Impact of Remote Care in Patients Diagnosed With Thromboembolic Disease of Low Risk
- Conditions
- Thromboembolic Disease
- Interventions
- Other: 4G tablet
- Registration Number
- NCT05684770
- Lead Sponsor
- Centre Hospitalier Eure-Seine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 4G Tablet 4G tablet -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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