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ASSESSMENT OF HYPERTENSION MANAGEMENT AND FACTORS

ASSOCIATED WITH POOR TREATMENT OUTOMES AMONG


HYPERTENSIVE PATIENTS AT ST. PUOL HOSPITAL, ADDIS
ABABA, ETHIOPIA

BY DEJENE HAILU

A RESEARCH PROPOSAL SUBMITTED TO THE DEPARTMENT OF


PHARMACY, COLLEGE OFPUBLIC HEALTH AND MEDICAL
SCIENCES, JIMMA UNIVERSITY IN PARTIAL FULFILMENT OF
THE REQUIRMENTS FOR THE BACHELORS DEGREE IN
PHARMACY (B.PHARM)

DECEMBER 2013/14

JIMMA, ETHIOPIA
JIMMA UNIVERSITY

COLLEGE OF PUBLIC HEALTH AND MEDICAL SCIENCE

DEPARTMENT OF PHARMACY

ASSESSMENT OF HYPERTENSION MANAGEMENT AND FACTORS


ASSOCIATED WITH POOR TREATMENT OUTOMES AMONG
HYPERTENSIVE PATIENTS AT ST. PUOL HOSPITAL, ADDIS
ABABA, ETHIOPIA

BY: DEJENE HAILU

ADVISOR:

MULUGETA TAREKEGN (B.PHARM, MSC IN CLINICAL PHARMACY)


ABSTRACT

BACKGROUND:Hypertension is an overwhelming global challenge which is significant


risk factors for cardiovascular morbidity and mortality resulting from target-organ damage to
blood vessels in the heart, brain, kidney, and eyes.Medications to treat hypertension and other
chronic conditions work andare widely available. However, the broad benefits of these drugs
are not being realized because large proportions of patients are not taking these medicines the
way they are prescribed.

OBJECTIVE: The general objective of this study is to investigate or to assess hypertension


management and factors associated with poor patient’s treatments outcomes at ST.
PaulosHospital, at chronic cases follow up clinic fromFeb. 28 to March 9, 2014.

METHOD& MATERIALS: A cross-sectional study will be conducted and a convenience


sampling technique will be used to select 140 study subjects. A structured standard interview
questionnaire and 8-item morisky medication adherence scale will be used after some
modifications. Analysis will be done using tally sheet, pen, and pencil.

RESULT:Based on the finding the result of the study will be discussed and.

CONLUSION:Based on the result appropriate conclusion will be made.

RECOMMENDATION: Based on the result and discussion, appropriate recommendation


will be forward to concerned body
ACKNOWLEDGMENT

I would like to express my great appreciation to Mr.MulugetaTarekegn(B.pharm, Msc in


clinical pharmacy) for his valuable and constructive suggestions during the planning and
development of this proposal paper. His willingness to give his time so generously has been
very much appreciated..
I would like to express my very great appreciation to my friends and classmates who has
provided me their personal computer to perform this proposal.
TABLE OF CONTENTS

Content page

Abstract ……………………………………………………………………………….............
Acknowledgment……………………………………………………………………………...
Table of content………………………………………………………………………………
Abbreviations & acronyms...………………………………………………………….…….....
List of tables…………………………………………..………………………………………
Operational definitions……………………………………………………………………….
1. Introduction……………………………………………………………………….…...…
1.1 Background……………………..…………………………………………………
1.2 Statement of the problem…………………………..……………………….….….
1.3 Significance of the study………………………………………………….….....…
1.4 Objectives……………………………………………………………………….....
1.4.1 General Objectives………………………………………………………….....
1.4.2 Specific Objectives……………………………………………………….....…
2. Literature Review……………………………………………………………………….
3. Materials &Method …………………………………………..…………………….....
3.1 Study area and period………………………………….....……………………....
3.2 Study design………………………………………………...…………………....
3.3 Population……………………………………………………...…………………
3.3.1 Source population…………………………………………....…………….....
3.3.2 Study population……………………………………………..………………
3.4 Selection criteria …………………………………………………...…………….
3.4.1 Inclusion criteria…………………………………………………...…………
3.4.2 Exclusion criteria …………………………………………………...………..
3.5 Sample size& Sampling technique …………………………………….………
3.5.1 Sample size …………………………………………………………….…….
3.5.2 Sampling technique…………………………………………………………..
3.6 Study Variables…………………………………………………………….…….
3.6.1 Dependent variables……………………………………………………..…...
3.6.2 Independent variables………………………………………………………..
3.7 Data collection instrument & technique………………….……………....………
3.7.1 Instruments…………………………………………………………….…….
3.7.2 Data Collection Method………………………………………………...……
3.7.3 Quality Assurance……………………………………………………….…...
3.8 Data processing and analysis…………………………………………………..…
3.9 Ethical consideration………………………………………………………….….
3.10 Dissemination of result ………………………………………………………….
4. Project work plan……………………………………………………………….............
5. Research budget………………………………………………………………..............

5.1 Budget summary………………………………………………………………………..

Annex I Dummy table………………………………………………………………………

Reference………………………………………………………………………………………
ABBREVIATIONS & ACRONYMS

AHT Antihypertensive Treatment


AKUH Aga Khan University Hospital
AMI Acute Myocardial Infarction
BLH Black Lion Hospital
BP Blood Pressure
CI Confidence Interval
CMG Continuous Multiple-Interval Measure ofMedication Gaps.
CSA Central Statistical Agency
CV Cardiovascular
G.P.H.A Ghana Ports and Harbors Authority Hospital
GUH Gondar University Hospital
HBP High Blood Pressure
HTN Hypertension
LHU Local Health Unit
M Mean
MMAS-8 Morisky 8-item Medication Adherence Scale
MmHg Millimeter Mercury
OPD Out Patient Department
OR Odds Ratio
SD Standard Deviation
U.S United States
UMTH University of Maiduguri Teaching Hospital
VA Veterans Affairs
WHO World Health Organization
DUMMYTABLES

Table 4.1: Adherence and age Cross tabulationSt.Paulo’s hospital, chronic follow up clinic
from Feb. 22 to March 9, 2014…………………………………………………………
Table 4.2: Sexual distribution of the study participants at St. paulos Hospital, chronic follow
up clinic fromFeb. 22 to March 9, 2014…..………...............................................................
Table 4.3: Adherence and sex Cross tabulation St. Paulo’s hospital, chronic follow up clinic
from 2Feb. 22 to March 9, 2014……………………………………………………………
Table 4.4: Residence and distance from the institution of the study participantsat St Paulos
hospital, chronic follow up clinic fromFeb. 22 to March 9, 2014…………………………
Table 4.5.Adherence and Marital Status Cross tabulationSt.paulos hospital, chronic follow up
clinic Feb. 22 to March 9, 2014……………………………….………...………...........
Table 4.6:Educational status distribution of the study participants at St.Paulos hospital,
chronic follow up clinic fromFeb. 22 to March 9, 2014 ………………………………….
Table 4.7:Adherence and Educational background Cross tabulation St. Paulos hospital
chronic follow up clinic fromFeb. 22 to March 9, 2014…………………………………
Table 4.8:Average Monthly Income distribution of the study participants at St. Paulos
hospital chronic follow up clinicFeb. 22 to March 9, 2014……………………………
Table 4.9: Adherence and Income Cross tabulationSt.paulos hospital, chronic follow up
clinic Feb. 22 to March 9, 2014………………………………………………………….
Table 4.10: Adherence and Occupation Cross tabulationSt.Paulos hospital, chronic follow up
clinic from,Feb. 22 to March 9, 2014 ……………………………………………
Table 4.11:Reasons of non-adherence among the study participant at St. Paulos hospital,
chronic follow up clinic fromFeb. 22 to March 9, 2014………………………………
Table 4.12: Morisky Medication Adherence Scale……………………..……………..……

DEFINITIONS TERMS
Hypertension (HTN): -high blood pressure, a common disorder in which blood pressure
remains abnormally high (readings above 140/90 mmHg)

Adherent: -Respondents who had scored below the value expected to score in the study
(scored a total MMAS less than 4).
Non adherent: - Respondents who had scored above the value expected to score in the
study(a total MMAS score greater than or equals to 4).
Sedentary: a lifestyle of not engaging in any physical activity

Physical activity: Physical activity is a broad term that encompasses all forms of muscle
movement.These movements can range from sports to lifestyle activities.

Lifestyle modification: adopting a healthy lifestyle. This includes losing weight if overweight or
obese, limiting alcohol intake, increasing physical activity, reducing salt intake, limit alcohol intake
and stop smoking.

1. INTRODUCTION
1.1 BACKGROUND
Hypertension (HTN) or HBP (systolic blood pressure ≥140 mmHg and diastolic blood
pressure ≥90 mmHg) is an overwhelming global challenge [1, 2]. It is one of the most
significant risk factors for cardiovascular (CV) morbidity and mortality resulting from target-
organ damage to blood vessels in the heart, brain, kidney, and eyes [3, 4]. Hypertension
causes 7.1 million premature deaths each year worldwide and accounts for 13% of all deaths,
globally [5].

Analysis of the global burden of hypertension revealed that over 25% of the world's adult
population had hypertension in 2000, and the proportion is expected to increase to 29% by
2025[1, 2]. Even though the burden of hypertension is currently centered in economically
developed countries (37.3%), developing countries will feel a greater impact due to their
larger population proportion, a change in life style and sedentary life. Indeed, estimates
indicate that up to three-quarters of the world’s hypertensive population will be in
economically developing countries by the year 2025 [6].

In Africa, 15% of the population has hypertension [1, 2]. Although there is shortage of
extensive data, 6% of the Ethiopian population has been estimated to have HTN.
Approximately 30% of adults in Addis Ababa have hypertension above 140/90 mmHg or
reported use of anti-hypertensive medication [2].

Medications to treat hypertension and other chronic conditions work and are widely
available. However, the broad benefits of these drugs are not being realized because large
proportion of patients are not taking these medicines the way they are prescribed and this
indirectly raises the issue of therapeutic adherence among hypertensive persons [7]

The World Health Organization(WHO) defines adherence to long-term therapy as “the extent
to which a person’s behaviortaking medication, following a diet, and/or executing lifestyle
changes corresponds with agreed recommendations from a health care provider.”[8] Other
similar terms have been used instead of, adherence and the meaning is more or less identical
[9].Often, the terms adherence and compliance are used interchangeably. However, their
connotations are somewhat different: adherence presumes the patient’s agreement with the
recommendations, whereas compliance implies patient passivity [8].Recently, the term
“Concordance” is also suggested to be used. Compared with “adherence”, the term
concordance makes the patient the decision-maker in the process and denotes patients-
prescribers agreement and harmony. Although there are slight and subtle differences between
these terms, in clinical practice, these terms are used interchangeably [9].

Measurement of medication adherence is challenging because adherence is an individual


patient behavior. The following are some of the approaches that have been used:
1. Subjective measurements obtained by asking patients, family members, caregivers, and
physicians about the patient’s medication use;
2. Objective measurements obtained by counting pills, examining pharmacy refill records,
or using electronic medication event monitoring systems; and
3. Biochemical measurements obtained by adding a nontoxic marker to the medication and
detecting its presence in blood or urine or measurement of serum drug levels [10, 11].

Therapeutic non-adherence occurs when an individual’s health-seeking or maintenance


behavior lacks congruence with the recommendations as prescribed by a healthcare provider
[9].Many factors affect patient’s adherence with medication regimes. Pharmacists need to be
knowledgeable about the risk factors for non-adherence in order to help identify these issues
and assist their patients [11].

Many studies have been conducted to determine explanatory factors for “good” or “poor”
adherence in order to explain predict and monitor patients’ behaviors [12]. No single factor
has been found to reliably predict patient non-adherence [11]. Factors determining the level
of antihypertensive drug adherence have been identified as follows:
1. Factors linked to treatment: The complexity of the treatment and the drugs’ side
effects.
2. Factors linked to the doctor–patient interaction: The balance between established
medical guidelines and their own convictions, Communication between patient and
doctor, patient’s satisfaction with the healthcare system.
3. Factors linked to the patient: Socio-economic factors, the cost of treatment, lack of
medical insurance [11, 13,14].
LIFESTYLE MODIFICATION

A healthy lifestyle remains the cornerstone of the management of hypertension at all levels of the
disease. A healthy lifestyle decreases blood pressure, enhances antihypertensive drug efficacy and
decreases total cardiovascular risk.

The South African Hypertension Guidelines 2009 recommend lifestyle changes in all hypertensive
patients. Management of obesity, exercise, reduction in alcohol and increased dietary intake of
potassium and reduced salt are the obvious targets but remain difficult to implement. 17
It is possible to prevent the development of hypertension and to lower blood pressure levels by simply
adopting a healthy lifestyle. 22 The frustrations of advocating lifestyle changes are obvious to
healthcare providers in clinical practice.

Lifestyle modification, previously termed non-pharmacologic therapy, plays an important role in


hypertensive as well as non-hypertensive individuals. 25 In hypertensive individuals, lifestyle
modifications can serve as initial treatment before the start of drug therapy and as an adjunct to
medication in persons already on drug therapy. In hypertensive individuals with medication-
controlled BP, these therapies can facilitate drug step-down and drug withdrawal in highly motivated
individuals who achieve and sustain lifestyle changes. In non-hypertensives, lifestyle modifications
have the potential to prevent hypertension, and more broadly to reduce BP and thereby lower the risk
of BPrelated clinical complications in whole populations. Indeed, even an apparently small reduction
in BP, if applied to an entire population, could have an enormous beneficial effect on cardiovascular
events. For instance, a 3-mmHg reduction in systolic BP should lead to an 8% reduction in stroke
mortality and a 5% reduction in mortality from coronary heart disease. 25

In 1997, the World Health Organization emphasized that obesity is becoming a major health
problem in many developing countries, particularly in adult women. 9 This presents a significant threat
to the emergence ofnoncommunicablediseases in the developing world. Obesity is associated with
increasing risk of developing hypertension, coronary heart diseases, diabetes, stroke, and some forms
of cancer, in both African and white populations.
Salt reduction has been suggested as a possible adjunct to pharmacologic treatment to
enhance blood pressure control. Several studies 4, 16, 22 have investigated this issue and
found that, for hypertensive patients who are receiving antihypertensive medication, salt
restriction provides additional benefits in terms of blood pressure control. One of the larger
studies of this type was conducted by Erwtemann et al (1984). 37 who found that an
additional 3 mmHg decrease in diastolic blood pressure could be achieved through salt
restriction among patients taking diuretics and B-blockers.

Exercise programs that primarily involve endurance activity prevent the development of hypertension
and lower blood pressure in adults with normal blood pressure and those with hypertension. The
bloodpressure lowering effects of exercise are most pronounced in people with hypertension who
engage inendurance exercise with blood pressure decreasing approximately 5-7 mmHg after an
isolated exercisesession (acute) or following exercise training (chronic). 29
Moreover, blood pressure is reduced for up to 22 hours after an endurance exercise bout with the
greatest decreases among those with the highest baseline blood pressure.

Epidemiologic, clinical and experimental studies suggest that ingestion of a diet habitually
high in salt plays a role in the etiology and pathogenesis of hypertension
1.2 STATEMENT OF THE PROBLEM

Non adherence to treatment medication, especially in chronic diseases, is a complicated issue


affecting patients’ health, health expenditure, and resources’ utilization while adherence to
antihypertensive treatment (AHT) has been associated with improved blood pressure(BP),
decreased hospitalizations rates, and lower medical care costs [12, 15]. It has also long-term
survival advantages after acute myocardial infarction (AMI) appear to be class specific and
correlated positively in a dose-response–type fashion [12].

Despite the availability of effective treatments, studies have shown that in many countries
less than 25% of patients treated for hypertension achieve optimum blood pressure
(BP≤140/90 mmHg [9]. Survey conducted 2003-2004 showed only 37% of hypertensive
patients have their blood pressure controlled [1]. Uncontrolled high blood pressure indirectly
raises the issue of therapeutic adherence among hypertensive persons [10].WHO describes
poor adherence as the most important cause of uncontrolled blood pressure and estimates that
50–70% of people do not take their antihypertensive medication as prescribed [6]. Non
adherence rates for patients with hypertension are reported to be 50% after 1 year and 85%
after 5 years [11].Within the first year of treatment 16-50% of hypertensive patients
discontinue their anti-hypertensive medications. Even among those who remain on therapy
long term, missed medication doses are common [14].

The problem of non-adherence to medical treatment remains a challenge for the medical
professions and social scientists [1]. Non adherence to treatment medication, especially in
chronic diseases, is a complicated issue affecting patients’ health, health expenditure, and
resources’ utilization. This problem can constitute many forms, including not having a
prescription filled, taking an incorrect dose, taking medications at incorrect times, forgetting
to take doses, or stopping therapy before the recommended time [16]. As a result, substantial
numbers of patients do not get the maximum benefit of medical treatment, resulting in poor
health outcomes, lower quality of life and increased health care costs [1, 7].

Globally, “poor adherence has been estimated to cost approximately $177 billion annually in
total direct and indirect health care costs” [7]; It has been estimated that non adherence to
prescribed medications causes nearly 125,000 deaths annually [16]. 10% of hospital and 23%
of nursing-home admissions are due to medication non adherence [16]. One-third of all
Prescriptions are never filled, and over half of prescriptions that are filled are associated with
incorrect administration. Non adherence contributes to direct annual costs of $100 billion to
the U.S. health care system. Indirect costs exceed $1.5 billion annually in lost patient
earnings and $50 billion in lost productivity [16].
Motivating patients to implement lifestyle changes is probably one of the most difficult
aspects of managing hypertension. According to a review of literature in South Africa, 5, 6,
8 there appear to be no studies that have comprehensively assessed patient hypertension
knowledge, attitudes and perceptions on the importance of lifestyle modification in
controlling hypertension. In South Africa good lifestyle changes are further complicated by
varying socio-economic conditions, education levels and poor health care deliver.
Obesity is often associated with essential hypertension as stated by Opie (2004:455). The greater the
body mass, the more blood is needed to supply oxygen and nutrients to the muscle and other tissues.
Obesity also increases the number and length of blood vessels and therefore, increases resistance of
blood that has to travel longer distances through those vessels. The occurrence of obesity has
dramatically increased and is now estimated that over 50% American adults are either overweight or
obese (Loscalzo, 2005:15). Loscalzo (2005:15) further states that obesity adds to the development of
several cardiovascular disease risk factors, especially hypertension, diabetes mellitus, low cholesterol
elevated triglycerides and elevated levels of inflammatory markers.
It appears that there is a lack of knowledge about hypertension that leads to further serious
complications.
In general non-adherence with long-term medication and lifestyle modifications for
conditions such as hypertension, dyslipidemia and diabetes is a common problem that leads
to compromised health benefits and serious economic consequences in terms of wasted time,
money and uncured disease [17].
1.3 SIGNIFICANCE OF THE STUDY

Poor medication and lifestyle modifications adherence is relatively common. Studies have
shown 20%-30% of medication prescriptions are never filled and that, on average, 50% of
medications for chronic disease are not taken as prescribed. This lack of adherence to
medications has dramatic effects on individual and population-level health. Evidence
suggests that benefits attributable to improved self-management of chronic diseases could
result in a cost-to-savings ratio of approximately 1:10 [18].

This study is useful for creating awareness about the impact of non-adherence on health and
promoting appropriate medicine and lifestyle modification usage habit to earn desirable
outcomes. It also aimed to determine the knowledge of patients towards lifestyle
modificationand its importance in the management of hypertension. It is also aimed to
identify the common factors of poor adherence to anti-hypertensive drugs and lifestyle
modifications and giving recommendation for the health professional giving chronic care for
the patients. It can be used as a reference for other researchers performing similar studies.
2. OBJECTIVES
2.1 GENERAL OBJECTIVE

The general objective of this study isassessment of hypertension management and factors
associated with poor treatment outcomes among hypertensive patients at st.puol hospital,
Addis Ababa, Ethiopia fromFeb. 29 to March 9, 2014

2.2 SPECIFIC OBJECTIVES:


 To investigate the level of non-adherence to antihypertensive medication and
lifestyle modification at St. Paulo’s Hospital, chronic cases follow up clinic,
Addis Ababa, Ethiopia.
 To identifythe reasons for non-adherence in hypertensive patients in St Paulo’s
Hospital, at chronic cases follow up clinic,Addis Ababa, Ethiopia.
 To assess the knowledge, attitude and perception of hypertensive patients
toward controlling blood pressurein St Paulo’s Hospital, at chronic cases follow
up clinic,Addis Ababa, Ethiopia.
 To assess pattern of hypertension management in hypertensive patientsat St.
Paulo’s Hospital, chronic cases follow up clinic, Addis Ababa, Ethiopia.
 To identify common antihypertensive medication utilized by hypertensive
patients at St. Paulo’s Hospital, chronic cases follow up clinic, Addis Ababa,
Ethiopia.
 To identify the reasons for poor treatment outcomes in hypertensive patients in
St Paulo’s Hospital, at chronic cases follow up clinic, Addis Ababa, Ethiopia.
3. LITERATURE REVIEW

Many patients have uncontrolled blood pressure (BP) because they are not taking medications
as prescribed. Providers may have difficulty to accurately assess adherence and needs to
assess medication adherence to decide whether to address uncontrolled BP by improving
adherence to the current prescribed regimen or by intensifying the BP treatment regimen by
increasing doses or adding more medications [17].

A cross-sectional cohort study of 1169 veterans with diabetes presenting with BP ≥140/90
mm Hg at 9 Veterans Affairs (VA) facilities, U.S.A, from February 2005 to March 2006
indicated 1064 patients were receiving antihypertensive medication regularly from the VA.
Adherence assessments by providers correlated poorly with refill history. 211 (20%) patients
did not have BP medication available for ≥ 20% of days and among them 79 (37%) of the
patients have non-adherence, and intensified medications for 97 (46%). Providers’ intensified
BP medications for 451 (42%) patients, assessed also have non-adherence (44%). Continuous
multiple-interval measure of medication gaps (CMG) used to assess the proportion of time in
prior year that patient did not possess the prescribed medications; CMG ≥20% is considered
clinically significant non-adherence. The BP regimen was considered intensified if
medication was added or increased without stopping or decreasing another medication.
Providers recognized non-adherence for less than half of patients whose pharmacy records
indicated significant refill gaps, and often intensified BP medications even when suspected
serious non-adherence [17].

A cohort study conducted in U.S.A on 793 White and African-American (58%) patients
previously diagnosed with hypertension from 3 VA medical centers showed African-
American patients’ providers were significantly more active in advising and counseling about
hypertension care and medication adherence. African-American patients indicated greater
knowledge or heightened awareness of the importance of controlling their BP. In multivariate
models A modeling medication adherence, race was not significant, but having been told to
split one’s pills, believing one’s BP continues to be high, and having one’s provider discuss
things to do to make it easier to take BP medications were each significantly associated with
worse adherence, whereas having more confidence in one’s ability to take BP medications as
prescribed was associated with better adherence (all p’s ≤.02) [19]
A survey was conducted on 18806 newly diagnosed hypertensive patient ≥35 years of age in
2000 - 2001 using data obtained from 400 Italian primary care physicians in Italy. Patient
adherence was subdivided a priori into 3 categories; high (proportion of days covered,
≥80%), intermediate (proportion of days covered, 40% to 79%), and low (proportion of days
covered, ≤40%). At baseline (i.e., 6 months after index diagnosis), 8.1%, 40.5%, and 51.4%
of patients were classified as having high, intermediate, and low adherence levels,
respectively [12].

Another population-based retrospective study conducted at Local Health Unit of Florence


(Italy) on 31,306 patients, (men (48.0%), and women (52.0%)), with a mean age of 60.2 ±
14.5 years, including patients newly treated with antihypertensive, 18 years of age, with a
first prescription between January 1, 2004 and December 31, 2006 assessed shows, adherence
to AHT was poor in 8038 patients (25.7%), moderate in 4640 (14.8%), good in 5651
(18.1%), and excellent in 12,977 (41.5%) [20].

A semi-structured interview using anthropological approach based on an ethnographic survey


conducted from October 2002 to April 2004 in a rural area of south Eastern France with 68
hypertensive patients (39 women and 29 men, between the ages of 40 and 95, of whom 52
were over 60) who had been receiving treatment for over a year indicates prescription
compliance does not solely depend on the patient’s perception of cardiovascular risk, but also
on how the patient fully accepts the treatment and integrates it into his or her daily life.
Following the prescription requires a relationship based on trust between the doctor and
patient, in three forms: reasoned trust, emotional trust and conceded trust [12].

A semi‐standard survey interview conducted on 518 patients with AHT at the clinic of
Penang General Hospital, Malaysia, to assess adherence for AHT usingMorisky Medication
Adherence Scale (MMAS). An independent sample T‐test with a response rate 73.36% was
used to determine whether there is a significant difference between patients’ who were
hospitalized (n = 12) and who were not (n = 368), with poor adherence. The results show
that, 195 (51.3%) patients had poor adherence to antihypertensive medication. Much higher
level of hospitalization for patients with poor adherence (M = 4.50, SD = 0.384) than who are
adherent (M = 2.82, SD = 1.486) [21].
Thematic content analysis of qualitative study which is conducted on 16 patients at
Sandamen Provisional Hospital of Quetta city, Pakistan, indicated five major themes that can
change the beliefs and experiences of hypertensive patients.

1. Perceived benefits and risks of medications


2. physician's interaction with patients
3. perception toward traditional remedies
4. layman concept toward medications and
5. Beliefs toward hypertension and its control.

Physician's attitude, patient's past experiences, and knowledge related to hypertension were
noted as major contributing factors thus resulting in non-adherence to therapy prescribed
[22].

Another cross-sectional study conducted on 460 patients at the Aga Khan University
Hospital (AKUH) and National Institute of Cardiovascular Diseases, Karachi, Pakistan, from
September 2005–May 2006, using MMAS, with scores ranging from 0 (non-adherent) to 4
(adherent) and patient self-reports about the number of pills taken over a prescribed period,
showed that at a cut-off value of 80%, 77% of the cases were adherent. Upon univariate
analyses, increasing age, better awareness and increasing number of pills prescribed
significantly improved adherence, while depression showed no association. Younger age,
poor awareness, and symptomatic treatment adversely affected adherence to antihypertensive
medication in our population [6].

A cross-sectional study carried out with 223 hypertensive patients older than 18 years, treated
at six of the Family Health Strategy Units in Maceió (AL), Brazil, through interviews and
home blood pressure measurements, between January and April 2011 using MMAS-8. The
study shows adherence among the patients studied was 19.7%, while 34% had controlled BP
(> 140/90 mmHg). The average adherence value according to the MMAS-8 was 5.8 (± 1.8).
Adherent patients showed (OR = 6.1, CI [95%] = 3.0 to 12.0) to have blood pressure control
than those who reached mean (6 to <8) or low values (<6) at the adherence score [23].

Randomly sampled 152 non co morbid hypertensive outpatients, visiting the consultant
outpatient clinic of the cardiology unit of the department of medicine, University of
Interviewed Maiduguri Teaching Hospital (UMTH), Maiduguri, Borno state, Nigeria were to
assess adherence to AHT. Adherence was measured on a 12-point scale, recorded a mean
score of 9.37 + 1.22. The study participants had a mean age of 49.29±1.04 years and the
adherence level was 85.5%. The study shows significant association between adherence and
age, marital status, tribe, state of origin, cost of antihypertensive medications, number of
antihypertensive medications, age/gender with P < 0.01. Major reasons for non-adherence
were feeling worse (side effects of the antihypertensive medications), and feeling better with
P < 0.01 [3].

Randomly sampled eighty (80) outpatients suffering from co-morbid hypertension and
diabetes mellitus that visited the consultant outpatient clinics of the cardiology and
endocrinology units of the department of medicine, University of Maiduguri Teaching
Hospital (UMTH), Maiduguri, Bornostate, Nigeria were interviewed using a self-
administered pre-tested structured, mostly closed ended questionnaires. Adherence was
measured on a 12-point scale; Mean SD score of 9.4 ± 1.0 was recorded. The study
participants had a mean SD of age of 51.9 ± 7.8 years. The adherence level was 81.2%. The
study showed a significant association between age and adherence levels with P = 0.005.
Major reason for non-adherence to clinic appointment was travelled a lot (27.2%). Non
adherence to filling/refilling of prescriptions were mainly attributed to felt worse due to side
effects of medications (60.0%) and high cost of medications (20.0%). Busy work schedule
(22.2%), when felt better (22.2%) and when felt worse while taking medications (22.2%)
were major reasons responsible for not taking medications as prescribed [24].

A prospective study of 150 hypertensive patients on medication for 6 months, at the OPD of
Ghana Ports and Harbor Authority (G.P.H.A.) Hospital, Takoradi, was carried out using
MMAS-4. The study revealed that total adherence to anti-hypertensive medications regimens
was 19.3% and partial or medium adherence was 49.3%. Hence the adherence rates (i.e. those
who took their medications ≥ 75%) to anti-hypertensive medicines in the institution was
68.6% and the non-adherence rate was 31.4%. The major reasons for non-adherence were
forgetfulness (45.4%) by the patient to take medications on time or missed doses and side
effects of the medications (20.8%). Finance (10.4% was also a problem for the paying
patients who have to make up-front payment to re-fill their medicines [11].
Questionnaire-based cross-sectional study was conducted at the University Teaching Hospital
(UTH) inLusaka, Zambia on 237 adult patients aged 18 and above with previous diagnosis of
essential hypertensionreceiving outpatient care from the first week of November to the
second week of December 2010. Information was collected using self-report and modified
Hill-Bone compliance scale.The mean age was 57.8 &12.0 SD. The result showed
prevalence of adherence was 83% by self-report. The factors associated with non- adherence
included pill burden, drugs prescribed unavailability at the hospital pharmacy (83%), poor
patients counseling, a primary level of education, side effect of dizziness, missed
appointment due to lack of transport, and living at a distant from the hospital [25].

Cross-sectional study conducted at General medical outpatient clinics at a tertiary referral


hospital, Kenyatta National Hospital, Nairobi, Kenya. Adequacy of BP control and level of
adherence by the Hill-Bone score. Of 783 patients screened from 1st June and 30th
November 2007, 575 (73%) met the inclusioncriteria and 264 were randomly recruited; 67%
were female; mean age was 57.3 years. Number of antihypertensive drugs prescribed
was35.2% two drugs, 36.6% three drugs and 14.9% on four or more drugs. 26% had adequate
BP control and58.5% of those with inadequate BP control had BP of > 160/l00mmHg. 31.8%
of the patients were fully adherent to antihypertensive therapy. Poor BP control in 75% of
hypertensive patientsis largely due to non-adherence, with other associated factors being
obesity, increasing number of medications suboptimal drug combinations and doses [26].

A cross-sectional study conducted at Black lion hospital (BLH) chronic follow up unit, Addis
Ababa, Ethiopia with 286 study subjects was analyzed for adherence level using SPSS 16. P-
value <0.05 was considered significant association. The subjects included in the study
165(57.7%) were female and mean age was 52±13 year. The study revealed the adherence
level of respondents to medication, diet and exercise were 69.2%, 64.7%, and 43.7%
respectively. The medication and diet related adherence were found to be better in patients
who had been informed about their medicine. There was significant association between
marital status, work status, Health care facilities, duration of Hypertension and its treatment
and medication adherence [2].

Institution based cross sectional study conducted at University of Gondar Hospital (GUH),
Northwest Ethiopia on 384 participants using MMAS shows that more than half (64.6 %) of
the study participants were found to be adherent to their treatment. Factors such as
sex,distance from the hospital, number of co morbidities, Knowledge about HTN and its
treatment were associated with adherence behavior of patients. Early diagnosis and
management of co morbidities, adherence counseling and patient education about the disease
and its treatment are important to improve adherence status of patients [1].

LIFESTYLE MODIFICATION

An increased prevalence of hypertension in groups with high alcohol consumption has been
recognized for a number of years. More recently, several studies have suggested an
independent association between alcohol consumption and blood pressure levels in samples
from general populations. In multivariate analyses the association was shown to be
independent of a variety of potential confounding factors, including age, relative body
weight, exercise, and smoking status, that are known to be or are likely to be related to both
blood pressure and alcohol consumption. Of 30 cross-sectional population studies reviewed,
the majority reported small but significant elevations in blood pressure in those consuming
three drinks or more per day in comparison with nondrinkers. In two studies, one from
theUnited States and one from Australia, the maximum contribution to the prevalence of
hypertension of alcohol consumption greater than two drinks per day was estimated to be 5%
to 7%; the contribution in men (11%) was greater than that in women because of their greater
alcohol consumption. 39
4. MATERIALS AND METHODS

4.1 STUDY AREA & PERIOD

This study will be conducted inSt.Paulos hospital, chronic follow up clinic fromFeb. 22 to
March 9. This hospital is found in Addis Ababa city which is a capital city of Ethiopia.
Based on the 2007 census conducted by the central statistical of Ethiopia(CSA), Addis
Ababa city has a total population of 3,384,569. It lies at an altitude of 7,546
feet(2,300meters). The city has surface area of about 530.14km2. Language spoken
include Amharic (71%), Oromiffa (10.7%), gurage(8.37%), Tigrigna( 3.60%) , Silt’s
(1.82%) and Gamo (1.03%). The area was selected because it is central referral hospital
that provides organized hypertension follow up care.

4.1.2 STUDY DESIGN

The study will be conducted using hospital based descriptive cross –sectional study
design which involves quantitative methods.

4.1POPULATION
4.1.1 SOURCE POPULATION
The source populations will be all patients visiting St. Paulo’shospital and who were
diagnosed to have HTN.
4.1.2 STUDY POPULATION
All adult hypertensive patients attending the facility on out-patient basis during the study
period andvolunteered to take part in the study will be used for the study.

4.2SELECTION CRITERIA
4.2.1 INCLUSION CRITERIA
 Patients presented with a history of hypertension at OPD of this hospital for
at least six months duration and on medication during the study period.
 Diabetic hypertensive patients were a part of the study proved that they are
on anti-hypertensive medication.
 Patients who are clinically stable.
 Patients who are mentally stable.
4.2.2 EXCLUSION CRITERIA
 Pregnancy induced hypertension patients.
 Hypertensive patients less than six month duration of after diagnosis.
 Hypertensive urgency or emergency
 Patients with mental illnesses leading to confusion were excluded from
participatingin the study, e.g. delirium, dementia, psychosis, schizophrenia
etc

4.3 SAMPLE SIZE& SAMPLING TECHNIQUE


4.3.1 SAMPLE SIZE
The sample size was determined by using the following formula.
ni=(zα/2)2pq
d2
ni=(1.96)2(0.5)(0.5) =384
(0.05)2
Where

z=confidence interval (95%), ni =sample size, P=proportion of relatives, q=1-p,


d=margin of error (5%)

Since the total number of hypertensive patients is less than 10,000 the following correctional
formula was used.

nf = ni×N
ni+N

nf= 384×202 = 133


384+202
nf=133 +5% non-respondent rate
nf=140

Where ni= initial sample size which was 384.


N=sample population taken 202 hypertensive clients.
nf=exact sample size

4.3.2 SAMPLING TECHNIQUE


The study will be conducted usinga convenience sample.

4.4 STUDY VARIABLES


4.4.1 INDEPENDENT VARIABLES
 Socio demographic characteristics

 Age  Body mass index


 Sex  Non adherence
 Religion
 ethnicity
 marital status
 occupation
 monthly income
 distance from the
hospital
 place of
residence
 duration of illness
 Education status
 Social drug use
 Adherence
 Knowledge
4.4.2 DEPENDENT VARIABLES
 Treatment outcomes

4.5 DATA COLLECTION INSTRUMENT & TECHNIQUE


4.5.1 INSTRUMENT
The data will be collected using a questionnaire consisting of the 8- item morisky
medication adherence scale self-reported medication adherence questions relating to
medication use and major reasons for non-adherence.
Accessories materials like pen, pencil, calculator, binder, eraser and sharpener was
used.
4.6 DATA COLLECTION TECHNIQUE
The data will be collected by using interview technique using 8- item morisky
medication adherence scale and other types of questionnaire
4.6.1 QUALITY ASSURANCE
For completeness and consistency, standardized questionnaire of English version will be
translated to local languages Amharic andAfan Oromo. Then it will be back translated to
English and checked. The questionnaire in local languages will be pretested and used.

4.7DATA PROCESSING AND ANALYSIS


All the data collected will be analyzed manually and presented in the form of frequency
table, graphs &charts.A cut-off point was set at 4 and the respondents were categorized in to
adherent and non-adherent groups, based on the total score of MMAS. The respondents with
a score of below 4 were considered as adherent and a score of above 4 were considered as
non-adherent. This value was set from questionnaire characters because some of the
questions contained similar concept.

4.8ETHICAL CONSIDERATION
First an official permission and formal letter was received fromJimmaUniversity, CHMS
research and ethics committee and sentSt. Paulos hospital. Next, the reason why the data
were collected from the patient was explained to them. After the patient understood, data
collection proceeded accordingly by keeping privacy and confidentiality.

4.9DISSEMINATION OF RESULT
The final finding of the study will be disseminated for concerned bodies.

 School of pharmacy college of Public Health and medical Science


JimmaUniversity.
 CBE
5. WORK PLAN

S. Activities Responsible Months. 2013/2014


N body
Oct No Dec. Jan. Feb. Mar. Apr. May June
. v .

1 Topic selection Investigator


and approval

Proposal >>
development

3 Preparing >>
questionnaires

4 Approval of >>
proposal by
department and
advisor

5 Pre – test >>

6 Data collection >>

7 Data processing >>


and
summarizing

8 Data analysis >>

9 Report writing >

10 Developing the >>


final report

11 Research >>
defense and
submission
6. RESEARCH BUDGET

S.N Budget category Unit Unit Price Quantity Total price Remark
(Birr)

1) Stationary materials

1 Note book Pieces 10 4 40.00

2 Pen Pieces 4 4 16.00

3 Staples Pack 4.00 6 24.00

4 Pencil Pieces 1.00 6 6.00

5 Pencil eraser Pieces 4.00 6 24.00

Sub total 110.00

2) Service costs

1 Printing Page 1 70pgs 70.00

2 Photocopy and Binding Page/Pad 30 4pads 120.00

Sub Total 190.00

Grand Total 300.00

6.1 Budget Summary

S.No Description of the cost Cost in Birr

2 Stationary & Supplies cost 110.00

3 Service cost 190.00

Total 300.00
Dummy table

Table 4.1:Adherence and age Cross tabulation St. Paulo’sHospital,chronic follow up clinic from
Feb. 22 to March 9, 2014
Age of respondents
20-33 years 34-47 years 46-61 years 62-78 years
Adherent
Non
Adherent
Total

Table 4.2:Sexual distribution of the study participants atSt.paulos Hospital, chronic follow up
clinic fromFeb. 22 to March 9, 2014

Variables Frequency Percent (%)


Males
Females
Total
.

Table 4.3: Adherence and sex Cross tabulation St.paulos Hospital, chronic follow up clinic
from.Feb.22 to March 9, 2014

Sex Adherent Non adherent OR


Male
Female
Table 4.4: Residence and distance from the institution of the study participants atSt.paulos
Hospital, chronic follow up clinic from Feb.22 to March 9, 2014

Variable Number Percent (%)


Residence Urban
Rural
Total
Distance from <5 KMs
health institution >5 KMs
Total

Table 4.5Adherence and Marital Status Cross tabulationSt.Paulos Hospital, chronic follow up
clinic from Feb.22 to March 9, 2014
Adherent Non adherent Total
Married
Widowed
Single
Divorced

Table 4.6: Educational status distribution of the study participants atSt.paulos Hospital, chronic
follow up clinic from Feb.22 to March 9, 2014

Variables Frequency Percent


Illiterate
Primary education (grade 1-8)
Educational status Secondary education (grade 9-12)
Colleges and University
Total
Table 4.7:Adherence and Educational background Cross tabulationSt.paulos Hospital, chronic
follow up clinic from Feb. 22 to March 9, 2014
Adherent Non Adherent Total
Illiterate
Secondary education (grade 9-12)
Primary education (grade 1-8)
Collegesand University

Table 4.8: Average Monthly Income distribution of the study participants at St.paulos Hospital,
chronic follow up clinic from Feb. 22 to March 9, 2014
Variable Frequency Percent

<500 ETB

500-1000 ETB

1000-2000 ETB

>2000 ETB

Total

Table 4.9:Adherence and Income Cross tabulation St.paulosHospital,chronic follow up clinic


from Feb.22 to March 9, 2014

Adherent Non Adherent Total


<500 ETB
500-1000 ETB
1000-2000 ETB
>2000 ETB
Table 4.10: Adherence and Occupation Cross tabulationSt.paulos Hospital, chronic follow up
clinic from Feb.22 to March 9, 2014

Adherent Non Adherent Total


Government Employee
Student
Farmer
Daily Labor
Business Man/Woman
Others

Table 4.11: Reasons of non-adherence among the study participant at St.paulos Hospital,
chronic follow up clinic from Feb.22 to March 9, 2014

Reasons for non-adherence Frequency Percent

Forgetfulness and carelessness

Being busy and forget it

Feeling well

Feeling sick, side effects

Can’t afford the cost (drugs are expensive)

Drugs you are taking are too many.

Others

NB: Some patients had more than one reason for non-adherence
REFERENCES

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ANNEXES
Annex –I: Data Collection Format
Questionnaire onassessment of hypertension management and factors associated with poor
treatments outcome atSt.paulos Hospital, chronic follow up clinic, from Feb.22 to March 9,
2014

PART A

Socio demographic characteristic of the study participants.

1. Age _______Years

2. Sex Male [ ] Female [ ]

3. Ethnicity Oromo [ ] Amhara[ ]


Harari [ ] Gurage[ ]
Somali[ ] Tigre [ ]
Others [ ]

4. Religion Muslim [] Orthodox []


Protestant [ ] Others [ ]

5. Marital status Married [ ] Single [ ]


Divorced [ ] Widowed [ ]

6. Occupation government employee [ ] farmer [ ]


Student [ ]Businessman/woman [ ]
daily labor [ ]Others specify []

7. Place of residence urban [ ] rural [ ]


8. Level of education Illiterate []Primary[ ]
Secondary [ ] Colleges and university [ ]

9. How much is your monthly income? <500 [ ] 500-1000 [ ]

1000-2000 [ ] >2000 [ ]
10. What medication do you take for your hypertension?
...............................................................................................................................................
...............................................................................................................................................
............................................................................................

11 How long have you been taking these medicines?


6 months []6 months- 1 year[]

1 year -5 years [ ]5 years and above[]

PART B: - Morisky 8-item medication adherence questionnaire

You indicated that you are taking medication for your “high blood pressure”. Individuals
have identified several issues regarding their medication-taking behavior and we are
interested in your experiences. There is no right or wrong answer. Please answer each
question based on your personal experience with your antihypertensive medication.
Interviewers may self-identify regarding difficulties they may experience concerning
medication-taking behavior.

Table 4.12: Morisky Medication Adherence Scale


No MMAS-8 Yes No
.
1 Do you sometimes forget to take your pills?
2 People sometimes miss taking their medications for reasons other
than forgetting. Thinking over the past two weeks, were there any
days when you did not take your medicine?
3 Have you ever cut back or stopped taking your medication without
telling your doctor, because you felt worse when you took it?
4 When you travel or leave home, do you sometimes forget to bring
along your medication?
5 Did you take your medicine yesterday?
6 When you feel like your blood pressure is under control, do you
sometimes stop taking your medicine?
7 Taking medication every day is a real inconvenience for some
people. Do you ever feel hassled about sticking to your blood
pressure treatment plan?

8. How often do you have difficulty remembering to take all your medications? (Please circle the
correct number)
Never/Rarely……………………………………….0
Once in a while…………………………………….1
Sometimes………………………………………....1
Usually…………………………………………….1
All the time………………………………………..1
PART C
1.Poor Medication Adherence Reason Related Questions

1. Do you take your medications as prescribed?


(a) Yes [ ] (b) no [ ]

2. If No, why?
(a) You cannot afford to buy the medicationsalways.
(b) The schedule of your work makes itimpossible.
(c) Don’t believe in the medication
(d) You cannot swallow medication(s)
(e) Medications you are taking are too many
(f) Forget to take medications
(g) Others specify

2.physical Activity

1. How would you rate your overall physical activity level?

a. walking briskly, running

[ ] level 1- little or no activity

[ ] level 2- occasional activity

[ ] level 3- regular physical activity at least3 times per week

b. lifting and carrying

[ ] level 1- little or no activity

[ ] level 2- occasional activity


[ ] level 3- regular physical activity at least3 times per week

2. Does your work or daily activity primarily

Involve (tick most appropriate) :

[ ] sitting

[ ] standing

[ ] walking or other exercise

[ ] heavy labour

[ ] other (please specify) : …………

3. how often do you engage in vigorous exercise which markedly increases your breathing
such as :

vigorous walking, cycling, running, swimming, etc?

[ ] seldom or never

[ ] less than once a week

[ ] 1-2 times per week

[ ] 3-5 times per week

[ ] 6 or more times per week

4. when you exercise, how long do you spend at each session?

[ ] 0-14 minutes

[ ] 15-29 minutes

[ ] 30-44 minutes

[ ] 45-59 minutes
[ ] 60 or more minutes

5. On average, how many times per day do you lift objects which weigh 25kg or more?

[ ] rarely or never

[ ] 1-4 times

[ ] 5-14 times

[ ] 15-24 times

[ ] 25 times or more

3.lifestyle

Please check how often you use each of the following on a weekly basis. please mark a box for
everyfood item according to your usual intake. if you eat some foods only rarely or occasionally,
mark the“less than one” category.

times per week

none<1 1-3 4-7 >7

cheese[ ] [] [] [][]

eggs [] [] [] [] []

fried foods (chips,

fried meat, eggs) [ ] [ ] [] [] []

cooked salt [ ] [] [] [] []

added salt [ ] [] [] [] []

fish[ ] [] [] [] []

fruits[ ] [] [] [] []
vegetables[ ] [] [] [] []

4.knowledge, Attitudes and perceptions

1. What BP reading do you consider to be your ideal? ………………………..

2. Do you believe exercise can help lower your blood pressure?

[ ] yes [ ] no

3. If you do exercise, who advised you on how to exercise?

no one [ ] doctor [ ] nurse [ ] physiotherapist [

dietitian [ ] friend [ ] [ ] media [ ]

4. How much time do you think the medical professionals spend talking to you about the benefits
ofexercise?

None [ ] less than 5 minutes [ ]

5-10 minutes [ ]More than 10 minutes [ ]

5. What are the benefits of exercise?

a………………………………………………………………

b………………………………………………………………

c………………………………………………………………

d………………………………………………………………

e……………………………………………………………….

6. If you do not exercise, whynot?


………………………………………………………………………………………………………
……………………………………………………………………………………………………..c
an a balanced diet assist in lowering bp?

[ ] yes [ ] no

8. did a medical professional teach you a balanced diet?

[ ] yes [ ] no

9. do you eat a balanced diet?

[ ] yes [ ] no

10. why/ why not?

………………………………………………………………………………………………………
…………………………………………………………

……………………………………………………………………………

11. Does adding salt to food affect your Bp?

[ ] yes [ ] no

12. Did a medical professional teach you about the dangers of too much salt?

[ ] yes [ ] no

13. Does alcohol affect BP?

[ ] yes [ ] no

14. Did medical professional teach you about the dangers of alcohol?

[ ] yes [ ] no

15. Does smoking affect blood pressure?

[ ] yes [ ] no
16. Did a medical professional teach you about the dangers of smoking?

[ ] yes [ ] no

17. Do you smoke?

[ ] yes[ ] no

18. If yes, how many per day?

………………………………………………………

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