Outcomes and Cost Consequences of Using an Internet Co-Management Module to Improve the Quality of Type 1 Diabetes Care

September 30, 2008 updated by: University of Washington
The researchers will conduct a 12-month randomized controlled trial comparing usual care versus chronic disease management using the Internet among patients with type 1 diabetes receiving care in the Diabetes Care Center at the University of Washington.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We will conduct a 12-month randomized controlled trial comparing usual care versus chronic disease management using the Internet among patients with type 1 diabetes on multiple daily injections with insulin glargine and rapid-acting analogs. Specifically, the objectives of the study are to:

  1. Evaluate the difference in glycemic control (HbA1c) between intervention and control,
  2. Evaluate the difference in resource utilization and costs of care between intervention and control, and
  3. Evaluate the difference in satisfaction with care between intervention and control.

A total of 80-85 subjects will be recruited from patients receiving care in the Diabetes Care Center (DCC) at the University of Washington in Seattle. As part of a pretest-posttest experimental design, intervention-group subjects will be trained in the use of an existing diabetes disease-management module comprising six related Web sites that are accessed from home via links displayed within the University's "MyUW" Internet portal. These sites allow patients to:

  1. View their entire electronic medical record including clinical reminders, the same record used by providers,
  2. Upload blood glucose readings stored in a digital meter,
  3. Manually enter medication, nutrition, and exercise data into an online daily diary,
  4. Communicate with providers regarding treatment recommendations or other questions using a clinical e-mail service,
  5. Obtain additional information from a traditional education site whose content and links were sanctioned by the Medical Director of the DCC, and
  6. Employ a second education site to collaboratively generate action plans intended to enhance self-efficacy.

In addition to login and password protection, access to confidential information from home requires the use of secondary authentication (SecureID). All clinical and other data can be viewed by patients and providers in online trended displays that will be used by a nurse practitioner to review cases no less than weekly. As the control group, subjects receiving usual care will not have access to the diabetes module and related case-management services being evaluated.

The primary clinical outcome for the study is the between group differences in glycemic control using HbA1c as the metric. A co-primary outcome is all direct medical care utilization. Satisfaction with diabetes care, employing both a quantitative survey (Patient Assessment of Chronic Illness Care) and semi-structured interviews performed on a 20% purposive sub-sample of intervention patients, is a secondary outcome measure.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington, Diabetes Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Computer and Internet access at home
  • Receiving care at the University of Washington Diabetes Care Center

Exclusion Criteria:

  • Non-English speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Hemoglobin A1c

Secondary Outcome Measures

Outcome Measure
Utilization
Satisfaction with care

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Aventis Pharmaceuticals

Investigators

  • Principal Investigator: Harold I Goldberg, MD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

October 2, 2008

Last Update Submitted That Met QC Criteria

September 30, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-3892-G-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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