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

Sponsor
Centre Hospitalier Eure-Seine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05684770
Collaborator
(none)
50
1
30

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 4G tablet
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Evaluation of Feasibility and Impact of Remote Care in Patients With Thromboembolic Disease of Low Risk
Anticipated Study Start Date :
Jan 13, 2023
Anticipated Primary Completion Date :
Jul 13, 2024
Anticipated Study Completion Date :
Jul 13, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: 4G Tablet

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. Evaluation of complication rate related to thromboembolic disease [6 months and 1 year]

  3. Evaluation of hospitalisation rate related to thromboembolic disease [1 year]

  4. Evaluation of treatment compliance [6 months and 1 year]

    This will be evaluated by the communication between the physician and the patient during consultation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Centre Hospitalier Eure-Seine

Investigators

  • Principal Investigator: Vincent Eble, MD, CH Eure-Seine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Eure-Seine
ClinicalTrials.gov Identifier:
NCT05684770
Other Study ID Numbers:
  • 2022-A00894-39
  • CHES N°22/02
First Posted:
Jan 13, 2023
Last Update Posted:
Jan 13, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 13, 2023