Influence on lifestyle measures and five-year coronary risk by a comprehensive lifestyle intervention programme in patients with coronary heart disease 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. 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] 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 Disease management programme for secondary prevention of coronary heart disease and heart failure in primary care: a cluster 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 Improving coronary heart disease self-management using mobile technologies (Text4Heart): a randomised controlled trial protocol Randomized trial of an internet-based computer-tailored expert system for physical activity in patients with heart disease Text Message and Internet Support for Coronary Heart Disease Self-Management: Results From the Text4Heart Randomized Controlled Trial A randomised, feasibility trial of a tele-health intervention for Acute Coronary Syndrome patients with depression ('MoodCare'): Study protocol A Web-Based Program Improves Physical Activity Outcomes in a Primary Care Angina Population: Randomized Controlled Trial Costs of a Community Pharmacist-Led Medicines Management Service for Patients with Coronary Heart Disease in England Randomised controlled trial of a secondary prevention program for myocardial infarction patients ('ProActive Heart'): study protocol. Secondary prevention program for myocardial infarction patients A comparison of live counseling with a web-based lifestyle and medication intervention to reduce coronary heart disease risk: a randomized clinical trial. Cost-effectiveness of a coronary heart disease secondary prevention program in patients with myocardial infarction: results from a randomised controlled trial (ProActive Heart) Quality of care for secondary prevention for patients with coronary heart disease: results of the Hastening the Effective Application of Research through Technology (HEART) trial. Coaching patients with coronary heart disease to achieve the target cholesterol: a method to bridge the gap between evidence-based medicine and the "real world"--randomized controlled trial. Prediction of 10-year coronary heart disease risk in Caribbean type 2 diabetic patients using the UKPDS risk engine. Nurse case management of hypercholesterolemia in patients with coronary heart disease: results of a randomized clinical trial. Association of temporal trends in risk factors and treatment uptake with coronary heart disease mortality, 1994-2005. 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 Evaluating the efficacy of an education and treatment program for patients with coronary heart disease. A pharmacist-led follow-up program for patients with established coronary heart disease in North Norway – a randomized controlled trial
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 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 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 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 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 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 Cardiac rehabilitation ( CR ) is a secondary prevention program that offers education and support to assist patients with coronary heart disease ( CHD ) make lifestyle changes . Despite the benefits of CR , attendance at centre-based sessions remains low . Mobile technology ( mHealth ) has potential to reach more patients by delivering CR directly to mobile phones , thus providing an alternative to centre-based CR . The aim of this trial is to evaluate if a mHealth comprehensive CR program can improve adherence to healthy lifestyle behaviours ( for example , physically active , fruit and vegetable intake , not smoking , low alcohol consumption ) over and above usual CR services in New Zeal and adults diagnosed with CHD . Methods / design A two-arm , parallel , r and omised controlled trial will be conducted at two Auckl and hospitals in New Zeal and . One hundred twenty participants will be r and omised to receive a 24-week evidence - and theory-based personalised text message program and access to a supporting website in addition to usual CR care or usual CR care alone ( control ) . The primary outcome is the proportion of participants adhering to healthy behaviours at 6 months , measured using a composite health behaviour score . Secondary outcomes include overall cardiovascular disease risk , body composition , illness perceptions , self-efficacy , hospital anxiety/depression and medication adherence . Discussion This study is one of the first to examine an mHealth-delivered comprehensive CR program . Strengths of the trial include quality research design and in-depth description of the intervention to aid replication . If effective , the trial has potential to augment st and ard CR practice s and to be used as a model for other disease prevention or self-management programs . Trial registryAustralian New Zeal and Clinical Trials Registry : Background : The CardioFit internet-based expert system was design ed to promote physical activity in patients with coronary heart disease ( CHD ) who were not participating in cardiac rehabilitation . Design : This r and omized controlled trial compared CardioFit to usual care to assess its effects on physical activity following hospitalization for acute coronary syndromes . Methods : A total of 223 participants were recruited at the University of Ottawa Heart Institute or London Health Sciences Centre and r and omly assigned to either  CardioFit  ( n = 115 ) or  usual care ( n = 108 ) . The CardioFit group received a personally tailored physical-activity plan upon discharge from the hospital and access to a secure website for activity planning and tracking . They completed five online tutorials over a 6-month period and were in email contact with an exercise specialist . Usual care consisted of physical activity guidance from an attending cardiologist .  Physical activity was measured by pedometer and self-reported over a 7-day period , 6 and 12 months after r and omization . Results : The CardioFit internet-based physical activity expert system significantly increased objective ly measured ( p = 0.023 ) and self-reported physical activity ( p = 0.047 ) compared to usual care . Emotional ( p = 0.038 ) and physical ( p = 0.031 ) dimensions of heart disease health-related quality of life were also higher with CardioFit compared to usual care . Conclusions : Patients with CHD using an internet-based activity prescription with online coaching were more physically active at follow up than those receiving usual care . Use of the CardioFit program could extend the reach of rehabilitation and secondary -prevention services Background Mobile technology has the potential to deliver behavior change interventions ( mHealth ) to reduce coronary heart disease ( CHD ) at modest cost . Previous studies have focused on single behaviors ; however , cardiac rehabilitation ( CR ) , a component of CHD self-management , needs to address multiple risk factors . Objective The aim was to investigate the effectiveness of a mHealth-delivered comprehensive CR program ( Text4Heart ) to improve adherence to recommended lifestyle behaviors ( smoking cessation , physical activity , healthy diet , and nonharmful alcohol use ) in addition to usual care ( traditional CR ) . Methods A 2-arm , parallel , r and omized controlled trial was conducted in New Zeal and adults diagnosed with CHD . Participants were recruited in-hospital and were encouraged to attend center-based CR ( usual care control ) . In addition , the intervention group received a personalized 24-week mHealth program , framed in social cognitive theory , sent by fully automated daily short message service ( SMS ) text messages and a supporting website . The primary outcome was adherence to healthy lifestyle behaviors measured using a self-reported composite health behavior score ( ≥3 ) at 3 and 6 months . Secondary outcomes included clinical outcomes , medication adherence score , self-efficacy , illness perceptions , and anxiety and /or depression at 6 months . Baseline and 6-month follow-up assessment s ( unblinded ) were conducted in person . Results Eligible patients ( N=123 ) recruited from 2 large metropolitan hospitals were r and omized to the intervention ( n=61 ) or the control ( n=62 ) group . Participants were predominantly male ( 100/123 , 81.3 % ) , New Zeal and European ( 73/123 , 59.3 % ) , with a mean age of 59.5 ( SD 11.1 ) years . A significant treatment effect in favor of the intervention was observed for the primary outcome at 3 months ( AOR 2.55 , 95 % CI 1.12 - 5.84 ; P=.03 ) , but not at 6 months ( AOR 1.93 , 95 % CI 0.83 - 4.53 ; P=.13 ) . The intervention group reported significantly greater medication adherence score ( mean difference : 0.58 , 95 % CI 0.19 - 0.97 ; P=.004 ) . The majority of intervention participants reported reading all their text messages ( 52/61 , 85 % ) . The number of visits to the website per person ranged from zero to 100 ( median 3 ) over the 6-month intervention period . Conclusions A mHealth CR intervention plus usual care showed a positive effect on adherence to multiple lifestyle behavior changes at 3 months in New Zeal and adults with CHD compared to usual care alone . The effect was not sustained to the end of the 6-month intervention . A larger study is needed to determine the size of the effect in the longer term and whether the change in behavior reduces adverse cardiovascular events . Trial Registration ACTRN 12613000901707 ; https://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?id=364758&is Review = true ( Archived by WebCite at http://www.webcitation.org/6c4qhcHKt Background Coronary heart disease ( CHD ) and depression are leading causes of disease burden globally and the two often co-exist . Depression is common after Myocardial Infa rct ion ( MI ) and it has been estimated that 15 - 35 % of patients experience depressive symptoms . Co-morbid depression can impair health related quality of life ( HRQOL ) , decrease medication adherence and appropriate utilisation of health services , lead to increased morbidity and suicide risk , and is associated with poorer CHD risk factor profiles and reduced survival . We aim to determine the feasibility of conducting a r and omised , multi-centre trial design ed to compare a tele-health program ( MoodCare ) for depression and CHD secondary prevention , with Usual Care ( UC ) . Methods Over 1600 patients admitted after index admission for Acute Coronary Syndrome ( ACS ) are being screened for depression at six metropolitan hospitals in the Australian states of Victoria and Queensl and . Consenting participants are then contacted at two weeks post-discharge for baseline assessment . One hundred eligible participants are to be r and omised to an intervention or a usual medical care control group ( 50 per group ) . The intervention consists of up to 10 × 30 - 40 minute structured telephone sessions , delivered by registered psychologists , commencing within two weeks of baseline screening . The intervention focuses on depression management , lifestyle factors ( physical activity , healthy eating , smoking cessation , alcohol intake ) , medication adherence and managing co-morbidities . Data collection occurs at baseline ( Time 1 ) , 6 months ( post-intervention ) ( Time 2 ) , 12 months ( Time 3 ) and 24 months follow-up for longer term effects ( Time 4 ) . We are comparing depression ( Cardiac Depression Scale [ CDS ] ) and HRQOL ( Short Form-12 [ SF-12 ] ) scores between treatment and UC groups , assessing the feasibility of the program through patient acceptability and exploring long term maintenance effects . A cost-effectiveness analysis of the costs and outcomes for patients in the intervention and control groups is being conducted from the perspective of health care costs to the government . Discussion This manuscript presents the protocol for a r and omised , multi-centre trial to evaluate the feasibility of a tele-based depression management and CHD secondary prevention program for ACS patients . The results of this trial will provide valuable new information about potential psychological and wellbeing benefits , cost-effectiveness and acceptability of an innovative tele-based depression management and secondary prevention program for CHD patients experiencing depression . Trial Registration NumberAustralia and New Zeal and Clinical Trials Register ( ANZCTR ) : Background Angina affects more than 50 million people worldwide . Secondary prevention interventions such as cardiac rehabilitation are not widely available for this population . An Internet-based version could offer a feasible alternative . Objective Our aim was to examine the effectiveness of a Web-based cardiac rehabilitation program for those with angina . Methods We conducted a r and omized controlled trial , recruiting those diagnosed with angina from general practitioners ( GPs ) in primary care to an intervention or control group . Intervention group participants were offered a 6-week Web-based rehabilitation program ( “ ActivateYourHeart ” ) . The program was introduced during a face-to-face appointment and then delivered via the Internet ( no further face-to-face contact ) . The program contained information about the secondary prevention of coronary heart disease ( CHD ) and set each user goals around physical activity , diet , managing emotions , and smoking . Performance against goals was review ed throughout the program and goals were then reset/modified . Participants completed an online  exercise diary and communicated with rehabilitation specialists through an email link/synchronized chat room . Participants in the control group continued with GP treatment as usual , which consisted of being placed on a CHD register and attending an annual review . Outcomes were measured at 6-week and 6-month follow-ups during face-to-face assessment s. The primary outcome measure was change in daily steps at 6 weeks , measured using an accelerometer . Secondary outcome measures were energy expenditure ( EE ) , duration of sedentary activity ( DSA ) , duration of moderate activity ( DMA ) , weight , diastolic/systolic blood pressure , and body fat percentage . Self-assessed question naire outcomes included fat/fiber intake , anxiety/depression , self-efficacy , and quality of life ( QOL ) . Results A total of 94 participants were recruited and r and omized to the intervention ( n=48 ) or the usual care  ( n=46 ) group ; 84 and 73 participants completed the 6-week and 6-month follow-ups , respectively . The mean number of log-ins to the program was 18.68 ( SD 13.13 , range 1 - 51 ) , an average of 3 log-ins per week per participant . Change in daily steps walked at the 6-week follow-up was + 497 ( SD 2171 ) in the intervention group and –861 ( SD 2534 ) in the control group ( 95 % CI 263 - 2451 , P=.02 ) . Significant intervention effects were observed at the 6-week follow-up in EE ( + 43.94 kcal , 95 % CI 43.93 - 309.98 , P=.01 ) , DSA ( –7.79 minutes , 95 % CI –55.01 to –7.01 , P=.01 ) , DMA ( + 6.31 minutes , 95 % CI 6.01 - 51.20 , P=.01 ) , weight ( –0.56 kg , 95 % CI –1.78 to –0.15 , P=.02 ) , self-efficacy ( 95 % CI 0.30 - 4.79 , P=.03 ) , emotional QOL score ( 95 % CI 0.01 - 0.54 , P=.04 ) , and angina frequency ( 95 % CI 8.57 - 35.05 , P=.002 ) . Significant benefits in angina frequency ( 95 % CI 1.89 - 29.41 , P=.02 ) and social QOL score ( 95 % CI 0.05 - 0.54 , P=.02 ) were also observed at the 6-month follow-up . Conclusions An Internet-based secondary prevention intervention could be offered to those with angina . A larger pragmatic trial is required to provide definitive evidence of effectiveness and cost-effectiveness . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 90110503 ; http://www.controlled-trials.com/IS RCT N90110503/IS RCT N90110503 ( Archived by WebCite at http://www.webcitation.org/6RYVOQFKM ) Background Coronary heart disease ( CHD ) is the most common cause of death in the UK . CHD cost the UK National Health Service ( NHS ) £ 3.5 billion in 2003 . The economic impact of community pharmacists providing a medicines management service for patients with CHD has not been rigorously evaluated ; the full economic costs of such interventions are rarely presented in the literature . Objective To examine the incremental costs of a 1-year community pharmacistled medicines management service for patients with CHD in the UK , from a healthcare system and patient perspective . Methods and participants A cost-minimisation analysis was conducted alongside a multicentre r and omised controlled trial . The primary study participants were patients with CHD identified from general practice computer records . Patients ( intervention , n = 980 ; control , n = 500 ) from 38 general practice s in nine geographical areas in the UK were included in the study .Intervention and outcomes measures The intervention consisted of a review of pharmaceuticals and lifestyle advice by pharmacists in their premises , with recommendations communicated to the patient ’s GP . The main outcome measure was the incremental cost per patient in the intervention group compared with the control group . Annual costs ( £ , 2003/4 values ) included the costs of the intervention ( training and delivery costs ) , the usual costs of NHS treatment ( costs of pharmaceuticals , GP and hospital visits ) and costs borne by patients . Data were collected in the 12 months before and 12 months after the intervention . Results The total NHS cost increased between baseline and follow-up in both groups ( from £ 1243 to £ 1286 [ 3 % ] in the control group and from £ 1410 to £ 1433 [ 2 % ] in the intervention group).The greater cost in the intervention group largely reflects the additional cost of the pharmacist training and the time taken to deliver the intervention ; the difference in costs between the intervention and control groups , after controlling for differences in costs at baseline at follow-up , was statistically significant ( p = 0.001 ) . The costs of pharmaceuticals was higher in the intervention group ( £ 769.20 vs £ 742.3 ; p = 0.04).According to the sensitivity analysis , the intervention cost would need to decrease by 35 % to achieve equivalence between costs in each arm of the trial . Difference to costs of patients and their carers at follow-up were not statistically significant . Conclusions The introduction of a 1-year pharmacist-led medicines management service is likely to increase the total cost of CHD treatment and prevention from the healthcare perspective , as the cost of the intervention outweighed the observed reduction in the cost of drugs in the intervention group . No changes in costs from the patient perspective were found Background Coronary heart disease ( CHD ) is a significant cause of health and economic burden . Secondary prevention programs play a pivotal role in the treatment and management of those affected by CHD although participation rates are poor due to patient , provider , health system and societal-level barriers . As such , there is a need to develop innovative secondary prevention programs to address the treatment gap . Telephone-delivered care is convenient , flexible and has been shown to improve behavioural and clinical outcomes following myocardial infa rct ion ( MI ) . This paper presents the design of a r and omised controlled trial to evaluate the efficacy of a six-month telephone-delivered secondary prevention program for  MI patients ( ProActive Heart ) . Methods 550 adult MI patients have been recruited over a 14 month period ( December 2007 to January 2009 ) through two Brisbane metropolitan hospitals , and r and omised to an intervention or control group ( n = 225 per group ) . The intervention commences within two weeks of hospital discharge delivered by study -trained health professionals ( ' health coaches ' ) during up to 10 × 30 minute scripted telephone health coaching sessions . Participants also receive a ProActive Heart h and book and an educational re source to use during the health coaching sessions . The intervention focuses on appropriate modification of CHD risk factors , compliance with pharmacological management , and management of psychosocial issues . Data collection occurs at baseline or prior to commencement of the intervention ( Time 1 ) , six months follow-up or the completion of the intervention ( Time 2 ) , and at 12 months follow-up for longer term outcomes ( Time 3 ) . Primary outcome measures include quality of life ( Short Form-36 ) and physical activity ( Active Australia Survey ) . A cost-effective analysis of the costs and outcomes for patients in the intervention and control groups is being conducted from the perspective of health care costs to the government . Discussion The results of this study will provide valuable new information about an innovative telephone-delivered cost-effective secondary prevention program for MI patients .Trial Registration 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 Background Participation in coronary heart disease ( CHD ) secondary prevention programs is low . Telephone-delivered CHD secondary prevention programs may overcome the treatment gap . The telephone-based health coaching ProActive Heart trial intervention has previously been shown to be effective for improving health-related quality of life , physical activity , body mass index , diet , alcohol intake and anxiety . As a secondary aim , the current study evaluated the cost-effectiveness of the ProActive Heart intervention compared to usual care . Methods 430 adult myocardial infa rct ion patients were r and omised to a six-month  CHD secondary prevention ‘ health coaching ’ intervention or ‘ usual care ’ control group . Primary outcome variables were health-related quality of life ( SF-36 ) and physical activity ( Active Australia Survey ) . Data were collected at baseline , six-months ( post-intervention ) and 12 months ( six-months post-intervention completion ) for longer term effects . Cost-effectiveness data [ health utility ( SF-6D ) and health care utilisation ] were collected using self-reported ( general practitioner , specialist , other health professionals , health services , and medication ) and cl aims data ( hospitalisation rates ) . Intervention effects are presented as mean differences ( 95 % CI ) , p-value . Results Improvements in health status ( SF-6D ) were observed in both groups , with no significant difference between the groups at six [ 0.012 ( -0.016 , 0.041 ) , p = 0.372 ] or 12 months [ 0.011 ( -0.028 , 0.051 ) p = 0.738 ] . Patients in the health coaching group were significantly more likely to be admitted to hospital due to causes unrelated to cardiovascular disease ( p = 0.042 ) . The overall cost for the health coaching group was higher ( $ 10,574 vs. $ 8,534 , p = 0.021 ) , mainly due to higher hospitalisation ( both CHD and non-CHD ) costs ( $ 6,841 vs. $ 4,984 , p = 0.036 ) . The incremental cost-effectiveness ratio was $ 85,423 per QALY . Conclusions There was no intervention effect measured using the SF-36/SF-6D and ProActive Heart result ed in significantly increased costs . The cost per QALY gained from ProActive Heart was high and above acceptable limits compared to usual care BACKGROUND Effective therapies for reducing mortality rates in persons with coronary heart disease ( CHD ) remain underused . We report the results of an effectiveness trial of a quality improvement effort to increase the use of 3-hydroxy-3methylglutaryl coenzyme A ( HMG CoA ) reductase inhibitors , beta-blockers , and angiotensin-converting enzyme ( ACE ) inhibitors in patients with CHD in a network-model managed-care setting . METHODS Patients with CHD were identified by search ing a cl aims data base . The use of therapies was assessed by linkage with a pharmacy data base . An intervention , consisting of a guideline summary , peer comparison performance feedback , and patient specific chart reminders was evaluated in a r and omized , practice -based effectiveness trial . RESULTS Data were available for > 700 patients per year ( 1999 - 2002 ) in 131 practice s. At baseline ( 1999 ) , 55 % of patients were receiving HMG CoA reductase inhibitors , 39 % of patients were receiving beta-blockers , and 24 % of patients were receiving ACE inhibitors . The use of all 3 types of medications increased steadily with time , with the exception of a decrease in the use of HMG CoA reductase inhibitors in the final year ( 2002 ) . No difference in medication use was observed between r and omized groups . CONCLUSIONS The observed pattern of care supports the contention that the quality of outpatient care for secondary prevention of CHD improved from 1999 to 2002 in this setting . The basis for the inconsistent pattern of use of HMG CoA reductase inhibitors is not certain , but may relate to concerns about toxicity . Central ized mailings of guideline summaries , performance feedback reports , and chart reminders had no observable impact on quality of care in this setting . More intensive intervention may be required to improve the quality of outpatient care for the secondary prevention of CHD Community studies have demonstrated suboptimal achievement of lipid targets in the management of patients with coronary heart disease ( CHD ) . An effective strategy is required for the application of evidence -based prevention therapy for CHD . The objective of this study was to test coaching as a technique to assist patients in achieving the target cholesterol level of < 4.5 mmol/L. Patients with established CHD ( n = 245 ) underwent a stratified r and omization by cardiac procedure ( coronary artery bypass graft surgery or percutaneous coronary intervention ) to receive either the coaching intervention ( n = 121 ) or usual medical care ( n = 124 ) . The primary outcome measure was fasting serum total cholesterol ( TC ) , serum triglyceride ( TG ) , high-density lipoprotein cholesterol ( HDL-C ) , and calculated low-density lipoprotein cholesterol ( LDL-C ) level , measured at 6 months post-r and omization . At 6 months , the serum TC and LDL-C levels were significantly lower in the coaching intervention group ( n = 107 ) than the usual care group ( n = 112 ) : mean TC ( 95%CI ) 5.00 ( 4.82 - 5.17 ) mmol/L versus 5.54 ( 5.36 - 5.72 ) mmol/L ( P < .0001 ) ; mean LDL-C ( 95%CI ) 3.11 ( 2.94 - 3.29 ) mmol/L versus 3.57 ( 3.39 - 3.75 ) mmol/L ( P < .0004 ) , respectively . Coaching had no impact on TG or on HDL-C levels . Multivariate analysis showed that being coached ( P < .001 ) had an effect of equal magnitude to being prescribed lipid-lowering drug therapy ( P < .001 ) . The effectiveness of the coaching intervention is best explained by both adherence to drug therapy and to dietary advice given . Coaching may be an appropriate method to reduce the treatment gap in applying evidence -based medicine to the " real world . 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 Despite the large body of evidence confirming the effectiveness of lipid lowering for the secondary prevention of coronary heart disease ( CHD ) events , undertreatment of hyperlipidemia is common . This study tested the effectiveness of a nurse case management program to lower blood lipids in patients with CHD . METHODS A total of 228 consecutive , eligible adults with hypercholesterolemia and CHD were recruited during hospitalization after coronary revascularization . Patients were r and omized to receive lipid management , including individualized lifestyle modification and pharmacologic intervention , from a nurse practitioner for 1 year after discharge in addition to their usual care ( NURS ) , or to usual care enhanced with feedback on lipids to their primary provider and /or cardiologist ( EUC ) . RESULTS Significantly more patients in the NURS group than in the EUC group achieved low-density lipoprotein cholesterol ( LDL-C ) levels < 2.59 mmol/dL ( 100 mg/dL , 65 % vs 35 % , P = .0001 ) . Favorable changes in lipids and lipoproteins were accompanied by significant improvements in dietary and exercise patterns in the NURS group . In a multivariate analysis adjusting for other covariates , being assigned to the NURS group ( P = .0001 ) and being on a lipid-lowering medication ( P = .001 ) were significant independent predictors of LDL-C level . CONCLUSIONS Control of hypercholesterolemia in patients who have undergone coronary revascularization can be improved by a nurse case-management program . Because the National Cholesterol Education Program Adult Treatment Panel III guidelines have broadened the definition of high-risk population s that warrant aggressive treatment , nurse case-management programs may offer key opportunities to enhance appropriate application of new treatment paradigms CONTEXT Coronary heart disease ( CHD ) mortality has declined substantially in Canada since 1994 . OBJECTIVE To determine what proportion of this decline was associated with temporal trends in CHD risk factors and advancements in medical treatments . DESIGN , SETTING , AND PATIENTS Prospect i ve analytic study of the Ontario , Canada , population aged 25 to 84 years between 1994 and 2005 , using an up date d version of the vali date d IMPACT model , which integrates data on population size , CHD mortality , risk factors , and treatment uptake changes . Relative risks and regression coefficients from the published literature quantified the relationship between CHD mortality and ( 1 ) evidence -based therapies in 8 distinct CHD sub population s ( acute myocardial infa rct ion [ AMI ] , acute coronary syndromes , secondary prevention post-AMI , chronic coronary artery disease , heart failure in the hospital vs in the community , and primary prevention for hyperlipidemia or hypertension ) and ( 2 ) population trends in 6 risk factors ( smoking , diabetes mellitus ,  systolic blood pressure ,  plasma cholesterol level , exercise , and obesity  ) . MAIN OUTCOME MEASURES The number of deaths prevented or delayed in 2005 ; secondary outcome measures were improvements in medical treatments and trends in risk factors . RESULTS Between 1994 and 2005 , the  age-adjusted CHD mortality rate  in Ontario decreased by 35 % from 191 to 125 deaths per 100,000 inhabitants , translating to an estimated 7585 fewer CHD deaths in 2005 . Improvements in medical and surgical treatments were associated with 43 % ( range , 11 % to 124 % ) of the total mortality decrease , most notably in AMI ( 8 % ; range , -5 % to 40 % ) , chronic stable coronary artery disease ( 17 % ; range , 7 % to 35 % ) , and heart failure occurring while in the community ( 10 % ; range , 6 % to 31 % ) . Trends in risk factors accounted for 3660 fewer CHD deaths prevented or delayed ( 48 % of total ; range , 28 % to 64 % ) , specifically , reductions in total cholesterol ( 23 % ; range , 10 % to 33 % ) and systolic blood pressure ( 20 % ; range , 13 % to 26 % ) . Increasing diabetes prevalence and body mass index had an inverse relationship associated with higher CHD mortality of 6 % ( range , 4 % to 8 % ) and 2 % ( range , 1 % to 4 % ) , respectively . CONCLUSION Between 1994 and 2005 , there was a decrease in CHD mortality rates in Ontario that was associated primarily with trends in risk factors and improvements in medical treatments , each explaining about half of the decrease 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 BACKGROUND Until now , there has not been any evaluated , disease-specific education and treatment program for patients with coronary heart disease ( CHD ) in Germany . It is thought that education can improve these patients ' physical activity and quality of life and teach them how to lessen their risk factors , what to do in case of an emergency , and how to assess their own medical treatment . METHODS A r and omized controlled open intervention trial was carried out from February 2010 to September 2011 . 196 patients were assigned to receive the intervention ( patient education ) , while 199 were assigned to a control group .  In an intention-to-treat analysis , baseline and follow-up data were compared after a mean interval of 220 days . The evaluative instruments included the Freiburg Question naire of Physical Activity , the MacNew Heart Disease Quality of Life Question naire , question naires regarding knowledge about CHD , ergometric performance ability , and the body-mass index . RESULTS The patients in the intervention group reported having increased their physical activity by a mean of 9.3 MET/week ( MET = metabolic equivalent of task ) , compared to 2.5 MET/week in the control group ; the difference of 6.8 MET/week was statistically significant ( p = 0.015 ) . The patients in the intervention group also rated their quality of life higher than those in the control group ( 0.2 ± 0.56 vs. 0.09 ± 0.53 [ mean ± st and ard deviation ] , p = 0.056 ) . They were significantly better informed than patients in the control group about risk factors and about what to do in an emergency . CONCLUSION Persistently unhealthy lifestyle is a common problem of CHD patients ; the education and treatment program presented here may be a suitable means of improving patients ' lifestyle for secondary prevention . Further studies will be needed to document long-term efficacy and to determine whether occasional refresher courses will be needed as well Objectives : The aim of the study was twofold ; 1 ) to develop a clinical pharmacist-led 12 month lasting follow-up program for patients with established coronary heart disease ( CHD ) discharged from the University Hospital of North Norway , and 2 ) to explore the impact of the program with regards to adherence to a medication assessment tool for secondary prevention of CHD and change in biomedical risk factors . Methods : A total of 102 patients aged 18 - 82 years were enrolled in a non-blinded r and omized controlled trial with an intervention group and a control group . The intervention comprised medication reconciliation , medication review and patient education during three meetings ; at discharge , after three months and after twelve months . The control group received st and ard care from their general practitioner . Primary outcomes were adherence to clinical guideline recommendations concerning prescription , therapy goal achievement and lifestyle education  defined in the medication assessment tool for secondary prevention of CHD ( MAT-CHDSP ) . Secondary outcomes included changes in the biomedical risk factors cholesterol , blood pressure and blood glucose . Results : Ninety-four patients completed the trial , 48 intervention group patients and 46 controls . Appropriate prescribing was high , but therapy goal achievement was low in both groups . Overall adherence to MAT-CHDSP criteria increased in both groups and was significantly higher in the intervention group at study end , 78.4 % vs. 62.0 % , p<0.001 . The difference was statistically significant for the documented lifestyle advices in intervention group patients . No significant improvements in biomedical risk factors were observed in favor of the intervention group . Conclusions : The study showed an increased guideline adherence in both study groups . This indicates that attention to clinical practice guideline recommendations in itself increases adherence – which may be a clinical pharmacist task . A larger adequately powered study is needed to show a significant difference in biomedical risk factor improvements in favor of the intervention . Amendments to the follow-up program are suggested before implementation in st and ard patient care can be recommended
Similarly , there was no clear evidence of effect for cardiovascular risk factors , although again the number of studies reporting these was small .
There was some evidence for beneficial effects on HRQOL , dietary outcomes , and physical activity , although firm conclusions can not yet be made .
The effects on healthcare utilisation and cost-effectiveness are also inconclusive , and trials are yet to measure the impact of  Internet interventions on compliance with medication .
BACKGROUND The Internet could provide a means of delivering secondary prevention programmes to people with coronary heart disease ( CHD ) .
OBJECTIVES To determine the effectiveness of Internet-based interventions targeting lifestyle changes and medicines management for the secondary prevention of CHD .