Do Home Monitors Improve Blood Pressure Control?

NCT ID: NCT01579136

Last Updated: 2012-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this study is to determine if home blood pressure monitors can help decrease blood pressure in patients with diabetes at a low income clinic.

Detailed Description

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Conditions

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Hypertension Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control group

This group will not get a home blood pressure monitor.

Group Type NO_INTERVENTION

No interventions assigned to this group

Home monitors

This group will be given a home blood pressure monitor to use.

Group Type EXPERIMENTAL

Home blood pressure monitor

Intervention Type BEHAVIORAL

The patients using home monitors checked their blood pressure on Monday, Wed, and Friday. They took 2 measurements 5 minutes apart after sitting 5 minutes in the left arm.

Interventions

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Home blood pressure monitor

The patients using home monitors checked their blood pressure on Monday, Wed, and Friday. They took 2 measurements 5 minutes apart after sitting 5 minutes in the left arm.

Intervention Type BEHAVIORAL

Other Intervention Names

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Home monitor: Omron BP760 upper arm monitor

Eligibility Criteria

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Inclusion Criteria

* over 18 years old,
* diabetes as defined by HgA1C over 6.5%,
* uncontrolled blood pressure (SBP \> 130 and or DBP \> 80)

Exclusion Criteria

* pregnancy,
* transplanted organ,
* MI/CHF/CVA within 3 months,
* dialysis,
* arrhythmia,
* metastatic cancer,
* dementia,
* visual or hearing difficulties
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Exempla Saint Joseph Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karen Weber, DO, FACP

Associate Director Outpatient Services, Internal Medicine Residency Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Caritas Clinic, Exempla Saint Joseph Hospital

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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201147

Identifier Type: -

Identifier Source: org_study_id