Influencing adherence among hypertensives. Electronic monitoring of adherence as a tool to improve blood pressure control. A randomized controlled trial. Pharmacist involvement in primary care improves hypertensive patient clinical outcomes. A controlled trial of health education in the physician's office. Nonpharmacologic intervention to reduce blood pressure in older patients with mild hypertension. Adherence to cardiovascular risk factor modification in patients with hypertension. Improving blood pressure control through provider education, provider alerts, and patient education: a cluster randomized trial. Improving blood pressure control in diabetes: limitations of a clinical reminder in influencing physician behavior. Hypertension improvement project: randomized trial of quality improvement for physicians and lifestyle modification for patients. Patterns of compliance with once versus twice daily antihypertensive drug therapy in primary care: a randomized clinical trial using electronic monitoring. Five-year findings of the hypertension detection and follow-up program. I. Reduction in mortality of persons with high blood pressure, including mild hypertension. Hypertension Detection and Follow-up Program Cooperative Group. Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol: a randomized controlled trial. Increasing compliance. Patient-operated hypertension groups. The effects of nonpharmacologic interventions on blood pressure of persons with high normal levels. Results of the Trials of Hypertension Prevention, Phase I. A randomized trial of special packaging of antihypertensive medications. Work-site treatment of hypertension by specially trained nurses. A controlled trial. A comparison of compliance techniques on the control of high blood pressure. Nurse-led adherence support in hypertension: a randomized controlled trial. Effect of pharmacist intervention and initiation of home blood pressure monitoring in patients with uncontrolled hypertension. Efficacy of a home blood pressure monitoring programme on therapeutic compliance in hypertension: the EAPACUM-HTA study. Improvement of medication compliance in uncontrolled hypertension. Effects of comprehensive lifestyle modification on blood pressure control: main results of the PREMIER clinical trial. Trial of Nonpharmacologic Intervention in the Elderly (TONE). Design and rationale of a blood pressure control trial. Pharmaceutical care program for patients with uncontrolled hypertension. Report of a double-blind clinical trial with ambulatory blood pressure monitoring. Non-pharmacological treatment of hypertension in primary health care: a 2-year open randomized controlled trial of lifestyle intervention against hypertension in eastern Finland. Randomised clinical trial of strategies for improving medication compliance in primary hypertension. Group versus individual academic detailing to improve the use of antihypertensive medications in primary care: a cluster-randomized controlled trial. Integration of depression and hypertension treatment: a pilot, randomized controlled trial. Comparing standard care with a physician and pharmacist team approach for uncontrolled hypertension. Rational prescribing in primary care (RaPP): a cluster randomized trial of a tailored intervention. Exercise and weight loss reduce blood pressure in men and women with mild hypertension: effects on cardiovascular, metabolic, and hemodynamic functioning. Comprehensive pharmaceutical care in the chain setting. Evaluation of a structured treatment and teaching programme on hypertension in general practice.
In the treatment of hypertension, problems of nonadherence and consequent poor blood pressure control are particularly severe. Alternative intervention strategies were compared to explore means of improving adherence and lowering blood pressures. In a 3 x 4 repeated measures analysis of variance design, 115 patients were randomly selected and randomly assigned to one of three treatment modalities (routine clinic care, patient education, and contingency contracting) and were followed over four clinic visits. Subjects' knowledge about hypertension and its management, adherence to requests for regular medical follow-up, and blood pressure levels were measured. Patient education was not effective in lowering blood pressures; it produced an untoward outcome, a dropout rate higher than that for patients receiving only routine clinic care. However, contingency contracting was an effective intervention strategy for improving patient knowledge, F (1,59) = 51.32, p less than .0001; adherence to requests for regular medical care, Max L (2) = 25.9, p less than .0001; and decreasing diastolic blood pressures, F (2,49) = 3.39, p less than .05. Poor adherence to antihypertensive drug regimens is believed to be a major contributor to treatment failure. Electronic monitoring of adherence may improve adherence and allow differentiation between those who are nonadherent and those who are pharmacologically nonresponsive. This study was designed to evaluate the effectiveness of electronic monitoring of adherence in lowering blood pressure (BP) in comparison with usual care.
                A total of 258 patients with high BP despite use of antihypertensive medication were randomly assigned to either continuation of usual care (with adjustment in antihypertensive medication if necessary) or to the introduction of electronic monitoring. Adherence to antihypertensive medication was monitored for 2 months without medication changes. The primary outcome measure was the proportion of patients who reached target BP levels after a 5-month follow-up period.
                At 5 months, 50.6% of the patients in the usual care group reached adequate BP, v 53.7% in the electronic monitoring group (P = .73). The percentages of patients with drug additions or increases in dosage were higher in the usual care group compared with those in whom adherence was monitored (P < .01).
                These data show that electronic monitoring in comparison to usual care results in similar BP control but leads to fewer drug changes and less drug use. This result is likely to be achieved by improving adherence. Hence a strategy that includes electronic monitoring has the potential to prevent unnecessary treatment escalation in patients with poor adherence. The practice of pharmaceutical care in primary care settings in Thailand is currently not generally accepted.
                To evaluate the effect of pharmacist involvement in treatment with hypertensive patients in primary care settings.
                The treatment objective was to stabilize the blood pressure (BP) of hypertensive patients in accordance with the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure guidelines. Patients were randomly assigned to a pharmacist-involved group (treatment) or a group with no pharmacist involvement (control). Pre- and post-test BPs, tablet counts, lifestyle modifications, and pharmacists' recommendations were recorded. The 6-month study was carried out in Mahasarakham University pharmacy and 2 primary care units. Patients were monitored monthly by reviewing their medications and supported by providing pharmaceutical care and counseling.
                From a total of 235 patients, the treatment group (n = 118) had a significant reduction in both systolic (S) and diastolic (D) BP compared with the 117 patients of the control group (p = 0.037, 0.027, respectively). The 158 patients (76 treatment, 82 control) with BPs >or=140/90 mm Hg at the beginning of the study showed significant BP reductions (p = 0.002 SBP, 0.008 DBP). The proportion of 158 patients whose BP became stabilized was higher in the treatment group (p = 0.017). The treatment group showed significantly better adherence (p = 0.014) and exercise control (p = 0.012) at the end of the study. Physicians accepted 42.72% of medication modifications and 5.34% of the suggestions for additional investigations.
                Hypertensive patients who received pharmacist input achieved a significantly greater benefit in BP reduction, BP control, and improvement in adherence rate and lifestyle modification. Screening of 6,144 patients in a general practice clinic to assist physician case-finding uncovered 983 (16%) who were uncontrolled hypertensives. Following physician recommendation, 115 patients volunteered for a controlled trial to test the effectiveness of supplementary strategies to the pharmaceutical management of high blood pressure. A study of nonparticipants indicated that about 7% of the practice population was eligible for cardiovascular health education. One group received a health education program, a second was allocated to self-monitor their blood pressure for 6 months, a third group was allocated to both strategies, and the final group, acting as a control, continued to receive their usual care. Physician monitoring of patients continued for the duration of the study and blood pressures decreased in all patients. The study's most important outcome was the joint reduction of blood pressure and medication strength. These were assessed by a "blind" clinician before and after the interventions according to criteria set out in the "stepped-care" approach to management of high blood pressure. People allocated to a health education program conducted in the doctor's common room did twice as well on this measure as those who were not so educated. Daily self-monitoring of blood pressure for 6 months proved to be too much for the majority of those so instructed. It is concluded that the general practice setting remains an important place for health education to prevent cardiac disease and suggestions are made for incorporating this into everyday practice. Although nonpharmacologic interventions are widely recommended in the therapy of high blood pressure in older adults, surprisingly little data exist to confirm the efficacy of these interventions in older persons.
                We conducted a randomized, controlled clinical trial in persons aged 60 to 85 years with a diastolic blood pressure of 85 to 100 mm Hg. The experimental arm was a nonpharmacologic intervention combining weight reduction, sodium restriction, and increased physical activity. The nonpharmacologic intervention consisted of eight weekly group and two individual sessions during the intensive phase, followed by four monthly group sessions during the maintenance phase. The control group received no treatment during the study. Blood pressure was assessed by certified technicians (blinded to group assignment) using random zero sphygmomanometers.
                Of 56 participants randomized, 47 completed the entire 6-month trial (21 in the intervention group and 26 in the control group). Attendance at the intervention sessions was excellent. The intervention group lost more weight (-2.1 kg) over 6 months than the control group (+0.3 kg). Trends for decreasing 24-hour urine sodium excretion in both the intervention and control groups, with greater trend in the intervention group, were not statistically significant. The intervention group experienced more reduction in systolic and diastolic blood pressure than did the control group (mean differences between groups at 6 months, 4.2/4.9 mm Hg, respectively).
                Our data indicate that a nonpharmacologic intervention will lower systolic and diastolic blood pressure levels in older people with borderline or mild elevations of diastolic blood pressure. The effectiveness of the support of a healthcare practitioner and a family member in producing changes in cardiovascular risk factor modification was tested in a randomised, controlled trial in patients with hypertension.
                The primary outcome measured after the 24-week intervention was blood pressure change. Secondary outcomes included patients' adherence to the programme, their knowledge about hypertension, exercise capacity, body weight, self-reported ability to control stress, adherence to medication and salt restriction, as well as symptoms.
                There were no marked improvements in blood pressure regulation in either group. The differences between the experimental and control groups were 3 mmHg (CI -6.18-12.18) for systolic blood pressure and 4 mmHg (CI -1.48-9.48) for diastolic blood pressure. The estimated blood pressure effects were small increases in both diastolic and systolic blood pressure, due to larger changes in the control group. These small changes were of no clinical significance. This intervention was not successful in reducing blood pressure of hypertensive patients who participated in a lifestyle programme. Secondary outcomes did show positive changes as a result of the given intervention. The absolute difference in improvement between the two groups was significantly greater for the experimental group than for the control group for the following variables: 24% better adherence to the programme (p = 0.007); 10% higher mean percentage score of hypertension knowledge and its management (p = 0.04); 20% more patients could control their stress levels (p = 0.05); 26% more patients could control their salt ingestion (p = 0.02); and 20% had better adherence to their given medication regimen (p = 0.05). The experimental group had a statistically significant weight reduction of 1 (+/- 4) kg relative to the control group (p = 0.03). Both groups increased their exercise capacity during the trial (p = 0.03). On the completion of the intervention, significantly fewer patients in the experimental group than in the control complained of tiredness (p = 0.05). Patients who had a 75% adherence or more to the programme were found to have maintained their knowledge and their exercise capacity, but not their weight loss after a maintenance phase of 12 weeks, during which time there was no intervention.
                Patients in a supported environment such as the one in this study were able to modify their cardiovascular risk factors, even though there were non-significant changes in blood pressure reported in this study. Inadequate blood pressure control is a persistent gap in quality care.
                To evaluate provider and patient interventions to improve blood pressure control.
                Cluster randomized, controlled trial.
                2 hospital-based and 8 community-based clinics in the Veterans Affairs Tennessee Valley Healthcare System.
                1341 veterans with essential hypertension cared for by 182 providers. Eligible patients had 2 or more blood pressure measurements greater than 140/90 mm Hg in a 6-month period and were taking a single antihypertensive agent.
                Providers who cared for eligible patients were randomly assigned to receive an e-mail with a Web-based link to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC 7) guidelines (provider education); provider education and a patient-specific hypertension computerized alert (provider education and alert); or provider education, hypertension alert, and patient education, in which patients were sent a letter advocating drug adherence, lifestyle modification, and conversations with providers (patient education).
                Proportion of patients with a systolic blood pressure less than 140 mm Hg at 6 months; intensification of antihypertensive medication.
                Mean baseline blood pressure was 157/83 mm Hg with no differences between groups (P = 0.105). Six-month follow-up data were available for 975 patients (73%). Patients of providers who were randomly assigned to the patient education group had better blood pressure control (138/75 mm Hg) than those in the provider education and alert or provider education alone groups (146/76 mm Hg and 145/78 mm Hg, respectively). More patients in the patient education group had a systolic blood pressure of 140 mm Hg or less compared with those in the provider education or provider education and alert groups (adjusted relative risk for the patient education group compared with the provider education alone group, 1.31 [95% CI, 1.06 to 1.62]; P = 0.012).
                Follow-up blood pressure measurements were missing for 27% of study patients. The study could not detect a mechanism by which patient education improved blood pressure control.
                A multifactorial intervention including patient education improved blood pressure control compared with provider education alone. Hypertension should be aggressively treated, especially in diabetic patients. But studies of physician prescribing habits reveal that physicians often delay making medication changes or initiating antihypertensive therapy. A chart-based reminder was designed to improve physician medication prescribing in this clinical situation.
                A randomized controlled trial was conducted at the Veterans Affairs Medical Center in Richmond, Virginia. Patients with diabetes and hypertension were selected. A highly visible chart reminder was applied to the front of outpatient charts in the intervention group practice. A chart review was conducted to assess physician-directed medication changes. A successful outcome was defined as any antihypertensive medication increase or addition at that same visit.
                Physicians were more likely to intensify antihypertensive medication as the blood pressure increased regardless of the reminder. Overall, only 33% of visits resulted in a medication change, even though 93% of patients had elevations over target blood pressure at the follow-up visit. Physicians in the intervention and control groups made changes to medication at similar rates (chi 2 = 0.621, p = .511).
                In this study, a chart reminder failed to improve physician compliance with the clinical guideline for hypertension management in diabetics, Sixth Report of the Joint National Committee on the Detection, Evaluation, Prevention and Treatment of High Blood Pressure. To inform the design of effective intervention strategies, further research should explore specific barriers to guideline adherence in this clinical situation. Despite widely publicized hypertension treatment guidelines for physicians and lifestyle recommendations for patients, blood pressure control rates remain low. In community-based primary care clinics, we performed a nested, 2 x 2 randomized, controlled trial of physician intervention versus control and/or patient intervention versus control. Physician intervention included internet-based training, self-monitoring, and quarterly feedback reports. Patient intervention included 20 weekly group sessions followed by 12 monthly telephone counseling contacts and focused on weight loss, Dietary Approaches to Stop Hypertension dietary pattern, exercise, and reduced sodium intake. The primary outcome was change in systolic blood pressure at 6 months. Eight primary care practices (32 physicians) were randomized to physician intervention or control groups. Within those practices, 574 patients were randomized to patient intervention or control groups. Patient mean age was 60 years, 61% were women, and 37% were black. Blood pressure data were available for 91% of patients at 6 months. The main effect of physician intervention on systolic blood pressure at 6 months, adjusted for baseline pressure, was 0.3 mm Hg (95% CI: 1.5 to 2.2; P=0.72). The main effect of the patient intervention was 2.6 mm Hg (95% CI: 4.4 to 0.7; P=0.01). The interaction of the 2 interventions was significant (P=0.03); the largest impact was observed with the combination of physician and patient intervention (9.7 +/- 12.7 mm Hg). Differences between treatment groups did not persist at 18 months. Combined physician and patient interventions lowers blood pressure; future research should focus on enhancing effectiveness and sustainability of these interventions. To evaluate patterns of compliance with once versus twice daily administration of antihypertensive therapy (primary-outcome measure) and relevance of partial compliance for blood pressure control (secondary outcome measure).
                Multicentre, nonblinded, parallel group randomized design.
                Nonacademic primary care practices across Canada.
                Patients with mild essential hypertension (diastolic blood pressure 95 to 110 mmHg) of either sex (40% women), age 18 to 80 years (average 55 years). One hundred and ninety-eight patients were randomized to active treatment; 14 patients discontinued the study because of side effects.
                After a four-week placebo run-in period, patients were randomized to amlodipine 5 mg once-a-day or diltiazem slow release formulation (SR) 90 mg twice daily. Doses were increased to 10 mg and 180 mg to achieve sitting diastolic blood pressure of 90 mmHg or less.
                During 20 weeks on active treatment, compliance was assessed by pill counts and medication event monitoring system (MEMS), assessing percentage of prescribed doses taken, percentage days correct doses taken, percentage prescribed doses taken on time and blood pressure control as determined by office blood pressure measurement.
                The percentage prescribed doses taken (by either pill count of MEMS) showed a high degree of compliance, similar for the two treatments. However, other parameters of compliance were significantly better with once versus twice daily therapy. Partial compliance (less than 80% by pill count) led to less blood pressure control with the short acting diltiazem, but did not affect blood pressure control for the long acting amlodipine. Side effects profiles did not differ between the two treatments.
                Within the constraints of a clinical trial, hypertensive patients in primary care show a high degree of overall compliance with once or twice daily pill-taking, but patterns of pill-taking are more erratic with twice versus once daily medication, particularly in men. The results suggest that the negative consequences of partial compliance for blood pressure control can be offset by choosing agents with a duration of action well beyond the dosing interval. The Hypertension Detection and Follow-up Program (HDFP), in a community-based, randomized controlled trial involving 10,940 persons with high blood pressure (BP), compared the effects on five-year mortality of a systematic antihypertensive treatment program (Stepped Care [SC]) and referral to community medical therapy (Referred Care [RC]). Participants, recruited by population-based screening of 158,906 people aged 30 to 69 years in 14 communities througout the United States, were randomly assigned to SC or RC groups within each center and by entry diastolic blood pressure (DBP) (90 to 104, 105 to 114, and 115 + mm Hg). Over the five years of the study, more than two thirds of the SC participants continued to receive medication, and more than 50% achieved BP levels within the normotensive range, at or below the HDFP goal for DBP. Controls of BP was consistently better for the SC than for the RC group. Five-year mortality from all causes was 17% lower for the SC group compared to the RC group (6.4 vs 7.7 per 100, P less than .01) and 20% lower for the SC subgroup with entry DBP of 90 to 104 mm Hg compared to the corresponding RC subgroup (5.9 vs 7.4 per 100, P less than .01). These findings of the HDFP indicate that the systematic effective management of hypertension has a great potential for reducing mortality for the large numbers of people with high BP in the population, including those with "mild" hypertension. Poor medication adherence diminishes the health benefits of pharmacotherapies. Elderly patients with coronary risk factors frequently require treatment with multiple medications, placing them at increased risk for nonadherence.
                To test the efficacy of a comprehensive pharmacy care program to improve medication adherence and its associated effects on blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C).
                A multiphase, prospective study with an observational phase and a randomized controlled trial conducted at the Walter Reed Army Medical Center of 200 community-based patients aged 65 years or older taking at least 4 chronic medications. The study was conducted from June 2004 to August 2006.
                After a 2-month run-in phase (measurement of baseline adherence, BP, and LDL-C), patients entered a 6-month intervention phase (standardized medication education, regular follow-up by pharmacists, and medications dispensed in time-specific packs). Following the intervention phase, patients were randomized to continued pharmacy care vs usual care for an additional 6 months.
                Primary end point of the observation phase was change in the proportion of pills taken vs baseline; secondary end points were the associated changes in BP and LDL-C. Primary end point of the randomization phase was the between-group comparison of medication persistence.
                A total of 200 elderly patients (77.1% men; mean [SD] age, 78 [8.3] years), taking a mean (SD) of 9 (3) chronic medications were enrolled. Coronary risk factors included drug-treated hypertension in 184 patients (91.5%) and drug-treated hyperlipidemia in 162 (80.6%). Mean (SD) baseline medication adherence was 61.2% (13.5%). After 6 months of intervention, medication adherence increased to 96.9% (5.2%; P<.001) and was associated with significant improvements in systolic BP (133.2 [14.9] to 129.9 [16.0] mm Hg; P = .02) and LDL-C (91.7 [26.1] to 86.8 [23.4] mg/dL; P = .001). Six months after randomization, the persistence of medication adherence decreased to 69.1% (16.4%) among those patients assigned to usual care, whereas it was sustained at 95.5% (7.7%) in pharmacy care (P<.001). This was associated with significant reductions in systolic BP in the pharmacy care group (-6.9 mm Hg; 95% CI, -10.7 to -3.1 mm Hg) vs the usual care group (-1.0 mm Hg; 95% CI, -5.9 to 3.9 mm Hg; P = .04), but no significant between-group differences in LDL-C levels or reductions.
                A pharmacy care program led to increases in medication adherence, medication persistence, and clinically meaningful reductions in BP, whereas discontinuation of the program was associated with decreased medication adherence and persistence.
                clinicaltrials.gov Identifier: NCT00393419 Compliance was compared in 52 previously noncompliant hypertensive patients randomly assigned for eight weeks to either a nurse-operated hypertension clinic (control) or a patient-operated hypertension group] (experimental). Control patients listened to audiotapes on hypertension and its management and met individually with a nurse who adjusted their drug regimens. Experimental patients were trained to take their own blood pressure (BP) and select their own drugs in a group program emphasizing informed self-help. After the eight-week training period and at two- and six-month follow-up visits, both groups had significantly lower BPs. Compared with control patients, experimental patients had lower diastolic BPs, better pill counts, and better attendance (all P < .05). This study suggests that training noncompliant patients in groups to manage their own hypertension may achieve better results than traditional management programs. To test the short-term feasibility and efficacy of seven nonpharmacologic interventions in persons with high normal diastolic blood pressure.
                Randomized control multicenter trials.
                Volunteers recruited from the community, treated and followed up at special clinics.
                Of 16,821 screenees, 2182 men and women, aged 30 through 54 years, with diastolic blood pressure from 80 through 89 mm Hg were selected. Of these, 50 did not return for follow-up blood pressure measurements.
                Three life-style change groups (weight reduction, sodium reduction, and stress management) were each compared with unmasked nonintervention controls over 18 months. Four nutritional supplement groups (calcium, magnesium, potassium, and fish oil) were each compared singly, in double-blind fashion, with placebo controls over 6 months.
                Primary: change in diastolic blood pressure from baseline to final follow-up, measured by blinded observers. Secondary: changes in systolic blood pressure and intervention compliance measures.
                Weight reduction intervention produced weight loss of 3.9 kg (P less than .01), diastolic blood pressure change of -2.3 mm Hg (P less than .01), and systolic blood pressure change of -2.9 mm Hg (P less than .01). Sodium reduction interventions lowered urinary sodium excretion by 44 mmol/24 h (P less than .01), diastolic blood pressure by 0.9 mm Hg (P less than .05), and systolic blood pressure by 1.7 mm Hg (P less than .01). Despite good compliance, neither stress management nor nutritional supplements reduced diastolic blood pressure or systolic blood pressure significantly (P greater than .05).
                Weight reduction is the most effective of the strategies tested for reducing blood pressure in normotensive persons. Sodium reduction is also effective. The long-term effects of weight reduction and sodium reduction, alone and in combination, require further evaluation. This article reports a randomized controlled trial designed to test the effects of special packaging of antihypertensive medication on compliance and blood pressure control. One hundred eighty subjects who had exhibited elevated blood pressure greater than 90 mmHg in the two years prior to the study were recruited from patients receiving care at a community hospital-based family medicine practice. After completing preenrollment interviews and blood pressure measurements, subjects were randomly assigned to receive their antihypertensive medications either in the usual vials or in special unit dose-reminder packaging. Follow-up interviews, pill counts, and blood pressure measurements were performed at three-month intervals. There were no statistically significant differences between the control and experimental groups with regard to age, sex, race, employment, education, marital status, insurance coverage, or blood pressure regimens. Prior to the intervention, the experimental group had slightly lower diastolic blood pressure and reported better compliance than the control group. Analyses performed on 165 subjects completing the first follow-up visit revealed no significant improvements in blood pressure control or compliance for patients receiving special medication packaging. While some patients found it easy to remember to take pills packaged using this format, they also found the packages somewhat more difficult and inconvenient to use. In contrast to previously reported work, this study did not demonstrate any significant improvement in compliance with special packaging of antihypertensive medications. The clinical efficacy of using specially trained nurses to treat hypertension at the patient's place of work was compared in a controlled trial with management by the patient's family doctor. The 457 study participants were selected from 21 906 volunteers in industry and government whose blood-pressure was screened. The nurses were allowed to prescribe and change drug therapy at the work site without prior physician approval. Patients randomly allocated to receive care at work were significantly more likely to be put on antihypertensive medications (94.7% vs 62.7%, to reach goal blood-pressure in the first six months (48.5% vs 27.5%), and to take the drugs prescribed (67.6% vs 49.1%). Only 6% of patients were dissatisfied with the care provided by the nurses. Thus provision of care at work by specially tranined nurses was well accepted and resulted in significantly improved blood-pressure control and medication compliance among employees with asymptomatic and uncomplicated hypertension. Four compliance strategies were compared with education alone to investigate their impact on the control of high blood pressure. One hundred twelve subjects with documented high blood pressure were randomly assigned to receive education alone, home blood pressure monitoring, contracts, pill packs, or a combination of techniques. Groups were similar in terms of age, sex, race, initial blood pressure, and medications. At the end of the year, there was no significant change in blood pressure for the group that received education alone (-3/-1 mm Hg). There was a statistically significant change in both systolic and diastolic blood pressure for all compliance groups (-17/-10 mm Hg). Information from compliance questionnaires adds further support to the observation that education alone does not influence compliance while the specific techniques studied did improve compliance. The study was too small to show any difference among techniques. Lack of medication adherence is a common reason for poor control of blood pressure in the community, increasing the risk of heart attacks and strokes.
                To evaluate the effect of nurse-led adherence support for people with uncontrolled high blood pressure compared with usual care.
                We recruited 245 women and men with uncontrolled hypertension (> or = 150/90 mmHg) from 21 general practices in Bristol, UK. Participants were randomized to receive nurse-led adherence support or usual care alone. Main outcome measures were adherence to medication ('timing compliance') and blood pressure.
                Mean baseline timing compliance (+/- SD) was high in both the intervention (90.8 +/- 15.6%) and the control group (94.5 +/- 7.6%). There was no evidence of an effect of the intervention on timing compliance at follow-up (adjusted difference in means -1.0%; 95% confidence interval (CI) -5.1 to 3.1). There was also no difference at follow-up between the groups with regard to systolic blood pressure (-2.7 mmHg; 95% CI -7.2 to 1.8) or diastolic blood pressure (0.2 mmHg; 95% CI -1.9 to 2.3). Projected costs for the primary care sector per consultation were 6.60 pound sterling for the intervention compared with 5.08 pound sterling for usual care.
                In this study, adherence to blood pressure medication was much higher than previously reported. There was no evidence of an effect of nurse-led adherence support on medication adherence or blood pressure compared with usual care. Nurse-led adherence support was also more expensive from a primary care perspective. This prospective, randomized, controlled study evaluated the impact of pharmacist-initiated home blood pressure monitoring and intervention on blood pressure control, therapy compliance, and quality of life (QOL). Subjects were 36 patients with uncontrolled stage 1 or 2 hypertension. Eighteen subjects received home blood pressure monitors, a diary, and instructions to measure blood pressure twice every morning. Home measurements were evaluated by a clinical pharmacist by telephone, and the patient's family physician was contacted with recommendations if mean monthly values were 140/90 mm Hg or higher. Eighteen control patients did not receive home monitors or pharmacist intervention. Office blood pressure measurements and QOL surveys (SF-36) were obtained at baseline and after 6 months. Mean absolute reductions in systolic and diastolic pressures were significantly reduced from baseline in intervention subjects (17.0 and 10.5 mm Hg, both p < 0.0001) but not in controls (7.0 and 3.8 mm Hg, p = 0.12 and p = 0.09). More intervention subjects (8) had blood pressure values below 140/90 at 6 months compared with controls (4). During the study 83.3% (15) of intervention subjects had drug therapy changes versus 33% (6) of controls (p < 0.01). Compliance and QOL were not significantly affected. Our data suggest that the combination of pharmacist intervention with home monitoring can improve blood pressure control in patients with uncontrolled hypertension. This may be related to increased modifications of drug regimens. To evaluate the efficacy of a programme of home blood pressure measurement (HBPM) on therapeutic compliance in mild-to-moderate hypertension.
                A prospective controlled multicentre clinical trial.
                Forty primary care centres in Spain, with a duration of 6 months.
                A total of 250 patients with newly diagnosed or uncontrolled hypertension were included.
                The patients were randomly selected and distributed in two groups: (1) the control group (CG) who received standard health intervention; (2) the intervention group (IG): the patients in this group received an OMRON in their homes for a programme of HBPM.
                Four visits were scheduled, for the measurement of blood pressure (BP). They were provided with an electronic monitor for measuring compliance (monitoring events medication system; MEMS). Therapeutic compliance was defined as a drug consumption of 80-110%. A number of variables were calculated using the MEMS. The mean BP were calculated and the percentage of controlled patients.
                A total of 200 patients completed the study (100 in each group). Compliance was observed in 74 and 92%, respectively, in the CG and IG [95% confidence interval (CI) 63.9-84.1 and 86.7-97.3; P = 0.0001], the mean percentage compliances were 87.6 and 93.5% (95% CI 81.2-94 and 80.7-98.3; P = 0.0001), the percentages of correct days were 83.6 and 89.4%, the percentages of subjects who took the medication at the prescribed time were 79.89 and 88.06%, and the levels of therapeutic cover were 86.7 and 93.1%. The number needed to treat to avoid one case of non-compliance was 5.6 patients. The differences in the mean decreases in BP were significant for diastolic BP, with a greater decrease observed in the IG.
                An HBPM programme using electronic monitors is effective in improving compliance in arterial hypertension, measured using the MEMS. 38 hypertensive Canadian steelworkers who were neither compliant with medications nor at goal diastolic blood-pressure six months after starting treatment were allocated either to a control group or to an experimental group who were taught how to measure their own blood-pressures, asked to chart their home blood-pressures and pill taking, and taught how to tailor pill taking to their daily habits and rituals; these men were also seen fortnightly by a highschool graduate with no formal health professional training who reinforced the experimental manoeuvres and rewarded improvements in compliance and blood-pressure. Six months later, average compliance had fallen by 1.5% in the control group but rose 21.3% in the experimental group. Blood-pressures fell in 17 of 20 experimental patients (to goal in 6) and in 10 of 18 control patients (to goal in 2). Weight loss, sodium reduction, increased physical activity, and limited alcohol intake are established recommendations that reduce blood pressure (BP). The Dietary Approaches to Stop Hypertension (DASH) diet also lowers BP. To date, no trial has evaluated the effects of simultaneously implementing these lifestyle recommendations.
                To determine the effect on BP of 2 multicomponent, behavioral interventions.
                Randomized trial with enrollment at 4 clinical centers (January 2000-June 2001) among 810 adults (mean [SD] age, 50 [8.9] years; 62% women; 34% African American) with above-optimal BP, including stage 1 hypertension (120-159 mm Hg systolic and 80-95 mm Hg diastolic), and who were not taking antihypertensive medications.
                Participants were randomized to one of 3 intervention groups: (1) "established," a behavioral intervention that implemented established recommendations (n = 268); (2) "established plus DASH,"which also implemented the DASH diet (n = 269); and (3) an "advice only" comparison group (n = 273).
                Blood pressure measurement and hypertension status at 6 months.
                Both behavioral interventions significantly reduced weight, improved fitness, and lowered sodium intake. The established plus DASH intervention also increased fruit, vegetable, and dairy intake. Across the groups, gradients in BP and hypertensive status were evident. After subtracting change in advice only, the mean net reduction in systolic BP was 3.7 mm Hg (P<.001) in the established group and 4.3 mm Hg (P<.001) in the established plus DASH group; the systolic BP difference between the established and established plus DASH groups was 0.6 mm Hg (P =.43). Compared with the baseline hypertension prevalence of 38%, the prevalence at 6 months was 26% in the advice only group, 17% in the established group (P =.01 compared with the advice only group), and 12% in the established plus DASH group (P<.001 compared with the advice only group; P =.12 compared with the established group). The prevalence of optimal BP (<120 mm Hg systolic and <80 mm Hg diastolic) was 19% in the advice only group, 30% in the established group (P =.005 compared with the advice only group), and 35% in the established plus DASH group (P<.001 compared with the advice only group; P =.24 compared with the established group).
                Individuals with above-optimal BP, including stage 1 hypertension, can make multiple lifestyle changes that lower BP and reduce their cardiovascular disease risk. National and international policy-making organizations advocate nonpharmacologic therapies to reduce blood pressure (BP). However, data to support such recommendations in older persons are virtually nonexistent. The Trials of Nonpharmacologic Intervention in the Elderly (TONE) is a randomized, controlled trial that will test whether weight loss or a reduced sodium (Na) intake or both can maintain satisfactory BP control, without unacceptable side effects, after withdrawal of antihypertensive drug therapy. Medication-treated hypertensives (aged 60 to 80 years) with a systolic BP less than 145 mm Hg and a diastolic BP less than 85 mm Hg who are taking one antihypertensive medication are randomly assigned to one of four groups: (1) weight loss alone, (2) reduced Na intake alone, (3) combined weight loss and reduced Na intake, or (4) usual life-style (control group). Overweight participants are randomized to one of these four groups, while nonoverweight individuals are assigned to either the reduced Na intake or the usual life-style group. The interventions, tailored to the needs of older persons, use behavioral approaches to accomplish intervention-specific goals (weight loss > or = 10 lb, daily Na intake < or = 80 mEqa). Three months after the start of intervention, antihypertensive drug therapy is withdrawn. The primary trial end point is a BP of 150/90 mm Hg or higher, resumption of antihypertensive drug therapy, or the occurrence of a BP-related clinical complication during 2 to 3 years of follow-up. It is anticipated that TONE findings may identify an effective and acceptable nonpharmacologic approach to control hypertension in the increasingly large number of older persons treated with antihypertensive drug therapy. Pharmaceutical care programs may be an option to improve blood pressure (BP) control in patients with uncontrolled hypertension. The aim of this study was to evaluate the efficacy of pharmaceutical care programs in treating patients with resistant hypertension.
                In a double-blind randomized clinical trial, 71 patients with uncontrolled BP were enrolled in a pharmaceutical care program or in a control group and underwent a series of cognitive tests. The primary outcome was change in ambulatory BP (ABP) between the baseline evaluation and the final visit 6 months later. The secondary outcomes were the frequency of drug-related problems and adherence as determined by plasma levels of hydrochlorothiazide.
                The delta-values between the intervention and control groups for ABP in the different daily periods, with the corresponding 95% confidence limits, adjusted for age and baseline BP were: 3 (-1 to 5), 2 (-2 to 4), and 5 (-1 to 6) mm Hg for 24 h, daily and nightly systolic BP, respectively. The corresponding values for diastolic BP were 1 (-1 to 3), 0 (-2 to 2), and 3 (-1 to 4) mm Hg, respectively. Hydrochlorothiazide was detected in the plasma in 21 of 27 patients in the intervention group that attended to all appointments and 24 of 30 patients in the control group (P = .904).
                The pharmaceutical care program tested in this trial was feasible and showed a trend for better BP control in patients with uncontrolled hypertension. To assess whether lifestyle counselling is effective in non-pharmacological treatment of hypertension in primary health care.
                Open randomized controlled trial.
                Ten municipal primary health care centres in eastern Finland.
                Seven hundred and fifteen subjects aged 25-74 years with systolic blood pressure 140-179 mmHg and/or diastolic blood pressure 90-109 mmHg or antihypertensive drug treatment.
                Systematic health counselling given by local public health nurses for 2 years.
                Blood pressure, lipids and lifestyle data were collected annually.
                Among participants with no antihypertensive drug treatment, the net reductions after 1 year both in systolic blood pressure [-2.6 mmHg; 95% confidence interval (CI), -4.7 to -0.5 mmHg] and in diastolic blood pressure (-2.7 mmHg; 95% CI, -4.0 to -1.4 mmHg) were significant in favour of the intervention group. This difference in blood pressure change was maintained during the second year. In participants with antihypertensive drug treatment, no significant difference in blood pressure reduction was seen between the groups during the study.
                A relatively modest, but systematic counselling in primary health care can, at least among untreated hypertensive subjects, produce reductions in blood pressure levels that are modest for the individual, but very important from the public health point of view. 230 Canadian steelworkers with hypertension took part in a randomised trial to see if compliance with antihypertensive drug regimens could be improved. For care and follow-up these men were randomly allocated to see either their own family doctors outside working-hours or industrial physicians during work shifts; the same men were randomly allocated to receive or not receive an educational programme aimed at instructing them about hypertension and its treatment. Surprisingly, the convenience of follow-up at work had no effect upon these men's compliance with antihypertensive drug regimens. Similarly, although men receiving health education learned a lot about hypertension, they were not more likely to take their medicine. To compare group versus individual academic detailing to increase diuretic or beta-blocker use in hypertension.
                We conducted a cluster-randomized controlled trial in a large health maintenance organization. Subjects (N=9820) were patients with newly treated hypertension in the year preceding the intervention (N=3692), the 9 months following the intervention (N=3556), and the second year following intervention (N=2572). We randomly allocated 3 practice sites to group detailing (N=227 prescribers), 3 to individual detailing (N=235 prescribers), and 3 to usual care (N=319 prescribers). Individual detailing entailed a physician-educator meeting individually with clinicians to address barriers to prescribing guideline-recommended medications. The group detailing intervention incorporated the same social marketing principles in small groups of clinicians.
                In the first year following the intervention, the rates of diuretic or beta-blocker use increased by 13.2% in the group detailing practices, 12.5% in the individual detailing practices, and 6.2% in the usual care practices. As compared with usual care practices, diuretic or beta-blocker use was more likely in group detailing practices (adjusted odds ratio (OR), 1.40; 95% confidence interval (CI), 1.11 - 1.76) and individual detailing practices (adjusted OR, 1.30; 95% CI, 0.95 - 1.79). Neither intervention affected blood pressure control. Two years following this single-visit intervention, there was still a trend suggesting a persistent effect of individual (OR, 1.22; 95% CI, 0.92 - 1.62), but not group, detailing (OR, 1.06; 95% CI, 0.80 - 1.39), as compared with usual care.
                Both group and individual academic detailing improved antihypertensive prescribing over and above usual care but may require reinforcement to sustain improvements. We wanted to examine whether integrating depression treatment into care for hypertension improved adherence to antidepressant and antihypertensive medications, depression outcomes, and blood pressure control among older primary care patients.
                Older adults prescribed pharmacotherapy for depression and hypertension from physicians at a large primary care practice in West Philadelphia were randomly assigned to an integrated care intervention or usual care. Outcomes were assessed at baseline, 2, 4, and 6 weeks using the Center for Epidemiologic Studies Depression Scale (CES-D) to assess depression, an electronic monitor to measure blood pressure, and the Medication Event Monitoring System to assess adherence.
                In all, 64 participants aged 50 to 80 years participated. Participants in the integrated care intervention had fewer depressive symptoms (CES-D mean scores, intervention 9.9 vs usual care 19.3; P <.01), lower systolic blood pressure (intervention 127.3 mm Hg vs usual care 141.3 mm Hg; P <.01), and lower diastolic blood pressure (intervention 75.8 mm Hg vs usual care 85.0 mm Hg; P <.01) compared with participants in the usual care group at 6 weeks. Compared with the usual care group, the proportion of participants in the intervention group who had 80% or greater adherence to an antidepressant medication (intervention 71.9% vs usual care 31.3%; P <.01) and to an antihypertensive medication (intervention 78.1% vs usual care 31.3%; P <.001) was greater at 6 weeks.
                A pilot, randomized controlled trial integrating depression and hypertension treatment was successful in improving patient outcomes. Integrated interventions may be more feasible and effective in real-world practices, where there are competing demands for limited resources. To assess the effect of a physician and pharmacist teamwork approach to uncontrolled hypertension in a medical resident teaching clinic, for patients who failed to meet the recommended goals of the fifth Joint National Commission on Detection, Evaluation and Treatment of High Blood Pressure.
                Physician and pharmacist teamwork can improve the rate of meeting national blood pressure goals in patients with previously uncontrolled hypertension.
                A single-blinded randomized controlled trial lasting 6 months.
                A primary care outpatient teaching clinic.
                A sample of 95 adult hypertensive patients who failed to meet national blood pressure goals based on three consecutive visits over a 6-month period.
                Patients were randomly assigned to a control arm of standard medical care or to an intervention arm in which a physician and pharmacist worked together as a team.
                At study completion, the percentage of patients achieving national goals due to intervention was more than double the percentage in the control arm (55% vs 20%, p < .001). Systolic blood pressure declined 23 mm Hg in the intervention arm versus 11 mm Hg in the control arm (p < .01). Diastolic blood pressure declined 14 and 3 mm Hg in the intervention and control arms, respectively (p < .001). The intervention worked equally as well in men and women and demonstrated noticeable promise in a minority of mixed-ancestry Hawaiians in whom hypertension is of special concern.
                Patients who fail to achieve national blood pressure goals under standard outpatient medical care may benefit from a program that includes a physician and pharmacist teamwork approach. A gap exists between evidence and practice regarding the management of cardiovascular risk factors. This gap could be narrowed if systematically developed clinical practice guidelines were effectively implemented in clinical practice. We evaluated the effects of a tailored intervention to support the implementation of systematically developed guidelines for the use of antihypertensive and cholesterol-lowering drugs for the primary prevention of cardiovascular disease.
                We conducted a cluster-randomized trial comparing a tailored intervention to passive dissemination of guidelines in 146 general practices in two geographical areas in Norway. Each practice was randomized to either the tailored intervention (70 practices; 257 physicians) or control group (69 practices; 244 physicians). Patients started on medication for hypertension or hypercholesterolemia during the study period and all patients already on treatment that consulted their physician during the trial were included. A multifaceted intervention was tailored to address identified barriers to change. Key components were an educational outreach visit with audit and feedback, and computerized reminders linked to the medical record system. Pharmacists conducted the visits. Outcomes were measured for all eligible patients seen in the participating practices during 1 y before and after the intervention. The main outcomes were the proportions of (1) first-time prescriptions for hypertension where thiazides were prescribed, (2) patients assessed for cardiovascular risk before prescribing antihypertensive or cholesterol-lowering drugs, and (3) patients treated for hypertension or hypercholesterolemia for 3 mo or more who had achieved recommended treatment goals. The intervention led to an increase in adherence to guideline recommendations on choice of antihypertensive drug. Thiazides were prescribed to 17% of patients in the intervention group versus 11% in the control group (relative risk 1.94; 95% confidence interval 1.49-2.49, adjusted for baseline differences and clustering effect). Little or no differences were found for risk assessment prior to prescribing and for achievement of treatment goals.
                Our tailored intervention had a significant impact on prescribing of antihypertensive drugs, but was ineffective in improving the quality of other aspects of managing hypertension and hypercholesterolemia in primary care. Lifestyle modifications have been recommended as the initial treatment strategy for lowering high blood pressure (BP). However, evidence for the efficacy of exercise and weight loss in the management of high BP remains controversial.
                One hundred thirty-three sedentary, overweight men and women with unmedicated high normal BP or stage 1 to 2 hypertension were randomly assigned to aerobic exercise only; a behavioral weight management program, including exercise; or a waiting list control group. Before and following treatment, systolic and diastolic BPs were measured in the clinic, during daily life, and during exercise and mental stress testing. Hemodynamic measures and metabolic functioning also were assessed.
                Although participants in both active treatment groups exhibited significant reductions in BP relative to controls, those in the weight management group generally had larger reductions. Weight management was associated with a 7-mm Hg systolic and a 5-mm Hg diastolic clinic BP reduction, compared with a 4-mm Hg systolic and diastolic BP reduction associated with aerobic exercise; the BP for controls did not change. Participants in both treatment groups also displayed reduced peripheral resistance and increased cardiac output compared with controls, with the greatest reductions in peripheral resistance in those in the weight management group. Weight management participants also exhibited significantly lower fasting and postprandial glucose and insulin levels than participants in the other groups.
                Although exercise alone was effective in reducing BP, the addition of a behavioral weight loss program enhanced this effect. Aerobic exercise combined with weight loss is recommended for the management of elevated BP in sedentary, overweight individuals. A controlled, randomized study was conducted in two chain pharmacies to determine the clinical value of comprehensive pharmacy services for hypertensive patients in a chain pharmacy setting. Twenty-seven patients were enrolled as intervention participants with 26 control subjects. Monthly services for the intervention group included blood pressure and heart rate assessments and counseling on lifestyle modifications and drug therapy. Control patients received initial and final blood pressure measurements and minimal counseling. Both study and control groups completed quality-of-life questionnaires upon entering and completing the study. Results showed that blood pressure control was significantly improved in the study group. Compliance rates as well as energy/fatigue scores (a quality-of-life scale) improved in the study group compared with the control population. Community pharmacists in chain stores could have a beneficial effect on the health care of large numbers of patients if pharmaceutical care programs were developed. Evaluation of a structured hypertension treatment and teaching programme in general practice.
                Prospective controlled trial; follow-up period 18 months.
                10 primary health care practices. PRACTICES AND PATIENTS: From each practice 20 patients (30 to 60 years old, mean of the last two blood pressure measurements at or above 160 and/or 95 mmHg) were randomly selected; in 5 practices these patients were to participate in the treatment and teaching programme; in the remaining 5 practices hypertension care was continued without the availability of such a programme (controls).
                Structured treatment and teaching programme based upon four group sessions for patients mainly conducted by paramedical personnel.
                Blood pressure, body weight, prescription of antihypertensive drugs - as documented in the patient's records.
                Of the 100 control patients 26 and of the 100 intervention patients 14 were lost to observation; 46 patients had agreed to participate in the programme. The mean number of prescribed antihypertensive agents per patient decreased in the intervention group (1.8 +/- 1.3 at baseline, vs 1.2 +/- 1.2 at follow-up) compared to the control group (1.6 +/- 1.3 vs 1.8 +/- 1.6); difference 0.8 (95% CI 0.4 to 1.1), p < 0.0001. In the control group 9% and in the intervention group 33% of patients had documented reductions of body weight (p < 0.0001). Blood pressure decreased in the intervention group (162 +/- 14/100 +/- 7 mmHg at baseline, vs 154 +/- 16/95 +/- 9 mmHg at follow-up) compared to the control group (161 +/- 13/98 +/- 7 mmHg vs 158 +/- 18/96 +/- 11 mmHg); differences for systolic blood pressure 5 (95% CI 0 to 10) mmHg, p = 0.071; for diastolic blood pressure 4 (1 to 7) mmHg, p = 0.018.
                The introduction of a structured hypertension treatment and teaching programme in general practice may lead to significant improvements of hypertension care.
Reducing the number of daily doses appears to be effective in increasing adherence to blood pressure lowering medication and should be tried as a first line strategy, although there is less evidence of an effect on blood pressure reduction. Some motivational strategies and complex interventions appear promising, but we need more evidence on their effect through carefully designed RCTs.