Understanding Health Care Information for African Americans With High Blood Pressure

Overview

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.

Full Title of Study: “Promoting Health Literacy of African Americans With High Blood Pressure”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2014

Detailed Description

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.

Interventions

  • Behavioral: Health Literacy-focused Self-help
    • Weekly 2-hour sessions over 6 weeks followed by 12 month follow-up with home blood pressure self monitoring with telephone counseling by community health workers.
  • Behavioral: Delayed Intervention Control
    • Given pamphlets on the importance of high blood pressure control and offered weekly workshops. This group will be offered the intervention at the conclusion of data collection.

Arms, Groups and Cohorts

  • Experimental: Health Literacy-focused Self-help
  • Placebo Comparator: Delayed intervention control

Clinical Trial Outcome Measures

Primary Measures

  • Decreased blood pressure
    • Time Frame: 12 months

Secondary Measures

  • Increase adherence to recommended blood pressure management
    • Time Frame: 12 months

Participating in This Clinical Trial

Inclusion Criteria

1. Self-identified as African American aged 18 years or older; 2. 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 3. Has a land-based telephone in the home or a cellular phone. Exclusion Criteria:

1. Participation in another ongoing trial; 2. Acute and/or terminal condition precluding participation, such as terminal cancer; 3. Hospitalization for stroke, myocardial infarction, coronary artery vascularization in the past 3 months; 4. Recipient of an organ transplant or on kidney dialysis; and 5. Psychiatric diagnosis precluding participation, such as schizophrenia or cognitive impairment as measured by Mini-Mental State Exam (score < 24)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Johns Hopkins University
  • Collaborator
    • National Institute of Nursing Research (NINR)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Benita Walton-Moss, DNS, Principal Investigator, Johns Hopkins University School of Nursing

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