Understanding Health Care Information for African Americans With High Blood Pressure

Johns Hopkins University

Status: Completed

Conditions: Hypertension

Treatments: Behavioral: Health Literacy-focused Self-help; Behavioral: Delayed Intervention Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01389037

1P30NR011409 (U.S. NIH Grant/Contract)

NA_00030713

Details and patient eligibility

About

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.

Full 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.

Enrollment: 198 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 2 patient groups, including a placebo group

Health Literacy-focused Self-help

Experimental group

Treatment:

Behavioral: Health Literacy-focused Self-help

Delayed intervention control

Placebo Comparator group

Treatment:

Behavioral: Delayed Intervention Control