CoCo trial: Color-coded blood pressure Control, a randomized controlled study.
ABSTRACT: Inadequate blood pressure (BP) control is a frequent challenge in general practice. The objective of this study was to determine whether a color-coded BP booklet using a traffic light scheme (red, >180 mmHg systolic BP and/or >110 mmHg diastolic BP; yellow, >140-180 mmHg systolic BP or >90-110 mmHg diastolic BP; green, ≤140 mmHg systolic BP and ≤90 mmHg diastolic BP) improves BP control and adherence with home BP measurement.In this two-group, randomized controlled trial, general practitioners recruited adult patients with a BP >140 mmHg systolic and/or >90 mmHg diastolic. Patients in the control group received a standard BP booklet and the intervention group used a color-coded booklet for daily home BP measurement. The main outcomes were changes in BP, BP control (treatment goal <140/90 mmHg), and adherence with home BP measurement after 6 months.One hundred and twenty-one of 137 included patients qualified for analysis. After 6 months, a significant decrease in systolic and diastolic BP was achieved in both groups, with no significant difference between the groups (16.1/7.9 mmHg in the intervention group versus 13.1/8.6 mmHg in the control group, P=0.3/0.7). BP control (treatment target <140/90 mmHg) was achieved significantly more often in the intervention group (43% versus 25%; P=0.037; number needed to treat of 5). Adherence with home BP measurement overall was high, with a trend in favor of the intervention group (98.6% versus 96.2%; P=0.1).Color-coded BP self-monitoring significantly improved BP control (number needed to treat of 5, meaning that every fifth patient utilizing color-coded self-monitoring achieved better BP control after 6 months), but no significant between-group difference was observed in BP change. A markedly higher percentage of patients achieved BP values in the normal range. This simple, inexpensive approach of color-coded BP self-monitoring is user-friendly and applicable in primary care, and should be implemented in the care of patients with arterial hypertension.
Project description:Insufficient blood pressure control is a frequent problem despite the existence of effective treatment. Insufficient adherence to self-monitoring as well as to therapy is a common reason. Blood pressure self-measurement at home (Home Blood Pressure Measurement, HBPM) has positive effects on treatment adherence and is helpful in achieving the target blood pressure. Only a few studies have investigated whether adherence to HBPM can be improved through simple measures resulting also in better blood pressure control.Improvement of self-monitoring and improved blood pressure control by using a new colour-coded blood pressure diary.Change in systolic and/or diastolic blood pressure 6 months after using the new colour-coded blood pressure diary.Secondary outcome: Adherence to blood pressure self-measurement (number of measurements/entries).Randomised controlled study.138 adult patients in primary care with uncontrolled hypertension despite therapy. The control group uses a conventional blood pressure diary; the intervention group uses the new colour-coded blood pressure diary (green, yellow, red according a traffic light system). EXPECTED RESULTS/CONCLUSION: The visual separation and entries in three colour-coded areas reflecting risk (green: blood pressure in the target range <or= 140/<or= 90 mmHg, yellow: blood pressure >140/>90 mmHg, red: blood pressure in danger zone > 180 mmHg/>110 mmHg) lead to better self-monitoring compared with the conventional (non-colour-coded) blood pressure booklet. The colour-coded, visualised information supports improved perception (awareness and interpretation) of blood pressure and triggers correct behaviour, in the means of improved adherence to the recommended treatment as well as better communication between patients and doctors resulting in improved blood pressure control.ClinicalTrials.gov ID NCT01013467.
Project description:Hypertension is a public health problem and a major risk factor for cardiovascular disease. The purpose of this study is to compare the effectiveness of a multidisciplinary program based on group and individual care versus group-only care, to promote blood pressure control in hypertensive patients in primary health care.Randomized controlled clinical trial. The study was conducted within the primary health care, in two units of the Family Health Strategy, covering 11,000 individuals, in Porto Alegre, Brazil. Two hundred and 56 patients, older than 40 years old and with uncontrolled hypertension, systolic blood pressure (BP) ?140 mmHg and/or diastolic BP ?90 mmHg or ?130 mmHg and/or diastolic BP ?80 mmHg for individuals with diabetes. Eligible patients were randomly assigned to a health care program aiming for blood pressure control, with the multidisciplinary program group or with the multidisciplinary program plus personalized care group. Primary outcome measures were reduction in systolic BP from baseline to 6 months. Secondary measures included proportion of patients with systolic or diastolic BP controlled. Student t test, Pearson's chi-squared test, Fisher's exact test, Mann-Whitney U test, Wilcoxon signed-ranks test and generalized estimating equation (GEE) model were used in the analysis.The baseline characteristics of participants were similar between groups. After 6 months of follow-up, systolic BP decreased markedly in both groups (? - 11.8 mmHg [SD, 20.2] in the multidisciplinary program group and ? - 12.9 mmHg [SD, 19.2] in the personalized care group; p?<?0.001). Similarly, we noted a significant change in diastolic BP over time in both groups (? - 8.1 mmHg [SD, 10.8] in the multidisciplinary program group and ? - 7.0 mmHg [SD, 11.5] in the personalized care group; p?<?0.001).The study demonstrates similar effectiveness of a group intervention in comparison to a personalized education program in hypertension patients to achieve BP control. These findings indicate that the intervention can be for all hypertensive patients assisted in primary health care.ClinicalTrials.gov Identifier NCT01696318 (May 2013).
Project description:Aims:The 2017 American College of Cardiology/American Heart Association (ACC/AHA) guideline on high blood pressure (BP) lowered the threshold defining hypertension and BP target in high-risk patients to 130/80?mmHg. Patients with coronary artery disease and systolic BP 130-139?mmHg or diastolic BP 80-89?mmHg should now receive medication to achieve this target. We aimed to investigate the relationship between BP and cardiovascular events in 'real-life' patients with coronary artery disease considered as having normal BP until the recent guideline. Methods and results:Data from 5956 patients with stable coronary artery disease, no history of hypertension or heart failure, and average BP <140/90?mmHg, enrolled in the CLARIFY registry (November 2009 to June 2010), were analysed. In a multivariable-adjusted Cox proportional hazards model, after a median follow-up of 5.0?years, diastolic BP 80-89?mmHg, but not systolic BP 130-139?mmHg, was associated with increased risk of the primary endpoint, a composite of cardiovascular death, myocardial infarction, or stroke (hazard ratio 2.15, 95% confidence interval 1.22-3.81 vs. 70-79?mmHg and 1.12, 0.64-1.97 vs. 120-129?mmHg). No significant increase in risk for the primary endpoint was observed for systolic BP <120?mmHg or diastolic BP <70?mmHg. Conclusion:In patients with stable coronary artery disease defined as having normal BP according to the 140/90?mmHg threshold, diastolic BP 80-89?mmHg was associated with increased cardiovascular risk, whereas systolic BP 130-139?mmHg was not, supporting the lower diastolic but not the lower systolic BP hypertension-defining threshold and treatment target in coronary artery disease. ClinicalTrials identifier:ISRCTN43070564.
Project description:Proteinuric diabetic kidney disease frequently progresses to ESRD. Control of BP delays progression, but the optimal BP to improve outcomes remains unclear. The objective of this analysis was to evaluate the relationship between BP and renal outcomes in proteinuric diabetic kidney disease.BP data from all 1448 randomized participants in the Veterans Affairs Nephropathy in Diabetes Trial were included in a post hoc analysis. The associations of mean on-treatment BP with the primary end point (decline in eGFR, ESRD, or death), renal end point (decline in eGFR or ESRD), rate of eGFR decline, and mortality were measured.The median (25th, 75th percentile) follow-up time was 2.2 (1.2, 3.0) years. There were 284 primary end points. In univariate analyses, both mean systolic and mean diastolic BPs were strongly associated (P<0.001) with the primary end point. After multivariate adjustment, the hazard of developing the primary end point became progressively higher as mean systolic BP rose from <120 to ? 150 mmHg (P=0.02), with a significantly higher hazard ratio for 140-149 versus 120-129 mmHg (1.51 [1.06, 2.15]; P=0.02). There was also a significant association of mean diastolic BP with the hazard of developing the primary end point (P<0.01), with a significantly higher hazard ratio when mean diastolic BP was 80-89 versus 70-79 mmHg (1.54 [1.05, 2.25]; P=0.03); there was also a strong trend when mean diastolic BP was <60 mmHg. Associations between BP and both renal end point and rate of eGFR decline were similar to those with the primary end point. No association of BP with mortality was observed, possibly because of the limited number of mortality events.In patients with proteinuric diabetic kidney disease, mean systolic BP ? 140 mmHg and mean diastolic BP ? 80 mmHg were associated with worse renal outcomes.
Project description:BACKGROUND:The purpose of this work was to describe the efficacy and safety of a telmisartan 80 mg + hydrochlorothiazide 25 mg (T80/H25) single-pill combination therapy in patients with moderate-severe hypertension (mean seated trough cuff systolic blood pressure [BP] ? 160 mmHg and diastolic BP ? 100 mmHg) in specific patient subpopulations. METHODS:This was a planned analysis of a double-blind, multicenter, parallel-group trial that demonstrated the superiority of a single-pill combination of T80/H25 versus T80 monotherapy in terms of systolic BP change from baseline to week 7. Subpopulations included older (aged ? 65 years) versus younger, gender, race, hypertension severity, and prior antihypertensive therapy. Endpoints were change from baseline in mean seated trough cuff systolic and diastolic BP, proportion of patients achieving their BP goal (systolic/diastolic BP < 140/90 mmHg), and proportion of patients attaining systolic BP reductions of >30 mmHg and >40 mmHg. RESULTS:Across all subgroups, the T80/H25 single-pill combination provided consistently greater systolic and diastolic BP reductions than T80 and more patients had systolic BP reductions of >30 mmHg. In the T80 and T80/H25 groups, BP control was achieved in 34.1% and 48.8% of men, 35.5% and 62.7% of women, 34.5% and 56.6% of Asians, 22.6% and 38.6% of blacks, 36.7% and 57.8% of whites, 36.9% and 57.5% of patients < 65 years, 29.3% and 49.3% ?65 years, 44.2% and 66.2% of those with grade 2 hypertension, 20.4% and 39.4% of those with grade 3 hypertension, 38.9% and 53.2% of previously untreated patients, 38.1% and 62.5% of patients previously treated with one antihypertensive, and 29.7% and 48.9% of patients previously treated with two or more antihypertensive agents respectively. Treatment was generally well tolerated across the patient subgroups. CONCLUSION:The T80/H25 single-pill combination provides consistent BP reductions and higher goal attainment rates versus T80 across a range of hypertensive patient subgroups, which are likely to have a positive impact on patients' cardiovascular risk.
Project description:The relationship between various categories of blood pressure (BP), subtypes of hypertension, and development of cardiovascular disease (CVD) have not been extensively studied. Therefore, our study aimed to explore this relationship in a random population sample of men born in 1943, living in Sweden and followed over a 21-year period.Participants were examined for the first time in 1993 (age 50 years), where data on medical history, concomitant diseases, and general health were collected. The examination was repeated in 2003 and with additional echocardiography also in 2014. Classification of participants according to their BP at the age of 50 years was as follows: optimal-normal BP (systolic blood pressure [SBP] <130 and diastolic BP [DBP] <85?mmHg), high-normal BP (130???SBP?<?140, 85???DBP?<?90?mmHg), isolated systolic-diastolic hypertension (ISH-IDH) (SBP ?140 and DBP <90 or SBP <140 and DBP ?90?mmHg), and systolic-diastolic hypertension (SDH) (SBP ?140 and DBP ?90?mmHg).During the follow-up, the incidence of heart failure (HF), CVD, and coronary heart disease were all lowest for those with optimal-normal BP. Participants with high-normal BP showed greater wall thickness and left ventricular mass index, larger LV size and larger left atrial size when compared with the optimal-normal BP group. Furthermore, those with high-normal BP, ISH-IDH, and SDH had a higher risk of CVD than those with optimal-normal BP. The adjusted relative risk of CVD was highest for SDH (hazard ratio [HR] 1.95; 95% confidence interval [95% CI] 1.37-2.79), followed by ISH-IDH (HR 1.34; 95% CI 0.93-1.95) and high-normal BP (HR 1.31; 95% CI 0.91-1.89).Over a 21-year follow-up, the participants with high-normal BP or ISH-IDH had a higher relative risk of CVD than those with optimal-normal BP.
Project description:Hypertension remains the most important cardiovascular risk factor in Poland. May Measurement Month is a global initiative organized by the International Society of Hypertension aimed at raising awareness of hypertension and the need for blood pressure (BP) screening and demonstrating the potential of the opportunistic BP measurements. An opportunistic cross-sectional survey of volunteers aged ?18 was carried out in 146 sites in May 2018. Blood pressure was measured in 6450 subjects (mean age: 41?±?15?years; 59% females). After multiple imputation, the age and sex standardized systolic and diastolic BP was 126.7/78.4?mmHg in the whole analysed group, 132.8/81.3?mmHg in subjects taking antihypertensive drugs, and 125.7/78.0?mmHg in those not taking any antihypertensive drugs. After multiple imputation, the proportions of subjects with high BP (systolic ?140?mmHg or diastolic ?90?mmHg or on treatment for raised BP) were 22.2% in the whole analysed group, 39.2% in subjects taking antihypertensive drugs, and 18.6% those not taking any antihypertensive drugs. Overall, hypertension was present in 32.8% of participants, among them 38.7% were not aware of the disease, 53.1% were taking antihypertensive drugs, and 32.3% had BP controlled to target (<140/90?mmHg). Blood pressure was increasing with increasing body mass index and alcohol intake. Smokers and project participants with diabetes had increased average BP. In conclusion, this project provides additional evidence for a considerable potential for further reduction of cardiovascular risk through improvement in detection and treatment of hypertension in Poland.
Project description:Secondary prevention after acute coronary syndrome (ACS) could reduce morbidity and mortality, but guideline targets are seldom reached. We hypothesized that nurse-led telephone-based intervention would increase adherence.The NAILED ACS trial is a prospective, controlled, randomized trial. Patients admitted for ACS at Östersund hospital, Sweden, were randomized to usual follow-up by a general practitioner or a nurse-led intervention. The intervention comprised telephone follow-up after 1 month and then yearly with lifestyle counselling and titration of medications until reaching target values for LDL-C (<2.5 mmol/L) and blood pressure (BP; <140/90 mmHg) or set targets were deemed unachievable. This is a 12-month exploratory analysis of the intervention.A total of 768 patients (396 intervention, 372 control) completed the 12-month follow-up. After titration at the 1-month follow-up, mean LDL-C was 0.38 mmol/L (95% CI 0.28 to 0.48, p<0.05), mean systolic BP 7 mmHg (95% CI 4.5 to 9.2, p<0.05), and mean diastolic BP 4 mmHg (95% CI 2.4 to 4.1, p<0.05) lower in the intervention group. Target values for LDL-C and systolic BP were met by 94.1% and 91.9% of intervention patients and 68.4% and 65.6% of controls (p<0.05). At 12 months, mean LDL was 0.3 mmol/L (95% CI 0.1 to 0.4, p <0.05), systolic BP 1.5 mmHg (95% CI -1.0 to 4.1, p = 0.24), and mean diastolic BP 2.1 mmHg (95% CI 0.6 to 3.6, p <0.05) lower in the intervention group. Target values for LDL-C and systolic BP were met in 77.7% and 68.9% of intervention patients and 63.2% and 63.7% of controls (p<0.05 and p = 0.125).Nurse-led telephone-based secondary prevention was significantly more efficient at improving LDL-C and diastolic BP levels than usual care. The effect of the intervention declined between 1 and 12 months. Further evaluation of the persistence to the intervention is needed.
Project description:Strategies are needed to improve adherence to the blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) level recommendations after stroke and transient ischemic attack (TIA). We investigated whether nurse-led, telephone-based follow-up that included medication titration was more efficient than usual care in improving BP and LDL-C levels 36 months after discharge following stroke or TIA.All patients admitted for stroke or TIA at Östersund hospital that could participate in the telephone-based follow-up were considered eligible. Participants were randomized to either nurse-led, telephone-based follow-up (intervention) or usual care (control). BP and LDL-C were measured one month after discharge and yearly thereafter. Intervention group patients who did not meet the target values received additional follow-up, including lifestyle counselling and medication titration, to reach their treatment goals (BP?<?140/90 mmHg, LDL-C?<?2.5 mmol/L). The primary outcome was the systolic BP level 36 months after discharge.Out of 871 randomized patients, 660 completed the 36-month follow-up. The mean systolic and diastolic BP values in the intervention group were 128.1 mmHg (95% CI 125.8-130.5) and 75.3 mmHg (95% CI 73.8-76.9), respectively. This was 6.1 mmHg (95% CI 3.6-8.6, p?<?0.001) and 3.4 mmHg (95% CI 1.8-5.1, p?<?0.001) lower than in the control group. The mean LDL-C level was 2.2 mmol/L in the intervention group, which was 0.3 mmol/L (95% CI 0.2-0.5, p?<?0.001) lower than in controls. A larger proportion of the intervention group reached the treatment goal for BP (systolic: 79.4% vs. 55.3%, p?<?0.001; diastolic: 90.3% vs. 77.9%, p?<?0.001) as well as for LDL-C (69.3% vs. 48.9%, p?<?0.001).Compared with usual care, a nurse-led telephone-based intervention that included medication titration after stroke or TIA improved BP and LDL-C levels and increased the proportion of patients that reached the treatment target 36 months after discharge.ISRCTN Registry ISRCTN23868518 (retrospectively registered, June 19, 2012).
Project description:<h4>Objectives</h4>To evaluate the effects of a low-sodium and high-potassium salt-substitute on lowering blood pressure (BP) among Tibetans living at high altitude (4300 meters).<h4>Method</h4>The study was a patient-blinded randomized controlled trial conducted between February and May 2009 in Dangxiong County, Tibetan Autonomous Region, China. A total of 282 Tibetans aged 40 or older with known hypertension (systolic BP?140 mmHg) were recruited and randomized to intervention (salt-substitute, 65% sodium chloride, 25% potassium chloride and 10% magnesium sulfate) or control (100% sodium chloride) in a 1: 1 allocation ratio with three months' supply. Primary outcome was defined as the change in BP levels measured from baseline to followed-up with an automated sphygmomanometer. Per protocol (PP) and intention to treat (ITT) analyses were conducted.<h4>Results</h4>After the three months' intervention period, the net reduction in SBP/DBP in the intervention group in comparison to the control group was -8.2/-3.4 mmHg (all p<0.05) in PP analysis, after adjusting for baseline BP and other variables. ITT analysis showed the net reduction in SBP/DBP at -7.6/-3.5 mmHg with multiple imputations (all p<0.05). Furthermore, the whole distribution of blood pressure showed an overall decline in SBP/DBP and the proportion of patients with BP under control (SBP/DBP<140 mmHg) was significantly higher in salt-substitute group in comparison to the regular salt group (19.2% vs. 8.8%, p?=?0.027).<h4>Conclusion</h4>Low sodium high potassium salt-substitute is effective in lowering both systolic and diastolic blood pressure and offers a simple, low-cost approach for hypertension control among Tibetans in China.<h4>Trial registration</h4>ClinicalTrials.gov NCT01429246.