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NCT Number: NCT06350344

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 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.

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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;
  • 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

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

Treatment and study plan

mobile venous thromboembolism application (mVTEA)

Device

mVTEA 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.

Primary outcomes

  1. VTE-related composite event

    Time frame: At 1-year follow-up

    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.

Secondary outcomes

  1. VTE-KAP questionnaire score

    Time frame: At 3, 12, and 24-month follow-up

    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.

  2. Generic quality of life

    Time frame: At 3, 12, and 24-month follow-up

    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.

  3. VTE events

    Time frame: At 3, 6, 12, and 24-month follow-up

    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.

  4. Major bleeding

    Time frame: At 3, 6, 12, and 24-month follow-up

    The major bleeding events as defined by the International Society on Thrombosis and Hemostasis (ISTH) will be documented during the follow-up.

  5. VTE-related hospitalization

    Time frame: At 3, 6, 12, and 24-month follow-up

    Hospitalization due to the new-onset DVT and/or PE will be documented during the follow-up.

  6. New-onset of atrial fibrillation or atrial flutter

    Time frame: At 3, 6, 12, and 24-month follow-up

    The new-onset of atrial fibrillation or atrial flutter will be documented during the follow-up.

  7. Death

    Time frame: At 3, 6, 12, and 24-month follow-up

    Death will be documented during the follow-up. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

ZHI-GENG JIN, Doctor

CONTACT

[email protected]

8615801402223

Sponsors and collaborators

Lead sponsor

Navy General Hospital, Beijing

Other

Registry information

Official study title

Smart Technology Facilitated Patient-centered Venous Thromboembolism Management: A Multicenter Cohort Study

Acronym: SmaVTE-COR

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 5, 2024
Registry last updated
Jul 17, 2024

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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