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

NCT ID: NCT05684770

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2028-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Thromboembolic Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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4G Tablet

Group Type EXPERIMENTAL

4G tablet

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Eure-Seine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent Eble, MD

Role: PRINCIPAL_INVESTIGATOR

CH Eure-Seine

Locations

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Centre Hospitalier Eure-Seine

Évreux, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Lydia BEN BEKKOU, ARC

Role: CONTACT

+332 32 33 86 75

Facility Contacts

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BEN BEKKOU Lydia

Role: primary

02 32 33 86 75

AIDENE Dihia

Role: backup

02 32 33 86 75

Other Identifiers

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CHES N°22/02

Identifier Type: OTHER

Identifier Source: secondary_id

2022-A00894-39

Identifier Type: -

Identifier Source: org_study_id

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