Importance: Mobile applications (apps) may help improve hypertension self-management. Objective: To investigate the effect of an artificial intelligence smartphone coaching app to promote home monitoring and hypertension-related behaviors on systolic blood pressure level compared with a blood pressure tracking app. Design, Setting, and Participants: This was a 2-group, open, randomized clinical trial. Participants with uncontrolled hypertension were recruited in 2016 and 2017 and were followed up for 6 months. Data analysis was performed from April 2019 to December 2019. Interventions: Intervention group participants received a smartphone coaching app to promote home monitoring and behavioral changes associated with hypertension self-management plus a home blood pressure monitor. Control participants received a blood pressure tracking app plus a home blood pressure monitor. Main Outcomes and Measures: The primary study outcome was systolic blood pressure at 6 months. Secondary outcomes included self-reported antihypertensive medication adherence, home monitoring and self-management practices, measures of self-efficacy associated with blood pressure, weight, and self-reported health behaviors. Results: There were 333 participants randomized, and 297 completed the follow-up assessment. Among the participants who completed the study, the mean (SD) age was 58.9 (12.8) years, 182 (61.3%) were women, and 103 (34.7%) were black. Baseline mean (SD) systolic blood pressure was 140.6 (12.2) mm Hg among intervention participants and 141.8 (13.4) mm Hg among control participants. After 6 months, the corresponding mean (SD) systolic blood pressures were 132.3 (15.0) mm Hg and 135.0 (13.9) mm Hg, with a between-group adjusted difference of -2.0 mm Hg (95% CI, -4.9 mm Hg to 0.8 mm Hg; P = .16). At 6 months, self-confidence in controlling blood pressure was greater in the intervention group (0.36 point on a 5-point scale; 95% CI, 0.18 point to 0.54 point; P < .001). There were no significant differences between the 2 groups in other secondary outcomes. The adjusted difference in self-reported physical activity was 26.7 minutes per week (95% CI, -5.4 minutes per week to 58.8 minutes per week; P = .10). Subgroup analysis raised the possibility that intervention effects differed by age. Conclusions and Relevance: Among individuals with uncontrolled hypertension, those randomized to a smartphone coaching app plus home monitor had similar systolic blood pressure compared with those who received a blood pressure tracking app plus home monitor. Given the direction of the difference in systolic blood pressure between groups and the possibility for differences in treatment effects across subgroups, future studies are warranted. Trial Registration: ClinicalTrials.gov Identifier: NCT03288142.
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