Impact of Self-Management of Oral Anticoagulation in the Elderly in Terms of Mortality and Morbidity: a Randomized Controlled Trial - SPOG 60+
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 6
- 主要终点
- combined endpoint of all thromboembolic events requiring hospitalisation and all major bleeding complications
研究概览
简要总结
Self-management is safe and reliable in patients with long-term oral anticoagulation (OAC). However, no study has yet assessed the safety and efficacy of OAC self-management in elderly patients with major thromboembolic and haemorrhagic complications as primary outcomes.
In this multi-centre, open, randomised controlled trial, patients aged 60 years or will be randomised into a self-management or routine care group and followed up for at least two years.
The primary hypothesis of the study is that self-management of oral anticoagulation is superior compared to routine control in terms of reducing thromboembolic events requiring hospitalisation and all major bleeding complications as the primary endpoint.
详细描述
Oral anticoagulation (OAC) has been shown to be highly effective in preventing thromboembolic complications in patients for whom it is indicated. Numerous studies have documented that elderly patients seem to benefit most from OAC therapy. Atrial fibrillation (AF), the incidence of which increases with age and approaches 10% for individuals aged ≥ 80 years, carries the main risk for stroke, and among elderly patients without antithrombotic therapy,
Despite its proven benefit, numerous studies have reported reluctance in prescribing OAC due to a variety of barriers, especially in the elderly. Risk of haemorrhage, which is in fact twice as great in those over 70 years of age as in younger patients, is one of the major determinants of refusal to prescribe OAC therapy. The risk of stroke rises steeply in patients with atrial fibrillation when INR values are less than 1.8 and INR values greater than 4 to 5 are rapidly associated with increased bleeding rates. Due to relatively small therapeutic ranges, the reality is often that only a small percentage of the INR values have been found to be within the target range, which can be low as 29% of INR measurements, as seen in routine care patients prior to participation in a randomised self-management programme study.
One way to improve OAC care is by introducing patients' self-management of OAC therapy. In this context it is important to differentiate between INR self-testing alone, and full self-management. Self-management includes self-adaptation of the anticoagulation treatment based on self-monitoring results after the patients have participated in a structured instruction and treatment programme.
Our study aims to provide answers to this important medical question by examining elderly patients receiving long-term anticoagulation treatment and randomised into self-management versus routine-care groups, with thromboembolic and haemorrhagic complications as primary outcomes.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •long-term anticoagulation
- •either with phenprocoumon or acenocoumarol
- •age ≥ 60 years
- •written informed consent
排除标准
- •previous participation in a self-management OAC programme
- •severe cognitive
- •terminal illness
结局指标
主要结局
combined endpoint of all thromboembolic events requiring hospitalisation and all major bleeding complications
时间窗: during the time of follow up (at least two years)
次要结局
- frequency and duration of hospitalisation(during the time of follow up (at least two years))
- mortality(during the time of follow up (at least two years))
- recurrence of stroke(during the time of follow up (at least two years))
- numbers of INR values above 4.5 or lower than 1.7(during the time of follow up (at least two years))
- treatment-related quality of life analysis(during the time of follow up (at least two years))
- cost-effectiveness evaluations(during the time of follow up (at least two years))
- median of squared INR value deviation (INR - ½(Upper Value of Target INR Range + Lower Value of Target INR Range))(during the time of follow up (at least two years))
- percentage of individual patients' INR values within the target range and the percentage of time within target range(during the time of follow up (at least two years))