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OpenTrials
Completed

NCT Number: NCT00105898

Internet-based Diabetes Education and Case Management

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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Key information

Age range

25 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Boston Healthcare System Brockton Campus, Brockton, MA

Brockton, Massachusetts, 02301, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Web-based care management

Procedure

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

Telephone and face-to-face care management

Procedure

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

Internet access alone

Procedure

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

Primary outcomes

  1. Change in HbA1c at 12 months

    Time frame: 12 months

Secondary outcomes

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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2010
First posted
Mar 18, 2005
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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