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临床试验/NCT00399880
NCT00399880已完成不适用

Improving Medication Adherence Through Graphically Enhanced Interventions in Acute Coronary Syndromes

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2006年11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
130
试验地点
2
主要终点
Adherence to Refills and Medications Scale (ARMS)

研究概览

简要总结

Coronary heart disease (CHD) is the leading cause of death in the United States. Most people who die from CHD die of a heart attack. Acute coronary syndrome (ACS) is a term that includes mild heart attacks, as well as other episodes of chest pain that may serve as a warning sign for an upcoming heart attack.

There are many medicines that can help prevent and treat ACS. However, at least 25% of patients don't take their medications as prescribed. When patients don't take their medications, we say they are noncompliant or nonadherent with the treatment.

The period following hospital discharge is a vulnerable time for many patients. Patients are often confused about what to do when they return home from the hospital. Many patients don't take their medications correctly, or they don't take them at all. Patients with poor literacy skills have more trouble than others, because it is harder for them to follow written instructions. Overall, about half of the adults in the U.S. have poor literacy skills. It is important to develop ways to help these adults manage their health better.

The purposes of this research project are 1) to learn more about the relationship between low literacy and medication adherence after hospital discharge, and 2) to test a strategy designed to help patients take their medicines more regularly. We will recruit consenting patients hospitalized with ACS. We will measure their literacy skills, ask questions about how they take their medicines, and measure other related factors like social support and self-efficacy. Patients will then be assigned to 1 of 2 groups. One group will receive only usual care at hospital discharge, which usually includes the nurse and physician briefly reviewing the medication prescriptions. The other group will receive an illustrated daily medication schedule and special, tailored counseling from a pharmacist at their time of discharge. About 1 week after patients leave the hospital we will contact them by phone to ask them questions about how they have been taking their medicines. We will get data from patients records for 6 months to see if the intervention had an impact on their medication compliance, blood pressure, cholesterol, and diabetes measurements.

If this study is successful, this simple strategy could be implemented by hospitals to improve medication compliance after discharge. This study will also provide more information about how patients' literacy skills affect their medication compliance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

  • Present with acute chest pain or angina equivalent, lasting ≥ 10 minutes of suspected ischemic origin, within the previous 24 hours of presentation to the hospital.
  • Patient must have documented objective evidence of myocardial ischemia based on a or b:
  • EKG changes in ≥ 2 contiguous leads shown by:
  • * Transient (< 30 min) ST-segment elevation of ≥ 1.0mm
  • * Transient or persistent ST-segment depression of ≥ 0.5mm (flat or downsloping at the J-point and at 80ms after the J-point)
  • * Persistent T-wave inversion of ≥ 2.0mm
  • Abnormal elevation of cardiac enzymes
  • * Elevation of creating kinase (CK) and creatine kinase-myocardial band (CK-MB)
  • * Elevation of troponin

排除标准

  • Previously enrolled in the study
  • Police custody
  • Corrected visual acuity worse than 20/60
  • Lack of cooperation
  • Severe hearing impairment
  • Too ill to participate
  • Unintelligible speech
  • Age younger than 18 years
  • Native language other than English
  • Psychotic illness
  • Caregiver administers all medications
  • Delirium/severe dementia
  • Does not fill prescriptions at Grady
  • No regular telephone/address
  • Not taking chronic medications prior to admission

研究组 & 干预措施

Health literacy intervention

Experimental

Illustrated medication schedules, pill boxes, pharmacist counseling

干预措施: Health literacy intervention (Behavioral)

Usual care

No Intervention

结局指标

主要结局

Adherence to Refills and Medications Scale (ARMS)

时间窗: Approximately 2 weeks after hospital discharge

Validated self-report measure of medication adherence. Possible range 12-48, with lower values indicating better adherence.

次要结局

  • Self-Efficacy for Appropriate Medication Use Scale (SEAMS)(Approximately 2 weeks after hospital discharge)

研究者

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

Sunil Kripalani

Associate Professor

Vanderbilt University Medical Center

研究点 (2)

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