Mental Health Care Support in Rural India: A Cluster Randomized Clinical Trial.

Importance: More than 150 million people in India need mental health care but few have access to affordable care, especially in rural areas. Objective: To determine whether a multifaceted intervention involving a digital health care model along with a community-based antistigma campaign leads to reduced depression risk and lower mental health-related stigma among adults residing in rural India. Design, Setting, and Participants: This parallel, cluster randomized, usual care-controlled trial was conducted from September 2020 to December 2021 with blinded follow-up assessments at 3, 6, and 12 months at 44 rural primary health centers across 3 districts in Haryana and Andhra Pradesh states in India. Adults aged 18 years and older at high risk of depression or self-harm defined by either a Patient Health Questionnaire-9 item (PHQ-9) score of 10 or greater, a Generalized Anxiety Disorder-7 item (GAD-7) score of 10 or greater, or a score of 2 or greater on the self-harm/suicide risk question on the PHQ-9. A second cohort of adults not at high risk were selected randomly from the remaining screened population. Data were cleaned and analyzed from April 2022 to February 2023. Interventions: The 12-month intervention included a community-based antistigma campaign involving all participants and a digital mental health intervention involving only participants at high risk. Primary health care workers were trained to identify and manage participants at high risk using the Mental Health Gap Action Programme guidelines from the World Health Organization. Main Outcomes and Measures: The 2 coprimary outcomes assessed at 12 months were mean PHQ-9 scores in the high-risk cohort and mean behavior scores in the combined high-risk and non-high-risk cohorts using the Mental Health Knowledge, Attitude, and Behavior scale. Results: Altogether, 9928 participants were recruited (3365 at high risk and 6563 not at high risk; 5638 [57%] female and 4290 [43%] male; mean [SD] age, 43 [16] years) with 9057 (91.2%) followed up at 12 months. Mean PHQ-9 scores at 12 months for the high-risk cohort were lower in the intervention vs control groups (2.77 vs 4.48; mean difference, -1.71; 95% CI, -2.53 to -0.89; P < .001). The remission rate in the high-risk cohort (PHQ-9 and GAD-7 scores <5 and no risk of self-harm) was higher in the intervention vs control group (74.7% vs 50.6%; odds ratio [OR], 2.88; 95% CI, 1.53 to 5.42; P = .001). Across both cohorts, there was no difference in 12-month behavior scores in the intervention vs control group (17.39 vs 17.74; mean difference, -0.35; 95% CI, -1.11 to 0.41; P = .36). Conclusions and Relevance: A multifaceted intervention was effective in reducing depression risk but did not improve intended help-seeking behaviors for mental illness. Trial Registration: Clinical Trial Registry India: CTRI/2018/08/015355.

Rationale, Design, and Intervention Development of a Mobile Health-Led Primary Care Program for Management of Type 2 Diabetes in Rural Thailand: Protocol for a SMARThealth Diabetes Study.

BACKGROUND: Noncommunicable diseases (NCDs), particularly diabetes and chronic kidney diseases, pose a significant health burden in Thailand, especially among socioeconomically disadvantaged populations. The existing primary health care system faces challenges in providing optimal care for NCDs due to inadequate primary care workforce. The SMARThealth program offers a technology-based solution to enhance NCD management through task-sharing among nonphysician health care workers. OBJECTIVE: This study aims to adapt and implement the SMARThealth Diabetes program in rural Thailand to improve diabetes management. The main objectives are to (1) adapt, validate, and integrate the SMARThealth Diabetes program for improving the management of type 2 diabetes mellitus at the primary health care level; and (2) to determine the feasibility and acceptability of the SMARThealth Diabetes program in rural communities of Thailand. METHODS: A pragmatic, type 2 hybrid effectiveness or implementation, parallel-group cluster randomized controlled trial of 12 months duration and involving 51 subdistrict health offices in rural communities of Kamphaeng Phet province, Thailand, will be conducted. The intervention arm will receive the SMARThealth Diabetes program, including workforce restructuring, clinical decision support system, and continuous performance monitoring, while the control arm will continue with usual practice. Data will be collected using the SMARThealth platform and will be stored on a server in Thailand. The primary outcome measure will be the change in mean hemoglobin A1c (HbA1c) measured at randomization and 12 months from randomization between the intervention and control clusters. Secondary outcomes will include the difference in change in albuminuria status, estimated glomerular filtration rate, systolic blood pressure, and low-density lipoprotein cholesterol level. The analysis for change in HbA1c between baseline and end of study will be performed using linear mixed models. Any imbalances between the 2 arms will be addressed by sensitivity analyses. Additionally, a mixed methods process evaluation will be conducted to assess the implementation process, that will include in-depth interviews and focus group discussions, in addition to the quantitative data collected during the implementation process. The qualitative data will be thematically analyzed to explore factors that promote or inhibit the implementation and maintenance of the program. RESULTS: The data collection commenced in November 2022, and the results will be ready for publication by the first quarter of 2025. Effectiveness of the intervention package will be assessed by change in mean HbA1c measures, and detailed feasibility, barriers, and enablers for the implementation of the intervention will be documented through a detailed process evaluation. CONCLUSIONS: The study protocol outlines a novel approach to enhancing diabetes management in rural Thailand through digital technology-based interventions that will facilitate task-sharing among health care workers. This can help inform future strategies for improving NCD care in low-resource settings globally. TRIAL REGISTRATION: Thai Clinical Trials Registry TCTR20200322006; https://www.thaiclinicaltrials.org/show/TCTR20200322006. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/59266.

deliVERy of Optimal blood pressure coNtrol in afrICA (VERONICA)-Nigeria study: Rationale and Design of a Randomised Clinical Trial.

BACKGROUND: Blood pressure (BP) control among treated patients in Africa is very suboptimal, with low levels of combination therapy use and therapeutic inertia being among the major barriers to effective control of hypertension. The VERONICA-Nigeria study aims to evaluate, among Black African adults with hypertension, the effectiveness and safety of a triple pill-based treatment protocol compared to Nigeria hypertension treatment protocol for the treatment of hypertension. METHODS: This study involves a randomised, parallel-group and open-label trial. Adults with uncontrolled hypertension (n=300), untreated or receiving monotherapy, with no contraindication to study treatments will be randomly assigned 1:1 to treatment with a triple pill based-treatment protocol or Nigeria hypertension treatment protocol. Follow-up is for 6 months, with interim follow up visits at month 1, 2, and 3. In a non-comparative extension treatment period, participants completing the 6 months randomised period and on ≤3 BP-lowering drugs will receive treatment with the triple pill-based treatment protocol for 12 months. The primary outcome is change in home mean SBP from baseline to month 6, and key secondary efficacy outcome is percentage of participants with clinic BP <140/90 mmHg at month 6. The primary safety outcome is discontinuation of trial treatment due to adverse events from randomization to month 6. Economic evaluation will be conducted to assess the cost-effectiveness of the triple pill-based treatment protocol, and process evaluation will be conducted to understand the context in which the trial was conducted, implementation of the trial and interventions and mechanisms of effect, and potential barriers and facilitators to implementing the intervention in clinical practice. CONCLUSION: The VERONICA-Nigeria trial will provide evidence of effectiveness and safety of the triple-based treatment protocol for the pharmacological management of hypertension, in Black African adults. TRIAL REGISTRATION: PACTR202107579572114.

The Chinese version of patient experience with treatment and self-management (PETS vs. 2.0): translation and validation in patients with multimorbidity in primary care in Hong Kong.

BACKGROUND: Validated and comprehensive tools to measure treatment burden are needed for healthcare professionals to understand the treatment burden of patients in China. The study aimed to translate and validate the Chinese version of Patient Experience with Treatment and Self-management (PETS vs. 2.0) in patients with multimorbidity in primary care. METHODOLOGY: The translation process of the 60-item PETS vs. 2.0 followed the Functional Assessment of Chronic Illness Therapy (FACIT) Translation, Formatting, and Testing Guidelines. Computer-assisted assessments were conducted in adult primary care patients with multimorbidity from three general out-patient clinics in Hong Kong. A sample of 502 patients completed the assessments from July to December 2023. Internal reliability was examined using Cronbach's alphas for each domain of the PETS vs. 2.0. Concurrent validity was assessed through the correlations between different domains of PETS vs. 2.0 with established measures including quality of life, frailty, and depression. Confirmatory Factor Analysis (CFA) with maximum likelihood method was carried out to assess the construct validity. RESULTS: The mean age of participants was 64.9 years old and 56.2% were female. Internal consistency reliability was acceptable (alpha ≥ 0.70) for most domains. Higher scores of PETS domains were significantly correlated with worse quality of life, higher level of frailty, and more depressive symptoms (p < 0.05). In CFA, after setting the covariances on the error variances, the adjusted model revealed an acceptable model fit (χ2/df = 1.741; root mean square error of approximation (RMSEA) = 0.038; standardized root mean square residual (SRMR) = 0.058; comparative fit index (CFI) = 0.911; Tucker-Lewis Index (TLI) = 0.903). All standardized factor loadings were 0.30 or above. Significant positive correlations between the latent factors were found for all factor pairs (correlation coefficient < 0.8). CONCLUSIONS: The Chinese version of PETS vs. 2.0 is a reliable and valid tool for assessing the perceived treatment burden in patients with multimorbidity in primary care. All domains and items in the original questionnaires were retained.

Colchicine to reduce coronavirus disease-19-related inflammation and cardiovascular complications in high-risk patients post-acute infection with SARS-COV-2-a study protocol for a randomized controlled trial.

BACKGROUND: There is no known effective pharmacological therapy for long COVID, which is characterized by wide-ranging, multisystemic, fluctuating, or relapsing symptoms in a large proportion of survivors of acute COVID. This randomized controlled trial aims to assess the safety and efficacy of an anti-inflammatory agent colchicine, to reduce symptoms among those at high risk of developing long COVID. METHODS: This multi-centre, parallel arm, 1:1 individual randomized, placebo-controlled, double-blind superiority trial will enrol 350 individuals with persistent post-COVID symptoms. Participants will be randomized to either colchicine 0.5 mg once daily (< 70 kg) or twice daily (≥ 70 kg) or matched placebo for 26 weeks and will be followed up until 52 weeks after randomization. The primary trial objective is to demonstrate the superiority of colchicine over a placebo in improving distance walked in 6 min at 52 weeks from baseline. The secondary objectives are to assess the efficacy of colchicine compared to placebo with respect to lung function, inflammatory markers, constitutional symptoms, and mental health state. In a sub-sample of 100 participants, cardiac biomarkers of myocardial injury and myocardial oedema using MRI will be compared. DISCUSSION: Persistent inflammatory response following SARS-CoV-19 is one of the postulated pathophysiological mechanisms of long COVID. Colchicine, a low-cost anti-inflammatory agent, acts via multiple inflammatory pathways and has an established safety profile. This trial will generate evidence for an important health priority that can rapidly translate into practice. TRIAL REGISTRATION: This clinical trial has been registered prospectively on www. CLINICALTRIALS: gov with registration CTRI/2021/11/038234 dated November 24, 2021.

The association of hypertension among married Indian couples: a nationally representative cross-sectional study.

Mounting evidence demonstrates that intimate partners sharing risk factors have similar propensities for chronic conditions such as hypertension. The objective was to study whether spousal hypertension was associated with one's own hypertension status independent of known risk factors, and stratified by socio-demographic subgroups (age, sex, wealth quintile, caste endogamy). Data were from heterosexual married couples (n = 50,023, women: 18-49 years, men: 21-54 years) who participated in the National Family Health Survey-V (2019-2021). Hypertension was defined as self-reported diagnosis of hypertension or average of three blood pressure measurements ≥ 140 systolic or 90 mmHg diastolic BP. Among married adults, the prevalence of hypertension among men (38.8 years [SD 8.3]) and women (33.9 years [SD 7.9]) were 29.1% [95% CI 28.5-29.8] and 20.6% [95% CI 20.0-21.1] respectively. The prevalence of hypertension among both partners was 8.4% [95% CI 8.0-8.8]. Women and men were more likely to have hypertension if their spouses had the condition (husband with hypertension: PR 1.37 [95% CI 1.30-1.44]; wife with hypertension: PR 1.32 [95% CI 1.26-1.38]), after adjusting for known risk factors. Spouse's hypertension status was consistently associated with own status across all socio-demographic subgroups examined. These findings present opportunities to consider married couples as a unit in efforts to diagnose and treat hypertension.

An insight into the prokaryotic diversity from a polymetallic nodule-rich region in the Central Indian Ocean Basin using next generation sequencing approach.

Deep sea is a vast, dark, and difficult-to-access terrain and is now looked upon as a unique niche harboring diverse microorganism. We used a metataxonomic approach to decipher the microbial diversity present in the water column (surface to near bottom), water overlaying the sediments, and the deep-sea sediments (up to 35 cm) from the Indian Contract Region (ICR) in the Central Indian Ocean Basin (CIOB). Samples were collected from #IRZ (Impact Reference Zone), #PRZ (Potential Reference Zone), and #BC20 (Control site, outside potential mining area) with an average water depth of 5,200 m. 16S rRNA (V3-V4 region) amplicon sequencing on the MiSeq platform resulted in 942,851 ASVs across 65 water and sediment samples. Higher prokaryotic diversity was observed below 200 m in the water column to the seafloor. Proteobacteria was the most dominant bacterial phylum among all the water samples while Firmicutes, Actinobacteria and, Bacteroidota dominated the sediments. Sediment (below 10 cm) was co-dominated by Firmicutes. Thermoplasmata was the dominant archaeal group in the water column while Crenarchaeota was in the sediments. BC20 was less diverse than IRZ and PRZ. Deep Sea microorganisms could play a vital role in the mineralization processes, nutrient cycling, and also different biogeochemical cycles.

Centre-level variation in the survival of patients receiving haemodialysis in India: findings from a nationwide private haemodialysis network.

Background: There are no large studies examining survival in patients receiving haemodialysis in India or considering centre-level effects on survival. We measured survival variation between dialysis centres across India and evaluated the extent to which differences are explained by measured centre characteristics. Methods: This is a multilevel analysis of patient survival in centres of the NephroPlus dialysis network consisting of 193 centres across India. Patients receiving haemodialysis at a centre for ≥90 days between April 2014 and June 2019 were included, with analyses restricted to centres with ≥10 such patients. The primary outcome was all-cause mortality, measured from 90 days after joining a centre. Proportional hazards models with shared frailty were used to model centre- and patient-level effects on survival. Findings: Amongst 23,601 patients (median age 53 years; 29% female), the unadjusted centre-specific 180-day Kaplan-Meier survival estimates ranged between 55% (95% confidence interval [CI] 38-80%) and 100%, with a median of 88% (interquartile interval 83%-92%). After accounting for multilevel factors, estimated 180-day survival ranged between 83% (73-89%) and 97% (95-98%), with 90% 180-day survival in the average centre. The mortality rate in patients attending rural centres was 32% (Hazard Ratio 1.32; 95% CI 1.06-1.65) higher than those at urban centres in adjusted analyses. Multiple patient characteristics were associated with mortality. Interpretation: This is the first national benchmark for survival amongst dialysis patients in India. Centre- and patient-level characteristics are associated with survival but there remains unexplained variation between centres. As India continues to widen dialysis access, ongoing quality improvement programs will be an important part of ensuring that patients experience the best possible outcomes at the point of care. Funding: This project received no external funding.

The association of hypertension among married Indian couples: a nationally representative cross-sectional study.

Mounting evidence demonstrates that intimate partners sharing risk factors have similar propensities for chronic conditions such as hypertension. The objective was to study whether spousal hypertension was associated with one's own hypertension status independent of known risk factors, and stratified by socio-demographic subgroups (age, sex, wealth quintile, caste endogamy). Data were from heterosexual married couples (n = 50,023, women: 18-49y, men: 21-54y) who participated in the National Family Health Survey-V (2019-21). Hypertension was defined as self-reported diagnosis of hypertension or average of three blood pressure measurements ≥ 140 systolic or 90 mmHg diastolic BP. Among married adults, the prevalence of hypertension among men (38.8 years [SD: 8.3]) and women (33.9 years [SD: 7.9]) were 29.1% [95%CI: 28.5-29.8] and 20.6% [95%CI: 20.0-21.1] respectively. The prevalence of hypertension among both partners was 8.4% [95%CI: 8.0-8.8]. Women and men were more likely to have hypertension if their spouses had the condition (husband with hypertension: PR = 1.37 [95%CI: 1.30-1.44]; wife with hypertension: PR = 1.32 [95%CI: 1.26-1.38]), after adjusting for known risk factors. Spouse's hypertension status was consistently associated with own status across all socio-demographic subgroups examined. These findings present opportunities to consider married couples as a unit in efforts to diagnose and treat hypertension.