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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Eure-Seine

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 4G tablet

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: 4G TabletExperimental treatment 1 intervention

Trial outcomes

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

Time frame
6 months

Secondary outcomes

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

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
2

Evaluation of complication rate related to thromboembolic disease

Time frame
6 months and 1 year
3

Evaluation of hospitalisation rate related to thromboembolic disease

Time frame
1 year
4

Evaluation of treatment compliance

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

Time frame
6 months and 1 year

Other outcomes

Sponsors and contacts

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