Hyponatremia in the Prevention of Hospitalized Patients Falls (PRECAHI)
Effectiveness of Early Intervention in the Diagnosis and Treatment of Hyponatremia in the Prevention of Hospitalized Patients Falls
研究概览
详细说明
Effectiveness of early intervention in the diagnosis and treatment of hyponatremia in the prevention of hospitalized patients´ falls.
Aims:
- To assess the effectiveness of corrective activity of hyponatremia in falls reducing incidence.
- To assess the cost-effectiveness ratio of the two proposed strategies: conventional treatment versus early intervention.
Cross ecological quasi-experimental study. The project will take place in Gregorio Marañón Hospital (Madrid, Spain) in the following inpatient adult Units: Neurology, Rehabilitation 1, Geriatrics, Internal Medicine (Group A), Cardiology, Rehabilitation 2, Gastroenterology, Neurosurgery and Oncology (Group B).
The estimated sample size for a confidence level of 95% (α = 0.05) and power of 90% (β = 0.010), taking into account a decrease in the incidence of falls of 20% restocking losses, is 124 patients per group (ie, the 124 patients receiving regular performance ** and 124 patients receiving the experimental intervention *, if necessary, by participant Unit).
Data collection: In each of the study participants Units both interventions will be held. First the participants Units have been randomized in two groups (Group A: Neurology, Rehabilitation 1, Geriatrics, Internal Medicine; Group B: Cardiology, Rehabilitation 2, Gastroenterology, Neurosurgery and Oncology). All patients hospitalized in these Units will be potentially included. First of all, collaborators will give them an informed consent to ask for their participation.
The interventions are:
- Experimental intervention: early diagnosis, treatment of hyponatremia until resolution and valuation according to the Dynamic Gait Index test. Duration: 6 months
- Habitual action: the usual pattern of work will be performed in all patients who enter. Duration: 6 months.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Madrid、西班牙、28007
- Hospital General Universitario Gregorio Marañon
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age >65 years
- Admitted to a participating study unit
- Wish to participate in the study and signature of informed consent.
Exclusion Criteria:
- Transfer of the patient to a unit not included in the study
- Deterioration of the patient's condition to severe or extremely painful
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Early hyponatremia diagnosis and treatment
The early diagnosis of hiponatremia is not a stándar procedure.
In the experimental arm, hyponatremia will be diagnosed and treated early.
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In the experimental group, hyponatremia will be diagnosed and treated early.
Therefore, the researchers will review the patients' sodium levels at admission and throughout their stay.
Usual pattern of work will be performed in all patients who enter in Hospital.
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无干预:No intervention
Usual pattern of work will be performed in all patients who enter in Hospital.
Duration: 6 months.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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To evaluate the effectiveness of treatment of hyponatremia in reducing the incidence of falls.
大体时间:1 year
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The effectiveness will be measured in terms of less incidence of falls
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1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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To evaluate the cost-effectiveness of the 2 strategies proposed: conventional treatment vs early intervention.
大体时间:1 year
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The cost-effectiveness will be indirectly measured using Average cost per inpatient day
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1 year
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合作者和调查者
调查人员
- 首席研究员:Carmen Lobo-Rodriguez, pHd、carmen.lobo@salud.madrid.org
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Early detection and treatment of hyponatremia的临床试验
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Zealand University HospitalUniversity of Copenhagen; Steno Diabetes Center Copenhagen; Holbaek Sygehus招聘中