Smart Technology Facilitated Patient-Centered Venous Thromboembolism Management (the SmaVTE Study): Protocol for a Randomized Controlled Trial (Preprint)
Authors: Jin Zhi-Geng , Zhang Zhe-Qi , Liu Bin-Bin , Wang Hao , Yang Ying , Ren Li-Na , Zhang Hui , Ji Wei , Zhai Zhen-Guo , Guo Yutao 
Published: October 2024

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 like the Health Belief Model and Knowledge-Attitude-Practice model, may further improve patient engagement and adherence. To address this, we have developed a smart technique-assisted patient-centered care mHealth 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 (KAP) of VTE in patients with or at high risk of VTE.

METHODS

The SmaVTE (Smart Technology Facilitated Patient-Centered VTE 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 to October 2024. 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 with conventional post-discharge 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 two groups. Secondary outcomes include scores on each domain of the questionnaire, quality of life, VTE events, chronic thromboembolic pulmonary hypertension, chronic thromboembolic pulmonary disease, post-pulmonary embolism syndrome, major bleeding events, VTE-related hospitalizations or rehospitalizations, deaths, and new-onset of 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 completed in November 2024. As of the submission of the paper, there were 42 patients have been enrolled in this clinical trial. At present, all included patients were 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.

CLINICALTRIAL

ClinicalTrials.gov NCT06350331