Intervention to Improve Medication Adherence in Cardiovascular Patients
Nurse- and Web Based Intervention to Improve Medication Adherence in High Risk Cardiovascular Patients.
研究概览
地位
条件
详细说明
Poor adherence to medication is one of the limitations in the treatment of cardiovascular disease. As a consequence the risk of premature death, hospital admissions and related costs is increasing. Therefore, detection of apparent poor adherence and interventions to improve adherence, are of great importance to enhance cardiovascular risk management over time.
This study is a prospective randomized trial, which compares 1) usual care with 2) the effect of a personalized visualization of cardiovascular risk levels (website) to support self management and 3) the additional effect of a communication intervention by a nurse on adherence on top of 2). Adherence is determined and continuously monitored with a dedicated calculation of refill data obtained from patient's pharmacy.
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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Nijmegen、荷兰、6500 HB
- Radboud University Medical Centre
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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:
- All subsequent patients, included in the hospital-screening program with manifestations of atherosclerotic disease (acute coronary syndrome, peripheral arterial disease or stroke/TIA) or elevated cardiovascular risk due to hypertension, diabetes or hyperlipidemia.
Exclusion Criteria:
- Age below 18 years, actual pregnancy, problems with Dutch language or logistic problems, which may hinder intervention on adherence behavior. Severe co-morbidity, including mental handicap, according to their physician.
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: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:Lifestyle counseling
Group consultation and individual nurse consultation
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A nurse-based intervention with face-to-face contacts based on motivational interviewing techniques and influence on behavioral determinants.
Well-trained nurses in our hospital will apply these behavioral change interventions.
An individual contact will take about twenty minutes.
This website shows patient's lab results, life style issues, blood pressure and weight in various risk monitors.
These lab results and lifestyle changes will be visualized in risk monitors and provide structural feedback to the patient.
The results of the screening and the two additional visits can be seen by the patient.
group consultations with peers and a nurse individual consultation with a nurse
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实验性的:e health
An individual web based entry
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This website shows patient's lab results, life style issues, blood pressure and weight in various risk monitors.
These lab results and lifestyle changes will be visualized in risk monitors and provide structural feedback to the patient.
The results of the screening and the two additional visits can be seen by the patient.
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无干预:usual care
Usual care
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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 |
---|---|---|
Change in degree of Adherence
大体时间:Change from baseline in degree of Adherence at 12 month
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The degree of Adherence to medication for each group at 12 month from baseline, as calculated by prescription refill data
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Change from baseline in degree of Adherence at 12 month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Clinical outcome
大体时间:Change from baseline in level of LDL-Cholesterol at 12 months
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Change in LDL-Cholesterol level in each group at 12 months from baseline
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Change from baseline in level of LDL-Cholesterol at 12 months
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Clinical outcome
大体时间:Change from baseline in Sytolic Blood Pressure at 12 months
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Change in Systolic Blood Pressure in each group at 12 months from baseline
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Change from baseline in Sytolic Blood Pressure at 12 months
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Clinical outcome
大体时间:Change from baseline in Body Mass Index at 12 months
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Change in Body Mass Index (BMI) in each group at 12 months from baseline
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Change from baseline in Body Mass Index at 12 months
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Clinical outcome
大体时间:Change from baseline in Waist Circumference at 12 months
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Change in Waist Circumference in each group at 12 months from baseline
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Change from baseline in Waist Circumference at 12 months
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合作者和调查者
调查人员
- 首席研究员:Bas JH Bredie, MD、Radboud University Medical Center
出版物和有用的链接
一般刊物
- Sieben A, van Onzenoort HA, van Dulmen S, van Laarhoven C, Bredie SJ. A nurse-based intervention for improving medication adherence in cardiovascular patients: an evaluation of a randomized controlled trial. Patient Prefer Adherence. 2019 May 23;13:837-852. doi: 10.2147/PPA.S197481. eCollection 2019.
- Sieben A, van Onzenoort HA, van Laarhoven KJ, Bredie SJ. A Multifaceted Nurse- and Web-Based Intervention for Improving Adherence to Treatment in Patients With Cardiovascular Disease: Rationale and Design of the MIRROR Trial. JMIR Res Protoc. 2016 Sep 13;5(3):e187. doi: 10.2196/resprot.5750.
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 (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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Life style counseling的临床试验
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University Hospital, Strasbourg, France终止
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University of Illinois at ChicagoNational Institute on Minority Health and Health Disparities (NIMHD)完全的
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University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)完全的
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Rigshospitalet, DenmarkNovo Nordisk A/S; Copenhagen University Hospital at Herlev; Danish Cancer Society; TrygFonden, Denmark完全的
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University of PittsburghNational Institutes of Health (NIH)终止