SIGNIFICANCE OF PATIENT COUNSELING IN DIABETES MELLITUS; A PROSPECTIVE STUDY

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1 WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES Reddy et al. SJIF Impact Factor Volume 4, Issue 08, Research Article ISSN SIGNIFICANCE OF PATIENT COUNSELING IN DIABETES MELLITUS; A PROSPECTIVE STUDY Y. Hrushikesh Reddy* 1, D. Ashok Kumar 2, Mallesh M 2, M. Purushothaman 3 1 Assistant Professor, Department of Pharmacy Practice, P. Rami Reddy Memorial College of Pharmacy, Kadapa, AP Pharm.D Intern, Department of Pharmacy Practice, P. Rami Reddy Memorial College of Pharmacy, Kadapa, AP Principal, P. Rami Reddy Memorial College of Pharmacy, Kadapa, AP Article Received on 09 June 2015, Revised on 30 June 2015, Accepted on 18 July 2015 *Correspondence for Author Y. Hrushikesh Reddy Assistant Professor, Department of Pharmacy Practice, P. Rami Reddy Memorial College of Pharmacy, Kadapa, AP ABSTRACT To assess the impact of pharmacist providing patient counseling in bringing therapeutic outcomes and Quality of life (QOL) improvement in Type II Diabetes Mellitus (DM) patients. A prospective observational study was conducted for a period of 10 months from July 2014 to April 2015 at Rajiv Gandhi Institute of Medical Sciences (RIMS), a tertiary care teaching hospital, Kadapa. A total of 125 patients with Type II DM were assigned into 3 groups. They were received basic diabetic counselling (regarding disease, medication & life style modifications) for 3 months at each visit. RBS, FBS, PPBS, TC, TG, HDL, LDL & the effects of mono, double & triple combination therapies were measured at baseline & at the end of the study. QOL was assessed by the using the KAP questionnaire and SF 12. Significant reductions were found in FBS (228 ± 10.5 to 140 ± 5.6), RBS (350 ± 25.5 to 203 ± 10.6), PPBS (250 ± 20.5 to 143 ± 10.3) & also greater reductions were observed in TC, TG, HDL, LDL levels in all the groups after the counseling. Dramatic improvement in patient s QOL was found. The study concluded that chronic diseases like DM affect the QOL of patients so the pharmacist providing patient counseling has a major impact in improving the health care outcomes like glycemic control & QOL. KEYWORDS: Type-II Diabetes Mellitus, Patient counseling, Quality of life. Vol 4, Issue 08,

2 ABBREVIATIONS DM: Diabetes Mellitus; RBS: Random Blood Sugar; FBS: Fasting Blood Sugar PPBS: Post Prandial Blood Sugar; TC: Total Cholesterol; TG: Triglycerides; HDL: High Density Lipoprotein; LDL: Low Density Lipoprotein; QOL: Quality of Life; SF 12: Short Form 12; KAP: Knowledge, Attitude & Practice; RIMS: Rajiv Gandhi Institute of Medical Sciences; MET: Metformin; GLB: Glibenclamide; GLM: Glimepiride; PGZ: Pioglitazone; SEM: Standard Error Mean; ANOVA: Analysis of variance. INTRODUCTION Diabetes mellitus (DM) is a group of metabolic disorders characterized by the hyperglycemia. It is associated with abnormalities in carbohydrate, fat, and protein metabolism and results in chronic complications including microvascular and macrovascular disorders. [1] The economic burden of DM approximated $245 billion in 2012 (United States), including direct medical and treatment costs as well as indirect costs attributed to disability and mortality. [2] DM is the leading cause of blindness in adults aged 20 to 74 years and the leading contributor to development of end-stage renal disease. It also accounts for approximately 82,000 lower extremity amputations annually. Finally, a cardiovascular event is responsible for two-thirds of deaths in individuals with Type 2 DM. [1] The prevalence of Type-II diabetes, especially in India has grown over the past decade, despite of the enormous facilities available to control its growth. According to the diabetic atlas 2006 published by the international diabetes federation, the number of people with diabetes in India currently around 40.9 million is expected to risk to 69.9 million by 2025 unless urgent preventive steps are taken. [3] Type II DM is less common in non- western countries where the diet contains fewer calories & daily caloric expenditure is higher. However as people in these countries adopt western lifestyles hence weight gain & Type II DM is becoming virtually epidemic. [3] Although efforts to control hyperglycemia and associated symptoms are important, the major challenges in optimally managing the patient with DM are targeted at reducing or preventing complications, and improving life expectancy and quality of life. [1] The goal of Pharmaceutical care is to improve patient health outcomes by ensuring effective, safe, and cost-effective drug therapy. Pharmacists are in a prime position to ensure that use of medications by the patients safely and appropriately. [4, 5, 6] Patient counseling is an important task for achieving pharmaceutical care by providing medication related information orally or in written form to the patients or their representatives. [7, 8] Nutritional counseling forms an essential component in the management of diabetes. [9, 10] Patient adherence to medication and Vol 4, Issue 08,

3 lifestyle modifications plays an important role in diabetes management. [11] The possible benefits of physical activity for the patient with Type 2 Diabetes are substantial, and studies strengthen the importance of long-term physical activity programs for the treatment and prevention of this common metabolic abnormality and its complications. [12, 13] Continuous education programmes and counseling helps Diabetic patients to emphasize and re-emphasize the importance of risk factor, prevention, adherence to medication and behavioral changes to prevent recurrences of disease, there progression, and ultimately minimize hospitalization. [14] METHODS AND MATERIALS A prospective observational study was conducted for period of 10 months from July 2014 to April 2015 at RIMS, Kadapa an 800 bedded tertiary care teaching hospital. A total of 125 patients with Type II DM were assigned randomly into 3 groups [Fig No. 1] based on treatment regimen as follows 1. Group - I: patients with monotherapy. 2. Group - II: patients with double combination therapy. 3. Group - III: patients with triple combination therapy. At baseline patients were interviewed to obtain their medical and medication history and the details were noted in a data collection proforma regarding FBS, RBS, PPBS, TC, TG, HDL, LDL, effects of mono, double & triple combination therapy & all the baseline parameters were recorded. All these patients were counseled regarding disease, medication (direction of use, advice on side effects & precautions), life style modifications (exercise, nutrition, personal hygiene, self-monitoring of glucose, self-care regarding foot care, eye care etc.) &. Patients were asked to come back for follow-up after 3 months once at each visit and all the parameters were recorded then. Feedback question were asked to assess the patients understanding of what was taught to them. Ethical clearance The study was approved by the Human Research Ethical committee, RIMS, Kadapa. Study Materials A specialized patient data collection proforma was used to collect the patient s data and the patients prescriptions were reviewed at every visit, patient counseling was done for the patients & all the details were collected in Patient counseling proforma and the patients QOL Vol 4, Issue 08,

4 was assessed by using the Knowledge, Attitude & Practice (KAP) Questionnaire and SF 12 questionnaire, [15, 16] based on these patient s physical and mental components were calculated. RESULTS & DISCUSSION All patients baseline parameters [Table No. 1] were recorded before the counseling as control values and after the counseling all parameters were recorded & compared the effect of counseling along with medication to the baseline values. Fig No. 2, 3 & 4 gives the statistics of the groups I, II & III respectively, highest number of patients are under double combination therapy and least were on triple combination. Overall male (n-67) patients are identified more when compared with females (n-58). Metformin was the mostly used drug; even in the combinations Metformin has its major proportion and Glibenclamide follows it. Effect of Patient Counseling on FBS Values Significant reductions [p = *** ] were found in FBS values, the baseline values in group-i was 220 ± 8 which were reduced to 203 ± 11 after 3 months followed by reduction to 180 ± 3 & 172 ± 7 by 6 and 9 months respectively. Similar reductions were observed in group-ii (225 ± 10 to 145 ± 3) & Group-III (228 ± 10.5 to 140 ± 5.6) from baseline to 9 months after the counselling {Fig No. 5}. Effect of Patient Counseling on RBS Values Significant reductions [p = < ***] were found in RBS values, the baseline values in group-i was 331 ± 10 which were reduced to 298 ± 7 after 3 months followed by reduction to 263 ± 9 & 230 ± 9 by 6 and 9 months respectively. Similar reductions were observed in group-ii (208 ± 10 to 342 ± 18) & Group-III (350 ± 25.5 to 203 ± 10.6) from baseline to 9 months after the counselling {Fig No. 6}. Effect of Patient Counseling on PPBS Values A Notable reductions [p = **] were found in PPBS values, the baseline values in group-i was 230 ± 12 which were reduced to 211 ± 3 after 3 months followed by reduction to 193 ± 4 & 181 ± 5 by 6 and 9 months respectively. Similar reductions were observed in group-ii (250 ± 20.5 to 143 ± 10.3) & Group-III (243 ± 9 to 145 ± 11) from baseline to 9 months after the counselling {Fig No. 7}. Vol 4, Issue 08,

5 Effect of Patient Counseling on TC Values Significant reductions [p= *** ] were found in TC values, the baseline values in group-i was 135 ± 9 which were reduced to 128 ± 6 after 3 months followed by reduction to 112 ± 5 to 104 ± 9 by 6 and 9 months respectively. Similar reductions were observed in group-ii (100 ± 4 to 128 ± 7) & Group-III (170 ± 4 to 121 ± 2) from baseline to 9 months after the counselling {Fig No. 8}. Effect of Patient Counseling on TG Values Significant reductions [p = ** ] were found in TG values, the baseline values in group-i was 140 ± 16 which were reduced to 129 ± 8 after 3 months followed by reduction to 115 ± 4 & 107 ± 9 by 6 and 9 months respectively. Similar reductions were observed in group-ii (140 ± 11 to 105 ± 2) & Group-III (160 ± 6 to 131 ± 6) from baseline to 9 months after the counselling {Fig No. 9}. Effect of Patient Counseling on HDL Values HDL values were increased moderately [p = ], the baseline values in group-i was 38 ± 2 which were reduced to 39 ± 2 after 3 months followed by increase to 41 ± 4 & 43 ± 4 by 6 and 9 months respectively. HDL increase was also observed in group-ii (39 ± 6 to 49 ± 6) & Group-III (41 ± 3 to 45 ± 4) from baseline to 9 months after the counselling {Fig No. 10}. Effect of Patient Counseling on LDL Values Mild reductions [p = ] were found in LDL values, the baseline values in group-i was 78 ± 7 which were reduced to 70 ± 5 after 3 months followed by reduction to 63 ± 6 & 50 ± 4 by 6 and 9 months respectively. Similar reductions were observed in group-ii (70 ± 10 to 62 ± 2) & Group-III (98 ± 6 to 51 ± 3) from baseline to 9 months after the counselling {Fig No. 11}. Assessment of Patient Counseling on Knowledge, Attitude and Practice All the patients were undergone through KAP questionnaire by the pharmacists prior to the counseling and also after counseling [Table No. 2], significant improvement was observed after the counseling. Assessment of Patient Counseling on Quality of Life SF 12 questionnaire was used to analyze the quality of life of the patients, greater improvement in patient s physical and mental components was observed [Table No. 3 & 4] after the counseling to the patients. Vol 4, Issue 08,

6 Table No. 1 Baseline Characteristics of Each Group. Parameter Group - I Group - II Group - III Sex (M/F) 28/7 27/32 12/9 Age 55 ± ± ± 3.5 Diabetes Duration 3.5 ± ± ± 0.5 FBS 220 ± ± ± 10.5 RBS 331 ± ± ± 25.5 PPBS 230 ± ± ± 9 Total cholesterol 135 ± ± ± 4 Serum Triglycerides 140 ± ± ± 6 HDL 38 ± 2 39 ± 6 41 ± 3 LDL 78 ± 7 70 ± ± 6 Table No. 2 - Effect of Patient Counseling on Knowledge, Attitude and Practice. Sl. No KAP Questionnaire Pre Counseling (%) Post Counseling (%) Yes No Yes No Diabetes is a condition in which blood sugar level is higher than the normal? 119(95.2) 6(4.8) 124(99.2) 1(0.8) Diabetes is caused due to increased 2(1.6) 123(98.4) intake of sugar (or) sugar products? 16(12.8) 109(87.2) Do you accept that a diabetes mellitus 117(93.6) patient should have a regular blood 81(64.8) 44(35.2) 8(6.4) sugar checkup at least once in a month? Do you know about suitable diabetic diets are essential for blood glucose 41(32.8) 84(67.2) 118(94.4) 7(5.6) level? Do you know that suitable regular exercise (yoga& walking) and other life style modifications are essential for 67(53.6) 58(46.4) 102(81.6) 23(18.4) blood glucose control? Do you know that regular exercise increased blood circulation and there by helps in utilization of excess amount of 32(25.6) 93(74.4) 105(84) 20(16) glucose by tissues? Do you know about the symptoms and consequences of diabetes? 69(55.2) 83(66.4) 101(80.8) 24(19.2) Do you know the diabetic patients may experience blurred vision, confusion, sweating, and increase the heart beat 26(20.8) 99(79.2) 92(73.6) 33(26.4) due to fall in blood glucose than normal? In order to overcome the above situation, the patients should carry and eat a sugar candy (or) a teaspoonful 53(42.4) 72(57.6) 119(95.2) 6(4.8) sugar or even a biscuit? Are you carrying regularly the diabetic I.D proof always with you? 26(20.8) 99(79.2) 89(71.2) 36(28.8) Vol 4, Issue 08,

7 Do you know that blood sugar and urine sugar test tells about your control of diabetes? Do you know that diabetic patient need proper foot care? Foot care includes keeping your foot clean & wearing foot ware of proper size with more comfort? Do you know that diabetic foot wares are available in market separately? Do you know that smoking and alcohol can worsen your diabetes condition? Do you know that regular intake of diabetic medication can control your blood sugar level? Do you know that diabetic patients required measuring his/her BP at least once in two months? Do you think that regular monitoring of diabetes is improved your life period? Do you think that regular control of diabetes will prevent other co-morbid conditions? Do you think this information is helping you to control diabetes? 79(63.2) 46(36.8) 121(96.8) 4(3.2) 36(28.8) 89(71.2) 119(95.2) 6(4.8) 36(28.8) 89(71.2) 119(95.2) 6(4.8) 13(10.4) 112(9.6) 117(93.6) 8(6.4) 42(33.6) 83(66.4) 93(74.4) 32(25.6) 113(90.4) 12(9.6) 122(97.6) 3(2.4) 79(63.2) 46(36.8) 118(94.4) 7(5.6) 38(30.4) 87(69.6) 120(96) 5(4) 38(30.4) 87(69.6) 116(92.8) 9(7.2) 43(34.4) 82(65.6) 122(97.6) 3(2.4) Table No. 3 - Assessment of Physical Components. Sl. No. Physical Components Average Score at Pre- Counseling (%) Average Score at Post-Counseling (%) 1. Physical Functioning a Moderate activities b Climb several flights Role Physical a Accomplished less b Limited in kind Bodily Pain a Pain- magnitude General Health EVGFP Rating: a Health excellent Vol 4, Issue 08,

8 Table No. 4 - Assessment of Mental Components Sl. No. Mental Components Average Score at Pre- Counseling Average Score at Post- Counseling 1 Vitality a Proper life b Energy Social Functioning a Social time Role Emotional a Careful about life Mental Health a Peaceful b Happy Fig No. 1 Distribution of Patients Fig No. 2 Group I Statistics Fig No. 3 Group II Statistics Vol 4, Issue 08,

9 Fig No. 4 Group III Statistics Fig No. 5 Effect of Patient Counseling on FBS Values Data represents Mean ± SEM; One way ANOVA: p= *** Fig No. 6 Effect of Patient Counseling on RBS Values Data represents Mean ± SEM; One way ANOVA: p = < *** Fig No. 7 Effect of Patient Counseling on PPBS Values Vol 4, Issue 08,

10 Data represents Mean ± SEM; One way ANOVA: p = ** Fig No. 8 Effect of Patient Counseling on TC Values Data represents Mean ± SEM; One way ANOVA: p = *** Fig No. 9 Effect of Patient Counseling on TG Values Data represents Mean ± SEM; One way ANOVA: p = ** Fig No. 10 Effect of Patient Counseling on HDL Values Vol 4, Issue 08,

11 Data represents Mean ± SEM; One way ANOVA: p = Fig No. 11 Effect of Patient Counseling on LDL Values Data represents Mean ± SEM; One way ANOVA: p = CONCLUSION The management of chronic ailments like Diabetes Mellitus not only requires the prescription of the appropriate pharmacological regimen by the physician but also requires nonpharmacological measures, intensive education and counseling of the patient for better glycemic control. Various factors like understanding of the patients about the Diabetic causes, dietary regulations, self-monitoring of blood glucose levels are known to play a vital role in diabetes management. Patient adherence to medication and lifestyle modifications plays an important role in diabetes management. Pharmacist providing patient counseling helps support the diabetic patients in understanding the above aspects. Patient counseling has its unique role and response in controlling and preventing the morbidity and mortality associated with DM and thereby improves the quality of life of the diabetic patients. REFERENCES 1. Joseph T. Dipiro et al, Text book of Pharmacotherapy a Pathophysiologic Approach, Diabetes Mellitus, Mc Graw Hill Publications, 7th edition, 2008, chapter 77, Page No American Diabetes Association; Economic Costs of Diabetes in the U.S. in 2012; Diabetes Care Publish Ahead of Print, published online March 6, National Diabetes Information Clearing house, National Institute of Diabetes & Kidney Diseases, National Institute of Health, Treatments for Diabetes. Vol 4, Issue 08,

12 4. Palaian S., Chhetri A.K., Prabhu M., Rajan S., Shankar P. V., Role of Pharmacist in Counseling Diabetes Patients, IJP., 2005; 4: Gerber R.A., Liu G., Mccombs J.S., Impact of pharmacist consultations provided to patients with diabetes on healthcare costs in a health maintenance organization, Am J Manag Care., 1998; 4(7): American Diabetes Association, Standards of medical care for patients with diabetes mellitus, Dia. care., 2004; 2: USP medication counseling behaviour guideline. USP di update volumes I and II Rockville, the USP Convention Inc., 1997; : American Diabetes Association, Physical Activity/Exercise and Diabetes, Dia. Care., 2004; 27: Mellen P.B., Palla S.L., Goff D.C., Bonds D.E., Prevalence of Nutrition and Exercise Counseling for Patients with Hypertension, JGI MED., 2004; 19: Singh K., nutritional counseling in management of diabetes mellitus, int. j. diab. dev. countries., 1997; 17: Goldhaber-Fiebert J.D., Goldhaber-Fiebert S., Randomized C6ntrolled Community-Based Nutrition and Exercise Intervention Improves Glycemia and Cardiovascular Risk Factors in Type 2 Diabetic Patients in Rural Costa Rica, Dia. Care., 200; 26: Franz M.J., Bantle J. P., Beebe C. A., Brunzell J.D., Chiasson J. L., Garg A., Holzmeister L.A., Hoogwerf B., Davis D.E., Mooradian A.D., Purnell J.Q., and Wheeler M., Evidence-Based Nutrition Principles and Recommendations for the Treatment and Prevention of Diabetes and Related Complications, Dia. Care., 2002; 25: Albright A.L., Apovian C.M., Clark N.G., Franz M. J., Hoogwerf B. J., Lichtenstein A. J., Nutrition Recommendations and Interventions for Diabetes; A position statement of the American Diabetes Association, dia. Care., 2007; 30(1): S48-S D.A. Satpute, P. H. Patil, et al, Assessment of impact of patient counseling, nutrition & exercise in patients with Type II DM International Journal of Pharm Tech Research., 2009; 1: PP Praveena P, Impact of patient counseling on Knowledge, Attitude, Practice and Quality of Life in patients with Type II Diabetes mellitus and Hypertension Indian Journal of Pharmacy Practice Volume 4 Issue 1 Jan-Mar., 2011; 4(1): Shaoqi Rao et al Adaptation of the Audit of Diabetes-Dependent Quality of Life questionnaire to patients with diabetes in China Diabetes research and clinical practice, 2011; Vol 4, Issue 08,