Blood Pressure Telemonitoring and Goal Blood Pressure in Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frederick North, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01300338
First received: February 17, 2011
Last updated: March 24, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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?

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Mean Change in Systolic Blood Pressure [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Frederick North, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01300338     History of Changes
Other Study ID Numbers: 10-003562
Study First Received: February 17, 2011
Results First Received: March 24, 2014
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Diabetes

Additional relevant MeSH terms:
Hypertension
Diabetes Mellitus
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014