Understanding Health Care Information for African Americans With High Blood Pressure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Johns Hopkins University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01389037
First received: July 5, 2011
Last updated: July 6, 2011
Last verified: May 2011

July 5, 2011
July 6, 2011
October 2011
October 2012   (final data collection date for primary outcome measure)
Decreased blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01389037 on ClinicalTrials.gov Archive Site
Increase adherence to recommended blood pressure management [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
October 2012
October 2012   (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)
Both
18 Years and older
No
Contact: Benita Walton-Moss, DNS 410-955-1290 bmoss@son.jhmi.edu
United States
 
NCT01389037
NA_0030717, 1P30NR011409
No
Benita Walton-Moss, 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
May 2011

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