Smart Technology-Assisted Patient-Centered Management in Venous Thromboembolism: Pilot Study on Anticoagulation Adherence.

BACKGROUND

Achieving optimal adherence to anticoagulation therapy is a major challenge in the management of venous thromboembolism (VTE). Mobile health (mHealth) technologies may offer a scalable approach to supporting medication adherence and self-management.

OBJECTIVE

This pilot study aimed to assess the feasibility and preliminary impact of a smart technology-assisted, patient-centered care mHealth app for managing VTE (mVTEA) on short-term anticoagulation adherence among patients with VTE or at moderate-to-high risk of VTE.

METHODS

Baseline medication adherence and beliefs were assessed using the Chinese versions of the 8-item Morisky Medication Adherence Scale and the Beliefs about Medicines Questionnaire-Specific to characterize baseline status only. The primary outcome was perfect adherence at 1 month, assessed through structured telephone interviews, outpatient visits, and the mVTEA physician-patient communication module. During follow-up, researchers verified current medication regimens, recorded missed doses, assessed therapy continuation, and whenever possible, confirmed adherence through pharmacy refill records or remaining medication packaging. Secondary outcomes included the mVTEA check-in rate and clinical safety events (VTE recurrence, major bleeding per International Society on Thrombosis and Haemostasis criteria, VTE-related hospitalizations, VTE-related rehospitalizations, all-cause mortality).

RESULTS

In total, 45 participants completed the study (mean age 60.80, SD 15.20 years; n=16, 36% female). Baseline 8-item Morisky Medication Adherence Scale scores indicated suboptimal adherence (mean 6.24, SD 1.80), with 29% (13/45) classified as good adherence and 71% (32/45) as moderate or poor adherence. The primary contributors to nonadherence were forgetting to take medication. Baseline Beliefs about Medicines Questionnaire-Specific scores showed stronger beliefs in medication necessity than concerns (17.58, SD 2.52 vs 14.56, SD 3.34; P<.001; necessity-concerns differentials: 3.02, SD 4.60). At 1-month follow-up, all 45 participants achieved perfect adherence, and 80% (n=36) used the mVTEA check-in feature. Participants who engaged in check-ins demonstrated markedly more favorable necessity-concerns differentials profiles (29/36, 81% vs 0/9, 0%; P<.001). No VTE events, major bleeding, or other adverse outcomes were reported.

CONCLUSIONS

This pilot study supports the feasibility and acceptability of the mVTEA and provides preliminary signals that it may support short-term anticoagulation adherence. Larger randomized trials with longer follow-up and objective adherence measures are warranted, along with efforts to address the digital divide to ensure equitable access to mHealth-based anticoagulation support.