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Venous ThromboembolismSmaVTE-CORNCT06350344

Smart Technology Facilitated Patient-centered Venous Thromboembolism Management

A study testing mobile venous thromboembolism application (mVTEA) in people with Venous Thromboembolism and Digital Health, run by Navy General Hospital, Beijing at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
mobile venous thromboembolism application (mVTEA)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,353 participants
Where
1 siteChina
Study dates
1 Nov 2024to 31 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

ZHI-GENG JIN, Doctor contact

8615801402223

lwgjzg@163.com

China1 site

  • Sixth Medical Center of Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100048

Other trials in China

About this study

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

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.

Being tested
mobile venous thromboembolism application (mVTEA)
Keywords
Venous Thromboembolism, Mobile Health, Prophylaxis, Health Education
Medical subject headings
Venous Thromboembolism, Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT06350344
Study groupRoleWhat they receive
mVTEA Management GroupExperimentalPatients with high-risk of VTE will be discharged with mVTEA-assisted patient-centered VTE management.
Receives: Device: mobile venous thromboembolism application (mVTEA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 1-year follow-up

Secondary outcomes (7)

  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.

    Measured: At 3, 12, and 24-month follow-up

  2. 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.

    Measured: At 3, 12, and 24-month follow-up

  3. 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.

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

  4. Major bleeding

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

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

  5. VTE-related hospitalization

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

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

  6. New-onset of atrial fibrillation or atrial flutter

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

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

  7. Death

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2024
  2. Study start1 Nov 2024 (estimated)
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,353 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06350344
Sponsor's protocol ID
HZKY-PJ-2024-8-2
Acronym
SmaVTE-COR
Status last verified
Mar 2024
First submitted
31 Mar 2024
Last updated
17 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chew HK, Davies AM, Wun T, Harvey D, Zhou H, White RH. The incidence of venous thromboembolism among patients with primary lung cancer. J Thromb Haemost. 2008 Apr;6(4):601-8. doi: 10.1111/j.1538-7836.2008.02908.x. Epub 2008 Jan 17.

    PubMed 18208538

  • Kang MJ, Ryoo BY, Ryu MH, Koo DH, Chang HM, Lee JL, Kim TW, Kang YK. Venous thromboembolism (VTE) in patients with advanced gastric cancer: an Asian experience. Eur J Cancer. 2012 Mar;48(4):492-500. doi: 10.1016/j.ejca.2011.11.016. Epub 2011 Dec 12.

    PubMed 22169121

  • Henke PK, Kahn SR, Pannucci CJ, Secemksy EA, Evans NS, Khorana AA, Creager MA, Pradhan AD; American Heart Association Advocacy Coordinating Committee. Call to Action to Prevent Venous Thromboembolism in Hospitalized Patients: A Policy Statement From the American Heart Association. Circulation. 2020 Jun 16;141(24):e914-e931. doi: 10.1161/CIR.0000000000000769. Epub 2020 May 7.

    PubMed 32375490

Questions about this trial

What is this clinical trial studying?

A study testing mobile venous thromboembolism application (mVTEA) in people with Venous Thromboembolism and Digital Health, run by Navy General Hospital, Beijing at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ZHI-GENG JIN, Doctor (8615801402223, lwgjzg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VTE-related composite event (time frame: At 1-year follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06350344, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.

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