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

Thromboembolic Disease Clinical Trial

— TEVEDOM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05684770
• Other study ID #: 2022-A00894-39
• Secondary ID: CHES N°22/02
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 13, 2023
• Est. completion date: July 13, 2025

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Eure-Seine
• Contact: Sorina Mihailescu, MD
• Phone: +33232338833
• Email: sorina-dana.mihailescu[@]ch-eureseine.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 13, 2025
• Est. primary completion date: July 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolic Disease
• Thromboembolism

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Eure-Seine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	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	1 year
Secondary	Evaluation of complication rate related to thromboembolic disease		6 months and 1 year
Secondary	Evaluation of hospitalisation rate related to thromboembolic disease		1 year
Secondary	Evaluation of treatment compliance	This will be evaluated by the communication between the physician and the patient during consultation	6 months and 1 year