Thromboembolic Disease
Conditions
Brief 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.
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.
Sponsors
Centre Hospitalier Eure-Seine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 year | 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 |
| 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 | 6 months and 1 year | This will be evaluated by the communication between the physician and the patient during consultation |
Countries
France
Contacts
Primary ContactLydia BEN BEKKOU, ARC
Outcome results
None listed