Intervention Study to Control High Blood Pressure for Korean American (HBP)

This study has been completed.

Sponsor:

Collaborator:

Agency for Healthcare Research and Quality (AHRQ)

Information provided by:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT00473681

First received: May 14, 2007

Last updated: May 5, 2008

Last verified: May 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

May 14, 2007

Last Updated Date

May 5, 2008

Start Date ^ICMJE

September 2003

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Blood Pressure, Health-Related Quality of Life(Medical outcome Study Short Form-36) [ Time Frame: Baseling, 12month, 24month ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00473681 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Self-Care Behaviors of HBP Control(Hill-Bone adherence of HBP therapy scale) Enabling Skills(problem-solving skills, cognitive reframing, belief-in-self) Self-Help(Inventory of Adult Role Behaviors) [ Time Frame: Baseline, 3months, 9 months,15 months ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Intervention Study to Control High Blood Pressure for Korean American

Official Title ^ICMJE

High Blood Pressure Care for Korean Americans

Brief Summary

The primary objective of the proposed clinical trials is to compare the differential reduction in blood pressure in underserved hypertensive adult Korean American. The study is designed to test the effectiveness of a comprehensive self-help intervention program.

Detailed Description

CVD is the leading cause of mortality among KA. Recent statistics underscoring the high prevalence and impact of uncontrolled HBP upon this population warrant the development and implementation of effective intervention. KA experiences a great deal of social isolation, which makes it more difficult for them to make behavioral changes for health improvement. individual, family, and community behaviors are part of the HBP problem and also constitute major part of the solution. The proposed research is designed to investigate these issues in a KA population and to lay the groundwork for community-based self-help health education interventions to enhance appropriate care and BP control.

Comparison(s):This community-based self-help intervention approach offers a more culturally appropriate approach to closing the health status gap for KA. Incorporating a partnership with community leaders and health and human service care providers, this approach will utilize state-of-the-art health education strategies and a well-trained bilingual nurse from the community.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Condition ^ICMJE

High Blood Pressure

Intervention ^ICMJE

Behavioral: Self-Help Intervention Program-High Blood Pressure

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

445

Completion Date

August 2007

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Self-identified as first-generation Korean American
Age 40 to 65 years of age
SBP≥140 or DBP≥90mmHg on HBP medication
resident of Greater Baltimore census tracts
Written consent to participate in the screening/eligibility visit
SBP≥140 or DBP≥90mmHg at the KRC HBP verification visit
Written consent to participate in the clinical trial:agreeing to participate in study data collection procedures, receiving HBP education, using HBPMT, and permitting contact with their own medical care provider.

Exclusion Criteria:

Acute and/or terminal condition precluding participation such as terminal cancer or acute myocardial infarction
Psychiatric diagnosis precluding participation such as schizophrenia and cognitive impairment measured by self-report, chart review, or clinical assessment.

Gender

Both

Ages

40 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00473681

Other Study ID Numbers ^ICMJE

R01 HS13160

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Johns Hopkins University

Collaborators ^ICMJE

Agency for Healthcare Research and Quality (AHRQ)

Investigators ^ICMJE

Principal Investigator:

Miyong D Kim, PhD

Johns Hopkins university, School of Nursing

Information Provided By

Johns Hopkins University

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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