- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005699
Improving Hypertension Control in the Inner City
Study Overview
Status
Conditions
Detailed Description
BACKGROUND:
The study was 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 program consisted of a community wide education program, an intensive intervention directed toward individuals with hypertension, and an intervention for health care providers. The program was developed by a coalition of community organizations. In the community wide educational intervention, a baseline household survey was used to identify barriers to hypertension control in the community. This information was used in planning the intervention strategies, targeting the educational efforts, and developing the educational messages. Existing community organizations (churches, local media, neighborhood organizations, etc) were used to implement educational efforts over a three year period. Program success was evaluated by comparing findings on a follow-up household survey with those at baseline. Level of blood pressure control was the primary outcome measure. For the intensive educational program for hypertensives, the investigators developed a hypertension registry of individuals with high blood pressure who were identified from a number of community sources. All individuals on the registry receive educational material through the mail. Individuals with uncontrolled hypertension were randomized to receive the usual mailed educational materials or a more intensive personalized 12 month intervention using lay health advisors.
In the evaluation, the investigators compared blood pressure control morbidity and mortality between these two intervention arms of the registry. The innovative educational approach to health care providers utilized the existing community-based Area Health Education Center (AHEC) network to communicate community-determined hypertension control needs and community-determined hypertension control strategies to health care providers and students. The research was designed to elucidate community factors in the inner city that dictated strategies necessary for success in a variety inner city environments. Specifically, the investigators examined the effect of community size and level of community stress (as indicated by poverty, crime, etc.) on program development and outcome. To do this, they implemented the program in one city-wide community (Milwaukee) and in three well defined, homogeneous inner city neighborhoods of Chicago which had differing levels of community stress indicators. They evaluated the effect of size and community stress levels on the program strategies and successes.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Hypertensive
described as hypertensive according to AHA guidelines at time of trial
|
Controls
described as non-hypertensive according to AHA guidelines at time of trial
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jane Kotchen, Medical College of Wisconsin
Publications and helpful links
General Publications
- Kotchen JM, Shakoor-Abdulllah B, Walker W, Peters B, Kotchen TA. Planning for a community-based hypertension control program in the inner city. J Hum Hypertens. 1996 Sep;10 Suppl 3:S9-13.
- Kotchen JM, Shakoor-Abdullah B, Walker WE, Chelius TH, Hoffmann RG, Kotchen TA. Hypertension control and access to medical care in the inner city. Am J Public Health. 1998 Nov;88(11):1696-9. doi: 10.2105/ajph.88.11.1696.
- Shakoor-Abdullah B, Kotchen JM, Walker WE, Chelius TH, Hoffmann RG. Incorporating socio-economic and risk factor diversity into the development of an African-American community blood pressure control program. Ethn Dis. 1997 Autumn;7(3):175-83.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4278
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
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