Health Literacy-Focused Program to Improve Blood Pressure Control in Korean Americans

March 6, 2017 updated by: Miyong Kim, University of Texas at Austin

Health Literacy Intervention for Korean Americans With High Blood Pressure (HBP)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Ellicott City, Maryland, United States, 21043
        • Korean Resource Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
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
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.
Other Names:
  • SI - intervention receiving group
ACTIVE_COMPARATOR: 2
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
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.
Other Names:
  • SI - intervention receiving group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Health literacy levels
Time Frame: Measured at Week 6 and Months 6, 12, 18, and 24
Measured at Week 6 and Months 6, 12, 18, and 24
Blood pressure control
Time Frame: Measured at Week 6 and Months 6, 12, 18, and 24
Measured at Week 6 and Months 6, 12, 18, and 24
Reduction in blood pressure
Time Frame: Measured at Month 24
Measured at Month 24

Secondary Outcome Measures

Outcome Measure
Time Frame
High blood pressure knowledge
Time Frame: Measured at Week 6 and Months 6, 12, 18, and 24
Measured at Week 6 and Months 6, 12, 18, and 24
Problem solving and communication skills
Time Frame: Measured at Week 6 and Months 6, 12, 18, and 24
Measured at Week 6 and Months 6, 12, 18, and 24
Adherence to high blood pressure treatment recommendations
Time Frame: Measured at Week 6 and Months 6, 12, 18, and 24
Measured at Week 6 and Months 6, 12, 18, and 24
Health care utilization
Time Frame: Measured at Week 6 and Months 6, 12, 18, and 24
Measured at Week 6 and Months 6, 12, 18, and 24
High blood pressure-related quality of life
Time Frame: Measured at Month 24
Measured at Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Miyong T. Kim, PhD, The Johns Hopkins University School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

November 30, 2006

First Submitted That Met QC Criteria

November 30, 2006

First Posted (ESTIMATE)

December 4, 2006

Study Record Updates

Last Update Posted (ACTUAL)

March 8, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 446
  • R01HL085567 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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