Cardiovascular disease risk reduction in rural China: a clustered randomized controlled trial in Zhejiang Quality of cardiovascular disease preventive care and physician/practice characteristics IMProving Adherence using Combination Therapy (IMPACT): design and protocol of a randomised controlled trial in primary care. Cost-effectiveness of lipid-lowering treatment according to lipid level. Rationale and design of the Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS): a factorial, cluster-randomized trial of 2 practical cardiovascular disease prevention strategies developed for rural Andhra Pradesh, India. The Adherence eValuation After Ischemic Stroke Longitudinal (AVAIL) registry: design, rationale, and baseline patient characteristics. Rationale and Design of the Pharmacist Intervention for Low Literacy in Cardiovascular Disease (PILL-CVD) Study Interventions Supporting Long‐term Adherence aNd Decreasing cardiovascular events (ISLAND): Pragmatic randomized trial protocol Reducing salt intake for prevention of cardiovascular diseases in high-risk patients by advanced health education intervention (RESIP-CVD study), Northern Thailand: study protocol for a cluster randomized trial National Study of Physician Awareness and Adherence to Cardiovascular Disease Prevention Guidelines The SPHERE Study. Secondary prevention of heart disease in general practice: protocol of a randomised controlled trial of tailored practice and patient care plans with parallel qualitative, economic and policy analyses. [ISRCTN24081411] A multifaceted quality improvement intervention for CVD risk management in Australian primary healthcare: a protocol for a process evaluation Patients’ and Providers’ Perspectives of a Polypill Strategy to Improve Cardiovascular Prevention in Australian Primary Health Care: A Qualitative Study Set Within a Pragmatic Randomized, Controlled Trial The @RISK Study: Risk communication for patients with type 2 diabetes: design of a randomised controlled trial Cost-effectiveness of interventions to control cardiovascular diseases and type 2 diabetes mellitus in South Asia: protocol for a systematic review The effects of Hartcoach, a life style intervention provided by telephone on the reduction of coronary risk factors: a randomised trial Physicians' perception, knowledge and awareness of cardiovascular risk factors and adherence to prevention guidelines: the PERCRO-DOC survey. National Study of Women’s Awareness, Preventive Action, and Barriers to Cardiovascular Health Pilot Testing of the PRAISEDD Intervention Among African American and Low-Income Older Adults Information and Risk Modification Trial (INFORM): design of a randomised controlled trial of communicating different types of information about coronary heart disease risk, alongside lifestyle advice, to achieve change in health-related behaviour A cluster-randomized trial of task shifting and blood pressure control in Ghana: study protocol The Cholesterol, Hypertension, And Glucose Education (CHANGE) study: results from a randomized controlled trial in African Americans with diabetes. HEART: heart exercise and remote technologies: A randomized controlled trial study protocol
Background Cardiovascular disease ( CVD ) is a major cause of death in China . Despite government efforts , the majority of hypertensive and diabetic patients in China do not receive proper treatment . Reducing CVD events requires long-term care that is proactive , patient-centred , community-based , and sustainable . We have design ed a package of interventions for patients at high risk of CVD to be implemented by family doctors based in township hospitals ( providers of primary care ) in rural Zhejiang , China . This trial aims to determine whether the systematic CVD risk reduction package results in reduced CVD events among patients at risk of CVD compared with usual care , and whether the package is cost-effective and suitable for routine implementation and scale-up . Methods / Design This is a prospect i ve , open-label , cluster r and omized controlled trial ( RCT ) with blinded data analysis . The trial will r and omize 67 township hospitals with 31,708 participants in three counties in Zhejiang Province . Participants will be identified from existing health records and will comprise adults aged 50 to 74 years , with a calculated 10-year CVD risk of 20 % or higher , or diabetes . In the intervention arm , participants will receive a package of interventions including : 1 ) healthy lifestyle counseling ( smoking cessation , and salt , oil , and alcohol reduction ) ; 2 ) prescription of a combination of drugs ( antihypertensives , aspirin , and statin ) ; and 3 ) adherence support for drug compliance and healthy lifestyle change . In the control arm , participants will receive usual care for hypertension and diabetes management at individual clinicians ’ discretion . The primary outcome is the incidence of severe CVD events over 24 months of follow-up . All CVD events will be defined according to the World Health Organization ( WHO ) monitoring of trends and determinants in cardiovascular disease ( MONICA ) definitions , diagnosed at the county hospital or higher level , and reported by the Zhejiang surveillance system . Secondary outcomes include : mean systolic and diastolic blood pressure , blood glucose , serum total cholesterol ( TC ) , and adherence to appointments , and drugs and lifestyle changes . Discussion This trial focuses on risk reduction of CVD rather than specific diseases . It is not design ed to compare therapeutic and healthy lifestyle interventions , but rather their combined effects in primary care setting s. Through the trial , we intend to underst and the effectiveness of the comprehensive CVD reduction package in routine practice . We also intend to underst and the barriers and facilitators to implementing the package , and thus to advise on policy and practice change . Trial registration Current Controlled Trials : IS RCT Abstract BACKGROUND : Quality of cardiovascular disease ( CVD ) preventive care is suboptimal . Recent data correlated increasing years in practice for physicians with lower- quality health care . OBJECTIVE : The purpose of this study was to assess physician awareness/adherence to national blood pressure , cholesterol , and CVD prevention guidelines for women according to physician/ practice characteristics . DESIGN : St and ardized online survey and experimental case studies were administered to 500 r and omly selected U.S. physicians . Multivariable regression models tested physician age , gender , specialty , and practice type as independent predictors of guideline awareness/adherence . RESULTS : Compared with older physicians ( 50 + years ) , younger physicians ( < 50 years ) reported a lower level of awareness of cholesterol guidelines ( P=.04 ) and lower incorporation of women ’s guidelines ( P=.02 ) . Yet , older physicians were less likely to recommend weight management for high-risk cases ( P=.03 ) and less confident in helping patients manage weight ( P=.045 ) than younger physicians . Older physicians were also less likely to identify a low-density lipoprotein < 100 mg/dL as optimal versus younger physicians ( P=.01 ) , as were solo versus nonsolo practitioners ( P=.02 ) . Solo practitioners were less aware of cholesterol guidelines ( P=.04 ) and were more likely to prescribe aspirin  for low-risk female patients than nonsolo practitioners ( P<.01 ) . Solo practitioners rated their clinical judgment as more effective than guidelines in improving patient health outcomes ( P<.01 ) and more frequently rated the patient as the greatest barrier to CVD prevention versus nonsolo practitioners ( P<.01 ) . CONCLUSIONS : Though guideline awareness is high , efforts to promote their utilization are needed and may improve quality outcomes . Targeted education and support for CVD prevention may be helpful to older and solo physicians BACKGROUND Cardiovascular disease ( CVD ) is the leading cause of death , and principal reason for the large difference in life expectancy between indigenous Māori and the non-indigenous population in New Zeal and . CVD guidelines recommend that people who are at high risk or who have had previous CVD should be offered aspirin , blood pressure lowering and lipid lowering therapies . However , prescribing and adherence rates are low and CVD events remain high . AIM To assess whether a medication strategy using a fixed dose combination pill ( ' polypill ' ) could improve prescribing and adherence to recommended medications , lower blood pressure and improve lipids compared with current care over 12 months . METHODS IMProving Adherence using Combination Therapy ( IMPACT ) is an open-label r and omised controlled trial comparing a once-daily polypill containing four preventive medications with usual care .  Six hundred participants who have had previous CVD events or are at high risk of CVD will be enrolled , including 300 Māori . Participants are identified , enrolled and prescribed either the polypill or current medications at their usual primary health care practice , with medications ( including the polypill ) dispensed through local community pharmacies . The polypill contains 75 mg aspirin , 40 mg simvastatin , 10 mg lisinopril and either 12.5 mg hydrochlorothiazide or 50 mg atenolol . Primary outcomes are adherence to guidelines -recommended medications and changes in systolic blood pressure and low density lipoprotein at 12 months . Secondary outcomes include other lipids , medication dispensing , barriers to adherence , CVD and other serious adverse events , quality of life and prescriber acceptability . The trial is registered with the Australian New Zeal and Clinical Trial Registry ( ACTRN12606000067572 ) BACKGROUND Recent studies suggest that the benefit of lipid-lowering treatment for the primary and secondary prevention of cardiovascular disease ( CVD ) extends to individuals with average cholesterol levels , to women and to the elderly . However , the proportion of the general population for which treatment is cost-effective has not been evaluated . OBJECTIVES AND METHODS Using data provided by the Canadian Heart Health Survey , the level of CVD risk was estimated for a r and om sample of the total population . A cost-effectiveness ratio for simvastatin was then calculated for each individual in the sample . Lastly , the proportion of the total population for which lipid-lowering therapy would be cost-effective for primary and secondary prevention of CVD was estimated according to total cholesterol ( TC ) levels . RESULTS Among the surveyed individuals who were 30 to 74 years of age , 2212 had CVD and 12,982 did not . Among those with a TC level higher than 6.2 mmol/L , the proportions of individuals for which lipid-lowering therapy was cost-effective ( at a level of less than 50,000 dollars per year of life saved ) were 85.6 % of men and 28.7 % of women for primary prevention , and 99.8 % of men and 86.1 % of women for secondary prevention . The estimated cost of one year of lipid-lowering treatment for all individuals in the population with a TC level higher than 6.2 mmol/L and for all individuals regardless of TC levels for whom treatment would be cost-effective was $ 1 billion and 3.9 billion dollars , respectively . CONCLUSIONS Lipid-lowering treatment for CVD prevention is cost-effective for a high proportion of the population , even for primary prevention . As a result , the cost of population -wide treatment for only one year is high even among individuals with a TC level higher than 6.2 mmol/L. Such costs should be considered in health care policy decisions BACKGROUND Developing countries are experiencing increasing levels of cardiovascular disease ( CVD ) . Although there is a good underst and ing of how to deliver CVD prevention programs in developed countries , there are few data regarding strategies for CVD prevention in re source -poor setting s. This study aim ed to implement and evaluate a CVD prevention program in a rural area of India . METHODS The 2 strategies of CVD prevention to be investigated are an algorithm-based care approach and a health-promotion campaign . A factorial , cluster-r and omized trial design will be used to evaluate these , in which villages will be exposed to one , both , or neither of the interventions for a period of about 12 months . Surveys of households in every village will be used to assess outcomes in all high-risk individuals and a sample of the general adult population . RESULTS The primary outcome of the algorithm-based component of this study will be the percentage of high-risk individuals that have been " identified"-defined as having received a cardiovascular-risk assessment in the last 12 months . The primary outcome for the health-promotion component will be the percentage of the adult population with correct knowledge about the effects of 6 behavioral determinants of cardiovascular risk ( green-leafy vegetables , fruits , oily foods , salt , smoking , physical activity ) . Secondary outcomes include a range of measures defining uptake of different preventive strategies . CONCLUSIONS This study will provide evidence about the effectiveness of a simple practical mechanism of CVD preventive care specifically design ed for delivery in a re source -poor area in India BACKGROUND Approximately one third of the 780,000 people in the United States who have a stroke each year have recurrent events . Although efficacious secondary prevention measures are available , levels of adherence to these strategies in patients who have had stroke are largely unknown . Underst and ing medication-taking behavior in this population is an important step to optimizing the appropriate use of proven secondary preventive therapies and reducing the risk of recurrent stroke . METHODS The Adherence eValuation After Ischemic Stroke Longitudinal ( AVAIL ) registry is a prospect i ve study of adherence to stroke prevention medications from hospital discharge to 1 year in patients admitted with stroke or transient ischemic attack . The primary outcomes are medication usage as determined by patient interviews after 3 and 12 months . Potential patient- , provider- , and system-level barriers to persistence of medication use are also collected . Secondary outcomes include the rates of recurrent stroke or transient ischemic attack , vascular events , and rehospitalization and functional status as measured by the modified Rankin score . RESULTS The AVAIL enrolled about 2,900 subjects from 106 hospitals from July 2006 through July 2008 . The 12-month follow-up will be completed in August 2009 . CONCLUSIONS The AVAIL registry will document the current state of adherence and persistence to stroke prevention medications among a nationwide sample of patients . These data will be used to design interventions to improve the quality of care post acute hospitalization and reduce the risks of future stroke and cardiovascular events Background —Medication errors and adverse drug events are common after hospital discharge due to changes in medication regimens , suboptimal discharge instructions , and prolonged time to follow-up . Pharmacist-based interventions may be effective in promoting the safe and effective use of medications , especially among high-risk patients such as those with low health literacy . Methods and Results —The Pharmacist Intervention for Low Literacy in Cardiovascular Disease ( PILL-CVD ) study is a r and omized controlled trial conducted at 2 academic centers — V and erbilt University Hospital and Brigham and Women 's Hospital . Patients admitted with acute coronary syndrome or acute decompensated heart failure were r and omly assigned to usual care or intervention . The intervention consisted of pharmacist-assisted medication reconciliation , inpatient pharmacist counseling , low-literacy adherence aids , and tailored telephone follow-up after discharge . The primary outcome is the occurrence of serious medication errors in the first 30 days after hospital discharge . Secondary outcomes are health care utilization , disease-specific quality of life , and cost-effectiveness .  Enrollment was completed September 2009 . A total of 862 patients were enrolled , and 430 patients were r and omly assigned to receive the intervention . Analyses will determine whether the intervention was effective in reducing serious medication errors , particularly in patients with low health literacy . Conclusions —The PILL-CVD study was design ed to reduce serious medication errors after hospitalization through a pharmacist-based intervention . The intervention , if effective , will inform health care facilities on the use of pharmacist-assisted medication reconciliation , inpatient counseling , low-literacy adherence aids , and patient follow-up after discharge . Clinical Trial Registration — clinical trials.gov . Identifier : NCT00632021 Background Guidelines recommend cardiac rehabilitation and long‐term use of cardiac medications for most patients who have had a myocardial infa rct ion ( MI ) , but adherence to these secondary prevention treatments is suboptimal . Methods This is a multicenter , pragmatic , 3‐arm r and omized trial . Eligible patients ( n = 2,742 ) with obstructive coronary artery disease are r and omized post‐MI to usual care or 1 of 2 intervention arms . Patients in the first intervention arm receive mail‐outs sent on behalf of their cardiologist at 4 , 8 , 20 , 32 , and 44 weeks post‐MI ; content is design ed to address determinants of adherence and facilitate discussion between the patient and their health care team . Patients in the second intervention arm receive mail‐outs plus automated interactive voice response system telephone calls 2 weeks after each letter , as well as a telephone call by trained lay health workers if the interactive voice response system identifies challenges with adherence . Outcomes are assessed 12 months post‐MI via patient self‐report and administrative data sources . Co‐ primary outcomes are adherence to cardiac medications and completion of cardiac rehabilitation . Secondary outcomes include cardiovascular events and mortality . An embedded , theory‐informed process evaluation will explore the mechanism of action ; an economic evaluation is also planned . Conclusions We describe a complete program evaluation of a highly pragmatic , health‐system intervention to support adherence to recommended treatments . Research ethics boards approved waiver of consent for patients enrolled in the trial with provision of multiple opportunities to opt out and a debrief at the time of outcome assessment . The methods used here may provide a model for similar interventions Background Decreasing salt consumption can prevent cardiovascular diseases ( CVD ) . Practically , it is difficult to promote people ’s awareness of daily salt intake and to change their eating habits in terms of reducing salt intake for better cardiovascular health . Health education programs visualizing daily dietary salt content and intake may promote lifestyle changes in patients at high risk of cardiovascular diseases . Methods / Design This is a cluster r and omized trial . A total of 800 high-CVD-risk patients attending diabetes and hypertension clinics at health centers in Muang District , Chiang Rai province , Thail and , will be studied with informed consent . A health center recruiting 100 participants is a cluster , the unit of r and omization . Eight clusters will be r and omized into intervention and control arms and followed up for 1 year . Within the intervention clusters the following will be undertaken : ( 1 )  salt content in the daily diet will be measured and shown to study participants ; ( 2 )  24-hour salt intake will be estimated in overnight-collected urine and the results shown to the participants ; ( 3 ) a dietician will assist small group health education classes in cooking meals with less salt . The primary outcome is blood pressure change at the 1-year follow-up . Secondary outcomes at the 1-year follow-up are estimated 24-hoursalt intake , incidence of CVD events and CVD death . The intention-to-treat analysis will be followed . Blood pressure and estimated 24-hour salt intake will be compared between intervention and control groups at the cluster and individual level at the 1-year follow-up . Clinical CVD events and deaths will be analyzed by time-event analysis . Retinal blood vessel calibers of CVD-risk patients will be assessed cross-sectionally . Behavioral change to reduce salt intake and the influencing factors will be determined by structured equation model ( SEM ) . Multilevel regression analyses will be applied . Finally , the cost effectiveness of the intervention will be analyzed . Discussion This study is unique as it will recruit the individuals most vulnerable to CVD morbidity and mortality by applying the general Framingham CVD risk scoring system . Dietary salt reduction will be applied as a prioritized , community level intervention for the prevention of CVD in a developing country . Trial registration IS RCT Background —Few data have evaluated physician adherence to cardiovascular disease ( CVD ) prevention guidelines according to physician specialty or patient characteristics , particularly gender . Methods and Results —An online study of 500 r and omly selected physicians ( 300 primary care physicians , 100 obstetricians/gynecologists , and 100 cardiologists ) used a st and ardized question naire to assess awareness of , adoption of , and barriers to national CVD prevention guidelines by specialty . An experimental case study design tested physician accuracy and determinants of CVD risk level assignment and application of guidelines among high- , intermediate- , or low-risk patients . Intermediate-risk women , as assessed by the Framingham risk score , were significantly more likely to be assigned to a lower-risk category by primary care physicians than men with identical risk profiles ( P<0.0001 ) , and trends were similar for obstetricians/gynecologists and cardiologists . Assignment of risk level significantly predicted recommendations for lifestyle  and preventive pharmacotherapy . After adjustment for risk assignment , the impact of patient gender on preventive care was not significant except for less aspirin ( P<0.01 ) and more weight management recommended ( P<0.04 ) for intermediate-risk women . Physicians did not rate themselves as very effective in their ability to help patients prevent CVD . Fewer than 1 in 5 physicians knew that more women than men die each year from CVD . Conclusions —Perception of risk was the primary factor associated with CVD preventive recommendations . Gender disparities in recommendations for preventive therapy were explained largely by the lower perceived risk despite similar calculated risk for women versus men . Educational interventions for physicians are needed to improve the quality of CVD preventive care and lower morbidity and mortality from CVD for men and women Background The aim of the SPHERE study is to design , implement and evaluate tailored practice and personal care plans to improve the process of care and objective clinical outcomes for patients with established coronary heart disease ( CHD ) in general practice across two different health systems on the isl and of Irel and .CHD is a common cause of death and a significant cause of morbidity in Irel and . Secondary prevention has been recommended as a key strategy for reducing levels of CHD mortality and general practice has been highlighted as an ideal setting for secondary prevention initiatives . Current indications suggest that there is considerable room for improvement in the provision of secondary prevention for patients with established heart disease on the isl and of Irel and . The review literature recommends structured programmes with continued support and follow-up of patients ; the provision of training , tailored to practice needs of access to evidence of effectiveness of secondary prevention ; structured recall programmes that also take account of individual practice needs ; and patient-centred consultations accompanied by attention to disease management guidelines . Methods SPHERE is a cluster r and omised controlled trial , with practice -level r and omisation to intervention and control groups , recruiting 960 patients from 48 practice s in three study centres ( Belfast , Dublin and Galway ) . Primary outcomes are blood pressure , total cholesterol , physical and mental health status ( SF-12 ) and hospital re-admissions . The intervention takes place over two years and data is collected at baseline , one-year and two-year follow-up . Data is obtained from medical charts , consultations with practitioners , and patient postal question naires . The SPHERE intervention involves the implementation of a structured systematic programme of care for patients with CHD attending general practice . It is a multi-faceted intervention that has been developed to respond to barriers and solutions to optimal secondary prevention identified in preliminary qualitative research with practitioners and patients . General practitioners and practice nurses attend training sessions in facilitating behaviour change and medication prescribing guidelines for secondary prevention of CHD . Patients are invited to attend regular four-monthly consultations over two years , during which targets and goals for secondary prevention are set and review ed . The analysis will be strengthened by economic , policy and qualitative components Background Cardiovascular disease ( CVD ) is the leading cause of death and disability worldwide . Despite the widespread availability of evidence -based clinical guidelines and vali date d risk predication equations for prevention and management of CVD , their translation into routine practice is limited . We developed a multifaceted quality improvement intervention for CVD risk management which incorporates electronic decision support , patient risk communication tools , computerised audit and feedback tools , and monthly , peer-ranked performance feedback via a web portal . The intervention was implemented in a cluster r and omised controlled trial in 60 primary healthcare services in Australia . Overall , there were improvements in risk factor recording and in prescribing of recommended treatments among under-treated individuals , but it is unclear how this intervention was used in practice and what factors promoted or hindered its use . This information is necessary to optimise intervention impact and maximally implement it in a post-trial context . In this study protocol , we outline our methods to conduct a theory-based , process evaluation of the intervention . Our aims are to underst and how , why , and for whom the intervention produced the observed outcomes and to develop effective strategies for translation and dissemination . Methods / Design We will conduct four discrete but inter-related studies taking a mixed methods approach . Our quantitative studies will examine ( 1 ) the longer term effectiveness of the intervention post-trial , ( 2 ) patient and health service level correlates with trial outcomes , and ( 3 ) the health economic impact of implementing the intervention at scale . The qualitative studies will ( 1 ) identify healthcare provider perspectives on implementation barriers and enablers and ( 2 ) use video ethnography and patient semi-structured interviews to underst and how cardiovascular risk is communicated in the doctor/patient interaction both with and without the use of intervention . We will also assess the costs of implementing the intervention in Australian primary healthcare setting s which will inform scale-up considerations . Discussion This mixed methods evaluation will provide a detailed underst and ing of the process of implementing a  quality improvement intervention and identify the factors that might influence scalability and sustainability . Trials registration 12611000478910 Background —This study explores health provider and patient attitudes toward the use of a cardiovascular polypill as a health service strategy to improve cardiovascular prevention . Methods and Results —In-depth , semistructured interviews ( n=94 ) were conducted with health providers and patients from Australian general practice , Aboriginal community-controlled and government-run Indigenous Health Services participating in a pragmatic r and omized controlled trial evaluating a polypill-based strategy for high-risk primary and secondary cardiovascular disease prevention . Interview topics included polypill strategy acceptability , factors affecting adherence , and trial implementation . Transcribed interview data were analyzed thematically and interpretively .  Polypill patients commented frequently on cost-savings , ease , and convenience of a daily-dosing pill . Most providers considered a polypill strategy to facilitate improved patient medication use . Indigenous Health Services providers and indigenous patients thought the strategy acceptable and beneficial for indigenous patients given the high disease burden . Providers noted the inflexibility of the fixed dose regimen , with dosages sometimes inappropriate for patients with complex management considerations . Future polypill formulations with varied strengths and classes of medications may overcome this barrier . Many providers suggested the polypill strategy , in its current formulations , might be more suited to high-risk primary prevention patients . Conclusions —The polypill strategy was generally acceptable to patients and providers in cardiovascular prevention . Limitations to provider acceptability of this particular polypill were revealed , as was a perception it might be more suitable for high-risk primary prevention patients , though future combinations could facilitate its use in secondary prevention . Participants suggested a polypill-based strategy as particularly appropriate for lowering the high cardiovascular burden  in indigenous population s. Clinical Trial Registration —URL : http://www.anzctr.org.au . ANZCTRN : 12608000583347 Background Patients with type 2 diabetes mellitus ( T2DM ) have an increased risk to develop severe diabetes related complications , especially cardiovascular disease ( CVD ) . The risk to develop CVD can be estimated by means of risk formulas . However , patients have difficulties to underst and the outcomes of these formulas . As a result , they may not recognize the importance of changing lifestyle and taking medication in time . Therefore , it is important to develop risk communication methods , that will improve the patients ' underst and ing of risks associated with having diabetes , which enables them to make informed choices about their diabetes care . The aim of this study is to investigate the effects of an intervention focussed on the communication of the absolute 10-year risk to develop CVD on risk perception , attitude and intention to change lifestyle behaviour in patients with T2DM . The conceptual framework of the intervention is based on the Theory of Planned Behaviour and the Self-regulation Theory . Methods A r and omised controlled trial will be performed in the Diabetes Care System West-Friesl and ( DCS ) , a managed care system . Newly referred T2DM patients of the DCS , younger than 75 years will be eligible for the study . The intervention group will be exposed to risk communication on CVD , on top of st and ard managed care of the DCS . This intervention consists of a simple explanation on the causes and consequences of CVD , and possibilities for prevention . The probabilities of CVD in 10 year will be explained in natural frequencies and visualised by a population diagram . The control group will receive st and ard managed care . The primary outcome is appropriateness of risk perception . Secondary outcomes are attitude and intention to change lifestyle behaviour and illness perception . Differences between baseline and follow-up ( 2 and 12 weeks ) between groups will be analysed according to the intention-to-treat principle . The study was powered on 120 patients in each group . Discussion This innovative risk communication method based on two behavioural theories might improve patient 's appropriateness of risk perception and attitude concerning lifestyle change . With a better underst and ing of their CVD risk , patients will be able to make informed choices concerning diabetes care . Trail registration The trial is registered as NTR1556 in the Dutch Trial Register Introduction While a number of strategies are being implemented to control cardiovascular diseases ( CVDs ) and type 2 diabetes mellitus ( T2DM ) , the cost-effectiveness of these in the South Asian context has not been systematic ally evaluated . We aim to systematic ally review the economic ( cost-effectiveness ) evidence available on the individual- , group- and population -level interventions for control of CVD and T2DM in South Asia . Methods and analysis This review will consider all relevant economic evaluations , either conducted alongside r and omised controlled trials or based on decision modelling estimates . These studies must include participants at risk of developing CVD/T2DM or with established disease in one or more of the South Asian countries ( India , Bangladesh , Pakistan , Sri Lanka , Nepal , Maldives , Bhutan and Afghanistan ) . We will identify relevant papers by systematic ally search ing all major data bases and registries . Selected articles will be screened by two independent research ers . Method ological quality of the studies will be assessed using a modified Drummond and a Phillips checklist . Cochrane guidelines will be followed for bias assessment in the effectiveness studies . Results Results will be presented in line with the PRISMA ( Preferred Reporting Items for Systematic review and Meta- analysis ) checklist , and overall quality of evidence will be presented as per the GRADE ( Grade s of Recommendation , Assessment , Development and Evaluation ) approach . Ethics and dissemination The study has received ethics approval from the All India Institute of Medical Sciences , New Delhi , India . The results of this review will provide policy-relevant recommendations for the uptake of cost-effectiveness evidence in prioritising decisions on essential chronic disease care packages for South Asia . Study registration number PROSPERO CRD42013006479 Background Cardiovascular disease ( CVD ) is the leading cause of death worldwide . Secondary prevention is essential , but participation rates for cardiac rehabilitation are low . Furthermore , current programmes do not accomplish that patients with CVD change their lifestyle in a way that their individual risk factors for recurrent events decrease , therefore more effective interventions are needed . In this study , the effectiveness of the Hartcoach-programme , a telephonic secondary prevention program focussing on self management , is studied . Methods / design A multicenter , r and omised parallel-group study is being conducted . Participants are 400 patients with acute myocardial infa rct ion ( STEMI , NSTEMI , ) and patients with chronic or unstable angina pectoris ( IAP ) . Patients are recruited through the participating hospitals and r and omly assigned to the experimental group ( Hartcoach-programme plus usual care ) or the control group ( usual care).The Hartcoach-programme consists of a period of six months during which the coach contacts the patient every four to six weeks by telephone . Coaches train patients to take responsibility for the achievement and maintenance of the defined target levels for their particular individual modifiable risk factors . Target levels and treatment goals are agreed by the nurse and patient together . Data collection is blinded and occurs at baseline and after 26 weeks ( post-intervention ) . Primary outcome is change in cardiovascular risk factors ( cholesterol , body mass index , waist circumference , blood pressure , physical activity and diet ) . Secondary outcomes include chances in glucose , HbA1c , medication adherence , self-management and quality of life . Discussion This study evaluates the effects of the Hartcoach-programme on the reduction of individual risk factors of patients with CVDs . Patients who are not invited to follow a hospital based rehabilitation programme or patients who are unable to adhere to such a programme , may be reached by this home based Hartcoach-programme . If positive results are found , the implementation of the Hartcoach-programme will be extended , having implication s for the management of many people with CVD.Trial registration BACKGROUND Cardiovascular diseases ( CVD ) are the major cause of premature death in the world . This study was design ed to examine the physicians ' knowledge and perception of CVD risk factors and perceived implementation of CVD prevention guidelines as well as barriers to their implementation . METHODS A question naire survey by face-to-face interviews was performed among 1382 r and omly selected physicians ( general practitioners/family medicine specialists , internists and cardiologists ) from different regions of Croatia . RESULTS Most physicians believe that guidelines are useful but only 56.9 % are really using some guidelines . 40.2 % favour Joint European guidelines . More primary care physicians use their own personal experience in prevention while internists and cardiologists tend more to use the guidelines . 80.6 % believe that they treat their patients with dyslipidemia well but only 53.3 % knew the LDL-cholesterol goal value for high-risk patients and only 56.2 % knew which HDL-cholesterol level is the marker of increased risk . Hypertension was perceived as the most important risk factor , particularly by primary care physicians , while cardiologists tend to favour diabetes . Although most physicians considered the lack of financial re sources as the main barrier in CVD prevention , at the same time most of them believe that it could primarily be improved by better patient education . CONCLUSIONS Although most physicians support the guidelines use , only half of them use them and in average their knowledge of guidelines is not satisfactory . This is , together with the lack of time and finances and perceived lack of patients ' awareness , probably one of the main causes why they do not manage risk factors better Background — There is growing awareness of cardiovascular disease ( CVD ) as the leading cause of death in women , but whether this greater awareness is associated with increased action by women to lower their personal or family ’s risk is unknown . Methods and Results — A nationally representative sample of 1008 women selected through r and om-digit dialing were given a st and ardized question naire about history of CVD/risk factors , awareness of leading cause of death , knowledge of healthy and personal levels of CVD risk factors , self-reported actions taken to reduce risk  , and barriers to heart health . The rate of awareness of CVD as the leading cause of death has nearly doubled since 1997 ( 55 % versus 30 % ) was significantly greater for whites compared with blacks and Hispanics ( 62 % versus 38 % and 34 % , respectively ) and was independently correlated with increased physical activity ( odds ratio , 1.35 ; 95 % CI , 1.00 to 1.83 ) and weight loss ( odds ratio , 1.47 ; 95 % CI , 1.14 to 2.02 ) in the previous year in logistic regression models . Fewer than half of the respondents were aware of healthy levels of risk factors . Awareness that personal level was not healthy was positively associated with action . Most women took steps to lower risk in family members and themselves . The most frequently cited barriers for heart health were confusion in the media ( 49 % ) , the belief that health is determined by a higher power ( 44 % ) , and caretaking responsibilities ( 36 % ) . Conclusions — General awareness of CVD risk among women is associated with preventive action . Educational interventions need to be targeted at racial/ethnic minority women Background and Research Objective : The incidence of cardiovascular disease ( CVD ) is particularly high among African American ( AA ) older adults , and these individuals are least likely to have access to CVD prevention activities . The purpose of this study was to test the feasibility of People Reducing Risk and Improving Strength through Exercise , Diet and Drug Adherence ( PRAISEDD ) , which is geared at increasing adherence to CVD prevention behaviors among AA and low-income older adults . Methods : This feasibility study was conducted in a senior housing site , using a single-group repeated- measures design and testing  physical activity , diet , medication adherence beliefs and behaviors , and blood pressure at baseline and after a 12-week intervention period . Of 22 participants , mean ( SD ) age was 76.4 ( 7.6 ) years , and most were female ( 64 % ) and AA ( 86 % ) . An intention-to-treat analysis was used . Results : There were significant decreases in systolic ( P = .02 ) and diastolic blood pressure ( P = .01 ) and a nonsignificant trend toward improvement in cholesterol intake ( P = .09 ) . There were no changes in time spent in moderate-level physical activity , sodium intake , medication adherence , or self-efficacy and outcome expectations across all 3 behaviors . Conclusion : The PRAISEDD intervention was feasible in a group of AA and low-income older adults and , after 12 weeks , result ed in improvements in blood pressure . Future research is needed to test a revised PRAISEDD intervention using a r and omized controlled design , a larger sample , and a longer follow-up period . The PRAISEDD intervention should be revised to incorporate environmental and policy changes that influence CVD prevention behaviors and explore the impact of social networking as it relates to diffusion of the intervention among participants in low-income housing facilities Background Cardiovascular disease ( CVD ) remains the leading cause of death globally . Primary prevention of CVD requires cost-effective strategies to identify individuals at high risk in order to help target preventive interventions . An integral part of this approach is the use of CVD risk scores . Limitations in previous studies have prevented reliable inference about the potential advantages and the potential harms of using CVD risk scores as part of preventive strategies . We aim to evaluate short-term effects of providing different types of information about coronary heart disease ( CHD ) risk , alongside lifestyle advice , on health-related behaviours . Methods / Design In a parallel-group , open r and omised trial , we are allocating 932 male and female blood donors with no previous history of CVD aged 40–84 years in Engl and to either no intervention ( control group ) or to one of three active intervention groups : i ) lifestyle advice only ; ii ) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic characteristics ; and iii ) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic and genetic characteristics . The primary outcome is change in objective ly measured physical activity . Secondary outcomes include : objective ly measured dietary behaviours ; cardiovascular risk factors ; current medication and healthcare usage ; perceived risk ; cognitive evaluation of provision of CHD risk scores ; and psychological outcomes . The follow-up assessment takes place 12 weeks after r and omisation . The experiences , attitudes and concerns of a subset of participants will be also studied using individual interviews and focus groups . Discussion The INFORM study has been design ed to provide robust findings about the short-term effects of providing different types of information on estimated 10-year CHD risk and lifestyle advice on health-related behaviours . Trial registration Current Controlled Trials IS RCT N17721237 . Registered 12 January 2015 Background Countries in sub-Saharan Africa ( SSA ) are experiencing an epidemic of cardiovascular disease ( CVD ) propelled by rapidly increasing rates of hypertension . Barriers to hypertension control in SSA include poor access to care and high out-of-pocket costs . Although SSA bears 24 % of the global disease burden , it has only 3 % of the global health workforce . Given such limited re sources , cost-effective strategies , such as task shifting , are needed to mitigate the rising CVD epidemic in SSA . Ghana , a country in SSA with an established community health worker program integrated within a national health insurance scheme provides an ideal platform to evaluate implementation of the World Health Organization ( WHO ) task-shifting strategy . This study will evaluate the comparative effectiveness of the implementation of the WHO Package targeted at CV risk assessment versus provision of health insurance coverage , on blood pressure ( BP ) reduction . Methods Using a cluster r and omized design , 32 community health centers ( CHCs ) and district hospitals in Ghana will be r and omized to either the  intervention  group ( 16 CHCs ) or the control group ( 16 CHCs ) . A total of 640 patients with uncomplicated hypertension ( BP 140–179/90–99 mm Hg and absence of target organ damage ) will be enrolled in this study ( 20 patients per CHC ) . The intervention consists of WHO Package of CV risk assessment , patient education , initiation and titration of antihypertensive medications , behavioral counseling on lifestyle behaviors , and medication adherence every three months for 12 months . The primary outcome is the mean change in systolic BP from baseline to 12 months . The secondary outcomes are rates of BP control at 12 months ; levels of physical activity , percent change in weight , and dietary intake of fruits and vegetables at 12 months ; and sustainability of intervention effects at 24 months . All outcomes will be assessed at baseline , six months and 12 months . Trained community health nurses will deliver the intervention as part of Ghana ’s community-based health planning and services ( CHPS ) program . Discussion Findings from this study will provide policy makers and other stakeholders needed information to recommend scalable and cost-effective policy with respect to comprehensive CV risk reduction and hypertension control in re source -poor setting s . Trial registration NCT01802372 BACKGROUND Cardiovascular disease ( CVD ) and diabetes account for one-third of the mortality difference between African American and white patients . We evaluated the effect of a CVD risk reduction intervention in African Americans with diabetes . METHODS We r and omized 359 African Americans with type 2 diabetes to receive usual care or a nurse telephone intervention .  The 12-month intervention provided monthly self-management support and quarterly medication management facilitation . Co primary outcomes were changes in systolic blood pressure ( SBP ) , hemoglobin A1c ( HbA1c ) , and low-density lipoprotein cholesterol ( LDL-C ) over 12 months . We estimated between-intervention group differences over time using linear mixed-effects models . The secondary outcome was self-reported medication adherence . RESULTS The sample was 72 % female ; 49 % had low health literacy , and 37 % had annual income < $ 10,000 . Model-based estimates for mean baseline SBP , HbA1c , and LDL-C were 136.8 mm Hg ( 95 % CI 135.0 - 138.6 ) , 8.0 % ( 95 % CI 7.8 - 8.2 ) , and 99.1 mg/dL ( 95 % CI 94.7 - 103.5 ) , respectively . Intervention patients received 9.9 ( SD 3.0 ) intervention calls on average . Primary providers replied to 76 % of nurse medication management facilitation contacts , 18 % of these result ed in medication changes . There were no between-group differences over time for SBP ( P = .11 ) , HbA1c ( P = .66 ) , or LDL-C ( P = .79 ) . Intervention patients were more likely than those receiving usual care to report improved medication adherence ( odds ratio 4.4 , 95 % CI 1.8 - 10.6 , P = .0008 ) , but adherent patients did not exhibit relative improvement in primary outcomes . CONCLUSIONS This intervention improved self-reported medication adherence but not CVD risk factor control among African Americans with diabetes . Further research is needed to determine how to maximally impact CVD risk factors in African American patients Background Cardiovascular disease ( CVD ) is the leading cause of death worldwide . Cardiac rehabilitation ( CR ) is aim ed at improving health behaviors to slow or reverse the progression of CVD disease . Exercise is a central element of CR . Technologies such as mobile phones and the Internet ( mHealth ) offer potential to overcome many of the psychological , physical , and geographical barriers that have been associated with lack of participation in exercise-based CR . We aim to trial the effectiveness of a mobile phone delivered exercise-based CR program to increase exercise capacity and functional outcomes compared with usual CR care in adults with CVD . This paper outlines the rationale and methods of the trial . Methods A single-blinded parallel two-arm r and omized controlled trial is being conducted . A total of 170 people will be r and omized at 1:1 ratio either to receive a  mHealth CR program  or usual care .  Participants are identified by CR nurses from two metropolitan hospitals in Auckl and , New Zeal and through outpatient clinics and existing data bases . Consenting participants are contacted to attend a baseline assessment . The intervention consists of a theory-based , personalized , automated package of text and video message components via participants ' mobile phones and the Internet to increase exercise behavior , delivered over six months . The control group will continue with usual CR . Data collection occurs at baseline and 24 weeks ( post-intervention ) . The primary outcome is change in maximal oxygen uptake from baseline to 24 weeks . Secondary outcomes include post-intervention measures on self-reported physical activity ( IPAQ ) , cardiovascular risk factors ( systolic blood pressure , weight , and waist to hip ratio ) , health related quality of life ( SF-36 ) , and cost-effectiveness . Discussion This manuscript presents the protocol for a r and omized controlled trial of a mHealth exercise-based CR program . Results of this trial will provide much needed information about physical and psychological well-being , and cost-effectiveness of an automated telecommunication intervention . If effective , this intervention has enormous potential to improve the delivery of CR and could easily be scaled up to be delivered nationally ( and internationally ) in a very short time , enhancing the translational aspect of this research . It also has potential to extend to comprehensive CR ( nutrition advice , smoking cessation , medication adherence).Trial Registration
Full prescription coverage , reduced copayments , FDC and counselling were facilitators associated with higher adherence .
BACKGROUND Secondary prevention is cost-effective for cardiovascular disease ( CVD ) , but uptake is suboptimal .
Underst and ing barriers and facilitators to adherence to secondary prevention for CVD at multiple health system levels may inform policy .
OBJECTIVES To conduct a systematic review of barriers and facilitators to adherence/persistence to secondary CVD prevention medications at health system level .