Intervention Study to Control High Blood Pressure for Korean American

High Blood Pressure Clinical Trial

— HBP  

Official title:

High Blood Pressure Care for Korean Americans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00473681
• Other study ID #: R01HS013160
• Status: Completed
• Phase: N/A
• First received: May 14, 2007
• Last updated: May 5, 2008
• Start date: September 2003
• Est. completion date: August 2007

Study information

• Verified date: May 2008
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Est. completion date: August 2007
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension

Intervention

Behavioral:
• Self-Help Intervention Program-High Blood Pressure

Locations

Country	Name	City	State
United States	Korean Resource Center	Ellicott city	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Han HR, Kang J, Kim KB, Ryu JP, Kim MT. Barriers to and strategies for recruiting Korean Americans for community-partnered health promotion research. J Immigr Minor Health. 2007 Apr;9(2):137-46. — View Citation

Han HR, Kim KB, Kang J, Jeong S, Kim EY, Kim MT. Knowledge, beliefs, and behaviors about hypertension control among middle-aged Korean Americans with hypertension. J Community Health. 2007 Oct;32(5):324-42. — View Citation

Kim EY, Han HR, Jeong S, Kim KB, Park H, Kang E, Shin HS, Kim MT. Does knowledge matter?: intentional medication nonadherence among middle-aged Korean Americans with high blood pressure. J Cardiovasc Nurs. 2007 Sep-Oct;22(5):397-404. — View Citation

Kim MT, Kim EY, Han HR, Jeong S, Lee JE, Park HJ, Kim KB, Hill MN. Mail education is as effective as in-class education in hypertensive Korean patients. J Clin Hypertens (Greenwich). 2008 Mar;10(3):176-84. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure, Health-Related Quality of Life(Medical outcome Study Short Form-36)		Baseling, 12month, 24month
Secondary	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)		Baseline, 3months, 9 months,15 months