HypertensionNCT00406614
Health Literacy-Focused Program to Improve Blood Pressure Control in Korean Americans
A study testing Health Literacy-Focused High Blood Pressure Intervention in people with Hypertension, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Health Literacy-Focused High Blood Pressure Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Korean Resource Center
Ellicott City, Maryland, 21043
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Health Literacy-Focused High Blood Pressure Intervention
- Keywords
- High Blood Pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Literacy-Focused High Blood Pressure InterventionBehavioural
Also called SI - intervention receiving group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Health Literacy-Focused High Blood Pressure Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health literacy levels
Measured: Measured at Week 6 and Months 6, 12, 18, and 24
Blood pressure control
Measured: Measured at Week 6 and Months 6, 12, 18, and 24
Reduction in blood pressure
Measured: Measured at Month 24
Secondary outcomes (5)
High blood pressure knowledge
Measured: Measured at Week 6 and Months 6, 12, 18, and 24
Problem solving and communication skills
Measured: Measured at Week 6 and Months 6, 12, 18, and 24
Adherence to high blood pressure treatment recommendations
Measured: Measured at Week 6 and Months 6, 12, 18, and 24
Health care utilization
Measured: Measured at Week 6 and Months 6, 12, 18, and 24
High blood pressure-related quality of life
Measured: Measured at Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startSep 2007
- Primary completionAug 2009
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Miyong Kim, Johns Hopkins University
- Investigators
- Miyong T. Kim, PhD, Principal investigator, The Johns Hopkins University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406614
- Sponsor's protocol ID
- 446
- Other IDs
- R01HL085567
- Status last verified
- Nov 2011
- First submitted
- 30 Nov 2006
- Last updated
- 8 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25554484Kim 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.
PubMed 24671049Lee 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.
PubMed 24652887Han 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.
PubMed 23730928Han 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.
PubMed 22790881Kim 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.
PubMed 22030252Han 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.
PubMed 21974763
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Literacy Intervention for Korean Americans With High Blood Pressure (HBP)
- ClinicalTrials.gov ID
- NCT00406614
- Acronym / sponsor ID
- 446
- Conditions
- Hypertension
- Keywords
- High Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 4 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Health Literacy-Focused High Blood Pressure InterventionLiteracy-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. |
| 2 | Active comparator | Behavioral: Health Literacy-Focused High Blood Pressure InterventionWait-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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Literacy-Focused High Blood Pressure InterventionAlso: SI - intervention receiving groupParticipants 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. | Behavioural | 1, 2 |
Primary outcome
Health literacy levels
Time frame: 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
Reduction in blood pressure
Time frame: Measured at Month 24
5 secondary outcomes
High blood pressure knowledge
Time frame: 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
Adherence to high blood pressure treatment recommendations
Time frame: 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
High blood pressure-related quality of life
Time frame: Measured at Month 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
- Derived from this study: PubMed 25554484Kim 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.
- Derived from this study: PubMed 24671049Kim 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.
- Derived from this study: PubMed 24652887Lee 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.
- Derived from this study: PubMed 23730928Han 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.
- Derived from this study: PubMed 22790881Han 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.
- Derived from this study: PubMed 22030252Kim 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.
- Derived from this study: PubMed 21974763Han 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.
- Click here for the Korean Resource Center web siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miyong T. Kim, PhD principal investigator
The Johns Hopkins University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Literacy-Focused High Blood Pressure Intervention in people with Hypertension, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health literacy levels (time frame: Measured at Week 6 and Months 6, 12, 18, and 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00406614, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.