Blood Pressure Telemonitoring and Goal Blood Pressure in Diabetes

March 24, 2014 updated by: Frederick North, Mayo Clinic

Does Home Telemonitoring Increase the Number of Diabetic Patients at Goal Blood Pressure in a Primary Care Practice?

Does home telemonitoring increase the number of diabetes patients at goal blood pressure in a primary care practice?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized control trial, two arms with block randomization. Primary care patients with diabetes and elevated blood pressure randomized to intervention or control. Intervention arm: home telemonitoring using the Ideal Life blood pressure cuff and telephone or internet transmission device to transmit blood pressure information to the Primary care manager team with otherwise normal care manager care. Control arm: Omron (off the shelf) home blood pressure monitor (no transmission of data) and usual care. We will be comparing blood pressure control between groups and provider contacts.

Study Type

Interventional

Enrollment (Actual)

50

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
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Age 18-75 (inclusive
  • Blood pressure in hypertensive range (systolic >= 140 or diastolic >=90
  • Diabetes

Exclusion criteria:

  • Pregnancy
  • Lack of computer with internet access or phone line
  • Lack of English language literacy
  • Arm size to large or small for cuff

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blood pressure with telemetry
Home blood pressure monitor with telemetry
Device: Blood pressure monitor with telemetry
Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager
Other Names:
  • Ideal Life Blood Pressure Monitor
Active Comparator: Blood pressure without telemetry
Home blood pressure self monitor without telemetry.
Device: Home blood pressure monitor without telemetry
Self monitor of blood pressure without telemetry
Other Names:
  • Omron blood pressure monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Systolic Blood Pressure
Time Frame: Baseline, 6 months
Average change in systolic blood pressure (top number of blood pressure reading) from baseline to 6 months.
Baseline, 6 months
Mean Change in Diastolic Blood Pressure
Time Frame: Baseline, 6 months
Average change in diastolic blood pressure (bottom number of blood pressure reading) from baseline to 6 months.
Baseline, 6 months

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Frederick North, MD, Mayo Clinic

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

March 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

February 17, 2011

First Submitted That Met QC Criteria

February 17, 2011

First Posted (Estimate)

February 21, 2011

Study Record Updates

Last Update Posted (Estimate)

April 24, 2014

Last Update Submitted That Met QC Criteria

March 24, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-003562

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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