Smart Technology Facilitated Patient-centered Care for Patients With Pulmonary Thromboembolism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNavy General Hospital, Beijing
About this 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.
This study aims to evaluate the effects of a smart technology-assisted, patient-centered mobile health application for pulmonary thromboembolism management (mPEA) on the long-term outcomes of patients with pulmonary thromboembolism (PTE). The findings are expected to inform clinical practice and provide an evidence base for the long-term management of patients with PTE.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Inpatients aged ≥18 years;
PTE confirmed through imaging examinations, meeting at least one of the following criteria: a.Newly diagnosed PTE during the current hospitalization; b. Prior PTE with imaging evidence of residual thrombus.
Signed informed consent.
Disqualifiers
Previous PTE combined with CTEPH;
Mental retardation or a combination of other serious illnesses that make them incapable of living on their own;
Inability to use smartphones, computer tablets and other smart devices;
Being pregnant or breastfeeding;
Trial design
Design model
Parallel
Treatments tested in this trial
mobile venous thromboembolism application (mVTEA)
Other interventionmVTEA 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.
Treatment groups
2,972 Participants
are divided into 2 treatment groupsGroup A: mPEA Management GroupExperimental treatment 1 intervention
Group B: Routine Management GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
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 recurrent VTE, newly diagnosed deep vein thrombosis (DVT), chronic thromboembolic pulmonary hypertension (CTEPH), major bleeding, VTE-related rehospitalization, and all-cause death.
Time frame
At 1-year follow-upSecondary outcomes
1
VTE events
VTE events will be documented at the 3, 6, 12, and 24-month follow-up after discharge. VTE events are categorized into two groups: recurrent VTE and newly diagnosed DVT. 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). DVT that occurred for the first time after discharge during the study period is classified as newly diagnosed DVT.
Time frame
At 3, 6, 12, and 24-month follow-up2
Chronic thromboembolic pulmonary hypertension (CTEPH)
The diagnosis of CTEPH will be documented at the 3, 6, 12, and 24-month follow-up.
Time frame
At 3, 6, 12, and 24-month follow-up3
Chronic thromboembolic pulmonary disease (CTEPD)
The diagnosis of CTEPD will be documented at the 3, 6, 12, and 24-month follow-up after discharge.
Time frame
At 3, 6, 12, and 24-month follow-up4
Post-pulmonary embolism syndrome (PPES)
The diagnosis of PPES will be documented at the 3, 6, 12, and 24-month follow-up after discharge
Time frame
At 3, 6, 12, and 24-month follow-upSponsors and contacts
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Source ClinicalTrials.gov