Venous ThromboembolismSmaVTE-RCTNCT06350331
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.
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
- Conditions the study is for
- Venous Thromboembolism, Digital Health, Health Education
- What is being tested?
- mobile venous thromboembolism application (mVTEA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteChina
- Study dates
- 17 Aug 2024to 30 Nov 2025
- 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;
- 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
Who cannot join
- 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.
China1 site
Sixth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100048
About this study
Official title: Smart Technology Facilitated Patient-centered Venous Thromboembolism Management: A Randomised Controlled 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 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.
- Conditions
- Venous Thromboembolism, Digital Health, Health Education
- 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)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.
| Study group | Role | What they receive |
|---|---|---|
| mVTEA Management Group | Experimental | Patients randomly assigned to the mVTEA management group will be discharged with mVTEA-assisted patient-centered VTE management. Receives: Other: mobile venous thromboembolism application (mVTEA) |
| Routine Management Group | No intervention | Patients randomly assigned to the routine management group will be given routine post-discharge management in accordance with local clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 will be evaluated at the third-month follow-up after discharge.
Measured: The third month after discharge from the hospital
Secondary outcomes (11)
Knowledge, attitude, and practice scores in the VTE-KAP questionnaire
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.
Measured: The third month after discharge from the hospital
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 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.
Measured: The third month after discharge from the hospital
VTE events
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).
Measured: 3 months after discharge
Chronic thromboembolic pulmonary hypertension (CTEPH)
The diagnosis of CTEPH will be documented at the third-month follow-up after discharge.
Measured: The third month after discharge
Chronic thromboembolic pulmonary disease (CTEPD)
The diagnosis of CTEPD will be documented at the third-month follow-up after discharge.
Measured: The third month after discharge
Post-pulmonary embolism syndrome (PPES)
The diagnosis of PPES will be documented at the third-month follow-up after discharge.
Measured: The third month after discharge
Major bleeding
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.
Measured: 3 months after discharge
VTE-related hospitalization
Hospitalization due to the new-onset DVT and/or PE will be documented during the 3-month follow-up after discharge.
Measured: 3 months after discharge
VTE-related rehospitalization
Rehospitalization due to VTE recurrence, progression, or complications related to VTE treatment will be documented during the 3-month follow-up after discharge.
Measured: 3 months after discharge
New-onset of atrial fibrillation or atrial flutter
The new-onset of atrial fibrillation or atrial flutter will be documented during the 3-month follow-up after discharge.
Measured: 3 months after discharge
Death
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.
Measured: 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start17 Aug 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navy General Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YU-TAO GUO, Doctor, Study chair, Sixth Medical Center of Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350331
- Sponsor's protocol ID
- HZKY-PJ-2024-8-1
- Acronym
- SmaVTE-RCT
- Status last verified
- May 2025
- First submitted
- 30 Mar 2024
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valerio L, Mavromanoli AC, Barco S, Abele C, Becker D, Bruch L, Ewert R, Faehling M, Fistera D, Gerhardt F, Ghofrani HA, Grgic A, Grunig E, Halank M, Held M, Hobohm L, Hoeper MM, Klok FA, Lankeit M, Leuchte HH, Martin N, Mayer E, Meyer FJ, Neurohr C, Opitz C, Schmidt KH, Seyfarth HJ, Wachter R, Wilkens H, Wild PS, Konstantinides SV, Rosenkranz S; FOCUS Investigators. Chronic thromboembolic pulmonary hypertension and impairment after pulmonary embolism: the FOCUS study. Eur Heart J. 2022 Sep 21;43(36):3387-3398. doi: 10.1093/eurheartj/ehac206.
PubMed 35484821Klok FA, Ageno W, Ay C, Back M, Barco S, Bertoletti L, Becattini C, Carlsen J, Delcroix M, van Es N, Huisman MV, Jara-Palomares L, Konstantinides S, Lang I, Meyer G, Ni Ainle F, Rosenkranz S, Pruszczyk P. Optimal follow-up after acute pulmonary embolism: a position paper of the European Society of Cardiology Working Group on Pulmonary Circulation and Right Ventricular Function, in collaboration with the European Society of Cardiology Working Group on Atherosclerosis and Vascular Biology, endorsed by the European Respiratory Society. Eur Heart J. 2022 Jan 25;43(3):183-189. doi: 10.1093/eurheartj/ehab816.
PubMed 34875048Schulman S, Angeras U, Bergqvist D, Eriksson B, Lassen MR, Fisher W; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients. J Thromb Haemost. 2010 Jan;8(1):202-4. doi: 10.1111/j.1538-7836.2009.03678.x. Epub 2009 Oct 30.
PubMed 19878532Jin ZG, Zhang ZQ, Liu BB, Wang H, Yang Y, Ren LN, Zhang H, Ji W, Zhai ZG, Guo YT. Smart Technology Facilitated Patient-Centered Venous Thromboembolism Management (the SmaVTE Study): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jun 5;14:e67254. doi: 10.2196/67254.
PubMed 40473232
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Technology Facilitated Patient-centered Venous Thromboembolism Management: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06350331
- Acronym / sponsor ID
- SmaVTE-RCT / HZKY-PJ-2024-8-1
- Conditions
- Venous Thromboembolism, Digital Health, Health Education
- Keywords
- Venous Thromboembolism, Mobile Health, Prophylaxis, Health Education
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Navy General Hospital, BeijingUniversity, hospital or other
- Study start
- 17 Aug 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mVTEA Management Group | Experimental | Other: mobile venous thromboembolism application (mVTEA)Patients randomly assigned to the mVTEA management group will be discharged with mVTEA-assisted patient-centered VTE management. |
| Routine Management Group | No intervention | –Patients randomly assigned to the routine management group will be given routine post-discharge management in accordance with local clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobile venous thromboembolism application (mVTEA)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. | Other | mVTEA Management Group |
Primary outcome
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.
11 secondary outcomes
Knowledge, attitude, and practice scores in the VTE-KAP questionnaire
Time frame: The third month after discharge from the hospital
Generic quality of life
Time frame: The third month after discharge from the hospital
VTE events
Time frame: 3 months after discharge
Chronic thromboembolic pulmonary hypertension (CTEPH)
Time frame: The third month after discharge
Chronic thromboembolic pulmonary disease (CTEPD)
Time frame: The third month after discharge
Post-pulmonary embolism syndrome (PPES)
Time frame: The third month after discharge
Major bleeding
Time frame: 3 months after discharge
VTE-related hospitalization
Time frame: 3 months after discharge
VTE-related rehospitalization
Time frame: 3 months after discharge
New-onset of atrial fibrillation or atrial flutter
Time frame: 3 months after discharge
Death
Time frame: 3 months after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Background: PubMed 35484821Valerio L, Mavromanoli AC, Barco S, Abele C, Becker D, Bruch L, Ewert R, Faehling M, Fistera D, Gerhardt F, Ghofrani HA, Grgic A, Grunig E, Halank M, Held M, Hobohm L, Hoeper MM, Klok FA, Lankeit M, Leuchte HH, Martin N, Mayer E, Meyer FJ, Neurohr C, Opitz C, Schmidt KH, Seyfarth HJ, Wachter R, Wilkens H, Wild PS, Konstantinides SV, Rosenkranz S; FOCUS Investigators. Chronic thromboembolic pulmonary hypertension and impairment after pulmonary embolism: the FOCUS study. Eur Heart J. 2022 Sep 21;43(36):3387-3398. doi: 10.1093/eurheartj/ehac206.
- Background: PubMed 34875048Klok FA, Ageno W, Ay C, Back M, Barco S, Bertoletti L, Becattini C, Carlsen J, Delcroix M, van Es N, Huisman MV, Jara-Palomares L, Konstantinides S, Lang I, Meyer G, Ni Ainle F, Rosenkranz S, Pruszczyk P. Optimal follow-up after acute pulmonary embolism: a position paper of the European Society of Cardiology Working Group on Pulmonary Circulation and Right Ventricular Function, in collaboration with the European Society of Cardiology Working Group on Atherosclerosis and Vascular Biology, endorsed by the European Respiratory Society. Eur Heart J. 2022 Jan 25;43(3):183-189. doi: 10.1093/eurheartj/ehab816.
- Background: PubMed 19878532Schulman S, Angeras U, Bergqvist D, Eriksson B, Lassen MR, Fisher W; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients. J Thromb Haemost. 2010 Jan;8(1):202-4. doi: 10.1111/j.1538-7836.2009.03678.x. Epub 2009 Oct 30.
- Derived from this study: PubMed 40473232Jin ZG, Zhang ZQ, Liu BB, Wang H, Yang Y, Ren LN, Zhang H, Ji W, Zhai ZG, Guo YT. Smart Technology Facilitated Patient-Centered Venous Thromboembolism Management (the SmaVTE Study): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jun 5;14:e67254. doi: 10.2196/67254.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
YU-TAO GUO, Doctor study chair
Sixth Medical Center of Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
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 4 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: enrolling by invitation, as of the sponsor's last update on 31 May 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VTE-KAP questionnaire score (time frame: The third month after discharge from the hospital). 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 NCT06350331, which also lists 4 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 31 May 2025.