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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Miyong T. Kim, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00406614
First received: November 30, 2006
Last updated: November 28, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Hypertension
Behavioral: Health Literacy-Focused High Blood Pressure Intervention
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Health Literacy Intervention for Korean Americans With High Blood Pressure (HBP)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Health literacy levels [ Time Frame: Measured at Week 6 and Months 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
  • Blood pressure control [ Time Frame: Measured at Week 6 and Months 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
  • Reduction in blood pressure [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • High blood pressure knowledge [ Time Frame: Measured at Week 6 and Months 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
  • Problem solving and communication skills [ Time Frame: Measured at Week 6 and Months 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
  • Adherence to high blood pressure treatment recommendations [ Time Frame: Measured at Week 6 and Months 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
  • Health care utilization [ Time Frame: Measured at Week 6 and Months 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
  • High blood pressure-related quality of life [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]

Enrollment: 360
Study Start Date: September 2007
Study Completion Date: July 2011
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: SI - intervention receiving group

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  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: NCT00406614

Locations
United States, Maryland
Korean Resource Center
Ellicott City, Maryland, United States, 21043
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Miyong T. Kim, PhD The Johns Hopkins University School of Nursing
  More Information

Additional Information:
No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Miyong T. Kim, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00406614     History of Changes
Other Study ID Numbers: 446, R01HL085567, R01 HL085567
Study First Received: November 30, 2006
Last Updated: November 28, 2011
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
High Blood Pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014