Blood Pressure Self Management for Hypertension & Prehypertension Using an Internet Enabled, Automated Self Management Program

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

COMPLETED

Clinical Phase

NA

Total Enrollment

404 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-12-31

Brief Summary

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The specific aim of the study is to assess the impact of an Internet-enabled, automated, self-management program on blood pressure control of employees of a large local company.

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Detailed Description

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We propose to conduct a randomized controlled trial of an Internet-enabled, automated self-management program. The study will be carried out through six local sites (offices) of a large employer. 3 sites will be intervention sites and 3 will be control sites.

Subjects enrolled from the intervention sites will receive a blood pressure meter and access to an Internet site where they can view their readings, read educational material regarding hypertension management and receive personalized tips and feedback.

Subjects enrolled from the control sites will have access to a blood pressure monitor located at their workplace but will only be provided with basic written information about hypertension at the start of the trial and will receive no feedback.

The trial will run for 6 months from the time of enrollment and the primary outcome measure will be a change in systolic blood pressure.

Conditions

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Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Intervention

Internet-based hypertension self-management platform

Group Type EXPERIMENTAL

Internet-enabled automated self-management program

Intervention Type OTHER

An internet platform to display blood pressure readings and provide subjects with automated messages and educational information about hypertension management.

Control

Installation of BP cuff for communal use at the worksite

Group Type ACTIVE_COMPARATOR

BP cuff at workplace

Intervention Type OTHER

Provided BP cuff for communal use at the worksite

Interventions

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Internet-enabled automated self-management program

An internet platform to display blood pressure readings and provide subjects with automated messages and educational information about hypertension management.

Intervention Type OTHER

BP cuff at workplace

Provided BP cuff for communal use at the worksite

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Full-time employees of EMC
* Aged 30 to 65 years at time of enrollment
* Any of the following
* A diagnosis of hypertension as defined by one of the following
* Taking an antihypertensive medication
* Being told at least twice by a physician or other health professional that the subject has high blood pressure†
* A BP \> 140/90 detected at screening by the research team on 2 separate occasions.
* A diagnosis of prehypertension as defined by a systolic BP between 120-139 or a diastolic BP between 80-89 detected at screening by the research team on 2 separate occasions
* Access to the Internet at work and / or at home

Exclusion Criteria

* Inability to self-monitor blood pressure due to musculoskeletal or cognitive impairment
* Known secondary cause of hypertension e.g. renal artery stenosis, Cushing's disease.

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No