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Blood Pressure Telemonitoring and Goal Blood Pressure in Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01300338
First Posted: February 21, 2011
Last Update Posted: April 24, 2014
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.
Information provided by (Responsible Party):
Frederick North, Mayo Clinic
  Purpose
Does home telemonitoring increase the number of diabetes patients at goal blood pressure in a primary care practice?

Condition Intervention
Diabetes Hypertension Device: Blood pressure monitor with telemetry Device: Home blood pressure monitor without telemetry

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Does Home Telemonitoring Increase the Number of Diabetic Patients at Goal Blood Pressure in a Primary Care Practice?

Further study details as provided by Frederick North, Mayo Clinic:

Primary Outcome Measures:
  • 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.

  • 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.


Enrollment: 50
Study Start Date: March 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Omron blood pressure monitor

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01300338


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Frederick North, MD Mayo Clinic
  More Information

Responsible Party: Frederick North, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01300338     History of Changes
Other Study ID Numbers: 10-003562
First Submitted: February 17, 2011
First Posted: February 21, 2011
Results First Submitted: March 24, 2014
Results First Posted: April 24, 2014
Last Update Posted: April 24, 2014
Last Verified: March 2014

Keywords provided by Frederick North, Mayo Clinic:
Diabetes