Hypertension is the leading cause of cardiovascular disease globally. Despite proven benefits, hypertension control is poor. We hypothesised that a comprehensive approach to lowering blood pressure and other risk factors, informed by detailed analysis of local barriers, would be superior to usual care in individuals with poorly controlled or newly diagnosed hypertension. We tested whether a model of care involving non-physician health workers (NPHWs), primary care physicians, family, and the provision of effective medications, could substantially reduce cardiovascular disease risk.
Methods
HOPE 4 was an open, community-based, cluster-randomised controlled trial involving 1371 individuals with new or poorly controlled hypertension from 30 communities (defined as townships) in Colombia and Malaysia. 16 communities were randomly assigned to control (usual care, n=727), and 14 (n=644) to the intervention. After community screening, the intervention included treatment of cardiovascular disease risk factors by NPHWs using tablet computer-based simplified management algorithms and counselling programmes; free antihypertensive and statin medications recommended by NPHWs but supervised by physicians; and support from a family member or friend (treatment supporter) to improve adherence to medications and healthy behaviours. The primary outcome was the change in Framingham Risk Score 10-year cardiovascular disease risk estimate at 12 months between intervention and control participants. The HOPE 4 trial is registered at ClinicalTrials.gov, NCT01826019.
Findings
All communities completed 12-month follow-up (data on 97% of living participants, n=1299). The reduction in Framingham Risk Score for 10-year cardiovascular disease risk was −6·40% (95% CI 8·00 to −4·80) in the control group and −11·17% (−12·88 to −9·47) in the intervention group, with a difference of change of −4·78% (95% CI −7·11 to −2·44, p<0·0001). There was an absolute 11·45 mm Hg (95% CI −14·94 to −7·97) greater reduction in systolic blood pressure, and a 0·41 mmol/L (95% CI −0·60 to −0·23) reduction in LDL with the intervention group (both p<0·0001). Change in blood pressure control status (<140 mm Hg) was 69% in the intervention group versus 30% in the control group (p<0·0001). There were no safety concerns with the intervention.
Interpretation
A comprehensive model of care led by NPHWs, involving primary care physicians and family that was informed by local context, substantially improved blood pressure control and cardiovascular disease risk. This strategy is effective, pragmatic, and has the potential to substantially reduce cardiovascular disease compared with current strategies that are typically physician based.
Funding
Canadian Institutes of Health Research; Grand Challenges Canada; Ontario SPOR Support Unit and the Ontario Ministry of Health and Long-Term Care; Boehringer Ingelheim; Department of Management of Non-Communicable Diseases, WHO; and Population Health Research Institute.
Jon-David Schwalm introduces the paper on community-based interventions for reducing cardiovascular risk in hypertension through the HOPE 4 study.
Introduction
Cardiovascular disease is the most common cause of death globally, and hypertension the most common risk factor for cardiovascular disease.1 In theory, there is no reason why the goal of reducing cardiovascular disease mortality by 30% by 2030, agreed to by the governments of the world,2 should not be met. Effective, inexpensive medicines to reduce risk factors have been available for many years.3 The challenge we face is how to identify those who might benefit from treatment, and ensure that they are treated. We now have extensive information from countries at all levels of development that many people with hypertension are unaware of it, or are untreated or uncontrolled.4 Consequently, fewer than 20% of individuals with hypertension have their blood pressure controlled. Similarly, despite compelling evidence of the benefits of statins in those with hypertension, uptake is extremely low in most parts of the world.5
This problem shares similarities with HIV a decade ago: treatment was available, but people in need were often unable to benefit. The global health community responded by investing in health system strengthening, seeking to create effective mechanisms to deliver treatment to those who could benefit at low cost.6 So far, however, this approach has not been matched by those seeking to reduce the preventable burden of cardiovascular disease.
Research in context
Evidence before this study
Hypertension is the leading cause of cardiovascular disease, with the majority of the burden in low-income and middle-income countries. The HOPE 4 programme was initiated in 2013, to address the burden of cardiovascular risk and hypertension. Initial phases of the programme included systematic reviews and mixed methods analysis to inform the design of the HOPE 4 intervention components to be tested in a cluster randomised controlled trial. We systematically searched electronic databases including MEDLINE, Embase, Global Health, LILACS, Africa-Wide Information, IMSEAR, IMEMR, and WPRIM from inception until May 8, 2013, to identify barriers to appropriate hypertension control at the patient, health-care provider, and health-system level. No limits were applied with respect to language. Controlled vocabulary, keywords (MeSH terms) and free-text terms were identified for each domain of our health systems framework which also focused on “hypertension”, “barriers”, and “obstacles”. No limits to study design were imposed. The barriers identified in the systematic review, coupled with the findings of qualitative health-system appraisals in Colombia and Malaysia led to the development of an intervention comprising of modification of health behaviours and initiation of free combination antihypertensive drugs plus statins, by non-physician health workers guided by a tablet computer-based decision support system, supervised by physicians, and involving an individual's family or friends to promote adherence.
Added value of this study
The HOPE 4 study shows that a comprehensive model of care that is informed by strategies to overcome country-specific barriers, resulted in a substantial reduction in cardiovascular disease risk and improved blood pressure control.
Implications of all the available evidence
Adoption of the HOPE 4 strategy could substantially enhance reduction in cardiovascular disease risk in those with hypertension, and in doing so help achieve the UN's General Assembly target that calls for a one-third reduction in premature cardiovascular disease mortality by 2030.
By drawing on the literature on health systems research, we can identify what such a response would look like. First, it would address all of the building blocks of health systems, and in particular the need for an appropriate workforce, access to affordable diagnostics and medicines, and evidence-based guidelines. Second, it should be tailored to the national context, recognising that health systems are embedded within wider systems of governance, beliefs, and norms. The health outcomes prevention and evaluation 4 (HOPE 4) project is, to our knowledge, the first attempt to do this.7 Working in two middle-income countries, Colombia and Malaysia, we have developed, implemented, and evaluated, in a cluster-randomised trial, a comprehensive model of care that takes full account of the local context. This innovative package has been designed to address the constrained resources affecting most countries based on systematic reviews of barriers to effective management of hypertension.8, 9 Thus, we used non-physician health workers (NPHWs) supported by physicians and, crucially, family and community members; a simple combination of antihypertensive drugs and a statin; and simplified guidelines, delivered through a tablet computer (henceforth called tablets).
Many of these components have been separately evaluated in previous research, although with mixed results.10, 11 Our intervention is innovative in how, by taking a systems approach, it is more than the sum of its parts. Importantly, our intervention is informed by an initial detailed health system assessment and barrier analysis in each country,12, 13 which used a combination of quantitative and qualitative research to identify the challenges that needed to be overcome in designing the intervention. In this study, we tested the effectiveness of this comprehensive intervention in reducing cardiovascular disease risk among people with hypertension in two middle-income countries.
The HOPE 4 study was a parallel-arm, cluster-randomised controlled trial done in 30 urban and rural communities in Colombia (Fundación Oftalmológica de Santander) and Malaysia (Universiti Teknologi MARA). We have previously reported details for the study rationale, trial design, and methods.7 We have also reported the results of the qualitative research that identified barriers and potential solutions to improving hypertension control, which were the basis for the development of the
Results
Between 2014 and 2017, 4904 participants were screened from 30 communities in Colombia and Malaysia (15 each). All screening in Colombia was door to door, whereas screening of most participants (n=2383, 88%) in Malaysia was done at non-medical community events. 1900 people were invited to participate in the study, and 1376 (72%) provided written informed consent. The proportion of eligible participants versus those enrolled was higher in Colombia (n=616, 86%) than Malaysia (n=760, 60%).
Discussion
A comprehensive, contextually appropriate model of care resulted in a substantial reduction in cardiovascular disease risk in two middle-income countries primarily through improvements in blood pressure, LDL, and some health behaviours. Other studies using NPHWs have shown a modest increased uptake of antihypertensives without translating into a reduction in blood pressure.24, 25 We showed a large reduction in blood pressure and cardiovascular disease risk, something significant for a
Data sharing
The Population Health Research Institute has a formal data sharing policy. Data will be disclosed only upon request and approval of the proposed use of the data by a review committee created by leaders of the study. This review will serve to ensure that patient privacy and rights, and data and research integrity, can be maintained. Review criteria will include demonstrated competence in data security and analysis and data will be shared to achieve the objectives in the approved protocol only.
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This study aimed to evaluate the effectiveness of a health empowerment programme (HEP) to enhance cardiovascular health for adults from low-income families.
A prospective cohort study (N = 219, Intervention group: n = 103, comparison group: n = 116) was conducted with participants recruited from January 2013 to November 2015 and followed up until January 2022. Throughout the study duration, intervention group were invited to participate in the HEP. The cardiovascular health status of both groups at baseline and follow-up were assessed using the adapted Ideal Cardiovascular Health Index (ICHI) defined by the American Heart Association. After inverse propensity score weighting, multiple linear regression and Poisson regression were employed to examine the effects of the HEP.
The HEP was associated with a greater increase in ICHI total score (B = 0.33, p < 0.001), and the increase of proportion of people achieving a normal blood pressure (Incidence rate ratio: 3.39, p < 0.05).
HEP can be an effective and sustainable strategy to reduce social disparities in cardiovascular health of adults from low-income families, as indicated by improvement in the ICHI total score and blood pressure status.
The sustainable HEP in the community setting has potential for generalizability and scalability to other financially challenged families.
Hypertension is the primary risk factor for stroke and heart disease, which are leading causes of death in South Africa. Despite the availability of treatments, there is an implementation gap in how best to deliver hypertension care in this resource-limited region.
We describe a three-arm parallel group individually randomized control trial to evaluate the effectiveness and implementation of a technology-supported, community-based intervention to improve blood pressure control among people with hypertension in rural KwaZulu-Natal. The study will compare three strategies: 1) standard of care (SOC arm) clinic-based management, 2) home-based blood pressure management supported by community blood pressure monitors (CBPM arm) and a mobile health application to record blood pressure readings and enable clinic-based nurses to remotely manage care, and 3) an identical strategy to the CBPM arm, except that participants will use a cellular blood pressure cuff, which automatically transmits completed readings over cellular networks directly to clinic-based nurses (eCBPM+ arm). The primary effectiveness outcome is change in blood pressure from enrollment to 6 months. The secondary effectiveness outcome is the proportion of participants with blood pressure control at 6 months. Acceptability, fidelity, sustainability, and cost-effectiveness of the interventions will also be assessed.
In this protocol, we report the development of interventions in partnership with the South Africa Department of Health, a description of the technology-enhanced interventions, and details of the study design so that our intervention and evaluation can inform similar efforts in rural, resource-limited settings.
Chronic coronary syndrome (CCS) represents a major challenge for physicians, particularly in the context of an increasing aging population. Additionally, CCS is often underestimated and under-recognised, particularly in female patients. As patients are frequently affected by several chronic comorbidities requiring polypharmacy, this can have a negative impact on patients' adherence to treatment. To overcome this barrier, single-pill combination (SPC), or fixed-dose combination, therapies are already widely used in the management of conditions such as hypertension, dyslipidaemia, and diabetes mellitus. The use of SPC anti-anginal therapy deserves careful consideration, as it has the potential to substantially improve treatment adherence and clinical outcomes, along with reducing the failure of pharmacological treatment before considering other interventions in patients with CCS.
Presentamos las tasas de incidencia y de mortalidad por enfermedades cardiovasculares (ECV) que se han reportado para Sudamérica estratificadas por país, por sexo y por ubicación urbana o rural en una cohorte multinacional incluida en el estudio Poblacional Urbano Rural Epidemiológico (PURE). Este estudio incluyó a 24.718 participantes de 51 comunidades urbanas y 49 rurales de Argentina, Brasil, Chile y Colombia, y el seguimiento medio fue de 10,3 años. La incidencia de ECV y las tasas de mortalidad se calcularon para la cohorte total y en subpoblaciones. Se examinaron las razones de riesgo y las fracciones atribuibles a la población (FAP) para ECV y para muerte por 12 factores de riesgo modificables, agrupados como metabólicos (hipertensión, diabetes, obesidad abdominal y colesterol no HDL alto), conductuales (tabaco, alcohol, calidad de la dieta y actividad física) y otros (educación, contaminación del aire en el hogar, fuerza y depresión). Las principales causas de muerte fueron ECV (31,1%), cáncer (30,6%) y enfermedades respiratorias (8,6%). Aproximadamente el 72% de la FAP para ECV y el 69% de la FAP para muertes se atribuyeron a 12 factores de riesgo modificables. Para ECV los principales FAP se debieron a hipertensión (18,7%), obesidad abdominal (15,4%), tabaquismo (13,5%), baja fuerza muscular (5,6%) y diabetes (5,3%). Para muerte, los principales FAP fueron tabaquismo (14,4%), hipertensión (12,0%), baja escolaridad (10,5%), obesidad abdominal (9,7%) y diabetes (5,5%). Las ECV, el cáncer y las enfermedades respiratorias representan más de dos tercios de las muertes en Sudamérica. Los hombres tienen tasas de ECV y de mortalidad consistentemente más altas que las mujeres. Una gran proporción de ECV y muertes prematuras podrían evitarse mediante el control de los factores de riesgo metabólicos y el consumo de tabaco, que son los principales factores de riesgo en la región tanto para ECV como para mortalidad de cualquier causa.
We present cardiovascular disease (CVD) incidence and mortality rates reported for South America stratified by country, sex, and urban/rural location in a multinational cohort included in the Population Urban Rural Epidemiological Study (PURE). This study included 24,718 participants from 51 urban and 49 rural communities in Argentina, Brazil, Chile, and Colombia and the mean follow-up was 10.3 years. CVD incidence and mortality rates were calculated for the total cohort and in subpopulations. Hazard ratios and population attributable fractions (PAFs) for CVD and death were examined for 12 modifiable risk factors, grouped as metabolic (hypertension, diabetes, abdominal obesity, and high non-HDL cholesterol), behavioural (smoking, alcohol, diet quality, and physical activity) and other (education, household air pollution, strength, and depression). The leading causes of death were CVD (31.1%), cancer (30.6%), and respiratory diseases (8.6%). Approximately 72% of the PAFs for CVD and 69% of the PAFs for deaths were attributed to 12 modifiable risk factors. For CVD, the main PAFs were due to hypertension (18.7%), abdominal obesity (15.4%), smoking (13.5%), low muscle strength (5.6%), and diabetes (5.3%). For death, the main PAFs were smoking (14.4%), hypertension (12.0%), low educational level (10.5%), abdominal obesity (9.7%), and diabetes (5.5%). Cardiovascular diseases, cancer, and respiratory diseases account for more than two-thirds of deaths in South America. Men have consistently higher CVD rates and mortality than women. A large proportion of CVD and premature deaths could be avoided by controlling metabolic risk factors and smoking, which are the main risk factors in the region for both CVD and all-cause mortality.
2023, Journal of Stroke and Cerebrovascular Diseases
To test the hypothesis that an Accredited social health activist (ASHA), a community health volunteer in a task-sharing model can help in sustained control of systolic blood pressure (BP) in rural people with Stroke and hypertension at 6 months follow up.
In this randomized trial two rural areas (Pakhowal and Sidhwan bet) with 70 and 94 villages respectively were screened for people with stroke and hypertension. They were assigned to either ASHA-assisted BP control in addition to standard-of-care (Pakhowal-intervention Group) or standard-of-care alone (Sidhwan bet- Control Group). Assessors blinded to intervention conducted the baseline and 6 months follow-up visits to measure risk factors in both the rural areas.
A total of 140 people with stroke with mean age of 63.7 ± 11.5 years and 44.3% females were randomised. The baseline systolic BP was higher in the intervention group (n = 65,173.5 ± 22.9 mmHg) compared to the control group (n = 75,163 ± 18.7 mmHg, p = 0.004). The follow-up systolic BP was lower in the intervention group compared to the control group 145 ± 17.2 mmHg and 166.6 ± 25.7 mmHg respectively (p < 0.0001). According to the intention-to-treat analysis a total of 69.2% of patients in the intervention group achieved systolic BP control compared to 18.9% in the control group patients (OR 9, 95% CI 3.9-20.3; p < 0.0001).
Task sharing with ASHA a community health volunteer can improve BP control in rural people with stroke and hypertension. They can also help in the adoption of healthy behaviour.