Dataset Information

Effectiveness of Standard vs Enhanced Self-measurement of Blood Pressure Paired With a Connected Smartphone Application: A Randomized Clinical Trial.

ABSTRACT:

Importance

Self-measured blood pressure (SMBP) with commercially available connected smartphone applications may help patients effectively use SMBP measurements.

Objective

To determine if enhanced SMBP paired with a connected smartphone application was superior to standard SMBP for blood pressure (BP) reduction or patient satisfaction.

Design, setting, and participants

This randomized clinical trial was conducted among 23 health systems participating in PCORnet, the National Patient-Centered Clinical Research Network, and included patients who reported having uncontrolled BP at their last clinic visit, a desire to lower their BP, and a smartphone. Enrollment and randomization occurred from August 3, 2019, to December 31, 2020, which was followed by 6 months of follow-up for each patient. Analysis commenced shortly thereafter.

Interventions

Eligible participants were randomly assigned to enhanced SMBP using a device that paired with a connected smartphone application (enhanced) or a standard device (standard). Participants received their device in the mail, along with web-based educational materials and phone-based support as needed. No clinician engagement was undertaken, and the study provided no special mechanisms for delivering measurements to clinicians for use in BP management.

Main outcomes and measures

Reduction in systolic BP, defined as the difference between clinic BP at baseline and the most recent clinic BP extracted from electronic health records at 6 months.

Results

Enrolled participants (1051 enhanced [50.0%] vs 1050 standard [50.0%]; 1191 women [56.7%]) were mostly middle-aged or older (mean [SD] age, 58 [13] years), nearly a third were Black or Hispanic (645 [31%]), and most were relatively comfortable using technology (mean [SD], 4.1 [1.1] of 5). The mean (SD) change in systolic BP from baseline to 6 months was -10.8 (18) mm Hg vs -10.6 (18) mm Hg (enhanced vs standard: adjusted difference, -0.19 mm Hg; 95% CI, -1.83 to 1.44; P = .81). Secondary outcomes were mostly null, except for documented attainment of BP control to lower than 140/<90 mm Hg, which occurred in 32% enhanced vs 29% standard groups (odds ratio, 1.15; 95% CI, 1.01-1.34). Most participants were very likely to recommend their SMBP device to a friend (70% vs 69%).

Conclusions and relevance

This randomized clinical trial found that enhanced SMBP paired with a smartphone application is not superior to standard SMBP for BP reduction or patient satisfaction.

Trial registration

ClinicalTrials.gov Identifier: NCT03796689.

SUBMITTER: Pletcher MJ

PROVIDER: S-EPMC9379824 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effectiveness of Standard vs Enhanced Self-measurement of Blood Pressure Paired With a Connected Smartphone Application: A Randomized Clinical Trial.

Pletcher Mark J MJ Fontil Valy V Modrow Madelaine Faulkner MF Carton Thomas T Chamberlain Alanna M AM Todd Jonathan J O'Brien Emily C EC Sheer Amy A Vittinghoff Eric E Park Soo S Orozco Jaime J Lin Feng F Maeztu Carlos C Wozniak Gregory G Rakotz Michael M Shay Christina M CM Cooper-DeHoff Rhonda M RM

JAMA internal medicine 20221001 10

<h4>Importance</h4>Self-measured blood pressure (SMBP) with commercially available connected smartphone applications may help patients effectively use SMBP measurements.<h4>Objective</h4>To determine if enhanced SMBP paired with a connected smartphone application was superior to standard SMBP for blood pressure (BP) reduction or patient satisfaction.<h4>Design, setting, and participants</h4>This randomized clinical trial was conducted among 23 health systems participating in PCORnet, the Nationa ...[more]

PMID: 35969408

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Project description:Hypertension is an immense challenge in public health. As one of the most prevalent medical conditions worldwide, it is a major cause of premature death. At present, the detection, diagnosis and monitoring of hypertension are subject to several limitations. In this review, we conducted a literature search on blood pressure measurement using only a smartphone, which has the potential to overcome current limitations and thus pave the way for long-term ambulatory blood pressure monitoring on a large scale. Among the 333 articles identified, we included 25 relevant articles over the past decade (November 2011-November 2021) and analyzed the described approaches to the types of underlying data recorded with smartphone sensors, the signal processing techniques applied to construct the desired signals, the features extracted from the constructed signals, and the algorithms used to estimate blood pressure. In addition, we analyzed the validation of the proposed methods against reference blood pressure measurements. We further examined and compared the effectiveness of the proposed approaches. Among the 25 articles, 23 propose an approach that requires direct contact between the sensor and the subject and two articles propose a contactless approach based on facial videos. The sample sizes in the identified articles range from three to 3000 subjects, where 8 articles used sample sizes of 85 or more subjects. Furthermore, 10 articles include hypertensive subjects in their participant pools. The methodologies applied for the evaluation of blood pressure measurement accuracy vary considerably among the analyzed articles. There is no consistency regarding the methods for blood pressure data collection and the reference blood pressure measurement and validation. Moreover, no established protocol is currently available for the validation of blood pressure measuring technologies using only a smartphone. We conclude the review with a discussion of the results and with recommendations for future research on the topic.

Project description:ImportanceOlder patients with hypertension receiving intensive systolic blood pressure control (110-130 mm Hg) have lower incidences of cardiovascular events than those receiving standard control (130-150 mm Hg). Nevertheless, the mortality reduction is insignificant, and intensive blood pressure management results in more medical costs from treatments and subsequent adverse events.ObjectiveTo examine the incremental lifetime outcomes, costs, and cost-effectiveness of intensive vs standard blood pressure control in older patients with hypertension from the health care payer's perspective.Design, setting, and participantsThis economic analysis was conducted with a Markov model to examine the cost-effectiveness of intensive blood pressure management among patients aged 60 to 80 years with hypertension. Treatment outcome data from the Trial of Intensive Blood-Pressure Control in Older Patients With Hypertension (STEP trial) and different cardiovascular risk assessment models for a hypothetical cohort of STEP-eligible patients were used. Costs and utilities were obtained from published sources. The incremental cost-effectiveness ratio (ICER) against the willingness-to-pay threshold was used to evaluate whether the management was cost-effective. Extensive sensitivity, subgroup, and scenario analyses were performed to address uncertainty. The US and UK population using race-specific cardiovascular risk models were conducted in the generalizability analysis. Data for the STEP trial were collected from February 10 to March 10, 2022, and were analyzed for the present study from March 10 to May 15, 2022.InterventionsHypertension treatments with a systolic blood pressure target of 110 to 130 mm Hg or 130 to 150 mm Hg.Main outcomes and measuresIncremental lifetime quality-adjusted life-years (QALYs), costs, and ICER are discounted at the given rates annually.ResultsAfter simulating 10 000 STEP-eligible patients assumed to be 66 years of age (4650 men [46.5%] and 5350 women [53.5%]) in the model, the ICER values were ¥51 675 ($12 362) per QALY gained in China, $25 417 per QALY gained in the US, and £4679 ($7004) per QALY gained in the UK. Simulations projected that the intensive management in China being cost-effective were 94.3% and 100% below the willingness-to-pay thresholds of 1 time (¥89 300 [$21 364]/QALY) and 3 times (¥267 900 [$64 090]/QALY) the gross domestic product per capita, respectively. The US had 86.9% and 95.6% probabilities of cost-effectiveness at $50 000/QALY and $100 000/QALY, respectively, and the UK had 99.1% and 100% of probabilities of cost-effectiveness at £20 000 ($29 940)/QALY and £30 000 ($44 910)/QALY, respectively.Conclusions and relevanceIn this economic evaluation, the intensive systolic blood pressure control in older patients produced fewer cardiovascular events and had acceptable costs per QALY gained, well below the typical willingness-to-pay thresholds. The cost-effective advantages of intensive blood pressure management in older patients were consistent over various clinical scenarios across different countries.

Project description:BackgroundIn the Systolic Blood Pressure Intervention Trial (SPRINT), adults at high risk for cardiovascular disease who received intensive systolic blood-pressure control (target, <120 mm Hg) had significantly lower rates of death and cardiovascular disease events than did those who received standard control (target, <140 mm Hg). On the basis of these data, we wanted to determine the lifetime health benefits and health care costs associated with intensive control versus standard control.MethodsWe used a microsimulation model to apply SPRINT treatment effects and health care costs from national sources to a hypothetical cohort of SPRINT-eligible adults. The model projected lifetime costs of treatment and monitoring in patients with hypertension, cardiovascular disease events and subsequent treatment costs, treatment-related risks of serious adverse events and subsequent costs, and quality-adjusted life-years (QALYs) for intensive control versus standard control of systolic blood pressure.ResultsWe determined that the mean number of QALYs would be 0.27 higher among patients who received intensive control than among those who received standard control and would cost approximately $47,000 more per QALY gained if there were a reduction in adherence and treatment effects after 5 years; the cost would be approximately $28,000 more per QALY gained if the treatment effects persisted for the remaining lifetime of the patient. Most simulation results indicated that intensive treatment would be cost-effective (51 to 79% below the willingness-to-pay threshold of $50,000 per QALY and 76 to 93% below the threshold of $100,000 per QALY), regardless of whether treatment effects were reduced after 5 years or persisted for the remaining lifetime.ConclusionsIn this simulation study, intensive systolic blood-pressure control prevented cardiovascular disease events and prolonged life and did so at levels below common willingness-to-pay thresholds per QALY, regardless of whether benefits were reduced after 5 years or persisted for the patient's remaining lifetime. (Funded by the National Heart, Lung, and Blood Institute and others; SPRINT ClinicalTrials.gov number, NCT01206062 .).

Project description:ImportanceThe effect of intensive blood pressure lowering on brain health remains uncertain.ObjectiveTo evaluate the association of intensive blood pressure treatment with cerebral white matter lesion and brain volumes.Design, setting, and participantsA substudy of a multicenter randomized clinical trial of hypertensive adults 50 years or older without a history of diabetes or stroke at 27 sites in the United States. Randomization began on November 8, 2010. The overall trial was stopped early because of benefit for its primary outcome (a composite of cardiovascular events) and all-cause mortality on August 20, 2015. Brain magnetic resonance imaging (MRI) was performed on a subset of participants at baseline (n = 670) and at 4 years of follow-up (n = 449); final follow-up date was July 1, 2016.InterventionsParticipants were randomized to a systolic blood pressure (SBP) goal of either less than 120 mm Hg (intensive treatment, n = 355) or less than 140 mm Hg (standard treatment, n = 315).Main outcomes and measuresThe primary outcome was change in total white matter lesion volume from baseline. Change in total brain volume was a secondary outcome.ResultsAmong 670 recruited patients who had baseline MRI (mean age, 67.3 [SD, 8.2] years; 40.4% women), 449 (67.0%) completed the follow-up MRI at a median of 3.97 years after randomization, after a median intervention period of 3.40 years. In the intensive treatment group, based on a robust linear mixed model, mean white matter lesion volume increased from 4.57 to 5.49 cm3 (difference, 0.92 cm3 [95% CI, 0.69 to 1.14]) vs an increase from 4.40 to 5.85 cm3 (difference, 1.45 cm3 [95% CI, 1.21 to 1.70]) in the standard treatment group (between-group difference in change, -0.54 cm3 [95% CI, -0.87 to -0.20]). Mean total brain volume decreased from 1134.5 to 1104.0 cm3 (difference, -30.6 cm3 [95% CI, -32.3 to -28.8]) in the intensive treatment group vs a decrease from 1134.0 to 1107.1 cm3 (difference, -26.9 cm3 [95% CI, 24.8 to 28.8]) in the standard treatment group (between-group difference in change, -3.7 cm3 [95% CI, -6.3 to -1.1]).Conclusions and relevanceAmong hypertensive adults, targeting an SBP of less than 120 mm Hg, compared with less than 140 mm Hg, was significantly associated with a smaller increase in cerebral white matter lesion volume and a greater decrease in total brain volume, although the differences were small.Trial registrationClinicalTrials.gov Identifier: NCT01206062.

Dataset Information

Effectiveness of Standard vs Enhanced Self-measurement of Blood Pressure Paired With a Connected Smartphone Application: A Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Effectiveness of Standard vs Enhanced Self-measurement of Blood Pressure Paired With a Connected Smartphone Application: A Randomized Clinical Trial.

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