TY - JOUR
T1 - Effectiveness of Standard vs Enhanced Self-measurement of Blood Pressure Paired with a Connected Smartphone Application
T2 - A Randomized Clinical Trial
AU - Pletcher, Mark J.
AU - Fontil, Valy
AU - Modrow, Madelaine Faulkner
AU - Carton, Thomas
AU - Chamberlain, Alanna M.
AU - Todd, Jonathan
AU - O'Brien, Emily C.
AU - Sheer, Amy
AU - Vittinghoff, Eric
AU - Park, Soo
AU - Orozco, Jaime
AU - Lin, Feng
AU - Maeztu, Carlos
AU - Wozniak, Gregory
AU - Rakotz, Michael
AU - Shay, Christina M.
AU - Cooper-Dehoff, Rhonda M.
N1 - Publisher Copyright:
© 2022 American Medical Association. All rights reserved.
PY - 2022/10
Y1 - 2022/10
N2 - 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.
AB - 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.
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U2 - 10.1001/jamainternmed.2022.3355
DO - 10.1001/jamainternmed.2022.3355
M3 - Article
C2 - 35969408
AN - SCOPUS:85136559860
SN - 2168-6106
VL - 182
SP - 1025
EP - 1034
JO - JAMA internal medicine
JF - JAMA internal medicine
IS - 10
ER -