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临床试验/NCT01325116
NCT01325116已完成不适用

Delayed Educational Reminders for Long-term Medication Adherence in ST-Elevation Myocardial Infarction (DERLA-STEMI): Cluster-randomized Controlled Trial

Hamilton Health Sciences Corporation2 个研究点 分布在 1 个国家目标入组 852 人开始时间: 2011年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
852
试验地点
2
主要终点
Cardiac Medication Use

研究概览

简要总结

ST segment elevation myocardial infarction (STEMI) is a common presentation of heart attack constituting approximately 30% of all cases. Clinical guidelines around the world support the prolonged use of secondary preventative medications including aspirin, clopidogrel, statin, beta-blocker and angiotensin blockers with the highest recommendations. While in-hospital and discharge prescription rates are excellent, adherence to these essential life-saving medications is far less than ideal, even a few months following hospital discharge. The investigators plan to capitalize on the existing structure of the SMART-AMI project already underway in LHIN IV to undertake a randomized controlled trial evaluating a reminder sent on behalf of the interventional cardiologists, delivered by mail, at 1, 2, 5, 8, and 11-months post-discharge, reviewing the evidence for life-saving cardiac medications and urging long-term adherence to secondary preventative cardiac medications. This will be sent to the family physician and the patient, using audience-appropriate language. If the DERLA-STEMI project is accepted by physicians and patients, found to be both feasible and effective, then this simple and low-cost intervention will be studied in all patients with an abnormal coronary angiogram.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admitted with STEMI to a hospital in LHIN IV, coronary angiogram with and without PCI at Hamilton General Hospital during hospital admission

排除标准

  • Non-english speaking

研究组 & 干预措施

Control

Active Comparator

Usual post-STEMI care

干预措施: Educational Reminder (Behavioral)

Intervention

Experimental

Recurrent, personalized, educational reminders sent via post on behalf of the interventional cardiologist to the patient and their family physician urging long-term adherence to secondary prevention medications post-STEMI. A copy of the letter will be provided to the patient to take to their pharmacist.

干预措施: Educational Reminder (Behavioral)

结局指标

主要结局

Cardiac Medication Use

时间窗: 3 and 12 months

Proportion of patients who report taking all cardiac medication classes, measured three and twelve months post-STEMI. Specifically, we will assess whether patients are taking a statin, beta-blocker, angiotensin modifier (ACE or ARB), and aspirin at twelve months, and whether they are taking these plus a secondary antiplatelet (clopidogrel, prasugrel, or ticagrelor) at three months.

次要结局

  • Adherence(3 and 12 Months)
  • Statin Dose(3 and 12 months)
  • Use of medication combinations(3 and 12 months)
  • Medication Side-effects(3 and 12 months)
  • Other Evidence-based Cardiac Medication Use(3 and 12 months)
  • Discussion with Family physician/specialist(3 and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jon-David Schwalm

Interventional Cardiologist

McMaster University

研究点 (2)

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