Evaluation of Integrating Self Blood Pressure Monitoring Into Urban Primary Care Practices (ESBPM)

August 13, 2012 updated by: Stella Yi, New York City Department of Health and Mental Hygiene

Evaluation of Integrating Self Blood Pressure Monitoring Into Urban Primary Care Practices to Improve Ethnic/ Racial Disparities in Hypertension

Background:

Hypertension (HTN) is a major risk factor for cardiovascular disease (CVD), the leading cause of death in the United States and New York City (NYC). One in 4 NYC adults has hypertension, with higher prevalence in both Blacks and Latinos compared to Whites (Angell 2008). In NYC, only 65% of all adults with HTN and on treatment are controlled (Angell 2008).

Self-blood pressure monitoring (SBPM) is associated with reduced blood pressure in patients with hypertension (Cappuccio 2004). Studies suggest that SBPM may increase control either by inducing clinicians to titrate medication more actively, (Agency for Healthcare Research and Quality 2002) by engaging patients to participate in their own health care, (Taylor 2007) or a combination of the two.

However, minimal research has been done to evaluate the effectiveness of SBPM in different racial and/or ethnic groups or in low income populations or to discern effective patterns of SBPM use by patients. Best practices for integration of self monitoring into HTN into regular treatment have also yet to be established.

Objectives:

The goal of this study is to assess the impact of SBPM under conditions consistent with existing community health clinic resources and infrastructure in NYC's medically underserved neighborhoods using commonly available automated home BP monitors. By using a community clinic's electronic health record (EHR) and automated BP monitors with the capability to transmit readings to a research database, we can facilitate a more rigorous evaluation of a pilot SBPM intervention and assess patterns of home monitor use and clinical management and their association with outcomes.

The three specific aims of this intervention are to:

  1. Assess whether use of SBPM reduces elevated BP and increases HTN control to similar levels in two historically understudied minority populations, Blacks and Latinos.
  2. Confirm pilot findings by assessing the impact of SBPM on BP and HTN control compared to usual care using randomized controlled trial methodology.
  3. Develop standards and refine guidance for the effective use of SBPM that can be easily communicated to key stakeholders.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

899

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10463
        • Riverdale Family Practice
      • Brooklyn, New York, United States, 11220
        • Lutheran Family Health Centers
      • New York, New York, United States, 10029
        • New York City Department of Health and Mental Hygiene
      • New York, New York, United States, 10031
        • Heritage Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients attending one of the participating primary care clinics
  • Diagnosis of hypertension for at least 6 months
  • Ethnicity or Race of Latino, Black or White
  • Physically and mentally able to monitor BP at home
  • *Uncontrolled BP at last office visit
  • *Uncontrolled BP at current office visit

Note: *Uncontrolled BP is defined as systolic BP ≥ 140 and/or diastolic BP ≥ 90, or systolic BP ≥ 130 and/or diastolic BP ≥ 80 mm Hg for participants with chronic kidney disease or diabetes.

Exclusion Criteria:

  • Arm circumference greater than 17.5 inches (maximum size of large BP cuff)
  • Already monitoring BP at home at request of health care provider
  • No access to a land line telephone line (to upload home readings)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Other: Home Blood Pressure Monitor Group
Participants receive home monitors, modems, educational materials and training. Participants will send home BP readings to research database monthly and receive usual care by providers for 9 months.
No Intervention: Control
Participants receive usual care by providers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute and relative changes in systolic and diastolic BP in the intervention and control groups.
Time Frame: 9 months
9 months
Proportion of intervention participants achieving BP control compared to control participants
Time Frame: 9 months
9 months
Trajectory of BP changes over time.
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York City Department of Health and Mental Hygiene

Collaborators

NYU Langone Health
Robert Wood Johnson Foundation
Riverdale Family Practice, New York City
Heritage Health Center (HHHNYC), New York City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

May 12, 2010

First Submitted That Met QC Criteria

May 13, 2010

First Posted (Estimate)

May 14, 2010

Study Record Updates

Last Update Posted (Estimate)

August 14, 2012

Last Update Submitted That Met QC Criteria

August 13, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCIP-CVD-ESBPM2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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