Blood Pressure Telemonitoring and Goal Blood Pressure in Diabetes

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01300338
• Other study ID #: 10-003562
• Status: Completed
• Phase: N/A
• First received: February 17, 2011
• Last updated: March 24, 2014
• Start date: March 2011
• Est. completion date: October 2012

Study information

• Verified date: March 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes
• Hypertension

Intervention

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
• Home blood pressure monitor without telemetry
Self monitor of blood pressure without telemetry

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Systolic Blood Pressure	Average change in systolic blood pressure (top number of blood pressure reading) from baseline to 6 months.	Baseline, 6 months	No
Primary	Mean Change in Diastolic Blood Pressure	Average change in diastolic blood pressure (bottom number of blood pressure reading) from baseline to 6 months.	Baseline, 6 months	No