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临床试验/NCT00406614
NCT00406614已完成不适用

Health Literacy Intervention for Korean Americans With High Blood Pressure (HBP)

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2007年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
360
试验地点
2
主要终点
Reduction in blood pressure

研究概览

简要总结

Many Korean Americans are at risk for developing high blood pressure. Low health literacy levels may play a role in this risk. The purpose of this study is to evaluate a literacy-focused program aimed at reducing blood pressure levels in older Korean Americans.

详细描述

In the last decade, significant progress has been made in improving the heart health of individuals in the United States. However, despite these advances, many racial and ethnic minority groups still have high rates of cardiovascular disease. Korean Americans, in particular, are more prone to developing high blood pressure than other Americans or individuals living in Korea. Possible reasons for this may include stress, diet, or lifestyle changes that occur as a result of immigration. Because many Korean Americans have low health literacy skills, it may be harder for them to understand medication dosing instructions, keep track of medical appointments, or comprehend written medical information. Korean Americans have traditionally been identified as a "hard to reach" group, and few programs have specifically targeted these individuals with regards to improving blood pressure control. The purpose of this study is to evaluate a health literacy-focused intervention that aims to improve blood pressure control among older Korean Americans. The results from this study may be helpful in developing future literacy-focused blood pressure programs targeted to minority groups in the United States.

In this study, participants will be randomly assigned to either a literacy-focused high blood pressure intervention or a wait-list control group, which will initially involve usual care from a regular medical provider. Participants in the intervention group will attend a weekly 2-hour educational session for 6 weeks. Bilingual research nurses and other professionals will facilitate these sessions, and each participant will receive a Korean language workbook with examples of medical terminology, prescription and appointment slips, and blood pressure management strategies. For 12 months, participants will self-monitor their blood pressure and record these measurements through a telephone management system. Community health workers will conduct telephone counseling on a monthly basis and those participants with uncontrolled blood pressure will receive more intensive support and follow-up counseling. Study visits will occur at Week 6 and Months 6, 12, 18, and 24, at which time blood pressure, height, and weight will be measured. In addition, participants will complete questionnaires that assess health literacy, high blood pressure knowledge, problem solving and communication skills, treatment adherence, health care utilization, and quality of life. Participants in the control group will take part in the intervention once the study has been completed.

研究设计

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

入排标准

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

入选标准

  • Self-identifies as a first-generation Korean American
  • Systolic blood pressure greater than 140 mm Hg and/or diastolic blood pressure greater than 90 mm Hg OR currently on medication to treat high blood pressure
  • Access to a telephone

排除标准

  • Current participation in another clinical trial
  • Acute and/or terminal medical condition that would make study participation difficult (e.g., terminal cancer, acute heart attack)
  • Psychiatric diagnosis that would make study participation difficult (e.g., schizophrenia, cognitive impairment)

结局指标

主要结局

Reduction in blood pressure

时间窗: Measured at Month 24

Health literacy levels

时间窗: Measured at Week 6 and Months 6, 12, 18, and 24

Blood pressure control

时间窗: Measured at Week 6 and Months 6, 12, 18, and 24

次要结局

  • High blood pressure knowledge(Measured at Week 6 and Months 6, 12, 18, and 24)
  • Adherence to high blood pressure treatment recommendations(Measured at Week 6 and Months 6, 12, 18, and 24)
  • Problem solving and communication skills(Measured at Week 6 and Months 6, 12, 18, and 24)
  • High blood pressure-related quality of life(Measured at Month 24)
  • Health care utilization(Measured at Week 6 and Months 6, 12, 18, and 24)

研究者

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

Miyong Kim

Professor

Johns Hopkins University

研究点 (2)

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