Search

There is a dearth of psychological interventions for self-harm that have been tested and found acceptable by youth in low- and middle income countries. ĀTMAN (Sanskrit word meaning "self" or "self-existent essence") is one such contextually adapted psychological intervention developed in India. It has three key elements; problem-solving, emotion regulation, and social network strengthening skills. We delivered ATMAN in a series of young people who self-harm to optimize the content, structure and delivery mechanisms, and to assess their experiences of therapy and engagement. ATMAN was delivered sequentially by a psychiatrist and non-specialist counselor in 16 participants between 14 to 24 years who presented to a tertiary level public hospital in Mumbai with self-harm. Quantitative measurement tools included Beck's Scale for Suicidal Ideation (BSI), the Patient Health Questionnaire −9 (PHQ-9), Functional Assessment of Self-Mutilation, and session feedback form. Qualitative tools included PSYCHLOPS and exit interviews. Eight female and four male participants completed therapy with a mean of five sessions and an average duration of 50 min. There were no differences in module wise feedback ratings of the psychiatrist and counselor. There were significant differences in the pre- and post-therapy scores on BSI (mean difference (confidence interval)) (−16.8 (−20.2, −13.3)) and PHQ-9 (−10.8 (−14.5, −7.04)). Various content modifications were undertaken during this phase. ATMAN was acceptable to youth in India who self-harm. Modifications introduced during pilot trial phase make ATMAN better suited to the needs of the youth. ATMAN has the potential to be delivered by non- specialist counselors and to be integrated at all levels of health care settings including primary health care to reduce the burden of suicide in young people. However, an extended randomized controlled trial of ATMAN treatment with multiple counselors will help in identifying key competencies that should be developed during training and supervision, and various quality assurance measures that can be undertaken for effective implementation of ATMAN. [ABSTRACT FROM AUTHOR]

Introduction: Most Indians are vegetarian or eat very little meat, which could imply high potassium intake. Because a high-potassium diet could counterbalance the adverse health effects of high-sodium intake, this study aimed to describe potassium relative to sodium intake and investigate the relationship between blood pressure and potassium intake relative to sodium intake in rural and urban India.Methods: Investigators collected 24-hour urines from 1,445 participants in a subset of 2 population-based surveys in North India in 2012-2013. Standardized questionnaires were used to collect information on demography, behaviors (tobacco, alcohol consumption, physical activity, and diet [food frequency and 24-hour recall]), and medical history. After evaluating expected versus measured creatinine excretion, the authors calculated median urine potassium excretion and sodium/potassium ratio, according to sex and urban or rural residence, and estimated least square means for the urine measures by participant demographics and comorbidities, after accounting for caloric intake. Two-year blood pressure follow-up data were available in the urban study, and ANCOVA regression was used to determine the association with urine measures. All the statistical analyses of the data were done in January 2019.Results: Acceptable 24-hour urine collections were available in 1,397 participants (rural, n=730). Median urine potassium excretions were 1,492 (IQR=1,012-2,063) and 975 (615-1,497) mg/day; sodium/potassium ratios met the recommended target of <1 in 2.9% rural and 6.6% urban participants. Rural participants did not have higher potassium or lower (better) sodium/potassium ratios when diagnosed with hypertension or other cardiovascular conditions. Higher potassium excretion was associated with lower blood pressure during follow-up among the urban participants (mean systolic blood pressure, 129 vs 133 mm Hg in highest vs lowest potassium excretion tertiles; p=0.029).Conclusions: Low potassium intake in India warrants dietary policies promoting intake of potassium-rich foods to improve heart health. This approach may be more acceptable than programs focused on sodium reduction alone. [ABSTRACT FROM AUTHOR]

Background: Achievement of diabetes care goals is suboptimal globally. Diabetes-focused quality improvement (QI) is effective but remains untested in South Asia.Objective: To compare the effect of a multicomponent QI strategy versus usual care on cardiometabolic profiles in patients with poorly controlled diabetes.Design: Parallel, open-label, pragmatic randomized, controlled trial. (ClinicalTrials.gov: NCT01212328).Setting: Diabetes clinics in India and Pakistan.Patients: 1146 patients (575 in the intervention group and 571 in the usual care group) with type 2 diabetes and poor cardiometabolic profiles (glycated hemoglobin [HbA1c] level ≥8% plus systolic blood pressure [BP] ≥140 mm Hg and/or low-density lipoprotein cholesterol [LDLc] level ≥130 mg/dL).Intervention: Multicomponent QI strategy comprising nonphysician care coordinators and decision-support electronic health records.Measurements: Proportions achieving HbA1c level less than 7% plus BP less than 130/80 mm Hg and/or LDLc level less than 100 mg/dL (primary outcome); mean risk factor reductions, health-related quality of life (HRQL), and treatment satisfaction (secondary outcomes).Results: Baseline characteristics were similar between groups. Median diabetes duration was 7.0 years; 6.8% and 39.4% of participants had preexisting cardiovascular and microvascular disease, respectively; mean HbA1c level was 9.9%; mean BP was 143.3/81.7 mm Hg; and mean LDLc level was 122.4 mg/dL. Over a median of 28 months, a greater percentage of intervention participants achieved the primary outcome (18.2% vs. 8.1%; relative risk, 2.24 [95% CI, 1.71 to 2.92]). Compared with usual care, intervention participants achieved larger reductions in HbA1c level (-0.50% [CI, -0.69% to -0.32%]), systolic BP (-4.04 mm Hg [CI, -5.85 to -2.22 mm Hg]), diastolic BP (-2.03 mm Hg [CI, -3.00 to -1.05 mm Hg]), and LDLc level (-7.86 mg/dL [CI, -10.90 to -4.81 mg/dL]) and reported higher HRQL and treatment satisfaction.Limitation: Findings were confined to urban specialist diabetes clinics.Conclusion: Multicomponent QI improves achievement of diabetes care goals, even in resource-challenged clinics.Primary Funding Source: National Heart, Lung, and Blood Institute and UnitedHealth Group. [ABSTRACT FROM AUTHOR]

Background: Effective task-shifting interventions targeted at reducing the global cardiovascular disease (CVD) epidemic in low and middle-income countries (LMICs) are urgently needed.Methods: DISHA is a cluster randomised controlled trial conducted across 10 sites (5 in phase 1 and 5 in phase 2) in India in 120 clusters. At each site, 12 clusters were randomly selected from a district. A cluster is defined as a small village with 250-300 households and well defined geographical boundaries. They were then randomly allocated to intervention and control clusters in a 1:1 allocation sequence. If any of the intervention and control clusters were <10 km apart, one was dropped and replaced with another randomly selected cluster from the same district. The study included a representative baseline cross-sectional survey, development of a structured intervention model, delivery of intervention for a minimum period of 18 months by trained frontline health workers (mainly Anganwadi workers and ASHA workers) and a post intervention survey in a representative sample. The study staff had no information on intervention allocation until the completion of the baseline survey. In order to ensure comparability of data across sites, the DISHA study follows a common protocol and manual of operation with standardized measurement techniques.Discussion: Our study is the largest community based cluster randomised trial in low and middle-income country settings designed to test the effectiveness of 'task shifting' interventions involving frontline health workers for cardiovascular risk reduction.Trial Registration: CTRI/2013/10/004049 . Registered 7 October 2013. [ABSTRACT FROM AUTHOR]

Background: Given the shortage of cardiac rehabilitation (CR) programs in India and poor uptake worldwide, there is an urgent need to find alternative models of CR that are inexpensive and may offer choice to subgroups with poor uptake (e.g., women and elderly).Objectives: This study sought to evaluate the effects of yoga-based CR (Yoga-CaRe) on major cardiovascular events and self-rated health in a multicenter randomized controlled trial.Methods: The trial was conducted in 24 medical centers across India. This study recruited 3,959 patients with acute myocardial infarction with a median and minimum follow-up of 22 and 6 months. Patients were individually randomized to receive either a Yoga-CaRe program (n = 1,970) or enhanced standard care involving educational advice (n = 1,989). The co-primary outcomes were: 1) first occurrence of major adverse cardiovascular events (MACE) (composite of all-cause mortality, myocardial infarction, stroke, or emergency cardiovascular hospitalization); and 2) self-rated health on the European Quality of Life-5 Dimensions-5 Level visual analogue scale at 12 weeks.Results: MACE occurred in 131 (6.7%) patients in the Yoga-CaRe group and 146 (7.4%) patients in the enhanced standard care group (hazard ratio with Yoga-CaRe: 0.90; 95% confidence interval [CI]: 0.71 to 1.15; p = 0.41). Self-rated health was 77 in Yoga-CaRe and 75.7 in the enhanced standard care group (baseline-adjusted mean difference in favor of Yoga-CaRe: 1.5; 95% CI: 0.5 to 2.5; p = 0.002). The Yoga-CaRe group had greater return to pre-infarct activities, but there was no difference in tobacco cessation or medication adherence between the treatment groups (secondary outcomes).Conclusions: Yoga-CaRe improved self-rated health and return to pre-infarct activities after acute myocardial infarction, but the trial lacked statistical power to show a difference in MACE. Yoga-CaRe may be an option when conventional CR is unavailable or unacceptable to individuals. (A study on effectiveness of YOGA based cardiac rehabilitation programme in India and United Kingdom; CTRI/2012/02/002408). [ABSTRACT FROM AUTHOR]

Abstract Background Cardiac rehabilitation (CR) is a standard treatment for secondary prevention of acute myocardial infarction (AMI) in high income countries (HICs), but it is inaccessible to most patients in India due to high costs and skills required for multidisciplinary CR teams. We developed a low-cost and scalable CR program based on culturally-acceptable practice of yoga (Yoga-CaRe). In this paper, we report the rationale and design for evaluation of its effectiveness and cost-effectiveness. Methods This is a multi-center, single-blind, two-arm parallel-group randomized controlled trial across 22 cardiac care hospitals in India. Four thousand patients aged 18–80 years with AMI will be recruited and randomized 1:1 to receive Yoga-CaRe program (13 sessions supervised by an instructor and encouragement to self-practice daily) or enhanced standard care (3 sessions of health education) delivered over a period of three months. Participants will be followed 3-monthly till the end of the trial. The co-primary outcomes are a) time to occurrence of first cardiovascular event (composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and emergency cardiovascular hospitalization), and b) quality of life (Euro-QoL-5L) at 12 weeks. Secondary outcomes include need for revascularization procedures, return to pre-infarct activities, tobacco cessation, medication adherence, and cost-effectiveness of the intervention. Conclusion This trial will alone contribute >20% participants to existing meta-analyses of randomized trials of CR worldwide. If Yoga-CaRe is found to be effective, it has the potential to save millions of lives and transform care of AMI patients in India and other low and middle income country settings. Highlights • Yoga-CaRe trial is one of the largest trials which provides information on much needed data on CR from LMICs • The study is sufficiently powered to address research questions on policy relevant clinical outcomes • Yoga-CaRe programme, if proven to be beneficial may reduce the unmet needs of cardiac rehabilitation across the globe [ABSTRACT FROM AUTHOR]

Importance: Wide heterogeneity exists in acute myocardial infarction treatment and outcomes in India.Objective: To evaluate the effect of a locally adapted quality improvement tool kit on clinical outcomes and process measures in Kerala, a southern Indian state.Design, Setting, and Participants: Cluster randomized, stepped-wedge clinical trial conducted between November 10, 2014, and November 9, 2016, in 63 hospitals in Kerala, India, with a last date of follow-up of December 31, 2016. During 5 predefined steps over the study period, hospitals were randomly selected to move in a 1-way crossover from the control group to the intervention group. Consecutively presenting patients with acute myocardial infarction were offered participation.Interventions: Hospitals provided either usual care (control group; n = 10 066 participants [step 0: n = 2915; step 1: n = 2649; step 2: n = 2251; step 3: n = 1422; step 4; n = 829; step 5: n = 0]) or care using a quality improvement tool kit (intervention group; n = 11 308 participants [step 0: n = 0; step 1: n = 662; step 2: n = 1265; step 3: n = 2432; step 4: n = 3214; step 5: n = 3735]) that consisted of audit and feedback, checklists, patient education materials, and linkage to emergency cardiovascular care and quality improvement training.Main Outcomes and Measures: The primary outcome was the composite of all-cause death, reinfarction, stroke, or major bleeding using standardized definitions at 30 days. Secondary outcomes included the primary outcome's individual components, 30-day cardiovascular death, medication use, and tobacco cessation counseling. Mixed-effects logistic regression models were used to account for clustering and temporal trends.Results: Among 21 374 eligible randomized participants (mean age, 60.6 [SD, 12.0] years; n = 16 183 men [76%] ; n = 13 689 [64%] with ST-segment elevation myocardial infarction), 21 079 (99%) completed the trial. The primary composite outcome was observed in 5.3% of the intervention participants and 6.4% of the control participants. The observed difference in 30-day major adverse cardiovascular event rates between the groups was not statistically significant after adjustment (adjusted risk difference, -0.09% [95% CI, -1.32% to 1.14%]; adjusted odds ratio, 0.98 [95% CI, 0.80-1.21]). The intervention group had a higher rate of medication use including reperfusion but no effect on tobacco cessation counseling. There were no unexpected adverse events reported.Conclusions and Relevance: Among patients with acute myocardial infarction in Kerala, India, use of a quality improvement intervention compared with usual care did not decrease a composite of 30-day major adverse cardiovascular events. Further research is needed to understand the lack of efficacy.Trial Registration: clinicaltrials.gov Identifier: NCT02256657. [ABSTRACT FROM AUTHOR]