Internet-based Diabetes Education and Case Management

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Hypertension
• Interventions: Procedure: Telephone and face-to-face care management; Procedure: Web-based care management; Procedure: Internet access alone

• Registration Number: NCT00105898
• Lead Sponsor: US Department of Veterans Affairs

Brief Summary

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.

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-03-17
• Study First Submitted QC: 2005-03-17
• Study First Posted: 2005-03-18
• Primary Completion: 2007-04
• Study Completion: 2010-06
• Status Verified: 2010-08
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

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Exclusion Criteria

• Visual impairment that affects ability to read

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Telephone and face-to-face care management	Comparator
Arm 1	Web-based care management	Intervention group
Arm 3	Internet access alone	Comparator

Primary Outcome Measures

Name	Time	Method
Change in HbA1c at 12 months	12 months

Secondary Outcome Measures

Name	Time	Method
Change in blood pressure, lipid profile and diabetes-related stress (self-report) at 12 months; cost-effectiveness analysis of the interventions.	12 months

Trial Locations

Locations (1)

VA Boston Healthcare System Brockton Campus, Brockton, MA; 🇺🇸 Brockton, Massachusetts, United States