Blood Pressure Telemonitoring and Goal Blood Pressure in Diabetes

Not Applicable

Completed

• Conditions: Diabetes; Hypertension
• Interventions: Device: Blood pressure monitor with telemetry; Device: Home blood pressure monitor without telemetry

• Registration Number: NCT01300338
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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 Timeline

• Study First Submitted: 2011-02-17
• Study First Submitted QC: 2011-02-17
• Study First Posted: 2011-02-21
• Study Start: 2011-03
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2014-03
• Results First Submitted: 2014-03-24
• Results First Submitted QC: 2014-03-24
• Last Update Submitted: 2014-03-24
• Results First Posted: 2014-04-24
• Last Update Posted: 2014-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blood pressure with telemetry	Blood pressure monitor with telemetry	Home blood pressure monitor with telemetry
Blood pressure without telemetry	Home blood pressure monitor without telemetry	Home blood pressure self monitor without telemetry.

Primary Outcome Measures

Name	Time	Method
Mean Change in Systolic Blood Pressure	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	Baseline, 6 months	Average change in diastolic blood pressure (bottom number of blood pressure reading) from baseline to 6 months.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States