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临床试验/NCT01389037
NCT01389037已完成不适用

Promoting Health Literacy of African Americans With High Blood Pressure

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2011年10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
198
试验地点
2
主要终点
Decreased blood pressure

研究概览

简要总结

This clinical trial focuses on helping African Americans with high blood pressure to manage their disease. The study will target their ability to read and understand health information (also called health literacy). The research method relies on community participation in equal partnership with the researchers to provide interactive workshops and home blood pressure self-monitoring with the assistance of telephone counseling by community health workers.

详细描述

The purpose of this study is to develop a culturally sensitive intervention focused on health literacy that is designed to reduce high blood pressure (HBP) in a vulnerable African American (AA) population. A community-based participatory research approach delivered by community health workers (CHW) will be used to address the following specific aims: Aim 1. To examine the effect of health literacy on self-care skills, including HBP knowledge, adherence to HBP and substance abuse treatment recommendations, communication skills, health care utilization, and BP outcomes in AAs with HBP. Aim 2. To conduct a pilot randomized, controlled trial with a delayed intervention control group to test the effectiveness of a health literacy-focused self-help HBP intervention program using CHWs in 100 AAs who reside in Baltimore City.

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
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

  • Self-identified as African American aged 18 years or older;
  • Systolic BP >140 and/or Diastolic BP >90 mmHg or SBP >135 and/or DBP >85 mmHg for individuals with diabetes mellitus or chronic kidney disease or on HBP medication; and
  • Has a land-based telephone in the home or a cellular phone.

排除标准

  • Participation in another ongoing trial;
  • Acute and/or terminal condition precluding participation, such as terminal cancer;
  • Hospitalization for stroke, myocardial infarction, coronary artery vascularization in the past 3 months;
  • Recipient of an organ transplant or on kidney dialysis; and
  • Psychiatric diagnosis precluding participation, such as schizophrenia or cognitive impairment as measured by Mini-Mental State Exam (score < 24)

研究组 & 干预措施

Delayed intervention control

Placebo Comparator

干预措施: Delayed Intervention Control (Behavioral)

Health Literacy-focused Self-help

Experimental

干预措施: Health Literacy-focused Self-help (Behavioral)

结局指标

主要结局

Decreased blood pressure

时间窗: 12 months

次要结局

  • Increase adherence to recommended blood pressure management(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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