Smart Technology Facilitated Patient-Centered Venous Thromboembolism Management (the SmaVTE Study): Protocol for a Randomized Controlled Trial

Background
Venous thromboembolism (VTE) is a significant public health issue, with a rising global incidence despite extensive research efforts. Patient-centered care, which tailors treatment to individual needs, has shown potential in enhancing outcomes. The integration of smart technologies with psychological frameworks such as the health belief model and the knowledge-attitude-practice (KAP) model may further improve patient engagement and adherence. To address this, we have developed a smart technique–assisted patient-centered care mobile health app for managing VTE (mVTEA), which integrates psychological frameworks to improve patient outcomes in VTE management.


Objective
This study aims to investigate the impact of the mVTEA app on the knowledge, attitudes, and practices of VTE in patients with or at high risk of VTE.


Methods
The SmaVTE (smart technology facilitated patient-centered venous thromboembolism management) study is a 2-armed, single-center, parallel-group, randomized controlled trial. A total of 256 hospitalized patients with or at high risk of VTE will be recruited on the day of their discharge from August 2024 to June 2025. Participants will be randomly allocated to either the mVTEA management group or the routine management group in a 1:1 ratio. The mVTEA management group (n=128) will receive patient-centered VTE management facilitated by the mVTEA app after discharge. The routine management group (n=128) will be administered conventional postdischarge management according to local clinical practice. The KAP of patients will be assessed by a structured KAP questionnaire on VTE. The primary outcome is the difference in patients’ KAP on VTE at 3-month follow-up between the 2 groups. Secondary outcomes include scores on each domain of the questionnaire, quality of life, VTE events, chronic thromboembolic pulmonary hypertension, chronic thromboembolic pulmonary disease, postpulmonary embolism syndrome, major bleeding events, VTE-related hospitalizations or rehospitalizations, deaths, and new-onset atrial fibrillation or atrial flutter at 3-month follow-up.


Results
Participants are currently being recruited. The first participant was enrolled in August 2024, which marked the official start of the study. The recruitment process is expected to be completed in June 2025. As of the submission of the paper, 185 patients had been enrolled in this clinical trial. At present, all included patients are being followed up according to the outlined schedule.


Conclusions
The SmaVTE study offers a pioneering approach to VTE prevention and treatment by combining smart technology with patient-centered care and established theoretical frameworks. The findings could significantly impact clinical practice and inspire further research into the integration of smart technologies with behavioral science theories.


Trial Registration
ClinicalTrials.gov NCT06350331; https://clinicaltrials.gov/study/NCT06350331


International Registered Report Identifier (IRRID)
DERR1-10.2196/67254