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Original Investigation
June 2018

Association of a Smartphone Application With Medication Adherence and Blood Pressure ControlThe MedISAFE-BP Randomized Clinical Trial

Author Affiliations
  • 1Center for Healthcare Delivery Sciences (C4HDS) and Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
  • 2Department of Internal Medicine, Atrius Health, Boston, Massachusetts
  • 3Evidation Health, San Mateo, California
JAMA Intern Med. 2018;178(6):802-809. doi:10.1001/jamainternmed.2018.0447
Key Points

Question  Does use of a smartphone application (app) improve self-reported adherence to antihypertensive medications and blood pressure control?

Findings  In this randomized clinical trial of 411 adults with poorly controlled hypertension, patients randomized to receive a smartphone app had a small improvement in self-reported medication adherence with no difference in blood pressure compared with controls.

Meaning  Use of a smartphone app resulted in a small improvement in self-reported medication adherence but did not affect blood pressure; the benefit of this and other stand-alone mobile health interventions on clinical outcomes remains to be established.

Abstract

Importance  Medication nonadherence accounts for up to half of uncontrolled hypertension. Smartphone applications (apps) that aim to improve adherence are widely available but have not been rigorously evaluated.

Objective  To determine if the Medisafe smartphone app improves self-reported medication adherence and blood pressure control.

Design, Setting, and Participants  This was a 2-arm, randomized clinical trial (Medication Adherence Improvement Support App For Engagement—Blood Pressure [MedISAFE-BP]). Participants were recruited through an online platform and were mailed a home blood pressure cuff to confirm eligibility and to provide follow-up measurements. Of 5577 participants who were screened, 412 completed consent, met inclusion criteria (confirmed uncontrolled hypertension, taking 1 to 3 antihypertensive medications), and were randomized in a ratio of 1:1 to intervention or control.

Interventions  Intervention arm participants were instructed to download and use the Medisafe app, which includes reminder alerts, adherence reports, and optional peer support.

Main Outcomes and Measures  Co–primary outcomes were change from baseline to 12 weeks in self-reported medication adherence, measured by the Morisky medication adherence scale (MMAS) (range, 0-8, with lower scores indicating lower adherence), and change in systolic blood pressure.

Results  Participants (n = 411; 209 in the intervention group and 202 controls) had a mean age of 52.0 years and mean body mass index, calculated as weight in kilograms divided by height in meters squared, of 35.5; 247 (60%) were female, and 103 (25%) were black. After 12 weeks, the mean (SD) score on the MMAS improved by 0.4 (1.5) among intervention participants and remained unchanged among controls (between-group difference: 0.4; 95% CI, 0.1-0.7; P = .01). The mean (SD) systolic blood pressure at baseline was 151.4 (9.0) mm Hg and 151.3 (9.4) mm Hg, among intervention and control participants, respectively. After 12 weeks, the mean (SD) systolic blood pressure decreased by 10.6 (16.0) mm Hg among intervention participants and 10.1 (15.4) mm Hg among controls (between-group difference: −0.5; 95% CI, −3.7 to 2.7; P = .78).

Conclusions and Relevance  Among individuals with poorly controlled hypertension, patients randomized to use a smartphone app had a small improvement in self-reported medication adherence but no change in systolic blood pressure compared with controls.

Trial Registration  clinicaltrials.gov Identifier: NCT02727543

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