Understanding Health Care Information for African Americans With High Blood Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01389037
Recruitment Status : Completed
First Posted : July 7, 2011
Last Update Posted : December 11, 2017
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Johns Hopkins University

July 5, 2011
July 7, 2011
December 11, 2017
October 2011
June 2014   (Final data collection date for primary outcome measure)
Decreased blood pressure [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT01389037 on Archive Site
Increase adherence to recommended blood pressure management [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
Understanding Health Care Information for African Americans With High Blood Pressure
Promoting Health Literacy of African Americans With High Blood Pressure
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.
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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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.
  • Experimental: Health Literacy-focused Self-help
    Intervention: Behavioral: Health Literacy-focused Self-help
  • Placebo Comparator: Delayed intervention control
    Intervention: Behavioral: Delayed Intervention Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2014
June 2014   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
1P30NR011409 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Johns Hopkins University
Johns Hopkins University
National Institute of Nursing Research (NINR)
Principal Investigator: Benita Walton-Moss, DNS Johns Hopkins University School of Nursing
Johns Hopkins University
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP