NCT00473681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
445

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

May 7, 2008

Status Verified

May 1, 2008

Enrollment Period

2.9 years

First QC Date

May 14, 2007

Last Update Submit

May 5, 2008

Conditions

High Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure, Health-Related Quality of Life(Medical outcome Study Short Form-36)

    Baseling, 12month, 24month

Secondary Outcomes (1)

  • 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

Interventions

Self-Help Intervention Program-High Blood PressureBEHAVIORAL

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korean Resource Center

Ellicott City, Maryland, 21042, United States

Location

Related Publications (8)

  • 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. doi: 10.1007/s10903-006-9022-x.

    PMID: 17186370BACKGROUND

  • 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. doi: 10.1111/j.1751-7176.2008.07571.x.

    PMID: 18326962RESULT

  • 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. doi: 10.1007/s10900-007-9051-y.

    PMID: 17922204RESULT

  • 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. doi: 10.1097/01.JCN.0000287038.23186.bd.

    PMID: 17724422RESULT

  • Han HR, Chan K, Song H, Nguyen T, Lee JE, Kim MT. Development and evaluation of a hypertension knowledge test for Korean hypertensive patients. J Clin Hypertens (Greenwich). 2011 Oct;13(10):750-7. doi: 10.1111/j.1751-7176.2011.00497.x. Epub 2011 Jul 14.

    PMID: 21974763DERIVED

  • Kim MT, Han HR, Hedlin H, Kim J, Song HJ, Kim KB, Hill MN. Teletransmitted monitoring of blood pressure and bilingual nurse counseling-sustained improvements in blood pressure control during 12 months in hypertensive Korean Americans. J Clin Hypertens (Greenwich). 2011 Aug;13(8):605-12. doi: 10.1111/j.1751-7176.2011.00479.x. Epub 2011 Jun 27.

    PMID: 21806771DERIVED

  • Kim J, Han HR, Song H, Lee J, Kim KB, Kim MT. Compliance with home blood pressure monitoring among middle-aged Korean Americans with hypertension. J Clin Hypertens (Greenwich). 2010 Apr;12(4):253-60. doi: 10.1111/j.1751-7176.2009.00218.x.

    PMID: 20433546DERIVED

  • Han HR, Kim J, Kim KB, Jeong S, Levine D, Li C, Song H, Kim MT. Implementation and success of nurse telephone counseling in linguistically isolated Korean American patients with high blood pressure. Patient Educ Couns. 2010 Jul;80(1):130-4. doi: 10.1016/j.pec.2009.10.012. Epub 2009 Nov 30.

    PMID: 19945816DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Miyong D Kim, PhD

    Johns Hopkins university, School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 14, 2007

First Posted

May 15, 2007

Study Start

September 1, 2003

Primary Completion

August 1, 2006

Study Completion

August 1, 2007

Last Updated

May 7, 2008

Record last verified: 2008-05

Locations

US(1)