Prospective validation of a mobile health application for blood pressure management in patients with hypertensive disorders of pregnancy: study protocol for a randomized controlled trial.

BACKGROUND: Hypertensive disorders of pregnancy (HDP) pose significant risks to both maternal and fetal health, contributing to global morbidity and mortality. Management of HDP is complex, particularly because of concerns regarding potential negative effects on utero-placental circulation and limited therapeutic options due to fetal safety. Our study investigates whether blood pressure monitoring through a mobile health (mHealth) application can aid in addressing the challenges of blood pressure management in pregnant individuals with HDP. Additionally, we aim to assess whether this intervention can improve short-term maternal and fetal outcomes and potentially mitigate long-term cardiovascular consequences. METHODS: This prospective, randomized, single-center trial will include 580 pregnant participants who meet the HDP criteria or who have a heightened risk of pregnancy-related hypertension due to factors such as multiple pregnancies, obesity, diabetes, or a history of HDP in prior pregnancies leading to preterm birth. Participants will be randomized to either the mHealth intervention group or the standard care group. The primary endpoint is the difference in systolic blood pressure from enrollment to 1 month after childbirth. The secondary endpoints include various blood pressure parameters, obstetric outcomes, body mass index trajectory, step counts, mood assessment, and drug adherence. CONCLUSIONS: This study emphasizes the potential of mHealth interventions, such as the Heart4U application, to improve blood pressure management in pregnant individuals with HDP. By leveraging technology to enhance engagement, communication, and monitoring, this study aims to positively impact maternal, fetal, and postpartum outcomes associated with HDP. This innovative approach demonstrates the potential of personalized technology-driven solutions for managing complex health conditions. TRIAL REGISTRATION: ClinicalTrials.gov NCT05995106. Registered on 16 August 2023.

Aortic Stiffness Is Associated With Higher Nighttime Ambulatory Blood Pressure in Middle-Aged and Older Adults.

PURPOSE: The objective of this study was to determine the relationship between aortic stiffening and brachial and central ambulatory blood pressure (AMBP) in a nonclinical sample of middle-aged and older adults (MA/O). We hypothesized aortic stiffness would be positively associated with 24-hr, daytime, and nighttime brachial and central AMBP. METHODS: Fifty-one participants aged ≥50 yr (21 males and 30 females, mean age 63.4 ± 9.0 yr) with a body mass index <35 kg/m 2 who also had a resting brachial blood pressure (BP) <160/100 mmHg with or without BP medications were recruited for this cross-sectional analysis. All participants underwent measures of aortic stiffness (carotid-femoral pulse wave velocity [cfPWV]) and 24-hr AMBP monitoring. Bivariate correlations assessed the relationship between cfPWV, brachial, and central AMBP. Partial correlations were used to independently adjust for traditional cardiovascular disease (CVD) risk factors including age, sex, waist circumference, glucose, and augmentation index normalized to heart rate 75 bpm, a surrogate measure of arterial stiffness, and in a multivariable combined model. RESULTS: Nighttime brachial systolic BP ( r = 0.31) and central systolic BP ( r = 0.30) were correlated with cfPWV in the multivariable combined model ( P ≤ .05). Nighttime brachial pulse pressure and central pulse pressure were correlated with cfPWV after independently adjusting for all CVD risk factors ( P ≤ .05, all) but not when combined in the multivariable model ( P > .05). CONCLUSIONS: Higher nighttime brachial and central AMBP with older age are related, in part, to greater aortic stiffening. Therefore, interventions to lower or prevent aortic stiffening may also lower nighttime BP in MA/O adults to lower CVD risk.

Virtual Expansion of the YMCA's Blood Pressure Self-Monitoring (BPSM) Program: Using Telehealth to Adapt an Evidence-Based Program to Reach Rural Communities in South Carolina.

CONTEXT: Disparities in cardiovascular disease prevalence and death exist among South Carolina's rural residents. Blood pressure self-monitoring (BPSM), where individuals measure their own blood pressure outside of the clinical environment, coupled with additional support, is an evidence-based, cost-effective strategy that is underutilized at large. PROGRAM: The YMCA's BPSM program is an evidence-based, 4-month program that includes 2 individualized office hours with a Healthy Heart Ambassador and 4 nutrition education sessions per month. Participants are provided with a blood pressure cuff and notebook to track their blood pressure at home in between sessions. IMPLEMENTATION: The SC Department of Health and Environmental Control partnered with the SC Alliance of YMCAs to expand the YMCA's BPSM program virtually. The traditional program was adapted to allow for virtual participant encounters. To target rural communities, partnerships were leveraged or established with rural health centers, federally qualified health centers, free medical clinics, and other state health department regions for participant referrals into the program. EVALUATION: A developmental evaluation design was utilized to monitor the virtual adaptation of the YMCA's BPSM program from April 2021 to May 2023. At the end of the project, 10 referral sources were identified to refer participants to the program. In total, 253 participants were referred to the program, 126 participants enrolled into the program, and 52 participants completed the program. Completers of the virtual program were successful in improving their blood pressure. DISCUSSION: Successes of the virtual program were not without challenges. Lessons learned from the virtual expansion of this program included ensuring participants' readiness to engage in a 4-month program, assessing participants' digital literacy, and considering broadband access in rural areas. Improvements in blood pressure and the program's reach demonstrate merit in continuing to scale the virtual adaptation of this program; however, contextual and structural factors should be considered.

A Case Series Study Assessing an Equity-Focused Implementation of Self-Monitoring Blood Pressure Programs Using Telehealth.

CONTEXT: Self-monitoring blood pressure (SMBP) programs are an evidence-based hypertension management intervention facilitated through telehealth. SMBP programs can provide a continuum of care beyond a clinical setting by facilitating hypertension management at home; however, equitable access to SMBP is a concern. OBJECTIVES: To evaluate the implementation of telehealth SMBP programs using an equity lens in 5 federally qualified health centers (FQHCs) in Massachusetts (MA). DESIGN: A prospective case series study. SETTING: Five FQHCs. PARTICIPANTS: The MA Department of Public Health (MDPH) selected 5 FQHCs to implement SMBP programs using telehealth. FQHCs were selected if their patient population experiences inequities due to social determinants of health and has higher rates of cardiovascular disease. Each of the 5 FQHCs reported data on patients enrolled in their SMBP programs totaling 241 patients examined in this study. INTERVENTION: SMBP programs implemented through telehealth. MAIN OUTCOME MEASURE: Systolic blood pressure and diastolic blood pressure. RESULTS: Approximately 53.5% of SMBP participants experienced a decrease in blood pressure. The average blood pressure decreased from 146/87 to 136/81 mm Hg. Among all patients across the 5 FQHCs, the average blood pressure decreased by 10.06/5.34 mm Hg (P < .001). Blood pressure improved in all racial, ethnic, and language subgroups. CONCLUSIONS: Five MA FQHCs successfully implemented equitable telehealth SMBP programs. SMBP participants enrolled in the programs demonstrated notable improvements in their blood pressure at the conclusion of the program. A flexible, pragmatic study design that was adjusted to meet unique patient needs; engaging nonphysician team members, particularly community health workers; adapting health information technology; and partnerships with community-based organizations were critical facilitators to program success.

Remote Blood Pressure Monitoring With Social Support for Patients With Hypertension: A Randomized Clinical Trial.

Importance: Hypertension management has traditionally been based on office visits. Integrating remote monitoring into routine clinical practices and leveraging social support might improve blood pressure (BP) control. Objective: To evaluate the effectiveness of a bidirectional text monitoring program focused on BP control and medication adherence with and without social support in adults with hypertension. Design, Setting, and Participants: This randomized clinical trial included adults aged 18 to 75 treated at an academic family medicine practice in Philadelphia in 2018 and 2019. Patients had been seen at least twice in the prior 24 months and had at least 2 elevated BP measurements (>150/90 mm Hg or >140/90 mm Hg for patients aged 18-59 years or with diabetes or chronic kidney disease) during visits. All participants had a cell phone with text messaging, offered at least 1 support partner, and were taking maintenance medications to treat hypertension. Patients were randomized 2:2:1 to remote monitoring of BP and medication adherence (RM), remote monitoring of BP and medication adherence with feedback provided to a social support partner (SS), or usual care (UC). Data were analyzed on an intention-to-treat basis between October 14, 2019, and May 30, 2020, and were revisited from May 23 through June 2, 2023. Interventions: The RM and SS groups received an automatic home BP monitor, 3 weekly texts requesting BP measurements, 1 weekly text inquiring about medication adherence, and a weekly text with feedback. In the SS arm, support partners received a weekly progress report. The UC group received UC through their primary care practice. Clinicians caring for the patients in the intervention groups received nudges via electronic health records to adjust medications when 3 of 10 reported BP measurements were elevated. Patients were followed up for 4 months. Main Outcomes and Measures: The primary outcome was systolic BP at 4 months measured during the final follow-up visit. Secondary outcomes included achievement of normotension and diastolic BP. Results: In all, 246 patients (mean [SD] age, 50.9 [11.4] years; 175 females [71.1%]; 223 Black individuals [90.7%] and 13 White individuals [5.3%]) were included in the intention-to-treat analysis: 100 patients in the RM arm, 97 in the SS arm, and 49 in the UC arm. Compared with the UC arm, there was no significant difference in systolic or diastolic BP at the 4-month follow-up visit in the RM arm (systolic BP adjusted mean difference, -5.25 [95% CI, -10.65 to 0.15] mm Hg; diastolic BP adjusted mean difference, -1.94 [95% CI, -5.14 to 1.27] mm Hg) or the SS arm (systolic BP adjusted mean difference, -0.91 [95% CI, -6.37 to 4.55] mm Hg; diastolic BP adjusted mean difference, -0.63 [95% CI, -3.77 to 2.51] mm Hg). Of the 206 patients with a final BP measurement at 4 months, BP was controlled in 49% (41 of 84) of patients in the RM arm, 31% (27 of 87) of patients in the SS arm, and 40% (14 of 35) of patients in the UC arm; these rates did not differ significantly between the intervention arms and the UC group. Conclusions and Relevance: In this randomized clinical trial, neither remote BP monitoring nor remote BP monitoring with social support improved BP control compared with UC in adults with hypertension. Additional efforts are needed to examine whether interventions directed at helping patients remember to take their BP medications can lead to improved BP control. Trial Registration: ClinicalTrials.gov Identifier: NCT03416283.

The relationship between ambulatory arterial stiffness index and incident atrial fibrillation.

BACKGROUND: The ambulatory arterial stiffness index (AASI) is an indirect measure of blood pressure variability and arterial stiffness which are atrial fibrillation (AF) risk factors. The relationship between AASI and AF development has not been previously investigated and was the primary aim of this study. METHODS: This was an observational cohort study of adults (aged 18-85 years) in sinus rhythm, who underwent 24-h ambulatory blood pressure monitoring (ABPM) for the diagnosis of hypertension or its control. RESULTS: Eight hundred and twenty-one patients (49% men) aged 58.7 ± 15.3 years were followed up for a median of 4.0 years (3317 patient-years). In total, 75 patients (9.1%) developed ≥1 AF episode during follow-up. The mean AASI was 0.46 ± 0.17 (median 0.46). AASI values (0.52 ± 0.16 vs. 0.45 ± 0.17; p < .001) and the proportion of AASI values above the median (65.3% vs. 48.4%; p = .005) were greater among the patients who developed AF versus those that did not respectively. AASI significantly correlated with age (r = .49; 95% confidence interval: 0.44-0.54: p < .001). On Kaplan-Meier analysis, higher baseline AASI by median, tertiles, and quartiles were all significantly associated with AF development (X2: 10.13; p < .001). On Cox regression analyses, both a 1-standard deviation increase and AASI > median were independent predictors of AF, but this relationship was no longer significant when age was included in the model. CONCLUSIONS: AASI is an independent predictor of AF development. However, this relationship becomes insignificant after adjustment for age which is higher correlated with AASI.

A pilot study of electronic blood pressure interpretation of home blood pressure readings in primary care.

BACKGROUND: Home blood pressure (BP) monitoring is an acceptable method with high accuracy and acceptability amongst patients. It has the potential to save many hours of clinical time and is less likely to suffer from white coat bias. However, it can raise anxiety in patients who may not interpret readings immediately. AIM: A pilot study using an auto formatted excel spreadsheet which gave instantaneous colour coded feedback was sent to patients to assess its acceptability. METHOD: This auto interpretation tool was sent to patients with their consent. It enabled patients to receive immediate feedback about this blood pressure control. A follow-up questionnaire was later sent to ask the patients and the staff about their experience. RESULTS: Hypertensive patients under 75 years of age who were sending regular home BP readings were enrolled (n = 96); of these, 31 responded within 1 month. Patient satisfaction was high; 74% preferred the electronic tool, 77% found the colour indicator reassuring, and 87% wanted to continue the electronic interpretation tool regardless of their initial preference. Staff satisfaction was excellent at 100%. CONCLUSION: This hypertension triage tool allows for interpretation by patients and non-clinicians with benefits of instantaneous reassurance, user and provider satisfaction all at reduced costs. Patients without MS Excel could not use this tool. The pilot study reinforced our hypothesis that such a modality has the potential to increase patient satisfaction and safety, and can be applied to a larger number of patients. Eventually an NHS app could be developed and rolled out for the large population.

Fidelity to and utility of a home blood pressure self-monitoring regime in people with pre-hypertension: results from the REVERSE study.

INTRODUCTION: Around 40% of adults have pre-hypertension (120-139/80-89mmHg) increasing their risk of developing hypertension and associated cardiovascular conditions. Guidance on pre-hypertension management focuses on improving lifestyle. Self-monitoring may improve awareness and understanding of blood pressure (BP) for people with pre-hypertension, allowing them to modify their lifestyle risks. AIM: To determine the fidelity to and utility of a home BP self-monitoring regime in people with pre-hypertension. METHOD: This sub-study is part of a larger prospective, non-randomised feasibility study. Individuals with pre-hypertension were identified via GP records and pharmacy NHS Health Checks in Northwest England. Participants received training for home BP self-monitoring. They were asked to complete two readings (leaving a 5-minute interval) on the first three days of the month for six months, colour-code their readings and take action using a simple algorithm, then send them to the research team within 7 days. RESULTS: Eighty participants (aged 40-79, mean=59) enrolled. The majority were female (n=45, 56%), White British (n=79, 99%), and had not previously monitored their BP (n=55, 69%). Seventy-five (94%) participants completed the training. Sixty-one (81%) received online training and 14 (19%) opted for a face-to-face session. Sixty-one (81%) completed all six months of readings, 51 (68%) also returned them on time. All in-person training participants completed all six months of readings on time. Reasons for non-compliance to the protocol included battery issues, forgetting, and struggling to find a consistent time for readings. CONCLUSION: Home BP self-monitoring can be feasible and easily implementable for people with pre-hypertension - however, some barriers were identified.

Sleep Duration and Blood Pressure in Youth Referred for Elevated Blood Pressure Evaluation.

OBJECTIVES: Sleep promotion is not specifically recommended as a target for hypertension management. We examined associations of sleep duration and timing with blood pressure parameters in patients referred to pediatric nephrology clinic for elevated blood pressure evaluation. METHODS: This is a retrospective study of initial ambulatory blood pressure monitoring data and self-report sleep data collected from patients referred to nephrology clinic for the evaluation of elevated blood pressure. Linear and logistic regression modeling determined associations between sleep exposures (duration and timing) and continuous and dichotomous blood pressure outcomes, respectively, adjusted for age, sex, body mass index, and weekday versus weekend status. RESULTS: The study sample included 539 patients with mean age 14.6 years and 56% meeting hypertension criteria. Sleep duration averaged 9.1 hours per night. Average timing of sleep onset and offset were 11:06 pm and 8:18 am, respectively. Longer sleep duration was associated with better daytime blood pressure parameters (eg, every extra hour of sleep duration was associated with a reduced odds of wake hypertension [odds ratio, 0.88; 95% CI, 0.79-0.99]). Later sleep onset was associated with worse daytime blood pressure parameters (eg, each additional hour of later sleep onset was associated with higher wake systolic blood pressure index [mean wake blood pressure/95th percentile]) (ß = 0.07; 95% CI, 0.02-0.13). Associations were consistent across sex, age, body mass index, and weekday status. CONCLUSIONS: Longer sleep duration and earlier sleep onset were associated with lower blood pressure. This suggests that sleep optimization may be an important target for intervention in hypertension management.

Influence of Aortic Arch Morphology on Renal Perfusion in Patients with Coarctation of the Aorta: An Exploratory Study.

Objectives: The configuration of the aortic arch, particularly a Gothic arch shape, in individuals with corrected coarctation of the aorta (CoA) has been associated with a decreased systolic wave amplitude across the arch, which could potentially impair renal perfusion and elevate the risk of arterial hypertension. This study aims to explore the relationship between the morphological characteristics of the aortic arch and their impact on renal perfusion in patients with CoA. Methods: Seventy-one subjects with corrected CoA underwent continuous 24 h ambulatory blood pressure monitoring, computed tomography to assess the aortic arch, and renal perfusion scanning. Subjects were stratified into three groups based on the height-to-width (H/W) ratio of their aortic arch: Group 1 with a H/W ratio of <0.65, Group 2 with a H/W ratio between 0.65 and 0.85, and Group 3 with a H/W ratio of >0.85. Results: Groups 1 and 2 (53,78% and 62.63%) presented with a higher hypertension prevalence of elevated blood pressure than Group 3 (38.89%). Notable variations were observed among the subjects in the time to peak perfusion (Tmax) in the left kidney across the groups. Group 1 showed a median Tmax at 0.27, Group 2 at 0.13, and Group 3 at -0.38 (p-value = 0.079). The differences in Tmax for the right kidney followed a similar trend but were not statistically significant (Group 1 at 0.61, Group 2 at 0.22, and Group 3 at 0.11; p-value = 0.229). Conclusions: This study suggests that variations in the aortic arch morphology might not significantly influence renal perfusion in CoA patients. This indicates the potential adaptability of the renal blood flow, which appears to compensate for reduced perfusion, thus minimizing adverse effects on the kidney function. This adaptability suggests an inherent physiological resilience, emphasizing the need for further targeted research to understand the specific interactions and impacts on treatment strategies for CoA.

Blood pressure variability assessed by office, home, and ambulatory measurements before and during antihypertensive drug treatment: a sub-analysis of the REVERENT randomized trial.

OBJECTIVES: Blood pressure (BP) variability (BPV) can be assessed using office (OBP), home (HBP), or ambulatory BP (ABP) measurements. This analysis investigated the association and agreement between OBP, HBP, and ABP measurements for BPV assessment at baseline and 10 weeks after initiating antihypertensive drug therapy. METHODS: Untreated hypertensive patients with elevated BPV were randomized to receive an angiotensin-converting enzyme inhibitor (ramipril) or a calcium channel blocker (nifedipine GITS) in a 10-week, open-label, blinded-end point study. BPV was assessed using standard deviation (SD) and coefficient of variation (CV) (reading-to-reading analyses). RESULTS: Data from 146 participants from three research centers (Athens/Greece; Milan/Italy; Shanghai/China) were analyzed [mean age 53 ±â€Š10 (SD) years, male individuals 60%, baseline systolic OBP, HBP, and 24 h ABP 144 ±â€Š9, 138 ±â€Š10, and 143 ±â€Š10 mmHg, respectively]. Post-treatment minus pre-treatment systolic CV difference was: OBP: 0.3%, P  = 0.28; HBP: -0.2%, P  = 0.20; 24 h ABP: 1.1%, P  < 0.001. Home and ambulatory (not office) BPV indices presented weak-to-moderate correlation, both before and during treatment (range of coefficients 0.04-0.33). The correlation coefficient between systolic HBP and awake ABP CV was 0.21 and 0.28 before and during treatment, respectively ( P  < 0.05/< 0.001, respectively). Home and ambulatory (not office) BPV indices presented slight-to-fair agreement (range 64-73%) in detecting participants with high systolic BPV (top quartile of respective distributions) both before and during treatment (kappa range 0.04-0.27). CONCLUSION: These data showed a weak-to-moderate association between out-of-office (but not office) BPV indices both before and during BP-lowering treatment, with reasonable agreement in detecting individuals with high BPV. Out-of-office BP measurements provide more similar and consistent BPV information than office measurements.

Empowering Low-Income Patients with Home Blood Pressure Monitors to Improve Hypertension Control.

INTRODUCTION: Effective management of hypertension (HTN) is a priority in primary care. With telehealth now considered a staple care delivery method, uninsured and low-income patients without home blood pressure (BP) monitors may need additional attention and resources to achieve successful HTN control. METHODS: This prospective study at an underserved community clinic assessed the impact of distributing free BP monitors on patients' HTN control and therapy adherence. Enrollees were randomized into 2 groups, both completing 4 primary care physician (PCP) visits over a 6-month study period. Intervention participants collected home BP readings to report to their PCP and comparison participants completed an equivalent number of visits without having home BP data available for their PCP to review. Both groups completed an initial and final Therapy Adherence Scale (TAS) questionnaire. RESULTS: 263 patients were invited and 200 participants (mean age 50, 60% female, 19% Black, 67% Hispanic) completed the study. Intervention and comparison subjects featured comparable initial BP levels and TAS scores. After adjusting for age, race, ethnicity, sex, presence of diabetes and therapy adherence, intervention participants experienced higher odds of controlled HTN (OR 4.0; 95% Confidence Interval 2.1 to 7.7). A greater proportion of participants achieved BP control in the intervention arm compared with the comparison arm (82% vs 54% of participants, P < .001). TAS scores were higher in the intervention group (Mean = 44.1 vs 41.1; P < .001). DISCUSSION: The provision of free home BP monitors to low-income patients may feasibly and effectively improve BP control and therapy adherence.

Prevalence of masked hypertension in attended versus unattended office blood pressure measurement.

There is a controversial debate regarding whether unattended blood pressure (BP) measurement should be regarded as the new gold standard of office BP measurement. Unattended BP measurement eliminates the white-coat effect and reduces external influences on the patient. On the other hand, it might underestimate real-life BP. The present study compares the prevalence of masked hypertension using attended versus unattended office BP measurements. We performed a cross-sectional study on 213 patients in a general practitioner's outpatient clinic and compared attended and unattended office BP with 24h-ambulatory BP monitoring (24h-ABPM). Masked hypertension was defined as pressure ≥135/85 mmHg in daytime ABPM with office systolic BP < 140/90 mmHg. Median attended and unattended office BPs were 140/86 and 134/80 mmHg with a median 24h-BP of 129/79 mmHg and daytime ABP of 133/82 mmHg. The number of patients with masked hypertension was 45/213 (21.2%) using unattended and 23/213 (10.8%) using attended office BP measurements (p < .0001). Bland-Altman analysis revealed a 7.4 mmHg systolic and 6.2 mmHg diastolic bias between the attended versus unattended office BP, and two systolic and -1.7 mmHg diastolic biases between the unattended office BP and daytime ambulatory BP. In linear regression analysis, an unattended office BP of 134 mmHg corresponded to 140 mmHg in attended BP measurement. Using a cut-off of 135/85 mmHg instead of 140/90 mmHg in unattended office BP measurement, the rate of masked hypertension was 26/213 (12.2%). Thus, unattended office BP measurement results in a substantial increase in the prevalence of masked hypertension using the traditional definition of hypertension. The present findings suggest that it might be reasonable to use a definition of 135/85 mmHg.