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A cluster-randomized controlled trial to evaluate the effects of a simplified cardiovascular management program in Tibet, China and Haryana, India: study design and rationale.

ABSTRACT: 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.

SUBMITTER: Ajay VS

PROVIDER: S-EPMC4180354 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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A cluster-randomized controlled trial to evaluate the effects of a simplified cardiovascular management program in Tibet, China and Haryana, India: study design and rationale.

Ajay Vamadevan S VS Tian Maoyi M Chen Hao H Wu Yangfeng Y Li Xian X Dunzhu Danzeng D Ali Mohammed K MK Tandon Nikhil N Krishnan Anand A Prabhakaran Dorairaj D Yan Lijing L LL

BMC public health 20140906

<h4>Background</h4>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 ...[more]

PMID: 25194850

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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:BackgroundThe Cardiovascular Health Awareness Program (CHAP) uses volunteers to provide cardiovascular disease (CVD) and diabetes screening in a community setting, referrals to primary care providers, and locally available programs targeting lifestyle modification. CHAP has been adapted to target older adults residing in social housing, a vulnerable segment of the population. Older adults living in social housing report poorer health status and have a higher burden of a multitude of chronic illnesses, such as CVD and diabetes. The study objective is to evaluate whether there is a reduction in unplanned CVD-related Emergency Department (ED) visits and hospital admissions among residents of social seniors' housing buildings receiving the CHAP program for 1 year compared to residents in matched buildings not receiving the program.Methods/designThis is a pragmatic, cluster randomized controlled trial in community-based social (subsidized) housing buildings in Ontario and Quebec. All residents of 14 matched pairs (intervention/control) of apartment buildings will be included. Buildings with 50-200 apartment units with the majority of residents aged 55+ and a unique postal code are included. All individuals residing within the buildings at the start of the intervention period are included (intention to treat, open cohort). The intervention instrument consists of CHAP screens for high blood pressure using automated blood pressure monitors and for diabetes using the Canadian Diabetes Risk (CANRISK) assessment tool. Monthly drop-in sessions for screening/monitoring are held within a common area of the building. Group health education sessions are also held monthly. Reports are sent to family doctors, and attendees are encouraged to visit their family doctor. The primary outcome measure is monthly CVD-related ED visits and hospitalizations over a 1-year period post randomization. Secondary outcomes are all ED visits, hospitalizations, quality of life, cost-effectiveness, and participant experience.DiscussionIt is anticipated that CVD-related ED visits and hospitalizations will decrease in the intervention buildings. Using the volunteer-led CHAP program, there is significant opportunity to improve the health of older adults in social housing.Trial registrationClinicalTrials.gov,NCT03549845. Registered on 15 May 2018. Updated on 21 May 2019.

Project description:The high-risk strategy has been proven effective in preventing cardiovascular disease; however, the population benefits from these interventions remain unknown. This study aims to assess, at the population level, the effects of an evidence-based high cardiovascular risk management program delivered by village doctors in rural China.The study will employ a cluster-randomized controlled trial in which a total of 120 villages in five northern provinces of China, will be assigned to either intervention (60 villages) or control (60 villages). Village doctors in intervention villages will be trained to implement a simple evidence-based management program designed to identify, treat and follow-up as many as possible individuals at high-risk of cardiovascular disease in the village. The intervention will also include performance feedback as well as a performance-based incentive payment scheme and will last for 2 years. We will draw two different (independent) random samples, before and after the intervention, 20 men aged?50 years and 20 women aged?60 years from each village in each sample and a total of 9,600 participants from 2 samples to measure the study outcomes at the population level. The primary outcome will be the pre-post difference in mean systolic blood pressure, analyzed with a generalized estimating equations extension of linear regression model to account for cluster effect. Secondary outcomes will include monthly clinic visits, provision of lifestyle advice, use of antihypertensive medications and use of aspirin. Process and economic evaluations will also be conducted.This trial will be the first implementation trial in the world to evaluate the population impact of the high-risk strategy in prevention and control of cardiovascular disease. The results are expected to provide important information (effectiveness, cost-effectiveness, feasibility and acceptability) to guide policy making for rural China as well as other resource-limited countries.The trial is registered at ClinicalTrials.gov (NCT01259700). Date of initial registration is December 13, 2010.

Project description:BackgroundPoor child feces management (CFM) is believed to be an important source of exposure to enteric pathogens that contribute to a large disease burden in low-income settings. While access to sanitation facilities is improving, national surveys indicate that even households with latrines often do not safely dispose of their child's feces. Working with caregivers in rural Odisha, India, we co-developed an intervention aimed at improving safe disposal of child feces and encouraging child latrine use at an earlier age. We describe the rationale for the intervention and summarize the protocol for a cluster randomized trial (CRT) to evaluate its effectiveness at changing CFM practices.MethodsThe intervention consists of six behavior change strategies together with hardware provision: wash basin and bucket with lid to aid safe management of soiled nappies and a novel latrine training mat to aid safe disposal and latrine training. The intervention will be offered at the village level to interested caregivers of children < 5 years of age by a community-based organization. Following a baseline survey, 74 villages were randomly allocated to either intervention or control arm. The primary outcome is caregiver reported safe disposal of child feces after last defecation, either by the caregiver disposing of the child's feces into the latrine or the child using the latrine, measured approximately four to six months following intervention delivery. Secondary outcomes include fecal contamination of household drinking water and the childs' hands. A process evaluation will also be conducted to assess intervention fidelity and reach, and explore implementer and participant feedback.DiscussionThis study addresses a crucial knowledge gap in sanitation by developing a scalable intervention to improve safe management of child feces. The behavior change strategies were designed following the Risks, Attitudes, Norms, Abilities and Self-Regulation (RANAS) approach, which has shown to be effective for other environmental behavior change interventions in low-income settings. The latrine training mat hardware is a novel design developed cooperatively and manufactured locally. The evaluation follows a rigorous CRT study design assessing the impact of the intervention on CFM behavior change, as well as fecal contamination of two sources of potential exposure.Trial registrationThis trial is registered at ISRCTN: ISRCTN15831099.

Project description:Understanding the burden and pattern of mental disorders as well as mapping the existing resources for delivery of mental health services in India, has been a felt need over decades. Recognizing this necessity, the Ministry of Health and Family Welfare, Government of India, commissioned the National Mental Health Survey (NMHS) in the year 2014-15. The NMHS aimed to estimate the prevalence and burden of mental health disorders in India and identify current treatment gaps, existing patterns of health-care seeking, service utilization patterns, along with an understanding of the impact and disability due to these disorders. This paper describes the design, steps and the methodology adopted for phase 1 of the NMHS conducted in India. The NMHS phase 1 covered a representative population of 39,532 from 12 states across 6 regions of India, namely, the states of Punjab and Uttar Pradesh (North); Tamil Nadu and Kerala (South); Jharkhand and West Bengal (East); Rajasthan and Gujarat (West); Madhya Pradesh and Chhattisgarh (Central) and Assam and Manipur (North East). The NMHS of India (2015-16) is a unique representative survey which adopted a uniform and standardized methodology which sought to overcome limitations of previous surveys. It employed a multi-stage, stratified, random cluster sampling technique, with random selection of clusters based on Probability Proportionate to Size. It was expected that the findings from the NMHS 2015-16 would reveal the burden of mental disorders, the magnitude of the treatment gap, existing challenges and prevailing barriers in the mental-health delivery systems in the country at a single point in time. It is hoped that the results of NMHS will provide the evidence to strengthen and implement mental health policies and programs in the near future and provide the rationale to enhance investment in mental health care in India. It is also hoped that the NMHS will provide a framework for conducting similar population based surveys on mental health and other public health problems in low and middle-income countries.

Project description:IntroductionThe primary aim of the National Institute of Health Research-funded global health research group, Warwick-India-Canada (WIC), is to reduce the burden of psychotic disorders in India. India has a large pool of undetected and untreated patients with psychosis and a treatment gap exceeding 75%. Evidence-based packages of care have been piloted, but delivery of treatments still remains a challenge. Even when patients access treatment, there is minimal to no continuity of care. The overarching ambition of WIC programme is to improve patient outcomes through (1) developing culturally tailored clinical interventions, (2) early identification and timely treatment of individuals with mental illness and (3) improving access to care by exploiting the potential of digital technologies.Methods and analysisThis multicentre, multicomponent research programme, comprising five work packages and two cross-cutting themes, is being conducted at two sites in India: Schizophrenia Research Foundation, Chennai (South India) and All India Institute of Medical Sciences, New Delhi (North India). WIC will (1) develop and evaluate evidence-informed interventions for early and first-episode psychosis; (2) determine pathways of care for early psychosis; (3) investigate the efficacy and cost-effectiveness of community care models, including digital and mobile technologies; (4) develop strategies to reduce the burden of mental illnesses among youth; (5) assess the economic burden of psychosis on patients and their carers; and (6) determine the feasibility of an early intervention in psychosis programme in India.Ethics and disseminationThis study was approved by the University of Warwick's Biomedical and Scientific Research Ethics Committee (reference: REGO-2018-2208), Coventry, UK and research ethics committees of all participating organisations. Research findings will be disseminated through peer-reviewed scientific publications, presentations at learnt societies and visual media.

Project description:BackgroundOver 75% of the annual estimated 9.5 million deaths in India occur in the home, and the large majority of these do not have a certified cause. India and other developing countries urgently need reliable quantification of the causes of death. They also need better epidemiological evidence about the relevance of physical (such as blood pressure and obesity), behavioral (such as smoking, alcohol, HIV-1 risk taking, and immunization history), and biological (such as blood lipids and gene polymorphisms) measurements to the development of disease in individuals or disease rates in populations. We report here on the rationale, design, and implementation of the world's largest prospective study of the causes and correlates of mortality.Methods and findingsWe will monitor nearly 14 million people in 2.4 million nationally representative Indian households (6.3 million people in 1.1 million households in the 1998-2003 sample frame and 7.6 million people in 1.3 million households in the 2004-2014 sample frame) for vital status and, if dead, the causes of death through a well-validated verbal autopsy (VA) instrument. About 300,000 deaths from 1998-2003 and some 700,000 deaths from 2004-2014 are expected; of these about 850,000 will be coded by two physicians to provide causes of death by gender, age, socioeconomic status, and geographical region. Pilot studies will evaluate the addition of physical and biological measurements, specifically dried blood spots. Preliminary results from over 35,000 deaths suggest that VA can ascertain the leading causes of death, reduce the misclassification of causes, and derive the probable underlying cause of death when it has not been reported. VA yields broad classification of the underlying causes in about 90% of deaths before age 70. In old age, however, the proportion of classifiable deaths is lower. By tracking underlying demographic denominators, the study permits quantification of absolute mortality rates. Household case-control, proportional mortality, and nested case-control methods permit quantification of risk factors.ConclusionsThis study will reliably document not only the underlying cause of child and adult deaths but also key risk factors (behavioral, physical, environmental, and eventually, genetic). It offers a globally replicable model for reliably estimating cause-specific mortality using VA and strengthens India's flagship mortality monitoring system. Despite the misclassification that is still expected, the new cause-of-death data will be substantially better than that available previously.

Dataset Information

A cluster-randomized controlled trial to evaluate the effects of a simplified cardiovascular management program in Tibet, China and Haryana, India: study design and rationale.

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A cluster-randomized controlled trial to evaluate the effects of a simplified cardiovascular management program in Tibet, China and Haryana, India: study design and rationale.

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