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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:
National Institute of Nursing Research (NINR)
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01389037
First received: July 5, 2011
Last updated: July 6, 2011
Last verified: May 2011
History of Changes
  Purpose

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 Intervention
Hypertension
 Behavioral: Health Literacy-focused Self-help
Behavioral: Delayed Intervention Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Promoting Health Literacy of African Americans With High Blood Pressure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Decreased blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Increase adherence to recommended blood pressure management [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389037

Contacts
Contact: Benita Walton-Moss, DNS 410-955-1290 bmoss@son.jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Not yet recruiting
Baltimore, Maryland, United States, 21205
Contact: Benita Walton-Moss, DNS     410-955-1290     bmoss@son.jhmi.edu    
Sponsors and Collaborators
Johns Hopkins University
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Benita Walton-Moss, DNS Johns Hopkins University School of Nursing
  More Information

No publications provided

Responsible Party: Benita Walton-Moss, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01389037     History of Changes
Other Study ID Numbers: NA_0030717, 1P30NR011409
Study First Received: July 5, 2011
Last Updated: July 6, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013