Study of the Interest of Patients Undergoing Anti-thrombotic Treatment in a Digital Application of Therapeutic Assistance
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Return of the tablet in working order and to its use
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Return of the tablet in working order and to its use
时间窗: 1 month
return (yes/no) and use
次要结局
- Questionnaire on compliance with antithrombotic treatments on application(1 month)
- Analyses of patient treatment knowledge assessment questionnaires(Day 0 - 1 month)
- Analogical visual scale of patient satisfaction(1 month)
- Number of calls from city physicians and pharmacists received by the investigator(1 month)
- Reporting of adverse events via the dedicated field on the educational tablet(1 month)
- Number of pages consulted on the educational tablet(1 month)