Home Blood Pressure Monitoring Project (HBPM)

April 4, 2012 updated by: Kaiser Permanente

Home Blood Pressure Monitoring Program

The goal of this project is to improve hypertension control at Kaiser Permanente Colorado (KPCO) by implementing a population-based multi-factorial intervention that uses home BP monitors that can download BP readings to KPCO's health records via internet, interactive voice response (IVR) technology, and multidisciplinary care team. Participants will be randomized to either the home blood pressure monitoring group receiving the multi-factorial intervention or the usual care group who will be receiving Kaiser standard of care. We will determine the proportion of patients in each group who achieve their target BP goals at 6 months, according to national clinical practice guidelines. The study hypothesis is that a higher proportion of patients with uncontrolled hypertension in the home blood pressure monitoring (HBPM) group will achieve their target blood pressure compared to those in the usual care (UC) group.

Study Overview

Status

Completed

Conditions

Detailed Description

STUDY OBJECTIVES:

Primary:

• To determine the proportion of patients in each group who achieve their target BP goals at 6 months, according to national clinical practice guidelines

Secondary:

The following parameters will be evaluated between groups:

  • Change in BP measures between baseline and at 6 months
  • Proportion of patients who are receiving antihypertensive treatments in accordance to national clinical practice guidelines
  • Adherence to hypertensive medication regimen during the 6-month follow-up period
  • Patient satisfaction with the care model.

Study Type

Interventional

Enrollment (Actual)

348

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

    • Colorado
      • Denver, Colorado, United States, 80231
        • Kaiser Permanente Colorado, Institute of Health Research

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 85 years At least 1 diagnosis for hypertension,

    • Receive primary care from one of the participating clinics,
    • The two most recent BPs documented within that last 24 months are elevated (SBP>140 and/or DBP>90)
    • Receiving < 3 antihypertensive medications, and
    • Have access to a computer with a USB port.

Exclusion Criteria:

  • Pregnant, or breast-feeding,
  • Patients on dialysis or being followed by nephrology,
  • Patients with coronary artery disease, given these patients are already followed by the Clinical Pharmacy Cardiac Risk Service (CPCRS),
  • On KPCO "Do Not Call" or deceased list,
  • PCP does not give permission to include patient in the study,
  • BP is at or below target at the baseline study visit,
  • Not English-speaking.

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
No Intervention: Usual Care
The control group receiving usual care
Experimental: Home Blood Pressure Monitoring Group
Intervention group
Home blood pressure readings are taken at least 3 times a week, uploaded to a Microsoft Health Vault account through American Heart Association Heart360 at least 1 time per week. Patients are followed by a clinical pharmacist, with physician oversight, who will make adjustments to antihypertensive medications or suggest additional medications using national JNC VII and KPCO hypertension guidelines.
Other Names:
  • HBPM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BP at 6 months
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: David J Magid, MD, MPH, Kaiser Permanente
  • Principal Investigator: Kari Olson, PharmD, Kaiser Permanente
  • Principal Investigator: Sarah J Billups, PharmD, Kaiser Permanente

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.

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

July 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

July 13, 2010

First Submitted That Met QC Criteria

July 13, 2010

First Posted (Estimate)

July 15, 2010

Study Record Updates

Last Update Posted (Estimate)

April 6, 2012

Last Update Submitted That Met QC Criteria

April 4, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CO-08DMagi-01

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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