Suspended

APPLIACStudy of the Interest of Patients Undergoing Anti-thrombotic Treatment in a Digital Application of Therapeutic Assistance

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What is being tested

use of digital tablet

Other
Who is being recruted

Cardiovascular Diseases

+ Vascular Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: November 2019
See protocol details

Summary

Principal SponsorFondation Hôpital Saint-Joseph
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 21, 2019

Actual date on which the first participant was enrolled.

The risk of bleeding varies in different populations and according to the treatment used. Severe bleeding under AVK has an incidence of 0.6 to 10% per year. Fatal hemorrhage is in the order of 1%. The risk factors for bleeding are controversial: history of bleeding in the patient, instability of the International Normalized Ratio (INR) at the time of introduction of KVAs and during the first few months, poor patient compliance, drug combinations (antiplatelet, non-steroidal anti-inflammatory drugs: NSAIDs, paracetamol, etc.) or association with alcohol. National pharmacovigilance data indicate that serious accidents are not uncommon due to frequent misuse of antithrombotics in common practice. There are risk factors related to the patient and his or her comorbidities: history of bleeding, stroke, comorbidities such as age > 65 years, diabetes, cancer, chronic renal failure. Despite the various aids to therapeutic patient education (surveillance logbook, computerised INR monitoring), there has been no decrease in the frequency of iatrogenic accidents, either in hospitals or in urban medicine. The use of smartphone applications in the medical field is increasingly evolving among healthcare professionals and patients. They allow for more personalized care, and can also promote interaction with health professionals. Strengthening the link between specialist doctors and the general practitioner for joint patient management will improve their follow-up and reduce the risk of iatrogeny. In 2016, a survey was conducted in the vascular medicine department of the Groupe Hospitalier Paris Saint-Joseph (GHPSJ) to assess access to smartphones among patients on anti-thrombotic medication. Of the 100 patients enrolled, 74 were on anticoagulant or platelet aggregation therapy. Of these, 50 had a mobile phone and 24% used the Internet and made downloads to their phones. This raises the question of the interest that patients might have in a mobile application on the use of anti-thrombotics. As the profile of patients seen in hospital is different from those consulting in general medicine, it seems interesting to study these two populations in order to know if there is a difference in their attitude towards the smartphone. In order to find a new way to limit the iatrogeny of antithrombotic drugs, the investigators wanted to set up a medical application (educational tablet) for patients to provide them with support to better manage their treatment.

Official TitleStudy of the Interest of Patients Undergoing Anti-thrombotic Treatment in a Digital Application of Therapeutic Assistance
Principal SponsorFondation Hôpital Saint-Joseph
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

25 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesVascular Diseases

Criteria

Inclusion Criteria: * Patient ≥ 18 years old * Patient hospitalized in the vascular medicine department of the GHPSJ or attending a general medical consultation at the CMT * Patient with at least one vascular pathology: pulmonary embolism, venous thrombosis or phlebitis, cardiac arrhythmia by atrial fibrillation, obliterating arteriopathy of the lower limbs or myocardial infarction * Patient on antithrombotic treatment\[anticoagulants : AVK or Anticoagulants Oraux Directs (AOD), or antiplatelet agents\] * Patient affiliated to a health insurance plan * Patient able to read and understand the French language * Patient capable of giving free, informed and express consent Exclusion Criteria: * Patient not residing in Ile de France * Patient whose investigator considers that he/she is not able to use a digital tablet * Patient deprived of liberty * Patient under guardianship or curatorship * Refusal to participate in the study * Patient judged not to be included by the investigator on the basis of the inclusion questionnaire

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
if the patient is included in the study, an educational tablet (digital tablet) is given to the patient. The first connection to the tablet and then to the "My medication protects my vessels" application is made by the investigator in the presence of the patient. The application is configured by the investigator with the choice of the vascular pathology(s) corresponding to the patient included and the prescribed anti-thrombotic treatments. Thus, for each patient, the content of the tablet is adapted and personalized according to his vascular profile. After discharge from hospital, the patient has the educational tablet at his disposal for 1 month at home. The application offers patients various information supports (tools, questionnaires and pill box). Throughout its use, it may contact the investigating physician via a telephone number available within the application if it encounters a problem related to the study.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Groupe Hospitalier Paris Saint-Joseph

Paris, FranceOpen Groupe Hospitalier Paris Saint-Joseph in Google Maps
SuspendedOne Study Center