Effectivity of a Joint Didactic Intervention by School for Patients on Inappropriate Control Prothrombin Time Anticoagulated Patients. Protocol for Developing a Randomized and Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Time on INR therapeutic levels in the last six months receiving VKA treatment
研究概览
简要总结
Background: Oral anticoagulant drugs represent an essential tool in thrombo-embolic events prevention. Most used are vitamin K antagonists (VKA), which plasma level is monitored measuring prothrombin time using the International Normalized Ratio. If it takes values out of recommended range, the patient will have a higher risk of suffering from thromboembolic or hemorrhagic complications. Previous researches have shown that, at best, only 33% of total patients keep values on therapeutic level.
The investigators intend to improve International Normalized Ratio control figures by a joint didactic intervention based on Junta de Andalucía School for Patients method that will be practiced by anticoagulated patients themselves.
Methods: A randomized clinical trial was carried out at primary care centers from one healthcare area in Malaga (Andalusia, Spain). Study population: patients included on oral anticoagulant therapy program using vitamin K antagonists.
First step: detection of patients on oral anticoagulation program with International Normalized Ratio on therapeutic level during 65% or less over total time. Second step: patients with inappropriate International Normalized Ratio control were practiced a joint didactic intervention "from peer to peer", by a previously trained and expert anticoagulated patient.
Study variables: time on therapeutic levels before and after intervention, sociodemographic variables, vital signs, existence of cardiovascular risk factors, basic blood test, other prescribed drugs, accompanying diseases and social support.
Almost-experimental analytic study with before-after statistical analysis of the intervention. Lineal regression models were applied on main variables results (International Normalized Ratio value, time on therapeutic level) inputting sociodemographic variables, accompanying diseases and social support.
详细描述
Background and current status:
It has been proved that oral anticoagulant therapy (OAT) is effective in preventing situations with high risk of thromboembolic events and in treating them. It significantly decreases ischemic stroke rates as well as their severity and death risk. However it is a therapy with special features, highlighting: doses and response variability, the close therapeutic range, interactions with other drugs and foods, and potentially severe side effects. This fact compels the investigators to make a close monitoring of those patients.
An important impact in developing cardioembolic or hemorrhagic events due to a inappropriate coagulation control using vitamin K antagonists (VKA), has been described; because of control variations around 15% could result in so relevant clinical problems.
The main OAT indications are deep vein thrombosis, pulmonary embolism, embolic conditions prevention in patients suffering from atrial fibrillation or heart prosthetic valve wearers. Most common embolic event is ictus, which could lead to an important inability and dependence state, what would associate a significant increase in health resources use and costs. Atrial fibrillation (AF) is nowadays the pathology which requires most anticoagulant therapy indications. This fact is partially due to the population aging, since there are both incidence and prevalence increases of this arrhythmia, specially in elderly patients.
Control of patients on OAT were performed in hospitals until a few years ago; nevertheless, changes in social and healthy contexts besides the expansion in this drugs prescribing joined to primary health care qualification and evolution, the development of coagulation handheld measuring devices and the need to improve patients accessibility, had justified the control decentralization and due to this facts, OAT monitoring can be practiced to stable patients on primary care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Patients on VKA treatment for at least the last six months in primary care environment.
- •Patients on inappropriate INR level control.
- •Patients in whom we have access to, at least, 80% of their INR levels. controls in last six months of treatment with VKA, although they are enrolled in another primary care center.
- •Patients who have given written informed consent to take part in the study
排除标准
- •Patients suffering from cognitive impairment wich prevents understanding what was written in the information sheet and informed consent.
- •Limited mobility patients, terminal patients, alcoholism or drug addiction, severe psychiatric illness or any other reason which makes patients to be present at center´s meetings imposible.
研究组 & 干预措施
Patient Education Group
A group educational intervention was practiced to half of the patients, by one expert patient, so that every patient must attend to one group meeting and they continued with their usual controls
干预措施: Patient education group (Behavioral)
Control group
Control group performed usual clinical practice, that is, people will be schedule by nurses about one time per month, except cases in which controls are inappropriate.
结局指标
主要结局
Time on INR therapeutic levels in the last six months receiving VKA treatment
时间窗: Six months
Appropriate INR level control will be assessed in two ways: measuring the therapeutic INR values percentages or Time percentages in therapeutic values estimated using Rosendaal method
次要结局
- Sociodemographic(Six months)
- Body mass index (BMI)(0 and 12 months.)
- Chronic renal failure(0 and 12 months.)
- Atrial fibrillation(0 and 12 months.)
- Smoking habit(0 and 12 months.)
- Diastolic and systolic blood pressure(0 and 12 months.)
- Heart rate(0 and 12 months.)
- diabetes(0 and 12 months.)
- Arterial hypertension(0 and 12 months.)
- Dyslipidemia(0 and 12 months.)
- Interventional cardiac valve diseases with or without atrial fibrillation(0 and 12 months.)
- Total cholesterol(0 and 12 months.)
- Anticoagulant type(0 and 12 months.)
- Consumption of "gastric protector"(0 and 12 months.)
- Ischemic cardiopathy(0 and 12 months.)
- Thromboembolic diseases history (stroke, transient ischemic attack)(0 and 12 months.)
- Alcohol consumption(0 and 12 months.)
- Hemorrhagic stroke(0 and 12 months.)
- Congestive heart failure(0 and 12 months.)
- Glomerular filtration rates(0 and 12 months.)
- HDL Cholesterol(0 and 12 months.)
- LDL cholesterol(0 and 12 months.)
- Triglycerides(0 and 12 months.)
- Total number of drugs(0 and 12 months.)
- Usual consumption of food rich in vitamin K(0 and 12 months.)
研究者
Francisco Javier Navarro Moya
Effectiveness and Research Unit Coordinator. District of Malaga. Andalusian Health Service. Spain
Andaluz Health Service