Understanding Health Care Information for African Americans With High Blood Pressure

NCT ID: NCT01389037

Last Updated: 2017-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-06-30

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.

Conditions

Hypertension

Keywords

African American; High blood pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Health Literacy-focused Self-help

Group Type: EXPERIMENTAL

Health Literacy-focused Self-help

Intervention Type: BEHAVIORAL

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.

Delayed intervention control

Group Type: PLACEBO_COMPARATOR

Delayed Intervention Control

Intervention Type: BEHAVIORAL

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.

Interventions

Health 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.

Intervention Type: BEHAVIORAL

Delayed 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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benita Walton-Moss, DNS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University School of Nursing

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

1P30NR011409

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00030713

Identifier Type: -

Identifier Source: org_study_id