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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Thromboembolic Disease
• Intervention / Treatment: Other: 4G tablet

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lydia BEN BEKKOU, ARC; Phone Number: +332 32 33 86 75; Email: arc2.circe@ch-eureseine.fr

Study Locations

• France
  • Évreux, France, 27000
    • Recruiting
    • Centre Hospitalier Eure-Seine
    • Contact: BEN BEKKOU Lydia; Phone Number: 02 32 33 86 75; Email: arc2.circe@ch-eureseine.fr
    • Contact: AIDENE Dihia; Phone Number: 02 32 33 86 75; Email: arc.circe@ch-eureseine.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4G Tablet	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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
Evaluation of treatment compliance	This will be evaluated by the communication between the physician and the patient during consultation	6 months and 1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Eure-Seine
• Investigators: Principal Investigator: Vincent Eble, MD, CH Eure-Seine

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Actual): January 13, 2023

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thromboembolism; Pharmaceutical Preparations; Dosage Forms; Tablets
• Other Study ID Numbers: 2022-A00894-39; CHES N°22/02 (Other Identifier: CH Eure-Seine)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No