A Randomized Trial of Home Blood-Pressure Reduction by Alcohol Guidance during Outpatient Visits: OSAKE study.
Ontology highlight
ABSTRACT: Objective
To evaluate the effectiveness of the nurse-led alcohol guidance to control home blood pressure in the morning (HBP) among male patients with hypertension during outpatient visits.Method
We enrolled 53 male patients with an HBP of ≥ 135/85 mmHg with excessive drinking (alcohol ≥210 g/week or ≥60 g/day habitually) among outpatients in a randomized trial. Patients were assigned to a nurse-led intervention (in which patients were encouraged to reduce their alcohol consumption in addition to the usual treatment every 2 months) or to the control (in which patients were followed by their doctor as usual). The primary outcomes were the mean HBP of 5 consecutive days at 6 months and alcohol consumption.Results
Twenty-eight and 25 patients were randomized to intervention and control groups, respectively (mean age; 62.7 years old and 64.5, respectively). At baseline, the mean HBP was 143/90 mmHg in the intervention group and 144/88 mmHg in the control group (n.s.). At 6 months, the mean HBP was 131/82 mmHg and 145/87 mmHg, respectively (SBP<0.001, DBP=0.09). An HBP level of less than 135/85 mmHg was achieved among 55.6% of the participants in the intervention group versus 16.7% in the control group (P=0.004). At baseline, the weekly alcohol consumption was 479±353 g in the intervention group and 360±182 g in the control group (n.s.). At 6 months, it was 256±206 g and 413±260 g, respectively (p=0.020).Conclusions
We confirmed the effectiveness of the nurse-led alcohol guidance to control the HBP in male patients with hypertension during outpatient visits.
SUBMITTER: Kabayama M
PROVIDER: S-EPMC8557396 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:BackgroundHome blood pressure monitoring (HBPM) is cited as an effective approach for improving blood pressure control. The objective of this study was to determine the effectiveness of HBPM combined with a health education session in reducing blood pressure and improving medication adherence among adults with hypertension.MethodsTwo hundred thirteen participants were enrolled in a 3-month study and randomized to receive HBPM or usual care. Participants were also randomized to receive an educational session delivered using a pamphlet or a computer-based program. Topics of the educational session included preventing hypertension, managing weight, staying active, and cutting down on salt and fat.ResultsAt the 3-month follow-up, there was a reduction in ambulatory blood pressure among the HBPM group. However, the differences found within the HBPM group were no greater than those found among the control group. We did not detect a statistically significant difference in adherence to medication when comparing the HBPM to the usual care group.ConclusionsHBPM and educational session did not lower blood pressure or improve medication adherence in our sample. A greater effect may have been seen if coupled with an enhanced educational intervention and if blood pressure measures were shared with the provided. The findings of this study provide useful insights for future HBPM studies.
| S-EPMC6361075 | biostudies-literature
Project description:BACKGROUND:Uncontrolled hypertension is a major problem among non-Hispanic black men, who are underrepresented in pharmacist intervention trials in traditional health care settings. METHODS:We enrolled a cohort of 319 black male patrons with systolic blood pressure of 140 mm Hg or more from 52 black-owned barbershops (nontraditional health care setting) in a cluster-randomized trial in which barbershops were assigned to a pharmacist-led intervention (in which barbers encouraged meetings in barbershops with specialty-trained pharmacists who prescribed drug therapy under a collaborative practice agreement with the participants’ doctors) or to an active control approach (in which barbers encouraged lifestyle modification and doctor appointments). The primary outcome was reduction in systolic blood pressure at 6 months. RESULTS:At baseline, the mean systolic blood pressure was 152.8 mm Hg in the intervention group and 154.6 mm Hg in the control group. At 6 months, the mean systolic blood pressure fell by 27.0 mm Hg (to 125.8 mm Hg) in the intervention group and by 9.3 mm Hg (to 145.4 mm Hg) in the control group; the mean reduction was 21.6 mm Hg greater with the intervention (95% confidence interval, 14.7 to 28.4; P<0.001). A blood-pressure level of less than 130/80 mm Hg was achieved among 63.6% of the participants in the intervention group versus 11.7% of the participants in the control group (P<0.001). In the intervention group, the rate of cohort retention was 95%, and there were few adverse events (three cases of acute kidney injury). CONCLUSIONS:Among black male barbershop patrons with uncontrolled hypertension, health promotion by barbers resulted in larger blood-pressure reduction when coupled with medication management in barbershops by specialty-trained pharmacists. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov number, NCT02321618 .).
| S-EPMC6018053 | biostudies-literature
Project description:ImportanceOnly about half of patients with high blood pressure (BP) in the United States have their BP controlled. Practical, robust, and sustainable models are needed to improve BP control in patients with uncontrolled hypertension.ObjectivesTo determine whether an intervention combining home BP telemonitoring with pharmacist case management improves BP control compared with usual care and to determine whether BP control is maintained after the intervention is stopped.Design, setting, and patientsA cluster randomized clinical trial of 450 adults with uncontrolled BP recruited from 14,692 patients with electronic medical records across 16 primary care clinics in an integrated health system in Minneapolis-St Paul, Minnesota, with 12 months of intervention and 6 months of postintervention follow-up.InterventionsEight clinics were randomized to provide usual care to patients (n = 222) and 8 clinics were randomized to provide a telemonitoring intervention (n = 228). Intervention patients received home BP telemonitors and transmitted BP data to pharmacists who adjusted antihypertensive therapy accordingly.Main outcomes and measuresControl of systolic BP to less than 140 mm Hg and diastolic BP to less than 90 mm Hg (<130/80 mm Hg in patients with diabetes or chronic kidney disease) at 6 and 12 months. Secondary outcomes were change in BP, patient satisfaction, and BP control at 18 months (6 months after intervention stopped).ResultsAt baseline, enrollees were 45% women, 82% white, mean (SD) age was 61.1 (12.0) years, and mean systolic BP was 148 mm Hg and diastolic BP was 85 mm Hg. Blood pressure was controlled at both 6 and 12 months in 57.2% (95% CI, 44.8% to 68.7%) of patients in the telemonitoring intervention group vs 30.0% (95% CI, 23.2% to 37.8%) of patients in the usual care group (P = .001). At 18 months (6 months of postintervention follow-up), BP was controlled in 71.8% (95% CI, 65.0% to 77.8%) of patients in the telemonitoring intervention group vs 57.1% (95% CI, 51.5% to 62.6%) of patients in the usual care group (P = .003). Compared with the usual care group, systolic BP decreased more from baseline among patients in the telemonitoring intervention group at 6 months (-10.7 mm Hg [95% CI, -14.3 to -7.3 mm Hg]; P<.001), at 12 months (-9.7 mm Hg [95% CI, -13.4 to -6.0 mm Hg]; P<.001), and at 18 months (-6.6 mm Hg [95% CI, -10.7 to -2.5 mm Hg]; P = .004). Compared with the usual care group, diastolic BP decreased more from baseline among patients in the telemonitoring intervention group at 6 months (-6.0 mm Hg [95% CI, -8.6 to -3.4 mm Hg]; P<.001), at 12 months (-5.1 mm Hg [95% CI, -7.4 to -2.8 mm Hg]; P<.001), and at 18 months (-3.0 mm Hg [95% CI, -6.3 to 0.3 mm Hg]; P = .07).Conclusions and relevanceHome BP telemonitoring and pharmacist case management achieved better BP control compared with usual care during 12 months of intervention that persisted during 6 months of postintervention follow-up.Trial registrationclinicaltrials.gov Identifier: NCT00781365.
| S-EPMC4311883 | biostudies-literature
Project description:This paper reports subgroup analysis of a successful cluster-randomized trial to identify attributes of hypertensive patients who benefited more or less from an intervention combining blood pressure (BP) telemonitoring and pharmacist management. The end point was BP < 140/90 mm Hg at 6-month follow-up. Fourteen baseline patient characteristics were selected a priori as subgroup variables. Among the 351 trial participants, 44% were female, 84% non-Hispanic white, mean age was 60.9 years, and mean BP was 149/86 mm Hg. The overall adjusted odds ratio for BP control in the intervention versus usual care group was 3.64 (P < .001). The effect of the intervention was significantly larger in patients who were younger (interaction P = .02), did not have diabetes (P = .005), had high baseline diastolic BP (P = .02), added salt less than daily in food preparation (P = .007), and took 0-2 (rather than 3-6) antihypertensive medication classes at baseline (P = .02). These findings may help prioritize patients for whom the intervention is most effective.
| S-EPMC5107124 | biostudies-literature
Project description:ImportancePractical health promotion strategies for improving cardiometabolic health in older adults are needed.ObjectiveTo examine the efficacy of a sedentary behavior reduction intervention for reducing sitting time and improving blood pressure in older adults.Design, setting, and participantsThis parallel-group randomized clinical trial was conducted in adults aged 60 to 89 years with high sitting time and body mass index of 30 to 50 from January 1, 2019, to November 31, 2022, at a health care system in Washington State.InterventionParticipants were randomized 1:1 to the sitting reduction intervention or a healthy living attention control condition for 6 months. Intervention participants received 10 health coaching contacts, sitting reduction goals, and a standing desk and fitness tracker to prompt sitting breaks. The attention control group received 10 health coaching contacts to set general healthy living goals, excluding physical activity or sedentary behavior.Main outcomes and measuresThe primary outcome, measured at baseline, 3 months, and 6 months, was sitting time assessed using accelerometers worn for 7 days at each time point. Coprimary outcomes were systolic and diastolic blood pressure measured at baseline and 6 months.ResultsA total of 283 participants (140 intervention and 143 control) were randomized (baseline mean [SD] age, 68.8 [6.2] years; 186 [65.7%] female; mean [SD] body mass index, 34.9 [4.7]). At baseline, 147 (51.9%) had a hypertension diagnosis and 97 (69.3%) took at least 1 antihypertensive medication. Sitting time was reduced, favoring the intervention arm, with a difference in the mean change of -31.44 min/d at 3 months (95% CI, -48.69 to -14.19 min/d; P < .001) and -31.85 min/d at 6 months (95% CI, -52.91 to -10.79 min/d; P = .003). Systolic blood pressure change was lower by 3.48 mm Hg, favoring the intervention arm at 6 months (95% CI, -6.68 to -0.28 mm Hg; P = .03). There were 6 serious adverse events in each arm and none were study related.Conclusions and relevanceIn this study of a 6-month sitting reduction intervention, older adults in the intervention reduced sedentary time by more than 30 min/d and reduced systolic blood pressure. Sitting reduction could be a promising approach to improve health in older adults.Trial registrationClinicalTrials.gov Identifier: NCT03739762.
| S-EPMC10973891 | biostudies-literature
Project description:The authors investigated the effectiveness of home-based transcutaneous electrical acupoint stimulation (TEAS) combined with lifestyle modification on blood pressure (BP) control and explored the feasibility of the trial design in this prospective, randomized controlled trial. The authors recruited individuals with high-normal BP who had a systolic blood pressure (SBP) of 120-139 mm Hg and a diastolic blood pressure (DBP) of 80-89 mm Hg, or both. Participants were randomly assigned to receive either lifestyle modification combined with TEAS four times weekly for 12 weeks at home (intervention group) or solely lifestyle modification (control group). The primary outcome was the change in mean SBP at week 12 from the baseline measurement. A total of 60 participants were randomized in a 1:1 ratio, and an intention-to-treat analysis was performed on all of the outcomes. The mean difference in the change in SBP for the intervention group (compared to the control) at week 12 was -3.85 mm Hg (95% CI: -7.58 to -.12; p = .043); for the DBP, the change was -2.27 mm Hg (95% CI: -5.76 to 1.23; p = .199). There was no difference in the proportion of progression to hypertension, quality of life, body mass index (BMI) or waist circumference. In addition, two participants reported TEAS-related adverse events. The authors found a reduction in SBP control in the pragmatic, home-based intervention by using TEAS combined with lifestyle modification in adults with high-normal BP. Trial Registration: The study was registered in the Chinese Clinical Trial Registry (ChiCTR 1900024982) on August 6, 2019.
| S-EPMC9380160 | biostudies-literature
Project description:Rationale & objectiveObservational studies have reported a U-shaped association between blood pressure (BP) before a hemodialysis session and death. In contrast, because a linear association between out-of-dialysis-unit BP and death has been reported, home BP may be a better target for treatment. To test the feasibility of this approach, we conducted a pilot trial of treating home versus predialysis BP in hemodialysis patients.Study designA 4-month, parallel, randomized, controlled trial.Settings & participants50 prevalent hemodialysis patients in San Francisco and Seattle. Participants were randomly assigned using 1:1 block randomization, stratified by site.InterventionsTo target home systolic BP (SBP) of 100-<140 mm Hg versus predialysis SBP of 100-<140mm Hg. Home and predialysis SBPs were ascertained every 2 weeks. Dry weight and BP medications were adjusted to reach the target SBP.OutcomesPrimary outcomes were feasibility, adherence, safety. and tolerability.Results50 of 70 (71%) patients who were approached agreed to participate. All enrollees completed the study except for 1 who received a kidney transplant. In the home BP treatment group, adherence to obtaining/reporting home BP was 97.4% (and consistent over the 4 months). There was no increased frequency of high (defined as SBP>200mm Hg; 0.2% vs 0%) or low (defined as<90mm Hg; 1.8% vs 1.2%) predialysis BP readings in the home versus predialysis treatment arms, respectively. However, participants in the home BP arm had higher frequency of fatigue (32% vs 16%).LimitationsSmall sample size.ConclusionsThis pilot trial demonstrates feasibility and high adherence to home BP measurement and treatment in hemodialysis patients. Larger trials to test the long-term feasibility, efficacy, and safety of home BP treatment in hemodialysis patients should be conducted.FundersNational Institutes of Health, Satellite Healthcare, and Northwest Kidney Centers.Trial registrationRegistered at ClinicalTrials.gov with study number NCT03459807.
| S-EPMC7752836 | biostudies-literature
Project description:BackgroundSome studies have suggested reductions in blood pressure (BP)with statin treatment, particularly in persons with hypertension. Randomized trial evidence is limited.MethodsWe performed a randomized, double-blind, placebo-controlled trial with equal allocation to simvastatin, 20 mg; pravastatin sodium,40 mg; or placebo for 6 months. Nine hundred seventy-three men and women without known cardiovascular disease or diabetes mellitus, with low-density lipoprotein cholesterol screening levels of 115 to 190 mg/dL, had assessment of systolic and diastolic BP (SBP and DBP, respectively). Blood pressure values were compared for placebo vs statins by intention-to-treat (ITT) analysis. Additional analyses were performed that (1) were confined to subjects with neither high baseline BP (SBP>140 mm Hg or DBP>90 mm Hg) nor receiving BP medications, to exclude groups in whom BP medications or medication changes may have influenced results, and (2) separately evaluated simvastatin and pravastatin (vs placebo). The time course of BP changes after statin initiation and the effect of stopping statins on BP were examined.ResultsStatins modestly but significantly reduced BP relative to placebo,by 2.2 mm Hg for SBP (P=.02) and 2.4 mm Hg for DBP (P<.001) in ITT analysis. Blood pressure reductions ranged from 2.4 to 2.8 mm Hg for both SBP and DBP with both simvastatin and pravastatin, in those subjects with full follow-up, and without potential for influence by BP medications (ie, neither receiving nor meriting BP medications).ConclusionsReductions in SBP and DBP occurred with hydrophilic and lipophilic statins and extended to normotensive subjects. These modest effects may contribute to the reduced risk of stroke and cardiovascular events reported on statins. Trial Registration clinicaltrials.gov Identifier: NCT00330980.
| S-EPMC4285458 | biostudies-literature
Project description:Background: Acupuncture at specific acupoints has experimentally been found to reduce chronically elevated blood pressure. Objective: To examine effectiveness of electroacupuncture (EA) at select acupoints to reduce systolic blood pressure (SBP) and diastolic blood pressures (DBP) in hypertensive patients. Design: Two-arm parallel study. Patients: Sixty-five hypertensive patients not receiving medication were assigned randomly to one of the two acupuncture intervention (33 versus 32 patients). Intervention: Patients were assessed with 24-hour ambulatory blood pressure monitoring. They were treated with 30-minutes of EA at PC 5-6+ST 36-37 or LI 6-7+GB 37-39 once weekly for 8 weeks. Four acupuncturists provided single-blinded treatment. Main outcome measures: Primary outcomes measuring effectiveness of EA were peak and average SBP and DBP. Secondary outcomes examined underlying mechanisms of acupuncture with plasma norepinephrine, renin, and aldosterone before and after 8 weeks of treatment. Outcomes were obtained by double-blinded evaluation. Results: After 8 weeks, 33 patients treated with EA at PC 5-6+ST 36-37 had decreased peak and average SBP and DBP, compared with 32 patients treated with EA at LI 6-7+GB 37-39 control acupoints. Changes in blood pressures significantly differed between the two patient groups. In 14 patients, a long-lasting blood pressure-lowering acupuncture effect was observed for an additional 4 weeks of EA at PC 5-6+ST 36-37. After treatment, the plasma concentration of norepinephrine, which was initially elevated, was decreased by 41%; likewise, renin was decreased by 67% and aldosterone by 22%. Conclusions: EA at select acupoints reduces blood pressure. Sympathetic and renin-aldosterone systems were likely related to the long-lasting EA actions.
| S-EPMC4555646 | biostudies-literature
Project description:BackgroundThe burden of time is often the primary reason why patients discontinue their treatment. Telemedicine may help patients adhere to treatment by offering convenience.ObjectiveThis study examined the efficacy and safety of telemedicine for the management of hypertension in Japan.MethodsPatients with uncomplicated hypertension were recruited through web advertising between November 2015 and February 2017. They were then screened, stratified by office systolic blood pressure (SBP), and randomized into two groups: usual care (UC) and telemedicine. The telemedicine group used a 3G network-attached home blood pressure (BP) monitoring device, consulted hypertension specialists from an academic hospital through web-based video visits, and received prescription medication by mail for 1 year. The UC group used the same BP monitoring device but was managed using self-recorded BP readings, which included their diary entries and office BP taken in a community practice setting.ResultsInitial screening was completed by 99 patients, 54% of whom had untreated hypertension. Baseline BP was similar between the groups, but the weekly average SBP at the end of the 1-year study period was significantly lower in the telemedicine group (125, SD 9 mmHg vs 131, SD 12 mmHg, respectively; P=.02). SBP in the telemedicine group was 3.4 mmHg lower in the morning and 5.8 mmHg lower in the evening. The rate of SBP control (135 mmHg) was better in the telemedicine group (85.3% vs 70.0%; P=.01), and significant adverse events were not observed.ConclusionsWe present evidence suggesting that antihypertensive therapy via home BP telemonitoring and web-based video visits achieve better BP control than conventional care and is a safe treatment alternative that warrants further investigation.Trial registrationUMIN-CTR UMIN000025372; https://tinyurl.com/47ejkn4b.
| S-EPMC8441608 | biostudies-literature