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.

Figure 1.. CONSORT Diagram

All randomized participants were analyzed besides 1 that was randomized in error before completion of baseline surveys, and who withdrew consent before study staff could intervene. Per protocol, multiple imputation was used to impute missing clinic blood pressure (BP) measurements for 39 participants (1.9%) for whom linked electronic health record (EHR) data were not available, and to impute missing responses for the primary patient-reported outcome (PRO) (Net Promoter Score) for 865 participants (41%). App indicates smartphone application; SMBP, self-measured blood pressure.

Figure 2.. Average Clinic Systolic Blood Pressure (BP) by Week

Average clinic systolic blood pressures (BPs) recorded in the electronic health record (A) and total number of clinic visits (B) by week for standard (orange) and enhanced (blue) groups. The excess clinic visits occurring in week 0 are explained by visits on the day of randomization (in-clinic recruitment).