High Blood PressureHBPNCT00473681
Intervention Study to Control High Blood Pressure for Korean American
A study testing Self-Help Intervention Program-High Blood Pressure in people with High Blood Pressure, run by Johns Hopkins University at 1 site in United States.
Trial summary
The primary objective of the proposed clinical trials is to compare the differential reduction in blood pressure in underserved hypertensive adult Korean American. The study is designed to test the effectiveness of a comprehensive self-help intervention program. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- Self-Help Intervention Program-High Blood Pressure
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 445 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Aug 2007
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identified as first-generation Korean American
- Age 40 to 65 years of age
- SBP≥140 or DBP≥90mmHg on HBP medication
- resident of Greater Baltimore census tracts
- Written consent to participate in the screening/eligibility visit
- SBP≥140 or DBP≥90mmHg at the KRC HBP verification visit
- Written consent to participate in the clinical trial:agreeing to participate in study data collection procedures, receiving HBP education, using HBPMT, and permitting contact with their own medical care provider.
Who cannot join
- Acute and/or terminal condition precluding participation such as terminal cancer or acute myocardial infarction
- Psychiatric diagnosis precluding participation such as schizophrenia and cognitive impairment measured by self-report, chart review, or clinical assessment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Korean Resource Center
Ellicott City, Maryland, 21042
About this study
Official title: High Blood Pressure Care for Korean Americans
The primary objective of the proposed clinical trials is to compare the differential reduction in blood pressure in underserved hypertensive adult Korean American. The study is designed to test the effectiveness of a comprehensive self-help intervention program.
Read the detailed description
CVD is the leading cause of mortality among KA. Recent statistics underscoring the high prevalence and impact of uncontrolled HBP upon this population warrant the development and implementation of effective intervention. KA experiences a great deal of social isolation, which makes it more difficult for them to make behavioral changes for health improvement. individual, family, and community behaviors are part of the HBP problem and also constitute major part of the solution. The proposed research is designed to investigate these issues in a KA population and to lay the groundwork for community-based self-help health education interventions to enhance appropriate care and BP control.
Comparison(s):This community-based self-help intervention approach offers a more culturally appropriate approach to closing the health status gap for KA. Incorporating a partnership with community leaders and health and human service care providers, this approach will utilize state-of-the-art health education strategies and a well-trained bilingual nurse from the community.
- Conditions
- High Blood Pressure
- Being tested
- Self-Help Intervention Program-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.
Self-Help Intervention Program-High Blood PressureBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure, Health-Related Quality of Life(Medical outcome Study Short Form-36)
Measured: Baseling, 12month, 24month
Secondary outcomes (1)
Self-Care Behaviors of HBP Control(Hill-Bone adherence of HBP therapy scale) Enabling Skills(problem-solving skills, cognitive reframing, belief-in-self) Self-Help(Inventory of Adult Role Behaviors)
Measured: Baseline, 3months, 9 months,15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2007 (estimated)
- Study startSep 2003
- Primary completionAug 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 445 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Investigators
- Miyong D Kim, PhD, Principal investigator, Johns Hopkins university, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473681
- Sponsor's protocol ID
- R01HS013160
- Acronym
- HBP
- Status last verified
- May 2008
- First submitted
- 14 May 2007
- Last updated
- 7 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Han HR, Kang J, Kim KB, Ryu JP, Kim MT. Barriers to and strategies for recruiting Korean Americans for community-partnered health promotion research. J Immigr Minor Health. 2007 Apr;9(2):137-46. doi: 10.1007/s10903-006-9022-x.
PubMed 17186370Kim MT, Kim EY, Han HR, Jeong S, Lee JE, Park HJ, Kim KB, Hill MN. Mail education is as effective as in-class education in hypertensive Korean patients. J Clin Hypertens (Greenwich). 2008 Mar;10(3):176-84. doi: 10.1111/j.1751-7176.2008.07571.x.
PubMed 18326962Han HR, Kim KB, Kang J, Jeong S, Kim EY, Kim MT. Knowledge, beliefs, and behaviors about hypertension control among middle-aged Korean Americans with hypertension. J Community Health. 2007 Oct;32(5):324-42. doi: 10.1007/s10900-007-9051-y.
PubMed 17922204Kim EY, Han HR, Jeong S, Kim KB, Park H, Kang E, Shin HS, Kim MT. Does knowledge matter?: intentional medication nonadherence among middle-aged Korean Americans with high blood pressure. J Cardiovasc Nurs. 2007 Sep-Oct;22(5):397-404. doi: 10.1097/01.JCN.0000287038.23186.bd.
PubMed 17724422Han 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 21974763Kim MT, Han HR, Hedlin H, Kim J, Song HJ, Kim KB, Hill MN. Teletransmitted monitoring of blood pressure and bilingual nurse counseling-sustained improvements in blood pressure control during 12 months in hypertensive Korean Americans. J Clin Hypertens (Greenwich). 2011 Aug;13(8):605-12. doi: 10.1111/j.1751-7176.2011.00479.x. Epub 2011 Jun 27.
PubMed 21806771Kim J, Han HR, Song H, Lee J, Kim KB, Kim MT. Compliance with home blood pressure monitoring among middle-aged Korean Americans with hypertension. J Clin Hypertens (Greenwich). 2010 Apr;12(4):253-60. doi: 10.1111/j.1751-7176.2009.00218.x.
PubMed 20433546Han HR, Kim J, Kim KB, Jeong S, Levine D, Li C, Song H, Kim MT. Implementation and success of nurse telephone counseling in linguistically isolated Korean American patients with high blood pressure. Patient Educ Couns. 2010 Jul;80(1):130-4. doi: 10.1016/j.pec.2009.10.012. Epub 2009 Nov 30.
PubMed 19945816
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Blood Pressure Care for Korean Americans
- ClinicalTrials.gov ID
- NCT00473681
- Acronym / sponsor ID
- HBP / R01HS013160
- Conditions
- High Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Sep 2003
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 15 May 2007 (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.
The primary objective of the proposed clinical trials is to compare the differential reduction in blood pressure in underserved hypertensive adult Korean American. The study is designed to test the effectiveness of a comprehensive self-help intervention program.
Detailed description
CVD is the leading cause of mortality among KA. Recent statistics underscoring the high prevalence and impact of uncontrolled HBP upon this population warrant the development and implementation of effective intervention. KA experiences a great deal of social isolation, which makes it more difficult for them to make behavioral changes for health improvement. individual, family, and community behaviors are part of the HBP problem and also constitute major part of the solution. The proposed research is designed to investigate these issues in a KA population and to lay the groundwork for community-based self-help health education interventions to enhance appropriate care and BP control.
Comparison(s):This community-based self-help intervention approach offers a more culturally appropriate approach to closing the health status gap for KA. Incorporating a partnership with community leaders and health and human service care providers, this approach will utilize state-of-the-art health education strategies and a well-trained bilingual nurse from the community.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Self-identified as first-generation Korean American
- Age 40 to 65 years of age
- SBP≥140 or DBP≥90mmHg on HBP medication
- resident of Greater Baltimore census tracts
- Written consent to participate in the screening/eligibility visit
Key exclusion criteria (2 listed)
- Acute and/or terminal condition precluding participation such as terminal cancer or acute myocardial infarction
- Psychiatric diagnosis precluding participation such as schizophrenia and cognitive impairment measured by self-report, chart review, or clinical assessment.
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 |
|---|---|---|
| Self-Help Intervention Program-High Blood Pressure | Behavioural | – |
Primary outcome
Blood Pressure, Health-Related Quality of Life(Medical outcome Study Short Form-36)
Time frame: Baseling, 12month, 24month
1 secondary outcome
Self-Care Behaviors of HBP Control(Hill-Bone adherence of HBP therapy scale) Enabling Skills(problem-solving skills, cognitive reframing, belief-in-self) Self-Help(Inventory of Adult Role Behaviors)
Time frame: Baseline, 3months, 9 months,15 months
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 7 May 2008.
- Background: PubMed 17186370Han HR, Kang J, Kim KB, Ryu JP, Kim MT. Barriers to and strategies for recruiting Korean Americans for community-partnered health promotion research. J Immigr Minor Health. 2007 Apr;9(2):137-46. doi: 10.1007/s10903-006-9022-x.
- Results publication: PubMed 18326962Kim MT, Kim EY, Han HR, Jeong S, Lee JE, Park HJ, Kim KB, Hill MN. Mail education is as effective as in-class education in hypertensive Korean patients. J Clin Hypertens (Greenwich). 2008 Mar;10(3):176-84. doi: 10.1111/j.1751-7176.2008.07571.x.
- Results publication: PubMed 17922204Han HR, Kim KB, Kang J, Jeong S, Kim EY, Kim MT. Knowledge, beliefs, and behaviors about hypertension control among middle-aged Korean Americans with hypertension. J Community Health. 2007 Oct;32(5):324-42. doi: 10.1007/s10900-007-9051-y.
- Results publication: PubMed 17724422Kim EY, Han HR, Jeong S, Kim KB, Park H, Kang E, Shin HS, Kim MT. Does knowledge matter?: intentional medication nonadherence among middle-aged Korean Americans with high blood pressure. J Cardiovasc Nurs. 2007 Sep-Oct;22(5):397-404. doi: 10.1097/01.JCN.0000287038.23186.bd.
- 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.
- Derived from this study: PubMed 21806771Kim MT, Han HR, Hedlin H, Kim J, Song HJ, Kim KB, Hill MN. Teletransmitted monitoring of blood pressure and bilingual nurse counseling-sustained improvements in blood pressure control during 12 months in hypertensive Korean Americans. J Clin Hypertens (Greenwich). 2011 Aug;13(8):605-12. doi: 10.1111/j.1751-7176.2011.00479.x. Epub 2011 Jun 27.
- Derived from this study: PubMed 20433546Kim J, Han HR, Song H, Lee J, Kim KB, Kim MT. Compliance with home blood pressure monitoring among middle-aged Korean Americans with hypertension. J Clin Hypertens (Greenwich). 2010 Apr;12(4):253-60. doi: 10.1111/j.1751-7176.2009.00218.x.
- Derived from this study: PubMed 19945816Han HR, Kim J, Kim KB, Jeong S, Levine D, Li C, Song H, Kim MT. Implementation and success of nurse telephone counseling in linguistically isolated Korean American patients with high blood pressure. Patient Educ Couns. 2010 Jul;80(1):130-4. doi: 10.1016/j.pec.2009.10.012. Epub 2009 Nov 30.
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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 D Kim, PhD principal investigator
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 Self-Help Intervention Program-High Blood Pressure in people with High Blood Pressure, run by Johns Hopkins University 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 7 inclusion and 2 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 7 May 2008. 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?
Blood Pressure, Health-Related Quality of Life(Medical outcome Study Short Form-36) (time frame: Baseling, 12month, 24month). 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 NCT00473681, which also lists 8 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 7 May 2008.