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OpenTrials
Completed

NCT Number: NCT00194506

Cyber Disease Management: Using the World Wide Web to Share the Medical Record With Patients at Home

This is a 12-month randomized, controlled trial of a Web-based diabetes co-management module among type 2 patients at the University of Washington's Roosevelt General Internal Medicine Clinic.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington, General Internal Medicine Clinic, Roosevelt

Seattle, Washington, 98195, United States

About this study

We will conduct a randomized controlled trial to determine whether a fully computerized, diabetes mellitus (DM) disease-management module (known as Cyber-DM) can improve the quality of adult diabetes care. The module will be Web-based, include a graphical HTML "front end" user interface, and will be incorporated into each patient's existing Web-based electronic medical record --the Medical Information Networked Database (MIND) repository at the University of Washington Academic Medical Centers. This Web site will include five components that will enable patients to interact asynchronously from their homes with their clinic-based providers:

  • An integrated view of their actual medical record as it relates to diabetes care that can generate customized patient education materials.
  • Real-time clinical reminders of the need to obtain preventive services such as HbA1c, urine-protein and cholesterol determinations, and retinal examinations.
  • An electronic version of the SDMTM diabetes-care algorithms indicating where on the "road-map" to adequate control they currently stand treatment-wise.
  • The ability to download glucometer readings and medication-use information from home directly into the MIND repository.
  • Secure email communication between patients, their primary care physicians, and clinic staff.

A total of 80-85 diabetic patients who are regular utilizers of the UW's General Internal Medicine Clinic and who have home Internet access will be randomized to the experimental and control arms of the trial. Control subjects will receive usual care. We hypothesize that use of Cyber-DM will increase compliance with guideline-indicated care processes, improve glycemic control, and reduce utilization costs. A trial this size would have the statistical power to detect a change in HbA1c of 0.50%. Secure Socket Layer technology, session specific "cookie" files, and a custom database application that manages logins/passwords and audits all accesses to the system will provide security for this information tool.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • computer and Internet access at home
  • receiving care for type 2 diabetes at the University of Washington, General Internal Medicine Clinic, Roosevelt

Exclusion criteria

  • non-English speaking

Treatment and study plan

Internet co-management module

Behavioral

Primary outcomes

  1. Hemoglobin A1c

Secondary outcomes

  1. Utilization

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Center for Health Management Research

Registry information

Important dates

Study start
2002
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
Apr 14, 2006

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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