Clinical trial NCT00406614: Health Literacy-Focused Program to Improve Blood Pressure Control in Korean Americans
Official title: Health Literacy Intervention for Korean Americans With High Blood Pressure (HBP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: High Blood Pressure
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2006-12-04
Enrollment: 360
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: In the last decade, significant progress has been made in improving the heart health of individuals in the United States. However, despite these advances, many racial and ethnic minority groups still have high rates of cardiovascular disease. Korean Americans, in particular, are more prone to developing high blood pressure than other Americans or individuals living in Korea. Possible reasons for this may include stress, diet, or lifestyle changes that occur as a result of immigration. Because many Korean Americans have low health literacy skills, it may be harder for them to understand medication dosing instructions, keep track of medical appointments, or comprehend written medical information. Korean Americans have traditionally been identified as a "hard to reach" group, and few programs have specifically targeted these individuals with regards to improving blood pressure control. The purpose of this study is to evaluate a health literacy-focused intervention that aims to improve blood pressure control among older Korean Americans. The results from this study may be helpful in developing future literacy-focused blood pressure programs targeted to minority groups in the United States.

In this study, participants will be randomly assigned to either a literacy-focused high blood pressure intervention or a wait-list control group, which will initially involve usual care from a regular medical provider. Participants in the intervention group will attend a weekly 2-hour educational session for 6 weeks. Bilingual research nurses and other professionals will facilitate these sessions, and each participant will receive a Korean language workbook with examples of medical terminology, prescription and appointment slips, and blood pressure management strategies. For 12 months, participants will self-monitor their blood pressure and record these measurements through a telephone management system. Community health workers will conduct telephone counseling on a monthly basis and those participants with uncontrolled blood pressure will receive more intensive support and follow-up counseling. Study visits will occur at Week 6 and Months 6, 12, 18, and 24, at which time blood pressure, height, and weight will be measured. In addition, participants will complete questionnaires that assess health literacy, high blood pressure knowledge, problem solving and communication skills, treatment adherence, health care utilization, and quality of life. Participants in the control group will take part in the intervention once the study has been completed.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Health literacy levels
timeFrame: Measured at Week 6 and Months 6, 12, 18, and 24
measure: Blood pressure control
timeFrame: Measured at Week 6 and Months 6, 12, 18, and 24
measure: Reduction in blood pressure
timeFrame: Measured at Month 24
Secondary outcomes:
measure: High blood pressure knowledge
timeFrame: Measured at Week 6 and Months 6, 12, 18, and 24
measure: Problem solving and communication skills
timeFrame: Measured at Week 6 and Months 6, 12, 18, and 24
measure: Adherence to high blood pressure treatment recommendations
timeFrame: Measured at Week 6 and Months 6, 12, 18, and 24
measure: Health care utilization
timeFrame: Measured at Week 6 and Months 6, 12, 18, and 24
measure: High blood pressure-related quality of life
timeFrame: Measured at Month 24
Other outcomes:
Locations:
city: Ellicott City
country: United States
facility: Korean Resource Center
state: Maryland
Study officials:
affiliation: The Johns Hopkins University School of Nursing
name: Miyong T. Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.