The effect of a decision aid intervention on decision making about coronary heart disease risk reduction: secondary analyses of a randomized trial 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 randomized trial of an intervention to improve use and adherence to effective coronary heart disease prevention strategies The effect of a smartphone-based coronary heart disease prevention (SBCHDP) programme on awareness and knowledge of CHD, stress, and cardiac-related lifestyle behaviours among the working population in Singapore: a pilot randomised controlled trial 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 Multiple risk factor intervention trial. Risk factor changes and mortality results. Multiple Risk Factor Intervention Trial Research Group. Influence on lifestyle measures and five-year coronary risk by a comprehensive lifestyle intervention programme in patients with coronary heart disease Coronary heart disease and all-causes mortality in the Multiple Risk Factor Intervention Trial: subgroup findings and comparisons with other trials. A comparison of live counseling with a web-based lifestyle and medication intervention to reduce coronary heart disease risk: a randomized clinical trial. The impact of a decision aid about heart disease prevention on patients' discussions with their doctor and their plans for prevention: a pilot randomized trial Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. Heart and Estrogen/progestin Replacement Study (HERS) Research Group. Designing and implementing a comparative effectiveness study of two strategies for delivering high quality CHD prevention: methods and participant characteristics for the Heart to Health study. Coronary heart disease death, nonfatal acute myocardial infarction and other clinical outcomes in the Multiple Risk Factor Intervention Trial. Multiple Risk Factor Intervention Trial Research Group. Effects of the mediterranean lifestyle program on multiple risk behaviors and psychosocial outcomes among women at risk for heart disease Prediction of 10-year coronary heart disease risk in Caribbean type 2 diabetic patients using the UKPDS risk engine. Implementation of case management to reduce cardiovascular disease risk in the Stanford and San Mateo Heart to Heart randomized controlled trial: study protocol and baseline characteristics Proactive Multifactorial Intervention Strategy Reduces the Risk of Cardiovascular Disease Estimated with Region-Specific Risk Assessment Models in Pacific Asian Patients Participating in the CRUCIAL Trial Acceptance of guideline recommendations and perceived implementation of coronary heart disease prevention among primary care physicians in five European countries: the Reassessing European Attitudes about Cardiovascular Treatment (REACT) survey. The Omega-3 Index: a new risk factor for death from coronary heart disease? A Randomised Trial of a Weight Loss Intervention for Overweight and Obese People Diagnosed with Coronary Heart Disease and/or Type 2 Diabetes Long-term follow-up of moderately hypercholesterolemic hypertensive patients following randomization to pravastatin vs usual care: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT). A novel programme to evaluate and communicate 10-year risk of CHD reduces predicted risk and improves patients' modifiable risk factor profile Disease management programme for secondary prevention of coronary heart disease and heart failure in primary care: a cluster randomised controlled trial
Background Decision aids offer promise as a practical solution to improve patient decision making about coronary heart disease ( CHD ) prevention medications and help patients choose medications to which they are likely to adhere . However , little data is available on decision aids design ed to promote adherence . Methods In this paper , we report on secondary analyses of a r and omized trial of a CHD adherence intervention ( second generation decision aid plus tailored messages ) versus usual care in an effort to underst and how the decision aid facilitates adherence . We focus on data collected from the primary study visit , when  intervention participants presented 45 minutes early to a previously scheduled provider visit ; viewed the decision aid , indicating their intent for CHD risk reduction after each decision aid component ( individualized risk assessment and education , values clarification , and coaching ) ; and filled out a post-decision aid survey assessing their knowledge , perceived risk , decisional conflict , and intent for CHD risk reduction . Control participants  did not present early and received usual care from their provider . Following the provider visit , participants in both groups completed post-visit surveys assessing the number and quality of CHD discussion s with their provider , their intent for CHD risk reduction , and their feelings about the decision aid . Results We enrolled 160 patients into our study ( 81 intervention , 79  control ) . Within the decision aid group , the decision aid significantly increased knowledge of effective CHD prevention strategies ( + 21 percentage points ; adjusted p<.0001 ) and the accuracy of perceived CHD risk ( + 33 percentage points ; adjusted p<.0001 ) , and significantly decreased decisional conflict ( -0.63 ; adjusted p<.0001 ) . Comparing between study groups , the decision aid also significantly increased CHD prevention discussion s with providers ( + 31 percentage points ; adjusted p<.0001 ) and improved perceptions of some features of patient-provider interactions . Further , it increased participants ’ intentions for any effective CHD risk reducing strategies ( + 21 percentage points ; 95 % CI 5 to 37 percentage points ) , with a majority of the effect from the educational component of the decision aid . Ninety-nine percent of participants found the decision aid easy to underst and and 93 % felt it easy to use . Conclusions Decision aids can play an important role in improving decisions about CHD prevention and increasing patient-provider discussion s and intent to reduce CHD risk 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 Efficacious strategies for the primary prevention of coronary heart disease ( CHD ) are underused , and , when used , have low adherence . Existing efforts to improve use and adherence to these efficacious strategies have been so intensive that they are impractical for clinical practice . Methods We conducted a r and omized trial of a CHD prevention intervention ( including a computerized decision aid and automated tailored adherence messages ) at one university general internal medicine practice . After obtaining informed consent and collecting baseline data , we r and omized patients ( men and women age 40 - 79 with no prior history of cardiovascular disease ) to either the intervention or usual care . We then saw them for two additional study visits over 3 months . For intervention participants , we administered the decision aid at the primary study visit ( 1 week after baseline visit ) and then mailed 3 tailored adherence reminders at 2 , 4 , and 6 weeks . We assessed our outcomes ( including the predicted likelihood of angina , myocardial infa rct ion , and CHD death over 10 years ( CHD risk ) and self-reported adherence ) between groups at 3 month follow-up . Data collection occurred from June 2007 through December 2009 . All study procedures were IRB approved . Results We r and omized 160 eligible patients ( 81 intervention ; 79 control ) and followed 96 % to study conclusion . Mean predicted CHD risk at baseline was 11.3 % . The intervention increased self-reported adherence to chosen risk reducing strategies by 25 percentage points ( 95 % CI 8 % to 42 % ) , with the biggest effect for aspirin . It also changed predicted CHD risk by -1.1 % ( 95 % CI -0.16 % to -2 % ) , with a larger effect in a pre-specified subgroup of high risk patients . Conclusion A computerized intervention that involves patients in CHD decision making and supports adherence to effective prevention strategies can improve adherence and reduce predicted CHD risk . Clinical trials registration number Clinical Trials.gov : Abstract Background Coronary heart disease ( CHD ) is the most prevalent type of cardiac disease among adults worldwide , including those in Singapore . Most of its risk factors , such as smoking , physical inactivity and high blood pressure , are preventable . mHealth has improved in the last decade , showing promising results in chronic disease prevention and health promotion worldwide . Our aim was to develop and examine the effect of a 4-week Smartphone-Based Coronary Heart Disease Prevention ( SBCHDP ) programme in improving awareness and knowledge of CHD , perceived stress as well as cardiac-related lifestyle behaviours in the working population of Singapore . Methods The smartphone app “ Care4Heart ” was developed as the main component of the programme . App content was review ed and vali date d by a panel of experts , including two cardiologists and two experienced cardiology-trained nurses . A pilot r and omised controlled trial was conducted . Eighty working people were recruited and r and omised to either the intervention group ( n = 40 ) or the control group ( n = 40 ) . The intervention group underwent a 4-week SBCHDP programme , whereas the control group were offered health promotion websites only . The participants ’ CHD knowledge , perceived stress and behavioural risk factors were measured at baseline and on the 4th week using the Heart Disease Fact Question naire-2 , Perceived Stress Scale , and Behavioural Risk Factor Surveillance System . Results After the SBCHDP programme , participants in the intervention group had a better awareness of CHD being the second leading cause of death in Singapore ( X2 = 6.486 , p = 0.039 ) , a better overall CHD knowledge level ( t = 3.171 , p = 0.002 ) , and better behaviour concerning blood cholesterol control ( X2 = 4.54 , p = 0.033 ) than participants in the control group . Conclusion This pilot study partially confirmed the positive effects of the SBCHDP programme in improving awareness and knowledge of CHD among the working population . Due to the small sample size and short follow-up period , this study was underpowered to detect significant differences between groups . A full-scale longitudinal study is required in the future to confirm the effectiveness of the SBCHDP programme 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 The Multiple Risk Factor Intervention Trial was a r and omized primary prevention trial to test the effect of a multifactor intervention program on mortality from coronary heart disease ( CHD )  in 12,866 high-risk men aged 35 to 57 years . Men were r and omly assigned either to a special intervention ( SI ) program consisting of stepped-care treatment for hypertension , counseling for cigarette smoking , and dietary advice for lowering blood cholesterol levels , or to their usual sources of health care in the community ( UC ) . Over an average follow-up period of seven years , risk factor levels declined in both groups , but to a greater degree for the SI men . Mortality from CHD was 17.9 deaths per 1,000 in the SI group and 19.3 per 1,000 in the UC group , a statistically nonsignificant difference of 7.1 % ( 90 % confidence interval , -15 % to 25 ) . Total mortality rates were 41.2 per 1,000 ( SI ) and 40.4 per 1,000 ( UC ) . Three possible explanations for these findings are considered : ( 1 ) the overall intervention program , under these circumstances , does not affect CHD mortality ; ( 2 ) the intervention used does affect CHD mortality , but the benefit was not observed in this trial of seven years ' average duration , with lower-than-expected mortality and with considerable risk factor change in the UC group ; and ( 3 ) measures to reduce cigarette smoking and to lower blood cholesterol levels may have reduced CHD mortality within subgroups of the SI cohort , with a possibly unfavorable response to antihypertensive drug therapy in certain but not all hypertensive subjects . This last possibility was considered most likely , needs further investigation , and lends support to some preventive measures while requiring re assessment of others Background Lifestyle measures of coronary heart disease ( CHD ) prevention have been overshadowed by the efficacy of drug treatments . This is particularly the case in the setting of secondary prevention where the benefits of lipid lowering , anti-platelet and anti-hypertensive drugs have been emphasised in numerous trials . Lifestyle measures address several CHD risk factors at once and are generally free of serious side effects . Objectives The objective of the present study was to determine whether a comprehensive programme of lifestyle modification could favourably influence dietary and exercise habits in addition to smoking cessation over two years . In addition , an attempt was made to evaluate if this programme could favourably influence the five-year CHD-risk in the male population included in the study . Design A total of 197 patients with proven coronary heart disease were included and r and omised to a lifestyle intervention programme or to usual care . Follow-up was after a period of two years . Methods Intervention comprised a low fat diet , regular exercise , smoking cessation , psychosocial support and education , delivered by nurses on the rationale for pharmacological and lifestyle measures . Usual care comprised follow-up in the routine outpatient clinic . Both groups were given the same comprehensive medication according to recent guidelines . Results Patients in the lifestyle intervention group reduced the intake of saturated fat , sugar and cholesterol ( P<0.001 ) , increased their exercise level ( P<0.01 ) and stopped smoking ( P<0.05 ) when compared with the usual care group . A sub analysis of the influence of five-year CHD calculated risk in males result ed in a relative risk reduction of 22 % ( 95 % confidence intervals 9 - 35 ) . Although significant , this result must be interpreted with caution due to poor statistical power and reproducibility of the method . Conclusions In the presence of modern drug treatments for secondary cardiovascular disease prevention it remains possible through a favourable diet , exercise and smoking cessation to show an additional reduction in the five-year risk for CHD in males The Multiple Risk Factor Intervention Trial ( MRFIT ) was a r and omized primary prevention trial to test whether a special intervention ( SI ) program to reduce high blood pressure , elevated blood cholesterol , and /or cigarette smoking could lower  coronary heart disease ( CHD ) mortality in middle-aged men at above average risk . After an average follow-up period of 7 years , risk factor levels were reduced substantially more in SI than in usual-care ( UC ) men ; however , SI-UC differences in CHD mortality ( 7.1 % ) and total mortality ( -2.1 % ) were not statistically significant . Subgroup analysis showed 35 % fewer SI than UC CHD deaths ( P = 0.14 ) but no all-causes mortality difference in men comparable to the cohort having dietary and smoking intervention in Oslo ( the " Oslo-like " cohort ) . Among the subgroup hypertensive at entry , SI-UC differences in CHD and total mortality appeared to be heterogeneous : CHD mortality was 24 % lower in SI than UC men with a normal resting ECG at baseline , but 67 % higher if baseline ECG abnormalities were present ( nominal P = 0.02 , for difference in relative risk estimates ) . These findings were supported by within-group analyses and are generally consistent with results of other CHD/cardiovascular disease prevention trials . They pose a new hypothesis about possible adverse effects of diuretic therapy in a minority of the hypertensive population IMPORTANCE Most primary care clinicians lack the skills and re sources to offer effective lifestyle and medication ( L&M ) counseling to reduce coronary heart disease ( CHD ) risk . Thus , effective and feasible CHD prevention programs are needed for typical practice setting s. OBJECTIVE To assess the effectiveness , acceptability , and cost-effectiveness of a combined L&M intervention to reduce CHD risk offered in counselor-delivered and web-based formats . DESIGN , SETTING , AND PARTICIPANTS A comparative effectiveness trial in 5 diverse family medicine practice s in North Carolina . Participants were established patients , aged 35 to 79 years , with no known cardiovascular disease , and at moderate to high risk for CHD ( 10-year Framingham Risk Score [ FRS ] , ≥10 % ) . INTERVENTIONS Participants were r and omized to counselor-delivered or web-based format , each including 4 intensive and 3 maintenance sessions . After r and omization , both formats used a web-based decision aid showing potential CHD risk reduction associated with L&M risk-reducing strategies . Participants chose the risk-reducing strategies they wished to follow . MAIN OUTCOMES AND MEASURES The primary outcome was within-group change in FRS at 4-month follow-up . Other measures included st and ardized assessment s of blood pressure , blood lipid levels , lifestyle behaviors , and medication adherence . Acceptability and cost-effectiveness were also assessed . Outcomes were assessed at 4 and 12 months . RESULTS Of 2274 screened patients , 385 were r and omized ( 192 counselor ; 193 web ) : mean age , 62 years ; 24 % African American ; and mean FRS , 16.9 % . Follow-up at 4 and 12 months included 91 % and 87 % of the r and omized participants , respectively . There was a sustained reduction in FRS at both 4 months ( primary outcome ) and 12 months for both counselor-based ( -2.3 % [ 95 % CI , -3.0 % to -1.6 % ] and -1.9 % [ 95 % CI , -2.8 % to -1.1 % ] , respectively ) and web-based groups ( -1.5 % [ 95 % CI , -2.2 % to -0.9 % ] and -1.7 % [ 95 % CI , -2.6 % to -0.8 % ] respectively ) . At 4 months , the adjusted difference in FRS between groups was -1.0 % ( 95 % CI , -1.8 % to -0.1 % ) ( P = .03 ) , and at 12 months , it was -0.6 % ( 95 % CI , -1.7 % to 0.5 % ) ( P = .30 ) . The 12-month costs from the payer perspective were $ 207 and $ 110 per person for the counselor- and web-based interventions , respectively . CONCLUSIONS AND RELEVANCE Both intervention formats reduced CHD risk through 12-month follow-up . The web format was less expensive . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01245686 Abstract Background Low utilization of effective coronary heart disease ( CHD ) prevention strategies may be due to many factors , but chief among them is the lack of patient involvement in prevention decisions . We undertook this study to test the effectiveness of an individually-tailored , computerized decision aid about CHD on patients ' discussion s with their doctor and their plans for CHD prevention . Methods We conducted a pilot r and omized trial in a convenience sample of adults with no previous history of cardiovascular disease to test the effectiveness of an individually-tailored , computerized decision aid about CHD prevention against a risk factor list that patients could present to their doctor . Results We enrolled 75 adults . Mean age was 53 . 59 % were female , 73 % white , and 23 % African-American . 66 % had some college education . 43 % had a 10-year CHD risk of 0–5 % , 25 % a risk of 6–10 % , 24 % a risk of 11–20 % , and 5 % a risk of > 20 % . 78 % had at least one option to reduce their CHD risk , but only 45 % accurately identified the strategies best supported by evidence . 41 patients received the decision aid  , 34 received  usual care . In unadjusted analysis , the decision aid increased the proportion of patients who discussed CHD risk reduction with their doctor from 24 % to 40 % ( absolute difference 16 % ; 95 % CI -4 % to + 37 % ) and increased the proportion who had a specific plan to reduce their risk from 24 % to 37 % ( absolute difference 13 % ; 95 % CI -7 % to + 34 % ) . In pre-post testing , the decision aid also appeared to increase the proportion of patients with plans to intervene on their CHD risk ( absolute increase ranging from 21 % to 47 % for planned medication use and 5 % to 16 % for planned behavioral interventions ) . Conclusion Our study confirms patients ' limited knowledge about their CHD risk and effective risk reduction options and provides preliminary evidence that an individually-tailored decision aid about CHD prevention might be expected to increase patients ' discussion s about CHD prevention with their doctor and their plans for CHD risk reduction . These findings should be replicated in studies with a larger sample size and patients at overall higher risk of CHD . Trial Registration : Clinical Trials.gov CONTEXT Observational studies have found lower rates of coronary heart disease ( CHD ) in postmenopausal women who take estrogen than in women who do not , but this potential benefit has not been confirmed in clinical trials . OBJECTIVE To determine if estrogen plus progestin therapy alters the risk for CHD events in postmenopausal women with established coronary disease . DESIGN R and omized , blinded , placebo-controlled secondary prevention trial . SETTING Outpatient and community setting s at 20 US clinical centers . PARTICIPANTS A total of 2763 women with coronary disease , younger than 80 years , and postmenopausal with an intact uterus . Mean age was 66.7 years . INTERVENTION Either 0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate in 1 tablet daily ( n = 1380 ) or a placebo of identical appearance ( n = 1383 ) . Follow-up averaged 4.1 years ; 82 % of those assigned to hormone treatment were taking it at the end of 1 year , and 75 % at the end of 3 years . MAIN OUTCOME MEASURES The primary outcome was the occurrence of nonfatal myocardial infa rct ion ( MI ) or CHD death . Secondary cardiovascular outcomes included coronary revascularization , unstable angina , congestive heart failure , resuscitated cardiac arrest , stroke or transient ischemic attack , and peripheral arterial disease . All-cause mortality was also considered . RESULTS Overall , there were no significant differences between groups in the primary outcome or in any of the secondary cardiovascular outcomes : 172 women in the hormone group and 176 women in the placebo group had MI or CHD death ( relative hazard [ RH ] , 0.99 ; 95 % confidence interval [ CI ] , 0.80 - 1.22 ) . The lack of an overall effect occurred despite a net 11 % lower low-density lipoprotein cholesterol level and 10 % higher high-density lipoprotein cholesterol level in the hormone group compared with the placebo group ( each P<.001 ) . Within the overall null effect , there was a statistically significant time trend , with more CHD events in the hormone group than in the placebo group in year 1 and fewer in years 4 and 5 . More women in the hormone group than in the placebo group experienced venous thromboembolic events ( 34 vs 12 ; RH , 2.89 ; 95 % CI , 1.50 - 5.58 ) and gallbladder disease ( 84 vs 62 ; RH , 1.38 ; 95 % CI , 1.00 - 1.92 ) . There were no significant differences in several other end points for which power was limited , including fracture , cancer , and total mortality ( 131 vs 123 deaths ; RH , 1.08 ; 95 % CI , 0.84 - 1.38 ) . CONCLUSIONS During an average follow-up of 4.1 years , treatment with oral conjugated equine estrogen plus medroxyprogesterone acetate did not reduce the overall rate of CHD events in postmenopausal women with established coronary disease . The treatment did increase the rate of thromboembolic events and gallbladder disease . Based on the finding of no overall cardiovascular benefit and a pattern of early increase in risk of CHD events , we do not recommend starting this treatment for the purpose of secondary prevention of CHD . However , given the favorable pattern of CHD events after several years of therapy , it could be appropriate for women already receiving this treatment to continue BACKGROUND Although lifestyle and medications are effective for coronary heart disease ( CHD ) risk reduction , few studies have examined the comparative effectiveness of various strategies for delivering high quality CHD risk reduction . In this paper , we report on the design and baseline characteristics of participants for just such a trial . METHODS We conducted a r and omized trial of the same lifestyle and medication intervention delivered in two alternate formats : counselor-delivered or web-based . The trial was conducted at 5 diverse practice s in a family medicine research network and included men and women age 35 - 79 who were at high risk of CHD events based on 10-year predicted Framingham risk of ≥10 % or a known history of cardiovascular disease . After individual-level r and omization , participants in both arms received a decision aid plus four intensive intervention visits and 3 maintenance visits over 12 months . The primary outcome was change in 10-year predicted CHD risk among patients without prior cardiovascular disease . Secondary outcomes , measured among all participants , included changes in CHD risk factors , cost-effectiveness , and acceptability at 4 and 12-month follow-up . RESULTS We r and omized 489 eligible patients : 389 without and 100 with a known history of cardiovascular disease . Mean age was 62.3 . 75 % were white , 25 % African-American . 45 % had a college education . 88 % had health insurance . Mean 10-year predicted CHD risk was 16.9 % . CONCLUSION We have successfully recruited a diverse sample of practice s and patients that will provide a rich sample in which to test the comparative effectiveness of two strategies to implement high quality CHD prevention The Multiple Risk Factor Intervention Trial was a r and omized clinical study to test whether a special-intervention ( SI ) program aim ed at reducing serum cholesterol levels , blood pressure and cigarette smoking would prevent coronary heart disease ( CHD ) in middle-aged men . The main endpoint reported here is the percentage of participants experiencing first major CHD events ( either nonfatal acute myocardial infa rct ion [ AMI ] or CHD death ) during 7 years of follow-up . This outcome was slightly less frequent in the 6,428 SI men than in the 6,438 men assigned to their usual source of care ( UC ) . However , the relative difference -- either 1 % ( 95 % confidence interval -17 % to 16 % ) or 8 % ( 95 % confidence interval -5 % to 20 % ) , depending on how AMI was classified -- was not statistically significant . Regression analyses within the SI and UC groups suggested that the cholesterol and cigarette smoking interventions reduced the number of first major CHD events : the associations between lowering the levels of these 2 factors and reductions in CHD rates were significant ( p less than 0.001 ) and of the anticipated magnitude . A similar analysis of antihypertensive treatment in the SI group revealed no favorable association between lowering blood pressure and CHD rate , and other subgroup comparisons suggested that a mixture of beneficial and adverse effects may underlie this finding . Thus , the nonsignificant overall UC/SI contrast in CHD rates may reflect a combination of the expected beneficial effects of the cholesterol and smoking interventions with unexpected heterogeneous effects of the antihypertensive intervention . Seven of 8 other prespecified cardiovascular endpoints occurred less frequently among SI than among UC men , the difference being nominally significant ( p less than 0.05 ) for angina pectoris , congestive heart failure and peripheral arterial disease Background : The Mediterranean Lifestyle Program was evaluated for its effects on multiple behavioral risk factors for coronary heart disease ( CHD )  among postmenopausal women with diabetes . Purpose : Our purpose is to test a comprehensive lifestyle management intervention to reduce CHD risk in postmenopausal women with type 2 diabetes . Methods : Participants ( N = 279 ) were r and omized to usual care ( UC ) or Mediterranean Lifestyle Program , a lifestyle change intervention aim ed at the behavioral risk factors ( eating patterns , physical activity , stress management , and social support ) affecting risk for CHD in postmenopausal women with type 2 diabetes . Results : In original and intent-to-treat analyses ,  Mediterranean Lifestyle Program participants showed significantly greater improvement in dietary behaviors , physical activity , stress management , perceived support , and weight loss at 6 months compared to UC . Conclusions : This study demonstrated the effectiveness of the Mediterranean Lifestyle Program in improving self-care among women with type 2 diabetes , showed that postmenopausal women could make comprehensive lifestyle changes , and provided evidence that a program using social-cognitive strategies and peer support can be used to modify multiple lifestyle behaviors OBJECTIVE Primary prevention of Coronary Heart Disease ( CHD ) in diabetic patients should be based on absolute CHD risk calculation . This study was aim ed to determine the levels of 10-year CHD risk in Caribbean type 2 diabetic patients using the diabetes specific United Kingdom Prospect i ve Diabetes Study ( UKPDS ) risk engine calculator . SUBJECTS AND METHODS Three hundred and twenty-five ( 106 males , 219 females ) type 2 diabetic patients resident in two Caribbean Isl and s of Tobago and Trinidad met the UKPDS risk engine inclusion criteria . Records of their sex , age , ethnicity , smoking habit , diabetes duration , systolic blood pressure , total cholesterol , HDL-cholesterol and glycated haemoglobin were entered into the UKPDS risk engine calculator programme and the absolute 10-year CHD and stroke risk levels were computed . The 10-year CHD and stroke risks were statistically stratified into < 15 % , 15 - 30 % and > 30 % CHD risk levels and differences between patients of African and Asian-Indian origin were compared . RESULTS In comparison with patients in Tobago , type 2 diabetic patients in Trinidad , irrespective of gender , had higher proportion of 10-year CHD risk ( 10.4 vs. 23.6 % , P<0.001 ) whereas the overall 10-year stroke risk prediction was higher in patients resident in Tobago ( 16.9 vs. 11.4 % , P<0.001 ) . Ethnicity-based analysis revealed that irrespective of gender , higher proportion of patients of Indian origin scored > 30 % of absolute 10-year CHD risk compared with patients of African descent ( 3.2 vs. 28.2 % , P<0.001 ) . CONCLUSIONS The results of the study identified diabetic patients resident in Trinidad and patients of Indian origin as the most vulnerable groups for CHD . These groups of diabetic patients should have priority in primary or secondary prevention of coronary heart disease Background Case management has emerged as a promising alternative approach to supplement traditional one-on-one sessions between patients and doctors for improving the quality of care in chronic diseases such as coronary heart disease ( CHD ) . However , data are lacking in terms of its efficacy and cost-effectiveness when implemented in ethnic and low-income population s. Methods The Stanford and San Mateo Heart to Heart ( HTH ) project is a r and omized controlled clinical trial design ed to rigorously evaluate the efficacy and cost-effectiveness of a multi-risk cardiovascular case management program in low-income , primarily ethnic minority patients served by a local county health care system in California . R and omization occurred at the patient level . The primary outcome measure is the absolute CHD risk over 10 years . Secondary outcome measures include adherence to guidelines on CHD prevention practice . We documented the study design , methodology , and baseline sociodemographic , clinical and lifestyle characteristics of 419 participants . Results We achieved equal distributions of the sociodemographic , biophysical and lifestyle characteristics between the two r and omization groups . HTH participants had a mean age of 56 years , 63 % were Latinos/Hispanics , 65 % female , 61 % less educated , and 62 % were not employed . Twenty percent of participants reported having a prior  cardiovascular event . 10-year CHD risk averaged 18 % in men and 13 % in women despite a modest low-density lipoprotein cholesterol level and a high on-treatment percentage at baseline . Sixty-three percent of participants were diagnosed with diabetes and an additional 22 % had metabolic syndrome . In addition , many participants had depressed high-density lipoprotein ( HDL ) cholesterol levels and elevated values of total cholesterol-to-HDL ratio , triglycerides , triglyceride-to-HDL ratio , and blood pressure . Furthermore , nearly 70 % of participants were obese , 45 % had a family history of CHD or stroke , and 16 % were current smokers . Conclusion We have recruited an ethnically diverse , low-income cohort in which to implement a case management approach and test its efficacy and cost-effectiveness . HTH will advance the scientific underst and ing of better strategies for CHD prevention among these priority sub population s and aid in guiding future practice that will reduce health disparities Despite race , ethnic , and regional differences in cardiovascular disease risk , many worldwide hypertension management guidelines recommend the use of the Framingham coronary heart disease ( CHD ) risk equation to guide treatment decisions . This sub analysis of the recently published CRUCIAL trial compared the treatment-related reductions in calculated CHD and stroke risk among Pacific Asian ( PA ) patients using a variety of region-specific risk assessment models . As a result , greater reductions in systolic and diastolic blood pressure , low-density lipoprotein cholesterol , and triglycerides were observed in the proactive multifactorial intervention ( PMI ) arm compared with the usual care arm at Week 52 for PA patients . The relative percentage change in 10-yr CHD risk between baseline and Week 52 in the PMI versus usual care arms was greatest using the NIPPON DATA 80 fatal CHD model ( LS [ least square ] mean difference -42.6 % ) , and similar in the SCORE fatal CHD and Framingham total CHD models ( LS mean difference -29.4 % and -30.8 % , respectively ) . The single-pill based PMI approach is consistently effective in reducing cardiovascular disease risk , evaluated using a variety of risk assessment models . ( Clinical Trials.gov registration number : NCT00407537 BACKGROUND Although primary care is the major target of coronary heart disease ( CHD ) clinical recommendations , little is known of how community physicians view guidelines and their implementation . The REACT survey was design ed to assess the views , and perceived implementation , of CHD and lipid treatment guidelines among primary care physicians . METHODS Semi-structured vali date d telephone interviews were conducted , in the relevant native tongue , with 754 r and omly selected primary care physicians ( GPs and family doctors ) in five European countries ( France , Germany , Italy , Sweden and the UK ) . RESULTS Most physicians ( 89 % ) agreed with the content of current guidelines and reported use of them ( 81 % ) . However , only 18 % of physicians believed that guidelines were being implemented to a major extent . Key barriers to greater implementation of guidelines were seen as lack of time ( 38 % of all physicians ) , prescription costs ( 30 % ) , and patient compliance ( 17 % ) . Suggestions for ways to improve implementation centred on more education , both for physicians themselves ( 29 % ) and patients ( 25 % ) ; promoting , publicizing or increasing guideline availability ( 23 % ) ; simplifying the guidelines ( 17 % ) ; and making them clearer ( 12 % ) . Physicians perceived diabetes to be the most important risk factor for CHD , followed by hypertension and raised LDL-C. Most physicians ( 92 % ) believe their patients do associate high cholesterol levels with CHD . After establishing that a patient is ' at risk ' of CHD , physicians reported spending an average of 16.5 minutes discussing risk factors and lifestyle changes or treatment that is required . Factors preventing this included insufficient time ( 42 % ) , having too many other patients to see ( 27 % ) and feeling that patients did not listen or underst and anyway ( 21 % ) . CONCLUSIONS Primary care physicians need more information and support on the implementation of CHD and cholesterol guideline recommendations . This need is recognized by clinicians BACKGROUND Low intakes or blood levels of eicosapentaenoic and docosahexaenoic acids ( EPA + DHA ) are independently associated with increased risk of death from coronary heart disease ( CHD ) . In r and omized secondary prevention trials , fish or fish oil have been demonstrated to reduce total and CHD mortality at intakes of about 1 g/day . Red blood cell ( RBC ) fatty acid ( FA ) composition reflects long-term intake of EPA + DHA . We propose that the RBC EPA + DHA ( hereafter called the Omega-3 Index ) be considered a new risk factor for death from CHD . METHODS We conducted clinical and laboratory experiments to generate data necessary for the validation of the Omega-3 Index as a CHD risk predictor . The relationship between this putative marker and risk for CHD death , especially sudden cardiac death ( SCD ) , was then evaluated in several published primary and secondary prevention studies . RESULTS The Omega-3 Index was inversely associated with risk for CHD mortality . An Omega-3 Index of > or = 8 % was associated with the greatest cardioprotection , whereas an index of < or = 4 % was associated with the least . CONCLUSION The Omega-3 Index may represent a novel , physiologically relevant , easily modified , independent , and grade d risk factor for death from CHD that could have significant clinical utility Background Weight reduction limits disease progression in obese people with coronary heart disease ( CHD ) and /or type 2 diabetes mellitus ( T2DM ) . Purpose To test a 16-week group-based weight reduction intervention combining exercise , diet and behaviour change strategies aim ed to increase self-efficacy  ( Healthy Eating and Exercise Lifestyle Program — HEELP ) on weight , body mass index ( BMI ) , waist circumference and exercise . Methods Participants with CHD and /or T2DM and BMI between 27 to 39 kg/m2 were r and omised to HEELP  ( n = 83 ) or usual care ( n = 65 ) . Results Participants were aged a mean 63.47 years ( SD 8.9 ) , male ( 58 % ) and Caucasian ( 79 % ) . HEELP participants lost significantly more weight , BMI and waist circumference and exercised more days/week for a longer duration /week than usual care . Clinical ly significant weight loss ( ≥5 % ) was more common in HEELP than usual care . Conclusion The HEELP result ed in weight loss and improved exercise behaviour in obese people with CHD and T2DM The authors conducted a r and omized , controlled , multicenter trial , in which they assigned well-controlled hypertensive participants aged 55 years and older with moderate hypercholesterolemia to receive pravastatin ( n=5170 ) or usual care ( n=5185 ) for 4 to 8 years , when trial therapy was discontinued . Passive surveillance using national data bases to ascertain deaths and hospitalizations continued for a total follow-up of 8 to 13 years to assess whether mortality and morbidity differences persisted or new differences developed . During the post-trial period , fatal and nonfatal outcomes were available for 98 % and 64 % of participants , respectively . The primary outcome was all-cause mortality and the secondary outcomes included cardiovascular mortality , coronary heart disease ( CHD ) , stroke , heart failure , cardiovascular disease , and end-stage renal disease . No significant differences appeared in mortality for pravastatin vs usual care ( hazard ratio [ HR ] , 0.96 ; 95 % confidence interval [ CI ] , 0.89 - 1.03 ) or other secondary outcomes . Similar to the previously reported in-trial result , there was a significant treatment effect for CHD in black patients ( HR , 0.79 ; 95 % CI , 0.64 - 0.98 ) . However , the in-trial result showing a significant treatment by race effect did not remain significant during the entire follow-up ( P=.08 ) . These findings are consistent with evidence from other large trials that show statins prevent CHD and add evidence that they are effective for CHD prevention in black patients Aims We assessed whether a novel programme to evaluate/communicate predicted coronary heart disease ( CHD ) risk could lower patients ' predicted Framingham CHD risk vs. usual care . Methods The Risk Evaluation and Communication Health Outcomes and Utilization Trial was a prospect i ve , controlled , cluster-r and omised trial in nine European countries , among patients at moderate cardiovascular risk . Following baseline assessment s , physicians in the intervention group calculated patients ' predicted CHD risk and were instructed to advise patients according to a risk evaluation/communication programme . Usual care physicians did not calculate patients ' risk and provided usual care only . The primary end-point was Framingham 10-year CHD risk at 6 months with intervention vs. usual care . Results Of 1103 patients across 100 sites , 524 patients receiving intervention , and 461 receiving usual care , were analysed for efficacy . After 6 months , mean predicted risks were 12.5 % with intervention , and 13.7 % with usual care [ odds ratio = 0.896 ; p = 0.001 , adjusted for risk at baseline ( 17.2 % intervention ; 16.9 % usual care ) and other covariates ] . The proportion of patients achieving both blood pressure and low-density lipoprotein cholesterol targets was significantly higher with intervention ( 25.4 % ) than usual care ( 14.1 % ; p < 0.001 ) , and 29.3 % of smokers in the intervention group quit smoking vs. 21.4 % of those receiving usual care ( p = 0.04 ) . Conclusions A physician-implemented CHD risk evaluation/communication programme improved patients ' modifiable risk factor profile , and lowered predicted CHD risk compared with usual care . By combining this strategy with more intensive treatment to reduce residual modifiable risk , we believe that substantial improvements in cardiovascular disease prevention could be achieved in clinical practice Aims : To evaluate the effect of a disease management programme for patients with coronary heart disease ( CHD ) and chronic heart failure ( CHF ) in primary care . Methods : A cluster r and omised controlled trial of 1316 patients with CHD and CHF from 20 primary care practice s in the UK was carried out . Care in the intervention practice s was delivered by specialist nurses trained in the management of patients with CHD and CHF . Usual care was delivered by the primary healthcare team in the control practice s. Results : At follow up , significantly more patients with a history of myocardial infa rct ion in the intervention group were prescribed a beta-blocker compared to the control group ( adjusted OR 1.43 , 95 % CI 1.19 to 1.99 ) . Significantly more patients with CHD in the intervention group had adequate management of their blood pressure ( < 140/85 mm Hg ) ( OR 1.61 , 95 % CI 1.22 to 2.13 ) and their cholesterol ( < 5 mmol/l ) ( OR 1.58 , 95 % CI 1.05 to 2.37 ) compared to those in the control group . Significantly more patients with an unconfirmed diagnosis of CHF had a diagnosis of left ventricular systolic dysfunction confirmed ( OR 4.69 , 95 % CI 1.88 to 11.66 ) or excluded ( OR 3.80 , 95 % CI 1.50 to 9.64 ) in the intervention group compared to the control group . There were significant improvements in some quality -of-life measures in patients with CHD in the intervention group . Conclusions : Disease management programmes can lead to improvements in the care of patients with CHD and presumed CHF in primary care
Multifactorial lifestyle interventions aim ed at improving modifiable risk factors in patients with established CHD reduce the risk for fatal cardiovascular events .
Therefore , they may have added value in secondary prevention of CHD
CONTEXT Coronary heart disease ( CHD ) is responsible for about 15 % of all deaths worldwide and is identified as a top priority for decision makers .
Both primary and secondary prevention are considered key strategies in the prevention of CHD .
The aim of this study was to assess the efficacy of nonpharmacologic interventions with multiple lifestyle components in patients with established CHD in comparison to usual care .