Enrolling by Invitation

NCT Number: NCT06350331

Smart Technology Facilitated Patient-centered Venous Thromboembolism Management

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 evaluate the impact of mobile venous thromboembolism application (mVTEA) based patient-centered management of venous thromboembolism (VTE) on patients' perceptions of thromboprophylaxis, in order to enhance clinical practice and establish a foundation of evidence for managing patients with VTE.

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Key information

Conditions

Venous Thromboembolism Adherence Interventions Behavior Cardiovascular Diseases Digital Health Embolism and Thrombosis Health Behavior Health Education Medication Adherence Patient Acceptance of Health Care Patient Compliance Thromboembolism Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sixth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100048, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inpatients ≥18 years of age at admission;
Previous or current definitive diagnosis of DVT and/or PE by imaging, or at high risk of VTE at discharge: Padua score ≥4 for medical patients and Caprini score ≥5 for surgical patients.
Signed informed consent

Exclusion criteria

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;
Have participated in similar trials or are undergoing other clinical trials.

Treatment and study plan

mobile venous thromboembolism application (mVTEA)

Other

mVTEA will assist in the management of patients 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, photo, and voice interactions.

Primary outcomes

VTE-KAP questionnaire score

Time frame: The third month after discharge from the hospital

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 will be evaluated at the third-month follow-up after discharge.

Secondary outcomes

Knowledge, attitude, and practice scores in the VTE-KAP questionnaire

Time frame: The third month after discharge from the hospital

The knowledge domain contains 7 questions to assess patients' levels of knowledge regarding VTE prevention and treatment. The total score of knowledge for each study participant ranged from 7 to 53. The attitude domain contains 20 questions to assess patients' attitudes towards VTE prevention and treatment. Each question was scored and the ﬁnal attitude score ranged between 20 and 100. The practice domain contained 26 questions with a score range of 21 to 130 for assessing the implementation of VTE prevention and treatment behaviors in the study patients. The higher the score, the higher the level of knowledge, attitude and practice. The patients' knowledge, attitude, and practice scores in the VTE-KAP questionnaire will be assessed at the third-month follow-up after discharge separately.
Generic quality of life

Time frame: The third month after discharge from the hospital

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 the third-month follow-up after discharge. 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.
VTE events

Time frame: 3 months after discharge

VTE events will be documented during the 3-month follow-up after discharge. VTE events are categorized into three groups: new-onset VTE, hospital-acquired VTE (HA-VTE), and recurrent 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.

Recurrent VTE is defined as the appearance of new evidence of VTE after acute VTE has been treated in the acute phase (2 weeks) with significant clinical improvement in signs and symptoms. According to the time of VTE recurrence, it is further categorized into early VTE recurrence (within 3 months after the last VTE occurrence) and late VTE recurrence (more than 3 months after the last VTE occurrence).
Chronic thromboembolic pulmonary hypertension (CTEPH)

Time frame: The third month after discharge

The diagnosis of CTEPH will be documented at the third-month follow-up after discharge.
Chronic thromboembolic pulmonary disease (CTEPD)

Time frame: The third month after discharge

The diagnosis of CTEPD will be documented at the third-month follow-up after discharge.
Post-pulmonary embolism syndrome (PPES)

Time frame: The third month after discharge

The diagnosis of PPES will be documented at the third-month follow-up after discharge.
Major bleeding

Time frame: 3 months after discharge

The major bleeding events as defined by the International Society on Thrombosis and Hemostasis (ISTH) will be documented during the 3-month follow-up after discharge.
VTE-related hospitalization

Time frame: 3 months after discharge

Hospitalization due to the new-onset DVT and/or PE will be documented during the 3-month follow-up after discharge.
VTE-related rehospitalization

Time frame: 3 months after discharge

Rehospitalization due to VTE recurrence, progression, or complications related to VTE treatment will be documented during the 3-month follow-up after discharge.
New-onset of atrial fibrillation or atrial flutter

Time frame: 3 months after discharge

The new-onset of atrial fibrillation or atrial flutter will be documented during the 3-month follow-up after discharge.
Death

Time frame: 3 months after discharge

Death will be documented during the 3-month follow-up after discharge. It is categorized into all-cause death and PE-related death. All-cause death is defined as death that occurs during the study period, regardless of cause.PE-related death is defined as death that is unequivocally due to PE.

Sponsors and collaborators

Lead sponsor

Navy General Hospital, Beijing

Other

Registry information

Official study title

Smart Technology Facilitated Patient-centered Venous Thromboembolism Management: A Randomised Controlled Trial

Acronym: SmaVTE-RCT

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Apr 5, 2024
Registry last updated: May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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