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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Health Literacy-focused Self-help Behavioral: Delayed Intervention Control Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Promoting Health Literacy of African Americans With High Blood Pressure
Actual Study Start Date : October 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Health Literacy-focused Self-help 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.

Placebo Comparator: Delayed intervention control 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.

Primary Outcome Measures :
  1. Decreased blood pressure [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Increase adherence to recommended blood pressure management [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01389037

United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
National Institute of Nursing Research (NINR)
Principal Investigator: Benita Walton-Moss, DNS Johns Hopkins University School of Nursing

Responsible Party: Johns Hopkins University Identifier: NCT01389037     History of Changes
Other Study ID Numbers: NA_00030713
1P30NR011409 ( U.S. NIH Grant/Contract )
First Posted: July 7, 2011    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017

Keywords provided by Johns Hopkins University:
African American
High blood pressure

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases