¹ Clinical Pharmacology Department, HCG Cancer Centre, Kalburagi & Padmavathi College of Pharmacy, Dharmapuri, India;

² govt. Headquarters Hospital, Krishnagiri, India

Corresponding Author: Dr. John Thomas Palathingal, Clinical Pharmacologist, HCG Cancer Centre, Healthcare Global Enterprises, Kalburagi, Karnataka-585102, India. Mobile Number: +919791140261; E-mail: johnpt1993@gmail.com.

Orcid: https://orcid.org/0000-0002-0032-5804.

	ABSTRACT
	INTRODUCTION
	MATERIALS AND METHODS
	STATISTICAL ANALYSIS
	RESULTS
	DISCUSSION
	CONCLUSION
	ACKNOLEDGEMENT
	CONFLICT OF INTEREST
	ETHICAL APPROVAL
	REFERENCES

	ABSTRACT

Background: The prevalence of Diabetes Mellitus is growing at a dreadful rate across the globe. India is considered to have the highest population of diabetics in the world and this is a growing concern. Aim: To assess the adherence in diabetic patients towards treatment. Methodology: A Cross sectional study was conducted in tertiary care hospital, Tamil Nadu- during May 2017. Convenient method of sampling was adopted. All type 2 diabetic patients having age above 35year was recruited. Data was collected through face to face interview method by using structured questionnaire. A total of 200 diabetic patients from Tamil Nadu were included in this questionnaire-based study. Participants who fulfilled the eligibility criteria were approached in person and the necessary study specific data was collected. We used questionnaire namely Morisky Medication Adherence Scale to assess the subjects. The scores were calculated and examined. Results: About 71.5% of the total population had poor medication adherence scores 24% with medium medication adherence scores and 4.5% of them had high medication adherence. We were able to find four factors that influenced a patient’s level of adherence which were Forgetfulness (70%), Dietary restriction was difficult to maintain (72.5%). Not aware of the consequences of missing the dose (67.5%), Fear to becoming dependent on treatment (42.5%), Fear of side effect (42%). Conclusion: The fact that knowledge and self-awareness about one’s medical condition is vital to medication adherence. Healthcare professionals as well as patient need to be made aware of the relationship between knowledge and medication adherence. Continuous patient education is needed to improve patient adherence and attitude towards treatment.

	INTRODUCTION

   Diabetes mellitus is a group of diseases which is characterized by chronic elevation of glucose in the blood. According to WHO Diabetes mellitus is a chronic disease caused by inherited and/or acquired deficiency in production of insulin by the pancreas, or by the ineffectiveness of the insulin produced. Such a deficiency results in increased concentrations of glucose in the blood, which in turn damage many of the body's systems, in particular the blood vessels and nerves and it leads to complications like diabetic retinopathy, nephropathy and neuropathy (1). Diabetes is highly prevalent, affecting approximately 425 million people worldwide. India is one of the 6 countries of the IDF SEA region. in 425 million people 82 million people were from SEA Region and this number is expected to increase to 151 million in the year of 2045. There were over 72 million cases of diabetes in India in the year of 2017. Most of this increase will occur in the developing countries like India and will result from population ageing, unhealthy diet, and obesity and lifestyle habits (2). In this Maturity-Onset Diabetes of the Young (MODY) is one of the rare type in which it is due to heterogenous inherited genetic disorder that results in beta cells dysfunction characterized by non- insulin dependent form of diabetes (3). With regard to the Indian scenario, there has been a significant increase in the prevalence of diabetes in both the rural and urban settings. The patterns of diabetes incidence related to the geographical distribution of diabetes in India, Rough estimation show that the prevalence of diabetes in rural populations is one-quarter that of urban population for India (4, 5). Results from a large community based study conducted by the Indian Council of Medical research (ICMR) found that a lower proportion of the population is affected in states of Northern India (Chandigarh 0.12 million, Jharkhand 0.96 million) as compared to Southern India (Maharashtra 9.2 million, Tamil Nadu 4.8 million) chronic condition like Type 2 DM has the capacity to destroy the lives of high number of population (6) .

There are two main factors that would reasonable to affect one’s medical condition. The first one is the level of understanding regarding the medical condition and second thing is how well one follows to the medication plan initiated by the physician. Diabetes Mellitus like most chronic illnesses is generally treated with long term pharmacotherapy and life style modifications and studies suggest that close to 50% of patients are non-compliant with their medicines which is resulting in development of complications like diabetic nephropathy, retinopathy, neuropathy which is leads to increased rate of morbidity and mortality (6).

WHO defining adherence as “the extent to which the patient follows medical instructions given by health care provider” A person’s rate of adherence is expressed as a percentage of amounts of medication is taken as prescribed. Adherence rates may different depending on the type and number of disease being treated, and are typically lower for chronic versus acute conditions (7). Diabetes Mellitus is commonly associated with sedentary lifestyles, unhealthy diets,obesity; hence lifestyle modification is considered as aessential measure in undertaking the problem (8). Nevertheless, lifestyle modification is considered to be very challenging and therefore we come to a point where we need an alternative. Medication is vital in regulating the disorder. Though, adherence to one’s medication regimen is a keyelement of successful management (9). Awareness plays important role in preventing, managing and controlling chronic illness. This will help individuals remain more careful when making decisions that canimpact his/her health. The level of Diabetic awareness in India is terrible. A study conducted in Kolar, India assessed that only around 50.8% of the population was conscious about a disorder called diabetes (10). The Chennai Urban Rural Epidemiological Survey indicated that close to 25% of the populations were unconscious about Diabetes Mellitus and hardly 40% of the participants felt that the occurrence of diabetes was increasing; 22.2% of the populations and 41% of known diabetic subjects felt that diabetes can be prevented (11).

Diabetes Mellitus self-management is the keystone for appropriate management of patients with Type 2 diabetes, and disease education has a major role in improving diabetes outcomes. Diabetic Mellitus Knowledge has been related to achieving better medication adherence and in futureglycemiccontrol (12). However, attainment of optimum glycemic control, which moderates the possibility of diabetic complications and risk of death, is based on rational use of available anti-diabetic regimen, good medcation adherence to prescribed treatments and successful self-management by patients (13). Appropriate patient counselling and discharge medicines with timely review required for medication adherence (14). Adequate glyceamic control was defined as patients that have fasting plasma glucose level between 90 mg/dL – 100mg/dL. Patient adherence is examined in order to test the attainment of a medicationregimen as well as to check on the patient's health and tolerance of the treatment. Medication adherence can be monitored by using indirect and direct methods. Common indirect methods include requesting self-reports from patients, as well as pursuing information from health practitioners andfromothers such as spouses and other family members. Direct methods for measuring medication adherence include blood and urine analyses, which usually confirm the presence of a drug in the body or measure drug concentration in body. Management of diabetes is time consuming and demanding and requires an equal effort to be put from the patient as well as the concerned healthcare professionals. Strict dietary plans, lifestyle modifications, regular exercise, need to be made. Medications need to be taken habitually without any fail and appropriate glucose monitoring is essential. Building awareness amongst the people by the healthcare workers is basic to improving the condition in individuals. This can be done though effective patient counselling, by the use of visual aids, leaflets, posters and campaigns are highlighting importance of understanding the medical condition (15).

The purpose of this study was to measure the level of knowledge regarding diabetes as well as the extent of medication adherence. The factors contributing towards medication adherence was also measured. This project is proposed to determine a relationship between the diabetic knowledge of a person, its effect on their medication adherence as well as their glycaemic levels.

	MATERIALS AND METHODS

   This is a prospective cross sectional study which was conducted in tertiary care hospital, Krishnagiri (Tamil Nadu). A total of 225 of type 2 DM patients were included in our study. All the patients were screened as per our designed protocol. The inclusion criteria of our study were Patients aged 35 years and above of either sex who had been diagnosed with Type 2 DM for more than one year on either on parenteral (Insulin) or oral anti-diabetic medication treatment and were willing to participate were assessed. Patients who had Type 2 DM along with other co-morbidities were also included (Cardiovascular, Endocrine, Respiratory and Neurological diseases). Patients diagnosed with Type 1 diabetes and women with Gestational diabetes mellitus were excluded from the study. A detailed pro forma was filled for each patient after taking written informed consent. The patients who failed to give proper information or who did not have an accompanying family member or relative to give consent or information were excluded from the study. For the assessment of Medication Adherence; the Questionnaire MMAS (Morisky Medication Adherence Scale) answered by the participants were scores; each correct answer was awarded a score of 0 while an incorrect answer was awarded a score of 1. The scores were added up and the participants were categorized as-Score 8 is High Adherence, between 6 - < 8 is Moderate Adherence, < 6 is Poor Adherence.

	STATISTICAL ANALYSIS

   The data obtained from the patients were analyzed in two ways. The first being a basic descriptive analysis using Microsoft Word Excel 2007 and the second being a thorough statistical study using JMP 8.0. On analysis using statistical tools such as Chi-square test and logistical regression, it was inferred that the objectives of the study were fulfilled. Statistical significance was considered at P-values < 0.05.

	RESULTS

   A batch of 225 patients were screened and obtained their consent for studies, as well as base line characteristics were framed among patients. Based on inclusion and exclusion criteria 200 patients were selected among them and were assessed using Morisky adherence measurement scale questionnaire. Patient counselling was provided using PILTs.

Patient demographics

A total of 200 case notes of patient with type-2 diabetes were included. The majority 61% were males and 39% were females. In that 31% population are belongs to the age group of 50-59 years and 10% population belongs to the age group of 35-39years. Approximately 54% population have school education. Approximately 47% population have family history of diabetes. According to body mass index (BMI) 54% was found to normal weight and 40% were overweight. 61.5% patients were found with co-morbidity, The most frequent co-morbidity was hypertension (31%) followed by Dyslipidaemia (11.5%), ischemic heart disease (9%) chronickidney disease(3%), and other disease such as peptic ulcer, COPD, asthma and hyperthyroidism with individual frequency of less than 4% all constituted total co-morbid disease. Oral hypoglycaemic agent were prescribed for 151 (75.4%) of patients while insulin & OHA was prescribed in 49 (24.5%) of the patient. Of the patient on OHA, 312 (88.9%) where on monotherapy while 39 (11.1%) where on combination therapy. Out of 200 patients 92 patients (46%) was under go blood sugar monitoring in once in a month and once in three month respectively and 14 patients (7%) carried out their blood sugar monitoring in once in 6 months and 2 patients (1%) done their blood sugar monitoring once in a year (Table 1).

Adherence towards treatment

According to MMAS -8 about 4.5% population shows high medication adherence and 24% shows medium adherence towards treatment and remaining 71.5% patientshowsnonadherent towards anti-diabetic therapy (Table 2).

Participant’s response to morisky medication adherence scale

Patients response towarsmorisky medication adherence scale (MMAS-8) were presented in table 3. Most of patients shows non adherence towards questions include When you travel or leave home, do you sometimes forget to bring your medicines (70%), Do you sometimes forget to take your medicines (59%), Taking medicine every day is really inconvenient for some people. Do you ever hassle about sticking to your treatment plan (42.5%) (Table 3).

Association between attitudes towards adherence and patient background characteristics

Out of 123 male patients 74% (n=91) are poor adherent toward therapy and out of 77 female patients 67.5% (n=52) are poor adherent towards therapy. Patients age group which shows high medication adherence were60-69 years and age group which shows medium medication adherence are 50-59 years and poor medication adherence were seen in patients more than 70 years. According to duration of disease patients show high medication adherence were in the age group of 11-15years (8.3%), medium adherence shows 16-20 years (36.3%) and most of the patients show poor adherence belongs to the duration of 1-5 year (75.8%).

According to anti diabetic therapy population shows poor adherence is prescribed with OHA+ insulin (75.5%) (Table 4).

Reasons for non-adherence to drugs in diabetic patients

The rate of noncompliance in 145 (72.5%) patients was very high in the dietary restriction while 55 (27.5%) were compliance.106 (53%) were non-compliant in lack of exercise and 94 (47%) were compliant in the total number of patients. 105 (53%) patients were more noncompliance about not having the awareness on the consequences of missing the dose while 65 (32.5%) are compliance. A high number of patients i.e., 144 (72%) are noncompliance to missing drugs very often and 56 (28%) are compliance. The number of patients 39 (19.5%) who discontinued the prescribed OHAs self was less noncompliance with compliance patients 161 (80.5%). Only 32 patients (16%) who are noncompliance shifted to alternative treatment. In all the patients, only 92 (46%) noncompliance patients had side effect of medication while 108 patients (54%) were compliance. A number of 58 patients (29%) were reported that they have difficulty to access hospital. 46 patients (23%) are believed that medication was not effective, and finally 74 patients (37%) are having fear to becoming dependent on treatment (Table 5).

	DISCUSSION

   The study was conducted in patients who had type II diabetes mellitus having age more than 35years. It is a general assumption that gender doesn’t play a role in influencing the risk of being affected by type II DM, however the disorder has had a predominant effect on middle aged men as compared to women. According to our sample population, we had a higher number of male representatives (61%) as compared to the female representations (39%). Out of the 200 samples that were studied, the minimum age of the participants fixed was 35years and high portion of the population belonged to the 50-59 years category (31%). Studies propose that the condition of type II DM is falling in India and that the prevalence of the disease is not restricted to the elderly; rather subjects under the age of 40 are at a risk due to life style changes.33% population belongs to the age of 33%. Our study was conducted in type II DM patients from rural settings. Samples are collected from a tertiary care hospital, Krishnagiri. The Participants of this study were derived from various backgrounds with regard to education. We had a majority of graduates (12%), 45% who had completed their basic schooling, 41% of illiterate individuals and a 2% minority of post graduates.

The Body Mass Index (BMI) has always been associated with an increased risk of being target to chronic illnesses like Type 2 DM, Hypertension, Dyslipidemia and other diseases. It can be defined as a simple index of weight-for-height that is commonly used to classify underweight, overweight and obesity in adults. It is defined as the weight in kilograms divided by the square of the height in metres (kg/m2). Many studies have been conducted to link BMI with Type II DM. 40% patients with diabetes are overweight.

Most diabetic individuals suffer from one or more co-morbidities in that, cardiovascular problems leading the list. According to the Medical Expenditure Panel Survey, most adults with diabetes have at least one co-morbid chronic disease (15) and as many as 40% have at least three (16-17). The Canadian National Population Health Survey found that about 44% (n=3,324) of the patients with diabetes had any additional co-morbidity with the incidence increasing with age (18). On analyzing the types of co-morbidities present in our representative sample, we were able to identify clear dominants. Only 36% population were found with no co-morbidity, and remaining 64% are affected by diseases such as Hypertension, Dyslipidemia, Hypothyroidism, CKD, Hypertension was the most common disorder that appeared in 31% of the individuals and Dyslipidemia (11.5%), IHD (9%) , peptic ulcer (4%) ,CKD (3%) were the other leaders in the ranks. It was also interesting to observe that these disorders were also found in various combinations in many of the participants.

On reviewing the number of anti-diabetic medications prescribed to the participants, we categorized them into two groups, either oral hypoglycemic agents (OHA) or a combination of Insulin with one other OHA. About 75.5% were given with oral anti-diabetic agents and remaining 24.5% are treated with Insulin and accompanying OHA. Type 2 DM is a chronic disease (19), one that cannot be cured, only controlled. The participants that were sampled mostly fell into the category of 1 to 5 years (45%), the send highest representation of 32% fell into the category of 6 to10 years and only 6% belonged to the the16-20 years category. According to family history of diabetes about 47% population out of 200 are having family history of diabetes.

Adherence is defined as the extent to which a person’s behaviour in terms of taking medications, following diets, or executing lifestyle changes coincides with medical or health advice (20). Medical professionals are very often challenged by patient’s non-compliance with pharmaceutical treatments. We were able to assess the participant’s level of medication adherence with the help of Morisky Medication Adherence Scale (MMAS-8). They were grouped into categories based on their test scores as having High Adherence (HA), Moderate Adherence (MA) or Poor Adherence (PA). From table 2, we can see that only a 4.5% (9 patients) of the patients showed High adherence levels while a whopping 71.5 % (143 subjects) had poor adherence. We went on to look into the factors that could influence the patients Adherence. On analyzing the data, we were able to find four clear causes. About 59% of our sample population was found to be non-adherent because of forgetfulness. Interestingly enough, an almost equal number, 67.5% Not aware of the consequences of missing the dose, 42.5% Fear to becoming dependent on treatment.

The obvious suspect “forgetfulness” was a factor that influenced the medication adherence of 59% of the volunteers. About 42.5% of the patient’s felt hassled over the need to take medications every single day and simply chose not be adherent and 25% patients were stop taking medications while they feel symptoms are under control. It is important to educate patients that diabetic treatment is a lifelong therapy and discontinuation are associated with increased rate of morbidity and mortality.

Poor awareness among the diabetic population tends to impact the progress of type II DM and its complications which are largely avoidable (21). As mentioned in the earlier sections, Diabetes mellitus is a condition that requires one to make alterations in their lifestyle. Eating healthier meals, cutting down on the portion sizes, moderate consumption of sweets, getting in at least 30 minutes of exercise each day, being attentive with medications are all easy ways to keep diabetes mellitus in control (22). For treatment success in patients with chronic conditions become more actively involved in the management of disease in making decisions about care. Both patient’s marital status and duration of disease were found to be significantly associated with their attitude toward complains to treatment. Gender and educational status didn’t really affect the adherence towards medication (23). In fact, there are a greater number of high medication adherence scores between 60-69 years of age in our study, duration of disease also associated with adherence towards medication, population having 16-20 years duration of disease show more adherence towards medication. Although it was able to comprehensively meet its objectives, this study comes with its own limitations. An important point to be noted is that since this study was based on questionnaires, as a researcher it makes it difficult to be sure that the participants answered each of the questions honestly. This always leads to the question as to how genuine the participant’s responses could have been, but it was chance we chose to take.

	CONCLUSION

   The fact that knowledge and self-awareness about one’s medical condition is vital to medication adherence. Healthcare professionals as well as patient need to be made aware of the relationship between knowledge and medication adherence. Continuous patient education is needed to improve patient adherence and attitude towards treatment.

	ACKNOLEDGEMENT

   We like to thank all the patients who volunteered to make this study.

	CONFLICT OF INTEREST

   The authors declare that no conflicting interests exist.

	ETHICAL APPROVAL

   This study protocol was submitted for ethical approval to the members of the ethical committee in the following organization: Government headquarters hospital Krishnagiri. The study was accepted by the board of members and the ethical clearance certificates were issued.s

	REFERENCES

1. WHO. Definition and diagnosis of diabetes mellitus and intermediate hyperglycaemia [Internet]. Who. int. 2006 [cited 30 May 2020]. Available from: https://www.who.int/diabetes/publications/diagnosis_diabetes2006/en/
2. IDF publications. The IDF South-East Asia Region prevalence of diabetes in india[Internet].Idf.org. 2017 [cited 30 May 2020]. Available from: https://www.idf.org/our-network/regions-members/south-east-asia/members/94-india.html
3. Dhakchinamoorthi K, Palathingal J, Sreenivasan S. Laurence Moon Bardet Biedl Syndrome with Maturity Onset Diabetes of the Young (Mody) - Case Report. Journal of Young Pharmacists. 2018; 11 (1): 114-116.
4. Wild S, Roglic G, Green A, Sicree R, et al. Global Prevalence of Diabetes: Estimates for the year 2000 and projections for 2030. Diabetes Care. 2004; 27 (5): 1047-1053.
5. Krentz A, Bailey C. Oral Antidiabetic Agents. Drugs. 2005; 65 (3): 385-411.
6. Anjana RM, Ali MK, Pradeepa R, et al. The need for obtaining accurate nationwide estimates of diabetes prevalence in India - rationale for a national study on diabetes. Indian J Med Res. 2011; 133 (4): 369-380.
7. E S. ADHERENCE TO LONG-TERM THERAPIES: EVIDENCE FOR ACTION [Internet]. World Health Organization. 2003 [cited 30 May 2020]. Available from: https://www.who.int/chp/knowledge/publications/adherence_report/en/
8. Simpson R, Shaw J, Zimmet P. The prevention of type 2 diabetes — lifestyle change or pharmacotherapy? A challenge for the 21st century. Diabetes Research and Clinical Practice. 2003; 59 (3): 165-180.
9. Cramer J. A Systematic Review of Adherence With Medications for Diabetes. Diabetes Care. 2004; 27 (5): 1218-1224.
10. Muninarayana C, Balachandra G, Hiremath S, Iyengar K, et al. Prevalence and awareness regarding diabetes mellitus in rural Tamaka, Kolar. International Journal of Diabetes in Developing Countries. 2010; 30 (1): 18.
11. Deepa M, Deepa R, Shanthirani CS, Datta M, et al. Awareness and knowledge of diabetes in Chennai— the Chennai Urban Rural Epidemiology Study [CURES-9]. J Assoc Physicians India. 2005; 53: 283-287.
12. Al-Qazaz H, Sulaiman S, Hassali M, Shafie A, et al. Diabetes knowledge, medication adherence and glycemic control among patients with type 2 diabetes. International Journal of Clinical Pharmacy. 2011; 33 (6): 1028-1035.
13. Yusuff K, Obe O, Joseph B. Adherence to anti-diabetic drug therapy and self management practices among type-2 diabetics in Nigeria. Pharmacy World & Science. 2008; 30 (6): 876-883.
14. Palathingal JT, et al. Role of combination therapy in relapsed Ewing's sarcoma. International Journal of Biomedical Science. 2019; 15 (4): 112-116.
15. O'Brien M, Petrie K, Raeburn J. Adherence to Medication Regimens: Updating a Complex Medical Issue. Medical Care Review. 1992; 49 (4): 435-454.
16. Druss B, Marcus S, Olfson M, Tanielian T, et al. Comparing The National Economic Burden Of Five Chronic Conditions. Health Affairs. 2001; 20 (6): 233-241.
17. Wolff J, Starfield B, Anderson G. Prevalence, Expenditures, and Complications of Multiple Chronic Conditions in the Elderly. Archives of Internal Medicine. 2002; 162 (20): 2269.
18. Maddigan S, Feeny D, Johnson J. Health-related quality of life deficits associated with diabetes and comorbidities in a Canadian National Population Health Survey. Quality of Life Research. 2005; 14 (5): 1311-1320.
19. Mathew E, Rajiah K. Assessment of medication adherence in type-2 diabetes patients on poly pharmacy and the effect of patient counseling given to them in a multispecialty hospital. Journal of Basic and Clinical Pharmacy. 2014; 5 (1): 15.
20. Curkendall S, Thomas N, Bell K, Juneau P, et al. Predictors of medication adherence in patients with type 2 diabetes mellitus. Current Medical Research and Opinion. 2013; 29 (10): 1275-1286.
21. Padma K, D Bele S, N Bodhare T, Valsangkar S. EVALUATION OF KNOWLEDGE AND SELF CARE PRACTICES IN DIABETIC PATIENTS AND THEIR ROLE IN DISEASE MANAGEMENT. National Journal of Community Medicine. 2012; 3 (1): 3-6.
22. Moodley L, Rambiritch V. An assessment of the level of knowledge about diabetes mellitus among diabetic patients in a primary healthcare setting. South African Family Practice. 2007; 49 (10): 16-16d.
23. Al-Qazaz H, Sulaiman S, Hassali M, Shafie A, et al. Diabetes knowledge, medication adherence and glycemic control among patients with type 2 diabetes. International Journal of Clinical Pharmacy. 2011; 33 (6): 1028-1035.

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