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Research Proposal on Formal Diabetes Self-Management Training and Hemoglobin A1C Kathy Bowers, Kim Garza, Erin Kibbey, Stephanie Monroe, and Erin RobertsFerris State University Research Proposal on Formal Diabetes Self-Management Training and Hemoglobin A1CIn the previous chapter of this research proposal a review of the literature was provided. ?Twenty different articles were reviewed on the topics of DSME and health care provider effects, DSME and costs, as well as DSME and patient outcomes. ?The last chapter also provided additional support for the use of Resnick's self-efficacy theory as a guiding framework. ?The third and final chapter of this research proposal will focus on the design and methodology for our proposed study. ?As such, this proposal will explain the research design selected to carry out the anticipated research questions as well as an explanation for why this design was chosen. ?Next, this chapter will define the setting and sample?for where the proposed research will take place. ?External and internal validity concerns will be addressed as it relates to the sampling type selected. ?In addition, a clear and precise account of how the data will be collected as well as the instruments used will also be detailed. ?Data analysis and the rationale for why certain methods were chosen will be reviewed. Since it is important to ensure a high degree of reliability and validity, this proposal will detail steps taken towards this attempt. ?Based on the proposed study design, sample, setting, and procedures for data collection and analysis this chapter will also describe the limitations and delimitations associated. ?Finally, this chapter will address how the proposed study would be conducted in an ethical manner, while protecting the rights of participants and adhering to ethical principles.Research DesignThis research study will be conducted through the use of a basic quantitative experimental pretest-posttest design. “In this design, the subjects are randomly assigned to groups, a pretest is given to both groups, the experimental group receives the experimental treatment and the comparison group receives the routine treatment, and a posttest is given to both groups” (Nieswiadomy, 2008, p.153). In order to assure complete randomization a small table of random digits will be used to arrange groups. According to Polit and Beck (2012) “randomization is the most trustworthy method of equalizing groups” (p.207).This research study will involve the collection of baseline A1C levels of all participants then randomly assigning a participant to formal DSME training from an accredited program taught by certified diabetic educators or assigning a participant to no formal educational protocol for persons diagnosed with type 2 diabetes.? After 3 months and 6 months the A1C levels will be retested in all participants.?According to Polit and Beck (2012) this type of experimental design is best suited for studies that focus on an intervention that changes behaviors or attitudes and when researchers want to assess both group’s differences and change within the groups. Because DSME does impact self-management and behaviors as described in chapter one this is the best method for this research study. The pretest-posttest control group design also allows for an accurate assessment of equality between the groups prior to the treatment taking place (Nieswiadomy, 2008).Setting and SampleThe target population for this study is people who have been newly or previously diagnosed with type 2 diabetes in the United States. The accessible population for this proposed study would be limited to those that have been diagnosed with type 2 diabetes in the state of Michigan from various primary care clinics, veteran’s affairs clinics, and outpatient clinics. Eligibility criteria includes having been diagnosed with type 2 diabetes, having never received formal diabetes education, can commit to completing the DSME course, and must be between the ages of 18-70 years old. Exclusion criteria includes a prior diagnosis of dementia, an active infection, diagnosis of an auto-immune disease or?cancer in the past five years, persons unable to consent for themselves, and persons unable to read or speak English.?Simple random probability sampling will be used to gather participants from clinical databases throughout the state. Taking into account the loss of participants and the number of newly diagnosed 2 people in Michigan we plan to obtain a probability sample of 1000 participants. It is estimated that about 70,000 adults aged 18-76 are newly diagnosed each year with diabetes in Michigan (Centers for Disease Control and Prevention, 2010). Since the proposed study will take place over 6 months we could expect an 18% or more loss of participants as well as an uncertain number of people that would refuse to participate. This should allow a confidence level of 95% taking into account that approximately 400 participants could refuse to be in the study out of the 1000 and still provide a provide a meaningful effect size. According to Polit and Beck (2012), "In probability sampling, researchers can specify the probability that an element of the population will be included in the sample. Greater confidence can be placed in the representativeness of probability samples" (p. 275). Using this method, a sampling frame would be created listing all of the eligible participants. Next a computer generated list of random numbers would be used to draw a sample of 1000 participants. Although this method can be laborious it is not subject to biases (Polit & Beck, 2012). This method also allows the estimation of sampling error and is likely to represent the target population (Polit & Beck, 2012).? A screening instrument will also be utilized by the trained researchers for use during the recruitment phase in order to ensure that prospective participants meet all eligibility criteria. Depending on the location of participants in may be necessary to offer two sites to carry out the research. If it is necessary to have two cites in order to carry out the research it would be ensured that the two DSME programs are American Diabetes Association certified with the same training completed by both of the instructors. In addition, both of the instructors would teach the class half the time at one site and half the time at the other site, to reduce variability between instructors. Selected participants from simple random sampling would then receive a letter inviting them to participate in the study followed by a phone call to explain the study and obtain informed consent for those that were interested in participation.According to Polit and Beck (2012) randomization, which is used in this study, is the most effective method for controlling individual characteristics and maintaining validity.? In addition validity can be maintained with larger sample sizes. Some issues that could cause variability in the results include the range of ages, demographics, cultural backgrounds, and poverty levels that could be represented in the sampling based on chance. Importantly this study proposes to use a true experimental design and thus should possess a high degree of internal validity (Polit & Beck, 2012). External validity of the study could be affected by variations in the settings and diabetes educators.MethodsThe purpose of this nursing research study is to demonstrate that a newly diagnosed type 2 diabetic that receives DSME will lower their A1C more within six months of receiving the formal training as opposed to a patient that does not receive formal education. In addition, there are several outcomes that will be followed in this study based on the results of the DSME intervention. By improving education for patients with the chronic illness of diabetes there may be improved health outcomes, decreased readmission rates to hospitals, increased patient satisfaction and improved self-management (Mensing, 2011).VariablesThe methods and procedures used will address the elements of the study hypotheses. The independent variable is formal DSME being used as an intervention. The dependent variable is the resulting A1C level. In addition there are confounding variables that also need to be addressed. As described in earlier chapters of this research proposal, the framework for this study is based on Resnick’s theory of self-efficacy. Therefore the confounding variables affecting Resnick’s self-efficacy theory and outcome prospects are: enactive attainment, vicarious experience, verbal persuasion and physiological feedback (Peterson & Bredow, 2009). Methods and ProceduresThe methods and procedures used in conducting this study will help answer the studies two research questions: does formal DSME from an accredited program after new diagnosis of type 2 diabetes have an effect on lowering A1C levels after 3 months and 6 months; and what are the barriers to newly diagnosed type 2 diabetic individuals receiving DSME? These questions will be answered by following a quantitative experimental pre-test and post-test design. This design will better assist in determining if the intervention of DSME has a causal relationship with A1C levels and offers greater control over the four confounding variables. In order to assess these relationships and confounding variables self-reporting questionnaires will be used because they are cost-effective, interviewer bias is limited, and they are easy to use (Polit & Beck, 2012). Participants that agree to be in the study that meet the inclusion and exclusion criteria can be approached by a research nurse trained in consenting and conducting the procedures of the study. All participants will be administered the same questionnaires and data collection instruments by the same trained research nurses, at the same intervals whether they are randomized to the control or intervention groups. Using only trained research personnel for data collection maintains continuity for both cohorts and decreases the likelihood of human error (Polit & Beck, 2012). The research personnel involved in this research study will be trained in the use of each of the questionnaires and data collection tools (Polit & Beck, 2012). Next a written informed consent, approved by the local institutional review board and Ferris State Institutional Review Board will be used to consent all participants (see Appendix A). This written informed consent will include 15 sections of required content established to protect research subjects: “Participant status, study goals, type of data, procedures, nature of the commitment, sponsorship, participant selection, potential risks, potential benefits, alternatives, compensation, confidentiality pledge, voluntary consent, right to withdraw and withhold information, and contact information” (Polit & Beck, 2012, p. 158). Once consented, each participant will receive a copy of the consent and one copy will be placed into the patient chart (see Appendix A). Following the quantitative experimental research design, data collection will involve obtaining a baseline A1C point of care testing (POCT) for all consented participants. Collecting demographic information on the participant will be included in the baseline data (Polit & Beck, 2012). The demographic data collected will include the patient’s age, race, sex, employment status, income level, education level, who they live with, who their main support person is, what their usual daily activities are, what diabetic and other medications they take, and usual daily diet. Collecting this demographic and personal information will help the researchers answer the second research study question by identifying any barriers to the formal DSME for the participants enrolled in the intervention group as well as identify whether the participants can be generalized to the population of interest. A tool to track the A1C was developed specifically for this study. A spreadsheet was developed that lists the participants and their A1C results. A POCT A1C machine (results ready in 6 minutes) can be used when obtaining the first A1C at enrollment and then again at the 3 and 6 month intervals. The data will be stored on the spreadsheet to analyze the statistical information at the end of the study (see Table 1).Table 1Participant A1C Tracking Tool at Various Time IntervalsPatient No.Date of A1CInitial A1CStart Date3 month A1C6 month A1CDifference in A1C 0 - 3 monthsDifference in A1C 3 - 6 months???????????????? The trained nurse researchers will obtain the A1C levels according to the above schedule by using a POCT machine that determines an A1C level from a finger stick drop of blood right at the Diabetic Education Center. The machine we have chosen to use is the Bayer’s A1CNow+?, which?is annually certified by the National Glycohemoglobin Standardization Program (NGSP) (Bayer HealthCare, 2011). In addition, A1C levels are currently used as a widely accepted measuring tool for long-term glycemic status in patients with diabetes (Fernandez-Riejos et al., 2011). The immediate use of a POCT to determine the A1C has led to a change in treatment and a decrease in A1C (2011). It has been found that POCT is a reliable method when compared to laboratory samples (2011). This information will help us answer research study question one to see if DSME has an effect on A1C levels.In order to measure the study outcomes a short questionnaire was created and given as a pre-test and at 3 and 6 months to help correlate the independent, dependent, and confounding variables and study outcomes.? This questionnaire will specifically ask the patient how many hospital admissions they have had in the past 3 months and how many episodes of hypo or hypoglycemic symptoms they experienced in the past 3 months.? This questionnaire will also ask the patient to rate their general state of health as good, fair or poor.? These results will be compared to see if resulting data is improving or worsening as time passes for patient's in either the control or treatment group.A randomization schedule will be set up ahead of time by one of the researchers that will not be involved in the consenting of the potential participants (Polit & Beck, 2012). This assigned researcher will follow the common method of making “sequentially numbered opaque sealed envelopes…containing assignment information. As each participant enters the study, he or she receives the next envelope in the sequence” (2012, p. 209). The sealed opaque envelopes will be stored in a locked cabinet, in a locked office with the randomization key being only available to the trained researcher not involved with patient consenting in order to maintain the blind randomization. Although time consuming, this random sampling will limit bias and will allow all participants an equal opportunity into both study groups (2012); (see Table 3). This schedule continues until there is an equal amount of participants in each group.Next pre-test and post-test questionnaires will be used in order to evaluate a patient’s baseline feelings, behaviors and beliefs about diabetes with the effect that DSME training has on the patient’s self-efficacy in diabetic self-management. The pretest questionnaires can be examined and compared to the post-test questionnaires to assess for change. The appraisal of diabetes dcale (ADS) is a patient self-reporting tool based on a Likert scale. This tool is a patient self-assessment of their feelings about their diabetes now and in the future (Carey, et al., n.d.). The information obtained from this patient questionnaire can help guide the trained diabetic educator to control the confounding variable of verbal persuasion which “involves verbally telling an individual that he or she has the capabilities to master the given behavior” (Peterson & Bredow, 2009, p. 122). According to the Resource Centers for Minority Aging Research (2006a): The scale is internally reliable as measured by Cronbach’s (0.73) and principle components analysis. Pearson product-moment correlation of the test-retest data show the ADS to be stable for both the 1-hour and 1-week retests. As measures of validity, correlation analyses of the ADS to other questionnaires indicate modest to strong relationships. Correlation between the ADS and HbA1c was modest. In general, ADS scores correlated well with measures of psychological adjustment and current stress, and moderately with health beliefs and perceived diabetes complications and susceptibility. (para. 1)Therefore, by using this questionnaire, a patient’s concerns can be addressed and verbal encouragement can be provided to positively promote patient self-efficacy. Also the outcome of improved patient satisfaction and self-management can be assessed using this questionnaire (see Appendix B). Another instrument that will be used to address the patient’s concerns is called the problem areas in diabetes (PAID) questionnaire developed by the Joslin Diabetes Center in Boston. This is another patient self-reporting tool that will be used to help healthcare providers assess the most important diabetic management issues to the patient emotionally (Nozaki, et al., 2009; Joslin Diabetes Center, 1999). “According to the recommendation of the measure’s authors, a total score was computed by summing the total item responses and multiplying this total by 1.25 to produce a total score that ranges from 0-100” (Nozaki, et al., 2009, p. 2; Joslin Diabetes Center, 1999). According to information cited by the Resource Centers for Minority Aging Research (2006b):Psychometric reports to date on the PAID have shown it to: (i) have consistently high internal reliability (i.e. a = 0.90); (ii) have sound ( r = 0.83) 2-month test–retest reliability using a sample of stable patients; (iii) to correlate strongly with a wide range of theoretically related constructs such as general emotional distress, depression, diabetes self-care behaviours, diabetes coping, and health beliefs; and (iv) to be a statistically significant predictor of glycaemic control in a study that tracked a managed care population control for 1 year. (para. 2) This instrument will be used in the same manner as the ADS questionnaire, by submitting it as a pre-test and post-test to see if the score changes after DSME intervention. In this case a lower score post-test would be considered an improvement (see Appendix C).Another tool to we plan to use in order to assess and evaluate the diabetic educational needs of the participants is the diabetes knowledge questionnaire (DKQ) by Garcia, Villagomez, Brown, Kouzekanani, and Hanis (2001). The DKQ is considered a valid and reliable measure of diabetes knowledge, with high internal consistency reliability ranging from α = .73 to .83 and construct validity reported in other studies (p. 18).? Accordingly, this questionnaire draws information about a respondent’s understanding of several items including the cause of diabetes, types of diabetes, self-management skills, and complications of the disease (see Appendix D). There are many physical symptoms that can affect a diabetic as they learn to manage their blood glucose. A participant could become fearful if they experience hypoglycemia after exercise. This could have a negative effect on their progress of diabetic self-management. This physiological feedback is one of the confounding variables that can be controlled with education and support so that participants can learn how to better evaluate and respond to their physical state (Peterson & Bredow, 2009). Using the DKQ as a pre-test and post-test is important in assessing the patient’s learned and adaptive response to how they feel physically in relation to what they learn at the formal DSME sessions.To further examine the relationship between the independent and dependent variable, quantitative studies can examine the predicted relationship as well as the direction and strength of the relationship between the variables (Polit & Beck, 2012). Self-efficacy outcomes can be measured using the generalized self-efficacy scale (GSE) developed by Schwarzer and Jerusalem in 1995. “Scoring: Responses are made on a 4-point scale. Sum up the responses to all 10 items to yield the final composite score with a range from 10 to 40” (Resource Centers for Minority Aging Research, 2006c, para. Administration). In addition research cited by the Resource Centers for Minority Aging Research has shown this scale has high reliability, stability, and construct validity. This questionnaire will be administered as a pre-test and post-test (see Appendix E). According to Polit & Beck (2012), this type of design is best suited for studies that focus on an intervention that changes behaviors or attitudes and when researchers want to assess both group differences and change within groups, similar to this research study. In addition it would be expected that the participant would have improved health outcomes and decreased hospital readmissions if the scores improve when comparing the pre to the post-test.The previously mentioned pre-tests and post-tests will be used to assess each participant’s self-efficacy at the beginning and at the end of the study. Comparing the beginning with the end data will help the researchers assess if there is a difference or improvement in knowledge and behavior toward their self-management of diabetes. The formal group DSME sessions will help control the confounding variables. For example, the confounding variable of vicarious experience is the positive influence on behaviors of the participant by observing the success of other people’s behavior or activities (Peterson & Bredow, 2009). The confounding variable of enactive attainment is also supported by the formal group DSME sessions because as the participants interact in active learning they can gain experience in self-care skills and therefore increase their belief that they can manage their care (2009). Data AnalysisThe sample for this proposed study is expected to be from a normal distribution of the population in Michigan, differences will be examined within both groups including knowledge, self-efficacy and A1C results. Since this study proposes the testing of differences between two group means, data analysis would include the use of a t-test. Accordingly, we are testing the difference in beginning A1C, 3 month A1C, and 6 month A1C for the control group as well as the experimental group and comparing the mean difference.? The t-test allows us to objectively determine if the variability can be attributed to the independent variable (presence of education) (Polit & Beck, 2012). By determining a t-test, an upper limit can be established to what is probable if the null hypothesis is true (2012).? If the t-test is larger than the upper limit, it is reliable to say that the presence of education is sufficiently large enough that it is unlikely related to chance, and thus reliable. Asserting confidence in the population parameter a confidence interval of 95% will be used. To reduce type 1 error we will use a significance level of 0.05%. In order to reduce type 2 error the sample size will be reflective of a medium sample size (Polit & Beck, 2012). Self-management spheres of influence typically are not associated with each other (Sarkar, Fisher & Schillinger, 2006). Therefore, univariate models will be utilized in the analysis of self-behaviors and outcomes. Multiple regression will be used to determine the influence of enhanced education and increased self-efficacy on A1C results. Scatter plots will also be used to show the positive or negative correlation between the variables (Polit & Beck, 2012). “A positive correlation occurs when high values on one variable are associated with high values on a second variable. If the slope of points begins at the lower left corner and extends to the upper right corner, the relationship is positive” (2012, p. 390). Reliability and Validity Assessment of knowledge about diabetes is an important element in the overall assessment and literacy of the patient with diabetes. In this research study the DKQ by Garcia et al. (2001), as previously mentioned, will be administered. National standards recommend obtaining baseline knowledge in order to effectively plan educational tools and evaluation outcomes (Mensing et al, 2007). Therefore, it is necessary in the design of research to administer the DKQ test to the random group and the control group. Cronbach’s internal consistency coefficient alpha will be used to measure reliability for the self-efficacy and the diabetes knowledge scales. Cronbach’s alpha will also be used to measure health literacy among the groups.Higher self-efficacy leads to testing blood sugars more frequently, administering medicine regularly and normally keeping scheduled medical appointments (Aljsem, Peyrot, Wissow, & Rubin, 2001). As previously described, one research question this study indented to evluation is whether factors in improving diabetes knowledge and self-efficacy lead to improved outcomes in adults with type 2 diabetes (Krichbaum, 2003). The GSE will be administered to all subjects on the first appointment by the registered nurse educator to assess a baseline. The PAID questionnaire will also be administered to each subject in the two groups. In order to assess predictive variability the test will be given at baseline (pre-test) and 6 months (post-test) to evaluate changes in self-efficacy. The reliability and validity of these instruments were detailed above. In order to provide reliability and validity the A1C test should be performed using a method that is certified by the NGSP and standardized to the Diabetes Control and Complications Trial (DCCT) reference assay (ADA, 2013). This is true of the POCT machine chosen to use for this proposed study. Accordingly, in order for a machine to achieve NGSP certification, an A1C testing method must successfully complete rigorous testing requirements annually (Bayer HealthCare, 2011). More information about this devices accuracy and clinical performance testing is available on Bayer’s website noted in the reference section of this proposal.Limitations and Delimitations A limitation of this proposed study could be the number of questionnaires used that can contribute to inefficiency including the length of time it takes participants to complete the questions and comprehension of the questions. Closed ended questions in both questionnaires were utilized to keep limitations to a minimum. Despite the research indicating the reliability and validity of instruments chosen it is also possible that people can under or over report on questionnaires effecting their reliability and validity in research.??Other potential limitations of our study could include amount of physician intervention, lack of support and or barriers to receiving DSME, and severity of diabetes. Exclusion criteria limits application of possible results to those that cannot speak or read English and thus results likely will not be representative of several minority groups. Although we don’t know exactly where our potential participants live yet, it may be possible that we have to consider more than one site to administer classes in order to not limit the results of our studies to effects related to these barriers. If we do have to consider two sites for the study then there are additional limitations imposed due to differences between teachers and facilities, although every attempt would be made to limit these differences whenever possible, as previously described. All of these could have an impact on A1C that are not from the class intervention itself.Ethical ConsiderationsAnytime humans are used as subjects within a research study, it is of the utmost importance to ensure that their personal rights are protected (Polit & Beck, 2012). Within our research study we have taken steps to make certain that rights have been and will be protected. This section will describe in detail how this proposed research study has considered and followed procedures in order to protect human rights throughout the study.One of the first ethical considerations for any research design is that of beneficence which is described as minimizing risks and maximizing benefits (Polit & Beck, 2012). It is essential that the researcher does everything in their power to minimize or prevent harm to the participant (2012). There will be no direct harm purposefully intended to any participant at any time. Our research design will include a risk-benefit assessment that will be used to ensure that the benefits of participation are properly aligned with the possible risks. All risks and benefits will be provided to the patient in writing in order for the participant to make an informed decision.This research study is aimed to determine the correlation between formal diabetes education and improvement in A1C. This can have many positive impacts on society and the health care profession as a whole to increase awareness of the importance of education to patients, physicians, and the general public. This research hypothesizes that it may also serve to decrease the cost of education or increase the insurance reimbursement rates to allow more access to diabetes education. All of these benefits to the population as a whole will outweigh any risk associated to the participant. Potential risks for participation in the proposed study could include: inconvenience, possible infection from A1C POCT, and emotional stress. These risks are minimal and provide no greater than the risk of everyday living or those ordinarily encountered with routine testing or procedures (Polit & Beck, 2012).Within our research study only qualified individuals will be used as researchers. Individuals that collect all pertinent information from the participants will sign confidentiality agreements as required by the supporting institution and required by the Institutional Review Board (IRB) and will be properly trained and qualified to participate as a researcher. Individuals collecting A1C POCT will be properly trained and evaluated on their use of the machine and will follow all guidelines set forth by the manufacturer as well as the institution supporting the research. All guidelines and protocols will be followed explicitly. If at any time throughout the research continuation of the study would produce undue harm to the participants, the study will be terminated immediately.Our study will also be cognizant of not only physical harm, but that of emotional or psychological harm. The researchers will demonstrate sensitivity when asking personal questions and will handle themselves with professionalism and courtesy at all times. Personal information will be protected and will be used throughout the study in an anonymous fashion.? All research participants will be assured that through participation, they will not be penalized or exposed to any danger (Polit & Beck, 2012).The second ethical consideration that this research design will follow is that of respect for human dignity. Participants can voluntarily decide if they would like to participate within the study and will not be penalized in any fashion if they chose to not participate. Individuals will have the right and ability to ask questions regarding the study at any time and can refuse to provide any information they desire as well as withdraw from the study at any time without any questions asked. In an effort to decrease the risk of coercion, participants will not be financially rewarded for their participation within this study.Full disclosure will be provided to all research participants in an attempt to allow the participant to make informed and voluntary decisions (Polit & Beck, 2012). The study will be described in detail to the participants, including their right to refuse or decline participation (2012). All participants will be advised at the beginning of the study and through written instruction all that will be required of them throughout the study. They will have the option to discontinue involvement, without penalty at any point throughout the research study and will be notified of any potential risk and benefits associated with participation.??In an effort to safeguard patient participation, we will obtain informed consent from all participants. The following pieces of information will be provided to the participant in regards to informed consent: participation status, study goals, type of data to be collected, nature of the commitment, sponsorship, participant selection, potential risks, potential benefits, alternatives, compensation, confidentiality pledge, voluntary consent, right to withdraw or withhold information, and contact information (Polit & Beck, 2012). This information will be provided to the patient via a signed consent form. Participants will have adequate time to review the consent before signing, and will also be signed by the researcher and a copy provided to the participant as well as kept on file by the researcher. The researchers will make every attempt to ensure that the informed consent is not only provided to the participant, but fully understood.The third ethical consideration our research design will intend to protect is that of justice. This is defined as the “right to fair treatment and privacy” (Polit & Beck, 2012, p. 155). All research participants will be treated fairly even those that decline participation or discontinue participation. All researchers will be properly trained and will demonstrate fair and equitable treatment at all times. Individual privacy will also be held with the highest standards available and will be maintained continuously. If at any time there is a privacy issue, participants will be notified at once.ConfidentialityFirst and foremost, all researchers will sign a confidentiality agreement and will uphold all the Health Insurance Portability and Accountability Act requirements. Information gathered from the participants that can be collected anonymously will be done so. For example, the use of our questionnaire will be anonymous, and the participant will not provide any personal information on the questionnaire. For reviewing records of those patients in the control group, all personal information will be deleted, and therefore anonymity would be provided as a means to protect privacy. Any information that is not able to be anonymous will be kept confidential and will not be reported in any manner that links the participant to the data. In order to maintain confidentiality, all personal information and data collected will be maintained in a locked or encrypted file, and access will be restricted to only those authorized through the research study. Any information stored on the computer will be de-identified or will use an identification number instead of personal information.External ReviewIn an attempt to ensure our research is not biased, we will obtain an external review and approval of our research study through IRB approval. The IRB is an institutional committee designed to review the ethical aspects of a research design (Polit & Beck, 2012). Our research plans will be submitted to the IRB for review and will follow the format set forth by the IRB of the institution. All information that is requested will be provided to the IRB, including a copy of our informed consent and questionnaire forms. We will not move forward with our research study unless IRB approval is obtained.SummaryIn summary, the third chapter of this research proposal has focused on the design and methodology for our proposed study of DSME and A1C. ?As such, this proposal explained the random controlled research design selected to carry out the anticipated research questions as well as an explanation for why this design was chosen. ?Next, this chapter described the setting and sample?for where the proposed research will take place. ?External and internal validity concerns were addressed as it related to the sampling type selected. ?By way of a table, a clear account as to how the data would be collected and organized was also provided. Instruments chosen for data analysis included the GSE, PAID, DKQ, and ADS. Reliability and validity of these instruments were also described. Proposed data analysis included the use of t-tests, scatter plots, confidence intervals, and multiple regression methods. Based on the proposed study design, sample, setting, and procedures for data collection and analysis this chapter also described the limitations and delimitations associated some of which included physician involvement with patients, barriers to receiving DSME not addressed by the study, and those individuals that are illiterate or excluded due to pre-determined exclusion criteria.? Finally, this chapter addressed how the proposed study would be conducted in an ethical manner, protecting the rights of participants and adhering to ethical principles.ReferencesAljasem, L., Peyrot, M., Wissow, L., & Rubin, R. (2001). The impact of barriers and self-efficacy on self-care behaviors in type 2 diabetes.? Diabetes Educator, 27(3), 393-404.American Diabetes Association [ADA]. (2013). Diagnosis and classification of diabetes mellitus. Diabetes Care,?36(S1), S67-74. doi:10.2337/dc13-S067Bayer HealthCare. (2011). Professionals?- A1CNow+??Overview. Retrieved from , M. P., Jorgensen, R. 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Retrieved from http:News_and_activities/Documents/PAID_Problem_areas_in_diabetes_questionnaire.pdfKrichbaum, K. (2003). Exploring the connection between self-efficacy and effective diabetes self-management. Diabetes Educator, 29(4), 653-662.Mensing, C., Boucher J., Cypress, M., Weinger, K., Mulcahy, K., & Barta, P. (2007). National standards for diabetes self-management education. Diabetes Care, 30(1), S96-103.Nieswiadomy, R. M. (2008).?Foundations of nursing research?(5th?ed.). Upper Saddle River, NJ: Pearson Education.Nieswiadomy, R. M. (2012). Foundations of nursing research. (6th ed.). Upper Saddle River, NJ: Pearson Health Science.Nozaki, T., Morita, C., Matsubayashi, S., Ishido, K., Yokoyama, H., Kawai, K., & . . . Kubo, C. (2009). Relation between psychosocial variables and the glycemic control of patients with type 2 diabetes: A cross-sectional and prospective study.?BioPsychoSocial Medicine,?3(4), 1-8. doi:10.1186/1751-0759-3-4Peterson, S. J., & Bredow, T. S. (2009). Middle range theories: Application to nursing research (2nd Ed.). Philadelphia, PA: Wolters Kluwer Health.Polit, D. F. & Beck, C. T. (2012).?Nursing research: Generating and assessing evidence for nursing practice?(9th?ed.). Philadelphia, PA: Lippincott Williams & Wilkins.Resource Centers for Minority Aging Research. (2006a). RCMAR measurement tools: Appraisal of diabetes scale (ADS). Retrieved from Centers for Minority Aging Research. (2006b). RCMAR measurement tools: Problem areas in diabetes (PAID). Retrieved from Centers for Minority Aging Research. (2006c). RCMAR measurement tools: Self efficacy scales. Retrieved from , U., Fisher, L., & Schillinger, D. (2006). Is self-efficacy associated with diabetes self-management across race/ethnicity and health literacy? Diabetes Care, 29(4), 823-829.Schwarzer, R., & Jerusalem, M. (1995). Generalized self-efficacy scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user’s portfolio. Causal and control beliefs (pp. 35-37). Windsor, UK: NFER-NELSON.Appendix APatient Informed Consent FormThe purpose of this consent form is to explain and ask you to participate in an experimental research study at the Diabetic Education Center. The purpose of the research study is to compare the results of two forms of diabetic education on newly diagnosed type 2 diabetic patients, like yourself to see which form of education supports better results. The goal of this research study is to improve diabetic self-management and patient outcomes, such as improved glycemic control (blood sugar levels), and general health and wellbeing. The patients agreeing to take part in this study will be randomly assigned to either a standard of care diabetic education treatment (which consists of receiving a standard diabetic education pamphlet), or to the intervention diabetic education treatment (which consists of attending and completing a formal diabetic education program). The chances of being randomly assigned to either the standard of care or intervention group is about 50%, like flipping a coin.The information collected will include blood being checked three times; at the beginning of the study, at 3 months, and then again at 6 months. This blood will amount to about two teaspoons and will be used to monitor your blood glucose levels over a 3 month period. In addition, you will be asked to complete several questionnaires that ask about your understanding and feelings about diabetes. Some of the questionnaires will be given to you to fill out after you give consent, and at your 3 month, and 6 month scheduled visits for the above finger sticks. While other questionnaires will be given to you to fill out after you have given consent and at the 6 month scheduled visit. Also your personal information, such as age, race, and gender will also be collected after consent in order to evaluate trends or specific needs for different diabetic populations. This information will all be de-identified to protect your privacy. This means that your name and any identifying information will be removed from this information and you will be assigned a number specific to you. The link identifying you to your assigned research number will be kept in a locked office indefinitely. Please understand that by signing this consent all study participants are agreeing to come to the Diabetic Education Clinic three times to have your finger sticks done and fill out patient study questionnaires. Those randomized to the intervention group will be asked to attend and complete a formal Diabetic Self-management Education program.This study is being paid for by the individual researchers who are volunteering their time to advance and to improve diabetic education. The Diabetic Education Center is providing the paper to print out the questionnaires and paying for the outside service of computer data analysis. The hemoglobin A1C levels are standard of care and will be billed to your insurance. Any co-payments will be the responsibility of the patient. The persons conducting the study are not receiving payment outside of their usual pay for the nursing care provided. This research study is being conducted as part of an academic requirement for the Master’s in nursing program at Ferris State University in Michigan.Only newly diagnosed type 2 diabetic people, 18 years old and older, who come to the Diabetic Education Center will be asked to participate in this research study. The goal is to have a total of 400 people take part in this study. However, if you are pregnant, unable to read and write English, or give your own consent, you will not be able to take part in this study.The potential risks of this study are that the blood collection may hurt as it involves a needle stick that can feel like a bee sting. Also, even though every precaution will be made to protect your medical information, there is always a risk that someone not involved in the research study may see your medical information. The information collected from this study may be shared with other health care providers and, your insurance agency. When this information is shared with the Institutional Review Board (s), or if it is shared with the Federal government or used in a nursing publication, the information will always be de-identified.Participating in this research study is completely voluntary. Aside from the standard of care finger sticks there is no additional cost to you for being in this study. However it may take you about 15 minutes, each time, to fill out the study questionnaires. There is no penalty or loss of benefit to refusing to take part in this research study. The alternative to taking part in this research study is to receive standard of care diabetic education, like receiving a pamphlet about diabetes. The potential benefits of this study is that you and others may learn how to better self-manage your diabetes and gain good control of your blood sugar levels on a regular basis. However, these potential benefits cannot be guaranteed.If you sign this informed consent and then later change your mind and decide not to partake any longer in the research study there is no penalty or loss of benefit to you. If you withdraw no further information will be collected and you will receive standard of care diabetic education. However, we cannot guarantee that the information already collected will not be used. In addition the persons conducting have the right to take you out of the study for any reason. A reason for stopping a patient’s participation would be the patient repeatedly not showing up for the scheduled finger stick and questionnaire visits.There is no monetary compensation provided to you for taking part in this study. The potential risks of participating in this study are minimal, however, by signing this consent you understand if you sustain injuries from your participation in this research project, you will not be automatically compensated by the Diabetic Education Center, or Ferris State University. Yet, signing this consent form does not stop you from taking legal action should you feel the need.If you have questions or concerns you may contact the studies researcher(s): Kathy Bowers, RN, BSN at 662-235-8181; Kim Garza, RN, BSN at 662-425-6723; Erin Kibbey, RN, BS at 662-446-7281; Stephanie Monroe, RN, BSN at 662-673-2524; or Erin Roberts, RN, BS at 662-593-4748. Because this research study involves minimal risk and primarily involves information collection we are available Monday – Friday, from 8 AM to 5 PM. By signing this informed consent you are saying that you understand and are agreeing to voluntarily take part in this diabetic education research study at the Diabetic Education Center. Your signature shows that this study has been explained to you; that you have read and understand this consent form, that all of your questions have been answered, and that you agree to take part in this study. A copy of this signed consent form will be given to you.Printed Name of Study Participant DateSignature of Study Participant DateWitness Signature DateAppendix BAppraisal of Diabetes Scale (ADS)DCAI-R (7/88)People differ in their thoughts and feelings about having diabetes. We would like to know how you feel about having diabetes. Therefore, please circle the answer to each question which is closest to the way you feel. Pease give your hones feelings - we are interested in how you feel, not what your doctor or family may think.How upsetting is having diabetes for you?1 2 3 4 5 Not Slightly Moderately Very Extremely At all upsetting upsetting upsetting upsettingHow much control over your diabetes do you have?1 2 3 4 5 None at Slight Moderate Large Total All amount amount amount amount How much uncertainty do you currently experience in your life as a result of being diabetic?1 2 3 4 5 None at Slight Moderate Large Extremely Large All amount amount amount amountHow Likely is your diabetes to worsen over the next several years?(Try to give an estimate based on your personal feelings rather than based on a rational judgment.)1 2 3 4 5 Not likely Slightly Moderately Very Extremely At all likely likely likely likelyDo you believe that achieving good diabetic control is due to your efforts as compared to factors which are beyond your control?1 2 3 4 5 Totally Slightly Moderately Mostly Totally Because because because because because Of me of me of me and of other of other Partly because factors factors Of other factorsHow effective are you in coping with your diabetes?1 2 3 4 5 Not at Slightly Moderately Very Extremely All effective effective effective effectiveTo what degree does your diabetes get in the way of your developing life goals?1 2 3 4 5 Not at Slight Moderate Large Extremely All amount amount amount large amount Scoring the ADS is easy: 1. Reverse score items # 2 and 6. ADS2R = 5 -ADS2 ADS6R = 5 -ADS6 2. Then sum all items, using the reversed scored items 2 and 6. Total score = ADS1 + ADSR2 + ADS3 + ADS4 + ADS5 + ADSR6 + ADS7 There is no manual. Interpretation is straightforward: The smaller the total score, the more positive the appraisal strategy. Thus, lower scores are better. Citation: Carey, M. P., Jorgensen, R. S., Weinstock, R. S., Sprafkin, R. P., Lantinga, L. J., Carnrike, C. L. M., Jr., Baker, M. T., & Meisler, A. W. (1991). Reliability and validity of the appraisal of diabetes scale. Journal of Behavioral Medicine, 14, 43-51. Michael P. Carey, PhD Director, Centers for Behavioral & Preventive Medicine Professor, Department of Psychiatry & Human Behavior (Medicine) Professor, Behavioral and Social Sciences (Public Health) Brown University Coro Building, Suite 314 One Hoppin Street Providence, RI 02903 Michael_Carey@brown.edu Appendix CProblem Areas in Diabetes (PAID) QuestionnaireINSTRUCTIONS: Which of the following diabetes issues are currently a problem for your?Circle the number that gives the best answer for you. Please provide an answer for each question. Somewhat Not a Minor Moderate serious Serious Problem problem problem problem problem 0 1 2 3 4Not having clear concrete goalsFor your diabetes care? 0 1 2 3 4Feeling discouraged with yourDiabetes treatment plan? 0 1 2 3 4Feeling scared when you think about Living with diabetes? 0 1 2 3 4Uncomfortable social situationsRelated to your diabetes care(e.g., people telling you what to eat)? 0 1 2 3 4Feelings of deprivation regarding food And meals? 0 1 2 3 4Feeling depressed when you thinkAbout living with diabetes? 0 1 2 3 4Not knowing if your mood or feelingsAre related to your diabetes? 0 1 2 3 4Feeling overwhelmed by your diabetes? 0 1 2 3 4Worrying about low blood sugar Reactions? 0 1 2 3 4 Feeling angry when you think about Living with diabetes? 0 1 2 3 4Feeling constantly concerned about Food and eating? 0 1 2 3 4Worrying about the future and thePossibility of serious complications? 0 1 2 3 4Feelings of guilt or anxiety when youGet off track with your diabetesManagement? 0 1 2 3 4Not “accepting” your diabetes? 0 1 2 3 4Feeling unsatisfied with your diabetesPhysician? 0 1 2 3 4Feeling that diabetes is taking up tooMuch of your mental and physicalEnergy every day? 0 1 2 3 4Feeling alone with your diabetes? 0 1 2 3 4Feeling that your friends and familyAre not supportive of your diabetesManagement efforts? 0 1 2 3 4Coping with complications of diabetes? 0 1 2 3 4Feeling “burned out” by the constantEffort needed to manage diabetes? 0 1 2 3 4(Joslin Diabetes Center, 1999) Appendix DPatient’s Diabetes Knowledge Questionnaire Don’t Questions Yes No KnowEating too much sugar and other sweet foods is a cause of diabetes. ____ ____ _____ The usual cause of diabetes is lack of effective insulin in the body. ____ ____ ____ Diabetes is caused by failure of the kidneys to keep sugar out of the urine. ____ ____ _____Kidneys produce insulin. ____ ____ _____In untreated diabetes, the amount of sugar in the blood usually increases. ____ ____ ____If I am diabetic, my children have a higher chance of being diabetic. ____ ____ ____ Diabetes can be cured. ____ ____ ____A fasting blood sugar level of 210 is too high. ____ ____ ____The best way to check my diabetes is by testing my urine. ____ ____ ____Regular exercise will increase the need for insulin or other diabeticMedication ____ ____ _____There are two main types of diabetes: Type1 (insulin-dependent) And Type 2 (non-insulin dependent) ____ ____ _____An insulin reaction is caused by too much food. _____ ____ _____Medication is more important than diet and exercise to control myDiabetes. _____ ____ _____Diabetes often causes poor circulation. _____ ____ ____Cuts and abrasions on diabetes heal more slowly. _____ ____ ____Diabetics should take extra care when cutting their toenails. ____ ____ ____A person with diabetes should cleanse a cut with iodine and alcohol. ____ ____ ____The way I prepare my food is as important as the foods I eat. ____ ____ ____Diabetes can damage my kidneys. _____ ____ ____Diabetes can cause loss of feeling in my hands, fingers and feet. _____ ____ ____Shaking and sweating are signs of high blood sugar. _____ ____ ____Frequent urination and thirst are signs of low blood sugar. _____ ____ ____Tight elastic hose or socks are not bad for diabetics _____ ____ ____A diabetic diet consists mostly of special foods. _____ ____ ___(This product was adapted from the DKQ “Diabetes Knowledge Questionnaire,”- Garcia and Associates for the diabetes self-management project at Gateway Community Health Center, Inc. with support from the Robert Wood Johnson Foundation in Princeton, NJ).Appendix EThe General Self-Efficacy Scale (GSE)Response format: 1= Not at all true; 2= Hardly true; 3= Moderately true; 4= Exactly trueI can always manage to solve difficult problems if I try hard enough. _____If someone opposes me, I can find the means and ways to get what I want.______It is easy for me to stick to my aims and accomplish my goals.______I am confident that I could deal efficiently with unexpected events.______Thanks to my resourcefulness, I know how to handle unforeseen situations.______I can solve most problems if I invest the necessary effort._____I can remain calm when facing difficulties because I can rely on my coping abilities.______When I am confronted with a problem, I can usually find several solutions.______If I am in trouble, I can usually think of a solution._______I can usually handle whatever comes my way._______ Scoring: responses are made on a 4-point scale. Sum up the responses to all 10 items to yield the final composite score with a range from 10 to 40. No recoding (Schwarzer, & Jerusalem, 1995). ................
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