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Recruiting NCT05684770

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

No phase Interventional Thromboembolic Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 4G tablet.
Who it may be relevant to
Registry conditions: Thromboembolic Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • 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 [Time frame: 1 year]
  • Evaluation of complication rate related to thromboembolic disease [Time frame: 6 months and 1 year]
  • Evaluation of hospitalisation rate related to thromboembolic disease [Time frame: 1 year]
  • Evaluation of treatment compliance [Time frame: 6 months and 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Centre Hospitalier Eure-Seine — Évreux

Identifiers

NCT: NCT05684770 · 2022-A00894-39 · CHES N°22/02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗