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3 Journal of The Association of Physicians of India Vol. 4 December 20 Original Article Assessment of Compliance to Treatment of Diabetes and Hypertension amongst Previously Diagnosed Patients from Rural Community of Raigad District of Maharashtra Kiranmayi Venkata Kakumani, Prasad Waingankar 2 Abstract Introduction: Substantial burden of diabetes and hypertension is on rise in India, leading to a twin epidemic. India, being a rural country, has unique problems regarding the treatment compliance which is a serious risk for morbidity and mortality. Objective: To assess the compliance to treatment of hypertension and diabetes amongst the diagnosed patients from rural area and to study reasons of non-compliance and knowledge and attitude. Material and Methods: Community based, cross sectional, observational study conducted in the rural communities of Tara and Barapada villages of Raigad district of Maharashtra. Survey was conducted covering population of 25 across 30 families, 250 at Barapada and 0 at Tara. All the cases of diabetes and hypertension diagnosed for more than one year were included. A structured and pre-tested questionnaire was administered including details on demography, medical documentation, treatment details and factors assessing the compliance, knowledge and attitude towards the diseases. Results: When reviewed the treatment adherence pattern based on documentary evidence and interview of the patient, on history of taking medication strictly since the detection illness, it was found that more than 70% of the Diabetics and more than 75% of the Hypertensive have discontinued the treatment in between. The most common reasons of non-compliance is the lack of sufficient motivation for treatment adherence as many mentioned (.4% diabetics, 55.8% hypertensives) difficulty to remember to take daily medication due to work or forgetfulness. This is followed by lack of money (50%diabetics, 55.8% hypertensives) and living far away from doctor in city (43% diabetics and 4% hypertensives) Conclusion: The study findings are only tip of iceberg and the nonadherence to the treatment of diabetes and hypertension in rural population is at alarmingly high. Illiteracy, lack of faith in treatment and motivation, unawareness and self-neglect as well as financial constraints and lack of specialist care in rural area is playing important role. Intern, 2 Associate Professor, Community Medicine, MGM Medical College, Navi Mumbai, Maharashtra Received: 4.09.205; Accepted: 07.0.20 Editorial Viewpoint Morbidity and mortality due to twin epidemic of diabetes and hypertension is on the rise in rural India. This study finds very high levels of non adherence to the treatment due to lack of awareness and healthcare facilities. Introduction Non-communicable diseases (NCDs) are chronic diseases of long duration and slow progression and are not transferable from one person to other. The four main types of NCDs are cardiovascular diseases, cancers, chronic respiratory diseases and diabetes. The NCD S have emerged as the leading cause of mortality worldwide with 80% of NCD deaths in the low and middle income countries. Raised blood pressure, has been seen as the leading cause of mortality with an estimation of.5% of global deaths and % of deaths are attributed to increased blood glucose. In India, NCDs are estimated to account for 0% of total deaths. Proportional mortality comparison shows that deaths due to diabetes alone are up to 2% while deaths due to cardiovascular diseases account for 2%. 2 Substantial burden of

Journal of The Association of Physicians of India Vol. 4 December 20 37 diabetes and hypertension is on the rise in India and these are coexistent in many leading to a twin epidemic. 3 One of the major challenges in limiting this epidemic is adherence/compliance to the long term medications. According to the World Health Organization (WHO), non-compliance with long-term medication for conditions such as hypertension, dyslipidaemia 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. Adherence to (or compliance to) medical regimen has been defined 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 health care provider. 4 India, being a rural country, has unique problems regarding the treatment compliance which is a serious risk for morbidity and mortality. 5, It has been seen that Good compliance has a positive effect on clinical outcome, suggesting that the management of CVD may be improved by improving patient compliance. 7 Therefore, it is necessary to know the reasons of non-compliance especially at the rural level where the awareness and knowledge of these diseases have been seen to be particularly low, 8 which can then be acted upon to improve the compliance rate for a positive outcome. However very little data is available on this in the central part of rural India. The high blood pressure is particularly liable to have non adherence to medication because it doesn t show symptoms unless it is very severe. 9 Delay in taking appropriate doses can worsen their condition. The symptoms of risk associated with poor adherence can take quite some time to appear when compared with other chronic diseases. 0 Most of the studies during the review of literature found indicating need of good treatment adherence for good treatment results and prevention of complications as well economic benefits implied in absence of complications. Also it was clear from the literature that situation in rural area need to be analysed further in view of expected low awareness and lack of focused interventions. This study has attempted to address these issues as non- communicable diseases are preventable with patient awareness, timely diagnosis and intervention. The study was conducted in villages of Tara and Barapada of Panvel tehsil (taluka) of Raigad District. Aim and Objectives Aim To study treatment compliance amongst previously diagnosed Diabetic and Hypertensive patients from rural community. Objectives. To assess the compliance to treatment of diabetes/ hypertension/both amongst the diagnosed patients from rural community of Raigad district of Maharashtra. 2. To study the reasons of noncompliance and knowledge and attitude towards non communicable diseases particularly diabetes and hypertension in a rural area Materials and Methods This was a community based, cross sectional, observational study conducted in the rural communities of Tara and Barapada of Raigad district of Maharashtra. A house to house survey was conducted covering population of 25, across 30 families, 250 at Barapada and 0 at Tara. All the known cases of diabetes and hypertension as identified by a physician and/or on anti-diabetic or anti-hypertensive medications (self-reported) for more than one year (Before st April 203) and willing to participate in study were included. Approval of the Institutional Ethics Committee was obtained prior to study commencement and written informed consent was obtained from each individual. A structured and pre-tested questionnaire was administered which included details on demography, medical documentation, treatment details and factors assessing the compliance, knowledge and attitude towards the diseases. The questions were translated and explained to the patients in local language. Effort was made to obtain the nearest correct possible birth date of each patient, to calculate the exact age, as otherwise there is tendency of rounding the age to the nearest division of 5 when asked directly. The blood pressure of the study sample was recorded with the help of a mercury sphygmomanometer. Existing evidence of blood sugar levels over the period since diagnosis of diabetes was checked to verify the level of compliance according to WHO criteria of Fasting blood sugar less than 2 mg/dl and/or Post-prandial blood sugar of less than 200mg/ dl as under control as a better option as there was reluctance from most of study subjects to getting urine checked, and similarly for hypertension, the patient s case papers/investigation reports/any evidence of complications and admissions were scrutinized. The study subjects were grouped into the socioeconomic classes according to the revised B. G. Prasad s socioeconomic classification based on price index of May 204. All study subjects were referred to specialists visiting Rural Health Training Centre (RHTC) for the review. The data was compiled and converted in the form of tables and graphs using Microsoft Excel and Epi Info. Statistical methods used were

38 Journal of The Association of Physicians of India Vol. 4 December 20 Study Subjects 20 5 0 5 0 MALE Fig. : Age and sex distribution 0 30-40 40-50 50-0 0-70 > 70 FEMALE Table : Age at onset / detection of morbidity 7 AGE GROUP (In Years) Measures Current age Age at onset of DM Age at onset of HT Female Male Female Male Female Male N 29 4 28 2 22 Mean 57.35 59.03 54.04 5.44 52.9 54.3 Std. Dev. 2..9 3.37 2.02 9.29 0.55 Minimum 39.95 34.57 38.2 33.07 3.95 35.9 25% 49.2 49.8 44.00 43.53 47.82 49.4 Median 54.9 2.34 5.95 48.25 50.50 54.82 75% 4.90.9.49 0.72 0.90.03 Maximum 95.4 80.80 92.4 77.80 75.24 77.80 Table 2: Socioeconomic class distribution SE Class Per capita monthly income Subjects Diabetics Hypertensives No. Percent No. Percent No. Percent Class Rs.557 and above 7 0.0 5.4 3.9 Class 2 Rs. 278-5570 42 0.0 2 59. 25 58.2 Class 3 Rs. 7-2785 8 25.7 25 25. Class 4 Rs. 83-70 3 4.3 2 4.5 2.3 Class 5 Below Rs. 83 0 0 0 0 0 0 Total 70 00.0 44 00.0 43 00.0 Table 3: Treatment adherence Taking regular drug treatment currently Taking regular drug treatment since detection History of complications History of symptomatic relief Diabetics Hypertensives 70.45% 2.8% 29.5% 23.3% 4.5% 2.33% 50% 4.5% simple frequencies and percentage. Results A total of 9 individuals from Tara and 5 from Barapada were included in study. Out of total 70 patients 2 (37.2%) were suffering 0 only from Hypertension, 27 (38.5%) were suffering only from Diabetes, while 7 (24.3%) were suffering from both Diabetes and Hypertension. The Figure shows the age and sex distribution and Table shows age at onset/detection. The median family size was (Mean.2, S.D. 3.2). Out of the total study population 38 (54.3%) were Muslims ( Females and 22 Males) and 32 (45.7%) were Hindus (3 Females and 9 Males). Total 4 patients (9.4%) were married while (8.%) were widowed. The 9% of the study subjects were either illiterate or having only primary education. Out of total 70, 52 (74.3%) had sedentary occupation. This proportion was 2 79.5% among Diabetics and 74.4% among Hypertensives. As seen in Table 2, as per B.G. Prasad s classification, majority of patients belonged to Socio economic Class 2 and 3. When reviewed the treatment adherence pattern based on documentary evidence and interview of the patient, on history of taking medication strictly since the detection illness, it was found that more than 70% of the Diabetics and more than 75% of the Hypertensives have discontinued the treatment in between. The details are seen in Table 3. As seen in Table 4, awareness level has been low in both diabetics and hypertensives and even around 25% were not satisfied about the treatment prescribed to them. Based on the available evidence of documented Blood Sugar levels only 45% of Diabetics were having sugar levels under control and others needed further intervention for treatment modification at RHTC and improvement in treatment compliance. Among the hypertensives 53% were having blood pressure levels within targeted range as per Joint National Committee 8 (JNC8) guidelines. 2 Discussion Compliance with medication has become a topic of much research, and various interventions have been proposed to improve patient compliance. However, it has proved difficult to compare studies of compliance because of a lack of standard terminology and methodology. 7 In this study the mean age at onset of Diabetes was 52 and for hypertension it was 53. This is relatively high considering the contemporary beliefs. The CURES investigation in Chennai in 200 demonstrated a temporal shift in the age at diagnosis to a younger group when compared to NUDS study published just 5 years earlier. 3,4

Journal of The Association of Physicians of India Vol. 4 December 20 39 Table 4: Treatment awareness and treatment behaviour Diabetics Hypertensives Aware that will get sick on stopping medication 75% 2.8% Stops taking medication if feels better symptomatically 25% 44.2% Aware that this disease causes complications 45.4% 5.2% Aware that medication will delay complications 75% 7.4% Feels that family facilitates intake of medicines 89.5% 88.4% Difficult to remember to take medicines due to work and usually.4% 55.8% forgets Living far away from treating Doctor in city and do not go for 43% 4.5% follow up frequently Financial constraints to continue medicines 50% 55.8% Agree that the drug treatment prescribed to them is correct and satisfactory 77.3% 74.4% Instead of age at onset this can be rather treated as the age at detection of morbidity and the possibility of delayed detection being the rural area cannot be denied. The studies exploring this aspect have been not found, however it needs to be further evaluated as even the rural lifestyle is supposed to have impact as an epidemiological factor for the NCDs. Education and awareness are important factors in disease prevention. The study population is having poor educational status with 23% illiterate and 4% having primary education. In the study done at rural Ludhiana 9 the percentage of illiterate was 39%. Considering the interventions this lack of education is one of the stumbling blocks. Majority of the study subjects (59%) was in Socio-economic class 2, in this study based on B. G. Prasad Classification updated for May 204. The composition of study population at rural Ludhiana 9 is similar as 54.% of the study subjects were in the high middle socio-economic class. The 70.45% Diabetics and 2.8% Hypertensives were found taking treatment regularly at the time of Interview compared to similar study in rural Ludhiana 9 where 82% of Diabetics were taking regular treatment. In a study conducted in coastal population in Southern India 5 compliance to hypertension treatment was found to be 82.2%, while 83.% of individuals with type 2 diabetes mellitus were on regular medication. It was found that despite 2.8% hypertensives taking medication regularly only 53% were having blood pressure levels within targeted range as per Joint National Committee 8. In the study conducted in coastal population in Southern India 8 among the individuals on regular medication, only 37.3% of them had controlled blood pressure (Criteria - <40/90 mmhg.) This conveys that blood pressure control was still far beyond the optimal target in rural population. Among the diabetics based on the available evidence of documented Blood Sugar levels only 45% of Diabetics were having sugar levels under control in this study. Compared to the coastal population study in Southern India 8 it was found that among the known cases of diabetes, compliance to treatment was 83.% and of these 73.5% had random blood sugar (RBS < 200 mg/dl) levels at the time of examination. In this study it was probed further and found that only 29.5% Diabetics and 23.3% Hypertensives never discontinued the treatment since started. These are very high levels of non-adherence to treatment. In a study conducted at rural area of Loni in Maharashtra showed that only 58 percent of the participants taking one pill a day and visiting regularly maintained satisfactory compliance to medication over a period of 2 months. The lowest level of compliance was associated with patients taking three pills a day with 28.3 percent in patients visiting regularly and 3.7 percent in those visiting irregularly which suggested that number of pills is directly proportional to compliance level. Percentage of drop outs from the therapy also increased with the increase in the number of pills per day. The frequency of blood sugar monitoring by the diabetics was not verified in this study through the structured questionnaire. Incidentally it was found quite poor while verifying the treatment documentation. In the rural Ludhina 9 study nearly three quarters of the studied sample performed regular monitoring of their blood glucose. In another study on prevalence and awareness regarding diabetes mellitus in rural Tamaka, Kolar showed monitoring of blood sugar was very poor (38.7%) and only 9.7% of the patients visited doctors on a regular basis. 7 The most common reasons of noncompliance is the lack of sufficient motivation for treatment adherence as many mentioned (.4% diabetics, 55.8% hypertensives) difficulty to remember to take daily medication due to work or forgetfulness. This is followed by lack of money (50%diabetics, 55.8% hypertensives) and living far away from doctor in city (43% diabetics and 4% hypertensives). In the study conducted in rural Ludhiana 9 one of the important reasons of non-compliance for follow-up was found as cost of check-up in 27%subjects while 5.7% of subjects, mentioned long distance between household and health facility as a reason. In similar way the study at Thiruvananthapuram, in South India, 8 the major factors associated with noncompliance were found to be the asymptomatic course of hypertension and the nonavailability of free-of-cost drugs from the local health centre pharmacy. The relatively asymptomatic course of the disease

40 Journal of The Association of Physicians of India Vol. 4 December 20 and lack of adequate knowledge about hypertension predispose patients to non-adherence to the drug regimen. In a study conducted at rural Mysore 9 when it was asked patients, regarding any of their medications, if it bothers them, no single patient mentioned that any of his or her medication is troublesome. However in our study though any major side effects of drugs were not complained only 77.3% diabetics and 74.4% hypertensives felt that medication prescribed to them is appropriate. It means almost 25% had lack of faith in the treatment and could be a major cause of non-compliance. Past research has shown that patients are more likely to be non-adherent when they have lack of belief towards the beneficial effects of their medications. Such belief of individuals can be related to theory of Health Belief Model (HBM). According to this theory, individuals will be more likely to adhere to medical regimen if they believe that the benefits (perceived benefits) of the behaviours considered are immense, and such behaviour is both possible and useful. 20 Conclusions The study findings are only tip of iceberg and the non-adherence to the treatment of Diabetes and Hypertension in rural population is at alarming levels. Illiteracy, lack of faith in treatment, lack of motivation, unawareness and self-neglect as well as financial constraints and lack of specialist care in rural area is playing important role in non- adherence to treatment. The impact of nonadherence will grow as burden of NCDs growing. Applying effective adherence interventions may have a far greater impact on the health of the population as there may not require much change in specific medical treatments. The point that the, most of the patients felt that family plays a very important role in facilitating regular intake of the medication should be kept in mind while planning the intervention. Also it is not only the pharmacological treatment but the lifestyle modifications including changes in the diet are required for the control of NCDs. It requires further research to study this aspect of treatment adherence as effective behaviour change communication can be used as an intervention combined for pharmacological as well non pharmacological treatment. A multidisciplinary approach towards adherence is definitely needed with strong commitment to make progress in this area with coordinated action from health professionals, researchers, health planners and policy-makers. References. Fact sheet on non-communicable diseases: WHO. Update March 203 Available from:http://www.who.int/mediacentre/ factsheets/fs355/en/ 2. World Health Organization Noncommunicable Diseases (NCD) Country Profiles, 204 Available From: http://www. who.int/nmh/countries/ind_en.pdf?ua= 3. Shashank RJ, Saboo B, Vadivale M, et al. Prevalence of Diagnosed and Undiagnosed Diabetes and Hypertension in India Results from the Screening India s Twin Epidemic (SITE) Study. Diabetes Technology and Therapeutics 202; 4:8-5. 4. Sabate E. Adherence to Long-Term Therapies: Evidence for Action. Geneva, Switzerland: WHO; 2003. 5. Srinivas G, Suresh E, Jagadeesan M, et al. Treatment-seeking behaviour and compliance of diabetic patients in a rural area of south India. Ann N Y Accad Sci 2002; 958:420-4.. Raju SA, Biradar SS, Kapatae R, et al. Role of Pharmacist towards knowledge attitude and practice in compliance with hypertension in north Karnataka in south Indian city A brief overview IRJP, 202; 3:7 20. 7. Cramer JA, Benedict Á, Muszbek N, et al. The significance of compliance and persistence in treatment of diabetes, hypertension and dyslipidemia: a review. Int J Clin Pract 2008; 2:7-87. 8. Deepa M, Bhansali A, Anjana RM, et al. Knowledge and awareness of diabetes in urban and rural India: The Indian Council of Medical Research India Diabetes Study (Phase I): Indian Council of Medical Research India Diabetes 4. Indian J Endocrinol Metab 204; 8:379 85. 9. Rampal L, Rampal S, Azhar MZ, et al. Prevalence, awareness, treatment and control of hypertension in Malyasia. J Public Health 2008; 22,,-8. 0. Rose LE, Kim MT, Dennison CR, et al. The contexts of adherence for African- Americans with high blood pressure. Journal of Advanced Nursing 2000; 32:587.. Dudala SR, Reddy KAK, Prabhu GR. Prasad s socio-economic status classification- An update for 204. Int J Res Health Sci [Internet] 204; 2:875-8. Available from:http://www.ijrhs.com/issues. php?val=volume2andiss=issue3 2. James PA, Oparil S, Carter BL, et al. 204 Evidence-based guideline for the management of high blood pressure in adults: Report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA 204;DOI:0.00/jama.203.284427. 3. Ramachandran A, Snehlatha C, Kapur A, et al. High prevalence of diabetes and impaired glucose tolerance in India: National Urban Diabetes Survey. Diabetologia 200; 44:094-0. 4. Mohan V, Deepa M, Deepa R, et al. Secular trends in the prevalence of diabetes and impaired glucose tolerance in urban South India- the Chennai Urban Rural Epidemiology Study (CURES-7). Diabetologia 200; 49:75. 5. Rao CR, Kamath VG, Shetty A, et al. Treatment Compliance among Patients with Hypertension and Type 2 Diabetes Mellitus in a Coastal Population of Southern India. Int J Prev Med 204; 5:992-8.. Kale S, Patil A, Mandlecha R. Compliance and Adverse drug Effects of Antihypertensives in Rural India. Journal of Clinical and Diagnostic Research 20; 5:775-779. 7. Muninarayana C, Balachandra G, Hiremath SG, et al. Prevalence and awareness regarding diabetes mellitus in rural Tamaka, Kolar. Int J Diab Dev Ctries 200; 30:8-2. 8. Susan R, Anu K, Achu T, et al. Antihypertensive Drug Compliance across Clinic and Community Settings, in Thiruvananthapuram. South India Health Sciences 202; :JS002A 9. Sathvik BS, Karibabsappa MV, Nagavi BG. Self - Reported Medication Adherence pattern of Rural Indian patients with Hypertension. Asian J Pharm Clin Res 203;,Suppl,49-52. 20. Janz NK, Becker MH. The health belief model: a decade later. Health Educ Q 984; :-47.