Improving Hypertension Control in East and Central Harlem

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Completed

CT.gov ID

NCT00211666

Collaborator

Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)

480

Enrollment

Location

Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

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.	N/A

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.

Study Design

Study Type:

Interventional

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 :

Sep 1, 2002

Study Completion Date :

Aug 1, 2006

Outcome Measures

Primary Outcome Measures

Differences in blood pressure reduction among the four study arms. []

Secondary Outcome Measures

Quality of life []
patient satisfaction []
costs []
cost-effectiness []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.