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Clinical Trials/NCT00105898
NCT00105898CompletedNot Applicable

Internet-based Diabetes Education and Case Management

US Department of Veterans Affairs1 site in 1 country152 target enrollmentStarted: February 1, 2005Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
152
Locations
1
Primary Endpoint
Change in HbA1c at 12 months

Study Overview

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:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
25 Years to 79 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Exclusion Criteria

  • •Visual impairment that affects ability to read

Arms & Interventions

Arm 1

Experimental

Intervention group

Intervention: Web-based care management (Procedure)

Arm 2

Active Comparator

Comparator

Intervention: Telephone and face-to-face care management (Procedure)

Arm 3

Sham Comparator

Comparator

Intervention: Internet access alone (Procedure)

Outcomes

Primary Outcomes

Change in HbA1c at 12 months

Time Frame: 12 months

Secondary Outcomes

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

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (1)

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