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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00473681
First received: May 14, 2007
Last updated: May 5, 2008
Last verified: May 2008
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: High Blood Pressure Care for Korean Americans

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 445
Study Start Date: September 2003
Study Completion Date: August 2007
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473681

Locations
United States, Maryland
Korean Resource Center
Ellicott city, Maryland, United States, 21042
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Miyong D Kim, PhD Johns Hopkins university, School of Nursing
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00473681     History of Changes
Other Study ID Numbers: R01 HS13160
Study First Received: May 14, 2007
Last Updated: May 5, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 25, 2014