Urban African-American Community Hypertension Control

To investigate whether a health education program, developed in partnership with the community and delivered by nurse supervised community health workers (CHWs), lowered high blood pressure (HBP) in inner city African American adults.

Study Overview

Detailed Description

BACKGROUND:

This population based study was significant because it offered a multidisciplinary, community HBP control program to help close the gap in health status for African Americans. The study was conducted in response to a demonstration and education initiative, "Improving Hypertensive Care for Inner City Minorities", which was reviewed and approved by the Clinical Applications and Prevention Advisory Committee in April 1992 and by the National Heart, Lung, and Blood Advisory Council in May 1992. The Request for Applications was released in October 1992.

DESIGN NARRATIVE:

The two and a half year intervention trial sought to extend and test the generalizability of prior work in a similar inner city African American community, which demonstrated the efficacy of planned health education programs that were culturally-sensitive, community-based and owned, and built upon appropriate behavioral and community activation theory and principles, in improving the control of HBP and decreasing related morbidity and mortality.

Five hundred men and 500 women were recruited from households in neighborhood blocks randomly assigned to a more or less intensive educational-behavioral intervention. Both groups received usual medical care, community HBP education, and HBP patient education materials. In addition, the more intensive group received 1) individualized educational counseling sessions with the CHW to increase understanding of HBP and to address barriers to control of HBP; 2) outreach and follow-up to address inadequate health care resources and health behavior related skills through interim monitoring and education "booster" sessions; and 3) mobilization of social support from a family member/friend identified by the participant as the primary source of daily reinforcement.

Statistical analysis focused on BP change in all adults with HBP on randomized blocks whether or not they participated in either of the intervention groups (program effectiveness), as well as BP change in all adults participating in the two interventions regardless of their level of compliance (intervention efficacy). In addition, the analysis focused on differences in the two groups regarding individuals' adherence to HBP lowering recommendations to enter/re-enter care, remain in care, modify lifestyle, and take HBP medication. Multiple regression was done to determine the contribution of the changes in the major independent variables (perceived barriers, use of health care resources and health care skills, and social support) to changes in the outcome and intervening variables which included adherence to HBP lowering recommendations.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1993

Study Completion (Actual)

August 1, 1998

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (Estimate)

May 26, 2000

Study Record Updates

Last Update Posted (Estimate)

February 18, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

May 1, 2002

More Information

Terms related to this study

Other Study ID Numbers

  • 4915
  • R01HL051111 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Diseases

Subscribe