JMIR Publications

ABSTRACT

Background:

Background:

Over the years, the Internet has enabled significant progress in the management of chronic diseases, particularly hypertension and diabetes mellitus. It has also opened up new avenues for online anti-coagulation management. However, there is insufficient evidence to support the effectiveness of online anti-coagulation management.

Objective:

Objective:

The purpose of this study was to compare the differences in the quality of anti-coagulation management and clinical adverse events between the smartphone app-based online management model and the conventional offline outpatient management model.

Methods:

Methods:

This study is a prospective cohort research including multiple national centers. Patients meeting the nadir criteria were split into an online management group using the Alfalfa App or an offline management group with traditional offline outpatient management , and they were then monitored for a 6-month follow-up to collect coagulation test results and clinical events. The effectiveness and safety of the two management models were assessed by the following indicators: time in therapeutic range (TTR), bleeding events, thromboembolic events, all-cause mortality events, cumulative event rates, and the distribution of the international normalized ratio (INR).

Results:

Results:

This national multi-center cohort study enrolled 522 patients between June 2019 and May 2021, with 519 patients reached the follow-up endpoint, including 260 in the offline management group and 259 in the online management group. There were no observable differences in baseline characteristics between the two groups of patients. The online management group had a significantly higher TTR than the offline management group (82.4% vs 71.6%, P<0.001) and a higher proportion of patients received effective anti-coagulation management (81.2% vs. 63.5%, P<0.001). The incidence of minor bleeding events in offline management group was significantly higher than that in online management group (12.1% vs 6.6%, P=0.048). Between the two groups, there was no statistically significant difference in the incidence of severe bleeding, thromboembolic and all-cause death events. In addition, compared with the offline management group, the online management group had a lower proportion of INR in the extreme sub-treatment range (17.6% vs 21.3%) and severe super-treatment range (0.0% vs 0.8%), and a higher proportion in the treatment range (50.4% vs 43.1%), with statistical significance.

Conclusions:

Conclusion: Compared with traditional offline outpatient management, online management via the Alfalfa App may be more beneficial because it can enhance patient anti-coagulation management quality, lower the frequency of small bleeding events, and improve INR distribution.