Smart Technology Facilitated Patient-centered Care for Patients With Pulmonary Thromboembolism

Venous Thromboembolism Clinical Trial

— SmaPE  

Official title:

Smart Technology Facilitated Patient-centered Care for Patients With Pulmonary Thromboembolism：A Multicenter, Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06382038
• Other study ID #: HZKY-PJ-2024-19
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Clinical Decision Support Systems
• Digital Health
• Pulmonary Embolism
• Pulmonary Thromboembolisms
• Thromboembolism
• Venous Thromboembolism

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