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1.  Preventive evidence into practice (PEP) study: implementation of guidelines to prevent primary vascular disease in general practice protocol for a cluster randomised controlled trial 
Background
There are significant gaps in the implementation and uptake of evidence-based guideline recommendations for cardiovascular disease (CVD) and diabetes in Australian general practice. This study protocol describes the methodology for a cluster randomised trial to evaluate the effectiveness of a model that aims to improve the implementation of these guidelines in Australian general practice developed by a collaboration between researchers, non-government organisations, and the profession.
Methods
We hypothesise that the intervention will alter the behaviour of clinicians and patients resulting in improvements of recording of lifestyle and physiological risk factors (by 20%) and increased adherence to guideline recommendations for: the management of CVD and diabetes risk factors (by 20%); and lifestyle and physiological risk factors of patients at risk (by 5%). Thirty-two general practices will be randomised in a 1:1 allocation to receive either the intervention or continue with usual care, after stratification by state. The intervention will be delivered through: small group education; audit of patient records to determine preventive care; and practice facilitation visits adapted to the needs of the practices. Outcome data will be extracted from electronic medical records and patient questionnaires, and qualitative evaluation from provider and patient interviews.
Discussion
We plan to disseminate study findings widely and directly inform implementation strategies by governments, professional bodies, and non-government organisations including the partner organisations.
doi:10.1186/1748-5908-8-8
PMCID: PMC3564812  PMID: 23327664
Primary care; Family medicine; Guidelines; Preventive care; Cardiovascular disease
2.  Design of a RCT evaluating the (cost-) effectiveness of a lifestyle intervention for male construction workers at risk for cardiovascular disease: The Health under Construction study 
BMC Public Health  2008;8:1.
Background
Of all workers in Dutch construction industry, 20% has an elevated risk of cardiovascular disease (CVD). A major risk factor for CVD risk is an unhealthy lifestyle. The aim of our study is to design a lifestyle intervention for construction workers with an elevated CVD risk, and to evaluate its (cost-) effectiveness.
Methods/Design
In a RCT, 692 participants will be randomised to either the control or the intervention group. The control group will receive usual care. For the intervention group, a lifestyle intervention has been designed based on interviews and current literature. The intervention will last 6 months and will comprise 3 face-to-face and 4 telephone contacts, consisting of individual counselling aimed at increasing daily physical activity (PA) and improving dietary behaviour, and/or smoking cessation. Counselling will take place at the Occupational Health Service (OHS), and will be done according to motivational interviewing (MI). Additional written information about healthy lifestyle will also be provided to those in the intervention group. At baseline, after 6 and after 12 months, measurements will take place. Primary outcome variables will be the lifestyle behaviours of concern, i.e. daily PA, dietary intake, and smoking status. Secondary outcome variables will be body mass index (BMI), systolic and diastolic blood pressure, total and HDL blood cholesterol, Hba1c and cardio-respiratory fitness (CRF). Sickness absenteeism and cost-effectiveness will be assessed as well. Multilevel analysis will be performed to compare all outcome measures between the intervention group and the control group.
Discussion
By improving lifestyle, CVD risk may be lowered, yielding benefits for both employee and employer. If proven effective, this lifestyle intervention will be implemented on a larger scale within the Occupational Health Services in construction industry.
Trial registration
Current Controlled Trials ISRCTN60545588
doi:10.1186/1471-2458-8-1
PMCID: PMC2254612  PMID: 18173844
3.  A tailored lifestyle intervention to reduce the cardiovascular disease risk of individuals with Familial Hypercholesterolemia (FH): design of the PRO-FIT randomised controlled trial 
BMC Public Health  2010;10:69.
Background
Because of a high cardiovascular disease (CVD) risk in people with Familial Hypercholesterolemia (FH), early prevention of cardiovascular disease is important for health gain and cost reduction. This project focuses on the development and evaluation of an innovative intervention aiming to reduce CVD risk by promoting a healthy lifestyle among people with FH.
Methods
This project is designed as a randomised controlled trial in which individuals with FH will be assigned randomly to a control or intervention group. In the intervention group (n = 200), participants will receive a personalized intervention which is a combination of web-based tailored lifestyle advice and personal counselling by a lifestyle coach. The control group (n = 200) will receive care as usual. Primary outcomes are biological indicators of CVD risk: systolic blood pressure, glucose, BMI, waist circumference and lipids (triglycerides, total, LDL and HDL cholesterol). Secondary outcomes are: healthy lifestyle behaviour (with regard to smoking, physical activity, dietary pattern and compliance to statin therapy) and psychological correlates and determinants of healthy lifestyle behaviour (knowledge, attitude, risk perception, social influence, self-efficacy, cues to action, intention and autonomy). Measurement will take place at baseline, and at 3 and 12 months after randomisation. Additionally, a throughout process-evaluation will be conducted to assess and monitor intervention implementation during the trial.
Discussion
Results of the PRO-FIT project will provide information about the effects and implementation of a healthy lifestyle intervention for individuals with FH. Our experiences with this intervention will be indicative about the suitability, feasibility and benefits of this approach for future interventions in other high-risk groups, such as Familial Combined Hypercholesterolemia (FCH) and diabetes.
Trial registration number
NTR1899
doi:10.1186/1471-2458-10-69
PMCID: PMC2834628  PMID: 20156339
4.  Comparing the effectiveness of two cardiovascular prevention programmes for highly educated professionals in general practice: a randomised clinical trial 
Background
Cardiovascular disease is a major cause of mortality and morbidity and its prevalence is set to increase. While the benefits of medical and lifestyle interventions are established, the effectiveness of interventions which seek to improve the way preventive care is delivered in general practice is less so. The aim was to study and to compare the effectiveness of 2 intervention programmes for reducing cardiovascular risk factors within general practice.
Methods
A randomised controlled trial was conducted in Belgium between 2007-2010 with 314 highly educated and mainly healthy professionals allocated to a medical (MP) or a medical + lifestyle (MLP) programme. The MP consisted of medical assessments (screening and follow-up) and the MLP added a tailored lifestyle change programme (web-based and individual coaching) to the MP. Primary outcomes were total cholesterol, blood pressure, and body mass index (BMI). The secondary outcomes were smoking status, fitness-score, and total cardiovascular risk.
Results
The mean age was 41 years, 95 (32%) participants were female, 7 had a personal cardiovascular event in their medical history and 3 had diabetes. There were no significant differences found between MP and MLP in primary or secondary outcomes. In both study conditions decreases of cholesterol, systolic blood pressure, and diastolic blood pressure were found. Unfavourable increases were found for BMI (p < .05). A significant decrease of the overall cardiovascular risk was reported (p < .001).
Conclusions
Both interventions are effective in reducing cardiovascular risk. In our population the combined medical and lifestyle programme was not superior to the medical programme.
Trial registration
ISRCTN23940498
doi:10.1186/1471-2261-13-38
PMCID: PMC3674968  PMID: 23725092
Cardiovascular diseases; Prevention; General practice; Lifestyle programmes
5.  The PreCardio-study protocol – a randomized clinical trial of a multidisciplinary electronic cardiovascular prevention programme 
Background
Cardiovascular diseases (CVD) are the leading cause of death and the third cause of disability in Europe. Prevention programmes should include interventions aimed at a reduction of medical risk factors (hypertension, hypercholesterol, hyperglycemia, overweight and obesity) as well as behavioural risk factors (sedentary lifestyle, high fat intake and low fruit and vegetable intake, smoking). The aim of this study is to investigate the effects of a multifaceted, multidisciplinary electronic prevention programme on cardiovascular risk factors.
Methods/Design
In a randomized controlled trial, one group will receive a maximal intervention (= intervention group). The intervention group will be compared to the control group receiving a minimal intervention. An inclusion of 350 patients in total, with a follow-up of 3 years is foreseen. The inclusion criteria are age between 25–65 and insured by the Onderlinge Ziekenkas, insuring for guaranteed income in case of illness for self-employed. The maximal intervention group receives several prevention consultations by their general practitioner (GP) using a new type of cardiovascular risk calculator with personalised feedback on behavioural risk factors. These patients receive a follow-up with intensive support of health behaviour change via different methods, i.e. a tailored website and personal advice of a multidisciplinary team (psychologist, physiotherapist and dietician). The aim of this strategy is to reduce cardiovascular risk factors according to the guidelines. The primary outcome measures will be cardiovascular risk factors. The secondary outcome measures are cardiovascular events, quality of life, costs and incremental cost effectiveness ratios. The control group receives prevention consultations using a new type of cardiovascular risk calculator and general feedback.
Discussion
This trial incorporates interventions by GPs and other health professionals aiming at a reduction of medical and behavioural cardiovascular risk factors. An assessment of clinical, psychological and economical outcome measures will be performed.
Trial registration
ISRCTN23940498
doi:10.1186/1471-2261-7-27
PMCID: PMC2045658  PMID: 17784946
6.  Evaluating an implementation strategy in cardiovascular prevention to improve prescribing of statins in Germany: an intention to treat analysis 
BMC Public Health  2013;13:623.
Background
The prescription of statins is an evidence-based treatment to reduce the risk of cardiovascular events in patients with elevated cardiovascular risk or with a cardiovascular disorder (CVD). In spite of this, many of these patients do not receive statins.
Methods
We evaluated the impact of a brief educational intervention in cardiovascular prevention in primary care physicians’ prescribing behaviour regarding statins beyond their participation in a randomised controlled trial (RCT). For this, prescribing data of all patients > 35 years who were counselled before and after the study period were analysed (each n > 75000). Outcome measure was prescription of Hydroxymethylglutaryl-CoA Reductase Inhibitors (statins) corresponding to patients’ overall risk for CVD. Appropriateness of prescribing was examined according to different risk groups based on the Anatomical Therapeutic Chemical Classification System (ATC codes).
Results
There was no consistent association between group allocation and statin prescription controlling for risk status in each risk group before and after study participation. However, we found a change to more significant drug configurations predicting the prescription of statins in the intervention group, which can be regarded as a small intervention effect.
Conclusion
Our results suggest that an active implementation of a brief evidence-based educational intervention does not lead to prescription modifications in everyday practice. Physician’s prescribing behaviour is affected by an established health care system, which is not easy to change.
Trial registration
ISRCTN71348772
doi:10.1186/1471-2458-13-623
PMCID: PMC3716622  PMID: 23819600
Evaluation studies; Intention to treat analysis; Cardiovascular diseases; Drug prescriptions; Hydroxymethylglutaryl-CoA Reductase Inhibitors
7.  The effects of Hartcoach, a life style intervention provided by telephone on the reduction of coronary risk factors: a randomised trial 
Background
Cardiovascular disease (CVD) is the leading cause of death worldwide. Secondary prevention is essential, but participation rates for cardiac rehabilitation are low. Furthermore, current programmes do not accomplish that patients with CVD change their lifestyle in a way that their individual risk factors for recurrent events decrease, therefore more effective interventions are needed. In this study, the effectiveness of the Hartcoach-programme, a telephonic secondary prevention program focussing on self management, is studied.
Methods/design
A multicenter, randomised parallel-group study is being conducted. Participants are 400 patients with acute myocardial infarction (STEMI, NSTEMI,) and patients with chronic or unstable angina pectoris (IAP). Patients are recruited through the participating hospitals and randomly assigned to the experimental group (Hartcoach-programme plus usual care) or the control group (usual care).
The Hartcoach-programme consists of a period of six months during which the coach contacts the patient every four to six weeks by telephone. Coaches train patients to take responsibility for the achievement and maintenance of the defined target levels for their particular individual modifiable risk factors. Target levels and treatment goals are agreed by the nurse and patient together. Data collection is blinded and occurs at baseline and after 26 weeks (post-intervention). Primary outcome is change in cardiovascular risk factors (cholesterol, body mass index, waist circumference, blood pressure, physical activity and diet). Secondary outcomes include chances in glucose, HbA1c, medication adherence, self-management and quality of life.
Discussion
This study evaluates the effects of the Hartcoach-programme on the reduction of individual risk factors of patients with CVDs. Patients who are not invited to follow a hospital based rehabilitation programme or patients who are unable to adhere to such a programme, may be reached by this home based Hartcoach-programme. If positive results are found, the implementation of the Hartcoach-programme will be extended, having implications for the management of many people with CVD.
Trial registration
NTR2388
doi:10.1186/1471-2261-12-47
PMCID: PMC3502523  PMID: 22734802
Cardiovascular disease; Secondary prevention; Self management; Nurse led telephonic intervention
8.  Multidisciplinary structured lifestyle intervention reduces the estimated risk of cardiovascular morbidity and mortality 
Netherlands Heart Journal  2004;12(10):443-449.
Background
Current guidelines for prevention and treatment of cardiovascular disease (CVD) emphasise the importance of a healthy lifestyle. However, successful lifestyle intervention is proving to be a challenge for healthcare professionals.
Objectives
Evaluation of the effect of lifestyle intervention on cardiovascular risk factors, on reaching treatment targets and on the estimated risk of cardiovascular morbidity and mortality.
Methods
The effect of a six-month multidisciplinary structured lifestyle intervention programme was assessed in 186 patients with and without a history of CVD.
Results
Multidisciplinary structured lifestyle intervention reduced the estimated ten-year risk of cardiovascular morbidity and mortality. The relative risk reduction was similar in patients with and without a history of CVD, the absolute risk reduction was higher in patients with a history of CVD. In both groups blood pressure and body weight decreased, and the maximal work rate and maximal oxygen uptake increased significantly. Blood levels of total cholesterol and cholesterol/HDL ratio decreased significantly in patients with a history of CVD. In addition, target levels for blood pressure and physical fitness were more frequently reached in both patient groups.
Conclusion
Multidisciplinary structured lifestyle intervention had beneficial effects on cardiovascular risk factors. Relative risk reduction was similar in patients with and without evidence of cardiovascular disease. Follow-up is needed to see how well these effects can be maintained.
PMCID: PMC2497152
cardiovascular disease; cardiovascular risk; lifestyle intervention; prevention; risk factor; treatment target
9.  Cost-effectiveness of a European preventive cardiology programme in primary care: a Markov modelling approach 
BMJ Open  2012;2(5):e001029.
Objective
To investigate the longer-term cost-effectiveness of a nurse-coordinated preventive cardiology programme for primary prevention of cardiovascular disease (CVD) compared to routine practice from a health service perspective.
Design
A matched, paired cluster-randomised controlled trial.
Setting
Six pairs of general practices in six countries.
Participants
1019 patients were randomised to the EUROACTION intervention programme and 1005 patients to usual care (UC) and who completed the 1-year follow-up.
Outcome measures
Evidence on health outcomes and costs was based on patient-level data from the study, which had a 1-year follow-up period. Future risk of CVD events was modelled, using published risk models based on patient characteristics. An individual-level Markov model for each patient was used to extrapolate beyond the end of the trial, which was populated with data from published sources. We used an 11-year time horizon and investigated the impact on the cost-effectiveness of varying the duration of the effect of the intervention beyond the end of the trial. Results are expressed as incremental cost per quality-adjusted life-year gained.
Results
Unadjusted results found the intervention to be more costly and also more effective than UC. However, after adjusting for differences in age, gender, country and baseline risk factors, the intervention was dominated by UC, but this analysis was not able to take into account the lifestyle changes in terms of diet and physical activity.
Conclusions
Although the EUROACTION study achieved healthier lifestyle changes and improvements in management of blood pressure and lipids for patients at high risk of CVD, compared to UC, it was not possible to show, using available risk equations which do not incorporate diet and physical activity, that the intervention reduced longer-term cardiovascular risk cost-effectively. Whether or not an intervention such as that offered by EUROACTION is cost-effective requires a longer-term trial with major cardiovascular events as the outcome.
Trial Registration number
ISRCTN 71715857.
doi:10.1136/bmjopen-2012-001029
PMCID: PMC3488746  PMID: 23065443
Health Economics; Cardiology; Primary Care
10.  Factors influencing participation in a vascular disease prevention lifestyle program among participants in a cluster randomized trial 
Background
Previous research suggests that lifestyle intervention for the prevention of diabetes and cardiovascular disease (CVD) are effective, however little is known about factors affecting participation in such programs. This study aims to explore factors influencing levels of participation in a lifestyle modification program conducted as part of a cluster randomized controlled trial of CVD prevention in primary care.
Methods
This concurrent mixed methods study used data from the intervention arm of a cluster RCT which recruited 30 practices through two rural and three urban primary care organizations. Practices were randomly allocated to intervention (n = 16) and control (n = 14) groups. In each practice up to 160 eligible patients aged between 40 and 64 years old, were invited to participate. Intervention practice staff were trained in lifestyle assessment and counseling and referred high risk patients to a lifestyle modification program (LMP) consisting of two individual and six group sessions over a nine month period. Data included a patient survey, clinical audit, practice survey on capacity for preventive care, referral and attendance records at the LMP and qualitative interviews with Intervention Officers facilitating the LMP. Multi-level logistic regression modelling was used to examine independent predictors of attendance at the LMP, supplemented with qualitative data from interviews with Intervention Officers facilitating the program.
Results
A total of 197 individuals were referred to the LMP (63% of those eligible). Over a third of patients (36.5%) referred to the LMP did not attend any sessions, with 59.4% attending at least half of the planned sessions. The only independent predictors of attendance at the program were employment status - not working (OR: 2.39 95% CI 1.15-4.94) and having high psychological distress (OR: 2.17 95% CI: 1.10-4.30). Qualitative data revealed that physical access to the program was a barrier, while GP/practice endorsement of the program and flexibility in program delivery facilitated attendance.
Conclusion
Barriers to attendance at a LMP for CVD prevention related mainly to external factors including work commitments and poor physical access to the programs rather than an individuals’ health risk profile or readiness to change. Improving physical access and offering flexibility in program delivery may enhance future attendance. Finally, associations between psychological distress and attendance rates warrant further investigation.
Trial registration
ACTRN12607000423415
doi:10.1186/1472-6963-13-201
PMCID: PMC3702446  PMID: 23725521
Preventive health care; Lifestyle modification; Attendance rates; Reach; Primary care; Family practice; Chronic disease prevention
11.  Secondary prevention of cardiovascular disease: a randomised trial of training in information management, evidence-based medicine, both or neither: the PIER trial. 
BACKGROUND: Sub-optimal management of cardiovascular disease (CVD) patients is widespread in primary and secondary care, with risk factors frequently unrecorded or untreated. AIM: To investigate the effectiveness of educational interventions developed in primary care, on recording, prescribing and control of risk factors among all patients recorded by their general practitioner as having CVD. DESIGN OF STUDY: Factorial, duster-randomised controlled trial. SETTING: Primary care teams representing the range of practice development in a geographically defined area in inner London. METHOD: Participating practices were randomly allocated to one of the four intervention groups: information, evidence, both or neither. Interventions were tailored to suit individual practice needs. At a mean of 19 months after baseline, and three months after the end of intervention, practices carried out the follow-up assessment of recording, treatment, and control of risk factors in the same CVD patients. RESULTS: Adequate recording of all three risk factors, found inapproximately a third of patients at baseline, increased non-significantly by 10.5% (95% confidence interval [CI] = 3.9 to 24.9) in the information (versus not information) group and by 6.6% (95% [CI] = 8.9 to 22.0) in the evidence (versus not evidence) group. Factorial improvements in prescribing and control of risk factors tended not to be significant. Adequate recording of an three risk factors showed the greatest improvement in the information plus evidence group (19.9% increase, P for heterogeneity across the four groups < or = 0.001). Mean change from baseline to follow-up within the four intervention groups suggested improvements in the combined information plus evidence group in cholesterol recording (22.5% increase), prescribing of lipid lowering drugs (4.4% increase) and mean cholesterol (0.7 mmol/l decrease). CONCLUSIONS: Adequate risk factor recording did not differ between the information (versus not information) or the evidence (versus not evidence) intervention groups. Combined training in information systems and evidence-based medicine should be considered in the design of future interventions, to improve secondary prevention of CVD.
PMCID: PMC1316085  PMID: 12392122
12.  Design and rationale of the tobacco, exercise and diet messages (TEXT ME) trial of a text message-based intervention for ongoing prevention of cardiovascular disease in people with coronary disease: a randomised controlled trial protocol 
BMJ Open  2012;2(1):e000606.
Background
Although supporting lifestyle change is an effective way of preventing further events in people with cardiovascular disease, providing access to such interventions is a major challenge. This study aims to investigate whether simple reminders about behaviour change sent via mobile phone text message decrease cardiovascular risk.
Methods and analysis
Randomised controlled trial with 6 months of follow-up to evaluate the feasibility, acceptability and effect on cardiovascular risk of repeated lifestyle reminders sent via mobile phone text messages compared to usual care. A total of 720 patients with coronary artery disease will be randomised to either standard care or the TEXT ME intervention. The intervention group will receive multiple weekly text messages that provide information, motivation, support to quit smoking (if relevant) and recommendations for healthy diets and exercise. The primary end point is a change in plasma low-density lipoprotein cholesterol at 6 months. Secondary end points include a change in systolic blood pressure, smoking status, quality of life, medication adherence, waist circumference, physical activity levels, nutritional status and mood at 6 months. Process outcomes related to acceptability and feasibility of TEXT ME will also be collected.
Ethics and dissemination
Primary ethics approval was received from Western Sydney Local Health Network Human Research Ethics Committee—Westmead. Results will be disseminated via the usual scientific forums including peer-reviewed publications and presentations at international conferences.
Clinical trials registration number
ACTRN12611000161921.
Article summary
Article focus
The article provides the rationale and protocol for a randomised controlled trial to test the efficacy of mobile phone text message reminders to promote behaviour change and reduce cardiac risk in patients with coronary heart disease.
Key messages
Mobile phone text messages may potentially be a cheap, safe and simple way to promote healthy behaviour, improve mood and increase compliance with cardiac medication. This in turn would reduce cardiovascular risk. The effectiveness of this approach needs to be tested in well-designed and rigorously conducted clinical trials.
Strengths and limitations of this study
The main strengths of the current study are that it uses a simple and inexpensive text message-based programme that is suitable for widespread use and will test this strategy in a randomised, controlled and blinded study. The study is, however, being conducted in only Australian tertiary centres and, therefore, the generalisability is somewhat limited, although the cohort size is relatively large.
doi:10.1136/bmjopen-2011-000606
PMCID: PMC3263439  PMID: 22267690
13.  Efficacy of a family practice-based lifestyle intervention program to increase physical activity and reduce clinical and physiological markers of vascular health in patients with high normal blood pressure and/or high normal blood glucose (SNAC): study protocol for a randomized controlled trial 
Trials  2011;12:45.
Background
Previous interventions to increase physical activity and reduce cardiovascular risk factors have been targeted at individuals with established disease; less attention has been given to intervention among individuals with high risk for disease nor has there been determination of the influence of setting in which the intervention is provided. In particular, family practice represents an ideal setting for the provision and long-term maintenance of lifestyle interventions for patients at risk (ie high-normal blood pressure or impaired glucose tolerance).
Methods/design
The Staged Nutrition and Activity Counseling (SNAC) study is a randomized clustered design clinical trial that will investigate the effectiveness and efficacy of a multi-component lifestyle intervention on cardiovascular disease risk factors and vascular function in patients at risk in primary care. Patients will be randomized by practice to either a standard of care lifestyle intervention or a behaviourally-based, matched prescriptive physical activity and diet change program. The primary goal is to increase physical activity and improve dietary intake according to Canada's Guides to Physical Activity Healthy Eating over 24 months. The primary intention to treat analysis will compare behavioral, physiological and metabolic outcomes at 6, 12 and 24 months post-randomization including estimation of incident hypertension and/or diabetes.
Discussion
The design features of our trial, and the practical problems (and solutions) associated with implementing these design features, particularly those that result in potential delay between recruitment, baseline data collection, randomization, intervention, and assessment will be discussed. Results of the SNAC trial will provide scientific rationale for the implementation of this lifestyle intervention in primary care.
Trial registration
ISRCTN: ISRCTN:42921300
doi:10.1186/1745-6215-12-45
PMCID: PMC3048556  PMID: 21324150
14.  Predictors of primary care referrals to a vascular disease prevention lifestyle program among participants in a cluster randomised trial 
Background
Cardiovascular disease accounts for a large burden of disease, but is amenable to prevention through lifestyle modification. This paper examines patient and practice predictors of referral to a lifestyle modification program (LMP) offered as part of a cluster randomised controlled trial (RCT) of prevention of vascular disease in primary care.
Methods
Data from the intervention arm of a cluster RCT which recruited 36 practices through two rural and three urban primary care organisations were used. In each practice, 160 eligible high risk patients were invited to participate. Practices were randomly allocated to intervention or control groups. Intervention practice staff were trained in screening, motivational interviewing and counselling and encouraged to refer high risk patients to a LMP involving individual and group sessions. Data include patient surveys; clinical audit; practice survey on capacity for preventive care; referral records from the LMP. Predictors of referral were examined using multi-level logistic regression modelling after adjustment for confounding factors.
Results
Of 301 eligible patients, 190 (63.1%) were referred to the LMP. Independent predictors of referral were baseline BMI ≥ 25 (OR 2.87 95%CI:1.10, 7.47), physical inactivity (OR 2.90 95%CI:1.36,6.14), contemplation/preparation/action stage of change for physical activity (OR 2.75 95%CI:1.07, 7.03), rural location (OR 12.50 95%CI:1.43, 109.7) and smaller practice size (1–3 GPs) (OR 16.05 95%CI:2.74, 94.24).
Conclusions
Providing a well-structured evidence-based lifestyle intervention, free of charge to patients, with coordination and support for referral processes resulted in over 60% of participating high risk patients being referred for disease prevention. Contrary to expectations, referrals were more frequent from rural and smaller practices suggesting that these practices may be more ready to engage with these programs.
Trial registration
ACTRN12607000423415
doi:10.1186/1472-6963-12-234
PMCID: PMC3483009  PMID: 22856459
Preventive health care; General practice; Health behaviour; Lifestyle modification; Referral
15.  EDUCORE project: a clinical trial, randomised by clusters, to assess the effect of a visual learning method on blood pressure control in the primary healthcare setting 
BMC Public Health  2010;10:449.
Background
High blood pressure (HBP) is a major risk factor for cardiovascular disease (CVD). European hypertension and cardiology societies as well as expert committees on CVD prevention recommend stratifying cardiovascular risk using the SCORE method, the modification of lifestyles to prevent CVD, and achieving good control over risk factors. The EDUCORE (Education and Coronary Risk Evaluation) project aims to determine whether the use of a cardiovascular risk visual learning method - the EDUCORE method - is more effective than normal clinical practice in improving the control of blood pressure within one year in patients with poorly controlled hypertension but no background of CVD;
Methods/Design
This work describes a protocol for a clinical trial, randomised by clusters and involving 22 primary healthcare clinics, to test the effectiveness of the EDUCORE method. The number of patients required was 736, all between 40 and 65 years of age (n = 368 in the EDUCORE and control groups), all of whom had been diagnosed with HBP at least one year ago, and all of whom had poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic ≥ 90 mmHg). All personnel taking part were explained the trial and trained in its methodology. The EDUCORE method contemplates the visualisation of low risk SCORE scores using images embodying different stages of a high risk action, plus the receipt of a pamphlet explaining how to better maintain cardiac health. The main outcome variable was the control of blood pressure; secondary outcome variables included the SCORE score, therapeutic compliance, quality of life, and total cholesterol level. All outcome variables were measured at the beginning of the experimental period and again at 6 and 12 months. Information on sex, age, educational level, physical activity, body mass index, consumption of medications, change of treatment and blood analysis results was also recorded;
Discussion
The EDUCORE method could provide a simple, inexpensive means of improving blood pressure control, and perhaps other health problems, in the primary healthcare setting;
Trial registration
The trial was registered with ClinicalTrials.gov, number NCT01155973 [http://ClinicalTrials.gov].
doi:10.1186/1471-2458-10-449
PMCID: PMC2920281  PMID: 20673325
16.  Protocol for the 'e-Nudge trial': a randomised controlled trial of electronic feedback to reduce the cardiovascular risk of individuals in general practice [ISRCTN64828380] 
Trials  2006;7:11.
Background
Cardiovascular disease (including coronary heart disease and stroke) is a major cause of death and disability in the United Kingdom, and is to a large extent preventable, by lifestyle modification and drug therapy. The recent standardisation of electronic codes for cardiovascular risk variables through the United Kingdom's new General Practice contract provides an opportunity for the application of risk algorithms to identify high risk individuals. This randomised controlled trial will test the benefits of an automated system of alert messages and practice searches to identify those at highest risk of cardiovascular disease in primary care databases.
Design
Patients over 50 years old in practice databases will be randomised to the intervention group that will receive the alert messages and searches, and a control group who will continue to receive usual care. In addition to those at high estimated risk, potentially high risk patients will be identified who have insufficient data to allow a risk estimate to be made. Further groups identified will be those with possible undiagnosed diabetes, based either on elevated past recorded blood glucose measurements, or an absence of recent blood glucose measurement in those with established cardiovascular disease.
Outcome measures
The intervention will be applied for two years, and outcome data will be collected for a further year. The primary outcome measure will be the annual rate of cardiovascular events in the intervention and control arms of the study. Secondary measures include the proportion of patients at high estimated cardiovascular risk, the proportion of patients with missing data for a risk estimate, and the proportion with undefined diabetes status at the end of the trial.
doi:10.1186/1745-6215-7-11
PMCID: PMC1471804  PMID: 16646967
17.  Evaluation of computer based clinical decision support system and risk chart for management of hypertension in primary care: randomised controlled trial 
BMJ : British Medical Journal  2000;320(7236):686-690.
Objectives
To investigate the effect of a computer based clinical decision support system and a risk chart on absolute cardiovascular risk, blood pressure, and prescribing of cardiovascular drugs in hypertensive patients.
Design
Cluster randomised controlled trial.
Setting
27 general practices in Avon.
Participants
614 patients aged between 60 and 79 years with high blood pressure.
Interventions
Patients were randomised to computer based clinical decision support system plus cardiovascular risk chart; cardiovascular risk chart alone; or usual care.
Main outcome measures
Percentage of patients in each group with a five year cardiovascular risk ⩾10%, systolic blood pressure, diastolic blood pressure, prescribing of cardiovascular drugs.
Results
Patients in the computer based clinical decision support system and chart only groups were no more likely to have cardiovascular risk reduced to below 10% than patients receiving usual care. Patients in the computer based clinical decision support group were more likely to have a cardiovascular risk ⩾10% than chart only patients, odds ratio 2.3 (95% confidence interval 1.1 to 4.8). The chart only group had significantly lower systolic blood pressure compared with the usual care group (difference in means −4.6 mm Hg (95% confidence interval −8.4 to −0.8)). Reduction of diastolic blood pressure did not differ between the three groups. The chart only group were twice as likely to be prescribed two classes of cardiovascular drugs and over three times as likely to be prescribed three or more classes of drugs compared with the other groups.
Conclusions
The computer based clinical decision support system did not confer any benefit in absolute risk reduction or blood pressure control and requires further development and evaluation before use in clinical care can be recommended. Use of chart guidelines are associated with a potentially important reduction in systolic blood pressure.
PMCID: PMC27312  PMID: 10710578
18.  Comparative effectiveness of lifestyle interventions on cardiovascular risk factors among a Dutch overweight working population: A randomized controlled trial 
BMC Public Health  2011;11:49.
Background
Overweight (Body Mass Index [BMI] ≥ 25 kg/m2) and obesity (BMI≥ 30 kg/m2) are associated with increased cardiovascular risk, posing a considerable burden to public health. The main aim of this study was to investigate lifestyle intervention effects on cardiovascular risk factors in healthy overweight employees.
Methods
Participants were 276 healthy overweight employees (69.2% male; mean age 44.0 years [SD 9.2]; mean BMI 29.7 kg/m2 [SD 3.1]). They were randomized to one of two intervention groups receiving a six month lifestyle intervention with behavior counseling by phone (phone group) or e-mail (Internet group), or to a control group receiving usual care. Body weight, height, waist circumference, sum of skinfolds, blood pressure, total cholesterol level and predicted aerobic fitness were measured at baseline, at 6 and at 24 months. Regression analyses included the 141 participants with complete data.
Results
At 6 months a significant favorable effect on total cholesterol level (-0.2 mmol/l, 95%CI -0.5 to -0.0) was observed in the phone group and a trend for improved aerobic fitness (1.9 ml/kg/min, 95%CI -0.2 to 3.9) in the Internet group. At two years, favorable trends for body weight (-2.1 kg, 95%CI -4.4 to 0.2) and aerobic fitness (2.3 ml/kg/min, 95%CI -0.2 to 4.8) were observed in the Internet group.
Conclusions
The intervention effects were independent of the used communication mode. However short-term results were in favor of the phone group and long-term results in favor of the internet group. Thus, we found limited evidence for our lifestyle intervention to be effective in reducing cardiovascular risk in a group of apparently healthy overweight workers.
Trial registration
ISRCTN04265725
doi:10.1186/1471-2458-11-49
PMCID: PMC3037864  PMID: 21261935
19.  Short and long term effects of a lifestyle intervention for construction workers at risk for cardiovascular disease: a randomized controlled trial 
BMC Public Health  2011;11:836.
Background
The prevalence of overweight and elevated cardiovascular disease (CVD) risk among workers in the construction industry is relatively high. Improving lifestyle lowers CVD risk and may have work-related benefits. The purpose of the study was to evaluate the effects on physical activity (PA), diet, and smoking of a lifestyle intervention consisting of individual counseling among male workers in the construction industry with an elevated risk of cardiovascular disease (CVD).
Methods
In a randomized controlled trial including 816 male blue- and white-collar workers in the construction industry with an elevated risk of CVD, usual care was compared to a 6-month lifestyle intervention. The intervention consisted of individual counseling using motivational interviewing techniques, and was delivered by an occupational physician or occupational nurse. In three face to face and four telephone contacts, the participant's risk profile, personal determinants, and barriers for behavior change were discussed, and personal goals were set. Participants chose to aim at either diet and PA, or smoking. Data were collected at baseline and after six and 12 months, by means of a questionnaire. To analyse the data, linear and logistic regression analyses were performed.
Results
The intervention had a statistically significant beneficial effect on snack intake (β-1.9, 95%CI -3.7; -0.02) and fruit intake (β 1.7, 95%CI 0.6; 2.9) at 6 months. The effect on snack intake was sustained until 12 months; 6 months after the intervention had ended (β -1.9, 95%CI -3.6; -0.2). The intervention effects on leisure time PA and metabolic equivalent-minutes were not statistically significant. The beneficial effect on smoking was statistically significant at 6 (OR smoking 0.3, 95%CI 0.1;0.7), but not at 12 months (OR 0.8, 95%CI 0.4; 1.6).
Conclusions
Beneficial effects on smoking, fruit, and snack intake can be achieved by an individual-based lifestyle intervention among male construction workers with an elevated risk of CVD. Future research should be done on strategies to improve leisure time PA and on determinants of maintenance of changed behavior. Considering the rising prevalence of unhealthy lifestyle and CVD, especially in the aging population, implementation of this intervention in the occupational health care setting is recommended.
Trial registration
Current Controlled Trials ISRCTN60545588
doi:10.1186/1471-2458-11-836
PMCID: PMC3247875  PMID: 22040007
20.  Long-term lifestyle intervention lowers the incidence of stroke in Japanese patients with type 2 diabetes: a nationwide multicentre randomised controlled trial (the Japan Diabetes Complications Study) 
Diabetologia  2010;53(3):419-428.
Aims/hypothesis
The aim of the study was to clarify whether a therapeutic intervention focused on lifestyle modification affected the incidence of vascular complications in patients with established diabetes.
Methods
A total of 2,033 eligible Japanese men and women aged 40–70 years with type 2 diabetes from 59 institutes were randomised to a conventional treatment group (CON), which continued to receive the usual care, and a lifestyle intervention group (INT), which received education on lifestyle modification regarding dietary habits, physical activities and adherence to treatment by telephone counselling and at each outpatient clinic visit, in addition to the usual care. Randomisation and open-label allocation were done by a central computer system. Primary analysis regarding measurements of control status and occurrence of macro- and microvascular complications was based on 1,304 participants followed for an 8 year period.
Results
Although status of control of most classic cardiovascular risk factors, including body weight, glycaemia, serum lipids and BP, did not differ between groups during the study period, the incidence of stroke in the INT group (5.48/1,000 patient-years) was significantly lower than in the CON group (9.52/1,000 patient-years) by Kaplan–Meier analysis (p = 0.02 by logrank test) and by multivariate Cox analysis (HR 0.62, 95% CI 0.39–0.98, p = 0.04). The incidence of CHD, retinopathy and nephropathy did not differ significantly between groups. Lipoprotein(a) was another significant independent risk factor for stroke.
Conclusions/interpretation
These findings suggest that lifestyle modification had limited effects on most typical control variables, but did have a significant effect on stroke incidence in patients with established type 2 diabetes.
Clinical Trial Registration: UMIN-CTR C000000222
Funding: The Ministry of Health, Labour and Welfare, Japan
Electronic supplementary material
The online version of this article (doi:10.1007/s00125-009-1622-2) contains a list of members of the Japan Diabetes Complications Study Group, which is available to authorized users.
doi:10.1007/s00125-009-1622-2
PMCID: PMC2815795  PMID: 20054522
Complications; Lifestyle intervention; Patient education; Stroke
21.  Individualised multifactorial lifestyle intervention trial for high-risk cardiovascular patients in primary care. 
BACKGROUND: The multiprofessional teams in Finnish health centres are well placed to carry out interventions aimed at the prevention of cardiovascular diseases. AIM: To evaluate the effectiveness of an individually tailored multifactorial lifestyle intervention in primary care for individuals at high risk for cardiovascular disease. DESIGN OF STUDY: A randomised controlled trial was conducted over 24 months with interim assessments at six and 12 months. SETTING: A health centre in Finland with a patient population of 11,000. METHOD: One hundred and fifty adults aged 18 to 65 years old with existing cardiovascular disease or multiple risk factors were randomised to active multiprofessional risk factor intervention or to standard care. The main outcome measure was a change in cardiovascular risk-factor score. Secondary outcomes were changes in blood pressure, weight, body-mass index, serum cholesterol, blood glucose, smoking cessation, and exercise habits. RESULTS: The cardiovascular risk score decreased by 28% in the intervention group (23% in the control group), body weight decreased by 3.7% (2%) and total cholesterol decreased by 10.8% (6.5%), while time engaged in exercise increased by 39% (43%). Differences were not significant. CONCLUSIONS: Cardiovascular risk levels of high-risk individuals decreased in both intervention and control groups. Primary care prevention should be targeted to high-risk persons. Long-term follow-up studies are needed.
PMCID: PMC1313979  PMID: 11458482
22.  The Treatment of cardiovascular Risk in Primary care using Electronic Decision suppOrt (TORPEDO) study: intervention development and protocol for a cluster randomised, controlled trial of an electronic decision support and quality improvement intervention in Australian primary healthcare 
BMJ Open  2012;2(6):e002177.
Background
Large gaps exist in the implementation of guideline recommendations for cardiovascular disease (CVD) risk management. Electronic decision support (EDS) systems are promising interventions to close these gaps but few have undergone clinical trial evaluation in Australia. We have developed HealthTracker, a multifaceted EDS and quality improvement intervention to improve the management of CVD risk.
Methods/design
It is hypothesised that the use of HealthTracker over a 12-month period will result in: (1) an increased proportion of patients receiving guideline-indicated measurements of CVD risk factors and (2) an increased proportion of patients at high risk will receive guideline-indicated prescriptions for lowering their CVD risk. Sixty health services (40 general practices and 20 Aboriginal Community Controlled Health Services (ACCHSs) will be randomised in a 1:1 allocation to receive either the intervention package or continue with usual care, stratified by service type, size and participation in existing quality improvement initiatives. The intervention consists of point-of-care decision support; a risk communication interface; a clinical audit tool to assess performance on CVD-related indicators; a quality improvement component comprising peer-ranked data feedback and support to develop strategies to improve performance. The control arm will continue with usual care without access to these intervention components. Quantitative data will be derived from cross-sectional samples at baseline and end of study via automated data extraction. Detailed process and economic evaluations will also be conducted.
Ethics and dissemination
The general practice component of the study is approved by the University of Sydney Human Research Ethics Committee (HREC) and the ACCHS component is approved by the Aboriginal Health and Medical Research Council HREC. Formal agreements with each of the participating sites have been signed. In addition to the usual scientific forums, results will be disseminated via newsletters, study websites, face-to-face feedback forums and workshops.
Trial registration
The trial is registered with the Australian Clinical Trials Registry ACTRN 12611000478910.
doi:10.1136/bmjopen-2012-002177
PMCID: PMC3533097  PMID: 23166140
Primary Care; Cardiology
23.  The TrueBlue study: Is practice nurse-led collaborative care effective in the management of depression for patients with heart disease or diabetes? 
BMC Family Practice  2009;10:46.
Background
In the presence of type 2 diabetes (T2DM) or coronary heart disease (CHD), depression is under diagnosed and under treated despite being associated with worse clinical outcomes. Our earlier pilot study demonstrated that it was feasible, acceptable and affordable for practice nurses to extend their role to include screening for and monitoring of depression alongside biological and lifestyle risk factors. The current study will compare the clinical outcomes of our model of practice nurse-led collaborative care with usual care for patients with depression and T2DM or CHD.
Methods
This is a cluster-randomised intervention trial. Eighteen general practices from regional and metropolitan areas agreed to join this study, and were allocated randomly to an intervention or control group. We aim to recruit 50 patients with co-morbid depression and diabetes or heart disease from each of these practices. In the intervention group, practice nurses (PNs) will be trained for their enhanced roles in this nurse-led collaborative care study. Patients will be invited to attend a practice nurse consultation every 3 months prior to seeing their usual general practitioner. The PN will assess psychological, physiological and lifestyle parameters then work with the patient to set management goals. The outcome of this assessment will form the basis of a GP Management Plan document. In the control group, the patients will continue to receive their usual care for the first six months of the study before the PNs undergo the training and switch to the intervention protocol. The primary clinical outcome will be a reduction in the depression score. The study will also measure the impact on physiological measures, quality of life and on patient attitude to health care delivered by practice nurses.
Conclusion
The strength of this programme is that it provides a sustainable model of chronic disease management with monitoring and self-management assistance for physiological, lifestyle and psychological risk factors for high-risk patients with co-morbid depression, diabetes or heart disease. The study will demonstrate whether nurse-led collaborative care achieves better outcomes than usual care.
doi:10.1186/1471-2296-10-46
PMCID: PMC2714499  PMID: 19545446
24.  The TrueBlue model of collaborative care using practice nurses as case managers for depression alongside diabetes or heart disease: a randomised trial 
BMJ Open  2013;3(1):e002171.
Objectives
To determine the effectiveness of collaborative care in reducing depression in primary care patients with diabetes or heart disease using practice nurses as case managers.
Design
A two-arm open randomised cluster trial with wait-list control for 6 months. The intervention was followed over 12 months.
Setting
Eleven Australian general practices, five randomly allocated to the intervention and six to the control.
Participants
400 primary care patients (206 intervention, 194 control) with depression and type 2 diabetes, coronary heart disease or both.
Intervention
The practice nurse acted as a case manager identifying depression, reviewing pathology results, lifestyle risk factors and patient goals and priorities. Usual care continued in the controls.
Main outcome measure
A five-point reduction in depression scores for patients with moderate-to-severe depression. Secondary outcome was improvements in physiological measures.
Results
Mean depression scores after 6 months of intervention for patients with moderate-to-severe depression decreased by 5.7±1.3 compared with 4.3±1.2 in control, a significant (p=0.012) difference. (The plus–minus is the 95% confidence range.) Intervention practices demonstrated adherence to treatment guidelines and intensification of treatment for depression, where exercise increased by 19%, referrals to exercise programmes by 16%, referrals to mental health workers (MHWs) by 7% and visits to MHWs by 17%. Control-practice exercise did not change, whereas referrals to exercise programmes dropped by 5% and visits to MHWs by 3%. Only referrals to MHW increased by 12%. Intervention improvements were sustained over 12 months, with a significant (p=0.015) decrease in 10-year cardiovascular disease risk from 27.4±3.4% to 24.8±3.8%. A review of patients indicated that the study's safety protocols were followed.
Conclusions
TrueBlue participants showed significantly improved depression and treatment intensification, sustained over 12 months of intervention and reduced 10-year cardiovascular disease risk. Collaborative care using practice nurses appears to be an effective primary care intervention.
Trial registration
ACTRN12609000333213 (Australia and New Zealand Clinical Trials Registry).
doi:10.1136/bmjopen-2012-002171
PMCID: PMC3563126  PMID: 23355671
Mental Health; Public Health
25.  The @RISK Study: Risk communication for patients with type 2 diabetes: design of a randomised controlled trial 
BMC Public Health  2010;10:457.
Background
Patients with type 2 diabetes mellitus (T2DM) have an increased risk to develop severe diabetes related complications, especially cardiovascular disease (CVD). The risk to develop CVD can be estimated by means of risk formulas. However, patients have difficulties to understand the outcomes of these formulas. As a result, they may not recognize the importance of changing lifestyle and taking medication in time. Therefore, it is important to develop risk communication methods, that will improve the patients' understanding of risks associated with having diabetes, which enables them to make informed choices about their diabetes care.
The aim of this study is to investigate the effects of an intervention focussed on the communication of the absolute 10-year risk to develop CVD on risk perception, attitude and intention to change lifestyle behaviour in patients with T2DM. The conceptual framework of the intervention is based on the Theory of Planned Behaviour and the Self-regulation Theory.
Methods
A randomised controlled trial will be performed in the Diabetes Care System West-Friesland (DCS), a managed care system. Newly referred T2DM patients of the DCS, younger than 75 years will be eligible for the study. The intervention group will be exposed to risk communication on CVD, on top of standard managed care of the DCS. This intervention consists of a simple explanation on the causes and consequences of CVD, and possibilities for prevention. The probabilities of CVD in 10 year will be explained in natural frequencies and visualised by a population diagram. The control group will receive standard managed care. The primary outcome is appropriateness of risk perception. Secondary outcomes are attitude and intention to change lifestyle behaviour and illness perception. Differences between baseline and follow-up (2 and 12 weeks) between groups will be analysed according to the intention-to-treat principle. The study was powered on 120 patients in each group.
Discussion
This innovative risk communication method based on two behavioural theories might improve patient's appropriateness of risk perception and attitude concerning lifestyle change. With a better understanding of their CVD risk, patients will be able to make informed choices concerning diabetes care.
Trail registration
The trial is registered as NTR1556 in the Dutch Trial Register.
doi:10.1186/1471-2458-10-457
PMCID: PMC2922111  PMID: 20687924

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