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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06382038
Other study ID # HZKY-PJ-2024-19
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date October 31, 2026

Study information

Verified date April 2024
Source Navy General Hospital, Beijing
Contact ZHI-GENG JIN, Doctor
Phone 8615801402223
Email lwgjzg@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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 pulmonary thromboembolism (PTE) on the long-term outcome of PTE patients, in order to enhance clinical practice and establish a foundation of evidence for managing patients with PTE.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 3078
Est. completion date October 31, 2026
Est. primary completion date October 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Inpatients =18 years of age at admission; - A definitive diagnosis of PTE by imaging, including one of the following: (1) a new diagnosis of PTE in the current admission; (2) previous PTE with a definitive presence of residual thrombus by imaging; - Signed informed consent. Exclusion Criteria: - Previous PTE combined with CTEPH; - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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 venous thromboembolism (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.

Locations

Country Name City State
China Sixth Medical Center of Chinese PLA General Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Navy General Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (2)

Schulman 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 recurrent VTE, chronic thromboembolic pulmonary hypertension (CTEPH), major bleeding, VTE-related rehospitalization, and all-cause death. At 1-year follow-up
Secondary Patient satisfaction with anticoagulant treatment Patient satisfaction with anticoagulant treatment is assessed by the Chinese version of Anti-Clot Treatment Scale (ACTS), which is a 16-item patient-reported instrument of satisfaction with anticoagulant treatment. The ACTS score takes values between 14 and 70. The higher the score, the higher the satisfaction with anticoagulant therapy. At 3, 6, and 12-month follow-up
Secondary 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. At 3, 12, and 24-month follow-up
Secondary Recurrent VTE 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). At 1, 3, 6, 9, 12, and 24-month follow-up
Secondary Chronic thromboembolic pulmonary hypertension (CTEPH) The diagnosis of CTEPH will be documented during the follow-up. At 1, 3, 6, 9, 12, and 24-month follow-up
Secondary 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 1, 3, 6, 9, 12, and 24-month follow-up
Secondary VTE-related hospitalization Rehospitalization due to VTE recurrence, progression, or complications related to VTE treatment will be documented during the follow-up. At 1, 3, 6, 9, 12, and 24-month follow-up
Secondary Death Death will be documented during the follow-up. It is categorized into all-cause death and PTE-related death. All-cause death is defined as death that occurs during the study period, regardless of cause. PTE-related death is defined as death that is unequivocally due to PTE. At 1, 3, 6, 9, 12, and 24-month follow-up
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