Self-management of Low Molecular Weight Heparin Therapy
Self-management of Heparin Therapy - Drug Use Problems and Compliance With Self-injected Low Molecular Weight Heparin in Ambulatory Care
There is very little data available on compliance with self-injected low molecular weight heparins (LMWH), but what there is, definitely shows that compliance represents a significant problem. We therefore aim to a) record drug use problems of patients including compliance, b) develop a "SOP" for first instruction by a pharmacist and for subsequent pharmaceutical care and c) to compare intensive pharmaceutical care (intervention) vs. standard care (control) provided in the pharmacy to patients with a prescription for a LMWH as an outpatient treatment.
Hypothesis:
Intensive pharmaceutical care in ambulatory patients who self-inject low molecular weight heparins results in improved compliance, more safety and satisfaction as well as in fewer complications.
研究概览
详细说明
Patient recruitment in community pharmacies enables the testing of the feasibility of the interventions under daily-practice conditions and facilitates the recruitment of a larger number of patients.
Data collection:
- telephone interviews with structured questionnaires at the beginning and at the end of the therapy
- monitored self-injection in the study center or at patient's home (direct observation technique [DOT])
- compliance measurement: answers from patient interviews, comparing number of used syringes vs. number of prescribed syringes (analogue "pill count"), measuring residual volume in recycled syringes
- recording of the fine motor skills by the adapted "Disabilities of the Arm, Shoulder and Hand" questionnaire (DASH questionnaire)
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Basle、瑞士、CH-4031
- University Hospital of Basle, Switzerland
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Bruderholz、瑞士、CH-4101
- Kantonsspital Baselland, Switzerland
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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:
- Patients are recruited from orthopedic clinics, an emergency department and from community pharmacies with a prescription for a LMWH as an outpatient treatment.
- self-application of the LMWH
german / english speaking
-> clinical setting:
Dalteparin
-> daily life setting:
- all LMWH (ready-to-use syringes)
- control group: self-application or application by another person (family member, medical person, etc.)
Exclusion Criteria:
- patient's home far away from study center
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 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：clinical setting: intervention
Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital. Intervention: patient education |
Possible, individualized interventions:
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无干预：clinical setting: standard care
Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
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实验性的：daily life setting: intervention
Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists. Intervention: patient education |
Possible, individualized interventions:
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无干预：daily life setting: standard care
Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
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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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Drug Use Problems
大体时间：during the individual drug therapy, an average of 18 days
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During a home visit and at her/his individual injection time, each patient was monitored when self-administering an s.c.
injection (directly observed therapy, DOT).
Score minimum = -2.00;
score maximum = +2.00 for the objective estimation of the application quality.
Higher score values represent better outcomes.
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during the individual drug therapy, an average of 18 days
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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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Compliance
大体时间：at the end of the individual drug therapy, an average of 18 days
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objectively determined by syringe count Therapy durations varied individually depending on the indication of the drug therapy (days to weeks).
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at the end of the individual drug therapy, an average of 18 days
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Patient Satisfaction
大体时间：at the end of the individual drug therapy, an average of 18 days
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at the end of the individual drug therapy, an average of 18 days
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合作者和调查者
合作者
调查人员
- 首席研究员：Kurt E. Hersberger, Prof. PhD、Pharmaceutical Care Research Group, University of Basle, Switzerland
出版物和有用的链接
一般刊物
- Mengiardi S, Tsakiris DA, Molnar V, et al. Impact of Pharmaceutical Care on Self-Administration of Outpatient Low-Molecular-Weight Heparin Therapy. Pharmacology & Pharmacy 5: 372-385, 2014
研究记录日期
研究主要日期
学习开始
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 (估计)
研究记录更新
最后更新发布 (估计)
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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