Blood Pressure Telemonitoring and Goal Blood Pressure in Diabetes

NCT ID: NCT01300338

Last Updated: 2014-04-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-10-31

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.

Conditions

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Diabetes Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Blood pressure with telemetry

Home blood pressure monitor with telemetry

Group Type EXPERIMENTAL

Blood pressure monitor with telemetry

Intervention Type DEVICE

Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager

Blood pressure without telemetry

Home blood pressure self monitor without telemetry.

Group Type ACTIVE_COMPARATOR

Home blood pressure monitor without telemetry

Intervention Type DEVICE

Self monitor of blood pressure without telemetry

Interventions

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Blood pressure monitor with telemetry

Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager

Intervention Type DEVICE

Home blood pressure monitor without telemetry

Self monitor of blood pressure without telemetry

Intervention Type DEVICE

Other Intervention Names

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Ideal Life Blood Pressure Monitor Omron blood pressure monitor

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Frederick North

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frederick North, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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10-003562

Identifier Type: -

Identifier Source: org_study_id

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