Hypertension
Conditions
Keywords
African American, High blood pressure
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.
Interventions
BEHAVIORALHealth 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.
BEHAVIORALDelayed 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.
Sponsors
National Institute of Nursing Research (NINR)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decreased blood pressure | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Increase adherence to recommended blood pressure management | 12 months |
Countries
United States
Outcome results
None listed