Home-based interventions for black patients with uncontrolled hypertension: a cluster randomized controlled trial.
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ABSTRACT:
SUBMITTER: Feldman PH
PROVIDER: S-EPMC5543816 | biostudies-literature | 2016 Mar
REPOSITORIES: biostudies-literature
Publications
Home-based interventions for black patients with uncontrolled hypertension: a cluster randomized controlled trial.
Feldman Penny H PH McDonald Margaret V MV Barrón Yolanda Y Gerber Linda M LM Peng Timothy R TR
Journal of comparative effectiveness research 20160307 2
<h4>Aim</h4>Assess the comparative effectiveness of two blood pressure (BP) control interventions for black patients with uncontrolled hypertension.<h4>Patients & methods</h4>A total of 845 patients were enrolled in a three-arm cluster randomized trial. On admission of an eligible patient, field nurses were randomized to usual care, a basic or augmented intervention.<h4>Results</h4>Across study arms there were no significant 12 months differences in BP control rates (primary outcome) (25% usual ...[more]
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Project description:OBJECTIVE: Evaluate the effectiveness of collaborative management of hypertension by primary care-pharmacist teams in community-based clinics. STUDY DESIGN: A 12-month prospective, single-blind, randomized, controlled trial in the Providence Primary Care Research Network of patients with hypertension and uncontrolled blood pressure. METHODS: As compared to usual primary care, intervention consisted of pharmacy practitioners participating in the active management of hypertension in the primary care office according to established collaborative treatment protocols. At baseline, there was no significant difference in blood pressure between groups. Primary outcome measures were the differences in mean systolic and diastolic blood pressures between arms at study end. Secondary measures included blood pressure goal attainment (<140/90 mmHg), hypertension-related knowledge, medication adherence, home blood pressure monitoring, resource utilization, quality of life, and satisfaction. RESULTS: A total of 463 subjects were enrolled (n = 233 control, n = 230 intervention). Subjects receiving the intervention achieved significantly lower systolic (p = 0.007) and diastolic (p = 0.002) blood pressures compared to control (137/75 mmHg vs. 143/78 mmHg). In addition, 62% of intervention subjects achieved target blood pressure compared to 44% of control subjects (p = 0.003). The intervention group received more total office visits (7.2 vs. 4.9, p < 0.0001), however had fewer physician visits (3.2 vs. 4.7, p < 0.0001) compared to control. Intervention subjects were prescribed more antihypertensive medications (2.7 vs. 2.4, p = 0.02), but did not take more antihypertensive pills per day (2.4 vs. 2.5, p = 0.87). There were minimal differences between groups in hypertension-related knowledge, medication adherence, quality of life, or satisfaction. CONCLUSIONS: Patients randomized to collaborative primary care-pharmacist hypertension management achieved significantly better blood pressure control compared to usual care with no difference in quality of life or satisfaction.
| S-EPMC2596500 | biostudies-other
Project description:BackgroundHypertension is a major global public health problem. Elevated blood pressure can cause cardiovascular and kidney diseases. We assessed the effectiveness of health education sessions and home support programs in reducing blood pressure among patients with uncontrolled hypertension in a suburban community of Nepal.MethodsWe conducted a community-based, open-level, parallel-group, cluster randomized controlled trial in Birendranagar municipality of Surkhet, Nepal. We randomly assigned four clusters (wards) into intervention and control arms. We provided four health education sessions, frequent home and usual care for intervention groups over six months. The participants of the control arm received only usual care from health facilities. The primary outcome of this study was the proportion of controlled systolic blood pressure (SBP). The analysis included all participants who completed follow-up at six months.Results125 participants were assigned to either the intervention (n = 63) or the control (n = 62) group. Of them, 60 participants in each group completed six months follow-up. The proportion of controlled SBP was significantly higher among the intervention participants compared to the control (58.3% vs. 40%). Odds ratio of this was 2.1 with 95% CI: 1.01-4.35 (p = 0.046) and that of controlled diastolic blood pressure (DBP) was 1.31 (0.63-2.72) (p = 0.600). The mean change (follow-up minus baseline) in SBP was significantly higher in the intervention than in the usual care (-18.7 mmHg vs. -11.2 mmHg, p = 0.041). Such mean change of DBP was also higher in the intervention (-10.95 mmHg vs. -5.53 mmHg, p = 0.065). The knowledge score on hypertension improved by 2.38 (SD 2.4) in the intervention arm, which was significantly different from that of the control group, 0.13 (1.8) (p<0.001).ConclusionsMultiple health education sessions complemented by frequent household visits by health volunteers can effectively improve knowledge on hypertension and reduce blood pressure among uncontrolled hypertensive patients at the community level in Nepal.Trial registrationClinicalTrial.gov: NCT02981251.
| S-EPMC8509872 | biostudies-literature
Project description:BackgroundA decrease in blood pressure, even modestly (ie, 2 mmHg), lowers cardiovascular morbidity and mortality. Low patient adherence to antihypertensive medication is the most significant modifiable patient-related barrier to achieving controlled blood pressure. Preliminary studies have shown that SMS text messaging and home blood pressure monitoring (HBPM) can be effective in promoting medication adherence and blood pressure control. The best strategy to engage with older patients of low socioeconomic status who are low adopters of technology and disproportionally affected by uncontrolled hypertension is still unknown.ObjectiveThe objective of this study is to improve blood pressure control in the older, low socioeconomic status population. The study will test two aims: First, we aim to evaluate the feasibility of conducting a randomized controlled trial by using an SMS-based approach among nonadherent, older patients of low socioeconomic status who have uncontrolled hypertension. Feasibility will be assessed in terms of recruitment rates per month (primary outcome); patient acceptability will be evaluated by monitoring retention rates and SMS response rates and using the validated Systems Usability Scale (secondary outcomes). Second, we aim to estimate the effects of the SMS approach on lowering blood pressure and adherence to antihypertensive medications.MethodsWe will recruit 24 patients of low socioeconomic status with uncontrolled hypertension (systolic BP>140 mmHg or diastolic BP>90 mmHg) showing low medication adherence and taking at least two antihypertensives, who have presented to two outpatient clinics of Wake Forest Baptist Health (Winston Salem, North Carolina, USA). Participants will be randomly assigned to either SMS and HBPM (n=12) or usual care and HBPM (n=12) intervention. Clinicians adjusting the patients' medications will be blinded to the study assignment. Text messages will be sent from a secure platform to assess medication adherence and HBPM on a weekly basis. The content and delivery frequency of the proposed SMS intervention are based on input from three focus groups conducted in Spring 2019. Participants in both study arms will receive education on HBPM and using an HBPM device. We hypothesize that we will successfully recruit 24 participants and the intervention will be acceptable to the participants. It will also improve medication adherence (assessed by question Medication Adherence Questionnaire scores) and blood pressure control.ResultsOur study was funded in July 2020. As of May 2021, we have enrolled 6 participants.ConclusionsOur findings will help design a larger efficacy trial to advance the field of eHealth delivery systems particularly for older adults of low socioeconomic status. This study addresses a highly significant topic and targets a population of high morbidity and mortality that has been traditionally underrepresented in clinical trials.Trial registrationClinicalTrials.gov NCT03596242; https://clinicaltrials.gov/ct2/show/NCT03596242.International registered report identifier (irrid)PRR1-10.2196/18984.
| S-EPMC8164117 | biostudies-literature
Project description:ImportanceRural Black participants need effective intervention to achieve better blood pressure (BP) control.ObjectiveAmong Black rural adults with persistently uncontrolled hypertension attending primary care clinics, to determine whether peer coaching (PC), practice facilitation (PF), or both (PCPF) are superior to enhanced usual care (EUC) in improving BP control.Design, setting, and participantsA cluster randomized clinical trial was conducted in 69 rural primary care practices across Alabama and North Carolina between September 23, 2016, and September 26, 2019. The participating practices were randomized to 4 groups: PC plus EUC, PF plus EUC, PCPF plus EUC, and EUC alone. The baseline EUC approach included a laptop for each participating practice with hyperlinks to participant education on hypertension, a binder of practice tips, a poster showing an algorithm for stepped care to improve BP, and 25 home BP monitors. The trial was stopped on February 28, 2021, after final data collection. The study included Black participants with persistently uncontrolled hypertension. Data were analyzed from February 28, 2021, to December 13, 2022.InterventionsPractice facilitators helped practices implement at least 4 quality improvement projects designed to improve BP control throughout 1 year. Peer coaches delivered a structured program via telephone on hypertension self-management throughout 1 year.Main outcomes and measuresThe primary outcome was the proportion of participants in each trial group with BP values of less than 140/90 mm Hg at 6 months and 12 months. The secondary outcome was a change in the systolic BP of participants at 6 months and 12 months.ResultsA total of 69 practices were randomized, and 1209 participants' data were included in the analysis. The mean (SD) age of participants was 58 (12) years, and 748 (62%) were women. In the intention-to-treat analyses, neither intervention alone nor in combination improved BP control or BP levels more than EUC (at 12 months, PF vs EUC odds ratio [OR], 0.94 [95% CI, 0.58-1.52]; PC vs EUC OR, 1.30 [95% CI, 0.83-2.04]; PCPF vs EUC OR, 1.02 [95% CI, 0.64-1.64]). In preplanned subgroup analyses, participants younger than 60 years in the PC and PCPF groups experienced a significant 5 mm Hg greater reduction in systolic BP than participants younger than 60 years in the EUC group at 12 months. Practicewide BP control estimates in PF groups suggested that BP control improved from 54% to 61%, a finding that was not observed in the trial's participants.Conclusions and relevanceThe results of this cluster randomized clinical trial demonstrated that neither PC nor PF demonstrated a superior improvement in overall BP control compared with EUC. However, PC led to a significant reduction in systolic BP among younger adults.Trial registrationClinicalTrials.gov Identifier: NCT02866669.
| S-EPMC10949149 | biostudies-literature
Project description:The aim of this trial was to evaluate the feasibility and effect of home-based transcutaneous electrical acupoint stimulation (TEAS) in patients with hypertension. In this randomized pilot trial, patients with hypertension were randomly assigned to the TEAS group or the usual care group. Participants in the usual care group were instructed to continue taking their antihypertensive drugs and received education on lifestyle modifications. In addition, participants in the TEAS group received 4 weekly sessions of noninvasive acupoint stimulation for 12 weeks at home. The primary outcome was the change in office systolic blood pressure at week 12 from baseline. Withdrawal from the study and adverse events associated with TEAS were also recorded. Sixty patients were randomized, with 30 patients in the TEAS group, of whom 1 was lost at week 36, and 30 patients in the usual care group, of whom 3 were lost by week 12. The reduction in systolic blood pressure at week 12 was greater in the TEAS group (-8.53 mm Hg; 95% CI [-13.37, -3.70 mm Hg]) than in the usual care group (-1.70 mm Hg; 95% CI [-4.29, -0.89 mm Hg]), with a between-group difference of -6.83 mm Hg (95% CI, [-12.23, -1.43 mm Hg]; P = 0.014). No TEAS-related adverse events occurred. In conclusion, home-based TEAS added to usual care for patients with hypertension was acceptable and safe and may be a potential treatment option. A larger randomized controlled trial of this intervention is warranted.
| S-EPMC8342269 | biostudies-literature
Project description:ImportanceGreater difficulty in controlling blood pressure (BP) and adverse lifestyle practices such as higher salt intake or less physical activity may account for some of the differences between BP control rates in Black vs White adults, thereby exposing Black adults to a higher risk of vascular events.ObjectiveTo determine whether a lifestyle coaching intervention or an enhanced pharmacotherapy protocol is more effective than usual care in improving BP control rates in Black adults treated within an integrated health care delivery system.Design, setting, and participantsShake, Rattle & Roll, a cluster randomized clinical trial, was conducted from June 5, 2013, to June 11, 2018, in a large integrated health care delivery system. Enrollment was completed during a 12-month period and interventions were implemented for 12 months. Follow-up lasted 48 months after enrollment. Panels of Black adult members of the health care delivery system with BP of at least 140/90 mm Hg from 98 adult primary care physicians were randomly assigned at the primary care physician level to usual care (UC group [n = 1129]), enhanced pharmacotherapy monitoring (EP group [n = 346]) of current BP management protocol, or diet and lifestyle coaching consisting of photographs, stories, and recipes, for example, that are appropriate for Black adults (LC group [n = 286]) focused on the Dietary Approaches to Stop Hypertension (DASH) diet. Data were analyzed from June 1, 2016, to March 25, 2022.InterventionsThe UC group received care per customary protocol. The EP group was contacted by a research nurse and/or a clinical pharmacist to discuss barriers to hypertension control, and drug therapy emphasized the use of thiazide diuretic intensification and addition of spironolactone as needed. The LC group received as many as 16 telephone sessions with a lifestyle coach and an emphasis on implementing reduction of sodium intake and the DASH diet.Main outcomes and measuresIntention-to-treat analysis of BP control rates at end of the 12-month intervention.ResultsAmong the 1761 participants, the mean (SD) age was 61 (13) years, and 1214 (68.9%) were women. At the end of the 12-month intervention period, there was no significant difference in BP control rate among study groups (UC, 61.8% [95% CI, 58.8%-64.9%]; EP, 64.5% [95% CI, 59.0%-69.4%]; LC, 67.8% [95% CI, 62.1%-73.2%]; LC vs EP, P = .07). However, greater BP control was present in the LC group vs UC at 24 months (UC, 61.2% [95% CI, 57.3%-64.7%]; EP, 67.6% [95% CI, 61.9%-72.8%]; LC, 72.4% [95% CI, 66.9%-78.1%]; LC vs UC, P = .001), and 48 months (UC, 64.5% [95% CI, 61.6%-67.2%]; EP, 66.5% [95% CI, 61.3%-71.3%]; LC, 73.1% [95% CI, 67.6%-77.9%]; LC vs UC, P = .006) after enrollment. The contribution of BP medication adherence to explain group differences was inconclusive.Conclusions and relevanceIn this cluster randomized clinical trial including Black adults with persistent uncontrolled hypertension, a 12-month LC intervention was more effective at controlling BP than UC at 24 and 48 months after enrollment. Further research is needed to explore the potential implementation of this intervention into clinical practice.Trial registrationClinicalTrials.gov Identifier: NCT01892592.
| S-EPMC9118047 | biostudies-literature
Project description:BackgroundUncontrolled hypertension (HTN) is a leading modifiable stroke risk factor contributing to global stroke disparities. This study is unique in testing a transitional care model aimed at controlling HTN in black and Hispanic poststroke, home health patients, an understudied group.MethodsA 3-arm randomized controlled trial design compared (i) usual home care (UHC), with (ii) UHC plus a 30-day nurse practitioner transitional care program, or (iii) UHC plus nurse practitioner plus a 60-day health coach program. The trial enrolled 495 black and Hispanic, English- and Spanish- speaking adults with uncontrolled systolic blood pressure (SBP ≥ 140 mm Hg) who had experienced a first-time or recurrent stroke or transient ischemic attack. The primary outcome was change in SBP from baseline to 3 and 12 months.ResultsMean participant age was 67; 57.0% were female; 69.7% were black, non-Hispanic; and 30.3% were Hispanic. Three-month follow-up retention was 87%; 12-month retention was 81%. SBP declined 9-10 mm Hg from baseline to 12 months across all groups; the greatest decrease occurred between baseline and 3 months. The interventions demonstrated no relative advantage compared to UHC.ConclusionThe significant across-the-board SBP decreases suggest that UHC nurse/patient/physician interactions were the central component of SBP reduction and that additional efforts to lower recurrent stroke risk should test incremental improvements in usual care, not resource-intensive transitional care interventions. They also suggest the potential value of pragmatic home care programs as part of a broader strategy to overcome HTN treatment barriers and improve secondary stroke prevention globally.Clinical trials registrationTrial Number NCT01918891.
| S-EPMC7109355 | biostudies-literature
Project description:A regulated stress response is essential for healthy child growth and development trajectories. We conducted a cluster-randomized trial in rural Bangladesh (funded by the Bill & Melinda Gates Foundation, ClinicalTrials.gov NCT01590095) to assess the effects of an integrated nutritional, water, sanitation, and handwashing intervention on child health. We previously reported on the primary outcomes of the trial, linear growth and caregiver-reported diarrhea. Here, we assessed additional prespecified outcomes: physiological stress response, oxidative stress, and DNA methylation (N = 759, ages 1-2 years). Eight neighboring pregnant women were grouped into a study cluster. Eight geographically adjacent clusters were block-randomized into the control or the combined nutrition, water, sanitation, and handwashing (N+WSH) intervention group (receiving nutritional counseling and lipid-based nutrient supplements, chlorinated drinking water, upgraded sanitation, and handwashing with soap). Participants and data collectors were not masked, but analyses were masked. There were 358 children (68 clusters) in the control group and 401 children (63 clusters) in the intervention group. We measured four F2-isoprostanes isomers (iPF(2α)-III; 2,3-dinor-iPF(2α)-III; iPF(2α)-VI; 8,12-iso-iPF(2α)-VI), salivary alpha-amylase and cortisol, and methylation of the glucocorticoid receptor (NR3C1) exon 1F promoter including the NGFI-A binding site. Compared with control, the N+WSH group had lower concentrations of F2-isoprostanes isomers (differences ranging from -0.16 to -0.19 log ng/mg of creatinine, P<0.01), elevated post-stressor cortisol (0.24 log µg/dl; P<0.01), higher cortisol residualized gain scores (0.06 µg/dl; P=0.023), and decreased methylation of the NGFI-A binding site (-0.04; P=0.037). The N+WSH intervention enhanced adaptive responses of the physiological stress system in early childhood.
2024-03-08 | GSE261098 | GEO
Project description:BACKGROUND:Frail older adults are predisposed to multiple comorbidities and adverse events. Recent interventional studies have shown that frailty can be improved and managed. In this study, effective individualized home-based exercise and nutrition interventions were developed for reducing frailty in older adults. METHODS:This study was a four-arm, single-blind, randomized controlled trial conducted between October 2015 and June 2017 at Miaoli General Hospital in Taiwan. Overall, 319 pre-frail or frail older adults were randomly assigned into one of the four study groups (control, exercise, nutrition, and exercise plus nutrition [combination]) and followed up during a 3-month intervention period and 3-month self-maintenance period. Improvement in frailty scores was the primary outcome. Secondary outcomes included improvements in physical performance and mental health. The measurements were performed at baseline, 1?month, 3?months, and 6?months. RESULTS:At the 6-month measurement, the exercise (difference in frailty score change from baseline: -?0.23; 95% confidence interval [CI]: -?0.41, -?0.05; p?=?0.012), nutrition (-?0.28; 95% CI: -?0.46, -?0.11; p?=?0.002), and combination (-?0.34; 95% CI: -?0.52, -?0.16; p?<? 0.001) groups exhibited significantly greater improvements in the frailty scores than the control group. Significant improvements were also observed in several physical performance parameters in the exercise, nutrition, and combination groups, as well as in the 12-Item Short Form Health Survey mental component summary score for the nutrition group. CONCLUSIONS:The designated home-based exercise and nutrition interventions can help pre-frail or frail older adults to improve their frailty score and physical performance. TRIAL REGISTRATION:Retrospectively registered at ClinicalTrials.gov (identifier: NCT03477097); registration date: March 26, 2018.
| S-EPMC6889427 | biostudies-literature
Project description:ObjectiveTo determine if an intervention consisting of telemonitoring and supervision by usual primary care clinicians of home self measured blood pressure and optional patient decision support leads to clinically important reductions in daytime systolic and diastolic ambulatory blood pressure in patients with uncontrolled blood pressure.DesignMulticentre randomised controlled trial.Setting20 primary care practices in south east Scotland.Participants401 people aged 29-95 years with uncontrolled blood pressure (mean daytime ambulatory measurement ≥ 135/85 mm Hg but ≤ 210/135 mm Hg).InterventionSelf measurement and transmission of blood pressure readings to a secure website for review by the attending nurse or doctor and participant, with optional automated patient decision support by text or email for six months.Main outcome measuresBlinded assessment of mean daytime systolic ambulatory blood pressure six months after randomisation.Results200 participants were randomised to the intervention and 201 to usual care; primary outcome data were available for 90% of participants (182 and 177, respectively). The mean difference in daytime systolic ambulatory blood pressure adjusted for baseline and minimisation factors between intervention and usual care was 4.3 mm Hg (95% confidence interval 2.0 to 6.5; P=0.0002) and for daytime diastolic ambulatory blood pressure was 2.3 mm Hg (0.9 to 3.6; P=0.001), with higher values in the usual care group. The intervention was associated with a mean increase of one general practitioner (95% confidence interval 0.5 to 1.6; P=0.0002) and 0.6 (0.1 to 1.0; P=0.01) practice nurse consultations during the course of the study.ConclusionsSupported self monitoring by telemonitoring is an effective method for achieving clinically important reductions in blood pressure in patients with uncontrolled hypertension in primary care settings. However, it was associated with increase in use of National Health Service resources. Further research is required to determine if the reduction in blood pressure is maintained in the longer term and if the intervention is cost effective.Trial registrationCurrent Controlled Trials ISRCTN72614272.
| S-EPMC3663293 | biostudies-literature