Internet-based Diabetes Education and Case Management

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

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2010-06-30

Brief Summary

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This study is comparing the effectiveness of web-based care management to either telephone-based care management or internet access alone, in patients with poorly controlled diabetes mellitus.

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Detailed Description

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Background:

Patients with diabetes and elevated hemoglobin A1c (HbA1c) are at risk for diabetes-related complications. Care-management may be helpful in these patients, by providing direct contact between such high-risk patients and the healthcare system. Web-based systems have previously shown promise as a means of neutralizing access barriers such as scheduling and travel to appointments and may be of particular help in improving diabetes care.

Objectives:

We examined the efficacy of two methods of diabetes education and care management: (1) a traditional model that involved telephone contact and face-to-face encounters (2) a web-based model with access to a diabetes care management web site. We compared these interventions to a study group that received no education or care management but was provided with a computer and access to diabetes self-management websites.

Methods:

This study employed a randomized, parallel group design involving patients with diabetes mellitus and an elevated HbA1c ( 8.5%). Participants assigned to web-based care management received a notebook computer, Internet access and interacted with a care manager through a diabetes education and care management website. Participants receiving telephone-based care management interacted with a care manager using telephone and face-to-face contact. Both care management models employed medication algorithms to improve glucose and BP control. These care management groups were compared to a study group that had no care management but received a notebook computer and Internet access with their "home page" containing links to a series of diabetes self-management websites (i.e. computer only group). The primary outcome measures were HbA1c, blood pressure, and scores on the Problem Areas in Diabetes (PAID) questionnaire, each measured over 12-months.

Status:

Complete

Conditions

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Diabetes Mellitus Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Intervention group

Group Type EXPERIMENTAL

Web-based care management

Intervention Type PROCEDURE

Participants interact with a care manager, sending and receiving messages using an internet portal that accepts uploads from glucose and BP meters

Arm 2

Comparator

Group Type ACTIVE_COMPARATOR

Telephone and face-to-face care management

Intervention Type PROCEDURE

Participants interact with a care manager via face-to-face and telephone contact

Arm 3

Comparator

Group Type SHAM_COMPARATOR

Internet access alone

Intervention Type PROCEDURE

Participants are given internet access and encouraged to seek diabetes information to help in their self management

Interventions

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Web-based care management

Participants interact with a care manager, sending and receiving messages using an internet portal that accepts uploads from glucose and BP meters

Intervention Type PROCEDURE

Telephone and face-to-face care management

Participants interact with a care manager via face-to-face and telephone contact

Intervention Type PROCEDURE

Internet access alone

Participants are given internet access and encouraged to seek diabetes information to help in their self management

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of diabetes mellitus
* Age 25-79 years
* HbA1c \>=8.5%
* Ability to speak and understand English
* Telephone access
* VA-based primary care provider
* Interest in using a glucose and BP monitor and notebook computer