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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00194506
• Other study ID #: 00-3882-E/A 05
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: April 12, 2006
• Start date: August 2002
• Est. completion date: May 2006

Study information

• Verified date: April 2006
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

1. An integrated view of their actual medical record as it relates to diabetes care that can generate customized patient education materials.

2. Real-time clinical reminders of the need to obtain preventive services such as HbA1c, urine-protein and cholesterol determinations, and retinal examinations.

3. An electronic version of the SDMTM diabetes-care algorithms indicating where on the "road-map" to adequate control they currently stand treatment-wise.

4. The ability to download glucometer readings and medication-use information from home directly into the MIND repository.

5. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Internet co-management module

Locations

Country	Name	City	State
United States	University of Washington, General Internal Medicine Clinic, Roosevelt	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Center for Health Management Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c
Secondary	Utilization