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Improving Hypertension Control in East and Central Harlem

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00211666
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 21, 2005
Agency for Healthcare Research and Quality (AHRQ)
Information provided by:
Icahn School of Medicine at Mount Sinai

Brief Summary:
This hypertension project is evaluating strategies developed to target problems underlying lack of blood pressure control among treated but uncontrolled hypertensive patients in East and Central Harlem.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Nurse management, home blood pressure monitors, and a chronic disease self management course. Not Applicable

Detailed Description:
The hypertension project will tailor improvement strategies to the problems identified as underlying underuse among treated but uncontrolled hypertensive patients in East and Central Harlem, New York City. Along with the communities’ 6 major health providers, we will first combine qualitative and quantitative methods to identify specific patient, provider, and system problems, and customize interventions to address them. In a randomized controlled trial, we will then randomly assign 480 patients among 4 arms: nurse management, blood pressure monitors alone, usual care, and peer led chronic disease self-management course. During the 18-month trial, patients self-monitor their blood pressure or attend a self-management course, or nurse managers will assess patients’ needs, counsel them, address any access barriers, and follow up with regular telephone contacts; convey information, including blood pressures from patients’ self-monitoring, between patients and physicians to inform possible medication changes; and ameliorate any systems problems. We will assess differences in blood pressure reductions among the 4 arms as the primary outcome, and in quality of life, patient satisfaction, costs, and cost-effectiveness as secondary outcomes. The findings will provide new knowledge about the relationship between these changes and patient and clinician knowledge, attitudes, and behaviors. The educational course is designed to teach patients tools for managing their chronic illness which will empower them to improve their overall health and is specifically tailored for patients living with asymptomatic chronic illnesses and will emphasize communication with health care providers. In partnership with community organizations and the policymakers, we will disseminate successful findings within these communities and throughout the state and the nation.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving the Delivery of Effective Care to Minorities
Study Start Date : September 2002
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Differences in blood pressure reduction among the four study arms.

Secondary Outcome Measures :
  1. Quality of life
  2. patient satisfaction
  3. costs
  4. cost-effectiness

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Male and female, English or Spanish speaking African American and/or Hispanic patients with uncontrolled hypertension who have been seen in either the Cardiology clinic, Internal Medicine Associates (IMA) or Geriatric clinic at least twice in a given year at least 18 years of age.

Exclusion Criteria:

This study is about hypertension control among African Americans and Hispanics, these are the ethnic groups with disparities in CVD that we want to improve so other races are excluded. The study is for adults with hypertension; therefore, we are excluding anyone who is under 18 years of age.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00211666

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United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Agency for Healthcare Research and Quality (AHRQ)
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Principal Investigator: Mark Chassin, MD Icahn School of Medicine at Mount Sinai

Layout table for additonal information Identifier: NCT00211666     History of Changes
Other Study ID Numbers: P01HS010859-05 ( U.S. AHRQ Grant/Contract )
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 21, 2005
Last Verified: September 2005

Keywords provided by Icahn School of Medicine at Mount Sinai:
blood pressure
self management
nurse management
racial disparities
cardiovascular disease

Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases