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A Cluster-Randomized, Controlled Trial of a Simplified Multifaceted Management Program for Individuals at High Cardiovascular Risk (SimCard Trial) in Rural Tibet, China, and Haryana, India.

ABSTRACT: In rural areas in China and India, the cardiovascular disease burden is high but economic and healthcare resources are limited. This study (the Simplified Cardiovascular Management Study [SimCard]) aims to develop and evaluate a simplified cardiovascular management program delivered by community health workers with the aid of a smartphone-based electronic decision support system.The SimCard study was a yearlong cluster-randomized, controlled trial conducted in 47 villages (27 in China and 20 in India). Recruited for the study were 2086 individuals with high cardiovascular risk (aged ?40 years with self-reported history of coronary heart disease, stroke, diabetes mellitus, and/or measured systolic blood pressure ?160 mm?Hg). Participants in the intervention villages were managed by community health workers through an Android-powered app on a monthly basis focusing on 2 medication use and 2 lifestyle modifications. In comparison with the control group, the intervention group had a 25.5% (P<0.001) higher net increase in the primary outcome of the proportion of patient-reported antihypertensive medication use pre- and post-intervention. There were also significant differences in certain secondary outcomes: aspirin use (net difference: 17.1%; P<0.001) and systolic blood pressure (-2.7 mm?Hg; P=0.04). However, no significant changes were observed in the lifestyle factors. The intervention was culturally tailored, and country-specific results revealed important differences between the regions.The results indicate that the simplified cardiovascular management program improved quality of primary care and clinical outcomes in resource-poor settings in China and India. Larger trials in more places are needed to ascertain the potential impacts on mortality and morbidity outcomes.URL: http://www.clinicaltrials.gov. Unique identifier: NCT01503814.

SUBMITTER: Tian M

PROVIDER: S-EPMC4558306 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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A Cluster-Randomized, Controlled Trial of a Simplified Multifaceted Management Program for Individuals at High Cardiovascular Risk (SimCard Trial) in Rural Tibet, China, and Haryana, India.

Tian Maoyi M Ajay Vamadevan S VS Dunzhu Danzeng D Hameed Safraj S SS Li Xian X Liu Zhong Z Li Cong C Chen Hao H Cho KaWing K Li Ruilai R Zhao Xingshan X Jindal Devraj D Rawal Ishita I Ali Mohammed K MK Peterson Eric D ED Ji Jiachao J Amarchand Ritvik R Krishnan Anand A Tandon Nikhil N Xu Li-Qun LQ Wu Yangfeng Y Prabhakaran Dorairaj D Yan Lijing L LL

Circulation 20150717 9

<h4>Background</h4>In rural areas in China and India, the cardiovascular disease burden is high but economic and healthcare resources are limited. This study (the Simplified Cardiovascular Management Study [SimCard]) aims to develop and evaluate a simplified cardiovascular management program delivered by community health workers with the aid of a smartphone-based electronic decision support system.<h4>Methods and results</h4>The SimCard study was a yearlong cluster-randomized, controlled trial c ...[more]

PMID: 26187183

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Project description:In resource-poor areas of China and India, the cardiovascular disease burden is high, but availability of and access to quality healthcare is limited. Establishing a management scheme that utilizes the local infrastructure and builds healthcare capacity is essential for cardiovascular disease prevention and management. The study aims to develop, implement, and evaluate the feasibility and effectiveness of a simplified, evidence-based cardiovascular management program delivered by community healthcare workers in resource-constrained areas in Tibet, China and Haryana, India.This yearlong cluster-randomized controlled trial will be conducted in 20 villages in Tibet and 20 villages in Haryana. Randomization of villages to usual care or intervention will be stratified by country. High cardiovascular disease risk individuals (aged 40 years or older, history of heart disease, stroke, diabetes, or measured systolic blood pressure of 160 mmHg or higher) will be screened at baseline. Community health workers in the intervention villages will be trained to manage and follow up high-risk patients on a monthly basis following a simplified '2+2' intervention model involving two lifestyle recommendations and the appropriate prescription of two medications. A customized electronic decision support system based on the intervention strategy will be developed to assist the community health workers with patient management. Baseline and follow-up surveys will be conducted in a standardized fashion in all villages. The primary outcome will be the net difference between-group in the proportion of high-risk patients taking antihypertensive medication pre- and post-intervention. Secondary outcomes will include the proportion of patients taking aspirin and changes in blood pressure. Process and economic evaluations will also be conducted.To our knowledge, this will be the first study to evaluate the effect of a simplified management program delivered by community health workers with the help of electronic decision support system on improving the health of high cardiovascular disease risk patients. If effective, this intervention strategy can serve as a model that can be implemented, where applicable, in rural China, India, and other resource-constrained areas.The trial was registered in the clinicaltrials.gov database on 30 December, 2011 and the registration number is NCT01503814.

Project description:BackgroundThe simplified cardiovascular management (SimCard Study) program was a cluster randomized controlled trial conducted in Tibet, China to evaluate a multifaceted intervention consisting of appropriate medication prescriptions and lifestyle recommendations delivered by village doctors. The intervention was effective in improving the management of cardiovascular diseases in resource-limited settings. The aim of this qualitative study was to examine stakeholder feedback and to inform future research and scaling up.MethodA total of 28 face-to-face individual interviews were conducted. The interviews were conducted in 6 out of 14 intervention villages by 2 interviewers who speak the local language. Participants included 18 community members at high risk of CVD, 6 village doctors, 2 local project coordinators, and 2 county officials. Interview guides were used to facilitate the interview covering the focus of perceived usefulness and content of the intervention, fidelity to the intervention, and potential scalability of the intervention. Qualitative interviews were coded using thematic analysis.ResultsThe average age of the participants was 41 years and 70% were female. Our findings showed that the intervention was delivered according to the protocol and was described as a useful program for CVD management by both high-risk individuals and village doctors. However, lack of knowledge among high-risk individuals, insufficient availability of healthcare providers, inadequate financial incentive, and incomplete infrastructure such as difficulty in transportation and cell phone signal were identified as the main barriers to successful implementation and scale-up.ConclusionThe intervention was implemented in line with the protocol and provided substantial benefits for relevant community members and health professionals. However, multiple health system barriers need to be addressed for successful scale-up in rural China.Trial registrationUnique identifier: NCT01503814 . Registered 11 December 2011.

Project description:BackgroundLow birth weight (LBW) infants constitute a vulnerable subset of infants with impaired immunity in early life. In India, there is scarcity of studies that focus on immunization practices in such infants. This analysis aimed to examine immunization practices in LBW infants with the intention to identify areas requiring intervention.MethodsData on immunization status of LBW infants enrolled in an individually randomized, double-masked, placebo-controlled trial of neonatal vitamin A supplementation were analysed. Study outcomes were full immunization by one year of age and delayed vaccination with DPT1 and DPT3. Multivariable logistic regression was performed to identify factors associated with the outcome(s).FindingsOut of 10 644 LBW infants enrolled in trial, immunization data were available for 10 517 (98.8%). Less than one-third (29.7%) were fully immunized by one year of age. Lowest wealth quintile (adjusted odds ratio (AOR) 0.39, 95% confidence interval (CI) 0.32-0.47), Muslim religion (AOR 0.41, 95% CI 0.35-0.48) and age of mother <20 years (AOR 0.62, 95% CI 0.52-0.73) were associated with decreased odds of full immunization. Proportion of infants with delayed vaccination for DPT1 and DPT3 were 52% and 81% respectively. Lowest wealth quintiles (AOR 1.51, 95% CI 1.25-1.82), Muslim religion (AOR 1.41, 95% CI 1.21-1.65), mother aged <20 years (AOR 1.31, 95% CI 1.11-1.53) and birth weight <2000 g (AOR 1.20, 95% CI 1.03-1.40) were associated with higher odds of delayed vaccination for DPT-1. Maternal education (≥12 years of schooling) was associated with high odds of full immunization (AOR 2.39, 95% CI 1.97-2.91) and low odds of delayed vaccination for both DPT-1 (AOR 0.59, 95% CI 0.49-0.73) and DPT-3 (AOR 0.57, 95% CI 0.43-0.76).ConclusionIn this population, LBW infants are at a risk of delayed and incomplete immunization and therefore need attention. The risks are even higher in identified subgroups that should specifically be targeted.

Project description:BackgroundIn many low income countries, the majority of acutely malnourished children are either brought to the health facility late or never at all due to reasons related to distance and associated costs. Integrated community case management (iCCM) is an integrated approach addressing disease and malnutrition through use of community health volunteers (CHVs) in children under-5 years. Evidence on the potential impact and practical experiences on integrating community-based management of acute malnutrition as part of an iCCM package is not well documented. In this study, we aim to investigate the effectiveness and cost effectiveness of integrating management of acute malnutrition into iCCM.MethodsThis is a two arm parallel groups, non-inferiority cluster randomized community trial (CRT) employing mixed methods approach (both qualitative and quantitative approaches). Baseline and end line data will be collected from eligible (malnourished) mother/caregiver-child dyads. Ten community units (CUs) with a cluster size of 24 study subjects will be randomized to either an intervention (5 CUs) and a control arm (5 CUs). CHV in the control arm, will only screening and refer MAM/SAM cases to the nearby health facility for treatment by healthcare professionals. In the intervention arm, however; CHVs will be trained both to screen/diagnose and also treat moderate acute malnutrition (MAM) and severe acute malnutrition (SAM) without complication. A paired-matching design where each control group will be matched with intervention group with similar characteristics will be matched to ensure balance between the two groups with respect to baseline characteristics. Qualitative data will be collected using key informant and in-depth interviews (KIIs) and focused group discussions (FGDs) to capture the views and experiences of stakeholders.DiscussionOur proposed intervention is based on an innovative approach of integrating and simplifying SAM and MAM management through CHWs bring the services closer to the community. The trial has received ethical approval from the Ethics Committee of AMREF Health Africa - Ethical and Scientific Review Committee (AMREF- ESRC), Nairobi, Kenya. The results will be disseminated through workshops, policy briefs, peer-reviewed publications, and presented to local and international conferences.Trial registrationPACTR201811870943127 ; Pre-results. 26 November 2018.

Project description:Background: There is increasing programming and research on male engagement and gender-equity (GE) counselling in family planning (FP) services. However, there is a lack of data on healthcare provider's perspectives on delivering these interventions. The objective of the paper is to present providers' perspectives on delivering a GE-focused FP intervention, CHARM, to married couples in rural India. Methods: In-depth interviews were carried out with 22 male village health care providers who were delivering a GE-focused FP intervention, CHARM, to 428 husbands (247 couples) rural Maharashtra, India. Providers were interviewed on their experiences and perspectives during delivery of CHARM. Major domains were identified during a thematic analysis. Results: Local male health providers are interested and can be engaged in delivering a GE-focused FP intervention. Providers believed that the CHARM intervention improves couples' communication, contraceptive use and strengthened their own capacity to provide FP services in accordance with national FP programmatic efforts. Providers found the low-tech flipchart including pictures and information helpful in supporting their service provision. Providers reported some challenges including lack of privacy and space for counselling, limited access to contraceptive options beyond pill and condom, numerous myths and misconceptions about contraceptives. Providers also reported persistent social norms related to expectancy of pregnancy early in marriage, and son preference. Conclusions: Providers in rural areas with high fertility and related maternal health complications are interested in and can successfully implement a GE-focused FP intervention. Future efforts using this approach may benefit from greater focus to support broader array of spacing contraceptives particularly among first time parents, none or one child parents. There is a need to better support engagement of wives possibly through female provider led sessions parallel to male programs, i.e. gender synchronized rather than couples' sessions. Trial registration: ClinicalTrials.gov NCT01593943, May 8, 2012.

Project description:BACKGROUND:Paediatric vaccination against influenza can result in indirect protection, by reducing transmission to their unvaccinated contacts. We investigated whether influenza vaccination of children would protect them and their household members in a resource-limited setting. METHODS:We did a cluster-randomised, blinded, controlled study in three villages in India. Clusters were defined as households (ie, dwellings that shared a courtyard), and children aged 6 months to 10 years were eligible for vaccination as and when they became age-eligible throughout the study. Households were randomly assigned (1:1) by a computer-based system to intramuscular trivalent inactivated influenza vaccine (IIV3) or a control of inactivated poliovirus vaccine (IPV) in the beginning of the study; vaccination occurred once a year for 3 years. The primary efficacy outcome was laboratory-confirmed influenza in a vaccinated child with febrile acute respiratory illness, analysed in the modified intention-to-treat population (ie, children who received at least one dose of vaccine, were under surveillance, and had not an influenza infection within 15 days of last vaccine dose). The secondary outcome for indirect effectiveness (surveillance study) was febrile acute respiratory illness in an unvaccinated household member of a vaccine study participant. Data from each year (year 1: November, 2009, to October, 2010; year 2: October, 2010, to October, 2011; and year 3: October, 2011, to May, 2012) were analysed separately. Safety was analysed among all participants who were vaccinated with at least one dose of the vaccine. This trial is registered with ClinicalTrials.gov, number NCT00934245. FINDINGS:Between Nov 1, 2009, to May 1, 2012, we enrolled 3208 households, of which 1959 had vaccine-eligible children. 1010 households were assigned to IIV3 and 949 households were assigned to IPV. In 3 years, we vaccinated 4345 children (2132 with IIV3 and 2213 with IPV) from 1868 households (968 with IIV3 and 900 with IPV) with 10?813 unvaccinated household contacts. In year 1, influenza virus was detected in 151 (10%) of 1572 IIV3 recipients and 206 (13%) of 1633 of IPV recipients (total IIV3 vaccine efficacy 25·6% [95% CI 6·8-40·6]; p=0·010). In year 2, 105 (6%) of 1705 IIV3 recipients and 182 (10%) of 1814 IPV recipients had influenza (vaccine efficacy 41·0% [24·1-54·1]; p<0·0001). In year 3, 20 (1%) of 1670 IIV3 recipients and 81 (5%) of 1786 IPV recipients had influenza (vaccine efficacy 74·2% [57·8-84·3]; p<0·0001). In year 1, total vaccine efficacy against influenza A(H1N1)pdm09 was 14·5% (-20·4 to 39·3). In year 2, total vaccine efficacy against influenza A(H3N2) was 64·5% (48·5-75·5). Total vaccine efficacy against influenza B was 32·5% (11·3-48·6) in year 1, 4·9% (-38·9 to 34·9) in year 2, and 76·5% (59·4-86·4) in year 3. Indirect vaccine effectiveness was statistically significant only in year 3 (38·1% [7·4-58·6], p=0·0197) when influenza was detected in 39 (1%) of 4323 IIV3-allocated and 60 (1%) of 4121 IPV-allocated household unvaccinated individuals. In the IIV3 group, 225 (12%) of 1632 children in year 1, 375 (22%) of 1718 in year 2, and 209 (12%) of 1673 in year 3 had an adverse reaction (compared with 216 [13%] of 1730, 380 [21%] of 1825, and 235 [13%] of 1796, respectively, in the IPV group). The most common reactions in both groups were fever and tenderness at site. No vaccine-related deaths occurred in either group. INTERPRETATION:IIV3 provided variable direct and indirect protection against influenza infection. Indirect protection was significant during the year of highest direct protection and should be considered when quantifying the effect of vaccination programmes. FUNDING:US Centers for Disease Control and Prevention.

Project description:BACKGROUND:New methods are required to manage hypertension in resource-poor settings. We hypothesised that a community health worker (CHW)-led group-based education and monitoring intervention would improve control of blood pressure (BP). METHODS AND FINDINGS:We conducted a baseline community-based survey followed by a cluster randomised controlled trial of people with hypertension in 3 rural regions of South India, each at differing stages of epidemiological transition. Participants with hypertension, defined as BP ≥ 140/90 mm Hg or taking antihypertensive medication, were advised to visit a doctor. In each region, villages were randomly assigned to intervention or usual care (UC) in a 1:2 ratio. In intervention clusters, trained CHWs delivered a group-based intervention to people with hypertension. The program, conducted fortnightly for 3 months, included monitoring of BP, education about hypertension, and support for healthy lifestyle change. Outcomes were assessed approximately 2 months after completion of the intervention. The primary outcome was control of BP (BP < 140/90 mm Hg), analysed using mixed effects regression, clustered by village within region and adjusted for baseline control of hypertension (using intention-to-treat principles). Of 2,382 potentially eligible people, 637 from 5 intervention clusters and 1,097 from 10 UC clusters were recruited between November 2015 and April 2016, with follow-up occurring in 459 in the intervention group and 1,012 in UC. Mean age was 56.9 years (SD 13.7). Baseline BP was similar between groups. Control of BP improved from baseline to follow-up more in the intervention group (from 227 [49.5%] to 320 [69.7%] individuals) than in the UC group (from 528 [52.2%] to 624 [61.7%] individuals) (odds ratio [OR] 1.6, 95% CI 1.2-2.1; P = 0.001). In secondary outcome analyses, there was a greater decline in systolic BP in the intervention than UC group (-5.0 mm Hg, 95% CI -7.1 to -3.0; P < 0.001) and a greater decline in diastolic BP (-2.1 mm Hg, 95% CI -3.6 to -0.6; P < 0.006), but no detectable difference in the use of BP-lowering medications between groups (OR 1.2, 95% CI 0.8-1.9; P = 0.34). Similar results were found when using imputation analyses that included those lost to follow-up. Limitations include a relatively short follow-up period and use of outcome assessors who were not blinded to the group allocation. CONCLUSIONS:While the durability of the effect is uncertain, this trial provides evidence that a low-cost program using CHWs to deliver an education and monitoring intervention is effective in controlling BP and is potentially scalable in resource-poor settings globally. TRIAL REGISTRATION:The trial was registered with the Clinical Trials Registry-India (CTRI/2016/02/006678).

Dataset Information

A Cluster-Randomized, Controlled Trial of a Simplified Multifaceted Management Program for Individuals at High Cardiovascular Risk (SimCard Trial) in Rural Tibet, China, and Haryana, India.

Publications

A Cluster-Randomized, Controlled Trial of a Simplified Multifaceted Management Program for Individuals at High Cardiovascular Risk (SimCard Trial) in Rural Tibet, China, and Haryana, India.

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