Study of the Interest of Patients Undergoing Anti-thrombotic Treatment in a Digital Application of Therapeutic Assistance — APPLIAC  

Vascular Diseases Clinical Trial

Official title: Study of the Interest of Patients Undergoing Anti-thrombotic Treatment in a Digital Application of Therapeutic Assistance

Status Terminated

Clinical Trial Summary

Medical ethics encourages medical personal to actively care for patients, however old they may be, if they have maintained their physical autonomy and mental integrity to travel the path of medical care together. Many of the patients are in this situation today and their age does not seem to be a limiting factor in the care required.

For more than 60 years, antithrombotics have played a major role in the management of thromboembolic and arterioatheromatous diseases. the doctors have therefore seen the advent of low molecular weight heparins, new platelet antiaggregants and then direct oral anticoagulants.

If their contribution is no longer discussed today, it is necessary to take into consideration the risks they cause, particularly in terms of haemorrhage. Indeed, antithrombotics are the leading cause of serious adverse reactions in France with anti-vitamins K (AVK) which are the leading cause of hospitalization for severe iatrogeny in France. This risk is increased by the coexistence of haemorrhagic risk factors: drug interaction, misuse, failure to comply with contraindications and precautions for use, especially as exposure to these drugs increases with age.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Vascular Diseases

• NCT number: NCT03968276
• Study type: Interventional
• Source: Groupe Hospitalier Paris Saint Joseph
• Status: Terminated
• Phase: N/A
• Start date: November 21, 2019
• Completion date: October 10, 2022