“IMPACT OF PATIENT COUNSELING ON KNOWLEDGE, ATTITUDE AND PRACTICE IN THE MANAGEMENT OF DIABETES MELLITUS”

M.PHARM DISSERTATION PROTOCOL

SUBMITTED TO THE

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA,

BANGALORE

BY

MD.MISBAH ULLAH KHAN

UNDER THE GUIDANCE OF

MR.NEELKANT REDDY PATIL
M.Pharm.
Department of PHARMACY PRACTICE

H.K.E. Society’s College of Pharmacy,

Gulbarga-585 105

2009-10

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA.

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

01 / NAME OF CANDIDATE AND ADDRESS
(in block letters) / MD.MISBAH ULLAH KHAN
DEPARTMENT OF PHARMACY PRACTICE
H K E S COLLEGE OF PHARMACY
MRMC CAMPUS,
MAHADEVAPPA RAMPURE ROAD,
GULBARGA-585105.
KARNATAKA.
02 /

NAME OF INSTITUTION

/ H K E S COLLEGE OF PHARMACY,
MRMC CAMPUS,
MAHADEVAPPA RAMPURE ROAD,
GULBARGA-585105.
KARNATAKA.
03 /

COURSE OF STUDY AND SUBJECT

/ MASTER OF PHARMACY
IN
PHARMACY PRACTICE
04 /

DATE OF ADDMISSION TO COURSE

/ 21- 06- 09
05 / TITLE OF THE TOPIC : / “IMPACT OF PATIENT COUNSELING ON KNOWLEDGE, ATTITUDE AND PRACTICE IN THE MANAGEMENT OF DIABETES MELLITUS”.
6.0 /
BRIEF RESUME OF THE INTENDED WORK
6.1 / Need for the study:
“The term DIABETES MELLITUS (DM) describes a metabolic disorder of multiple aetiology characterized by hyperglycaemia with disturbances of carbohydrate, fat and protein metabolism resulting from defect of insulin secretion, insulin action or both”. The effects of diabetes include long term damage, dysfunction and failure of various organs. Diabetes mellitus may present with characteristic symptoms such as thirst, Polyuria, blurring of vision and weight loss. In its most severe forms ketoacidosis or a non-ketotic hyperosmolar state may develop and lead to stupor, coma and, in absence of effective treatment, death. The long-term effects of diabetes mellitus includes progressive development of the specific complications of retinopathy with potential blindness, nephropathy that may lead to renal failure, and/or neuropathy with risk of foot ulcers, amputation, Charcot joints and features of autonomic dysfunction including sexual dysfunction. People with diabetes mellitus are at increased risk of cardiovascular, peripheral vascular and cerebrovascular disease.1
India leads the world with largest number of diabetic subjects earning the dubious distinction of being termed the “diabetes capital of the world”. The most disturbing trend is the shift in age of onset of diabetes to a younger age in the recent years. This could have long lasting adverse effects on nation’s health and economy. As per WHO, India will be the nation with highest number of diabetics in the world by 2030 followed by China and then USA.2 India has 41 million diabetics and this number is expected to increase to 70 million by 2025.3 India being one of the fastest developing country, and youth being the driving force for it, which will be hampered at the most is not a good sign. Proper patient education and general awareness about the disease can help in reducing the extent of this damage. This is an alarming sound as far as the health system of India is concerned all the corners of health system viz: Doctors, Pharmacists, and Nurses etc.have to realize this fact and plan accordingly to tackle this situation.2
The past two decades have seen an explosive increase in the number of people diagnosed with diabetes world wide.4 The number of cases world wide in 2000 among adults ≥ 20 years of age estimated to be ~ 171 million, this figure is 11% higher than previous estimate of 154 million. It was estimated that, there were 151 million people with diabetes in this sub population in 2000. The IDF
has subsequently released estimates of the number of people with diabetes for 2003 and forecast for 2025 of 194 million and 334 million, respectively.5
Aetiological Classification of Diabetes mellitus
Type 1 (Beta cells destruction, usually leading to absolute insulin deficiency) (IDDM)
-Auto immune
-Idiopathic.
Type 2 (May range from predominantly insulin resistant, with relative insulin deficiency to predominantly secretary defect, with or without insulin resistance.) (NIDDM)
Other specific types
-Genetic defects of beta-cell function
-Genetic defects in insulin action
-Diseases of the exocrine pancreas
-Endocrinopathies
-Drug or chemical induced diabetes,e.g.nicotinic acid, glucocorticoids,high-dose thiazides,pentamidine,interferon-alfa
-Infections
-Other genetic syndromes some times associated with diabetes
-Gestational diabetes 6
The role of pharmacists has changed dramatically over the past 30 years. Traditionally, pharmacists have been viewed as individuals who dispense medications to the public. The concept of pharmacy practice has gradually changed from a product oriented activity to a patient – oriented one. Pharmacists are now becoming indispensable in monitoring drug therapy in institutional settings. It is well documented that safe and effective drug therapy occurs most frequently when patients are well informed about medications and their use. Counseling is the sympathetic interaction between pharmacist and patient. It may go beyond the conveying of straightforward information about the drug and how and when to use it. The ultimate goal of this counseling is to provide information directed at encouraging the safe and appropriate use of drugs, thereby enhancing therapeutic outcomes. 7
Several studies have confirmed that the complications of diabetes can be reduced by proper control of blood glucose and that patients understanding of the disease improves when pharmacists provide them with useful, practical information.7
As diabetes is a chronic, incurable condition that has considerable impact on the life of each and every individual patient. The principle task for the health care team is to provide knowledge, self confidence and support. Patients with diabetes mellitus and their families provide maximum care themselves, but if counseling is done, the self management of disease is improved to level of effective treatment. Several studies have acknowledged the importance of pharmacist provided counseling in diabetic patients. 8
“KAP” study measures the Knowledge, Attitude and Practices of a community. It serves as an educational Diagnosis of the community. The main purpose of this KAP study is to explore changes in Knowledge, Attitude and Practices of the community, KAP Study tells us what people know about certain things, how they feel and also how they behave. The three topics that a (KAP) study measures are Knowledge, Attitude and Practice. The Knowledge possessed by a community refers to their understanding of given topic. Attitude refers to their feelings towards this subject, as well as any preconceived ideas that they may have towards it. Practice refers to the ways in which they demonstrate their knowledge and attitude through their actions.9
Hence in the study titled “impact of patient counseling on knowledge, attitude and practice in the management of diabetes mellitus” an attempt is made to evaluate the results of counseling in diabetic patients about their medication, disease and life style modifications, in terms of knowledge, attitude and practice(KAP)outcomes.
/ Review of literature
Patel d et al. conducted a study on education on diabetes and the aim was to spread knowledge about diabetes, covering maximum aspects of diabetes. The study gives important information about how to cope up with the disease and how to aware the community and role of pharmacist. The pharmacist can play an important role in diabetes care by screening patients at high risk for diabetes assessing patient health status and adherence to standards of care educating patients to empower them to care for themselves, referring patients to other healthcare professionals, as appropriate, and monitoring outcomes. Providing diabetes management services requires market survey, communication skills, and a commitment of time, effort and resources.2
The Fremantle diabetes study examined the effect of a 12 month pharmaceutical care (PC) program on vascular risk in type 2 diabetes. In this study patients were randomized to PC or usual care. PC patients had face- to- face goal- directed medication and life style counseling at baseline and at 6 and 12 months plus 6- weekly telephone assessments and provision of other educational material. The main outcome measure was change in HbA (1c). The study concluded that the 12 month PC programme in type 2 diabetes reduced glycemia and blood pressure. Pharmacist involvement contributed to improvement in HbA (1c) independently of Pharmacotherapeutic changes. 8
Tadros. L et al. Conducted a study on role of pharmacists in type 2 diabetes management.The aim of this study was to evaluate the impact of a clinical pharmacist providing direct patient care on the glycaemic control of patients with type 2 diabetes. They found the following results in the above mentioned study, that the patients mean fasting blood glucose level fell from 13.6 to 8.3 percent, demonstrating a significant important in glycaemic control. Patients showed increased self – esteem and motivation towards diabetes management, increased satisfaction, responsive service, improved health’s, and more public awareness. The study shows that pharmacist led educational programmes for diabetes patients can have a significant impact on glycaemic control and improve patients understanding and their quality of life.10
Salti.SI et al. conducted a study on epidemiology of diabetes mellitus in relation to other cardiovascular risk factors in Lebanon. In this study of 2518 Lebanese subjects(1138 males, 1380 females) aged 30 years and over reveled on overall prevalence of non – insulin dependent diabetes mellitus and impaired glucose tolerance of 13.1% and 6% respectively. The prevalence of non – insulin dependent was similar in both sexes, while impaired glucose tolerance was slightly higher among females, both steadily increased with age. The main risk factor was obesity (55% in males and 67% in females). Participants with diabetes and impaired glucose tolerance were more likely to have heart disease, and had slightly higher blood pressure and serum triglycerides. The results of this study indicate that, as in many developing countries, NIDDM in adults is becoming a major public health problem. The clustering of other cardiovascular risk factors with NIDDM and IGT deserves attention, especially in terms of their common denominators, namely sedentary life style and excessive consumption of caloric rich and high fat food acknowledgement.11
Palaian S et al. conducted a study on patient counseling by pharmacist by a focus on chronic illness, this study aimed on management of chronic illness by pharmacist there by improving patient compliance and quality of life. Pharmacists being active members of the health care trans can play an important role in providing patient counseling so as to improve the patient’s quality of life. More over the patient counseling by pharmacists also enables the doctors to spend more time on examination and diagnosis in the patients. It also helps in many ways to improve the quality of health care system with better patient care and therapeutic outcomes.12
Sisson et al. conducted a study on role of pharmacist in the management of patients with type 2 diabetes, the main objective was to summarize the current and future roles of pharmacists in providing care to educating patients with diabetes. The study stated that the increasing complexity of therapy regimens and overwhelming number of patients with type 2 diabetes, the pharmacist role has expanded beyond dispensing medications, counseling on adverse effects and monitoring on contraindications to include evaluation and initiation of new agents to optimize patient outcomes.13
Objectives of the study:
The present study will be carried out with the following objectives:
1.  To counsel diabetic patients about their disease, medications, management and life style modifications.
2.  To evaluate the impact of counseling.
7.0 / Materials and Methods
7.1 / Source of Data
1.  Case sheets of patients diagnosed with diabetes mellitus at HKES’S Basaveshwar Teaching and General Hospital, Gulbarga.
2.  Patient Medication Knowledge Assessment Questionnaire.(KAP)
3.  Laboratory Reports of patients from HKE’S Basaveshwar Teaching and General Hospital, Gulbarga.
7.2 / Methods of collection data :
(Including sampling procedure, if ANY)
Study Site:
Study will be conducted at HKES’s Basaveshwar Teaching and General Hospital, Gulbarga.
Study Duration:
Study will be carried out for a period of eight months (May 2010 onwards).
Study design:
A prospective study
Study Criteria:
Diabetes Mellitus patients will be enrolled into the study by considering following criteria.
Inclusion Criteria:
-Patients who were diagnosed and receiving drug therapy for diabetes mellitus along with/without co-morbid conditions.
-Patients willing to participate
Exclusion Criteria:
-Patients having gestational diabetes
-Mentally incompetent patients
Study procedure:
Study will be conducted at the department of medicine. Patient diagnosed with Diabetes mellitus, will be enrolled in the study considering the inclusion and exclusion criteria. Informed consent will be taken from each patient at the time of enrollment in to the study. Details regarding demography, disease and treatment will be collected from the medical records of the patient in a specially designed patient data collection form.
Assessment of medication knowledge and patient counseling:
The knowledge of the diabetes mellitus patients regarding disease medications, management life style will be assessed at the base line (first visit) with the help of specially designed knowledge, attitude and practice (KAP) questionnaires. After baseline assessment patients will be educated on disease, medications, its management and life style modifications by verbal means and providing information leaflets.
Again patients will be assessed on their follow up each at one month interval by means of (KAP)questionnaires.7
The data will be assessed by Mann-Whitney test.
7.4 / Does the study required any investigation and intervention to be conducted on patients or other humans or animals? If so, please describe Briefly.
Not applicable
7.5 / Has ethical clearance been obtained from your institution in case of 7.4
The protocol will be submitted for ethical committee clearance. Ethical clearance certificate will be submitted to the university as soon as the ethical committee of Basaveshwara Teaching and General Hospital, Gulbarga grants it.
8.0 / LIST OF REFERENCES
1.  Definition, Diagnosis, Treatment and Classification of Diabetes Mellitus and its Complications, Report of World Health Organization Consultation, 1999.
2.  Patel D, Patel HN, Pathak K, Venkatraghavan S, Rajesh V, Leelavathi D, Continuing Pharmacy Education Series: Diabetes Indian Journal of Hospital Pharmacy, 2009;46: 7-19.
3.  Ramchandran A, and snehalatha.C, current scenario of diabetes in Indian Journal of diabetes 2009; 1:18-29.