journal homepage: www.else vie r.com/locate /pateducou Please cite this article in press as: S. Chai, et al., The effect of diabetes self-management education on psychological status and blood glucose in newly diagnosed patients with diabetes type 2, Patient Educ Couns (2018), https://doi.org/10.1016/j.pec.2018.03.020
prevalence of depression and anxiety [10,11]. Therefore, the primary objective of the present study was to evaluate the efficacy of self-management education on psychological outcomes and glycemic control in newly diagnosed T2DM. 2. Methods 2.1. Study design The study was approved by the Ethics Committee in the First Hospital of Dandong. The patientsinvolvedin thestudywererecruited from both outpatients and inpatients of the First Hospital of Dandong. Thephysician in chargeof this researchfirst introducedtheprogram to patients eligible. With patients’ consent, the Informed Consent Forms were signed hereafter. Based on the statistical analysis, there was about 5%patienteligiblebut failing toparticipatein thisstudy.Patients had the right to refuse to participate in or withdraw from the study at anytime.FromMay12016toJuly12016,atotalof118newlydiagnosed T2DM were recruited into our study. The inclusion criteriawere newly diagnosed type 2 diabetes (!18 years) treated with oral hypoglycemic agents combined with or without insulin. Nursing mothers, pregnant woman, hepatorenal disease, or psychotic disorders were excluded. Eligible participants were divided into two groups according to completely randomized design: education group and control group. The program duration was six months. The education of the patients was accomplished by professional education nurses. All nurses were well-trained.Theeducationcoursesinthisstudyweredeliveredunder the guidance of Problem Based Learning (PBL). Lecturing approach, audio-visual approach, discussion approach and demonstration approaches were adopted. Lecturing approach was targeted at all patients and helped them to receive knowledge systematically. Audio- visual approach was implemented with the assistance of PowerPoint and video projector etc. Discussion approach was used to encourage patients to proactively ask questions and express their own feelings. Through discussion, patients were able to learn from each other and communicate on knowledge and experience of diabetes. In demon- stration approach, further explanation was given to patients with the help of specific models and teaching aids. As for the content of education courses, we designed a detailed curriculum in advance. We offered a two-hour course each week, comprising of two sessions of lectures (40 minutes each), two breaks (10 min each) and interactive session (20 min). In the interactive session, patients could communi- catewith each otherin groups or raiseany questions tothe lecturers. In control group, doctors make more health education with patients. Patients in the education group were given daily record sheets to track the diet, physical activities, medications and blood glucose. Patients shouldfill in the sheetsbasedon theirown conditions andreturn them by week. Based on the real-time information, we would assess the patient conditions and offer corresponding suggestions for better self- management. The Self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS) are the scales for assessing anxiety and depression, which includes 20 problems respectively, using a 4-point scalerangingfrom 1 (none,oralittleof thetime)to4 (most,orall of the time) [12,13]. The statistical score of all questions were calculated after completion of the answers. 2.2. Education group Patients in the education group were delivered 2-h diabetes education course by professional educational nurses every week. Patients in education group were divided into different groups by their most remarkable feature: overweight group (BMI ! 24 kg/m2, 30 patients); smoking group (!10 cigarettes per day, 10 patients); sedentary group (!7 hours per day, 12 patients); low education group (high school degree and less, 5 patients); drinking group (!50 g per day, 6 patients). The content of education included 2 S. Chai et al. / Patient Education and Counseling xxx (2018) xxx–xxx G Model PEC 5922 No. of Pages 6 healthydiet,exercise, self-monitoringofbloodglucose,complication prevention and understanding the risk factors of diabetes. Mean- while, the patients were provided with medical history assessment, physical examination and laboratory evaluation. The anxiety and depression scale was used to assess the psychological status of the patients at the beginning and end of the study. 2.3. Control group Patients in the control group did not receive diabetes education provided by professional education nurses. Diabetes education was usually provided upon routine outpatient visits. The length of education varied from 5 to 10 min. The content of education included healthy diet, exercise, self-monitoring of blood glucose, complication prevention and understanding the risk factors of diabetes. In addition, they were provided with medical history assessment, physical examination and laboratory evaluation. The anxiety and depression scale was used to assess the psychological status of the patients at the beginning and end of the study. 2.4. Statistical analysis SPSS 16 was used for statistical analysis. Data were expressed as mean Æ standard deviation or median (p25, p75). Statistical analysis included independent t-test, paired t-test and Mann- Whitney U test. P < 0.05 was considered statistically significant. 3. Results 3.1. Baseline data A total of 118 patients were assigned to the education group (n = 63) and control group (n = 55). No significant differences between groups were detected with respect to baseline clinical data and laboratory findings between the two groups. (Table 1) 3.2. Six months outcomes In education group, anxiety score decreased from 40.00 (38.00, 47.00) at baseline to 36.00 (30.75, 40.50) at the sixth month (P < 0.05), and depression score decreased from 41.00 (38.00, 47.75) at baseline to 35.50 (30.75, 42.25) at the sixth month (P < 0.05), respectively. In control group, anxiety score [42.00 (40.00, 44.50) vs. 42.50 (36.50, 47.50), P = 0.73] and depression score [42.00 (40.00, 42.00) vs. 44.00 (41.00, 47.50), P = 0.10] were not significantly lower at the sixth month, respectively. As compared with baseline, education group showed reduced fasting blood glucose (FBG) (8.00 mmol/L vs. 6.78 mmol/L, P < 0.00) and showed reduced postprandial blood glucose (PBG) (13.29 mmol/L vs. 7.90 mmol/L, P < 0.00) at the sixth month. In education group, HbA1 C significant- ly decreased at the sixth month compared with baseline [7.20% (6.40%, 9.10%) at baseline and 6.20% (5.80%, 6.60%) at the sixth month, P < 0.00]. FBG (8.00 mmol/L vs 7.70 mmol/L, P < 0.00) and PBG (12.67 mmol/L vs 10.58 mmol/L, P < 0.00) were significantly lower at the sixth month in control group than baseline. HbA1 C decreased from 7.90% (6.80%, 10.30%) at baseline to 6.70% (6.40%, 7.30%) (P < 0.00) at the sixth month in control group. (Table 2) 3.3. Group comparisons The education group showed significantly reduced anxiety score [36.00 (30.75, 40.50) vs. 42.50 (38.00, 47.00), P < 0.05] and depression score [35.50 (30.75, 42.25) vs. 44.00 (41.00, 47.50), P < 0.05] at the sixth month, compared with control group (Fig. 1A). Compared with control group, FBG [6.78 (6.43, 7.18) mmol/L vs. 7.70 (7.22, 8.23)mmol/L, P < 0.00] and PBG [7.90 (6.93, Please cite this article in press as: S. Chai, et al., The effect of diabetes self-management education on psychological status and blood glucose in newly diagnosed patients with diabetes type 2, Patient Educ Couns (2018), https://doi.org/10.1016/j.pec.2018.03.020
Poorly 10.00)mmol/L vs. 10.58 (8.70, 13.10)mmol/L, P < 0.00] significantly controlled blood glucose leads to serious complications, decreased at the sixth month in education group, respectively which will impose a large economic burden on the individual and (Fig. 1B). HbA1 C significantly decreased in education group healthcare system. Hence, caring of patients with diabetes is of compared to control group at the sixth month [6.20 (5.80, growing importance to public health. For proper control of 6.60)% vs. 6.70 (6.40, 7.30)%, P < 0.01] (Fig. 1C). There was no diabetes mellitus, it is essential for patients to actively participate difference in blood pressure (SBP), diastolic blood pressure (DBP), in their own management such as appropriate diet, physical body mass index (BMI), waist hip ratio (WHR), the ratio of urinary activity, blood glucose monitoring and adherence to medication. albumin to creatinine (UAER), blood lipids and depression scores The basic targets in the treatment of T2DM are the normalization of between education group and control group. blood glucose, blood pressure control and lipid management. Studies have shown that good glycemic control is associated with 4. Discussion and conclusion significant reduction in the risk of many complications. Control of diabetes is affected by both lifestyle factors and by pharmacologi- 4.1. Discussion cal treatments, and the management of diabetes is largely the responsibility of those affected. Several clinical practice guidelines Diabetes mellitus is a chronic and progressive disease and recommend a stepwise treatment pathway for T2DM. Diet control characterized by insulin resistance and relative insulin deficiency. and lifestyle intervention are considered as the cornerstones for Table 2 Comparison of pre- and post-intervention parameters each group parameter control group education group p-value Pre Post p-value Pre Post BMI(kg/m2)* 25.06 Æ 3.38 25.28 Æ 3.47 0.15 25.70 Æ 3.38 25.16 Æ 3.38 0.85 WHR* 0.89 Æ 0.06 0.88 Æ 0.06 0.07 0.88 Æ 0.06 0.87 Æ 0.05 0.23 SBP(mmHg)# 120.00(120.00, 140.00) 130.00(125.00, 140.00) 0.60 130.00(120.00, 140.00) 130.00(120.00, 140.00) 0.94 DBP(mmHg)# 80.00(80.00, 90.00) 85.00(80.00, 95.00) 0.01 80.00(80.00, 90.00) 80.00(80.00, 90.00) 0.45 FBG(mmol/L)# 8.00(7.00, 13.00) 7.70(7.22, 8.23) <0.00 8.00(7.00, 10.00) 6.78(6.43, 7.18) <0.00 PBG(mmol/L)# 12.67(10.05, 17.10) 10.58(8.70, 13.10) <0.00 13.29(9.70, 16.08) 7.90(6.93, 10.00) <0.00 HbAlc(%)# 7.90(6.80, 10.30) 6.70(6.40, 7.30) <0.00 7.20(6.40, 9.10) 6.20(5.80, 6.60) <0.00 UAER(mg/g)* 21.41 Æ 14.75 23.00 Æ 12.30 0.22 20.22 Æ 11.61 20.48 Æ 14.43 0.20 ALT(U/L)# 23.00(18.00, 29.00) 25.00(19.00, 31.00) 0.18 21.00(16.00, 33.00) 23.00(18.00, 30.00) 0.67 AST(U/L)# 21.00(17.00, 25.00) 21.00(18.00, 27.00) 0.41 19.00(17.00, 25.00) 19.00(16.00, 23.00) 0.11 CHO(mmol/L)* 5.30 Æ 1.17 5.25 Æ 0.93 0.65 5.35 Æ 1.06 5.14 Æ0.95 0.04 TG(mmol/L)# 1.80(1.30, 2.40) 1.95(1.42, 2.75) 0.09 1.60(1.00, 2.40) 1.49(1.16, 2.35) 0.47 HDL-C(mmol/L)# 1.26(1.07, 1.42) 1.24(1.10, 1.44) 0.85 1.37(1.08, 1.70) 1.36(1.11, 1.60) 0.50 LDL-C(mmol/L)* 3.29 Æ 0.93 3.28 Æ 0.80 0.90 3.18 Æ 0.75 3.12 Æ 0.77 0.47 anxiety score# 42.00(40.00, 44.50) 42.50(36.50,47.50) 0.73 40.00(38.00, 47.00) 36.00(30.75, 40.50) <0.05 depression score# 42.00(40.00, 42.00) 44.00(41.00, 47.50) 0.10 41.00(38.00, 47.75) 35.50(30.75, 42.25) <0.05 Abbreviations: BMI, body mass index; WHR, waist hip ratio; SBP, systolic blood pressure; DBP, diastolic blood pressure; FBG, fasting blood glucose; PBG, postprandial blood glucose; HbA1c, glycated haemoglobin A1 C ; UAER, urinary albumin to creatinine ratio; ALT, alanine aminotransferase; AST, aspartate aminotransferase; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol. *data expressed as mean Æ standard deviation and tested by independent t-test. # data expressed as median (p25, p75) and tested by Mann-Whitney U test. S. Chai et al. / Patient Education and Counseling xxx (2018) xxx–xxx 3 Table 1 Baseline characteristics of patients in the education group and control group parameter control group education group p value N(F/M) 55.00 (26.00/29.00) 63.00 (33.00/30.00) 0.58 Age* 53.00 Æ 9.00 55.00 Æ 7 0.00 0.10 Duration# 0.20(0.10, 0.50) 0.30 Æ 0.30 0.30 BMI(kg/m2)* 25.06 Æ 3.38 25.70 Æ 3.35 0.30 WHR* 0.89 Æ 0.06 0.88 Æ 0.06 0.59 SBP(mmHg)# 120.00(120.00, 140.00) 130.00(120.00, 140.00) 0.94 DBP(mmHg)# 80.00(80.00, 90.00) 80.00(80.00, 90.00) 0.91 FBG(mmol/L)# 8.00(7.00, 13.00) 8.00(7.00, 10.00) 0.22 PBG(mmol/L)# 12.67(10.05, 17.10) 13.29(9.70, 16.08) 0.89 HbAlc(%)# 7.90(6.80, 10.30) 7.20(6.40, 9.10) 0.07 UAER(mg/g)* 21.41 Æ 14.75 20.92 Æ 14.38 0.93 ALT(U/L)# 23.00(18.00, 29.00) 21.00(16.00, 33.00) 0.88 AST(U/L)# 21.00(17.00, 25.00) 19.00(17.00, 25.00) 0.67 Cholesterol(mmol/L)* 5.30 Æ 1.17 5.35 Æ 1.06 0.78 Triglyceride(mmol/L)# 1.80(1.30, 2.40) 1.60(1.00, 2.40) 0.37 HDL-C(mmol/L)# 1.26(1.07, 1.42) 1.37(1.08, 1.70) 0.12 LDL-C(mmol/L)* 3.29 Æ 0.93 3.18 Æ 0.75 0.47 anxiety score# 42.00(34.00, 42.50) 41.00(38.00,52.00) 0.25 depression score# 40.00(34.00, 45.50) 42.50(36.00, 51.00) 0.37 Abbreviations;: BMI, body mass index; WHR, waist hip ratio; SBP, systolic blood pressure; DBP, diastolic blood pressure; FBG, fasting blood glucose; PBG, postprandial blood glucose; HbA1c, glycated haemoglobin A1 C ; UAER, urinary albumin to creatinine ratio; ALT, alanine aminotransferase; AST, aspartate aminotransferase; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol. *data expressed as mean Æ standard deviation and tested by independent t-test. # data expressed as median (p25, p75) and tested by Mann-Whitney U test. G Model PEC 5922 No. of Pages 6 Please cite this article in press as: S. Chai, et al., The effect of diabetes self-management education on psychological status and blood glucose in newly diagnosed patients with diabetes type 2, Patient Educ Couns (2018), https://doi.org/10.1016/j.pec.2018.03.020
treatment of T2DM according to these guidelines. Comprehensive lifestyle interventions effectively decrease the incidence of diabetes in high-risk patients, but its effect in patients who already have T2DM are variable among trials [14,15]. So the role of education is to improve patients’ understanding of diabetes mellitus and enhance self-management practices. Meanwhile, active collaboration with care givers can improve clinical outcomes and quality of life. Similarly, mental health of patients with diabetes can not be ignored. Some studies have shown that both depressive disorders and anxiety disorders have a close relationship with type 2 diabetes [16,17]. Studies of adults suggest that psychological states, particularly depressive symptoms, may independently predict increased risk for type 2 diabetes [18,19]. Depressive symptoms have both been associated with increases in fasting insulin, insulin resistance, the onset of type 2 diabetes, and future risk for poorer glycemic control in T2DM [20,21]. Baumeister et al. [22] conducted a systematic review to evaluate the effectiveness of psychological and pharmacological interventions for depression in patients with both diabetes and depression. The results indicated that short- term glycemic control improved in pharmacological trials with depression remission. Xie et al. [23] reported that the psychosocial intervention was effective for depression symptoms and anxiety symptoms. Meanwhile, the additional effects indicated a better improvement of FBG, PBG, and HbA1c. These results demonstrated between Fig. 1. Changes in anxiety scores, depression scores, FBG, PBG and HbA1 C the education group and control group at the sixth month. Abbreviations;: A: anxiety and depression scores; B: FBG and PBG; C: HbA1 C ; CG: control group; EG: education group; FBG: fasting blood glucose; PBG: postprandial blood glucose; HbA1c: glycated haemoglobin A1 C . *p < 0.05, #p < 0.01 vs. CG (6m). 4 S. Chai et al. / Patient Education and Counseling xxx (2018) xxx–xxx G Model PEC 5922 No. of Pages 6 Please cite this article in press as: S. Chai, et al., The effect of diabetes self-management education on psychological status and blood glucose in newly diagnosed patients with diabetes type 2, Patient Educ Couns (2018), https://doi.org/10.1016/j.pec.2018.03.020 that the psychosocial intervention was very effective in treatment of T2DM patients with depression and anxiety. In addition, the improvement of anxiety and depression can also indirectly affect blood glucose. A recent study [24] focusing on psychological intervention for T2DM indicated that the patients turned to be more proactive in self-management, such as diet, along with the improvement of anxiety and depression. Therefore, the blood glucose was strictly controlled. In our study, the patients’ depression and anxiety scores have significantly decreased after 6 months’ self-management education, as compared with baseline data. Meanwhile, the blood glucose of patients have also been better controlled. Combining with the results of above listed studies, we believe that the improvement of depression and anxiety does play an active role in the control of blood glucose. As it’s known, there are many factors influencing the level of blood glucose. There is no denying that the improvement of blood glucose has been impacted by the professional education. Through systematic learning of diet, physical activities, diabetic medica- tions and complications, patients have gained a better under- standing of diabetes before enrollment. They have become capable of tackling with diabetes and also confident for proper self- management of diabetes. Therefore, the improvement of the psychological status of patients with diabetes promoted the outcome of education in turn. There are several possible pathophysiological mechanisms that may explain the possible relationship between depression and blood glucose level. Depres- sion is associated with disruption to the hypothalamic-pituitary- adrenal axis, causing an increase in cortisol and catecholamine, hormones responsible for antagonizing the hypoglycemic effects of insulin and resulting in IR [25]. People with diagnostic depression have increased levels of inflammation [26], and psychological stresses have been shown to activate the innate inflammatory response leading to IR in the early stage of T2DM [27]. Depression can also have influence on lifestyle associated with diabetes risk factors such as dietary intake, sleep disturbance and exercise [28,29]. Our study indicated both anxiety scores and depression scores were decreased at the sixth month as compared with baseline level in education group. Moreover, anxiety scores and depression scores of patients in the education group showed significant improvement as compared to the control group at the sixth month. The incidence of depression in patients with diabetes seems to be associated with family status, obesity, smoking habits, physical activity and sedentary lifestyle [30]. Therefore, in the education group, the content of education was mainly focused on these aspects. Patients were divided into different groups based on their actual situation. For example, there were an overweight group, a smoking group and a sedentary group. According to the assess- ment results of the patients, professional educators would define one pacesetter in each group every month. This approach was intended to stimulate the patients' motivation. With weight loss, quitting smoking and other lifestyle changes, the patients’ mental state and self-confidence had been significantly improved. The role of education professionals is to enable patients to acquire knowledge, while making active choices about their diseases. Subjective initiative cannot be given or taught, it is a spontaneous process that people must engage in for themselves. With the improvement of mental health, the control of blood glucose, quality of life and treatment adherence will be in a good direction. The present study found that there were significant improve- ments in blood glucose control at the sixth month in control group, compared with the baseline level. In control group, FBG, PBG and HbA1c reduced in different degrees by usual care compared with the baseline levels. In education group, FBG, PBG, HbA1 C and psychological scores improved significantly at the sixth month compared with the baseline levels. These results indicated that
both usual care and intensive education can improve glycemic control in some degree. But comparisons were made between the two groups. In the education group, FBG, PBG, and HbA1 C have improved significantly. Content of education in both the education and control groups involved diet, exercise, self-monitoring of blood glucose and prevention of complications. But in the education group, the content of education was more specific and detailed. On the basis of the patients’ ideal body weight and daily activity, the daily needs of calories were calculated. Individualized plan of daily or weekly exercises was formulated. Pictures and teaching aids were used to explain the complications of diabetes. Patients in the education group were delivered a 2-h diabetes education course by professional education nurses every week. While diabetes educa- tion was usually provided upon routine outpatient visits in control group. The length of course was usually from 5 to 10 min. The patients were merely provided with a brief principle of diet and exercise by doctors. The distinction of education can lead to difference in disease awareness. With the patients’ understanding of diabetes and the improvement of disease self-management, the mental state of the patients in the education group was improved. They became more active in self-management of blood glucose. The present findings were consistent with those of similar studies investigating the efficacy of structured group education compared with usual care [31,32]. Yang et al. [31] reported that there was significant improvement in glycemic outcomes from baseline to 3, 6 and 12 months in the structured education group, as compared with the usual care group. Research evidence [33] shown that intensified monthly self-monitoring of blood glucose combined with education was effective in improving postprandial glucose and HbA1 C in diabetes. The intervention group also showed higher improvements in knowledge, attitude and behavior than the control group. A recent study [34] reported that group education intervention may improve clinical outcomes, such as fasting glucose, systolic blood pressure (SBP) and diastolic blood pressure (DBP). However, our study indicated that education did not have any effect on other risk factors, including BMI, SBP, DBP, UAER, low- density lipoprotein cholesterol (LDL-C), and high-density lipopro- tein cholesterol (HDL-C), compared with control group. Studies of focused educational intervention did not yield consistent results. Some effects were shown on measures of glycemic control in studies that focused on diet or exercise alone. Recently, Huang and his colleagues [35] reported that diet modifications showed a significant improvement in all major cardiovascular risk factors associated with diabetes, such as the HbA1 C , SBP, DBP, and HDL-C, except for LDL-C and BMI. The physical activity intervention showed a significant improvement on HbA1 C and DBP, but not on the other risk factors (BMI, SBP, LDL-C, and HDL-C). The patient education program, however, did not show any difference in all the risk factors assessed in the study. There are many factors involved in the complexity of the education, including the variety of education programs and group size as well as the difference in education background. These factors need to be taken into account in interpretation of the results. The study was conducted in China. As it’s known, there are lots of differences between the Western and Eastern food. Carbohy- drate is the main type of diet in China, while the Western diet is dominated by meat, eggs and milk. Food difference plays an important role in the content of education. Carbohydrate should be appropriately controlled in Asia and high-fat food should be appropriately reduced in Europe and America. As mentioned earlier, a diagnosis of T2DM increases the risk of incidence of depression and may result in severe depression. Diabetes self- management is directly related to the prognosis of patients with diabetes. Therefore, in any case, self-management of blood glucose is suitable for all patients with diabetes in Asia, Europe and America. G Model PEC 5922 No. of Pages 6 S. Chai et al. / Patient Education and Counseling xxx (2018) xxx–xxx 5 There is also limitation to the present study. One shortcoming is that self-management education simply gives the patients the principle of diet and exercise, so the intensity of the exercise and variety of dietary regimen might also affect the clinical outcomes. Secondly, mental health is also affected by economic conditions, but we did not evaluate the patients’ incomes. Thirdly, we did not have a subgroup analysis of whether blood glucose levels were related to the severity of anxiety or depression. 4.2. Conclusion In summary, this paper indicated that self-management education was effective in improving psychological status and glycemic control. Intensive education did not lead to significant improvements in BMI, SBP, DBP, UAER, LDL-C, and HDL-C, compared to control group. 4.3. Practice implications Diabetes education plays a very important role in newly diagnosed patients with diabetes. Patients with newly diagnosed diabetes have mood swings, such as anxiety or depression, which can affect blood glucose levels. Through education, the mood of newly diagnosed patients with diabetes has been improved. Meanwhile, the blood glucose is better controlled. I confirm all patient/personal identifiers have been removed or disguised so the patient/person(s) described are not identifiable and cannot be identified through the details of the story. Funding: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. 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