The effects of education with printed material on glycemic control in patients with diabetes type 2 treated with different therapeutic regimens

Background/Aim. Diabetes mellitus (DM) is considered to be an epidemic, chronic and progressive disease. The treatment of DM reqiures substantial effort from both the diabetes treatment team and a patient. Patient education is one of the treatment elements. The most efficacious form and content of education has not yet been established. However, every DM education must include introduction to a substantial number of facts about diabetes. The aim of our study was to estimate the levels of DM knowledge and glycemic control in Serbian patients with DM type 2 as well as to estimate the effects of education using printed material on the levels of glycemic control and knowledge about DM. Also, the effects of education on glycemic control and the level of knowledge in differently treated patients were estimated. Methods. The patients with DM type 2 (n = 364), aged 40 to 65 years, from three regional health centers, were randomized for the study. After informed consent, patients filled out the questionnaire, and were checked for HbA1c and fasting blood glucose. Finally, booklet „Healthy lifestyle with diabetes mellitus type 2“ was given to them. The same procedure was repeated after 3, 6 and 18 months. Results. There was a significant improvement in HbA1c levels after 3 months (8.00 ± 1.66% vs 9.06 ± 2.23%, p < 0.01) and after 6 months (7.67 ± 1.75% vs 9.06 ± 2.23%, p < 0.01). There was no further improvement in HbA1c levels after 18 months (7.88 ± 1.46% vs 7.67 ± 1.75%, p > 0.05). There was a significant improvement in the average test score (percent of correct answers per test sheet) after three monts (64.6% vs 55.6%, p < 0.01). There were no further statistically significant changes in the general level of DM knowledge after 6 months (65.0 ± 32.5% vs 64.5 ± 33.7%, p > 0.05 ) and after 18 months ( 64.8 ± 32.7 vs 64.5 ± 33.7%, p > 0.05). There was a significant diffrence in educational intervention response in DM type 2 patients on different therapeutic regimens. Conclusion. Education with printed material led to improvement in glycemic control and level of DM knowledge in our patients. Education with printed material may be a useful adjunct to DM treatment and should be structured according to the treatment modality.

repeated after 3, 6 and 18 months.Results.There was a significant improvement in HbA1c levels after 3 months (8.00 ± 1.66% vs 9.06 ± 2.23%, p < 0.01) and after 6 months (7.67 ± 1.75% vs 9.06 ± 2.23%, p < 0.01).There was no further improvement in HbA1c levels after 18 months (7.88 ± 1.46% vs 7.67 ± 1.75%, p > 0.05).There was a significant improvement in the average test score (percent of correct answers per test sheet) after three monts (64.6% vs 55.6%, p < 0.01).There were no further statistically significant changes in the general level of DM knowledge after 6 months (65.0 ± 32.5% vs 64.5 ± 33.7%, p > 0.05 ) and after 18 months ( 64.8 ± 32.7 vs 64.5 ± 33.7%, p > 0.05).There was a significant diffrence in educational intervention response in DM type 2 patients on different therapeutic regimens.Conclusion.Education with printed material led to improvement in glycemic control and level of DM knowledge in our patients.Education with printed material may be a useful adjunct to DM treatment and should be structured according to the treatment modality.

Introduction
Diabetes mellitus (DM) is a chronic and progressive disease.Treatment of DM is nowdays in focus due to an unexpectedly large number of people affected with the disease 1, 2 , various treatment options [3][4][5][6][7][8][9] , the possibilities for DM prevention [10][11][12][13] and fact that the patient plays an active part in the treatment 14,15 .Patient education is an integral part of the treatment [16][17][18][19] .The best way and the best content of DM patient education has not yet been established 20 .Patient education in DM that only increases patient knowledge on diabetes facts does not neccessarily lead to better glycemic control 21,22 .Besides, good glycemic control is not the only positive DM treatment outcome [23][24][25] .It is postulated that patient education should be structured and enable the patient to make decisions that lead to good DM control, as well as to make him/her as independent from the medical team as much as possible.Diabetes treatment guidelines recommend diabetes patient education as an integral part of treatment [26][27][28] .However, inspite of treatment guidelines (for DM treatment, patient education and self-management of the disease) and variety of treatment options, the level of glycemic control is generally unsatisfied.It is estimated that less than one third of patients achieve good glycemic control.Diabetes education was mentioned as one of the elements of treatment that leads to good glycemic control 29 .However, there is neither a standardized educational program nor the recommended amount of facts that should be presented to DM patients in Serbia.
In 2004 UK Department of International Development provided the printed material "Healthy lifestyle with diabetes type 2" and the HbA1c assays, as a donation to help DM care in Serbia.The printed material included relevant facts about t DM type 2. The aim of our study was to estimate the impact of education with this printed material on glycemic control in DM type 2 patients treated with different therapeutic modalities.

Methods
Diabetes mellitus type 2 patients (aged 40 -65 years), having the disease for more than 6 months, were informed about the study during their regular checkup.The study was performed at two Clinical Centers and one General Hospital in Serbia.After signed informed consent, the patients were randomized for the study.In all the patients fasting plasma glucose (FPG) and HbA1c were measured and subsequently the patients fullfiled the Questionnaire.They answered the questionnaire without interference of medical stuff.At the end of visit the patients were given the printed material "Healthy lifestyle with diabetes type 2".The same procedure was repeated after 3, 6 and 18 months.The printed material was given to the patient only at the first visit.According to the Study Protocol DM therapy should not be changed during the first 6 months of the trial.The printed material was made in accordance with the educational programs of British Association for Diabetes and University of Michigan Diabetes Research and Training Center (UMDRTC).A two-way translation of the material was done prior to publishing.The material included six Chapters (Table 1).following the text in the printed material.Simple fact reproduction was required.There were 8 questions that were connected to the patients attitude towards diabetes.The Questionnaire was identical in all examining series.The Questionnaire contained multiple choice, open type questions.Fasting blood glucose was determined using glucose-oxidase procedure, using a polarographic oxygen analyzer (Bekman Glucose Analyzer).HbA1c was determined using Bayer DCA 2000 Reagent Kit, which is based on a latex immunoagglutination inhibition methodology.Statistical analysis was done using methods of descriptive and analytical statistics (Student`s t-test, x 2 test, Friedman`s test).Statistical package SPSS 10 was used for analysis.

Results
The study included 364 DM type 2 patients.Of them, 276 finished the study (2 patients died, 86 did not give sufficient data).There was no statistical significance between the number of males and females included in the study.Regarding age of the participants 19% were 41-50 yeras old, 42.3% were 51-60 years old and 38.2% were over 65 years old.The majority of patients (44.8%) had high school education (44.8%), 2.5% of the patients did not have elementary school education and 16.4% of patients had college/BA education.Average body mass index (BMI) was 27.6 ± 0.3 kg/m 2 , which is in the overweight range.
A significantly better glycemic control was achieved at 3 months (HbA1c: 8.00 ± 1.66% vs 9.06 ± 2.23%, p < 0.01) and 6 months (7.67 ± 1.75% vs 9.06 ± 2.23%, p < 0.01) from beginning of the study.From 6th to 18th month of the study, glycemic control, as seen through HbA1c, was not significantly improved (HbA1c 7.88 ± 1.46% vs 7.67 ± 1.75%, p > 0.05) (Figure 1).As expected, the patients treated with insulin had the highest level of HbA1c at the beginning of the study (9.99 ± 2.25%), followed by the patients treated with oral hypoglycemic drugs (8.79 ± 1.64%), and finally those controlled with lifestyle intervention (7.63 ± 1.94 %).Only the patients treated with lifestyle intervention did not show significant changes in the level of HbA1c during the study (Table 2).
The questionnaire analysis enabled us to differentiate three groups of questions: Type A -questions about general health issues (smoking, salt in everyday diet, hypertension, etc).The patients gave high percent of correct answers at the introductory test (95.5%), at 3 months (98.55%), 6 months (98.50%) and 18 months (99%).A change between the three series of answers was not statistically significant.This type of question was not further examined with regard to therapeutic regimens.).At last one correct answer was given by the majority of examinees (Table 3).There was a very low percent of RCA in all time series (introductory 4% vs 3 months -9% vs 6 months -6.5% vs 18 months: 6.0%).A significant change was achieved at three months and 6 months form baseline (p < 0.01; Figure 3) There was no difference between the percent of correct answers between the patients on different therapeutic regimens at the introductory testing.A statistically significant difference was registered in the number of RCA in the patients treated with insulin, 3 months after the beginning of the study (14% vs 7%, p < 0.05) and in patients treated exclusively with lifestyle change, in whom the difference was statistically highly significant after 3 months and was sustained at 18 months at the beginning of the study: 5.9%, 3 months 23.5%, 18 months 17.6%, p < 0.001) (Table 4).Type C -questions that deal with acute complications of diabetes (example question: How to resolve hypoglycemia?).There was a high percent of at least one correct answer (Table 5).There was a small number of in this type of questions also (Figure 4).Patients treated with insulin had the greatest number of correct answers in all test series.The percent of RCA increased significantly during the study in the patients treated with insulin (p < 0.01) and in the patients treated with oral hy-poglycemic drugs (p < 0.01).There were no RCA in the patients treated with lifestyle change after 3 and 18 months, which being a statistically significant change itself (Table 6).
Type D -questions that concern chronic complications of diabetes (example question: Diabetic foot, comprehension).There was a significant increase in the number of RCA in all test series and in patients with all therapeutic regimens, in comparison with the introductory testing (Table 7).

Discussion
The level of glycemic control seen through HbA1c is not satisfactory in our group of patients.It is, however, comparable to the other tested groups of patients in whom the education was done using printed material or where the patient was educated for self-management of DM [30][31][32][33][34][35][36][37][38][39][40] .The estimates of the average national HbA1c in the USA are 8.8 -8.9% 41 .Our group of patients showed glycemic control that was similar to the described ethnically -specific or low literacy groups [42][43][44][45][46] .
Since our examinees had a longer duration of DM and were regularly followed in the referent centers, we expected a somewhat lower level of HbA1c.Our results are comparable to the study that evaluated DM treatment at the University Center in the USA in which only 26.7% of patients reached the predefined HbA1c and only 3.2% achieved all guidelines proposed values of FPG, blood lipids and blood pressure 47 .
After educational intervention with the printed material the level of HbA1c was significantly reduced in patients treated both with insulin and oral hypoglycemic drugs.
The printed educational material led to a significant increase in the knowledge of diabetes facts, independently of the treatment regimen, similar to some previously reported studies [48][49][50][51] .The effects of educational intervention differ in patients treated with different therapeutic modalities -basic diabetes facts were best accepted by the patients that were treated with lifestyle change.Facts that reffer to selfmanagement and that influence daily decisions are best accepted by insulin treated patients.This group of patients also showed the greatest reduction in HbA1c levels throughout the study.Insulin patients should therefore be educated more often and with structured educational content -different skills in DM self-management should be involved (self glucose blood monitoring, use and dose correction of insulin, treatment of hypoglycemia etc.).Low level of RCA suggests that patient education and evaluation of DM knowledge (test form and the structure of questions for example) should be adapted to patient`s educational and literacy level 14,15 .We can also speculate that good effects of education with printed material in our group of patients was also due to the fact that this form of education is not a common way of health provider -patient communication in our country.It is also one of the reasons that we got a low percent of correct answers on some (predominantly multiple choice) questions.The printed material was available to the entire family 52 , and it could have led to better implementation of lifestyle change or medication adherence and consequently to better glycemic control.The Questionnaire was in part insufficiently accustomed to everyday life of our patients.Therefore, it required a somewhat different approach to some of diabetes problems suggesting that educational programs should adapt to the previous patients knowledge and answer patient's needs in a culturally competent manner.

Conclusion
Education using printed material, without the intervention of a diabetes educator, led to increase in diabetes knowledge as well as to improvement of glycemic control in our group of patients with DM type 2. We believe that this form of education among DM type 2 population can be a useful adjunct to DM treatment and it should be structured according to the disease treatment modality.

Fig. 2 -
Fig. 2 -Average test score (the percent of required correct answers per test sheet) during the study Type B -the questions that were testing knowledge of basic facts about DM (example question: What are the symptoms of diabetes?).At last one correct answer was given by the majority of examinees (Table3).There was a very low percent of RCA in all time series (introductory 4% vs 3 months -9% vs 6 months -6.5% vs 18 months: 6.0%).A significant change was achieved at three months and 6 months form baseline (p < 0.01; Figure3) There was no difference between the percent of correct answers between the patients on different therapeutic regimens at the introductory testing.A statistically significant difference was registered in the number of RCA in the patients treated with insulin, 3 months after the beginning of the study (14% vs 7%, p < 0.05) and in patients treated exclusively with lifestyle change, in whom the difference was statistically highly significant after 3 months and was sustained at 18 months at the beginning of the study: 5.9%, 3 months 23.5%, 18 months 17.6%, p < 0.001) (Table4).

Fig. 3 -
Fig. 3 -Required correct answers to type B questions (example question: What are the symptoms of diabetes?)

Fig. 4 -
Fig. 4 -Percent of required correct answers to type C questions (example question: What should you do when your blood sugar goes low?) p < 0.01 for 0 months vs 3 months, 0 month vs 6 months and 0 months vs 18 months

Table 5 Type C questions (example question: What should you do when your blood sugar goes low?) and answers at the introductory testing and 18 months after beginning of the study
Take a glass of juice, eat some chocolate, eat a sandwich