Impact of Remote Care in Patients Diagnosed With Thromboembolic Disease of Low Risk

NCT05684770 · tracked via the Priya Life Science France tracker

Sponsor

Centre Hospitalier Eure-Seine

Phase

Not applicable

Started

2025-09

Last updated

2025-09-15

Condition(s) studied

Thromboembolic Disease

Investigational drug(s) / intervention(s)

4G tablet

4G tablet: Participants will receive for the whole period 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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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 — 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

Trial sites (1)

Facility	City	Region	Status
Centre Hospitalier Eure-Seine	Évreux	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05684770 on ClinicalTrials.gov ↗ ← All trials in France