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

NCT05684770 | Recruiting

• 2 other identifiers: 2022-A00894-39CHES N°22/02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Thromboembolic Disease

Outcome Measures

Primary Outcomes (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

  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 Outcomes (4)

• 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

• 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

Study Arms (1)

4G Tablet

EXPERIMENTAL

Other: 4G tablet

Interventions

4G tablet OTHER

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.

4G Tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Centre Hospitalier Eure-Seine: lead

Study Sites (1)

Centre Hospitalier Eure-Seine

Évreux, 27000, France

RECRUITING

MeSH Terms

Conditions

Thromboembolism

Interventions

Tablets

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Vincent Eble, MD

  CH Eure-Seine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lydia BEN BEKKOU, ARC

CONTACT

+332 32 33 86 75; arc2.circe@ch-eureseine.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: January 13, 2023
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)