Evaluation of Feasibility and Impact of Remote Care in Patients With Thromboembolic Disease of Low Risk

Centre Hospitalier Eure-Seine1 site in 1 country50 target enrollmentSeptember 1, 2025

ConditionsThromboembolic Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Thromboembolic Disease
Sponsor: Centre Hospitalier Eure-Seine
Enrollment: 50
Locations: 1
Primary Endpoint: Number of participants in which the evaluation of medical and patient satisfaction regarding feasibility of organisation assessed by three scales (patient scale, hospital physician scale and primary care physician scale) is satisfactory
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to learn about the feasibility and impact of remote care in patients diagnosed with thromboembolic disease of low risk. The main questions it aims to answer are:

the evaluation of feasibility of organisation between different healthcare professionals (hospital physicians, primary care physician) at 6 months and 1 year
the evaluation of complication rate, hospitalisation related to thromboembolic disease rate, compliance to treatment rate at 6 months and 1 year Participants will receive indication of treatment according to national recommendations. Additionnally, they will receive for the length of study a 4G tablet in order to fill questionnaires, learn information about their drugs (patient education), have a remote consultation and evaluate treatment compliance.

Registry

clinicaltrials.gov

Start Date

September 1, 2025

End Date

March 1, 2028

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Centre Hospitalier Eure-Seine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•patients identified in the emergency department with a thromboembolic disease, with a deep vein thrombosis or pulmonary embolism with a low risk of mortality according to recommendations
•affiliated or beneficiary of social protection

Exclusion Criteria

•patient having a severe obstruction syndrome, a thromboembolic disease already under treatment or a suspicion of thrombocytopenia induced by heparin
•patient with an active hemorrhage or a major risk of hemorrhage, a renal severe failure, comorbidities such as cancer, or the impossibility to organise a consultation or a patient in a non favorable medico-social context
•patient with a caval thrombosis
•patient suffering of a disease at hemorrhagic risk or neurosurgery intervention done in the last month or other surgery in the last 15 days prior to inclusion
•patient with contraindication of direct oral anticoagulants, such as bitherapy with antiplatelet agent, imidazoles, macrolides, antiretroviral treatments or an anti-phospholipid syndrome
•patient that lives in an area not covered by internet
•patient that has no primary care physician
•patient not able to understand the study (language, psychological problem) or not able to read or write
•patient under legal protection

Outcomes

Primary Outcomes

Number of participants in which the evaluation of medical and patient satisfaction regarding feasibility of organisation assessed by three scales (patient scale, hospital physician scale and primary care physician scale) is satisfactory

Time Frame: 6 months

Three scales were created for this study : * patient scale : difficulty perceived to use the tablet, added value in the use of tablet, improvement of communication with physicians * hospital physician scale : global satisfaction (scale from 0 to 10), perception on the follow-up of patient through tablet, improvement of communication with patients and with primary care physician * primary care physician scale : global satisfaction (scale from 0 to 10), perception on the follow-up of patient through tablet, improvement of communication with patients and with hospital physician

Secondary Outcomes

Evaluation of treatment compliance(6 months and 1 year)
Number of patients in which the evaluation of medical and patient satisfaction regarding feasibility of organisation assessed by three scales (patient scale, hospital physician scale and primary care physician scale) is satisfactory(1 year)
Evaluation of complication rate related to thromboembolic disease(6 months and 1 year)
Evaluation of hospitalisation rate related to thromboembolic disease(1 year)