NCT00406614

Brief Summary

Many Korean Americans are at risk for developing high blood pressure. Low health literacy levels may play a role in this risk. The purpose of this study is to evaluate a literacy-focused program aimed at reducing blood pressure levels in older Korean Americans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable hypertension

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

First Submitted

Initial submission to the registry

November 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

March 8, 2017

Status Verified

November 1, 2011

Enrollment Period

1.9 years

First QC Date

November 30, 2006

Last Update Submit

March 6, 2017

Conditions

Hypertension

Keywords

High Blood Pressure

Outcome Measures

Primary Outcomes (3)

  • Health literacy levels

    Measured at Week 6 and Months 6, 12, 18, and 24

  • Blood pressure control

    Measured at Week 6 and Months 6, 12, 18, and 24

  • Reduction in blood pressure

    Measured at Month 24

Secondary Outcomes (5)

  • High blood pressure knowledge

    Measured at Week 6 and Months 6, 12, 18, and 24

  • Problem solving and communication skills

    Measured at Week 6 and Months 6, 12, 18, and 24

  • Adherence to high blood pressure treatment recommendations

    Measured at Week 6 and Months 6, 12, 18, and 24

  • Health care utilization

    Measured at Week 6 and Months 6, 12, 18, and 24

  • High blood pressure-related quality of life

    Measured at Month 24

Study Arms (2)

1

EXPERIMENTAL

Literacy-focused high blood pressure intervention. The intervention group will receive the health literacy -focused hypertension management intervention that will be delivered through 6 weeks of highly interactive group sessions in a classroom setting, followed by telephone counseling once a month for 12 months. Also, the intervention group will concurrently use home blood pressure monitoring with telephone transmission for 12 months.

Behavioral: Health Literacy-Focused High Blood Pressure Intervention

2

ACTIVE COMPARATOR

Wait-list control group will initially receive usual care from a regular medical provider. Participants in the control group will take part in the intervention once the study has been completed.

Behavioral: Health Literacy-Focused High Blood Pressure Intervention

Interventions

Health Literacy-Focused High Blood Pressure InterventionBEHAVIORAL

Participants assigned to the intervention group will attend a weekly 2-hour educational session for 6 weeks that will cover topics such as learning medical terminology, understanding the content of prescription and appointment slips, and blood pressure (BP) management strategies. Upon completion of the educational sessions, participants will submit BP measurements via telephone monitoring system for 12 months and Community Health Worker (CHW) will conduct telephone counseling once every month during the same 12-month period for support and follow-up counseling. Participants will continue to monitor BP measurement by logging BP data on BP diary book for another 12 months. Control group participants will receive the same intervention education following the completion of the study.

Also known as: SI - intervention receiving group
12

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identifies as a first-generation Korean American
  • Systolic blood pressure greater than 140 mm Hg and/or diastolic blood pressure greater than 90 mm Hg OR currently on medication to treat high blood pressure
  • Access to a telephone

You may not qualify if:

  • Current participation in another clinical trial
  • Acute and/or terminal medical condition that would make study participation difficult (e.g., terminal cancer, acute heart attack)
  • Psychiatric diagnosis that would make study participation difficult (e.g., schizophrenia, cognitive impairment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korean Resource Center

Ellicott City, Maryland, 21043, United States

Location

Related Publications (7)

  • Kim MT, Kim KB, Han HR, Huh B, Nguyen T, Lee HB. Prevalence and Predictors of Depression in Korean American Elderly: Findings from the Memory and Aging Study of Koreans (MASK). Am J Geriatr Psychiatry. 2015 Jul;23(7):671-83. doi: 10.1016/j.jagp.2014.11.003. Epub 2014 Nov 25.

    PMID: 25554484DERIVED

  • Kim KB, Han HR, Huh B, Nguyen T, Lee H, Kim MT. The effect of a community-based self-help multimodal behavioral intervention in Korean American seniors with high blood pressure. Am J Hypertens. 2014 Sep;27(9):1199-208. doi: 10.1093/ajh/hpu041. Epub 2014 Mar 26.

    PMID: 24671049DERIVED

  • Lee JE, Kim MT, Han HR. Correlates of Health-Related Quality of Life Among Korean Immigrant Elders. J Appl Gerontol. 2015 Oct;34(7):844-57. doi: 10.1177/0733464813490247. Epub 2013 Jun 11.

    PMID: 24652887DERIVED

  • Han HR, Park SY, Song H, Kim M, Kim KB, Lee HB. Feasibility and validity of dementia assessment by trained community health workers based on Clinical Dementia Rating. J Am Geriatr Soc. 2013 Jul;61(7):1141-5. doi: 10.1111/jgs.12309. Epub 2013 Jun 3.

    PMID: 23730928DERIVED

  • Han HR, Song Y, Song HJ, Kim MT. Influence of living arrangements on the management and control of hypertension: a mixed-methods study of Korean American elderly. J Immigr Minor Health. 2013 Oct;15(5):944-52. doi: 10.1007/s10903-012-9679-2.

    PMID: 22790881DERIVED

  • Kim MT, Song HJ, Han HR, Song Y, Nam S, Nguyen TH, Lee HC, Kim KB. Development and validation of the high blood pressure-focused health literacy scale. Patient Educ Couns. 2012 May;87(2):165-70. doi: 10.1016/j.pec.2011.09.005. Epub 2011 Oct 24.

    PMID: 22030252DERIVED

  • 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

Related Links

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Miyong T. Kim, PhD

    The Johns Hopkins University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 30, 2006

First Posted

December 4, 2006

Study Start

September 1, 2007

Primary Completion

August 1, 2009

Study Completion

July 1, 2011

Last Updated

March 8, 2017

Record last verified: 2011-11

Locations

US(1)