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Prudhvi et al. World Journal of Pharmaceutical and Medical Research
www.wjpmr.com 211
STUDY ON IMPACT OF CLINICAL PHARMACIST INTERVENTION ON
MEDICATION ADHERENCE IN STROKE PATIENTS IN TERTIARY CARE HOSPITAL
V. Prudhvi*, T. Sravani, U. Mounika, M. L. Prathyusha, N. Soujanya, A. M. S Sudhakar Babu
Department of Pharmacy Practice, AM Reddy Memorial College of Pharmacy, Petlurivaripalem, Narasaraopet, Guntur-
522 601, Andhra Pradesh, India.
Article Received on 05/04/2018 Article Revised on 26/04/2018 Article Accepted on 16/05/2018
INTRODUCTION
Stroke is a medical condition in which poor blood
flow to the brain results in cell death. Stroke is one of the
most common neurological disorders in clinical
practice.[1]
According to WHO, it is the second
commonest cause of death worldwide. It is forecasted
that the deaths because the of stroke will rise to 6.5
million by 2015 and by 2020, stroke and coronary artery
disease are expected to be the leading causes of losing
life. Earlier Surveys on stroke in different parts of India
shown that the prevalence of stroke varies in different
regions of India and ranges from 40 to 270 per 1, 00,000
populations. Stroke is responsible for around 11% of all
deaths worldwide.[2]
The causes of stroke are diverse
hypertension are the most common.[3]
Adherence can be summarized as “The extent to which a
person‟s behaviour taking medication, following a diet,
and/or executing lifestyle changes-corresponds with
agreed recommendations from a healthcare provider”[4]
Adherence to prescribed medication predicts outcome. In
a population-based sample of 1, 00,000 patients under
the age 65 with Diabetes, Hypertension,
Hypercholesterolemia, and Hospitalization rates as well
as healthcare costs were significantly lower for patients
with high medication adherence. [5]Stroke events were
almost twice as high in non-adherent study participants
and remained independently predictive of adverse events
after adjusting for baseline disease severity and known
risk factors.[6-12]
OBJECTIVE
General objective
To Assess the Risk factors, Medication adherence, cost
burden associated with stroke disease in a tertiary care
hospital.
Specific objectives
To evaluate the impact of Pharmacist counseling on
medication adherence for patients with Stroke disease.
wjpmr, 2018,4(6), 211-219 SJIF Impact Factor: 4.639
Research Article
ISSN 2455-3301
WJPMR
WORLD JOURNAL OF PHARMACEUTICAL
AND MEDICAL RESEARCH
www.wjpmr.com
*Corresponding Author: V. Prudhvi
Department of Pharmacy Practice, AM Reddy Memorial College of Pharmacy, Petlurivaripalem, Narasaraopet, Guntur- 522 601, Andhra
Pradesh, India.
ABSTRACT
Objective: The objective of this study was to evaluate the impact of pharmacist intervention on Risk factors and
Medication adherence for patients with stroke. Methodology: This Study was conducted in the Neurology
department of Lalitha Super Specialty Hospital, Guntur, and Andhra Pradesh. The procedure of the study was a
prospective randomized interventional comparative design was conducted in the hospitalized patients. A Self-
administered questionnaire was prepared using information and thorough review from the literature survey and
factors used in previous studies. Questionnaire statistically it was validated by using Cronbach‟s α value which
reported a good measure of. 0.79 Results & discussions: A sample of 120 patients were enrolled into the study. 76
(63%) patients are male and 44 (37%) patients were female respectively. In this study unintentional reasons for
non-adherence have been reported more frequently than intentional reasons before counselling causes of
noncompliance. The most prevalent causes of non-compliance were forgetfulness (48.11%), too expensive
(47%),confusion (42.45%), side effects (38.67%),Trouble reading pills (34.9%), Alter dosing schedule for
convenience (31.13%), Don‟t care to take medication (30.18%),Trouble swallowing pills (30.18%),Stop to see it
still need (20.75%), Think medication not effective (18.86%).The commonest reported reason for un intentional
non adherence was forgetfulness. This test performed by using chi square (χ2
test) test statistics. Chi square statistic
value is 53.6251 this result is significant at p < .05 whose p value is <0.00001. Conclusion: The current study
identified unintentional reasons for non-adherence to be more common than intentional non-adherence.
KEYWORDS: Stroke, Medication adherence, Cronbach alpha, Chi square test, Compliance, Noncompliance.
Prudhvi et al. World Journal of Pharmaceutical and Medical Research
www.wjpmr.com 212
To collect the demographic data of selected patients of
Stroke affected in South region.
To improves health and effectiveness of medication
therapy by patient education.
To educate and promote awareness of the importance of
adherence to stroke medication and outcomes to avoid
non adherence.
METHODOLOGY
Study design
This was a prospective randomized interventional
comparative study in which information was obtained on
the risk factors, mediational adherence associated with
stroke diseases by the administration of a structured
interviewer-administered questionnaire. The study was
carried out October-2017 to march- 2018.
Study site
The study was carried out in tertiary care hospital of
Guntur district.
Study Period
06 Months.
Study Population & Sampling
A sample of 120 subjects was drawn in order to yield 5
% accuracy at the 90% confidence level. Initially a total
of 150 sample size was collected and estimated to be the
sample size and due to non-response factor and
communication errors it was settled down to 120. The
estimated prevalence rate was derived from the study.
Since, knowledge of the cause of a disease is one of the
most important factors in the control of the disease, the
knowledge that „Stroke was caused by risk factors
smoking, alcohol, hypertension, diabetes mellitus was
taken as the prevalence rate for the purpose of
calculating the sample size.
Study Criteria
Inclusion criteria
1. Population who were 18 years or older of rural areas
who are interested to participate.
2. Stroke patients undergoing treatment in selected
neurology care center of Guntur district.
Exclusion criteria
1. The patients below 18yrs old.
2. The patients who were non respondent to the study.
3. The pregnant patients.
Study Tools
A Self-administered questionnaire was prepared using
information and thorough review from the literature
survey and factors used in previous studies and it was
validated by faculties in department of pharmacy practice
and who expertise as a physician in Neurology care
center. It consists of 11 questions.
1. Do you forget to take your medications regularly?
The intention of this question is to enquire whether the
patient is taking medications regularly and to evaluate
the patient behavior towards the medication.
2. Do you miss any of your prescribed doses in the past 2
weeks?
The intention of this question is to enquire whether the
patient has missed any of their prescribed doses in the
medication during the past two weeks.
3. Do you stop taking your medication, if you feel better
or if your symptoms are under control?
The intention of this question is to enquire whether the
patient stop medication when the patient feels or
believed by themselves that they are relieved
symptomatically or whether the patient stop medication
when their symptoms are in control.
4. Do you feel worse while you are on your medication
do you stop taking them?
The intention of this question is to enquire whether the
patient stop medications when they feel worse while
taking medication due to the occurrence of side effects
like headache, vertigo etc.
5. Do you take your medication at the prescribed time?
The intention of this question is to enquire whether the
patients administering medication at the right time.
6. Do you often feel difficult in remembering your
medication?
The intention of this question is to enquire whether the
patients is able to remember their medication daily or
how often they feel difficulty in remembering
medication.
7. Do you carry your medications with you regularly?
The intention of this question is to enquire whether the
patient is able to carry their medications with them
regularly where ever they go Example: office, tours.
8. Do you take your medication only if you are sick?
The intention of this question is to enquire whether the
patient administer medication only if when they feel sick
or with signs and symptoms.
9. Do you feel at times being careless to take your
medications?
The intention of this question is to enquire whether the
patient is active at the time when the medication is to be
taken.
10. Do you believe that taking medication regularly can
control your disease?
The intention of this question is to enquire whether the
patient believe that taking medication regularly can
control their disease this helps in evaluating the patient
attitude towards medication can be known.
Prudhvi et al. World Journal of Pharmaceutical and Medical Research
www.wjpmr.com 213
11. Are you afraid of being addicted to your medication
by taking it regularly?
The intention of this question is to enquire whether the
patient is afraid of being taking their medication
regularly at proper time.
Score ranges 0-1, where affirmative answers get no score
with a higher score representing a high level of
adherence. (The adherence score was given accordingly
< 3 -poor, 4-7: Medium, 8-11 are considered as high
level of adherence).
Questionnaire Validation
Two physicians with experience in Neurology
Department were asked to evaluate the clarity, relevance
and conciseness of items included in the questionnaire
(limitations on questionnaire was a feedback which was
rectified by eliminating). Statistically it was validated by
using Cronbach‟s α value which reported a good measure
of. 0.79
Interviewers
The interviews were carried out by the students of the
project members by telephone communication and
through direct interview. The interviewers were
familiarized with the questionnaire and trained in the
proper manner of questioning as well as being
familiarized with the operational definitions in order to
maintain the uniformity of interpretation and explanation
for the benefit of the illiterate and non-English speaking
respondents. It was stressed that the interviewers write
the responses as stated by the respondents and not their
own interpretation of what was stated. The interviewers
were also trained not to show bias or emotion during the
interview. Non-respondents were not replaced for the
purpose of the survey. A brief introduction about the
purpose and nature of the study and assurance about
confidentiality were explained to the respondents prior to
the interview. The interview for each respondent lasted
10 to 15 minutes on average.
Data analysis
The responses in the recording form were manually
checked for errors and omission. Standardized codes
were used to simplify the coding process and analysis.
Data were analyzed using Statistical Package for Social
Sciences (SPSS) software Version 11.0. Data analysis
was done based on the objectives of the study. Data
screening was done to determine associations or
correlations between variables. Chi square test was used
to compare differences in proportions for categorical
variables and Chi square test & Student paired t test for
trend was used to compare trends for selected ordinal
independent variables. A p value less than 0.05 was
considered to be statistically significant.
Study variables
Outcome variable
The main outcome variable in this study was attitudes of
the respondents towards those affected by stroke. The
responses to hypothetical statements on attitudes were
framed on own in taking follow up with questionnaires
based on +1,-1 values.
Independent variables
Two groups of independent variables were measured in
relation to the attitudes towards stroke medication
adherence.
(i) Socio-demographic characteristic of the
respondents: The age, gender, habits like smoking,
alcohol, family history were considered and risk factors
were evaluated.
(ii) Mediating Variables: General medications of
stroke, comorbid diseases along with questionnaires for
analyzing medication adherence were included and score
was given. The responses to questions under the
knowledge and attitudes sections were analyzed
individually and as aggregated scores.
Minimizing errors
The steps taken to minimize errors in data collection and
data entry were as follows:
1. The interviewers were familiarized with the
questionnaire and adequately trained to complete the
required responses to minimize interviewer bias.
2. A weekly assessment of completed questionnaires
was carried out by a single coordinator and feedback
provided to the interviewers.
3. Regular supervision of interviewers was carried out
during the course of data collection.
4. Random checks on the accuracy of the responses
were carried out by the coordinator by re-visiting the
housing units of the respondents and reviewing the
questionnaire with them.
5. Accuracy of data entry was assessed by a 10 %
reassessment of data entry and cross checks with the
hard copy of the data.
Ethical issues
The following ethical issues were considered in the
design of the study:
1. The participants were briefed regarding the nature,
objectives and method of study and their voluntary
participation acquired.
2. Participants were reserved the right to withdraw
from the study at any point of time.
3. Total confidentiality with regard to the identification
of the participants and information volunteered was
assured at all times during and after survey.
RESULTS AND DISCUSSION
To the best of our knowledge, this is our first study in
south India that evaluates risk factors, medication
adherence associated with stroke disease in a tertiary
Prudhvi et al. World Journal of Pharmaceutical and Medical Research
www.wjpmr.com 214
care hospital of Guntur district, Andhra Pradesh. The
results were obtained after 6 months duration study in the
neurology department of tertiary care hospital. A total of
120 patients enrolled into the study & the data was
analyzed using Microsoft excel 2010.
Gender distribution of the Participants
Out of 120 patients, males are more prone to the disease
than females with the data representing in the figure: 1.
76 (63%) patients are male and 44 (37%) patients were
female respectively.
Fig 1: Gender Distribution of the Participants.
Age based demographic details of the stroke patients
21 to 90Y Age groups were considered under the study.
From the collected data, more no. of patients lie in the
age range of 61-70Y were observed. The following data
denoting the no. of patients belonging to their respective
age groups in the table 01and Fig: 2
Table 1: Age based demographic details of the stroke patients.
Age Range(Y) 21-30 31-40 41-50 51-60 61-70 71-80 81-90 Total
No. of Patients 4 9 18 30 39 13 7 120
Fig 2: Age wise Range distribution of Participants.
Out of 120 patient‟s data, based on the range of age, the
number of patients are 4, 9, 18, 30, 39, 13, and 7.
respectively with the age range of 21-30,31-40,41-50,51-
60,61-70,71-80,81-90.
Distribution of frequency of patients in Types of
stroke
The data was also used to analyze the types of stroke
which were observed during this study with following
distribution of frequency in the table 02 and Fig: 3.
Prudhvi et al. World Journal of Pharmaceutical and Medical Research
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Table 2: Distribution of frequency of patients in Types of stroke.
Types of Stroke Ischemic Stroke Transient Ischemic Stroke Hemorrhagic stroke
No. of Patients 45 41 21
Percentage of Patients 37.5% 34.16% 17.5%
Fig 3: Distribution of frequency of patients in Types of stroke.
Out of 120 patients received data, 34.16% patients
having transient ischemic attack and 37.5% patients
having Ischemic Stroke and 17.5% patients having
Hemorrhagic stroke are reported.
Frequency of Risk factors distribution of stroke
patients
Frequency of risk factors distribution of stroke patients
has been studied considering factors like Age,
Hypertension, Diabetes mellitus, Smoking and Alcohol
consumption in the respective area of South India. The
results were attained in the table 03 as follows and
representing in the Fig: 4.
Table 3: Frequency of Risk factors distribution of stroke patients.
Risk factors Age, HTN, DM Age, HTN Age, DM Smoking Alcohol Abuse
No. of Patients 15 26 4 37 38
Percentage (%) 12.5 21.67 3.33 30.83 31.6
Fig 4: Frequency of Risk factors distribution of stroke patients.
There are various risk factors for provoking stroke which
include: Age, HTN, DM, Smoking, Alcohol
consumption. According to the data obtained, out of 120
subjects Age, HTN along with DM may be the reason for
the stroke in 15 patients; Age, HTN may be the reason in
26 patients; Age, DM may be the reason in 4 patients;
Smoking may be the reason for stroke in 32, Alcohol
consumption may be the reason for stroke in 39 patients.
Reasons for Non-Adherence
The most prevalent causes of non-compliance were
expensive medications(49.05%), forgetfulness(48.11%),
confusion(42.45%), side effects(38.67%), trouble
reading pills(34.9%), altering dosing schedule for
convenience(31.13%), don‟t care to take
medication(30.18%), trouble swallowing pills(30.18%),
stop to see if still needed(20.75%), fasting(19.81%),
Prudhvi et al. World Journal of Pharmaceutical and Medical Research
www.wjpmr.com 216
think medication not effective(18.86%). The most
common reason for intentional non-adherence was side
effects(38.67%) and the most common reason for
unintentional non-adherence was expensive medication.
Unintentional reasons for non-adherence were found to
be more common than intentional non-adherence. The
majority(n=77) of the subjects (49.3%) reported two
reasons, 36.3% reported three reasons, 11.6% reported
four reasons and 2.59% five reasons for non-adherence.
Intentional Non-Adherence
Table 4: Reasons for intentional Non-Adherence.
Reasons
Side
effects
Think medication
not effective
Don’t care to
take medication
Stop to see if
still needed
Alter dosing schedule
for convenience
Fasting
No. of Patients 41 20 32 22 33 21
Percentage (%) 38.67 18.86 30.18 20.75 31.13 19.81
Fig 5: Reasons for intentional Non-Adherence.
Out of 106 patients, reasons for intentional non-
adherence were side effects, Think medications not
effective, Don‟t care to take medications, stop to see if
still needed, Alter dosing schedule for convenience,
fasting the results were reported as 38.67%(41),
18.86%(20), 30.18%(32), 20.75%(22), 31.13%(33),
19.81%(21) respectively.
Non-Intentional Non-Adherence
Table 5: Reasons for Non-Intentional Non-Adherence.
Reasons Forgetfulness Confusion Expensive
Trouble
swallowing pills
Trouble
reading pills
No. of Patients 51 45 52 32 37
Percentage (%) 48.11 42.45 49.05 30.18 34.9
Fig 6: Reasons for Non-Intentional Non-Adherence.
In 106 patients, reasons for non-intentional adherence
were forgetfulness, confusion, expensive, trouble
swallowing pills, trouble reading pills the reasons were
reported are 48.11%,42.45%,49.05%,30.18%,34.9%.
Prudhvi et al. World Journal of Pharmaceutical and Medical Research
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Frequency of Drug therapy design in stroke patients
Most of the patients were prescribed with Triple regimen
therapy (41.66%) followed by Double regimen therapy
(35%), Single regimen therapy (14.16%) and quadruple
regimen therapy (9.16%) tabulated in table 06
representing in Fig: 7.
Table 6: Frequency of Drug therapy design in stroke patients.
Drug Therapy Design Quadruple Triple Double Single
No. of Patients 11 50 42 17
Percentage (%) 9.16 41.6 35 14.16
Fig 7: Frequency of Drug therapy design in stroke patients.
In a total data, based on the drug therapy design, 9.16%
patients receiving quadruple regimen, 41.6% patients
receiving triple regimen, 35% patients receiving double
regimen, 14.16% patients receiving single regimen.
NOTE: Through this study, Aspirin (70%) was reported
to be most preferable drug for treating the stroke disease.
This was followed by piracetam (67.5%), Statins
(46.3%), Clopidogrel (5.3%), Heparin (8.33%), Tirofiban
(11.6%).
The study finally focusses on assessing the risk factors,
medication adherence, associated with stroke disease
patients which was attained to an optimum best with
88.33% overall patients are non-compliance to
medication before counselling and 61.66% patients were
compliance after counselling. The scale used to measure
the non-compliance has been found to have an internal
consistency with Cronbach‟s alpha value of 0.7906.
Table 7: Data distribution of Adherence in stroke patients before & after counseling.
Intervention Before Counselling After Counselling
Level of Adherence POOR MEDIUM HIGH POOR MEDIUM HIGH
No. of Patients 62 44 14 18 58 44
Percentage (%) 51.66 36.66 11.66 15 48.3 36.6
Fig 8: Data distribution of Adherence in stroke patients before and after counseling.
Prudhvi et al. World Journal of Pharmaceutical and Medical Research
www.wjpmr.com 218
Improvement in Medication Adherence
Fig 9: Diagrammatic representation of Level of Adherence showing improvement.
Before Counselling, 88.33% of patients were non-adhere
to medications while 11.67% of patients were adhere to
medications by SDPQ. After Counselling, the final result
stating that 38.34% patients belonging to non-adhere
medications and 61.66% patients adhere to medications
by our counselling and follow-up.
This test performed by using chi square (χ2
test) test
statistics. Chi square statistic value is 53.6251 this result
is significant at p < .05 whose p value is <0.00001. & by
using student paired t-test considering the P-value 0.68
with 95% confidence interval. By conducting pharmacist
patient counselling on medication adherence for patients
with stroke which gives 95% confidence interval value
of P=0.68 which gives more confidence to conclude that
pharmacist interventions improves medication adherence
in stroke patients.
SUMMARY
1. The main aim of this study is to evaluate risk
factors, medication adherence associated with stroke
disease in a tertiary care hospital.
2. The general objective of the study is to assess the
risk factors, medication adherence associated with
stroke disease.
3. A self- designed questionnaire was prepared and a
prospective randomized interventional comparative
study was conducted on a sample of 120 patients
with stroke disease.
4. The questionnaire was validated by using
Cronbach‟s alpha and the value was found to be
0.07906.
5. The patients of 18yrs or older of rural areas and
patients undergoing treatment in selected neurology
care center were included in the study.
6. The patient demographic data was collected and
were questioned regarding the medication adherence
and the individual patient score was given.
7. From the data collected before counselling the
patients who were non adherent to the medication
was found to be 83.33and the patients who were
adherent were found to be 11.67.
8. The patient was counselled regarding the importance
of medication adherence and educated to overcome
the barriers of non -adherence to achieve desired
therapeutic outcome.
9. The patients were communicated through telephone
and a direct follow up of six months was done.
10. The patient who received continuous follow up are
questioned again to assess the medication adherence
before and after counselling.
11. From the data collected after the counselling the
patients who were non adherent was found to be
38.34 and the patients who were adherent was found
to be 61.66.
12. From the above study out of 120 patients the
provoking risk factors for stroke observed are age,
hypertension, diabetes mellitus, smoking and
alcohol.
13. By using chi square (χ2
test) test statistics. Chi
square statistic value is 53.6251 this result is
significant at p < .05 whose p value is <0.00001.
14. By using student paired T-test the P value was found
to be 0.68.Based on this value the study concluding
the main role of pharmacist intervention in
improving the patient medication adherence.
CONCLUSION
The main aim of this study is to evaluate risk factors,
medication adherence associated with stroke disease was
achieved successfully. This study concludes the
importance of the pharmacist intervention in overcoming
barriers contributing to the medication non-adherence
and improving the individual patient medication
adherence for achieving the desired therapeutic outcome
and also assessing the risk factors to decrease the risk
Prudhvi et al. World Journal of Pharmaceutical and Medical Research
www.wjpmr.com 219
ratio of stroke occurrence and helps in the secondary
prevention of the disease.
The present study shows that participants (patients) who
attended the interactive educational intervention session
on evaluation of risk factors, medication adherence
associated with stroke disease was much satisfied, and
considered more effective and valuable.
ACKNOWLEDGEMENTS
The authors are thankful to A.M. Reddy Memorial
College of Pharmacy for providing facilities for bringing
out this work.
REFERENCES
1. Gaddam VK, Prudhvi V, Daiva Krupa G, Reehana
SK , Kiran G, Sudhakhar AM S. Survey of
knowledge and awareness about cerebrovascular-
stroke and assessment of quality of life among
coastal andhra urban population. World journal of
pharmacy and Pharm Sci., 2016; 5(9): 1397-1415.
2. Kulshreshtha A, Anderson LM, Goyal A, Keenan
NL, Stroke in South Asia: A Systematic Review of
Epidemiologic Literature from 1980 to 2010. Neuro
epi, 2012; 38: 123-129.
3. Wolf PA, Kannel WB, Current status of risk factors
for stroke.Neuro Cli., 1983; 1(1): 317-343.
4. Parthasarathi G, Karin NH, Milap CN.Clinical
pharmacy practice. Second Edition.Hyderabad.
Universities Press (India) Private Ltd., 2012; pp 74-
76.
5. Neela V, Pooja RY, Arundhati C, Srinivasan R,
Apoorva D. Study on impact of Pharmacist
Intervention on Medication Adherence in Cardiac
Patients in Tertiary Care Hospital. Inventi Impact:
Pharm Prac., 2015; 2015(4): 148-150.
6. Jamison J, Graffy J, Mullis R, Mant J, Sutton S.
Barriers to medication adherence for the secondary
prevention of stroke: a qualitative interview study in
primary care. Br J Gen Pract., 2016; 66(649): 568–
576.
7. Ronan OC, Martin D, Marie J, Cathie S. Improving
adherence to medication in stroke survivors
(IAMSS): a randomised controlled trial: study
protocol. BMC Neur., 2010 Feb 24; 10: 15.
8. Stephenson J. Noncompliance may cause half of
antihypertensive drug failures. JAMA. 1999; 282(4):
313-4.
9. Kathleen A. Fairman, Brenda M. Evaluating
Medication Adherence: Which Measure Is Right for
Your Program? J Manag Care Spec Pharm, 2000;
6(6): 499-506.
10. Elise C, Marion F, Mark A, Sarah JB,John W,
and Alison JW. Psychological factors which
influence adherence to medication in stroke
survivors: a Systematic Review of Observational
Studies. Annals of Behavioral Medicine, 2017;
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11. Beatrice C, Vanessa B. Adherence to medication
and self management in stroke patients.Br J
Nurs, 2014; 23(3): 158-66.
12. Imran A, Steven RF. Practical Strategies to Improve
Patient Adherence to Treatment Regimens. South
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  • 1. Prudhvi et al. World Journal of Pharmaceutical and Medical Research www.wjpmr.com 211 STUDY ON IMPACT OF CLINICAL PHARMACIST INTERVENTION ON MEDICATION ADHERENCE IN STROKE PATIENTS IN TERTIARY CARE HOSPITAL V. Prudhvi*, T. Sravani, U. Mounika, M. L. Prathyusha, N. Soujanya, A. M. S Sudhakar Babu Department of Pharmacy Practice, AM Reddy Memorial College of Pharmacy, Petlurivaripalem, Narasaraopet, Guntur- 522 601, Andhra Pradesh, India. Article Received on 05/04/2018 Article Revised on 26/04/2018 Article Accepted on 16/05/2018 INTRODUCTION Stroke is a medical condition in which poor blood flow to the brain results in cell death. Stroke is one of the most common neurological disorders in clinical practice.[1] According to WHO, it is the second commonest cause of death worldwide. It is forecasted that the deaths because the of stroke will rise to 6.5 million by 2015 and by 2020, stroke and coronary artery disease are expected to be the leading causes of losing life. Earlier Surveys on stroke in different parts of India shown that the prevalence of stroke varies in different regions of India and ranges from 40 to 270 per 1, 00,000 populations. Stroke is responsible for around 11% of all deaths worldwide.[2] The causes of stroke are diverse hypertension are the most common.[3] Adherence can be summarized as “The extent to which a person‟s behaviour taking medication, following a diet, and/or executing lifestyle changes-corresponds with agreed recommendations from a healthcare provider”[4] Adherence to prescribed medication predicts outcome. In a population-based sample of 1, 00,000 patients under the age 65 with Diabetes, Hypertension, Hypercholesterolemia, and Hospitalization rates as well as healthcare costs were significantly lower for patients with high medication adherence. [5]Stroke events were almost twice as high in non-adherent study participants and remained independently predictive of adverse events after adjusting for baseline disease severity and known risk factors.[6-12] OBJECTIVE General objective To Assess the Risk factors, Medication adherence, cost burden associated with stroke disease in a tertiary care hospital. Specific objectives To evaluate the impact of Pharmacist counseling on medication adherence for patients with Stroke disease. wjpmr, 2018,4(6), 211-219 SJIF Impact Factor: 4.639 Research Article ISSN 2455-3301 WJPMR WORLD JOURNAL OF PHARMACEUTICAL AND MEDICAL RESEARCH www.wjpmr.com *Corresponding Author: V. Prudhvi Department of Pharmacy Practice, AM Reddy Memorial College of Pharmacy, Petlurivaripalem, Narasaraopet, Guntur- 522 601, Andhra Pradesh, India. ABSTRACT Objective: The objective of this study was to evaluate the impact of pharmacist intervention on Risk factors and Medication adherence for patients with stroke. Methodology: This Study was conducted in the Neurology department of Lalitha Super Specialty Hospital, Guntur, and Andhra Pradesh. The procedure of the study was a prospective randomized interventional comparative design was conducted in the hospitalized patients. A Self- administered questionnaire was prepared using information and thorough review from the literature survey and factors used in previous studies. Questionnaire statistically it was validated by using Cronbach‟s α value which reported a good measure of. 0.79 Results & discussions: A sample of 120 patients were enrolled into the study. 76 (63%) patients are male and 44 (37%) patients were female respectively. In this study unintentional reasons for non-adherence have been reported more frequently than intentional reasons before counselling causes of noncompliance. The most prevalent causes of non-compliance were forgetfulness (48.11%), too expensive (47%),confusion (42.45%), side effects (38.67%),Trouble reading pills (34.9%), Alter dosing schedule for convenience (31.13%), Don‟t care to take medication (30.18%),Trouble swallowing pills (30.18%),Stop to see it still need (20.75%), Think medication not effective (18.86%).The commonest reported reason for un intentional non adherence was forgetfulness. This test performed by using chi square (χ2 test) test statistics. Chi square statistic value is 53.6251 this result is significant at p < .05 whose p value is <0.00001. Conclusion: The current study identified unintentional reasons for non-adherence to be more common than intentional non-adherence. KEYWORDS: Stroke, Medication adherence, Cronbach alpha, Chi square test, Compliance, Noncompliance.
  • 2. Prudhvi et al. World Journal of Pharmaceutical and Medical Research www.wjpmr.com 212 To collect the demographic data of selected patients of Stroke affected in South region. To improves health and effectiveness of medication therapy by patient education. To educate and promote awareness of the importance of adherence to stroke medication and outcomes to avoid non adherence. METHODOLOGY Study design This was a prospective randomized interventional comparative study in which information was obtained on the risk factors, mediational adherence associated with stroke diseases by the administration of a structured interviewer-administered questionnaire. The study was carried out October-2017 to march- 2018. Study site The study was carried out in tertiary care hospital of Guntur district. Study Period 06 Months. Study Population & Sampling A sample of 120 subjects was drawn in order to yield 5 % accuracy at the 90% confidence level. Initially a total of 150 sample size was collected and estimated to be the sample size and due to non-response factor and communication errors it was settled down to 120. The estimated prevalence rate was derived from the study. Since, knowledge of the cause of a disease is one of the most important factors in the control of the disease, the knowledge that „Stroke was caused by risk factors smoking, alcohol, hypertension, diabetes mellitus was taken as the prevalence rate for the purpose of calculating the sample size. Study Criteria Inclusion criteria 1. Population who were 18 years or older of rural areas who are interested to participate. 2. Stroke patients undergoing treatment in selected neurology care center of Guntur district. Exclusion criteria 1. The patients below 18yrs old. 2. The patients who were non respondent to the study. 3. The pregnant patients. Study Tools A Self-administered questionnaire was prepared using information and thorough review from the literature survey and factors used in previous studies and it was validated by faculties in department of pharmacy practice and who expertise as a physician in Neurology care center. It consists of 11 questions. 1. Do you forget to take your medications regularly? The intention of this question is to enquire whether the patient is taking medications regularly and to evaluate the patient behavior towards the medication. 2. Do you miss any of your prescribed doses in the past 2 weeks? The intention of this question is to enquire whether the patient has missed any of their prescribed doses in the medication during the past two weeks. 3. Do you stop taking your medication, if you feel better or if your symptoms are under control? The intention of this question is to enquire whether the patient stop medication when the patient feels or believed by themselves that they are relieved symptomatically or whether the patient stop medication when their symptoms are in control. 4. Do you feel worse while you are on your medication do you stop taking them? The intention of this question is to enquire whether the patient stop medications when they feel worse while taking medication due to the occurrence of side effects like headache, vertigo etc. 5. Do you take your medication at the prescribed time? The intention of this question is to enquire whether the patients administering medication at the right time. 6. Do you often feel difficult in remembering your medication? The intention of this question is to enquire whether the patients is able to remember their medication daily or how often they feel difficulty in remembering medication. 7. Do you carry your medications with you regularly? The intention of this question is to enquire whether the patient is able to carry their medications with them regularly where ever they go Example: office, tours. 8. Do you take your medication only if you are sick? The intention of this question is to enquire whether the patient administer medication only if when they feel sick or with signs and symptoms. 9. Do you feel at times being careless to take your medications? The intention of this question is to enquire whether the patient is active at the time when the medication is to be taken. 10. Do you believe that taking medication regularly can control your disease? The intention of this question is to enquire whether the patient believe that taking medication regularly can control their disease this helps in evaluating the patient attitude towards medication can be known.
  • 3. Prudhvi et al. World Journal of Pharmaceutical and Medical Research www.wjpmr.com 213 11. Are you afraid of being addicted to your medication by taking it regularly? The intention of this question is to enquire whether the patient is afraid of being taking their medication regularly at proper time. Score ranges 0-1, where affirmative answers get no score with a higher score representing a high level of adherence. (The adherence score was given accordingly < 3 -poor, 4-7: Medium, 8-11 are considered as high level of adherence). Questionnaire Validation Two physicians with experience in Neurology Department were asked to evaluate the clarity, relevance and conciseness of items included in the questionnaire (limitations on questionnaire was a feedback which was rectified by eliminating). Statistically it was validated by using Cronbach‟s α value which reported a good measure of. 0.79 Interviewers The interviews were carried out by the students of the project members by telephone communication and through direct interview. The interviewers were familiarized with the questionnaire and trained in the proper manner of questioning as well as being familiarized with the operational definitions in order to maintain the uniformity of interpretation and explanation for the benefit of the illiterate and non-English speaking respondents. It was stressed that the interviewers write the responses as stated by the respondents and not their own interpretation of what was stated. The interviewers were also trained not to show bias or emotion during the interview. Non-respondents were not replaced for the purpose of the survey. A brief introduction about the purpose and nature of the study and assurance about confidentiality were explained to the respondents prior to the interview. The interview for each respondent lasted 10 to 15 minutes on average. Data analysis The responses in the recording form were manually checked for errors and omission. Standardized codes were used to simplify the coding process and analysis. Data were analyzed using Statistical Package for Social Sciences (SPSS) software Version 11.0. Data analysis was done based on the objectives of the study. Data screening was done to determine associations or correlations between variables. Chi square test was used to compare differences in proportions for categorical variables and Chi square test & Student paired t test for trend was used to compare trends for selected ordinal independent variables. A p value less than 0.05 was considered to be statistically significant. Study variables Outcome variable The main outcome variable in this study was attitudes of the respondents towards those affected by stroke. The responses to hypothetical statements on attitudes were framed on own in taking follow up with questionnaires based on +1,-1 values. Independent variables Two groups of independent variables were measured in relation to the attitudes towards stroke medication adherence. (i) Socio-demographic characteristic of the respondents: The age, gender, habits like smoking, alcohol, family history were considered and risk factors were evaluated. (ii) Mediating Variables: General medications of stroke, comorbid diseases along with questionnaires for analyzing medication adherence were included and score was given. The responses to questions under the knowledge and attitudes sections were analyzed individually and as aggregated scores. Minimizing errors The steps taken to minimize errors in data collection and data entry were as follows: 1. The interviewers were familiarized with the questionnaire and adequately trained to complete the required responses to minimize interviewer bias. 2. A weekly assessment of completed questionnaires was carried out by a single coordinator and feedback provided to the interviewers. 3. Regular supervision of interviewers was carried out during the course of data collection. 4. Random checks on the accuracy of the responses were carried out by the coordinator by re-visiting the housing units of the respondents and reviewing the questionnaire with them. 5. Accuracy of data entry was assessed by a 10 % reassessment of data entry and cross checks with the hard copy of the data. Ethical issues The following ethical issues were considered in the design of the study: 1. The participants were briefed regarding the nature, objectives and method of study and their voluntary participation acquired. 2. Participants were reserved the right to withdraw from the study at any point of time. 3. Total confidentiality with regard to the identification of the participants and information volunteered was assured at all times during and after survey. RESULTS AND DISCUSSION To the best of our knowledge, this is our first study in south India that evaluates risk factors, medication adherence associated with stroke disease in a tertiary
  • 4. Prudhvi et al. World Journal of Pharmaceutical and Medical Research www.wjpmr.com 214 care hospital of Guntur district, Andhra Pradesh. The results were obtained after 6 months duration study in the neurology department of tertiary care hospital. A total of 120 patients enrolled into the study & the data was analyzed using Microsoft excel 2010. Gender distribution of the Participants Out of 120 patients, males are more prone to the disease than females with the data representing in the figure: 1. 76 (63%) patients are male and 44 (37%) patients were female respectively. Fig 1: Gender Distribution of the Participants. Age based demographic details of the stroke patients 21 to 90Y Age groups were considered under the study. From the collected data, more no. of patients lie in the age range of 61-70Y were observed. The following data denoting the no. of patients belonging to their respective age groups in the table 01and Fig: 2 Table 1: Age based demographic details of the stroke patients. Age Range(Y) 21-30 31-40 41-50 51-60 61-70 71-80 81-90 Total No. of Patients 4 9 18 30 39 13 7 120 Fig 2: Age wise Range distribution of Participants. Out of 120 patient‟s data, based on the range of age, the number of patients are 4, 9, 18, 30, 39, 13, and 7. respectively with the age range of 21-30,31-40,41-50,51- 60,61-70,71-80,81-90. Distribution of frequency of patients in Types of stroke The data was also used to analyze the types of stroke which were observed during this study with following distribution of frequency in the table 02 and Fig: 3.
  • 5. Prudhvi et al. World Journal of Pharmaceutical and Medical Research www.wjpmr.com 215 Table 2: Distribution of frequency of patients in Types of stroke. Types of Stroke Ischemic Stroke Transient Ischemic Stroke Hemorrhagic stroke No. of Patients 45 41 21 Percentage of Patients 37.5% 34.16% 17.5% Fig 3: Distribution of frequency of patients in Types of stroke. Out of 120 patients received data, 34.16% patients having transient ischemic attack and 37.5% patients having Ischemic Stroke and 17.5% patients having Hemorrhagic stroke are reported. Frequency of Risk factors distribution of stroke patients Frequency of risk factors distribution of stroke patients has been studied considering factors like Age, Hypertension, Diabetes mellitus, Smoking and Alcohol consumption in the respective area of South India. The results were attained in the table 03 as follows and representing in the Fig: 4. Table 3: Frequency of Risk factors distribution of stroke patients. Risk factors Age, HTN, DM Age, HTN Age, DM Smoking Alcohol Abuse No. of Patients 15 26 4 37 38 Percentage (%) 12.5 21.67 3.33 30.83 31.6 Fig 4: Frequency of Risk factors distribution of stroke patients. There are various risk factors for provoking stroke which include: Age, HTN, DM, Smoking, Alcohol consumption. According to the data obtained, out of 120 subjects Age, HTN along with DM may be the reason for the stroke in 15 patients; Age, HTN may be the reason in 26 patients; Age, DM may be the reason in 4 patients; Smoking may be the reason for stroke in 32, Alcohol consumption may be the reason for stroke in 39 patients. Reasons for Non-Adherence The most prevalent causes of non-compliance were expensive medications(49.05%), forgetfulness(48.11%), confusion(42.45%), side effects(38.67%), trouble reading pills(34.9%), altering dosing schedule for convenience(31.13%), don‟t care to take medication(30.18%), trouble swallowing pills(30.18%), stop to see if still needed(20.75%), fasting(19.81%),
  • 6. Prudhvi et al. World Journal of Pharmaceutical and Medical Research www.wjpmr.com 216 think medication not effective(18.86%). The most common reason for intentional non-adherence was side effects(38.67%) and the most common reason for unintentional non-adherence was expensive medication. Unintentional reasons for non-adherence were found to be more common than intentional non-adherence. The majority(n=77) of the subjects (49.3%) reported two reasons, 36.3% reported three reasons, 11.6% reported four reasons and 2.59% five reasons for non-adherence. Intentional Non-Adherence Table 4: Reasons for intentional Non-Adherence. Reasons Side effects Think medication not effective Don’t care to take medication Stop to see if still needed Alter dosing schedule for convenience Fasting No. of Patients 41 20 32 22 33 21 Percentage (%) 38.67 18.86 30.18 20.75 31.13 19.81 Fig 5: Reasons for intentional Non-Adherence. Out of 106 patients, reasons for intentional non- adherence were side effects, Think medications not effective, Don‟t care to take medications, stop to see if still needed, Alter dosing schedule for convenience, fasting the results were reported as 38.67%(41), 18.86%(20), 30.18%(32), 20.75%(22), 31.13%(33), 19.81%(21) respectively. Non-Intentional Non-Adherence Table 5: Reasons for Non-Intentional Non-Adherence. Reasons Forgetfulness Confusion Expensive Trouble swallowing pills Trouble reading pills No. of Patients 51 45 52 32 37 Percentage (%) 48.11 42.45 49.05 30.18 34.9 Fig 6: Reasons for Non-Intentional Non-Adherence. In 106 patients, reasons for non-intentional adherence were forgetfulness, confusion, expensive, trouble swallowing pills, trouble reading pills the reasons were reported are 48.11%,42.45%,49.05%,30.18%,34.9%.
  • 7. Prudhvi et al. World Journal of Pharmaceutical and Medical Research www.wjpmr.com 217 Frequency of Drug therapy design in stroke patients Most of the patients were prescribed with Triple regimen therapy (41.66%) followed by Double regimen therapy (35%), Single regimen therapy (14.16%) and quadruple regimen therapy (9.16%) tabulated in table 06 representing in Fig: 7. Table 6: Frequency of Drug therapy design in stroke patients. Drug Therapy Design Quadruple Triple Double Single No. of Patients 11 50 42 17 Percentage (%) 9.16 41.6 35 14.16 Fig 7: Frequency of Drug therapy design in stroke patients. In a total data, based on the drug therapy design, 9.16% patients receiving quadruple regimen, 41.6% patients receiving triple regimen, 35% patients receiving double regimen, 14.16% patients receiving single regimen. NOTE: Through this study, Aspirin (70%) was reported to be most preferable drug for treating the stroke disease. This was followed by piracetam (67.5%), Statins (46.3%), Clopidogrel (5.3%), Heparin (8.33%), Tirofiban (11.6%). The study finally focusses on assessing the risk factors, medication adherence, associated with stroke disease patients which was attained to an optimum best with 88.33% overall patients are non-compliance to medication before counselling and 61.66% patients were compliance after counselling. The scale used to measure the non-compliance has been found to have an internal consistency with Cronbach‟s alpha value of 0.7906. Table 7: Data distribution of Adherence in stroke patients before & after counseling. Intervention Before Counselling After Counselling Level of Adherence POOR MEDIUM HIGH POOR MEDIUM HIGH No. of Patients 62 44 14 18 58 44 Percentage (%) 51.66 36.66 11.66 15 48.3 36.6 Fig 8: Data distribution of Adherence in stroke patients before and after counseling.
  • 8. Prudhvi et al. World Journal of Pharmaceutical and Medical Research www.wjpmr.com 218 Improvement in Medication Adherence Fig 9: Diagrammatic representation of Level of Adherence showing improvement. Before Counselling, 88.33% of patients were non-adhere to medications while 11.67% of patients were adhere to medications by SDPQ. After Counselling, the final result stating that 38.34% patients belonging to non-adhere medications and 61.66% patients adhere to medications by our counselling and follow-up. This test performed by using chi square (χ2 test) test statistics. Chi square statistic value is 53.6251 this result is significant at p < .05 whose p value is <0.00001. & by using student paired t-test considering the P-value 0.68 with 95% confidence interval. By conducting pharmacist patient counselling on medication adherence for patients with stroke which gives 95% confidence interval value of P=0.68 which gives more confidence to conclude that pharmacist interventions improves medication adherence in stroke patients. SUMMARY 1. The main aim of this study is to evaluate risk factors, medication adherence associated with stroke disease in a tertiary care hospital. 2. The general objective of the study is to assess the risk factors, medication adherence associated with stroke disease. 3. A self- designed questionnaire was prepared and a prospective randomized interventional comparative study was conducted on a sample of 120 patients with stroke disease. 4. The questionnaire was validated by using Cronbach‟s alpha and the value was found to be 0.07906. 5. The patients of 18yrs or older of rural areas and patients undergoing treatment in selected neurology care center were included in the study. 6. The patient demographic data was collected and were questioned regarding the medication adherence and the individual patient score was given. 7. From the data collected before counselling the patients who were non adherent to the medication was found to be 83.33and the patients who were adherent were found to be 11.67. 8. The patient was counselled regarding the importance of medication adherence and educated to overcome the barriers of non -adherence to achieve desired therapeutic outcome. 9. The patients were communicated through telephone and a direct follow up of six months was done. 10. The patient who received continuous follow up are questioned again to assess the medication adherence before and after counselling. 11. From the data collected after the counselling the patients who were non adherent was found to be 38.34 and the patients who were adherent was found to be 61.66. 12. From the above study out of 120 patients the provoking risk factors for stroke observed are age, hypertension, diabetes mellitus, smoking and alcohol. 13. By using chi square (χ2 test) test statistics. Chi square statistic value is 53.6251 this result is significant at p < .05 whose p value is <0.00001. 14. By using student paired T-test the P value was found to be 0.68.Based on this value the study concluding the main role of pharmacist intervention in improving the patient medication adherence. CONCLUSION The main aim of this study is to evaluate risk factors, medication adherence associated with stroke disease was achieved successfully. This study concludes the importance of the pharmacist intervention in overcoming barriers contributing to the medication non-adherence and improving the individual patient medication adherence for achieving the desired therapeutic outcome and also assessing the risk factors to decrease the risk
  • 9. Prudhvi et al. World Journal of Pharmaceutical and Medical Research www.wjpmr.com 219 ratio of stroke occurrence and helps in the secondary prevention of the disease. The present study shows that participants (patients) who attended the interactive educational intervention session on evaluation of risk factors, medication adherence associated with stroke disease was much satisfied, and considered more effective and valuable. ACKNOWLEDGEMENTS The authors are thankful to A.M. Reddy Memorial College of Pharmacy for providing facilities for bringing out this work. REFERENCES 1. Gaddam VK, Prudhvi V, Daiva Krupa G, Reehana SK , Kiran G, Sudhakhar AM S. Survey of knowledge and awareness about cerebrovascular- stroke and assessment of quality of life among coastal andhra urban population. World journal of pharmacy and Pharm Sci., 2016; 5(9): 1397-1415. 2. Kulshreshtha A, Anderson LM, Goyal A, Keenan NL, Stroke in South Asia: A Systematic Review of Epidemiologic Literature from 1980 to 2010. Neuro epi, 2012; 38: 123-129. 3. Wolf PA, Kannel WB, Current status of risk factors for stroke.Neuro Cli., 1983; 1(1): 317-343. 4. Parthasarathi G, Karin NH, Milap CN.Clinical pharmacy practice. Second Edition.Hyderabad. Universities Press (India) Private Ltd., 2012; pp 74- 76. 5. Neela V, Pooja RY, Arundhati C, Srinivasan R, Apoorva D. Study on impact of Pharmacist Intervention on Medication Adherence in Cardiac Patients in Tertiary Care Hospital. Inventi Impact: Pharm Prac., 2015; 2015(4): 148-150. 6. Jamison J, Graffy J, Mullis R, Mant J, Sutton S. Barriers to medication adherence for the secondary prevention of stroke: a qualitative interview study in primary care. Br J Gen Pract., 2016; 66(649): 568– 576. 7. Ronan OC, Martin D, Marie J, Cathie S. Improving adherence to medication in stroke survivors (IAMSS): a randomised controlled trial: study protocol. BMC Neur., 2010 Feb 24; 10: 15. 8. Stephenson J. Noncompliance may cause half of antihypertensive drug failures. JAMA. 1999; 282(4): 313-4. 9. Kathleen A. Fairman, Brenda M. Evaluating Medication Adherence: Which Measure Is Right for Your Program? J Manag Care Spec Pharm, 2000; 6(6): 499-506. 10. Elise C, Marion F, Mark A, Sarah JB,John W, and Alison JW. Psychological factors which influence adherence to medication in stroke survivors: a Systematic Review of Observational Studies. Annals of Behavioral Medicine, 2017; 51(6): 833–845. 11. Beatrice C, Vanessa B. Adherence to medication and self management in stroke patients.Br J Nurs, 2014; 23(3): 158-66. 12. Imran A, Steven RF. Practical Strategies to Improve Patient Adherence to Treatment Regimens. South Med J., 2015; 108(6): 325-31.