- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00473681
Intervention Study to Control High Blood Pressure for Korean American (HBP)
High Blood Pressure Care for Korean Americans
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Maryland
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Ellicott city, Maryland, Stati Uniti, 21042
- Korean Resource Center
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Blood Pressure, Health-Related Quality of Life(Medical outcome Study Short Form-36)
Lasso di tempo: Baseling, 12month, 24month
|
Baseling, 12month, 24month
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
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)
Lasso di tempo: Baseline, 3months, 9 months,15 months
|
Baseline, 3months, 9 months,15 months
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Miyong D Kim, PhD, Johns Hopkins University, School of Nursing
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- Kim 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.
- Han 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.
- Kim 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.
- 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.
- Kim 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.
- Kim 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.
- Han 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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Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- R01HS013160 (Sovvenzione/contratto AHRQ degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .