Blood Pressure Telemonitoring and Goal Blood Pressure in Diabetes

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

Detailed Description
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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.

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

Conditions
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Diabetes, Hypertension

Intervention / Treatment
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* Device: Blood pressure monitor with telemetry
* Device: Home blood pressure monitor without telemetry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes