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“EVALUATION OF THE IMPACT OF CLINICAL PHARMACIST PROVIDED PATIENT EDUCATION INTERVENTION ON HEALTH OUTCOME MEASURES OF TYPE II DIABETES MELLITUS IN RURAL POPULATION”

SYNOPSIS FOR M.PHARM DISSERTATION

SUBMITTED TO RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BY Y.L. SANTHOSH. B. Pharm

UNDER THE GUIDANCE OF K.V. RAMANATH M.Pharm, MBA (HRM&HSM), PhD.

DEPARTMENT OF PHARMACY PRACTICE SAC COLLEGE OF PHARMACY B.G.NAGARA RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERATION

1 Name of the candidate & Mr. Y.L. SANTHOSH Address DEPARTMENT OF PHARMACY PRACTICE, S.A.C. COLLEGE OF PHARMACY, B.G. NAGARA, KARNATAKA-571448.

PERMANENT ADDRESS: S/O LAKSHMI NARAYA GUPTHA.Y.S. BALAJI NILAYA, NEAR GEETHA MANDIR OPP.TO SAPTHAGIRI NILAYA CHINTHAMANI,KARNATAKA-563125.

2 Name of the institute S.A.C. COLLEGE OF PHARMACY B.G. NAGARA, NAGAMANGALA TALUK, MANDYA DISTRICT, KARNATAKA -571448

3 Course of the study MASTER OF PHARMACY (Pharmacy Practice)

4 Date of admission 08/06/2009

“EVALUATION OF THE IMPACT OF CLINICAL 5 Title of the topic PHARMACIST PROVIDED PATIENT EDUCATION INTERVENTION ON HEALTH OUTCOME MEASURES OF TYPE II DIABETES MELLITUS IN RURAL POPULATION” 6. 6 6.1 Need for study: -

Diabetes mellitus is a metabolic disorder characterized by chronic hyperglycemia with disturbances of carbohydrate, fat and protein metabolism resulting from defects in insulin secretion, insulin action, or both. The classification of diabetes is based on aetiological types. Type 1 indicates the processes of beta-cell destruction that may ultimately lead to diabetes in which insulin is required for survival. Type 2 diabetes is characterized by disorders of insulin action and /or insulin secretion. The third category, "other specific types of diabetes," includes diabetes caused by a specific and identified underlying defect, such as genetic defects or diseases of the exocrine pancreas.1

According to the Diabetes atlas 2006 published by the International Diabetes Federation, the number of people with diabetes in India is currently around 40.9 million is expected to rise to 69.9 million by 2025.2

Diabetes and other chronic non-communicable diseases (NCDs) are significant public health challenges in the 21st century. It is estimated that 3.8 million deaths were attributable to diabetes in 2007, equivalent to 6% of all deaths globally. India has the largest population of diabetes patients when compared to any other country, diabetes deaths accounts for 9.7%.

In India the prevalence of diabetes is increasing. Diabetes was once viewed as a rich man’s disease but this idea is wrong. The reason for prevalence of diabetes is changing lifestyle, Sedentary occupations, and irregular food habits. There have been corresponding changes in semi-urban environments also. So this leads to increase morbidity and mortality of non communicable diseases (NCDs). Prevention is therefore the best strategy. 3

Quality of life is an important health outcome in its own right, representing the ultimate goal of all health interventions. People with diabetes have a poor quality of life than people with no chronic illness. The goals of chronic care are ‘not to cure but to enhance functional status, minimize distressing symptoms, prolong life’ through secondary prevention and enhance quality of life .4 Quality of life (QOL) measurements are increasingly recognized as important in the assessment of chronic diseases and in evaluating medical outcomes.

Adherence to medication regimen is generally defined as ‘the extent to which patient’s medication-taking behavior coincides with the intention of the health advice he or she has been given’. Medication adherence is one of the important factors that can determine the therapeutic outcome. This therapeutic outcome is quite important especially in patients suffering from chronic illnesses. It is a known fact that whatever may be the efficacy of the drug, it cannot show its efficacy unless the patients take the drug. Therefore adherence is considered as vital link between the treatment and the therapeutic outcomes in medical care.18 19

KAP (Knowledge, Attitude and Practice) tells us what people know about certain things, how they feel and also how they behave. Knowledge refers to their understanding about diabetes; Attitude refers to their feelings as well as any preconceived ideas that they may have towards the disease; Practice refers to the ways in which they demonstrate their knowledge and attitude through their actions. Understanding the levels of Knowledge, Attitude and Practice will allow for a more efficient process of awareness creation among the people and illustrate the areas in which the population most needs education and training.

Several studies have reported the positive impact of clinical pharmacists provided patient education intervention counseling on glycemic control and quality of life outcomes in diabetic population.5 6 7 8

Adichunchunagiri Institute of Medical Sciences (AIMS) is a 750 bedded tertiary care teaching hospital situated in a rural area of B.G.Nagara of Nagamangala taluk. There were no studies conducted previously in this rural setup regarding the quality of life in Type II diabetes mellitus. Hence the present study is taken in rural population to assess the KAP /QoL by education on diabetes mellitus, life style modifications and evaluating its impact by pharmacist. This study is aimed at providing better management of the disease, by better glycemic controls and improving the quality of life of patients in rural population.

6.2 Review of the Literature:

 Subish Palaian et al carried out a prospective study on the impact of pharmacist provided patient counseling on DM in Manipal. Overall, 46 patients were randomized to receive Knowledge, Attitude, and Practice (KAP) Questionnaire consisted of 25 questions: seven attitude/practice questions and 18 knowledge-related questions. The results showed that the counseling by pharmacists was effective in improving patients’ knowledge but not in improving their attitudes and practices. 9

 Adepu Ramesh et al conducted a study on Quality of life in Type-II DM patients in two selected community pharmacies in Calicut, Kerala, India, after obtaining the pharmacists consent for a period of six months. Total 70 patients were enrolled in the study and divided in to two group’s test and control group. The results showed that the patient counseling by pharmacists not only improves the knowledge, attitude and practices of the patients towards their disease management but also increases their quality of life.10  Z Ghazanfari et al conducted a study on effect of a designed educational program on the lifestyle of the patients suffering from type 2 diabetes mellitus at Iranian Diabetes Society, Tehran, Iran. A total of 90 diabetic patients aged 30-60 years old were enrolled and divided into two groups by a randomized process. Where medication/education plus two hour educational sessions regarding healthy lifestyle to control and prevent diabetes were given. A questionnaire was used for data collection at baseline and 1- month follow up was made. The results of the educational program shows improved a significant increase in the knowledge (P< 0.001), attitude (P< 0.01) and practice (P< 0.01) of the intervention group towards healthy behaviors regarding nutrition, physical activity and self care.11

 Heather P. Whitley et al stated that medication adherence is an integral aspect of disease state management for patients with chronic illnesses. The study aimed to assess self-reported medication adherence, knowledge of therapeutic goals (hemoglobin A1C [A1C], low density lipoprotein cholesterol [LDL-C] and blood pressure [BP]) in diabetes patients. The results showed that 48% of total patients were non-adherence to medications. Actions may be taken to improve these aspects of patient knowledge, adherence to avoid unnecessary micro vascular and macro vascular complications.12

 Sarang Kim et al reported that limited health literacy is common problem with diabetic knowledge and associated with the outcomes. Because diabetes requires extensive self-care, differences in self-management behaviors may be a key contributor to the disparity in outcomes. An educational study showed that diabetes education was effective in improving self-management, diabetes knowledge, and glycemic control for patients with adequate and limited health literacy.13

 Hirono ishikawa served and developed a new health literacy scale, which showed good result in the better understanding of the patient’s potential barriers to self-management of disease and health-promoting behaviors.14

 Both the UK prospective Diabetes Study (UKPDS) and the Diabetes Control and Complications Trail Research Group have shown that improved glycemic control is associated with a decrease in the rates of diabetic complications including retinopathy, nephropathy and neuropathy.16 6.3 OBJECTIVES OF THE STUDY:

General Objectives:

 To evaluate the impact of pharmacist provied patient education intervention on health outcomes measures of Type II diabetes mellitus

Specific Objectives:

1. To evaluate the KAP ( Knowledge, Attitude, Practice) and of diabetes patients

2. To study the medication adherence behaviour in diabetes mellitus patients

3. To provide patient education on disease and treatment through one to one talking as well as with the help of patient education leaflets

4. To assess the impact of patient education in health outcome measures

MATERIALS AND METHODS:

Study design: The study is a prospective study. 7. 7.1.Materials:

Patient consent forms, data collection forms, patient diaries, questionnaires (KAP, QoL), patient information leaflets (English and kannada). Glucometer, Sphygmomanometer (B.P apparatus), Weighing machine, height measuring tapes will be used for BMI (Body mass index) calculations.

7.2. Inclusion Criteria:  Patients having age above 30 years with DM  Patients with one/two co-morbidities which does not interfere the study

Exclusion Criteria:  Type I – DM patients  Patients show unwillingness to sign the consent form  Diabetes mellitus Patients with worsened diseases conditions and end organ damages like CHF (congestive heart failure), CRF (chronic renal failure)  Pregnant/lactating females 7.3 METHOD OF COLLECTION OF DATA:

This is a prospective randomized study. Study will be conducted in both out and inpatients departments of Adichunchanagiri Hospital and Research Center Bellur, B.G.Nagara.

The data will be collected from those who fulfill the inclusion criteria. ‘Written informed consent form’ from patients will be obtained prior to enrolling them into the study. During the study, patient’s knowledge, attitude, practice (KAP) and the HRQoL in type2 Diabetes mellitus will be assessed by using the KAP questionnaire and quality of life questionnaire of the local language and English version (based on the patient understanding).

The glucose level will be checked at each follow up for both control and intervention groups. The blood glucose level will be checked by a validated Glucometer. Body mass index (BMI), blood pressure will be checked for the control and intervention groups.

Diabetes education, leaflets regarding the disease and drugs will be given only for intervention group at the each follow up and for the control group at the last follow up. Their medication adherence and level of literacy will be analyzed after obtaining the data from the each follow up s (data from questionnaires, during counseling, patient dairies / envelops). Total 3 follow ups will be done for both the groups after the baseline glucose level is obtained. The data will be analyzed by using appropriate statistically method. 7.4 Does the study require any investigation or interventions to be conducted on patients? YES 7.5 Has ethical clearance been obtained from your institution in case of above?

Ethical committee approval will be obtained by the Institutional Ethical committee of Adichunchanagiri Institute Of Medical Sciences (AIMS) B.G.Nagara.

7.6 Duration of the study: The study will be conducted over a period of 9 months.

7.7 Place of study: Adichunchanagiri Hospital and Research Center Bellur, B.G.Nagara.

List of references: 8. 1. World Health Organization. Definition, Diagnosis and Classification of Diabetes Mellitus and its Complications. Report of a WHO Consultation. Geneva: World Health Organization, 1999; 1-66. Available from: URL: http//www.who.com.

2. Mohan V, Sandeep S, Deepa R, and Shah B ,Varghese C, Epidemiology of Type2 diabetes: Indian Scenario: Indian J Med Res 125, 2007; 217-30.

3. A Report From The Diabetes Summit for South-East Asia, Chennai, India Nov 28th – 30th, 2008 Pract Diab Int Suppl 2009:1-35.

4. Grumbach, K. Chronic illness, co morbidities, and the need for medical generalism. Ann Fam Med.2003; 1(1): 4–7.

5. Tiggellar JM. Protocol for the treatment of essential hypertension and type 2 diabetes mellitus by pharmacist in ambulatory care clinics. Drug Intel Clin Pharm 1987; 21:521-9.

6. David Edelman, Maren k. Olsen, Tara k. Dudley, Mstat Amy C. Harris. Quality of care for patients diagnosed with diabetes at screening. Diabetes care.2003; 26 (2):367-71.

7. Elbert S. Huang, Sydney ES. Brown, AB Bernard G. Ewigman, Edward c. Foley. David o. Meltzer. Patient perceptions of quality of life with diabetes-related complications and treatments. Diabetes care 2007; 30:2478–83.

8. Fitzpatrick R, Fletcher A, Gore S, Jones D, Spiegel halters D, Cox D. Quality of life measures in health care. 1: Applications and issues in assessment. Br Med J 1992; 305:1074–7.

9.Palaian S, Acharya LD, Rao PGM, Shankar PR, Nair NM, Nair NP. Knowledge, attitude and practice outcomes: Evaluating the impact of Counseling in hospitalized diabetic patients in India. P & T 2006; 31:383-400.

10. Adepu R, Rasheed A, Nagavi, B.G, Effect of patient counseling on quality of life in type-2 diabetes mellitus patients in two selected South Indian community pharmacies: A study, IJPS, 2007; 69 (4), 519-24.

11. Ghazanfari Z, Ghofranipour F, Tavafian SS, Ahmadi F, Rajab A. Lifestyle Education and Diabetes Mellitus Type 2: A Non-Randomized Control Trial Iranian J Publ Health, 2007; 36 (2) 68-72. 12. Whitley HP, Fermo JD, Ragucci K, Chumney EC. Assessment of patient knowledge of diabetic goals, self-reported medication adherence, and goal attainment. Pharmacy Practice 2006 4(4): 183-90.

13. Kim Sarang, Love F, Quistberg Alex, Judy ba. Association of health literacy with self- management behavior in patients with diabetes. Diabetes care, 2004; 27(12); 2980-82.

14. Hirono Ishikawa, Takeaki Takeuchi, Yano Eiji. Measuring Functional, Communicative, and Critical Health Literacy Among Diabetic Patients. Diabetes Care 2008; 31(5):874–79.

15. Lindstrom J, Tuomilehto J. The diabetes risk score: a practical tool to predict type 2 diabetes risk. Diabetes Care 2003; 26(3):725-731

16. Denise Joffe, Robert T. Yanagisawa. Metabolic Syndrome and Type 2 Diabetes: Can We Stop the weight Gain with Diabetes? The Medical Clinics of North America 2007 91; 1107-23.

17. Satpute D.A, Patil P. H, Kuchake V. G, V.Ingle P, Surana S. J, Dighore P. N. Assessment of impact of patient counseling, nutrition and exercise in patients with type 2 diabetes mellitus. International journal of pharmtech research. 2009; 1(1); 1- 21.

18. Parthasarathi G, Mahesh P A. Medication Adherence. In: Parthasarathi G, Karin Nyfort-Hansen, Milap C Nahata, editors. A text book of clinical pharmacy practice. Chennai: Orient Longman private limited; 2004. p.54.

19. Osterberg L, Blaschke T, Adherence to Medication. N Engl J Med.2005 Aug 4;353(5):487-97

9 Signature of the candidate Y.L. SANTHOSH 10 Remarks of the guide The proposed research work is original and designed on rational basic. It would be a good contribution.

11 11.1 Name and Designation of Guide K.V.RAMANATH ACA/CDC/PGT-M.ph/SACP/36/2008-09 M.Pharm, MBA (HRM&HSM) PhD. Associate Professor Department of Pharmacy Practice S.A.C. college of pharmacy B.G. Nagara, Karnataka -571448

11.2 Signature

11.3 Co-Guide NOT APPLICABLE

NOT APPLICABLE 11.4 Signature

11.5 Head of the Department Dr. JIMMY JOSE M. Pharm, PhD. Prof. & H.O.D of Pharmacy Practice

SAC College of pharmacy, B.G. Nagara -48. 11.6 Signature

12 12.1 Remarks of the Principal

12.2 Signature

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