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

NCT03968276 | Terminated

• 1 other identifier: APPLIAC
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vascular Diseases

Keywords

antithrombotic treatment; digital therapeutic application assistance

Outcome Measures

Primary Outcomes (1)

• Return of the tablet in working order and to its use

  return (yes/no) and use

  1 month

Secondary Outcomes (6)

• Number of pages consulted on the educational tablet

  1 month

• Analyses of patient treatment knowledge assessment questionnaires

  Day 0 - 1 month

• Analogical visual scale of patient satisfaction

  1 month

• Questionnaire on compliance with antithrombotic treatments on application

  1 month

• Reporting of adverse events via the dedicated field on the educational tablet

  1 month

Study Arms (1)

use of digital tablet

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.

Other: use of digital tablet

Interventions

use of digital tablet OTHER

At the end of hospitalization, the patient has an educational tablet at his disposal for 1 month at home. Throughout its use, the patient may contact the investigating physician via a telephone number available within the application if he/she encounters a problem related to the study. At the end of this month, the patient must complete two questionnaires through the application to assess his or her knowledge of his or her condition and treatment, as well as his or her satisfaction with the use of the tablet. In this research, 1 month after inclusion, the patient will have an additional follow-up visit corresponding to a dedicated consultation in the vascular medicine department. It will allow the patient to review the use of the tablet and his or her satisfaction with the use of such a tool.

use of digital tablet

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Related Publications (2)

• Linkins LA, Choi PT, Douketis JD. Clinical impact of bleeding in patients taking oral anticoagulant therapy for venous thromboembolism: a meta-analysis. Ann Intern Med. 2003 Dec 2;139(11):893-900. doi: 10.7326/0003-4819-139-11-200312020-00007.

  PMID: 14644891 RESULT

• Dahri K, Loewen P. The risk of bleeding with warfarin: a systematic review and performance analysis of clinical prediction rules. Thromb Haemost. 2007 Nov;98(5):980-7.

  PMID: 18000602 RESULT

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Parinaz GHAFFARI, MD

  Fondation Hôpital Saint-Joseph

  STUDY DIRECTOR

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: May 27, 2019
• First Posted: May 30, 2019
• Study Start: November 21, 2019
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-10

Locations

FR (1)