Dataset Information

Cardiovascular risk factor reduction by community health workers in rural India: A cluster randomized trial.

ABSTRACT:

Background

There is a need to identify and test low-cost approaches for cardiovascular disease (CVD) risk reduction that can enable health systems to achieve such a strategy.

Objective

Community health workers (CHWs) are an integral part of health-care delivery system in lower income countries. Our aim was to assess impact of CHW based interventions in reducing CVD risk factors in rural households in India.

Methods

We performed an open-label cluster-randomized trial in 28 villages in 3 states of India with the household as a unit of randomization. Households with individuals at intermediate to high CVD risk were randomized to intervention and control groups. In the intervention group, trained CHWs delivered risk-reduction advice and monitored risk factors during 6 household visits over 12 months. Households in the non-intervention group received usual care. Primary outcomes were a reduction in systolic BP (SBP) and adherence to prescribed BP lowering drugs.

Results

We randomized 2312 households (3261 participants at intermediate or high risk) to intervention (1172 households) and control (1140 households). At baseline prevalence of tobacco use (48.5%) and hypertension (34.7%) were high. At 12 months, there was significant decline in SBP (mmHg) from baseline in both groups- controls 130.3 ± 21 to 128.3 ± 15; intervention 130.3 ± 21 to 127.6 ± 15 (P < .01 for before and after comparison) but there was no difference between the 2 groups at 12 months (P = .18). Adherence to antihypertensive drugs was greater in intervention vs control households (74.9% vs 61.4%, P = .001).

Conclusion

A 12-month CHW-led intervention at household level improved adherence to prescribed drugs, but did not impact SBP. To be more impactful, a more comprehensive solution that addresses escalation and access to useful therapies is needed.

SUBMITTER: Joshi R

PROVIDER: S-EPMC6842688 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Publications

Cardiovascular risk factor reduction by community health workers in rural India: A cluster randomized trial.

Joshi Rajnish R Agrawal Twinkle T Fathima Farah F Usha Thammattoor T Thomas Tinku T Misquith Dominic D Kalantri Shriprakash S Chidambaram Natesan N Raj Tony T Singamani Alben A Hegde Shailendra S Xavier Denis D Devereaux P J PJ Pais Prem P Gupta Rajeev R Yusuf Salim S

American heart journal 20190619

<h4>Background</h4>There is a need to identify and test low-cost approaches for cardiovascular disease (CVD) risk reduction that can enable health systems to achieve such a strategy.<h4>Objective</h4>Community health workers (CHWs) are an integral part of health-care delivery system in lower income countries. Our aim was to assess impact of CHW based interventions in reducing CVD risk factors in rural households in India.<h4>Methods</h4>We performed an open-label cluster-randomized trial in 28 v ...[more]

PMID: 31377568

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Project description:BackgroundEighty percent of premature mortality from cardiovascular disease occurs in low- and middle-income countries. Hypertension, diabetes, and smoking are the top risk factors causing this disease burden.ObjectivesThe study aimed to test the hypothesis that utilizing community health workers (CHWs) to manage hypertension, diabetes and smoking in an integrated manner would lead to improved control of these conditions.MethodsThis was a 2-year cluster (n = 12) randomized controlled trial of 3,556 adults (35 to 70 years of age) in a single town in India, who were screened at home for hypertension, diabetes, and smoking. Of these adults, 1,242 (35%) had at least 1 risk factor (hypertension = 650, diabetes = 317, smoking = 500) and were enrolled in the study. The intervention group had behavioral change communication through regular home visits from community health workers. The control group received usual care in the community. The primary outcomes were changes in systolic blood pressure, fasting blood glucose, and average number of cigarettes/bidis smoked daily among individuals with respective risk factors.ResultsThe mean ± SD change in systolic blood pressure at 2 years was -12.2 ± 19.5 mm Hg in the intervention group as compared with -6.4 ± 26.1 mm Hg in the control group, resulting in an adjusted difference of -8.9 mm Hg (95% confidence interval [CI]: -3.5 to -14.4 mm Hg; p = 0.001). The change in fasting blood glucose was -43.0 ± 83.5 mg/dl in the intervention group and -16.3 ± 77.2 mg/dl in the control group, leading to an adjusted difference of -21.3 mg/dl (95% CI: 18.4 to -61 mg/dl; p = 0.29). The change in mean number of cigarettes/bidis smoked was nonsignificant at +0.2 cigarettes/bidis (95% CI: 5.6 to -5.2 cigarettes/bidis; p = 0.93).ConclusionsA population-based strategy of integrated risk factor management through community health workers led to improved systolic blood pressure in hypertension, an inconclusive effect on fasting blood glucose in diabetes, and no demonstrable effect on smoking. (Study of a Community-Based Approach to Control Cardiovascular Risk Factors in India [SEHAT]; NCT02115711).

Project description:TRIAL DESIGN:With the rise in prevalence of non-communicable diseases in India and Kerala in particular, efforts to develop lifestyle interventions have increased. However, contextualised interventions are limited. We developed and implemented contextualised behavioural intervention strategies focusing on household dietary behaviours in selected rural areas in Kerala and conducted a community-based pragmatic cluster randomized controlled trial to assess its effectiveness to increase the intake of fruits and vegetables at individual level, and the procurement of fruits and vegetables at the household level and reduce the consumption of salt, sugar and oil at the household level. METHODS:Six out of 22 administrative units in the northern part of Thiruvananthapuram district of Kerala state were selected as geographic boundaries and randomized to either intervention or control arms. Stratified sampling was carried out and 30 clusters comprising 6-11 households were selected in each arm. A cluster was defined as a neighbourhood group functioning in rural areas under a state-sponsored community-based network (Kudumbasree). We screened 1237 households and recruited 479 (intervention: 240; control: 239) households and individuals (male or female aged 25-45 years) across the 60 clusters. 471 households and individuals completed the intervention and end-line survey and one was excluded due to pregnancy. Interventions were delivered for a period of one-year at household level at 0, 6, and 12 months, including counselling sessions, telephonic reminders, home visits and general awareness sessions through the respective neighbourhood groups in the intervention arm. Households in the control arm received general dietary information leaflets. Data from 478 households (239 in each arm) were included in the intention-to-treat analysis, with the household as the unit of analysis. RESULTS:There was significant, modest increase in fruit intake from baseline in the intervention arm (12.5%); but no significant impact of the intervention on vegetable intake over the control arm. There was a significant increase in vegetable procurement in the intervention arm compared to the control arm with the actual effect size showing an overall increase by19%; 34% of all households in the intervention arm had increased their procurement by at least 20%, compared to 17% in the control arm. Monthly household consumption of salt, sugar and oil was greatly reduced in the intervention arm compared to the control arm with the actual effect sizes showing an overall reduction by 45%, 40% and 48% respectively. CONCLUSIONS:The intervention enabled significant reduction in salt, sugar and oil consumption and improvement in fruit and vegetable procurement at the household level in the intervention arm. However, there was a disconnect between the demonstrated increase in FV procurement and the lack of increase in FV intake. We need to explore fruit and vegetable intake behaviour further to identify strategies or components that would have made a difference. We can take forward the lessons learned from this study to improve our understanding of human dietary behaviour and how that can be changed to improve health within this context.

Project description:BackgroundStroke has emerged as a leading cause of death in rural India. However, well-tested healthcare interventions to reduce stroke mortality in rural under-resourced settings are lacking. The aim of this study is to evaluate the effect of a community-based preventive intervention on stroke mortality in rural Gadchiroli, India.MethodsThe study is a two-arm, parallel group, cluster randomised controlled trial in which 32 villages will be randomised to the intervention and the enhanced usual care (EUC) arm. In the intervention arm, individuals ≥50 years of age will be screened for hypertension, diabetes and stroke by trained Community Health Workers (CHWs). Screened individuals who are positive will be referred to a mobile outreach clinic which will visit the intervention villages periodically. A physician in the clinic will confirm the diagnosis, provide guideline-based treatment and follow up patients. The CHWs will make home visits once a month to ensure medication compliance and counsel patients to reduce salt consumption and quit tobacco and alcohol. In the EUC arm, households will be provided information on the ill effects of tobacco use and steps to quit it. Individuals from both the arms will have access to the government's national programme for the prevention and control of non-communicable diseases, where treatment for hypertension, diabetes and preventive treatment after stroke is available at the nearest primary health centres (PHCs). The intervention will be implemented for 3.5 years. The primary outcome will be a reduction in stroke mortality in the last 2.5 years of the intervention.DiscussionThis trial will provide important information regarding the feasibility and effect of a community-based preventive intervention package on stroke mortality in a rural under-resourced setting and can inform India's non-communicable diseases prevention and control programme. If successful, such an intervention can be scaled up in the rural regions of India and other countries.Trial registrationClinical Trials Registry of India: CTRI/2015/12/006424. Registered on 8 December 2015.

Project description:Inadequate care during early childhood can lead to long-term deficits in skill development. Parenting programs are promising tools for improving parenting practices and opportunities for healthy development. We implemented a non-masked cluster-randomized controlled trial in rural China in order to assess the effectiveness of an integrated home-visitation program that includes both psychosocial stimulation and health promotion at fostering development and health outcomes of infants and toddlers in rural China. All 6-18 month-old children of two rural townships and their main caregiver were enrolled. Villages were stratified by township and randomly assigned to intervention or control. Specifically, in September 2015 we assigned 43 clusters to treatment (21 villages, 222 caregiver-child dyads) or control (22 villages, 227 caregiver-child dyads). In the intervention group, community health workers delivered education and training on how to provide young children with psychosocial stimulation and health care (henceforth psychosocial stimulation and health promotion) during bi-weekly home visits over the period of one year. The control group received no home visits. Primary outcomes include measures of child development (i.e. the Bayley Scales of Infant and Toddler Development, third edition-or Bayley-III) and health (i.e. measures of morbidity, nutrition, and growth). Secondary outcomes are measures of parenting practices. Intention-to-treat (ITT) effects show that the intervention led to an improvement of 0·24 standard deviations (SD) [95% CI 0·04 SD-0·44 SD] in cognitive development and to a reduction of 8·1 [95% CI 3·8-12·4] percentage points in the risk of diarrheal illness. In addition, we find positive effects on parenting practices mirroring these results. We conclude that an integrated psychosocial stimulation and health promotion program improves development and health outcomes of infants and toddlers (6-30 month-old children) in rural China. Because of low incremental costs of adding program components (that is, adding health promotion to psychosocial stimulation programs), integrated programs may be cost-effective.

Project description:BackgroundCommunity health workers (CHWs) can supplement professional medical providers, especially in rural settings where resources are particularly scarce. Yet, outcomes of studies evaluating CHWs effectiveness have been highly variable and lack impact when scaled nationally. This study examines if child and maternal outcomes are better when existing government CHWs, who are perinatal home visitors, receive ongoing enhanced supervision and monitoring, compared to standard care.Methods and findingsA cluster randomized controlled effectiveness trial was conducted comparing outcomes over 2 years when different supervision and support are provided. Primary health clinics were randomized by clinic to receive monitoring and supervision from either (1) existing supervisors (Standard Care (SC); n = 4 clinics, 23 CHWs, 392 mothers); or (2) supervisors from a nongovernmental organization that provided enhanced monitoring and supervision (Accountable Care [AC]; n = 4 clinic areas, 20 CHWs, 423 mothers). Assessments were conducted during pregnancy and at 3, 6, 15, and 24 months post-birth with high retention rates (76% to 86%). The primary outcome was the number of statistically significant intervention effects among 13 outcomes of interest; this approach allowed us to evaluate the intervention holistically while accounting for correlation among the 13 outcomes and considering multiple comparisons. The observed benefits were not statistically significant and did not show the AC's efficacy over the SC. Only the antiretroviral (ARV) adherence effect met the significance threshold established a priori (SC mean 2.3, AC mean 2.9, p < 0.025; 95% CI = [0.157, 1.576]). However, for 11 of the 13 outcomes, we observed an improvement in the AC compared to the SC. While the observed outcomes were not statistically significant, benefits were observed for 4 outcomes: increasing breastfeeding for 6 months, reducing malnutrition, increasing ARV adherence, and improving developmental milestones. The major study limitation was utilizing existing CHWs and being limited to a sample of 8 clinics. There were no major study-related adverse events.ConclusionsSupervision and monitoring were insufficient to improve CHWs' impact on maternal and child outcomes. Alternative strategies for staff recruitment and narrowing the intervention outcomes to the specific local community problems are needed for consistently high impact.Trial registrationClinicaltrials.gov, NCT02957799.

Project description:BackgroundWhile effective lay-health worker models for mental health care have been demonstrated through efficacy trials, there is limited evidence of the effectiveness of these models implemented in rural LMIC settings.AimTo evaluate the impact of a volunteer community-led intervention on reduction in depression and anxiety symptoms and improvement in functioning, and social participation among people living in rural Gujarat, India.MethodsStepped-wedge cluster randomized controlled trial was used to assess the effectiveness of delivery of psychosocial intervention across 645 villages in Mehsana district of Gujarat, India between April 2017 and August 2019. The primary outcome was an improvement in depression and/or anxiety symptoms assessed using GHQ-12 at 3-month follow-up. Secondary outcomes were improvement in (a) depression and anxiety (Patient Health Questionnaire, (PHQ-9), Generalized Anxiety Disorder (GAD-7) & Self-Reporting Questionnaire-20 (SRQ-20); b) quality of life (EQ- 5D); c) functioning (WHO-DAS-12), and social participation (Social Participation Scale SPS). Generalized linear mixed-effects models were used to assess the independent effect of the intervention.ResultsOut of a total of 1191 trial participants (608- intervention & 583-control), 1014 (85%) completed 3-month follow-up. In an adjusted analysis, participants in the intervention condition showed significant recovery from symptoms of depression or anxiety (OR 2.2; 95% CI 1.2 to 4.6; p<0.05) at the end of 3-months, with effects sustained at 8-month follow-up (OR 3.0; 95% CI 1.6 to 5.9). Intervention participants had improved scores on the PHQ-9 (Adjusted mean difference (AMD) -1.8; 95%CI -3.0 to -0.6), and SRQ-20 (AMD -1.7; 95%CI -2.7 to -0.6), at 3-months and PHQ-9, GAD-7, SRQ-20, EQ-5D and WHO-DAS at 8 months follow-up.ConclusionFindings suggest that Atmiyata had a significant effect on recovery from symptoms of depression and anxiety with sustained effects at 8-month follow-up.Trial registrationTrial registration details. The trial was registered prospectively with the "Clinical Trial Registry in India" (registry number: CTRI/2017/03/008139).

Dataset Information

Cardiovascular risk factor reduction by community health workers in rural India: A cluster randomized trial.

Background

Objective

Methods

Results

Conclusion

Publications

Cardiovascular risk factor reduction by community health workers in rural India: A cluster randomized trial.

Similar Datasets

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