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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mVTEA Management Group | Experimental | Patients with high-risk of VTE will be discharged with mVTEA-assisted patient-centered VTE management. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 1-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ZHI-GENG JIN, Doctor | Contact | 8615801402223 | lwgjzg@163.com |
| Name | Affiliation | Role |
|---|---|---|
| YU-TAO GUO, Doctor | Sixth Medical Center of Chinese PLA General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sixth Medical Center of Chinese PLA General Hospital | Beijing | Beijing Municipality | 100048 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18208538 | Background | 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. | |
| 22169121 | Background | 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. |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
| At 3, 12, and 24-month follow-up |
| 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. | At 3, 12, and 24-month follow-up |
| 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. | At 3, 6, 12, and 24-month follow-up |
| Major bleeding | The major bleeding events as defined by the International Society on Thrombosis and Hemostasis (ISTH) will be documented during the follow-up. | At 3, 6, 12, and 24-month follow-up |
| VTE-related hospitalization | Hospitalization due to the new-onset DVT and/or PE will be documented during the follow-up. | At 3, 6, 12, and 24-month follow-up |
| New-onset of atrial fibrillation or atrial flutter | The new-onset of atrial fibrillation or atrial flutter will be documented during the follow-up. | At 3, 6, 12, and 24-month follow-up |
| 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. | At 3, 6, 12, and 24-month follow-up |
| 32375490 | Background | 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. |
| D000099060 |
| Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |