The HTN is a chronic, NCD and a leading cause of mortality and accounts for 16.5% of global deaths [1]. It is not only the most common CVD but also the most important risk factor for other CVDs [2]. Ranking third as a means of reduction in Disability Adjusted Life Years (DALY), it requires lifelong treatment for control of the disease and preventing its complications [3]. In India, NCDs like CVD, cancer, diabetes and others account for around 60% of all deaths. Therefore, the National Program for Prevention and Control of Cancer, Diabetes, CVDs and Stroke (NPCDCS) was launched in 2010 with a view to preventing and controlling the major NCDs [4].
It has been estimated that a 5 mmHg reduction of Systolic Blood Pressure (SBP) in the population would result in a 14% overall reduction in mortality due to stroke, a 9% reduction in mortality due to CHD, and a 7% decrease in overall cause of mortality [5]. Compliance or adherence to therapy is a good indicator for predicting clinical outcome in the hypertensive patients. Compliance is defined as conforming to the recommendations of the healthcare provider with respect to the timing, dosage, and frequency of medication taking [6]. However, since HTN is often asymptomatic and disease progression is slower than most other chronic diseases, hypertensives are more prone for non compliance [7]. Various epidemiological studies have shown non compliance with outpatient drug therapy to be a major problem in management of HTN [8,9]. It was observed that while some patients discontinue treatment, as high as 54% to 83% turn non compliant within five years [10,11]. Hence, it becomes important to find out the reasons of non compliance so that necessary action can be taken to improve the disease management and halt its progress to complications. The study aimed to assess the compliance to treatment of HTN and to find out its association with various sociodemographic variables, presence of other comorbidities, BP control, duration of disease and knowledge about duration of continuation of antihypertensives.
Materials and Methods
A quantitative, cross-sectional study was conducted in Jamnagar, a coastal district in the M.P. Shah Government Medical College, Jamnagar, Gujarat, India for a period of one year, from July 2013 to June 2014.
Sample size was calculated using standard formula, a sample size of 384 was calculated which was rounded up to 400 [12]. Out of the total sample size, half of the study subjects were selected from the tertiary care hospital of the study district and remaining 200 were selected from CHCs of study district. There were 11 CHCs in study district at the time of study, from which five CHCs were chosen through simple random sampling technique. A total of 200 patients (40 patients×5 CHCs) was taken up from CHCs. Hypertensive patients attending NCD clinics at the Guru Govindsingh Government Hospital (GGH) and at the selected CHCs of Jamnagar district formed the study population.
The inclusion criteria for the study were patients aged 30 years or more, already diagnosed as having HTN and coming for the first time to the NCD clinic during the study. Patients who did not satisfy the inclusion criteria, or were unwilling to participate, critically ill, mentally ill and pregnant patients and those who were interviewed previously were excluded from the study.
Operational definitions: Joint National Committee (JNC) VII criteria have been used to define HTN [5]. Patient is said to be on treatment for HTN if there was regular use of a prescription medication for HTN [13]. Compliance was estimated by the direct method of self report by patient. Compliant patients are defined as those who have accepted their physician’s advice to start drug therapy and who take their medication at least 80% of the time [8]. Control of HTN was defined as BP <140/90 mmHg in a subject on regular antihypertensive therapy [13]. Socioeconomic status was estimated on the basis of Modified Prasad’s Classification (1961) which was modified according to AICPI (All India Consumer Price Index) of the year 2013 using AICPI [14].
Data collection: Data collection was done by personal interview that was carried out using a pretested, semistructured type of proforma designed by the investigators and it comprised of questions about sociodemographic factors, past history, family history, any other comorbid condition, his/her knowledge and attitude about HTN and their practices to control the disease including compliance to treatment. Along with clinical examination, anthropometric measurements like Height (Ht), Weight (Wt), Body Mass Index (BMI), Waist Circumference (WC) and Waist Hip Ratio (WHR) were taken as per standard recommendations. The BP was measured manually using a mercury column sphygmomanometer and stethoscope by the auscultatory method in a sitting position with the left forearm placed horizontal on the table. The subject was seated comfortably for at least 15 minutes before BP recording. Two readings were taken one before and one after the interview, and the two were at least 15 minutes apart. The average of these readings was recorded.
The study protocol was reviewed and approved by the Institutional Ethical Committee. An informed consent was taken from all participants of the study after fully explaining the purpose of the study and assuring them of full confidentiality. The interview was conducted in a language they well understood.
Statistical Analysis
The data entry was done using Microsoft Office Excel 2007 and data analysis was done using Microsoft Office Excel 2007 and MedCalc 10.4.8.0. The Chi-square test was used as the test of significance where p<0.05 was considered significant.
Results
In the present study, 228 (57%) of the hypertensives were female and the ratio between male and female patients was 1:1.33. More than 163 (40.75%) belonged to the age group of 60 years and above while 207 (51.8%) belonged to 40-59 years age group. Most i.e., 323 (80.8%) and 244 (61%) of the patients enrolled in the study were Hindus and belonged to nuclear families respectively. Majority i.e., 346 (86.5%) of the patients were married while 49 (12.3%) were either widow or widower. Though, 296 (74%) literacy was observed, most of the study subjects 195 (48.7%) were educated only up to primary level. Nearly half 181 (45.3%) of the study subjects were housewives. As per Modified Prasad’s Classification, the highest proportion 145 (36.3%) of participants in this study belonged to lower middle class (IV) and the least 23 (5.75%) were from lower class (I). Only 96 (24%) of the hypertensives were from rural areas. Health was not insured in 249 (62.2%) of the enrolled patients. Control of BP was achieved in only 116 (29%). Treatment compliance was seen in 359 (89.8%) of the patients [Table/Fig-1]. Among the non compliant patients, 28 (68.3%) had poor compliance whereas, 13 (31.7%) had discontinued the treatment.
Profile of the hypertensive patients.
Variables | Frequency (n) | Percentage (%) |
---|
Sex |
Male | 172 | 43 |
Female | 228 | 57 |
Age (in completed years) |
30-39 | 30 | 7.5 |
40-49 | 102 | 25.5 |
50-59 | 105 | 26.3 |
≥60 | 163 | 40.7 |
Religion |
Hindu | 323 | 80.8 |
Muslim | 75 | 18.7 |
Others | 2 | 0.5 |
Marital Status |
Married | 346 | 86.5 |
Never married | 5 | 1.2 |
Widow/widower | 49 | 12.3 |
Type of family |
Nuclear | 244 | 61 |
Joint | 86 | 21.5 |
Three generation | 70 | 17.5 |
Education |
Illiterate | 104 | 26 |
Up to primary | 195 | 48.7 |
Secondary and above | 101 | 25.3 |
Occupation |
Labourer | 63 | 15.8 |
Businessman | 34 | 8.4 |
Housewife | 181 | 45.3 |
Retired | 42 | 10.5 |
Others | 80 | 20 |
Socioeconomic class |
I (Upper Class) | 37 | 9.2 |
II (Upper Middle Class) | 105 | 26.2 |
III (Middle Class) | 90 | 22.5 |
IV (Lower Middle class) | 145 | 36.3 |
V (Lower Class) | 23 | 5.8 |
Locality |
Urban non slum | 215 | 53.8 |
Urban slum | 89 | 22.3 |
Rural | 96 | 24 |
Health insurance status |
Insured | 151 | 37.8 |
Not insured | 249 | 62.2 |
Treatment compliance |
Compliant | 359 | 89.8 |
Non compliant | 41 | 10.2 |
Status of blood pressure control |
Controlled | 116 | 29 |
Not controlled | 284 | 71 |
Compliance to treatment exhibited highly significant statistical association (p<0.001) with type of family (whether nuclear, joint or three generation), education level of the patient, the area of patient’s residence or locality (whether urban non slum, urban slum or rural), and socioeconomic and health insurance status of the patient. Statistical significant association (p<0.05) was also observed between compliance with age, marital status and occupation of the patient. No statistical association was noted between compliance with sex, religion and comorbidity (p>0.05) [Table/Fig-2]. It was observed that nearly half i.e., 190 (47.6%) of the patients were diagnosed as having HTN during the last four years. And the duration of illness was significantly associated (p<0.05) with compliance to the prescribed treatment, the lesser the duration of illness the more the compliance [Table/Fig-3]. We found highly significant association between knowledge about continuation of treatment and compliance; patients with improper knowledge about treatment were more likely to be non compliant. In fact, in the current study all the 353 (100%) patients who had the knowledge that the medications need to be continued life long were compliant to the therapy [Table/Fig-4]. The other reasons of non compliance were forgetfulness, financial reasons and it was also observed that patients did not like to carry their medications when away from home.
Correlates of compliance.
Variables | Compliant (%) (n=359) | Non compliant (%) (n=41) | Chi-square value (χ2) | p-value |
---|
Sex |
Male | 153 (88.9%) | 19 (11%) | χ2=0.208 | p=0.648* |
Female | 206 (90.3%) | 22 (9.6%) |
Age (in completed years) |
30-39 | 28 (93.3%) | 2 (6.7%) | χ2=2.193 | p=0.006‡ |
40-49 | 95 (93.1%) | 7 (6.9%) |
50-59 | 100 (95.2%) | 5 (4.8%) |
≥ 60 | 136 (83.4%) | 27 (16.6%) |
Religion |
Hindu | 292 (90.40%) | 31 (9.60%) | χ2=0.777 | p=0.378* |
Others | 67 (87%) | 10 (13%) |
Marital Status |
Married | 315 (91%) | 31(9%) | χ2=4.640 | p=0.0312‡ |
Single§ | 44 (81.4%) | 10 (18.51%) |
Type of family |
Nuclear | 227 (93%) | 17 (7%) | χ2=64.266 | p=0.0001† |
Joint | 79 (91.8%) | 7 (8.2%) |
Three generation | 53 (75.7%) | 17 (24.3%) |
Education |
Illiterate | 76 (73%) | 28 (27%) | χ2=44.398 | p<0.001† |
Up to primary | 183 (93.8%) | 12 (6.15%) |
Secondary and above | 100 (99%) | 1 (1%) |
Occupation |
Labourer | 53 (84.1%) | 10 (15.9%) | χ2=11.359 | p=0.022‡ |
Businessman | 33 (97%) | 1 (3%) |
Housewife | 162 (89.5%) | 19 (10.5%) |
Retired | 34 (80.9%) | 8 (19.1%) |
Others | 77 (96.2%) | 3 (3.8%) |
Socioeconomic class |
I (Upper Class) | 37 (100%) | 0 (0%) | χ2=54.377 | p<0.001† |
II (Upper Middle Class) | 97 (92.4%) | 8 (7.6%) |
III (Middle Class) | 87 (96.6%) | 3 (3.4%) |
IV (Lower Middle class) | 127 (87.6%) | 18 (12.4%) |
V (Lower Class) | 11 (47.8%) | 12 (52.2%) |
Locality |
Urban non slum | 207 (96.2%) | 8 (3.8%) | χ2=25.077 | p<0.001† |
Urban Slum | 77 (86.5%) | 12 (13.5%) |
Rural | 75 (78.1%) | 21 (21.9%) |
Health insurance status |
Insured | 125 (82.8%) | 26 (17.2%) | χ2=12.805 | p=0.0003† |
Not insured | 234 (94%) | 15 (6%) |
Status of BP Control |
Controlled | 106 (91.4%) | 10 (8.6%) | χ2=0.471 | p=0.492* |
Not controlled | 253 (89%) | 31 (11%) |
Comorbidity |
Yes | 196 (90.3%) | 21 (9.7%) | χ2=0.169 | p=0.6810* |
No | 163 (89.1%) | 20 (10.9%) |
*not significant (p>0.05), ‡significant (p<0.05), †highly significant (p<0.001) Single§: widow/widower and never married have been combined to form single
Association between duration of illness and compliance.
Duration of illness (years) | No. of compliant patients (%) (n=359) | No. of non compliant patients (%) (n=41) | Total (%) (n=400) |
---|
<1 | 52 (14.5%) | 3 (7.3%) | 55 (13.8%) |
1-4 | 127 (35.4%) | 8 (19.5%) | 135 (33.8%) |
5-9 | 99 (27.6%) | 12 (29.3%) | 111 (27.8%) |
10-14 | 57 (15.9%) | 9 (22%) | 66 (16.5%) |
≥15 | 24 (6.6%) | 9 (21.9%) | 33 (8.2%) |
χ2=15.37, df=4, p=0.00398 (<0.05, significant)
Association between knowledge and practice of compliance.
Knowledge | Compliant (%) (n=359) | Non compliant (%) (n=41) | Total (%) (n=400) |
---|
Medicines to be continued always | 353 (98.3%) | 0 (0%) | 353 (88.3%) |
To be discontinued when no problem (asymptomatic) | 4 (1.1%) | 37 (90.2%) | 41 (10.2%) |
Do not know | 2 (0.6%) | 4 (9.8%) | 6 (1.5%) |
Chi-square value=346.267, df=2, p<0.001, highly significant
Discussion
In the present study, more than half of the hypertensive patients were females. This was similar to findings of another study conducted in Sau Paulo [15]. Female predominance may be due to the fact that 40% of the respondents belonged to the age group of 60 years and above, hinting towards higher post menopausal women in the study. However, contrary to these findings, Jardim PC et al., found a male predominance in their study [16]. More than half of the patients belonged to the productive age group of 40-59 years. In a study done by Jesus ES et al., most of the patients were in 50 [15]. Similar to the findings of the study conducted in Sau Paulo, majority of the patients in present study were married (86.5%) and housewives (45.3%) [15].
A compliance rate of 89.8% was observed in the present study. This was higher as compared to those observed in studies conducted in Nigeria (77.5%), Ethiopia (64.6%), Brazil (46%), Malaysia (44.2%) and Iran (39.6%) [17-21]. We observed that amongst those who were non compliant to the prescribed pharmacotherapy, 68.3% had poor compliance while 31.7% had discontinued the treatment. Although, it has been suggested by some that it is possible to withdraw pharmacotherapy and continue lifestyle modification after several years, it has been observed that the patient becomes hypertensive again in absence of treatment and may sometimes result in grave complications [17,22].
In present study, most of the patients had no literacy (26%) or had minimum education (48.7%), belonged to middle class (48.75%) or lower class (42%) and without any health insurance (62.2%) and all these factors were found to be significantly associated with the status of compliance. Other factors found to be closely associated with compliance status were age of the patient, duration of illness, marital status and occupation of the patient, type of family (whether nuclear, joint or three generation), the area of patient’s residence or locality (whether urban non slum, urban slum or rural). Similar to our study, Novick D et al., in a prospective study carried out in six East Asian countries also found association of age with compliance to treatment. They observed that older patients discontinued treatment significantly earlier than younger patients [23]. The fact that married patients exhibited better compliance may be due to better support system and reminder to take medications.
Also, highly significant association between knowledge about continuation of treatment and compliance was observed; patients with improper knowledge about treatment were more likely to be non compliant. In a study carried out in Nigeria Familoni BO et al., reported that only about one-third of patients knew that HTN should ideally be treated for life, and more than half believed that antihypertensive drugs should be used only where there are ‘symptoms’ while others believed that the treatment should be for a period of time [24]. In the present study, patients blamed forgetfulness, financial reasons and the hassle of having to carry their medications when away from home as factors leading to non compliance. The reasons of non compliance elicited in the present study were mostly, in agreement with those found in various other studies conducted in India as well as other parts of the world [25,26]. In one study done in Nigeria, factors associated with non compliance included turning asymptomatic, forgetfulness, lack of funds to purchase drugs, side-effects of drugs, having a busy schedule but limited medication (3.6%) and tired of taking drugs [17]. In a study done in Cairo, Egypt, the main causes for discontinuation of treatment were becoming asymptomatic, when they consider themselves as cured, economic burden and the very long treatment period [25]. In another study done in the urban population of Tamil Nadu, socioeconomic factors, life style, nutrition, lack of patient motivation, lack of patient education programs and adverse reactions to antihypertensive drugs was found to contribute significantly to non compliance [26]. Though females have been found to be more compliant to any therapy, no statistical association was noted between compliance with sex in present study [27]. However, this was comparable to the finding of the study done by Novick D et al., in Asian patients taking antidepressants [23]. Similar to the study by Osamor PE and Owumi BE no statistical significant association was found between compliance and religion [17]. Overall control of BP was found to be very poor (29%). This was similar to the finding (32.5%) of the Prospective Urban Rural Epidemiology (PURE) study by Chow CK et al., [28].
Limitation
Compliance to treatment was based on self report and, therefore, suffers from recall bias and social desirability bias.
Conclusion
The study elicited the various factors leading to non compliance namely improper knowledge regarding continuation of medication, age, education, longer duration of illness, financial reasons amongst others. The findings of the study suggest measures should be taken for proper awareness regarding HTN and its treatment in patients. Patient Information Leaflets (PILs), use of awareness videos in waiting rooms of NCD clinics can play a role in this. Especially in aged patients suffering since a long duration, BP log book should be maintained to check compliance and patients with lower socioeconomic status should be prescribed medications that are available free of cost to ensure compliance.
*not significant (p>0.05), ‡significant (p<0.05), †highly significant (p<0.001) Single§: widow/widower and never married have been combined to form singleχ2=15.37, df=4, p=0.00398 (<0.05, significant)Chi-square value=346.267, df=2, p<0.001, highly significant