Abstract
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.