Understanding Health Care Information for African Americans With High Blood Pressure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Promoting Health Literacy of African Americans With High Blood Pressure

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Health Literacy-focused Self-help
* Behavioral: Delayed Intervention Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-identified as African American aged 18 years or older; 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 Has a land-based telephone in the home or a cellular phone. Exclusion Criteria: Participation in another ongoing trial; Acute and/or terminal condition precluding participation, such as terminal cancer; Hospitalization for stroke, myocardial infarction, coronary artery vascularization in the past 3 months; Recipient of an organ transplant or on kidney dialysis; and Psychiatric diagnosis precluding participation, such as schizophrenia or cognitive impairment as measured by Mini-Mental State Exam (score < 24)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health Literacy-focused Self-help<br> | Behavioral: Health Literacy-focused Self-help<br>* 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.<br>|
| Placebo Comparator: Delayed intervention control<br> | Behavioral: Delayed Intervention Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased blood pressure |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase adherence to recommended blood pressure management |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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African American, High blood pressure