Improving medication adherence among persons with cardiovascular disease through m-health and community health worker-led interventions in Kerala; protocol for a type II effectiveness-implementation research-(SHRADDHA-ENDIRA).

BACKGROUND: Cardiovascular disease (CVD) is the leading cause of mortality worldwide, and at present, India has the highest burden of acute coronary syndrome and ST-elevation myocardial infarction (MI). A key reason for poor outcomes is non-adherence to medication. METHODS: The intervention is a 2 × 2 factorial design trial applying two interventions individually and in combination with 1:1 allocation ratio: (i) ASHA-led medication adherence initiative comprising of home visits and (ii) m-health intervention using reminders and self-reporting of medication use. This design will lead to four potential experimental conditions: (i) ASHA-led intervention, (ii) m-health intervention, (iii) ASHA and m-health intervention combination, (iv) standard of care. The cluster randomized trial has been chosen as it randomizes communities instead of individuals, avoiding contamination between participants. Subcenters are a natural subset of the health system, and they will be considered as the cluster/unit. The factorial cluster randomized controlled trial (cRCT) will also incorporate a nested health economic evaluation to assess the cost-effectiveness and return on investment (ROI) of the interventions on medication adherence among patients with CVDs. The sample size has been calculated to be 393 individuals per arm with 4-5 subcenters in each arm. A process evaluation to understand the effect of the intervention in terms of acceptability, adoption (uptake), appropriateness, costs, feasibility, fidelity, penetration (integration of a practice within a specific setting), and sustainability will be done. DISCUSSION: The effect of different types of intervention alone and in combination will be assessed using a cluster randomized design involving 18 subcenter areas. The trial will explore local knowledge and perceptions and empower people by shifting the onus onto themselves for their medication adherence. The proposal is aligned to the WHO-NCD aims of improving the availability of the affordable basic technologies and essential medicines, training the health workforce and strengthening the capacity of at the primary care level, to address the control of NCDs. The proposal also helps expand the use of digital technologies to increase health service access and efficacy for NCD treatment and may help reduce cost of treatment. TRIAL REGISTRATION: The trial has been registered with the Clinical Trial Registry of India (CTRI), reference number CTRI/2023/10/059095.

Transmissibility of severe acute respiratory syndrome coronavirus 2 among household contacts of coronavirus disease 2019-positive patients: A community-based study in India.

BACKGROUND: This study identified the risk factors for severe acute respiratory syndrome coronavirus 2 infection among household contacts of index patients and determined the incubation period (IP), serial interval, and estimates of secondary infection rate in Kerala, India. METHODS: We conducted a cohort study in three districts of Kerala among the inhabitants of households of reverse transcriptase polymerase chain reaction-positive coronavirus disease 2019 patients between January and July 2021. About 147 index patients and 362 household contacts were followed up for 28 days to determine reverse transcriptase polymerase chain reaction positivity and the presence of total antibodies against SARS-CoV-2 on days 1, 7, 14, and 28. RESULTS: The mean IP, serial interval, and generation time were 1.6, 3, and 3.9 days, respectively. The secondary infection rate at 14 days was 43.0%. According to multivariable regression analysis persons who worked outside the home were protected (adjusted odds ratio [aOR], 0.45; 95% confidence interval [CI], 0.24-0.85), whereas those who had kissed the coronavirus disease 2019-positive patients during illness were more than twice at risk of infection (aOR, 2.23; 95% CI, 1.01-5.2) than those who had not kissed the patients. Sharing a toilet with the index patient increased the risk by more than twice (aOR, 2.5; 95% CI, 1.42-4.64) than not sharing a toilet. However, the contacts who reported using masks (aOR, 2.5; 95% CI, 1.4-4.4) were at a higher risk of infection in household settings. CONCLUSIONS: Household settings have a high secondary infection rate and the changing transmissibility dynamics such as IP, serial interval should be considered in the prevention and control of SARS-CoV-2.

Variations and Associated Factors in Symptom-to-Balloon (STB) Time and Door-to-Balloon (DTB) Time Before and After the COVID-19 Lockdown: A Hospital-Based Cross-Sectional Study.

INTRODUCTION: During the COVID-19 lockdown, India saw a major restriction in the movement of people. Patients with acute myocardial infarction (MI) required early interventions and follow-up of independent predictors like symptom-to-balloon (STB) time and door-to-balloon (DTB) time. This study aimed to determine changes in STB and DTB time before and after the COVID-19 lockdown and its associated risk factors. METHODS: A hospital-based cross-sectional study of 105 patients admitted to the cardiac care units (CCU) of two tertiary care centers in a district of Southern India for six months was conducted to compare the changes in STB and DTB time before and after the COVID-19 lockdown (three months before March 2020 and three months after March 2020), and data was collected from medical records. The data collected was then entered into Microsoft Excel (Microsoft Corporation, Washington, USA), numerically coded, and analyzed using SPSS Statistics version 21 (IBM Corp. Released 2012. IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp.). The Chi-square and Mann-Whitney U tests assessed the association between the dependent and independent variables. The STB/DTB time (before and after the COVID-19 lockdown) was the dependent variable, while the age, gender, co-morbidities, smoking status, and date of admission of patients (before and after the COVID-19 lockdown) were taken as the independent variables. A p-value of <0.05 was considered statistically significant. The predictor variables were identified using the regression method, where all variables with a significance of <0.2 were taken. RESULTS: The overall mean (±SD) STB time was 408.7 (±307.1) minutes, and the mean (±SD) DTB time was 161.7 (±261.6) minutes. The pre-lockdown mean STB time was 404.6 minutes, and the mean DTB time was 153 minutes, whereas the post-lockdown mean STB and DTB time were higher at 413.3 minutes and 171.6 minutes, respectively. Out of the total 105 patients, 95 (90.5%) had an STB time of ≥120 minutes, and 77 (73.3%) had an ideal DTB time of <90 minutes. There was no statistically significant variation in the STB and DTB time before and after the lockdown. Only the age group >60 years (38 (97.4%)) was found to be statistically significant with an STB time of ≥120 minutes after the lockdown (p-value=0.040), and patients referred from primary and secondary care centers (AOR (95% CI)=4.669 (1.129-19.298)) were found to be an independent factor in reducing DTB time before and after the COVID-19 lockdown. CONCLUSION: The efficiency of the health system, irrespective of the COVID-19 lockdown, was observed; nevertheless, a delay in the overall recognition of symptoms of MI was perceived. The importance of time factors in identifying the symptoms of non-communicable diseases (NCDs), especially MI and stroke, has to be ascertained among the general population.

Experiences and Beliefs on Tobacco Use, Cessation in India: A Qualitative Study.

Background: Almost 80% of global tobacco usage is concentrated in low- and-middle-income countries (LMICs) like India. Added to this, there is dearth of dedicated tobacco cessation specialist services in healthcare settings in these regions. Identification of challenges in the delivery of cessation interventions and understanding the experiences of tobacco users will aid in formulating successful quit strategies. Objectives: This qualitative study in India aimed to understand the perspectives of tobacco-using patients in healthcare facilities regarding tobacco use and cessation. Methods: This qualitative study was conducted in urban and rural areas of four study sites, two each in the North and South India. Using purposive sampling, patients who were tobacco users were selected from healthcare facilities. The interviews were transcribed, coded and organised into themes. Analysis was done using NVivo 10 software. Results: A total of 22 in-depth interviews were conducted on participants aged 23 to 80 years who were either current or past tobacco users. A majority of the participants were aware of their increased health risks associated with tobacco consumption and had attempted quitting; however, barriers such as peer influence, formed habit, certain cultural barriers and the addictive nature of nicotine prevented them from successfully quitting. Familial and peer support, the government's role in spreading public awareness, and limiting the sale of tobacco were stated as facilitators for tobacco cessation. Conclusions: The findings of this study point out that despite awareness of the perils of tobacco among smokers, there are various barriers and beliefs related to tobacco use and cessation. These findings would prove advantageous for policy-makers to implement and promote addiction treatment programmes for successful tobacco cessation efforts. In order to optimise strategies, policies must be well informed by ongoing dialogue between the public, service providers and policy-makers.

Menstrual practices, fertility intentions and decision-making regarding family planning by women belonging to various indigenous groups of Wayanad- A qualitative study.

Background: Among the different social groups in India, the tribes are the most vulnerable and socioeconomically deprived. The tribal population is distinct from the general population in terms of their unique cultural, traditional, and reproductive health practices. Therefore, the aim of the study was to conduct an exploratory analysis of the menstrual practices, fertility intentions and decision-making regarding family planning among various indigenous tribal women of Kerala. Methods: A qualitative study was conducted among the tribal women of Wayanad district using the grounded theory approach. Using purposive sampling 16 in-depth interviews, 6 key informant interviews and 2 focus group discussion (FGD) s were conducted. Interview guides were developed for in-depth interviews, key-informant interviews, and focus group discussion through extensive formative research with literature reviews and taking expert opinions. The interviews were conducted among women of reproductive age and their spouses hailing from Paniya and Kurichiya tribal groups in Kalpetta and Mananthavady areas of Wayanad district. Key informant interviews were also conducted among doctors, pharmacists, and community health workers. Results: The key findings of this study were the identification of a web of cultural practices pertaining to menstruation among persons of tribal origin. Unique traditional practices such as "Valayamapura" and "Thirandukalyanam" were reported and most of the women were keen to carry it forward. Fertility desires among couples were found to be not significantly influenced by any gender bias. Decision-making regarding family size were found to be on a mutual agreement between the spouses. The tribal women were aware of modern spacing methods, but preferred natural methods of contraception for temporary use and tubectomy as the permanent method. Non-contraceptive use of oral contraceptive pills (OCP) was prevalent, and the majority took it occasionally for postponement of menstruation to attend various social events. Conclusion: Menstruation-related myths and practices are prevalent and require educational interventions. More focus needs to be given to male sterilization as the permanent method of contraception. The study underscores the need to address gender inequalities and attitudes among tribal populations and to increase efforts to promote higher education among the tribes for busting cultural myths and practices.

Hypertension in urban slums of southern India: Burden, awareness, health seeking, control and risk factor profile.

INTRODUCTION: Hypertension is the leading risk factor for global disease burden. Inequalities in health among urban poor and non-poor is a matter of concern. The current study was done to estimate the prevalence of hypertension and to describe the health seeking and risk factor profile of people with hypertension in the urban slums of Kochi, Kerala, India. METHODS: Blood pressure of 5980 adults from 20 randomly selected slums were measured by door to door survey by trained nurses as a part of baseline assessment for a cluster randomised controlled trial. RESULTS: Prevalence of hypertension was found to be 34.8% (95% CI 33.5-34.9). Among those with hypertension, 66.9% were aware of their hypertensive status, of which 75.8% were initiated on treatment for hypertension. Proportion of hypertensive in the population who had their blood pressure under control was 24.5%. Among hypertensive, 53% were obese, 25.1% had diabetes mellitus, 14% had history of hospitalisation for high blood pressure. Of them, 60.3% had a per capita salt consumption above 8 g/day and 47.5% of them reported sitting for more than 8 h on a usual day. Mean monthly out of pocket expenditure for treatment of hypertension was $9(Median $8, IQR $16). CONCLUSION: One in three adults in urban slums of Kochi had hypertension. High rates of obesity, salt intake, physical inactivity prevails among the people with hypertension. Awareness, treatment initiation and control rate of hypertension are lower in urban slums as compared to non-slum urban areas. Slums require additional attention to ensure equitable and universal access to hypertension control.

Seroconversion and side effects after COVID vaccination among persons with type 2 diabetes in urban, rural, and tribal areas in Kerala, India.

Background: Persons with type 2 diabetes mellitus (T2DM) are at high-risk for COVID-19 infection and are a priority group for vaccination. Objectives: The objective of this study is to estimate the seroconversion and determine the side effects after COVID-19 vaccination among persons with T2DM in urban, rural, and tribal areas in Kerala. Methods: A cross-sectional study was conducted in urban, rural, and tribal field practice areas of a medical college in Central Kerala, among 396 persons with T2DM. The participants were selected by simple random sampling from the 200-250 diabetic patients visiting each health center. Qualitative and quantitative estimation of antibodies were done by WANTAI Ab enzyme-linked immunosorbent assay kit and Abbott SARS COV-2 IgG Quantitative assay, respectively. Results: The mean age of the respondents was 59.40 ± 12.25 years. A majority (65.5%) had received both doses of vaccine. About half (51.5%) experienced side effects after vaccination. Antibodies (IgG or IgM) were detected in 93.2% (95% confidence interval [CI] 90.2, 95.5) of participants. Those with a duration of diabetes ≥5 years, with a single dose of vaccine, were five times (adjusted odds ratio [aOR] - 5.23,95% CI 1.86, 14.66) and four times (aOR - 4.11, 95% CI 1.66, 10.13) more likely, respectively, to be seronegative. Those who took medication for diabetes were protected against a no antibody (aOR - 0.05, 95% CI 0.02, 0.148) response. The median antibody titer in a subset (150) of participants was 365.2 (90-1587) AU/ml. Past COVID infection was an independent determinant of high IgG titers (aOR - 4.95, 95% CI 1.50, 16.36). Conclusion: Reinforcing the importance of vaccination particularly among those with longer duration of diabetes is imperative.

Glycemic control and its determinants among people with type 2 diabetes mellitus in Ernakulam district, Kerala.

Background: Diabetes is a public health problem of colossal proportions. The National Family Health Survey 5 (2019-2020) has found high blood sugar levels among 13.5% of women and 15.6% of men in India. The high morbidity and mortality in diabetes mellitus are due to uncontrolled hyperglycemia resulting in micro- and macrovascular changes affecting multiple organs in the body. The objectives of this study were to estimate glycemic control and its determinants among type 2 diabetics in the Ernakulam district. Methods: A community-based cross-sectional study was conducted among 364 type 2 diabetics who had the disease for at least 5 years duration in the Ernakulam district of Kerala. Probability proportional to size cluster sampling technique was adopted. A semi-structured questionnaire was used to collect sociodemographic and behavioral profiles. Participants' HbA1c levels were assessed to determine glycemic control. Results: The proportion of people with good glycemic control was 21.4%. Determinants such as female gender adjusted odds ratio (aOR = 2.36, P = 0.005), body mass index >23 kg/m2 (aOR = 2.71, P = 0.002), combined drug treatment with Oral Hypoglycaemic agents (OHA) and insulin (aOR = 3.76, P = 0.004), and poor compliance with medications (aOR = 1.93, P = 0.030) were found to be significantly associated with poor glycemic control. Conclusions: Poor compliance with medications and unhealthy lifestyle choices has resulted in a high proportion of diabetics with poor glycemic control in the district. Women are particularly more vulnerable to uncontrolled hyperglycemia than males. Type 2 diabetes mellitus people should be encouraged to maintain strict glycemic control, which is an important measure for secondary prevention of complications.

Pattern of contraceptive use, determinants and fertility intentions among tribal women in Kerala, India: a cross-sectional study.

OBJECTIVES: To assess the pattern of contraceptive use and its determinants, knowledge regarding contraceptives including oral contraceptive pills and fertility intentions among tribal women in the reproductive age group. DESIGN: Community-based cross-sectional study. SETTING: Community development blocks in a predominantly tribal district of Wayanad in Kerala, India. PARTICIPANTS: Women in the reproductive age group (15-49 years) from the tribal groups in the district numbering 2495. OUTCOME MEASURES: PRIMARY: Prevalence of contraceptive use and its determinants. SECONDARY: Knowledge regarding contraceptives in general, oral contraceptives and fertility intentions. RESULTS: The mean age of the study participants was 30.8 years (SD=9.8) and belonged to various tribal groups such as Paniya (59.2%), Kurichiyar (13.6%) and Adiya (10.9%). Current use of contraceptive was reported by about a fourth, 658 (26.4%) (95% CI 27.9 to 24.9) of women. Following logistic regression, belonging to Paniya tribe (adjusted OR (aOR) 2.67, 95% CI 1.49 to 4.77; p<0.001) and age at menarche >13 years (aOR 1.69, 95% CI 1.14 to 2.52; p<0.009) had significantly higher use of contraceptives whereas social vulnerability as indicated by staying in a kutcha house had a lesser likelihood of use of contraceptive (aOR 0.55, 95% CI 0.31 to 0.95; p<0.03). Oral contraceptive use was low (4.8%) among this population and no abuse was observed.Less than half (47%) of the respondents had an above average knowledge on contraception. Multivariable logistic regression indicated that above average knowledge was 2.2 times more likely with higher education (95% CI 1.2 to 3.9), lesser among those who desired more than two children (aOR 0.59; 95% CI 0.38 to 0.94; p<0.02).Two children per family was the preferred choice for 1060 (42.5%) women. No gender bias in favour of the male child was observed. CONCLUSION: Awareness and use of contraceptives are poor though the fertility is not commensurately high. Along with developing targeted responses to contraceptive use among Indigenous people with indigenous data, awareness also requires attention. Ethnographic studies are also necessary to determine the differences in contraceptive use including traditional methods among the various Indigenous groups.

A Sustainable Community-Based Model of Noncommunicable Disease Risk Factor Surveillance (Shraddha-Jagrithi Project): Protocol for a Cohort Study.

BACKGROUND: India has a massive noncommunicable disease (NCD) burden, at an enormous cost to the individual, family, society, and health system at large, despite which prevention and surveillance are relatively neglected. If diagnosed early and treated adequately, risk factors for atherosclerotic cardiovascular disease would help decrease the mortality and morbidity burden. Surveillance for NCDs, creating awareness, positive lifestyle changes, and treatment are the proven measures known to prevent the progression of the disease. India is in a stage of rapid epidemiological transition, with the state of Kerala being at the forefront, pointing us towards likely disease burden and outcomes for the rest of the country in the future. A previous study done by the same investigators in a population of >100,000 revealed poor awareness, treatment of NCDs, and poor adherence to medicines in individuals with CVD. OBJECTIVE: This study aimed at assessing a sustainable, community-based surveillance model for NCDs with corporate support fully embedded in the public health system. METHODS: Frontline health workers will check all individuals in the target group (≥age 30 years) with further follow-up and treatment planned in a "spoke and hub" model using the public health system of primary health centers as spokes to the hubs of taluk or district hospitals. All data entry done by frontline health workers will be on a tablet PC, ensuring rapid acquisition and transfer of participant health details to primary health centers for further follow-up and treatment. RESULTS: The model will be evaluated based on the utilization rate of various services offered at all tier levels. The proportions of the target population screened, eligible individuals who reached the spoke or hub centers for risk stratification and care, and community-level control for hypertension and diabetes in annual surveys will be used as indicator variables. The model ensures diagnosis and follow-up treatment at no cost to the individual entirely through the tiered public health system of the state and country. CONCLUSIONS: Surveillance for NCDs is an essential facet of health care presently lacking in India. Atherosclerotic cardiovascular disease has a long gestation period in progression to the symptomatic phase of the disease, during which timely preventive and lifestyle measures would help prevent disease progression if implemented. Unfortunately, several asymptomatic individuals have never tested their plasma glucose, serum lipid levels, or blood pressure and are unaware of their disease status. Our model, implemented through the public health system using frontline health workers, would ensure individuals aged≥30 years at risk of disease are identified, and necessary lifestyle modifications and treatments are given. In addition, the surveillance at the community level would help create a general awareness of NCDs and lead to healthier lifestyle habits. TRIAL REGISTRATION: Clinical Trial Registry India CTRI/2018/07/014856; https://tinyurl.com/4saydnxf. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27299.

Risk Factors Associated with Preterm Delivery in Singleton Pregnancy in a Tertiary Care Hospital in South India: A Case Control Study.

BACKGROUND: Preterm delivery is a major obstetric complication and a leading cause of neonatal mortality and morbidity. It is also associated with significant costs in terms of psychological and financial hardship, to the families. OBJECTIVE: The primary objective of this study was to determine the risk factors associated with all preterm deliveries in singleton pregnancy in a tertiary care hospital and the secondary objective was to determine the fetal outcomes among women with preterm delivery. MATERIALS AND METHODS: A case control study was conducted between January 2019 and June 2019 in the Department of Obstetrics and Gynecology of a tertiary care center in Central Kerala, India. Women who delivered before 37 completed weeks of gestation were taken as cases and those who delivered at or after 37 weeks were considered as controls in a 1:1 ratio, approximately. Data regarding 191 cases and 200 controls were taken from delivery room records of the years 2016 to 2018 with the help of a predesigned checklist. Univariate and multivariate analysis were done to determine the magnitude of association between the exposure factors and preterm delivery. RESULTS: The mean age of study participants among the cases was 29.3 ± 5.1 years and controls was 28.1 ± 4.4. Pregnancy induced hypertension (aOR = 14.60; 95% CI 4.8, 44.1; p<0.001), abnormal amniotic fluid volume (aOR = 10.68; 95% CI 3.46, 32.98; p<0.001), premature rupture of membranes (PROM) (aOR = 10.27; 95% CI 4.82, 21.86; p<0.001), previous history of preterm delivery (aOR = 4.12; 95% CI 1.22, 13.85; p<0.002), history of urinary tract infection (UTI) during pregnancy (aOR = 3.67; 95% CI 1.39, 9.68; p<0.002), systemic diseases (aOR = 2.78; 95% CI 1.28, 6.39; p<0.001), anaemia (aOR = 2.54; 95% CI 1.28, 5.03; p<0.004) were found to be the independent risk factors for preterm delivery. On analyzing the fetal outcomes, the average birth weight of preterm babies was 2 ± 0.6 kg compared to 3.1kg among term babies. CONCLUSION: Early detection and adequate treatment of various conditions like anaemia, pregnancy induced hypertension, UTI and systemic illness can help in reduction of the prevalence of preterm delivery.

A novel banana fiber pad for menstrual hygiene in India: a feasibility and acceptability study.

BACKGROUND: Menstrual hygiene products used by women have evolved in the past several decades with comfort, ease of use and cost driving women's choices. In a country like India, where women form nearly 50% of the population, the sheer volume of periodic menstrual non-biodegradable waste generated has significant environmental implications. With majority of the country hailing from low-middle class backgrounds, observing healthy menstrual hygiene practices with environmentally friendly products necessitates the consideration of affordable and highly sustainable alternatives. Further, during the COVID-19 pandemic, period poverty is higher than ever, causing women to turn to the reusable product market for affordable and long lasting alternatives. Hence, we studied the Feasibility and Acceptability (FA) of a novel banana fiber based menstrual pad (BFP) amongst women living in rural and urban environments. METHODS: The quantitative study of FA of the BFP was conducted amongst 155 rural and 216 urban participants in India. For greater authenticity of the FA study, we considered participants who used BFP for more than 4 months (Rural = 111 and Urban = 186) in the study. The survey data included responses from participants from Bihar, Delhi, Karnataka, Kerala, Maharashtra, Tamil Nadu and West Bengal. A 22-item survey instrument was developed and validated using Exploratory Factor Analysis (EFA) and reliability test (Cronback's [Formula: see text]). Binomial logistic regression analysis was used to analyse the factors that affect the FA of BFP based on the survey responses. In addition to survey analysis, environmental sustainability through [Formula: see text] footprint analysis, microbial load, pH and the ability of the BFP to withstand pressure after absorption were also studied. RESULTS: The results indicated high levels of feasibility (rural [Formula: see text], urban [Formula: see text] and acceptability (rural [Formula: see text], urban [Formula: see text]) of BFPs across both participant groups. Comparing key BFP characteristics such as leakage and comfort to participants' prior practices revealed general satisfaction on the performance of BFP, leading to them recommending BFPs to others. User perception on the reasons for their preference of BFP highlighted their concern for environment, health and cost as decisive factors. The microbial load on a 3 year reused BFP was found to be similar to an unused BFP. Regression analysis showed cost as an important indicator for feasibility ([Formula: see text]; 95% CI = 1.083-3.248) and acceptability ([Formula: see text]; 95% CI = 1.203-3.748) amongst rural participants. CONCLUSION: Based on feasibility and acceptability results, BFP is a promising consideration as an environmentally sound, non-invasive; yet reusable alternative to fulfil MHM needs in populous countries such as India. Longer term studies in larger samples are necessary to validate these findings.

Uncontrolled Blood Pressure and Associated Factors Among Persons With Diabetes: A Community Based Study From Kerala, India.

The coexistence of raised blood pressure (BP) in people with type 2 diabetes mellitus (T2DM) is a major contributor to the development and progression of both macrovascular and microvascular complications. The aim of our study was to determine the prevalence of uncontrolled BP and its associated factors in persons with T2DM in a district in Kerala. METHODS: The study was conducted in Ernakulam district in Kerala, and a total of 3,092 individuals with T2DM were enrolled after obtaining consent. Those with a BP "above or equal to 140 mmHg" and/or "above or equal to 90 mmHg" were thus considered to have uncontrolled BP. If the BP was equal or >140 and/or 90 mmHg, a repeat reading was taken after 30 min and the average of the two was considered. Basic demographic details were enquired along with electronic measurement of BP, HbA1c estimation and screening for diabetic retinopathy, peripheral arterial disease (PAD), and peripheral neuropathy. Quantitative and qualitative variables were expressed as mean (SD) and proportions, respectively. The model for determinants of uncontrolled BP was developed adjusting for age, gender, education, duration of diabetes, occupation, body mass index (BMI) and clustering effect. RESULTS: The mean age of the study population was 59.51 ± 9.84 years. The mean duration of T2DM was found to be 11.3 ± 6.64 years. The proportion of uncontrolled HTN adjusted for clustering was 60% (95% CI 58 and 62%). Among them, only one in two persons (53.3%) had a history of hypertension. Age >60 years [adjusted odds ratio (aOR) 1.48, 95% CI 1.24, 1.76; p < 0.001], unemployment (aOR 1.33, 95% CI 1.01, 1.75; p < 0.01), duration of diabetes > 11 years (aOR 1.42, 95% CI 1.19, 1.68; p < 0.001), and BMI ≥23 (aOR 1.33, 95% CI 1.10, 1.59; p < 0.002) were found to be independent determinants of high BP levels when adjusted for the aforementioned variables, gender, education, and cluster effect. The association between complications, such as peripheral neuropathy, PAD, and retinopathy showed a higher risk among those with uncontrolled BP. Retinopathy was 1.35 times more (95% CI 1.02, 1.7, p < 0.03), PAD was 1.6 times more (95% CI 1.2, 2.07, p < 0.001), and peripheral neuropathy was 1.5 (95% CI 1.14, 1.9, p < 0.003) times more compared to their counterparts. CONCLUSION: Target BP levels were far from being achieved in a good majority of the persons with T2DM. To reduce further macrovascular and microvascular events among people with T2DM, effective awareness and more stringent screening measures need to be employed in this population.

Prevalence and Determinants of Somatization and Anxiety among Adult Women in an Urban Population in Kerala.

BACKGROUND: Common mental disorders (CMDs) such as somatization and anxiety are prevalent in general practice. These are twice more common in women. OBJECTIVES: The objective of this study is to estimate the prevalence and determinants of somatization and anxiety among adult women in an urban population of Kochi. MATERIALS AND METHODS: A cross-sectional study was conducted among 1210 adult women of Kochi in 2016-2017. The Patient Health Questionnaire-15; the Generalized Anxiety Disorder-7 questionnaire; the Hurt, Insult, Threaten, and Scream tool; and a semi-structured questionnaire were used to estimate the prevalence of somatization and anxiety. Descriptive statistics and univariate and multivariate analysis were done for factors associated with CMDs. RESULTS: Most of the respondents were married (77.7%), with a mean age of 45.24 ± 15.59. In the current study, 40.8% (95% confidence interval [CI] =38.09-43.62) had somatization and 23.9% (95% CI = 21.57-26.37) had anxiety disorders. In the final logistic regression model, hypertension, perception of illness, positive family history of mental illness, and arthritis were the four determinants common to somatization and anxiety. Menstrual problems (odds ratio [OR] =3.19; 95% CI = 1.12-5.9), cardiac illness (OR = 2.31; 95% CI = 1.08-4.9), and history of major surgeries (OR = 1.62; 95% CI = 1.14-2.41) were independent determinants of somatization. The status of being single (OR = 1.71; 95% CI = 1.25-2.32), adverse life circumstances (OR = 5.85; 95% CI = 3.98-8.6), diabetes (OR = 2.04; 95% CI = 1.25-3.34), sleep problems (OR = 1.64; 95% CI = 1.77-2.91), and history of drug use (OR = 4.89; 95% CI = 1.92-12.46) were independent determinants of anxiety. CONCLUSION: Mental health services for urban women deserve immediate attention as the prevalence of somatization and anxiety is high. Hence, it is important to screen for somatization and anxiety among women with noncommunicable diseases.

Assessment of vaccine coverage and associated factors among children in urban agglomerations of Kochi, Kerala, India.

CONTEXT: Urban population in India is growing exponentially. The public sector urban health delivery system has so far been limited in its reach and is far from adequate. AIMS: This study aims to estimate routine immunization coverage and associated factors among children (12-23 months and 60-84 months) in the urban Kochi Metropolitan Area of Kerala. SETTINGS AND DESIGN: A cross-sectional study was conducted in Kochi Metropolitan area. MATERIALS AND METHODS: A cluster sampling technique was used to collect data on immunization status from 310 children aged between 12 and 23 months and 308 children aged between 60 and 84 months. STATISTICAL ANALYSIS: Crude coverage details for each vaccine were estimated using percentages and confidence intervals. Bivariate and multivariate analysis were conducted to identify factors associated with immunization coverage. RESULTS: Among the children aged 12-23 months, 89% (95% CI 85.5%-92.5%) were fully immunized, 10% were partially immunized, and 1% unimmunized. Less than 10 years of schooling among mothers (OR 2.40, 95% CI 1.20-4.81) and living in a nuclear family (OR 1.72, 95% CI 1.06-3.14) were determinants associated with partial or unimmunization of children as per multivariate analysis. The coverage of individual vaccines was found to decrease after 18 months from 90% to 75% at 4-5 years for Diphtheria Pertussis Tetanus (DPT) booster. Bivariate analysis found lower birth order and belonging to the Muslim religion as significant factors for this decrease. CONCLUSION: Education of the mother and nuclear families emerged as areas of vulnerability in urban immunization coverage. Inadequate social support and competing priorities with regard to balancing work and home probably lead to delay or forgetfulness in vaccination. Therefore, a locally contextualized comprehensive strategy with strengthening of the primary health system is needed to improve the immunization coverage in urban areas.

The Effect of Yoga and Peer Support Interventions on the Quality of Life of Women with Diabetes: Results of a Randomized Controlled Trial.

OBJECTIVE: This was an interventional study to understand the effect of two low-cost interventions; yoga and peer support on the quality of life (QOL) of women with type 2 diabetes. METHODOLOGY: An open label parallel three-armed randomized control trial was conducted among 124 recruited women with diabetes for 3 months. Block randomization with a block length of six was carried out. In the yoga arm, sessions by an instructor, consisting of a group of postures coordinated with breathing were conducted for an hour, 2 days a week. In the peer support arm, each peer mentor after training visited 13-14 women with diabetes every week followed by a phone call. The meeting was about applying disease management plans in daily life. At the beginning and end of the study, QOL was assessed by the translated, validated World Health Organization QOL-BREF in four domains physical, psychological, social, and environmental domains. RESULTS: The majority (96%) of the study participants perceived the peer support and yoga intervention to be beneficial. Paired t-test revealed significant increases in the social and environmental domain in the peer group and in the environmental domain in the yoga group, though this disappeared in the between-group comparison perhaps due to poor glycemic control (hemoglobin A1c varied from 9.4 to 9.6) and the short duration of 3 months of the study. CONCLUSION: Peer support and yoga improved perceptions of QOL though its impact on scores was not significant due to a short period of study among women with poor glycemic control.

A Randomized controlled trial of the effect of yoga and peer support on glycaemic outcomes in women with type 2 diabetes mellitus: a feasibility study.

BACKGROUND: Type two diabetes is a complex and demanding chronic disease and its impact in a state (Kerala) which leads India in terms of the number of people with Diabetes is profound. Though the male to female ratio among the people with diabetes is roughly equal, women are uniquely and more severely affected. Management of type two Diabetes requires considerable dexterity on the part of the patient to manage drugs, diet and exercise. Therefore, in a low middle-income country like India it is necessary to look at low cost interventions that can empower the patient and build on available resources to help manage diabetes. Hence, we studied the feasibility and effect of two low cost interventions; yoga and peer support on glycaemic and other outcomes among women with type two diabetes. METHODS: An open label parallel three armed randomized control trial was conducted among 124 recruited women with Diabetes for three months. Block randomization with a block length of six was carried out with each group having at least 41 women. In the Yoga arm, sessions by an instructor, consisting of a group of postures coordinated with breathing were conducted for an hour, two days a week. In the peer support arm each peer mentor after training visited 13-14 women with diabetes every week followed by a phone call. The meeting was about applying disease management or prevention plans in daily life. RESULTS: There was a trend in decline of fasting plasma glucose in the peer and yoga group and of glycosylated haemoglobin (HbA1c) in the yoga group only, though not significant. A significant decrease was observed in diastolic blood pressure and hip circumference in the yoga group. The process indicated that most (80%) of the women in the yoga group attended classes regularly and 90% of the women in the peer group reported that peer mentoring was useful. CONCLUSION: The effect of yoga and peer support on glycaemic outcomes was incremental. Longer term studies are necessary to ascertain the benefits shown by this feasibility study. TRIAL REGISTRATION: CTRI/2011/12/002227 dated 14/12/2011.

Validation of WHOQOL-BREF in Malayalam and Determinants of Quality of Life Among People With Type 2 Diabetes in Kerala, India.

Quality of life (QOL) is an important health outcome in people with chronic conditions like diabetes and WHOQOL-BREF is a popular instrument used worldwide to assess QOL. However, QOL varies considerably from society to society depending on the culture of the person. Hence, the WHOQOL-BREF was translated to the local language, Malayalam. This article attempts to establish reliability, construct and discriminant validity of the translated WHOQOL-BREF, and determinants of QOL among people with type 2 diabetes. A cross-sectional study was undertaken among 200 patients with diabetes attending a primary care center in a rural area of Kerala, India. The translated version of WHOQOL-BREF was found to be internally consistent (Cronbach's α = .86) and demonstrated discriminant and construct validity. Education was found to be an independent determinant of QOL in the physical, psychological, and environmental domains. Thus, the translated version had good psychometric properties and education was an independent determinant of QOL in 3 of 4 domains.