search
Back to results

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

Primary Purpose

Thromboembolic Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
4G tablet
Sponsored by
Centre Hospitalier Eure-Seine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Thromboembolic Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    4G Tablet

    Arm Description

    Outcomes

    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
    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

    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
    Evaluation of complication rate related to thromboembolic disease
    Evaluation of hospitalisation rate related to thromboembolic disease
    Evaluation of treatment compliance
    This will be evaluated by the communication between the physician and the patient during consultation

    Full Information

    First Posted
    November 7, 2022
    Last Updated
    January 12, 2023
    Sponsor
    Centre Hospitalier Eure-Seine
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05684770
    Brief Title
    Impact of Remote Care in Patients Diagnosed With Thromboembolic Disease of Low Risk
    Acronym
    TEVEDOM
    Official Title
    Evaluation of Feasibility and Impact of Remote Care in Patients With Thromboembolic Disease of Low Risk
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 13, 2023 (Anticipated)
    Primary Completion Date
    July 13, 2024 (Anticipated)
    Study Completion Date
    July 13, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Eure-Seine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thromboembolic Disease

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    4G Tablet
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    4G tablet
    Intervention Description
    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 Measure Information:
    Title
    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
    Description
    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
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    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
    Description
    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
    Time Frame
    1 year
    Title
    Evaluation of complication rate related to thromboembolic disease
    Time Frame
    6 months and 1 year
    Title
    Evaluation of hospitalisation rate related to thromboembolic disease
    Time Frame
    1 year
    Title
    Evaluation of treatment compliance
    Description
    This will be evaluated by the communication between the physician and the patient during consultation
    Time Frame
    6 months and 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sorina Mihailescu, MD
    Phone
    +33232338833
    Email
    sorina-dana.mihailescu@ch-eureseine.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vincent Eble, MD
    Organizational Affiliation
    CH Eure-Seine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs