ClinicalTrials.gg
RecruitingNCT05684770TEVEDOMUpdated Sep 15, 2025

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

An interventional study of 4G tablet in Thromboembolic Disease, sponsored by Centre Hospitalier Eure-Seine. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Centre Hospitalier Eure-Seine · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.
02

Conditions studied

  • Thromboembolic Disease

Browse trials for

03

In context

Thromboembolism

288 studies on the registry are indexed under Thromboembolism; 42 are open to participants now.

This study's planned enrollment of 50 is below the median of 173 across 155 interventional studies indexed under Thromboembolism.

Browse Thromboembolism studies →

Lead sponsor

Centre Hospitalier Eure-Seine is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    4G Tablet

    Other: 4G tablet

Interventions

  • Other4G 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

Secondary outcomes

  1. 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

    Time frame: 1 year

  2. Evaluation of complication rate related to thromboembolic disease

    Time frame: 6 months and 1 year

  3. Evaluation of hospitalisation rate related to thromboembolic disease

    Time frame: 1 year

  4. Evaluation of treatment compliance

    This will be evaluated by the communication between the physician and the patient during consultation

    Time frame: 6 months and 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05684770
Lead sponsor
Centre Hospitalier Eure-Seine
Responsible party
Sponsor
First posted
Jan 13, 2023
Start date
Sep 2025 (estimated)
Primary completion
Mar 2027 (estimated)
Completion
Mar 2028 (estimated)
Last update
Sep 15, 2025

Study contacts

Lydia BEN BEKKOU, ARC
Contact
arc2.circe@ch-eureseine.fr
+332 32 33 86 75
Vincent Eble, MD
principal investigator · CH Eure-Seine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion