Understanding Health Care Information for African Americans With High Blood Pressure

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Health Literacy-focused Self-help; Behavioral: Delayed Intervention Control

• Registration Number: NCT01389037
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2011-07-05
• Study First Submitted QC: 2011-07-06
• Study First Posted: 2011-07-07
• Study Start: 2011-10
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-07
• Last Update Posted: 2017-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health Literacy-focused Self-help	Health Literacy-focused Self-help	-
Delayed intervention control	Delayed Intervention Control	-

Primary Outcome Measures

Name	Time	Method
Decreased blood pressure	12 months

Secondary Outcome Measures

Name	Time	Method
Increase adherence to recommended blood pressure management	12 months

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States