We compared the effect on blood pressure (BP) of a digital delivery personalized lifestyle-change program (LCP) coupled with a BP recording, interpretation and trend evaluation service (BTS) with the BTS alone as a digital plain diary, via App and website.Design and Method:
We enrolled 181 consecutive subjects (134 males; 52 ± 12 years old) that voluntarily joined LCP and 362 “double-control” matching subjects that that subscribed the BTS only. The BTS collects BP values, and after thorough consistency-checks, feeds a proprietary CE-certified medical device algorithm to provide both the actual BP interpretation and to determine the presence and direction of BP trends. The LCP, after collecting detailed clinical and lifestyle info, provides a 3-month personalized program for helping people to adopt lifestyle modifications potentially beneficial for BP reduction. It also promotes regular BP measurements via digital engagement, while BTS alone does not. Progress on program implementation, continuity of BP measurement and BP changes were monitored: subsequent counselling was provided accordingly. BP changes were evaluated comparing BP values recorded at the beginning and at the end of the LCP program.Results:
During the study period a total 15,389 BP values were collected. Subjects with discontinuous BP measurements during the LCP were excluded from evaluation. We hence analyzed the data of 129 LCP subjects (mean persistence time 2.3 months) and 258 “double-control” matching BTS subjects. Whilst non-significant differences were observed in BTS subjects, a significant reduction of BP in LCP subjects at the end of the program occurred for both systolic and diastolic BP: −4.7 ± 1.2 mmHg and −3.1 ± 0.8 mmHg, p < 0.0001 (respectively).Conclusions:
This pilot study demonstrates that personalized and actionable LCP prepared, delivered and monitored only through electronic means and coupled with a medical CE certified App for BP interpretation and trend analysis, provides a strong and effective adjunctive tool for BP reduction.