcher hypothesizes that a self-management program will have a positive effect
on people with type 2 diabetes. The positive effect is to include improved diet, physical activity,
BMI, Hemoglobin A1c, lipid test, blood pressure, goals, and motivation. The researcher will use
eight tools to collect the data. The first tool used for the study will be a demographic survey.
The demographic survey will be used to identify age, gender, ethnicity/race, household size, and
education level. See Appendix B for a copy of the tool.
The next set of tools will be used as baseline data before the first self-management class.
The physical and clinical data consists of four tools: BMI, hemoglobin A1c, lipid panel, blood
SELF-MANAGEMENT 22 pressure. The participants will then provide a four-day list of all things eaten in their diet and all
physical activity. The pre-class data will help provide a baseline of typical diet and physical
activity for each participant. Normal ranges will be used to compare to the patients. After the
self-management classes are completed, patients will have their clinic data obtained at specific
intervals to assess the effects of the self-management classes to their health. The clinical data
obtained by the participants will be compared against the national clinical standard data obtained
from the specialties for each data point: American Diabetes Association, National Heart, Lung,
and Blood Institute, and Centers For Disease Control. See Appendix C for a copy of the ranges
and tool format.
Pre-and post knowledge will be assessed using the University of Michigan’s Diabetes
Research Training Center’s Diabetes Knowledge And Empowerment Test Scale Short Form will
be used to obtain a baseline analysis of diabetes knowledge and willingness to making changes
in lives (Jessee & Rutledge, 2012). Permission will be obtained from the University of Michigan
in order to use the tool. The tool is broken into two parts: part one being the knowledge
assessment and part two being the empowerment sections. The Knowledge Test uses 20 diabetes
questions with possible answers being true, false, or do not know. The Empowerment Test
contains eight questions with answers being scored on a Likert Scale (1-strongly disagree to 5-
strongly agree). See Appendix E for a copy of the tools.
The Diabetes Knowledge and Empowerment Test Short Form assesses general diabetes
knowledge and empowerment and will provide a baseline of pre-class knowledge and can be
compared to post-class knowledge after the self-management classes finish. Using both the pre
and post class test data can compare the number of questions answered incorrectly. The test is
administered on a sheet of paper and the participants are asked to circle the correct answer. The
SELF-MANAGEMENT 23 empowerment test will be scored using the Likert scale. The University of Michigan concluded
that the test was reliable and valid for diabetes knowledge assessment and diabetes related
psychosocial self-efficacy alpha=0.94 (University of Michigan, 2013).
The behavior change 5-step goal-setting process evaluation tool (Tang et al., 2011) will
be administered to all patients to identify baseline goals and motivation towards diabetes self-
management. The assessment tool will also be administered to the patients at the end of the self-
management clinics to identify possible goal and motivational changes. The tool consists of five
steps regarding motivation and goals. Within the five steps of the tool, there are a total of 25
questions for the patient to answer regarding their views of their personal health. The tool does
not contain any reliability of validity testing, but does create individual results that can and will
be compared when assessing final data. Permission to use the tool will be obtained prior to the
start of the study. See Appendix E for a copy of the tool.
The final tool will be a Patient Satisfaction Survey (Dontje & Forrest, 2011) will be
administer to the patients at the conclusion of the self-management courses to examine the
patients views of the classes and evaluate if the class satisfaction impacts the self-management of
diabetes. Patient Satisfaction Survey asks multiple questions regarding the effectiveness and
satisfaction of a group visit for education regarding self-management of diabetes.
The tool begins with five questions that are on a Likert scale (1-poor to 5, excellent). The
sections then continue to promote the education classes to friends and family, what was a good
point to the patient, and what the patient did not like about the experience (Dontje & Forrest,
2011). The validity and reliability of the tool has not been tested. The purpose of the satisfaction
survey is to discover if there is a link between the patients satisfaction with the classes and
SELF-MANAGEMENT 24 changes in their clinical data like: BMI, Hemoglobin A1c, blood pressure, and lipid levels. See
Appendix F for a copy of the tool.
Procedures
Prior to the study beginning, permission will be obtained from South University, the IRB
of the Health Care Agency who manages the clinic, and the clinic itself. Upon entrance into the
study, all participants will receive written information regarding the study and consent will be
obtained. After receiving permission the participants of the study will have baseline data
collected to include: blood pressure, BMI, hemoglobin A1c, and a lipid panel as defined in the
definition of terms section.
Once baseline data has been obtained the participants of the study will fill out the
demographic form then continue on to fill out the pre-class assessment regarding diabetes
knowledge, empowerment, and willingness. The tools will all be provided to the participants and
the data will remain with only the researcher and the researcher’s professor. The forms and
assessments will be filled out at the indigent care clinic at the beginning of the first self-
management class.
The classes will begin once all baseline data has been collected. The classes will take
place over a three-week period, with each class meeting for 2 hours. The classes will contain the
information regarding healthy diets, medication management, psychosocial improvement
information, and physical activity, and lastly a time period for patients to ask questions in a one-
on-one setting. The classes will be led by Nurse Practitioner students from South University.
The healthy diets class will consist of diet education regarding the five food groups:
dairy, meats, fruits, vegetables, and grains. The class will provide an overview of what a healthy
plate should look like, healthy snack options, what to eat when one has diabetes, ways to make
SELF-MANAGEMENT 25 cooking at home more convenient and less expensive, and alternatives to fats and sweets. The
participants will be asked to record their food intake (all drinks, breakfast, lunch, dinners, and
snacks) for one week and bring the data to the third class.
The medication management portion of the classes will discuss how to take the
medications prescribed to the patients, the importance of taking the medication as prescribed, a
basic understanding of why medications are prescribed for them, and then conclude with a one-
on-one time with patients to answer questions regarding medications.
The psychosocial improvement portion of the classes will focus on group training and
answering questions about motivation, barriers, and goals. The class will specifically focus on
diabetes and why it is important to be proactive in the battle of the disease. Participants will
interact with the class leader by answering questions and understanding individual barriers to
obtaining a healthy lifestyle.
The physical activity class will discuss ways to increase physical activity both at a fitness
facility and at home. The goal is to create and awareness that physical activity can take place
anywhere, even while watching TV at home. The main topics will be to increase walking
distances daily, increase heart rate for 20 minutes three to five times per week, and the benefits
of increasing physical activity.
The third and final class will be a general overview of the previous classes. The
participants will be able to ask questions, meet one-on-one with class instructors, review the
dietary one-week log with instructors, and time to identify any weaknesses or barriers.
At the conclusion of the third self-management class the Diabetes Knowledge and
Empowerment tool will be administered again and the participants will also be given the patient
SELF-MANAGEMENT 26 satisfaction survey. All data will be complied and used to draw a conclusion in the projected data
analysis section.
The participants of the study will have follow up appointments at the clinic at specific
intervals when the classes have been completed. The time line for follow up appointments is: 1
month, 3 months, 6 months, 9 months, and 12 months. At all of the follow up appointments,
clinicians at the clinic will obtain participants BMI, weight, and blood pressure. At months
three, six, nine, and twelve the patients will have laboratory data collected to identify
hemoglobin A1c levels. At month twelve, the patients will also have a lipid level test performed.
After the conclusion of the twelve months study, participants will be thanked and
informed that any data obtained will be made available to them by request.
Projected Data Analysis
The data analysis will involve the use of MiniTab16 statistical software package. All
survey and demographic data will be summarized using descriptive statistics, frequency
distributions and summary statistics. The MiniTab16 software will also be used to calculate
multiple statistical values to help draw conclusions, relationships, and significance for the data.
The goal is to examine the significance of a three-part self-management class on patients
at an indigent care clinic in Savannah, GA who have type 2 diabetes. The hypothesis is that the
three-part self-management classes will create a positive impact on the patient in terms of
decreasing BMI, blood pressure, lipid levels, and hemoglobin A1C. The hypothesis continues by
increasing self-care and self-efficacy of type 2 diabetes and increasing knowledge and
empowerment.
SELF-MANAGEMENT 27
The statistical and clinical significance will be set at p>0.005. The demographic data will
be reported at the nominal level and will be reported with the descriptive statistic of mode
(Melnyk &Fineout-Overholt, 2011).
Descriptive Statistics
The descriptive statistics for the study will examine quantitative data to explore the
distribution of values and describe the sample (Tappen, 2011). The descriptive statistics should
help draw a conclusion to answer the research question as to what the effects are of three-part
self-management clinic for patients with type 2 diabetes.
Patient data will be compared using baseline data then 1 month, 3 month, 6 month, 9
month, and 1-year comparisons to evaluate hemoglobin A1c, blood pressure, lipid levels, and
BMI changes. The hemoglobin A1c, blood pressures, lipid levels, and BMI data will be
quantitative data that will be reported as measures of central tendency: mean, median, and mode.
The data will also be reported using dispersion and reported as a range. See Table 1.
Inferential Statistics
A conclusion of the tests performed for the study will be mean, median, range, simple
linear regression, and chi square analysis, all with the goal of creating clinical and statistical
significance of p>0.005. The study statistics will analyze both the difference and association of
type 2 diabetic patients participating in a three-part self-management program.
The clinical data (hemoglobin A1c, BMI, blood pressure, and lipid levels) will be
analyzed by comparing pre and post class data. The comparison will involve examining the
differences between pre class data and post class data and the effects the classes created for the
participants. The data will be analyzed using simple t test, which will show a difference between
SELF-MANAGEMENT 28 the two sets of data for each category (Tippen, 2011). The level of significance will be set at
p=0.005.
Table 1. Statistical Information
Variable Level of Measure Statistics Gender Nominal Frequency and Percentage
(%) Age Interval Mean, Median, Range
Years of Education Interval Mean, Median, Range Body Mass Index (BMI) Interval Mean, Median, Range,
Simple Linear Regression Analysis, Chi Square
Analysis Blood Pressure Interval Mean, Median, Range,
Simple Linear Regression Analysis, Chi Square
Analysis Lipid Levels Interval Mean, Median, Range,
Simple Linear Regression Analysis, Chi Square
Analysis Weight (in kg) Interval Mean, Median, Range,
Simple Linear Regression Analysis, Chi Square
Analysis Hemoglobin A1c Interval Mean, Median, Range,
Simple Linear Regression Analysis, Chi Square
Analysis Knowledge Interval Mean, Median, Range Satisfaction Interval Mean, Median, Range
The data will also be compared in an associations test to evaluate if there is an association
between having a self-management class by evaluating pre and post class data. Using the equal-
interval level of data a Pearson’s Product Moment Correlation Coefficient analysis will be
performed. Data will also be used in the nominal level of measure to perform a Chi Square
Analysis and have a p value of 0.005.
SELF-MANAGEMENT 29
Qualitative data will be obtained from patient satisfaction surveys. The data obtained will
be reported as descriptive statistics and will be reported using dispersion and reported as a range.
The patient satisfaction tool is scored using a Likert scale (1-poor to 5-excellent). The p value
will be set at 0.05 to determine statistical significance (Melnyk & Fineout-Overholt, 2011).
Overview
The projected statistical analysis section will review all data that was obtained by the
researcher. It will include the demographics, pre-class diabetes knowledge and empowerment
results, goals, initial clinical laboratory data (BMI, weight, blood pressure, hemoglobin A1c, and
lipid levels), post-class diabetes knowledge and empowerment results, and the follow-up one
month, three month, six month, nine month, and twelve month clinical laboratory data. The use
of t-test, Chi Square Analysis and Simple Linear Regression Analysis will help the researcher
draw conclusions about the relationship of three self-management classes on patients with type 2
diabetes.
SELF-MANAGEMENT 30
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SELF-MANAGEMENT 35
APPENDIX A Consent Paperwork
Consent to Participate in a Research Study
Introduction: A research study is being conducted to fulfill requirements for a Masters of Science in Nursing Degree. You are invited to participate in this study that examines the effects of a self-management class for those with Type 2 Diabetes. Purpose and Procedures: This study is intended to study the effect of if a post-orientation mentorship program on retention rates of new graduate nurses. If you agree to take part in this research program, you will be asked to participate in a self-management program that will involve three class, that will also involve follow up phone calls for one year at months 1, 3, 6, 9, and 12. At the end of the yearlong study there will be a follow-up questionnaire that will take no more than fifteen minutes to complete. Risks and Benefits: There are no risks associated with participation in this research study. You will not receive any direct benefits from participating in this study, however, your participation may help researchers better understand how self-management classes can improve the overall health of a patient with Type 2 Diabetes. Voluntariness: Your participation in this research study is voluntary. You may refuse to participate, discontinue participation, or skip any questions you do not wish to answer at anytime without penalty or loss of benefits to which you are otherwise entitled. Your decision will not affect your ability to use the clinic. Confidentiality: Only the researcher and the researcher’s professor will have access to research data associated with your identity. In the event of publication of this research, no personally identifying information will be disclosed. Results will be reported as group data. The information collected during this study will not be used for any future purposes and will be kept under lock and key in a safe deposit box accessible only to the researcher. Who to Contact with Questions: Questions about this research study should be directed to the researcher involved in this study, Daniel Tomlinson. He can be reached at 248-866-9343. You will receive a copy of this consent form. I certify that I have read this form and volunteer to participate in this research study. ___________________________ Print Name ___________________________ __________________________ Signature Date
SELF-MANAGEMENT 36
Appendix B Demographic Survey
Demographic Characteristics (Please answer one response per question) 1. Gender a. Male b. Female 2.Age (in years) _______ 3.Marital Status a. Never Married b. Married c. Divorced/Widowed 4.Race/Ethnicity a. White (non-Hispanic) b. Black or African American c. Asian/Pacific Islander d. Hispanic/Latino e. Other 5.Current Employment Status a. Full Time (40 hours per week) b. Part Time (16-39 hours per week) c. Not Working 6. How many people are in your household a. 1 b. 2 c. 3 d. 4 e. 5 f. 6 or more 7. Number of years of education?________ 8. What city and county do you live in? _______ 9.. At what age were you diagnosed with Type 2 Diabetes? _______
SELF-MANAGEMENT 37
Appendix C Clinical Normal
*National Heart, Lung, and Blood Institute
HbA1c eAG (estimated average glucose) (%) (mmol/mol)[25] (mmol/L) (mg/dL) 5 31 5.4 (4.2–6.7) 97 (76–120)
6 42 7.0 (5.5–8.5) 126 (100–152) 7 53 8.6 (6.8–10.3) 154 (123–185) 8 64 10.2 (8.1–12.1) 183 (147–217) 9 75 11.8 (9.4–13.9) 212 (170–249)
10 86 13.4 (10.7–15.7) 240 (193–282) 11 97 14.9 (12.0–17.5) 269 (217–314) 12 108 16.5 (13.3–19.3) 298 (240–347) 13 119 18.1 (15–21) 326 (260–380)
14 130 19.7 (16–23) 355 (290–410) 15 140 21.3 (17–25) 384 (310–440) 16 151 22.9 (19–26) 413 (330–480) 17 162 24.5 (20–28) 441 (460–510)
18 173 26.1 (21–30) 470 (380–540) 19 184 27.7 (23–32) 499 (410–570) *American Diabetes Association
Blood Pressure Category
Systolic mm Hg (upper #)
Diastolic mm Hg (lower #)
Normal
less than 120 and less than 80
Prehypertension 120 – 139 or 80 – 89
High Blood Pressure (Hypertension) Stage 1 140 – 159 or 90 – 99
High Blood Pressure (Hypertension) Stage 2 160 or higher or 100 or higher
Hypertensive Crisis (Emergency care needed) Higher than 180 or Higher than 110
SELF-MANAGEMENT 38
Appendix C Continued
Total cholesterol
(U.S. and some other countries)
Total cholesterol*
(Canada and most of Europe)
Below 200 mg/dL Below 5.2 mmol/L Desirable
200-239 mg/dL 5.2-6.2 mmol/L Borderline high
240 mg/dL and above Above 6.2 mmol/L High
LDL cholesterol
(U.S. and some other countries)
LDL cholesterol*
(Canada and most of Europe)
Below 70 mg/dL Below 1.8 mmol/L Ideal for people at very high risk of heart disease
Below 100 mg/dL Below 2.6 mmol/L Ideal for people at risk of heart disease
100-129 mg/dL 2.6-3.3 mmol/L Near ideal
130-159 mg/dL 3.4-4.1 mmol/L Borderline high
160-189 mg/dL 4.1-4.9 mmol/L High
190 mg/dL and above Above 4.9 mmol/L Very high
HDL cholesterol
(U.S. and some other countries)
HDL cholesterol*
(Canada and most of Europe)
Below 40 mg/dL (men)
Below 50 mg/dL (women)
Below 1 mmol/L (men)
Below 1.3 mmol/L (women)
Poor
40-49 mg/dL (men)
50-59 mg/dL (women)
1-1.3 mmol/L (men)
1.3-1.5 mmol/L (women)
Better
60 mg/dL and above 1.6 mmol/L and above Best
SELF-MANAGEMENT 39
Triglycerides
(U.S. and some other countries)
Triglycerides*
(Canada and most of Europe)
Below 150 mg/dL Below 1.7 mmol/L Desirable
150-199 mg/dL 1.7-2.2 mmol/L Borderline high
200-499 mg/dL 2.3-5.6 mmol/L High
500 mg/dL and above Above 5.6 mmol/L and above Very high
*Mayo Clinic
*American Diabetes Association
SELF-MANAGEMENT 40
Appendix D Diabetes Knowledge and Empowerment Pre and Post Survey
SELF-MANAGEMENT 41
SELF-MANAGEMENT 42
Diabetes Empowerment Scale-Short Form (DES-SF) The 8 items below constitute the DES-SF. The scale is scored by averaging the scores of all completed items (Strongly Disagree =1, Strongly Agree = 5)
Check the box that gives the best answer for you. In general, I believe that I: 1. ...know what part(s) of
taking care of my diabetes that I am dissatisfied with.
1 Strongly Disagree
2 Somewhat Disagree
3 Neutral
4 Somewhat
Agree
5 Strongly Agree
2. …am able to turn my
diabetes goals into a workable plan.
1 Strongly Disagree
2 Somewhat Disagree
3 Neutral
4 Somewhat
Agree
5 Strongly Agree
3. ...can try out different ways of overcoming barriers to my diabetes goals.
1 Strongly Disagree
2 Somewhat Disagree
3 Neutral
4 Somewhat
Agree
5 Strongly Agree
4. ...can find ways to feel better about having diabetes.
1 Strongly Disagree
2 Somewhat Disagree
3 Neutral
4 Somewhat
Agree
5 Strongly Agree
5. ...know the positive ways I cope with diabetes-related stress.
1 Strongly Disagree
2 Somewhat Disagree
3 Neutral
4 Somewhat
Agree
5 Strongly Agree
6. ...can ask for support for having and caring for my diabetes when I need it.
1 Strongly Disagree
2 Somewhat Disagree
3 Neutral
4 Somewhat
Agree
5 Strongly Agree
7. ...know what helps me stay motivated to care for my diabetes.
1 Strongly Disagree
2 Somewhat Disagree
3 Neutral
4 Somewhat
Agree
5 Strongly Agree
8. ...know enough about myself as a person to make diabetes care choices that are right for me.
1 Strongly Disagree
2 Somewhat Disagree
3 Neutral
4 Somewhat
Agree
5 Strongly Agree
SELF-MANAGEMENT 43
Appendix E Motivation Survey
5-Step behavioral goal-setting process.
Step one: define the problem? • What is the hardest thing about caring for diabetes for you? • Please tell me more about that. • Are there some specific examples you can give me?
Step two: recognize your feelings. • What are your thoughts about this? • Are you feeling (insert feeling) because (insert meaning)?
Step three: choose a goal. • What do you want? • How would this situation have to change for you to feel better about it? • Where would you like to be regarding this situation in (specific time: 1 month, 3 months,
1 year)? • What are your options? • What are barriers for you? • Who could help you? • What are the costs and benefits for each of your choices? • What would happen if you do not do anything about it? • Let’s develop a plan!
Step four: make a plan (I-SMART plan) to reach your goal. • Are you willing to do what you need to do to solve this problem? • How important is it to you on a scale of 1-10? • How confident are you that you will be able to reach this foal on a scale of 1-10? • What are some steps you could take to help you to reach this goal? • What are you going to do? • When are you going to do it?
Step five: experience and evaluate the plan • How did it go? • What did you learn? • What barriers did you encounter? • What, if anything, would you do differently next time? • What will you do when you leave here today?
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Appendix F Patient Satisfaction Survey
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Appendix G
IRB Application
INSTITUTIONAL REVIEW BOARD
FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH
APPLICATION FORM TO REQUEST A REVIEW OF A RESEARCH
PROTOCOL INVOLVING HUMAN SUBJECTS
This form is to be used for requesting IRB review for exempt, expedited and full board studies
Please note that handwritten and/or incomplete forms will be returned to you.
CHECKLIST FOR IRB APPLICATION SUBMISSION (to be completed by PI before submission to IRB)
Application Form with Signatures NIH Training Certificate(s) Protocol Research Proposal and/or Contract or Grant Solicitation Announcements/Recruitment Flyers Data Collection Instruments/Research Questions/Questionnaires/Surveys Informed Consent Documents
Parental/Legal Guardian Permission Form (if applicable) Child Assent Form (if applicable)
Approval from Study Sites (if applicable) Medical Screening Instrument (if applicable) Debriefing Plan Appendix A: Student as Principal Investigator Worksheet (if applicable)
For Official Use Only
Date received: Date reviewed: End date: File #:
SELF-MANAGEMENT 46 Submit one electronic copy of all the required documents to: Institutional Review Board Chair South University 709 Mall Blvd. Savannah, Georgia 31406 Email: IRB@southuniversity.edu Project Title
Type 2 Diabetes Self-Management
PART I - INVESTIGATOR and RESEARCH PERSONNEL
1) PRINCIPAL INVESTIGATOR (Undergraduate students cannot serve as Principal Investigator, but may be listed as a Co-Investigator.)
Name: Daniel P Tomlinson Dr. Mr. Ms. Professor
Highest Degree Completed: BSN Investigator Status: Faculty x Graduate Student Staff
E-mail Address: Dptomlin48@gmail.com College/Department: Nursing
Campus Mailing Address: 709 Mall Blvd. Savannah, GA Daytime Phone: 2488669343
2) CO-INVESTIGATOR – 1 (if applicable)
Name: Dr. Mr. Ms. Professor
Highest Degree Completed: Investigator Status:
Faculty Graduate Student
Other Undergraduate Staff
E-mail Address: College/Department:
Campus Mailing Address: Daytime Phone:
SELF-MANAGEMENT 47
3) CO-INVESTIGATOR – 2 (if applicable)
Name: Dr. Mr. Ms. Professor
Highest Degree Completed: Investigator Status:
Faculty Graduate Student
Other Undergraduate Staff
E-mail Address: College/Department:
Campus Mailing Address: Daytime Phone:
4) FACULTY SPONSOR (if applicable)
Name: Dr. Mr. Ms. Professor
Highest Degree Completed: E-mail Address:
College/Department: Campus Mailing Address:
Daytime Phone: 5) STUDENT INVESTIGATORS/RESEARCH ASSISTANTS (if applicable)
Name: E-mail: Phone: Name: E-mail: Phone: Name: E-mail: Phone: Name: E-mail: Phone: Name: E-mail: Phone:
PART II – FUNDING INFORMATION
1) Check all of the appropriate boxes for funding sources for this research. Include pending funding source(s).
Extramural College Department
Other: P.I. of Grant or Contract:
Sponsor: Contract/Grant No.
(if available):
Contract/Grant Title:
SELF-MANAGEMENT 48 Please provide one complete copy of the proposal submitted to the sponsor with this application. Please note that submission of your grant application is a regulatory requirement and will be maintained for the record with your application. The IRB will not utilize the grant during the review process other than to confirm that the grant proposal is consistent with the IRB proposal. You must submit all necessary documentation for the application in addition to the copy of the grant.
PART III – EDUCATION AND TRAINING All research personnel (faculty, staff, graduate students working on a thesis or dissertation, anyone using data for purposes of independent research, students involved in data collection, faculty sponsors, persons receiving grant monies for human subject research or those personnel with management responsibilities) must complete this section. 1) Have all key research personnel completed the required NIH training? No Yes x
If No, DO NOT submit this application. Your application will not be considered until you have completed the IRB training and can provide a copy of your NIH course completion certificate. (Please include a copy/copies of all certificate(s) with this application.) • You must attach your most recent NIH course completion certificate to each application submitted. Please note that this NIH training is a mandatory requirement to be completed every three years. 2) If other necessary training/education is required for completion of this study, please attach copies of certificates or other documentation (e.g., HIPAA training, phlebotomy training). PART IV – PRINCIPAL INVESTIGATOR ASSURANCE • I certify that the information provided in this application is complete and correct. • I understand that as Principal Investigator, I have the responsibility for the conduct of the study, the
ethical performance of the project and the protection of the rights and welfare of human participants.
• I agree to comply and to assure that all affiliated personnel comply with all South University IRB policies and procedures, as well as with all applicable federal, state and local laws regarding the protection of human participants in research.
• I agree that I have the appropriate expertise to conduct this study. • I assure that this study is performed by qualified personnel adhering to the South University IRB
approved protocol. Student PI’s must attach student PI worksheet (see appendix A). • I assure that no modification to the approved protocol and consent materials will be made without
first submitting for review and approval by the South University IRB an amendment to the approved protocol.
• I agree to obtain legally effective informed consent from the research participants as applicable to this research and as prescribed in the approved protocol.
• I will promptly report unanticipated problems to the South University IRB by using the Notification Form provided on the IRB website.
• I will adhere to all requirements for continuing review and will complete a Continuance Request form if my research extends beyond one year.
• I will advise the South University IRB of any change of address or contact information as long as this protocol remains active.
SELF-MANAGEMENT 49 • I assure that I have obtained all necessary approvals from entities other than South University IRB
that are necessary to conduct this research (e.g., cooperation letters or approvals from other institutions).
My signature below certifies that I am knowledgeable about the regulations and policies governing research with human subjects and have sufficient training and experience to conduct this particular study in accordance with the research protocol. Daniel Tomlinson
Principal Investigator
12/17/2013
Date (mm/dd/yyyy) Co-Investigator
Date (mm/dd/yyyy)
Faculty Sponsor
Date (mm/dd/yyyy)
PART V – ADMINISTRATIVE DATA 1) Proposed duration of data collection/analysis:Start date: December 2013End date: December 2014 South University IRB insists that the project approval is granted for a duration of not more than one year. Should the PIs need an extension beyond the proposed duration, they can apply by completing the Continuance Request Form. 2) If this research will result in a thesis or dissertation, please check the appropriate box. Undergraduate Level Project x Masters Level Project Doctoral Level Project
(Thesis, Capstone) (Thesis, Capstone) (Dissertation, Capstone) 3) Study population:
Age Range: 18 to 55 (include low/high age range) Gender: x Males x Females
Site of Subject Recruitment: Good Samaritan Clinic Inclusion Criteria: Type 2 Diabetes, Use Good Samaritan Clinic, Never attended self-
management classes before.
Will medical clearance or medical screening be necessary for participants to participate because of tissue or blood sampling, administration of substances such as food or drugs, or physical exercise conditioning? No Yesx If yes, explain how clearance will be obtained. If a screening instrument will be used, please attach a copy to the application.
Exclusion Criteria:
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Maximum Number of Participants Proposed: 25 4) Study Site:
Good Samaritan Clinic, Savannah, GA
5) Potentially Vulnerable Populations:
Please check any groups included in the study.
Children (under 18 years of age) Pregnant Women Elderly (65 & older) Psychologically Impaired
Cognitively Impaired Prisoners Native American Tribes and/or Tribal
Organizations Students enrolled in a class in which the
instructor is the investigator If you checked any of the above groups, your proposal will require full board review. 7) Conflict of Interest: Disclose all possible conflicts of interest. Is there any potential or perceived conflict of interest between the researcher, sponsor and/or South University associated with this study? Nox Yes
If yes, please explain: PART VI – SUMMARY OF STUDY ACTIVITIES Submission of a copy of a grant application or project proposal does not replace completion of this form. Please respond to each item. Incomplete forms will be returned to you.
1) Provide background information for the study including the objective of the proposed research, purpose, research question, hypothesis and other information deemed relevant.
2) Describe the research design of the study (i.e., state whether the study is correlational, experimental, etc. and define the variables).
SELF-MANAGEMENT 51
3) Describe the tasks that participants will be asked to perform including a step-by-step description of the procedures you plan to use with your subjects. Provide the approximate duration of subject participation for each procedure. If data collection instruments are to be used, indicate the time necessary to complete them, the frequency of administration, and the setting in which they will be administered, such as telephone, mail, or face-to-face interview. (You must submit a copy of each study instrument, including all questionnaires, surveys, protocols for interviews, etc.)
4) Describe the recruitment procedures. Attach a copy of any material used to recruit subjects (e.g., informed consent forms, advertisement, flyers, telephone scripts, verbal recruitment scripts, cover letters, etc.) Explain who will approach potential participants and take part in the research study and what will be done to protect the individual’s privacy in this process. Be sure to outline your data collection process, including how you will access participants. If someone will assist you with the data collection process (such as a university administrator), identify who will assist with the collection of the data and provide a letter of support from those individuals who will assist with the data collection process.
PART VII – PRIVACY PROCEDURES 1) Will data be recorded by audiotape? No x Yes
Will data be recorded by videotape? No x Yes Will photographs be taken? No x Yes Please explain how the disposition of the tapes/photographs/negatives will be handled. Indicate if the tapes/photographs/negatives will be erased or destroyed after transcription/development at the conclusion of the study. If you wish to retain the tapes/photographs/negatives beyond transcription/development, you must provide justification. Subjects must be informed of the collection and disposition of the tapes/photographs/negatives via the informed consent process.
2) Please clarify how subjects will be identified in audio or videotaped responses.
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3) Will you record any direct identifiers (e.g.,, names, social security numbers, addresses, telephone numbers, etc)? Nox Yes If yes, explain why it is necessary to record findings using these identifiers. Describe the coding system you will use to protect against disclosure of these identifiers. Describe how subject identifiers will be maintained or destroyed after the study is completed.
4) Will you retain a link between the study code numbers and direct identifiers after the data collection is complete? No Yes x
If yes, explain why this is necessary and state how long you will keep this link.
5) Will you provide a link or identifier to anyone outside the research team? No x Yes
If yes, explain why and to whom.
6) Where, how long, and in what format (such as paper, digital or electronic media, video, audio or photographic) will data be kept? In addition, describe what security provisions will be taken to protect these data (password protection, encryption, etc).
7) Will you place a copy of the consent form or other research study information in the participant’s
record such as medical, personal or educational record? (This information should be clearly explained in the consent document and/or process) No Yes
If yes, explain why this is necessary.
8) Will you obtain a Federal Certificate of Confidentiality for this research? No Yes If yes, submit documentation of application (and a copy of the Certificate of Confidentiality award if granted) with this application form. If the data collected contain information about illegal behavior, visit the NIH Certificates of Confidentiality Kiosk http://grants1.nih.gov/grants/policy/coc for information about obtaining a Federal Certificate of Confidentiality.
PART VIII – INFORMED CONSENT INFORMATION
1) Informed Consent: Please attach, as an appendix, an informed consent document to this
application. South University IRB requires that all activity involving human subjects be carried out only AFTER obtaining proper consent from the participants of the research. Thus an information sheet or cover letter that contains all required elements of informed consent must be attached to this application. You may access a template for this form on the South University IRB website. (Please attach an assent form for children/youth participation and permission forms for parents/legal guardians; or consent forms for adult participation).
2) Request for Waiver of Informed Consent: Provide a written justification for a waiver of informed
consent according to Section 46.116 of 45 CFR 46 (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116). Are you requesting a waiver of informed consent?
SELF-MANAGEMENT 53
No Yes
If yes, please explain.
3) Request for Waiver of Documentation of Consent (applies to studies that do not wish to have signatures of the participants, i.e. internet research): Are you requesting a waiver of documentation of consent?
No Yes
4) If yes, provide a written justification for a waiver of documentation of consent according to Section 46.117 of 45 CFR 46 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.117.
PART IX – RISKS AND BENEFITS
1) Does the research involve any of the possible risks or harms to subjects listed below? No Yes If Yes, independent scientific review may be required to determine if scientific merit justifies this risk.
Check all that apply:
Use of deception* *If deception is used, please describe in detail here. Also, describe the debriefing process and include the debriefing script. In addition, the principal investigator should offer the participant the opportunity to withdraw his/her data after finding out that deception was used in the study. Please include this information in the debriefing script submitted to the IRB. The debriefing script needs to be submitted with the application form irrespective of whether deception is used or not.
Use of confidential records (e.g. educational or medical records) Manipulation of psychological or social variables such as sensory deprivation, social isolation, psychological stressors
Presentation of materials which subjects might consider sensitive, offensive, threatening or degrading
Possible invasion of privacy of subject or family Social, legal, or economic risk Employment/occupational risk Students of the researcher Subordinates and colleagues of the researcher Residents of any facility (i.e., prison) Pregnant women Children and minors Elderly subjects (65+ years of age) Wards of the state Mentally and emotionally disability
SELF-MANAGEMENT 54
Individuals who are not fluent in English Other risks (specify):
Will any record of the subject’s participation in this study be made available to his or her supervisor, teacher, or employer? No Yes
If yes, please explain.
2) Describe the nature and degree of the risk or harm checked above. The described risks/harms must be disclosed in the consent form.
3) Explain what steps will be taken to minimize risks or harms and to protect subjects’ welfare. If the research include protected populations (See Part V, Item 5 above), please identify each group and answer this question for each group.
4) Describe the anticipated benefits of this research for individual participants in each subject group. If none, state “none”.
5) Describe the anticipated benefits of this research for society, and explain how the benefits outweigh the risks.
PART X – COMPENSATION INFORMATION
1) Will any compensation or inducements, i.e. course credit, be offered to the subjects for their
participation? No Yes
If yes, describe those inducements and include a statement in the informed consent document explaining how compensation will be handled in the event the participant withdraws from the study.
SELF-MANAGEMENT 55 APPENDIX A: Student as Principal Investigator Worksheet
Level: Masters Doctorate This project has been reviewed to determine that the scope, anticipated risks and benefits, and methodology are appropriate for this research by:
Approval of thesis/dissertation proposal by faculty committee My personal review and approval of research proposal Other:
The student researcher is qualified to conduct independent research based on the following credentials (check all that apply):
has completed a graduate research methods course has experience as an independent or closely supervised research assistant has completed NIH training Other:
FACULTY SPONSOR’S ASSURANCE
By my signature as sponsor on this research application, I certify that the student is knowledgeable about the regulations and policies governing research with human subjects and has sufficient training and experience to conduct this particular study in accordance with the research protocol. Additionally,
• I hereby confirm that I have thoroughly reviewed this IRB application, including the protocol
narrative, and deem it ready for submission. • I agree to meet with the investigator on a regular basis to monitor study progress. • I agree to be available, personally, to assist the investigator in solving problems, should they arise
during the course of the study. • I assure that the investigator will promptly report unanticipated problems and will adhere to all
requirements for continuing review. • If I am unavailable, e.g. sabbatical leave, vacation, or resignation, I will arrange for an alternate
faculty sponsor to assume responsibility during my absence, and I will advise the South University IRB, in writing, of such changes.
• The research is appropriate in design.
Print Faculty Sponsor Name Faculty Sponsor Signature
Date (mm/dd/yyyy)
Print PI Name
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PI Signature
Date (mm/dd/yyyy)
- 1) PRINCIPAL INVESTIGATOR
- (Undergraduate students cannot serve as Principal Investigator, but may be listed as a Co-Investigator.)
- 2) CO-INVESTIGATOR – 1 (if applicable)
- 3) CO-INVESTIGATOR – 2 (if applicable)
- 4) FACULTY SPONSOR (if applicable)
- 5) STUDENT INVESTIGATORS/RESEARCH ASSISTANTS (if applicable)
- UPART II – FUNDING INFORMATION
- UPART III – EDUCATION AND TRAINING
- UPART IV – PRINCIPAL INVESTIGATOR ASSURANCE
- 1) Proposed duration of data collection/analysis:Start date: December 2013End date: December 2014
- 3) Study population:
- 5) Potentially Vulnerable Populations:
- 7) Conflict of Interest: Disclose all possible conflicts of interest.
- Is there any potential or perceived conflict of interest between the researcher, sponsor and/or South University associated with this study? Nox Yes
- Submission of a copy of a grant application or project proposal does not replace completion of this form. Please respond to each item. Incomplete forms will be returned to you.
- 1) Provide background information for the study including the objective of the proposed research, purpose, research question, hypothesis and other information deemed relevant.
- If yes, please explain.
- If yes, please explain.
- FACULTY SPONSOR’S ASSURANCE