Smart Technology Facilitated Patient-centered Venous Thromboembolism Management
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNavy General Hospital, Beijing
About this trial
Smart technologies, such as wearable devices, mobile technologies, and artificial intelligence, are being investigated for use in health management. These technologies have the potential to be applied in disease pre-warning, decision-making support, health education, and healthcare maintenance. They are expected to address the challenges in managing thrombosis, improve access to high-quality medical resources in various regions, and enhance the development of a network for thrombosis rescue and treatment prevention.
The objective of this study is to observe the long-term effect of mobile venous thromboembolism application (mVTEA) based patient-centered management of venous thromboembolism (VTE) on thromboprophylaxis, and establish a foundation of evidence for managing patients with high-risk VTE.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Inpatients ≥18 years of age at admission;
At high-risk of VTE at discharge: Padua score ≥4 for medical patients and Caprini score ≥5 for surgical patients;
Signed informed consent.
Disqualifiers
Diagnosis of VTE at discharge;
Mental disorder or combination of other serious diseases leading to incapacity for independent living;
Inability to use smartphones, computer tablets and other smart devices;
Being pregnant or breastfeeding;
Trial design
Design model
Single group
Treatments tested in this trial
mobile venous thromboembolism application (mVTEA)
DevicemVTEA will assist in the management of patients with high-risk of VTE during the post-hospitalization follow-up phase. The mVTEA's doctor terminal automatically sends VTE-related health education materials in different frequencies and contents based on the patient's knowledge of VTE prevention and treatment, as well as their risk of thrombosis and bleeding during follow-up. In addition, thrombosis physicians on the mVTEA's doctor terminal can deliver health education to patients based on their condition. This can be done through the mVTEA doctor-patient communication module, which includes text, voice, and video communication.
Treatment groups
2,353 Participants
are divided into 1 treatment groupGroup A: mVTEA Management GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
VTE-related composite event
The primary outcome was the occurrence of VTE-related composite event at 1-year follow-up, which was defined as a composite of VTE, major bleeding, VTE-related hospitalization, and all-cause death.
Time frame
At 1-year follow-upSecondary outcomes
1
VTE-KAP questionnaire score
The VTE-KAP questionnaire is a self-administered questionnaire that includes demographic characteristics, knowledge, attitude, and practice (KAP) of patients towards VTE prevention and treatment. The VTE-KAP questionnaire consists of a total of 53 questions with an overall score range of 41 to 283. The higher the score, the higher the level of knowledge, attitude, and practice. The VTE-KAP questionnaire scores of the patients regarding the prevention and treatment of VTE will be evaluated at 3, 12, and 24-month follow-up.
Time frame
At 3, 12, and 24-month follow-up2
Generic quality of life
Generic, non-disease-specific health-related quality of life (QoL) is assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire and its corresponding visual analogue scale at 3, 12, and 24-month follow-up. Briefly, the EQ-5D-5L generates an overall index that ranges from 0 (lowest generic QoL) to 1 (highest generic QoL) and is calculated based on country-specific reference value sets. The EQ-5D-5L health index was calculated with the value set for China. The EuroQol visual analogue scale ranges from 0 to 100, with higher scores indicating better health.
Time frame
At 3, 12, and 24-month follow-up3
VTE events
VTE events will be documented during the follow-up. VTE events are categorized into two groups: new-onset VTE, and hospital-acquired VTE (HA-VTE). VTE that occurred for the first time during the study period, including deep vein thrombosis (DVT) and pulmonary embolism (PE), is classified as new-onset VTE. HA-VTE is defined as any new-onset VTE that has occurred within 90 days of hospital discharge.
Time frame
At 3, 6, 12, and 24-month follow-up4
Major bleeding
The major bleeding events as defined by the International Society on Thrombosis and Hemostasis (ISTH) will be documented during the follow-up.
Time frame
At 3, 6, 12, and 24-month follow-upSponsors and contacts
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Source ClinicalTrials.gov
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