Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka s5

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA

PERFORMA FOR REGISTRATION OF SUBJECT FOR

DISSERTATION

Mr. Shailendra Kumar 1. NAME OF THE CANDIDATE 1st year. M. Sc. Nursing AND ADDRESS (Medical Surgical Nursing) Shanti Dhama College of Nursing Bangalore Shanti Dhama College of Nursing 2. NAME OF THE INSTITUTION Bangalore

3. COURSE OF STUDY AND 1st Year, M. Sc. Nursing

SUBJECT Medical Surgical Nursing

4. DATE OF ADMISSION TO 25-07-2011

COURSE

5. TITLE OF THE TOPIC “ A study to assess the effectiveness of structured teaching programme regarding risk factors of hypercholesterolemia among cardiac patients who are attending cardiology outpatient department in selected hospital, Bangalore.”

1 6. BRIEF RESUME OF THE INTENDED WORK:

6.1 INTRODUCTION

“Every human being is the author of his own health or disease”

Gautama Siddharta

Cholesterol is a steroid found in the plasma membrane surrounding everybody cell. Its presence helps to stabilize important cellular structure and is required for many reactions that cells must perform to survive. Cholesterol is a constituent part of hormones as corticosteroid, oestrogen and testosterone. It is present in the bile salts need for digestion. The steroid nucleus a part of active hormone form of vitamin D called calcitrol1.

Cholesterol is a waxy fat like substance that the body needs to function normally cholesterol is naturally present in cell wall or membrane everywhere in the body including the brain, nerve, skin, liver, intestines and heart. Cholesterol is measured in milligrams per decilitre of blood1

High cholesterol is also called hypercholesterolemia or hyperlipidemia. High cholesterol is one of the causes of atherosclerosis. Atherosclerosis is one of the causative factor for coronary heart disease. High density lipoprotein cholesterol protects aganist atherosclerosis by preventing cholesterol from depositing on arterial walls as it circulates in the blood stream. High cholesterol in the blood stream, the excess may be deposited in arteries, including the coronary arteries of the heart, the carotid arteries to the brain and the arteries that supply to the legs1.

2 Total cholesterol measures the concentration of fat in the blood stream including cholesterol, triglyceride molecules. High density lipoprotein- good cholesterol and low density lipoprotein- bad cholesterol2

Accumulation of plaque deposits in the arteries. Plaque is composed of cholesterol, fatty sub stance, fibrous tissue and calcium. When iyt build up in the arteries, if results in atherosclerosis or coronary heart disease. Atherosclerosis can lead to plaque ruptures and blockage in the arteries, which increase the risk for heart attack, angina, stroke, circulation problems and death2.

Hypercholesteromia caused by are food high in saturated fats and cholesterol, life style changes, heredity- high levels of cholesterol may be inherent low density lipoprotein, chronic disease like diabetes and stroke etc2.

High cholesterol risk factors are; age, gender, alcoholism, smoking, smoking, diabetes, sedentary lifestyle. obese/overweight, stress, kidney disease and thyroid problems2

6.2. NEED FOR THE STUDY

Cardiovascular diseases are the biggest killer, claiming more than 17 million lives every year worldwide. The largest ever study representing 147 million people shows that most people with cholesterol levels are not getting the treatment. The need to reduce their risk of cardiovascular disease such as heart attack and stroke3

World health organization in their report states that high cholesterol contributes to

56% of cases of coronary artery disease and causes about 4.4 million deaths every year. In most parts of the world, the number of female deaths attributed to high cholesterol is slight till higher than the number of male deaths3.

3 17% of the Americans over age twenty have high cholesterol. At least 100 million

Americans have total cholesterol levels greater than 200mg/dl. At least 40 million

Americans have cholesterol greater than 240 mg/dl. At the age 50 years and older, men have more than women in total cholesterol levels greater than 200mg/dl3.

In India the prevalence of CAD is 4-6 times higher than any other ethnic group. Heart attacks and angina among Indian occur early, relatively at a young large and is more severe and extensive. 40% of the patients with acute myocardial infarction in India are below 40 years. A cross sectional study in Jammu and Kashmir has shown that the overall prevalence of CHD in the population was 7.54% (Rural-6.70%, urban-8.37%, males-7.88%, females- 6.63 %)4

A study was conducted by Stanley in U.S states that high cholesterol affects about

20% of adults over the age of 20. The highest prevalence occurs in women between the ages of 65 to 74 years4.

Guangi [2006] conducted a study on effects of demographic dietary and other lifestyle factors on prevalence of hyperlipidemia. 1166 randomly selected people of Hei Yi

Zhuang aged 7-84 years from 7 villages in Naso country. Prevalence rates of hyperchoesterolemia, hyperglycaemia, hyperlipidemia were 23.6% versus 27%.

12.3% versus 14.4% and 29.9% versus 34.2% respectively. Prevalence of hyperlipidemia was positively correlated with age, body mass index, blood pressure, alcohol and consumption, sex, cigarette smoking5.

The researcher is interested to provide structured teaching programme on risk factors of hypercholesterolemia, which plays an important role in reducing cardiovascular disease. It helps the people to life style changes such as avoiding tobacco use, regular physical activity and diets.

4 6.3. REVIEW OF LITERATURE

Studies related to risk factors of Hypercholesterolemia

A study was conducted on “Adherence to the Mediterranean Diet in Relation to

Ischemic Stroke Nonfatal Events in Non-hypercholesterolemia and

Hypercholesterolemia Participants: Results of a Case/Case-Control Study”. The aim of the work was to evaluate the association between adherence to the Mediterranean diet and the development of ischemic stroke according to cholesterol levels. During

2009-2010, 500 participants were enrolled; 250 were consecutive patients (77 ± 9 years, 55.6% men) with a first ischemic stroke and 250 population-based, control participants, matched to the patients by age and sex. Socio-demographic, clinical, dietary, and other lifestyle characteristics were measured. Adherence to the

Mediterranean diet was assessed by the validated MedDietScore (theoretical range: 0-

55). After various adjustments, each 1/55 unit increase in the MedDietScore was associated with 17% lower likelihood of having an ischemic stroke in non hypercholesterolemia participants (95%CI: 0.72-0.96) and 10% lower likelihood in participants with hypercholesterolemia (95%CI: 0.81-0.99). The present work highlights the cardio-protective benefits from the adoption of the Mediterranean diet, by showing its beneficial effect regarding ischemic stroke development, regardless of the presence of hypercholesterolemia6.

A study was conducted on “The evaluation of cascade testing for familial hypercholesterolemia”. Computer simulation was used to estimate the screening performance of three strategies of cascade testing for FH (a process of searching for relatives with FH once an individual is diagnosed with FH): (i) testing parents, siblings, and children (1st degree relatives) of an FH index case, (ii) testing (i) and

5 testing 1st degree relatives of subsequently identified relatives with FH, and (iii) testing (ii) and also testing aunts, uncles, nephews, nieces, grandparents, and first cousins (2nd or 3rd degree relatives) when 1st degree relatives of an individual with

FH are not available. For cascade testing to achieve detection rates of 80%, (i) 25%,

(ii) 11%, and (iii) 8% of FH index cases who are unrelated need to be identified. To identify these unrelated FH index cases, (i) 45% (ii) 23%, and (iii) 17% of all individuals with FH need to be identified independently of cascade testing. Cascade testing is not a suitable method of population screening for FH, because a separate method of systematically identifying new FH index cases is required to achieve a reasonable level of FH detection in the population. Such an alternative systematic method of identifying new cases could itself be the method of population screening7.

A study was conducted on “Usefulness of LDL-C-Related Parameters to Predict

Cardiovascular Risk and Effect of Pravastatin in Mild-to-Moderate

Hypercholesterolemia.” Low-density lipoprotein cholesterol (LDL-C), the ratio of

LDL-C to high-density lipoprotein cholesterol (HDL-C; LDL-C/HDL-C), and non-

HDL-C were evaluated to determine their ability to predict cardiovascular disease

(CVD) risk with pravastatin treatment. To determine the best parameter for predicting the efficacy of pravastatin, the diet plus pravastatin group was divided into tertiles to compare lipid parameters and CVD incidence versus the diet alone group.Results:

Significantly graded correlations were found between CVD and LDL-C/HDL-C and non-HDL-C. Significantly more CVD events were associated with LDL-C/HDL-C >

186 mg/dL and LDL-C/HDL-C > 2.98.

6 Studies related to diagnosis of hypercholesterolemia

A study on “Diagnosis and Management of Type I and Type V

Hyperlipoproteinemia” and the study showed both type I and type V hyperlipoproteinemia are characterized by severe hypertriglyceridemia due to an increase in chylomicrons. Type I hyperlipoproteinemia is caused by a decisive abnormality of the lipoprotein lipase (LPL)- apolipoprotein C-II system, whereas the cause of type V hyperlipoproteinemia is more complicated and more closely related to acquired environmental factors. Since the relationship of hypertriglyceridemia with atherosclerosis is not as clear as that ofhypercholesterolemia, and since type I and V hyperlipoproteinemia are relatively rare, few guidelines for their diagnosis and treatment have been established; however, type I and V hyperlipoproteinemia are clinically important as underlying disorders of acute pancreatitis, and appropriate management is necessary to prevent or treat such complications. Against such a background, here we propose guidelines primarily concerning the diagnosis and management of type I and V hyperlipoproteinemia in Japanese9.

Studies related to treatment of hypercholesterolemia

A study was conducted on “Treatment of Familial Hypercholesterolemia”

Combination or monotherapy with other current pharmacotherapies are options, but even with these some FH patients do not meet their low-density lipoprotein (LDL) cholesterol goals. In the cases of statin intolerance, LDL apheresis may be another treatment option. There are currently several novel therapies in development for LDL lowering that target either production or catabolism of LDL, plaque regression, and potentially gene transfer. The study conclude that there is a need beyond statins for

7 patients with FH, especially in cases of statin intolerance, and when even the highest doses of statin do not get patients to goal cholesterol levels10.

A study was conducted on “Ezetimibe: its novel effects on the prevention and the treatment of cholesterol gallstones and nonalcoholic Fatty liver disease” The cholesterol absorption inhibitor ezetimibe can significantly reduce plasma cholesterol concentrations by inhibiting the Niemann-Pick C1-like 1 protein (NPC1L1), an intestinal sterol influx transporter that can actively facilitate the uptake of cholesterol for intestinal absorption. Unexpectedly, ezetimibe treatment also induces a complete resistance to cholesterol gallstone formation and nonalcoholic fatty liver disease

(NAFLD) in addition to preventing hypercholesterolemia in mice on a Western diet.

Because chylomicrons are the vehicles with which the enterocytes transport cholesterol and fatty acids into the body, ezetimibe could prevent these two most prevalent hepatobiliary diseases possibly through the regulation of chylomicron- derived cholesterol and fatty acid metabolism in the liver. It is highly likely that there is an intestinal and hepatic cross-talk through the chylomicron pathway11.

Studies related to complications of hypercholesterolemia

A study was conducted on “Hypercholesterolemia promotes early renal dysfunction”

The aim of this study was to determine the effects of both hypercholesterolemia and aging on renal function in mice. Male hypercholesterolemic apolipoprotein E- deficient mice (ApoE, n=13) and age-matched C57BL/6 control mice (C57, n=15) were studied at 2 (young) and 8 (adult) month-old. At each time point, animals were placed in metabolic cages for 24 hours to urine volume and urinary creatinine quantification. Blood samples were collected for serum cholesterol, urea and creatinine measurements. Glomerular filtration rate (GFR) was estimated through

8 creatinine clearance determination. Mesangial expansion was evaluated by Periodic

Acid Schiff staining, renal fibrosis was determined through Masson's trichrome staining and neuronal nitric oxide synthase (nNOS) expression in the kidney was performed by Western Blotting. To statistical analysis two- way ANOVA followed by

Fisher's post hoc test was used12.

A study was conducted on “Long-term effects of nutraceuticals in elderly hypercholesterolemic patients”. This study was performed as a randomized, prospective, parallel group, single-blind study. Patients were included in the study if they had high total cholesterolemia, high low-density lipoprotein cholesterol (LDL-

C), >75 years of age, statin-intolerant, and were refusing other pharmaceutical treatments for hypercholesterolemia. At the baseline visit, eligible patients were randomized to either nutraceutical-combined pill (containing berberine 500 mg, policosanol 10 mg, red yeast rice 200 mg, folic acid 0.2 mg, coenzyme Q10 2.0 mg, and astaxanthin 0.5 mg) or placebo, and the first dose was dispensed. The efficacy, safety, and tolerability of the proposed treatment were fully assessed after 3, 6, and 12 months of treatment13.

A study was conducted on “Premature Coronary Artery Disease and Familial

Hypercholesterolemia: Need for Early Diagnosis and Cascade Screening in the Indian

Population”. Cardiovascular disease (CVD) is the leading cause of death in India, accounting for 28% of mortality. The average age of onset of CVD is younger (below

55 years) among Indians than in other populations. This may be due to bad lifestyle, genetic factors, or both. Hypertension, smoking, diabetes, and physical inactivity have been identified as modifiable risk factors for heart disease. Hypercholesterolemia is the most common and treatable cause of heart disease. Genetic factors that lead tohypercholesterolemia have not been fully studied in India. Familial

9 Hypercholesterolemia results from mutations in the LDL receptor, ApoB, PCSK9, and ApoE genes. There is an urgent need to screen subjects with premature CAD and their relatives in India for the presence of FH, identify the mutations that lead to high cholesterol, and carry out cascade screening in the at-risk relatives. Those harbouring mutations in the above genes can be treated to lower the cholesterol levels, prevent early CVD, and avoid death. A programme based on these lines has been initiated in

Delhi14.

10 6.4. STATEMENT OF THE PROBLEM

A study to assess the effectiveness of structured teaching programme regarding risk factors of hypercholesterolemia among cardiac patients who are attending cardiology outpatient department in selected hospital, Bangalore.

6.5. OBJECTIVES OF THE STUDY

1. To assess the existing knowledge regarding risk factors of

hypercholesterolemia among cardiac patient.

2. To develop and implement structured teaching programme on risk factors of

hypercholesterolemia among cardiac patients.

3. To assess the effectiveness of structured teaching programme on risk factors

of hypercholesterolemia among cardiac patients.

4. To find out the association between the pre-test knowledge score with the

selected demographic variables.

5. To find out the association between the post-test knowledge score with the

selected demographic variables.

6.6. OPERATIONAL DEFINITIONS:

 Effectiveness: It is the significant gain in knowledge on risk factors of

hypercholesterolemia among cardiac patients.

 Structured teaching programme: It refers to systematically developed

teaching with instructional aides designed for cardiac patient’s age group (35-

11 75 years) to provide information regarding risk factors of

hypercholesterolemia

 Risk factors: When added to others increase the likelihood of disease or

complications. Age, Gender, Alcoholism, Smoking, Diabetes, Sedentary life

style, Obesity, Stress, Kidney disease and thyroid problems.

 Hypercholesterolemia: Excess of cholesterol in blood which is more than

240mg/dl

 Cardiac patients: Persons who are suffering from cardio-vascular disease and

attending outpatient department in selected hospital, Bangalore.

6.7. HYPOTHESIS:

H1: There is a significant difference between pre test and post test knowledge scores of risk factors of hypercholesterolemia.

H2: There is a significant association between the pre-test knowledge and selected demographic variables.

H3: There is significant association between the post test knowledge score and selected demographic variables.

6.8. ASSUMPTIONS OF THE STUDY:

1. Cardiac patients may have some knowledge regarding risk factors of

hypercholesterolemia.

2. Structured teaching programme may help the patients to improve their

knowledge regarding risk factors of hypercholesterolemia.

12 3. Knowledge score may be influenced by the demographic variables of the

respondents.

6.9. DELIMITATIONS:

1. The study is delimited to knowledge aspects only.

2. The study is delimited to cardiac patients attending OPD only.

7. MATERIALS AND METHODS

7.1. SOURCE OF DATA:

Data will be collected from cardiac patients attending the OPD of selected hospital.

7.2. METHODS OF COLLECTION OF DATA:

7.2.1. SAMPLING CRITERIA:

Inclusion criteria:

1. Cardiac patients attending OPD of selected hospitals.

2. Patients who are willing to participate in the study.

3. Patients who are available at the time of study.

4. Patients who are in the age group 35 to 75 years.

Exclusion criteria:

1. Patients who are unable to read Kannada or English

13 2. Patients below 35 years or above 75 years.

3. Patients admitted in the hospital.

7.2.2. RESEARCH DESIGN:

The design adopted for the present study is Quasi-experimental, One group pre-test post test.

7.2.3. RESEARCH APPROACH:

The research approach adopted for the present study is evaluative approach.

7.2.4. VARIABLES UNDER STUDY:

Independent variable:

Structured Teaching programme

Dependent variable:

Knowledge

Extraneous variables:

Age, Gender, Religion, Education, Occupation, Socio-economic status, Area of residence.

7.2.5. SETTING:

The study will be conducted at the OPD of selected Hospital in Bangalore.

7.2.6. SAMPLING TECHNIQUE:

The sampling technique adopted for the present study is convenience sampling

14 7.2.7. SAMPLE SIZE:

The sample size for the present study is 50 patients with cardio-vascular problems.

7.2.8. TOOLS OF RESEARCH:

1. A demographic questionnaire will be prepared by the investigator to assess the

demographic characteristics of the respondents.

2. A knowledge questionnaire will be prepared to assess the knowledge of the

respondents regarding the risk factors of hypercholesterolemia.

7.2.9. COLLECTION OF DATA:

1. Permission will be obtained from the medical superintendent of the hospital

prior to the study.

2. Participants will be informed about the objectives of the study and informed

consent will be obtained from them.

3. Pre-test will be conducted using the demographic questionnaire and the

knowledge questionnaire.

4. A structured teaching programme will be administered to the respondents on

the day of pre-test.

5. Post test will be conducted on the 7th day of conducting the structured teaching

programme.

7.3. METHOD OF DATA ANALYSIS AND PRESENTATION:

1. Master data sheet

15 2. Mean, Standard deviation

3. ‘t’ Test to find out the effectiveness of structured teaching programme.

4. Chi-square test to find out the association between the knowledge score and

the demographic variables.

7.4. Does the study require any investigation or intervention to be conducted on patients or other humans or animals? If so, please describe briefly.

Yes, The study require administration of structured teaching programme to the individuals participating in the study.

7.5. Has ethical clearance been obtained from your institution in case of 7.4?

Ethical clearance will be obtained from the ethical clearance committee prior to the study.

16 8. LIST OF REFERENCES:

1. Marguerite Rodgers Kinney, “AACN, Clinical reference for critical care

nursing”, IV edition, Mosby publication (1998), Missouri, pp. 279, 455

2. Suzannec Smeltezer, Brenda Bare, “Brunner and Suddarth text book of

medical surgical nursing”, X edition, Lippincott Williams and Wilkins (2004),

pp. 1888

3. Joyce M Black, Jane Hokanson, “Medical surgical Nursing” VII edition,

Elsevier Publications, (2005), pp. 1428

4. C. R. Kothari, “Research methodology-methods and techniques”, II revised

edition, New age international publications (2008), India, pp. 113, 371

5. Denise F. Polit, Cheryl Tatano Beck, “Essentials of nursing research”, VI

edition, Lippincott Williams and Wilkins publications, (2009), India, pp. 319

6. Kastorini CM and Milionis HJ, “Adherence to the Mediterranean Diet in

Relation to Ischemic Stroke Nonfatal Events in Nonhypercholesterolemic and

Hypercholesterolemic Participants: Results of a Case/Case-Control Study”.

School of Medicine, University of Ioannina, Greece; Department of Nutrition

and Dietetics, Harokopio University, Athens, Greece

7. Morris JK, Wald DS and Wald NJ, “The evaluation of cascade testing for

familial hypercholesterolemia” Wolfson Institute of Preventive Medicine,

Barts and the London School of Medicine, Queen Mary University of London,

Charterhouse Square, London, UK

17 8. Mizuno K, Nakaya N and Teramoto T, “Usefulness of LDL-C-Related

Parameters to Predict Cardiovascular Risk and Effect of Pravastatin in Mild-

to-Moderate Hypercholesterolemia.” Department of Medicine, Nippon

Medical School

9. Gotoda T and Shirai K, “Diagnosis and Management of Type I and Type V

Hyperlipoproteinemia” Department of Clinical and Molecular Epidemiology,

22nd Century Medical and Research Center, University of Tokyo Hospital.

10. Raper A and Kolansky DM, “Treatment of Familial Hypercholesterolemia”,

Institute of Translational Medicine and Therapeutics, University of

Pennsylvania School of Medicine

11. De Bari O, Neuschwander-Tetri BA, “Ezetimibe: its novel effects on the

prevention and the treatment of cholesterol gallstones and nonalcoholic Fatty

liver disease” Division of Gastroenterology and Hepatology, Department of

Internal Medicine, Edward Doisy Research Center.

12. Balarini CM, Oliveira MZ, “Hypercholesterolemia promotes early renal

dysfunction” University of Alberta, Canada

13. Marazzi G and Cacciotti L, “Long-term effects of nutraceuticals in elderly

hypercholesterolemic patients” Department of Medical Sciences, IRCCS San

Raffaele, Rome, Italy.

14. Setia N and Verma IC, “Premature Coronary Artery Disease and Familial

Hypercholesterolemia: Need for Early Diagnosis and Cascade Screening in the

Indian Population” Center of Medical Genetics, Sir Ganga Ram Hospital,

Rajinder Nagar, New Delhi

18 19 9. Signature of the Candidate

10. Remarks of the guide

11. Name and Designation of

11.1 Guide

11.2 Signature

11.3 Co-Guide (if any)

11.4 Signature

11.5 Head of the Department

11.6 Signature

12.1 Remarks of the principal

12.2 Signature