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RAY SRIRATANA TABUCANON: IUIAS TEFRDIDNI FRE’SAVE TEEUUO CAEDEEF IAUSIVYE EIUVETIVEEDIECDIDS ISERU IIEOAVU VUEIAVAEE CIDIVEIUOECIADSEASEISFU2EOA UIUVE EUTTAIEVERAIREOA UIACEIUIASDF IRSE SOECDIDS ISERU IIEOAVU VU, SINGLE BLIND RANDOMIZED CONTROLLED TRIAL. THESIS ADVISOR: ASST.PROF. SOMKIAT SANGWATANAROJ, BACKGROUND: The prevalence of diabetes retinopathy (DR) was increased in type 2 diabetes patients (DM2) with coronary heart disease (CHD). Annual screening for diabetic retinopathy in DM2 were recommended as a standard of care. Showing and explaning to DM2 patients with retinal photography may motivate them to reduce CHD risk factors. OBJECTIVE: The aim of the study was to determine the visual feedback effects by showing the patient’s retinal photography for coronary heart disease risk factors reduction in DM2 with DR and CHD. METHODS: Fourty three DM2 patients with DR and CHD were prospectively enrolled and randomly assigned into two groups: showing and explaining retinal photography (RP) group and control group. The 6 minutes risk factor reduction education consisting of a basic knowledge of disease and related complications, diet control, physical activity, smoking cessation, and a stress reduction were provided to both groups. The primary end point was the difference of home blood pressure (BP) between baseline and that at 3 months after the randomization. Home BP was defined as a mean of home BP measured by a digital self-recorder twice a day for 7-consecuetive days. The secondary endpoints were the differences of body weight, waist circumferences, moderate physical activity, smoking rate, HbA1c, and lipid profiles at 3 months. RESULTS: A total of 21 patients in RP group and 22 patients in control group completed the study in a 3months period. The baseline characteristics between both groups were similar except for calcium channel blocker (CCB) was used more in RP group.There were no smokers in both groups. Baseline systolic BP/diastolic BP/mean arterial BP were 140±16/71±10/94±10 vs 132±18/69±10/90±11 mmHg for the intervention and control groups respectively. After 3 months the changes in systolic BP/diastolic BP/mean arterial BP were -8±14/-5±9/-6±9 vs +5±12/-1±9/+1±9 mmHg for the intervention and control groups respectively (p = 0.01 for systolic BP, 0.10 for diastolic BP, 0.01 for mean arterial BP). There is an increasing trend of physical activity and HDL-C in RP group (p = 0.14 for duration of duration of moderate physical activity in 1 week, p = 0.26 for HDL-C) CONCLUSIONS: Visual feedback of patients’ retinal photography for changing CHD risk factors in DM2 with DR and CHD have statistically significant effect on systolic BP reduction. The remaining CHD risk factors were not significantly different between both groups. There is an increasing trend of physical activity and HDL-C in RP group. Department : …………..Medicine…………….. Student’s signature ……………………………………… Field of study : ………...Medicine…………….. Advisor’s signature ……………………………………… Academic year : …………2012……………….. เรย์ ศรี รัตนาทาบูกานอน: ผลของการใช้ ภาพถ่ ายจอประสาทตาของผู้ป่วยประกอบการให้ คาแนะนาต่ อการลดปั จจัยเสี่ยงของโรคหลอดเ ลือดหัวใจEในผู้ป่วยเบาหวานชนิดที่E2Eที่มีเบาหวานขึน้ จอประสาทตาและโรคหลอดเลือดหัวใจ (SAVE TE EUUO CAEDEEF IAUSIV’EIUIAS TEFRDIDNI FRYEIUVETIVEEDIECDIDS ISERU IIEOAVU VUE IAVAEE CIDIVEIUOECIADSEASEISFUE2EOA UIUVEEUTTAIEVERAIREOA UIACEIUIASDF IRSE SOE CDIDS ISERU IIEOAVU VU) อาจารย์ที่ปรึกษาวิทยานิพนธ์หลัก ผศ.นพ.สมเกียรติ แสงวัฒนาโรจน์ , 141 หน้ า ที่มาของการวิจัย:ผู้ป่วยเบาหวานชนิดที่2 ที่มีโรคหลอดเลือดหัวใจร่ วมด้ วยพบความชุกของเบาหวานขึ ้นจอประสาทตาเพิ่มขึ ้น ผู้ป่วยเบาหวานชนิดที่2 ทุกรายจาเป็ นต้ องตรวจจอประสาทตาปี ละครัง้ เป็ นมาตรฐาน ดังนันการใช้ ้ ภาพถ่ายจอประสาทตาของผู้ป่วยเองมาใช้ ประกอบการให้ คาแนะนาเพื่อควบคุมปัจจัยเสี่ยงของโรคหลอดเลื อดหัวใจในผู้ป่วยเบาหวานชนิดที่2 ที่มีเบาหวานขึ ้นจอประสาทตาอาจทาให้ ผ้ ปู ่ วยเบาหวานชนิดที่2 ที่มีภาวะแทรกซ้ อนคือโรคเบาหวานขึ ้นจอประสาทตาและโรคหลอดเลือดหัวใจสามารถควบคุมปั จจัยเสี่ยงของโรคหลอดเ ลือดหัวใจได้ ดีขึ ้น วัตถุประสงค์ ของการวิจัย:เพื่อประเมินประสิทธิภาพของการให้ คาแนะนาผู้ป่วยเบาหวานชนิดที่ 2 ทีม่ ีโรคบาหวานขึ ้นจอประสาทตาร่ วมกับโรคหลอดเลือดหัวใจด้ วยภาพถ่ายจอประสาทตาประกอบในการลดปัจจัยเสี่ยงข องโรคหลอดเลือดหัวใจ วิธีการวิจัย:ทาการศึกษาในผู้ป่วยเบาหวานชนิดที่2ที่มีภาวะแทรกซ้ อนคือโรคเบาหวานขึ ้นจอประสาทตาและโรคหลอดเ ลือดหัวใจจานวน 43 คน โดยผู้ป่วยจะถูกสุ่มเป็ น 2 กลุ่มคือกลุ่มให้ คาแนะนาการลดปัจจัยเสี่ยงของโรคหลอดเลือดหัวใจโดยใช้ ภาพถ่ายจอประสาทตาประกอบและกลุ่มควบ คุม การให้ คาแนะนาประกอบด้ วยความรู้ พื ้นฐานของโรคเบาหวานและภาวะแทรกซ้ อน,การควบคุมอาหาร,กิจกรรมทางกาย, การเลิกบุหรี่ ,การลดความเครี ยดใช้ เวลาประมาณ 6 นาที และเก็บข้ อมูลระดับความดันโลหิตโดยใช้ เครื่ องวัดความดันโลหิตอัตโนมัติด้วยตนเองเป็ นเวลา1สัปดาห์ ,ชัง่ น ้าหนัก , วัดรอบเอว, ระดับน ้าตาลสะสม,โคเลสเตอรอล,ไตรกรี เซอไรด์ ,แอลดีแอลในเลือด,เอชดีแอลในเลือดก่อนและหลังเข้ าร่ วมวิจยั 3 เดือน ผลการศึกษา: มีผ้ ปู ่ วยกลุ่มศึกษาจานวน 21 คนและผู้ป่วยกลุ่มควบคุมจานวน 22 คน ข้ อมูลพื ้นฐานใน 2 กลุ่มไม่แตกต่างกัน ยกเว้ นกลุ่มศึกษาใช้ ยากลุ่มปิ ดกันแคลเซี ้ ยมมากกว่ากลุ่มควบคุม หลังปรับข้ อมูลพื ้นฐาน ความดันโลหิตซิสโตลิค/ความดันโลหิตไดแอสโตลิคความดันโลหิตเดลี่ย/ก่อนการศึกษาเท่ากับ140±16/71±10/94±10 และ 132±18/69±10 /90±11 มิลลิเมตรปรอทในกลุ่มศึกษาและควบคุมตามลาดับ หลังการศึกษา 3 เดือน การเปลี่ยนแปลงของความดันโลหิตซิสโตลิค/ความดันโลหิตไดแอสโตลิค/ความดันโลหิตเดลี่ย เท่ากับ -8±14/-5±9/-6±9 และ +5±12/-1±9/+1±9 มิลลิเมตรปรอทในกลุ่มศึกษาและควบคุมตามลาดับ (p= 0.01 สาหรับความดันซิสโตลิค, 0.10 สาหรับความดันไดแอสโตลิคและ 0.01 สาหรับความดันโลหิตเดลี่ย) และมีแนวโน้ มว่าผู้ป่วยในกลุ่มศึกษามีกิจกรรมระดับปานกลางและระดับเอชดีแอลในเลือดเพิ่มขึ ้น สรุปผลการศึกษา : การใช้ ภาพถ่ายจอประสาทตาของผู้ป่วยประกอบการให้ คาแนะนาต่อการลดปัจจัยเสี่ยงของโรคหลอดเลือดหัวใจ ในผู้ป่วยเบาหวานชนิดที่ 2 ที่มีเบาหวานขึ ้นจอประสาทตาและโรคหลอดเลือดหัวใจ นันสามารถลดความดั ้ นซิสโตลิคและความดันเดลี่ยได้ อย่างมีนยั สาคัญทางสถิติ และมีแนวโน้ มว่าผู้ป่วยในกลุ่มศึกษามีกิจกรรมระดับปานกลางและระดับเอชดีแอลในเลือดเพิ่มขึ ้น ภาควิชา……..อายุรศาสตร์ ………….. ลายมือชื่อนิสิต…………….…………………................................................. สาขาวิชา……….อายุรศาสตร์ …..……ลายมือชื่ออ.ที่ปรึกษาวิทยานิพนธ์หลัก……..…..……….................................. ปี การศึกษา……….2555……………. ลายมือชื่ออ.ที่ปรึกษาวิทยานิพนธ์ร่วม……..…..………................................... Background The prevalence of diabetes retinopathy was increased in type 2 diabetes patients with coronary heart disease. Type 2 diabetes patients with coronary heart disease are classified as high risk diabetes patients. Annual screening for diabetic retinopathy in type 2 diabetes mellitus patients were recommended as a standard of care. Feedback of medical imaging results can reveal visual evidence of actual bodily harm attributable to a given behavior. This may offer a particularly promising approach to motivating changes in health behavior to decrease risk (1). Showing and explaining to type2 diabetes patients with retinal photography may motivate them to reduce coronary heart disease risk factors. Method Study design and population The 3-month single blind randomized control trial was conducted at Cardiac center, King Chulalongkorn Memmorial Hospital, Bangkok, Thailand. The Ethical Committee approved the study. From February 8, 2012, through January 30, 2013, 43 type 2 diabetic patient with diabetic retinopathy and coronary heart disease aged ≥ 18 years was recruited from 44 patients responding to this study. Patient who could not understand the explanation, refused to participate in the study, pregnant or having advanced cancer were excluded. Intervention All Type 2 diabetes mellitus patients with diabetic retinopathy and coronary heart disease underwent coronary heart disease risk reduction counseling, standard treatment of coronary heart disease by the physician in charge, and retinal photograph to screen for diabetic retinopathy (DR). At baseline, data were collected on duration of type 2 diabetes mellitus, history of educational tutorial on coronary heart disease risk reduction, family history of coronary heart disease, degree of diabetic retinopathy, degree of coronary heart disease, smoking status, body weight, waist circumference, height, Body Mass Index (BMI), duration of moderate physical activity, home blood pressure monitoring, Glycosylated hemoglobin (HbA1c), total cholesterol, LDL-cholesterol, HDL-cholesterol and triglyceride. Home blood pressure monitoring was defined as a mean of home blood pressure (home BP) measured by digital self-recorder twice a day for 7-consecuetive days (2). Retinal photography was performed by a trained technician. The patient’s retinal photography was interpreted by an ophthalmologist. Diagnosis of diabetic retinopathy was diagnosis and grading by retinal photography following international clinical diabetic retinopathy and diabetic macular edema disease severity scale (3). - - No DR: No abnormalities. Mild non-proliferative diabetic retinopathy (NPDR): microaneurysms only. Moderate NPDR: more than just microaneurysms but less than severe NPDR. Severe NPDR: Any of the following: (1) more than 20 intraretinal hemorrhages in each of 4 quadrants, (2) definite venous beading in 2 or more quadrants, (3) prominent intraretinal microvascular abnormalities in 1 or more quadrants and no signs of proliferative retinopathy PDR (proliferative diabetic retinopathy): neovascularization, vitreous/preretinal hemorrhage. Coronary heart disease is defined as one or more lesions with ≥ 50% stenosis by coronary angiography. The risk factor reduction education consisting of a basic knowledge of disease and related complications, diet control, physical activity, smoking cessation, and stress reduction was a standardized and provided to both groups (duration: 6 min) to ensure equal conditions, both groups listened to a similar 6-minute education tutorial. Explaining the image was done with a concise and easy to understand method. Type 2 diabetes mellitus patients with diabetic retinopathy and coronary heart disease were prospectively enrolled and randomly assigned into two groups: showing and explaining retinal photograph (RP) group and control group. The RP group received image of their retina compared with image of normal retina. The control group received only for the risk factor education. Data were collected from participants on smoking status, body weight, waist circumference, height, Body Mass Index (BMI), duration of moderate physical activity, home blood pressure monitoring, Glycosylated hemoglobin (HbA1c), total cholesterol, LDL-cholesterol, HDLcholesterol, triglyceride in 3 months. Outcomes The primary outcome was the difference of home blood pressure monitoring at 3 months (including systolic blood pressure, diastolic blood pressure and mean arterial blood pressure). The secondary endpoints were the differences of body weight, waist circumference, duration of moderate physical activity, smoking rate, HbA1c, and lipid profiles in 3 months. Figure 1 Study Enrollment, Randomization, and Outcomes Type 2 diabetes mellitus & CHD & DR (n=44) Informed consent Did not provide consent (n=1) Baseline: Retinal photography & 7 days home BP monitoring Baseline: 7 days home BP monitoring, BW, waist circumference, duration of moderate physical activity, smoking status, HbA1c, total cholesterol, LDL-C, HDL-C, triglyceride Randomization (n=43) RP group (n=21) Control group (n=22) 1 Died before reaching primary end point (n=1) Died before reaching primary end point (n=1) RP group (n=20) Control group (n=21) At 3 months: 7 days home BP monitoring At 3 months: body weight, waist circumference, duration of moderate physical activity, smoking status, HbA1c, total cholesterol, LDL-C, HDL-C, triglyceride CHD = coronary heart disease, DR = diabetic retinopathy, BP = blood pressure, HbA1c= glycosylated hemoglobin, LDL-C = low density liproprotein-cholesterol, HDL-C = high density liproprotein-cholesterol, RP group = retinal photography group Data analyses For categorical data was show in number and percent. Continuous data was show in mean and standard deviation. Analysis by Fisher’s exact tests for the categorical variables. Unpaired t test for continuous variables. Linear regression analysis was used to adjusted for preexisting differences in categorical variables of baseline characteristic. ANCOVA was used to adjusted for preexisting differences in continuous variables of baseline characteristic. SPSS version 16 was used for data analyses. Results Baseline characteristics did not differ significantly between RP group and control group (Table 1), except for calcium channel blocker (CCB) was used more in RP group. The mean age was 64 years; 46% of patients were women, and the mean duration of type 2 diabetes mellitus was 5 years. No smokers in both groups. A total of 20 patients in RP group and 21 patients in control group completed the study at 3 months. Table 1 Baseline patient characteristics by Intervention group. Numbers are mean (SD) or percentage (%) Baseline Characteristic Demographic Age ( years) (mean (SD)) Female; n (%) Duration of Type 2 diabetes; (years) (mean(SD)) Income (Thai Baht) (mean (SD)) Family history of CAD Hypertension; n (%) Dyslipidemia; n (%) Diabetic nephropathy; n (%) Diabetic neuropathy; n (%) Ischemic stroke; n (%) Peripheral artery disease; n (%) RP (n = 21) Control (n = 22) p-value 64 (10) 65 (12) 0.76 10 (48) 5 (1) 10 (45) 4 (2) 1.0 0.50 31,538(61257) 4 (19) 20 (95) 12 (58) 12 (58) 14 (67) 1 (5) 1 (5) 27,523 (64813) 5 (23) 18 (82) 15 (38) 15 (38) 14 (64) 2 (1) 3 (14) 0.84 1.0 0.35 0.54 0.54 1.0 1.0 0.61 Number of significant CAD; n (%) Syntax score 2.5 (0.8) 20 (12) 2.5 (0.7) 22 (12) 0.92 0.58 Table 1(cont.) Baseline patient characteristics by treatment group. Numbers are mean (SD) or number (percentages) Baseline Characteristic RP (n = 21) Control (n =22) p-value Medication; n (%) - Diuretic 5 (24) 8 (36) 0.51 - Beta blocker 15 (71) 17 (77) 0.74 - ACEI/ARB 10 (48) 13 (59) 0.55 - Hydralazine 4 (19) 3 (14) 0.70 - Calcium channel blocker 10 (48) 3 (14) 0.02 - Aspirin 20 (95) 21 (95) 1.0 - Clopidogrel 13 (62) 15 (68) 0.74 - Sulfonylurea 3 (14) 8 (36) 0.16 - Metformin 4 (19) 1 (5) 0.19 - Insulin 15 (71) 9 (41) 0.07 - Fibrate 2 (10) 1 (5) 0.61 - Statin 19 (90) 0.23 22 (100) Clinical [mean (SD)] Systolic blood pressure; mmHg Diastolic blood pressure; mmHg Mean arterial blood pressure; mmHg Height; cm Body weight; kg Body mass index; kg/m2 Waist circumference; cm Duration of moderate physical activity; minute/week Laboratory measurements [mean (SD)] HbA1c; % Cholesterol; mg/dl LDL; mg/dl 140(16) 71 (10) 94 (10) 160 (11) 67 (14) 26 (4) 95 (10) 103 (128) 132 (18) 69 (10) 90 (11) 161 (10) 67 (14) 26 (4) 95 (11) 195 (367) 0.12 0.42 0.17 0.28 0.87 0.94 0.96 0.28 7.9 (2) 162 (30) 96 (31) 7.4 (1) 164 (30) 110 (52) 0.42 0.90 0.28 HDL; mg/dl Triglyceride; mg/dl GFR; ml/min/1.73 m2 43 (11) 152 (64) 40 (25) 38 (17) 139 (73) 49 (31) 0.21 0.57 0.31 RP = retinal photography There were 2 deaths, one from each group (1 with congestive heart failure from RP group, and 1 with intracerebral hemorrhage from control group) (Figure 1). Baseline systolic BP/ diastolic BP/ mean arterial BP were 140±16/71±10/94±10 vs 132±18/69±10/90±11 mmHg for the RP and control groups respectively (p = 0.12 for systolic BP, 0.42 for diastolic BP and 0.17 for mean arterial BP). After 3 months systolic BP/ diastolic BP/ mean arterial BP were 132±16/66±9/88±9 vs 137±20/68±10/91±11 mmHg for the RP and control groups respectively. Table 2. Changes in coronary heart disease risk factors. RP (n = 21) [mean (SD)] -8 (14) -5 (9) -6 (9) 0 (2) 0 (1) 0 (3) Control (n =22) [mean (SD)] +5 (12) -1 (9) +1 (9) 0 (4) 0(2) 0 (6) Different [mean (SD)] 13 (4) 4 (3) 7 (3) 0 (1) 0 (0) 0 (2) Parameters SBP change; mmHg DBP change; mmHg MABP change; mmHg Body weight change; kg BMI change; kg/m2 Waist circumference change; cm Duration of moderate physical activity change; minute/week +74 (261) -48 (276) 122 (82) Laboratory measurements HbA1c change; % -0.4 (2) -0.3 (1) 0.2 (0.5) Cholesterol change; mg/dl 0 (32) -7 (34) 7 (10) LDL change; mg/dl -4 (27) -10 (32) 6 (9) HDL change; mg/dl +1.8 (10) -1.5 (9) 3 (3) TG change; mg/dl -10 (92) +1 (66) 10 (24) SBP = systolic blood pressure, DBP = diastolic blood pressure, MABP = mean arterial blood pressure, BMI = body mass index, HbA1c = glycosylated hemoglobin, LDL = low density lipoprotein, HDL = high density lipoprotein, TG = triglyceride, RP = retinal photography p-value 0.01 0.10 0.01 0.78 0.70 0.9 0.14 0.78 0.49 0.50 0.26 0.66 The primary outcomes for the changes in systolic BP/ diastolic BP/ mean arterial BP were 8±14/-5±9/-6±9 vs +5±12/-1±9/+1±9 mmHg for the RP and control groups respectively (p = 0.01 for systolic BP, 0.01 for diastolic BP and 0.01 for mean arterial BP) (Table 2). Linear regression analysis was adjusted for CCB, there was no significant influence of CCB on systolic BP, diastolic BP and mean arterial BP (p= 0.27, 0.36 and 0.24 respectively).The secondary outcomes for the changes in body weight, waist circumferences, moderate physical activity, HbA1c, lipid profiles were not significantly different between both groups. However, there is an increasing trend of physical activity and HDL-C in RP group (p = 0.14 for duration of duration of moderate physical activity in 1 week, p = 0.26 for HDL-C) Discussion Type 2 diabetes mellitus with coronary heart disease remains major cardiovascular problem and major cause of hospitalization in Thailand(4). The prevalence of diabetes retinopathy was increased in type 2 diabetes patients with coronary heart disease. We hypothesized that visual feedback with retinal photography add on the education about coronary heart disease risk factors reduction may be more effective than education alone. Since getting people to change their health behaviors is generally very difficult and new intervention are needed by giving people visual evidence of how certain behaviors may be damaging their body could be an effective approach(1). This study found that education about coronary risk factors reduction combined with showing and explaining of patients’ retinal photography , as a potential motivation tool, was feasible, and led to a systolic and mean arterial blood pressure reduction after 3 months. Potential explanations for the results might be that visual feedback of patients’ medical images has a potential educationalmotivational role, capturing a teachable moment. This study found that there is a trend of increasing physical activity and HDL-C in RP group. Annual screening for diabetic retinopathy in type 2 diabetes mellitus patients are recommended as a standard of care. Retinal photography combined with education about coronary heart disease risk factors reduction in high risk diabetes patients for a better self-care in clinical practice have a benefit effect. However, the study has several important limitation such as small number of study population, short duration of follow up and no assessment about knowledge and motivation after completion of education about coronary risk factors reduction. Their can’t prove causality between the presence of diabetic retinopathy and motivation for reducing coronary heart disease risk factors.. To evaluate the long term outcomes, a prolongation of follow-up time was required. In conclusion, this study shows that visual feedback of patients’ retinal photography (RP) for changing coronary heart disease risk factors in type 2 diabetes mellitus with diabetic retinopathy and coronary heart disease have significant short term effect on systolic BP and mean arterial BP reduction. The remaining coronary heart disease risk factors were not significantly different . However, there is a trend of increasing physical activity and HDL-C in RP group. Reference 1. Hollands GJ, Hankins M, Marteau TM. Visual feedback of individuals' medical imaging results for changing health behaviour. Cochrane Database Syst Rev. 2010(1):CD007434. Epub 2010/01/22. 2. Parati G, Stergiou GS, Asmar R, Bilo G, de Leeuw P, Imai Y, et al. European Society of Hypertension guidelines for blood pressure monitoring at home: a summary report of the Second International Consensus Conference on Home Blood Pressure Monitoring. Journal of hypertension. 2008;26(8):1505-26. Epub 2008/07/16. 3. Wilkinson CP, Ferris FL, 3rd, Klein RE, Lee PP, Agardh CD, Davis M, et al. Proposed international clinical diabetic retinopathy and diabetic macular edema disease severity scales. Ophthalmology. 2003;110(9):1677-82. Epub 2003/09/18. 4. Pratipanawatr T, Rawdaree P, Chetthakul T, Bunnag P, Ngarmukos C, Benjasuratwong Y, et al. Thailand Diabetic Registry cohort: predicting death in Thai diabetic patients and causes of death. Journal of the Medical Association of Thailand = Chotmaihet thangphaet. 2010;93 Suppl 3:S12-20. Epub 2011/02/09.