Clinical trial NCT05684770: Impact of Remote Care in Patients Diagnosed With Thromboembolic Disease of Low Risk
Official title: Evaluation of Feasibility and Impact of Remote Care in Patients With Thromboembolic Disease of Low Risk
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Thromboembolic Disease
Lead sponsor: Centre Hospitalier Eure-Seine
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 1 year
measure: Evaluation of complication rate related to thromboembolic disease
timeFrame: 6 months and 1 year
measure: Evaluation of hospitalisation rate related to thromboembolic disease
timeFrame: 1 year
measure: Evaluation of treatment compliance
timeFrame: 6 months and 1 year
Other outcomes:
Locations:
Study officials:
affiliation: CH Eure-Seine
name: Vincent Eble, MD
role: PRINCIPAL_INVESTIGATOR
References: