Clinical trial NCT01389037: Understanding Health Care Information for African Americans With High Blood Pressure
Official title: Promoting Health Literacy of African Americans With High Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: African American
High blood pressure
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2011-07-07
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: Decreased blood pressure
timeFrame: 12 months
Secondary outcomes:
measure: Increase adherence to recommended blood pressure management
timeFrame: 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University School of Nursing
name: Benita Walton-Moss, DNS
role: PRINCIPAL_INVESTIGATOR
References: